[Title 40 CFR R]
[Code of Federal Regulations (annual edition) - July 1, 1999 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter R - TOXIC SUBSTANCES CONTROL ACT]
[From the U.S. Government Printing Office]


40PROTECTION OF ENVIRONMENT231999-07-011999-07-01falseTOXIC SUBSTANCES CONTROL ACTRSUBCHAPTER RPROTECTION OF ENVIRONMENTENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
               SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT


PART 700--GENERAL--Table of Contents




Subparts A-B  [Reserved]

                             Subpart C--Fees

Sec.
700.40  Purpose and applicability.
700.41  Radon user fees.
700.43  Definitions.
700.45  Fee payments.
700.49  Failure to remit fees.

    Authority: 15 U.S.C. 2625 and 2665.

    Source: 53 FR 31252, Aug. 17, 1988, unless otherwise noted.

Subparts A-B  [Reserved]



                             Subpart C--Fees



Sec. 700.40  Purpose and applicability.

    (a) Purpose. The purpose of this subpart is to collect fees from 
manufacturers, importers, and processors who submit notices and 
applications to EPA under section 5 of the Toxic Substances Control Act 
(15 U.S.C. 2604) to defray part of EPA's cost of administering the Act.
    (b) Applicability. This subpart applies to all manufacturers, 
importers, and processors who submit certain notices and applications to 
EPA under section 5 of the Act.



Sec. 700.41  Radon user fees.

    User fees relating to radon proficiency programs authorized under 
the Toxic Substances Control Act appear at 40 CFR part 195.

[59 FR 13177, Mar. 18, 1994]



Sec. 700.43  Definitions.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as 
definitions contained in Secs. 704.3, 720.3, and 725.3 of this chapter, 
apply to this subpart unless otherwise specified in this section. In 
addition, the following definitions apply:
    Consolidated microbial commercial activity notice or consolidated 
MCAN means any MCAN submitted to EPA that covers more than one 
microorganism (each being assigned a separate MCAN number by EPA) as a 
result of a prenotice agreement with EPA.
    Consolidated premanufacture notice or consolidated PMN means any PMN 
submitted to EPA that covers more than one chemical substance (each 
being assigned a separate PMN number by EPA) as a result of a prenotice 
agreement with EPA (See 48 FR 21734).
    Exemption application means any application submitted to EPA under 
section 5(h)(2) of the Act.
    Exemption notice means any notice submitted to EPA under 
Sec. 723.175 of this chapter.
    Final product means a new chemical substance (as ``new chemical 
substance'' is defined in Sec. 720.3 of this chapter) that is 
manufactured by a person for distribution in commerce, or for use by the 
person other than as an intermediate.
    Intermediate premanufacture notice or intermediate PMN means any PMN 
submitted to EPA for a chemical substance which is an intermediate (as 
``intermediate'' is defined in Sec. 720.3 of this chapter) in the 
production of a final product, provided that the PMN for the 
intermediate is submitted to EPA at the same time as, and together with, 
the PMN for the final product and that the PMN for the intermediate 
identifies the final product and describes the chemical reactions 
leading from the intermediate to the final product. If PMNs are 
submitted to EPA at the same time for several intermediates used in the 
production of a final product, each of those is an intermediate PMN if 
they all identify the final product and every other associated 
intermediate PMN and are submitted to EPA at the same time as, and 
together with, the PMN for the final product.
    Joint submitters means two or more persons who submit a section 5 
notice together.
    Microbial commercial activity notice or MCAN means any notice for 
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act 
in accordance with subpart D of part 725 of this chapter.

[[Page 6]]

    Person means a manufacturer, importer, or processor.
    Premanufacture notice or PMN means any notice submitted to EPA 
pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of 
this chapter or Sec. 723.250 of this chapter.
    Section 5 notice means any PMN, consolidated PMN, intermediate PMN, 
significant new use notice, exemption notice, exemption application, any 
MCAN or consolidated MCAN submitted under section 5 of the Act.
    Significant new use notice means any notice submitted to EPA 
pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of 
this chapter.
    Small business concern means any person whose total annual sales in 
the person's fiscal year preceding the date of the submission of the 
applicable section 5 notice, when combined with those of the parent 
company (if any), are less than $40 million.

[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, April 11, 1997]



Sec. 700.45  Fee payments.

    (a) Persons who must pay fees. Persons submitting a section 5 notice 
to EPA shall remit for each such notice the appropriate fee identified 
in paragraph (b) of this section in accordance with the procedures in 
paragraph (e) of this section.
    (b) Fees. Persons shall remit fee payments to EPA as follows:
    (1) Small business concerns. Small business concerns shall remit a 
fee of $100 for each section 5 notice submitted.
    (2) Others. Persons other than small business concerns shall remit 
fees according to the type of section 5 notice as follows:
    (i) Premanufacture notices and consolidated premanufacture notices. 
Persons shall remit a fee of $2,500 for each PMN or consolidated PMN 
submitted.
    (ii) Intermediate premanufacture notices. Persons shall remit a fee 
of $1,000 for each intermediate PMN. However, for the PMN for the final 
product the person shall submit the fee in paragraph (b)(2)(i) of this 
section.
    (iii) Significant new use notices. Persons shall remit a fee of 
$2,500 for each significant new use notice submitted.
    (iv) Exemption applications. Persons shall remit a fee of $2,500 for 
each exemption application submitted under section 5(h)(2) of the Act.
    (v) Exemption notices. Persons shall remit a fee of $2,500 for each 
exemption notice submitted under Sec. 723.175 of this chapter.
    (vi) MCAN and consolidated MCAN. Persons shall remit a fee of $2,500 
for each MCAN or consolidated MCAN submitted.
    (c) No fee required. Persons are exempt from remitting any fee for 
submissions under Secs. 720.38, 723.50, and subparts E, F, and G of part 
725 of this chapter.
    (d) Joint submitters. Joint submitters of a section 5 notice are 
required to remit the appropriate fee identified in paragraph (b) of 
this section for each section 5 notice regardless of the number of joint 
submitters for that notice. To qualify for the fee identified in 
paragraph (b)(1) of this section, each joint submitter of a section 5 
notice must qualify as a small business concern under Sec. 700.43.
    (e) Remittance procedure. (1) Each remittance under this section 
shall be in United States currency and shall be paid by money order, 
bank draft, or certified check drawn to the order of the Environmental 
Protection Agency.
    (2) Each remittance shall be sent to the Environmental Protection 
Agency, HQ Accounting Operations Branch (PM-226), P.O. 360399M, 
Pittsburgh, PA 15251-6399, ATTN: TSCA User Fee.
    (3) Persons who submit a section 5 notice shall place a unique 
identifying number, which must include the letters ``TS'' followed by a 
combination of 6 numbers (letters may be substituted for some numbers), 
on the front page of each section 5 notice submitted. The same 
identifying number and the submitter's name must appear on the 
corresponding fee remittance under this section. If a remittance applies 
to more than one section 5 notice, the person shall include the name of 
the submitter, the identifying number for each section 5 notice to which 
the remittance applies, and the amount of the remittance which applies 
to each notice. Any remittance not having the identifying name and 
number described above will be returned to the remitter.

[[Page 7]]

    (4)(i) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a PMN, consolidated PMN, intermediate PMN, or 
significant new use notice shall write or type the words, ``The company 
named in part 1, section A is a small business concern under 40 CFR 
700.43 and has remitted a fee of $100 in accordance with 40 CFR 
700.45(b).'' under ``CERTIFICATION'' on Page 2 of the Premanufacture 
Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).
    (ii) Each person who remits the fee identified in paragraph (b)(1) 
of this section for an exemption application under section 5(h)(2) of 
the Act shall include the words, ``Each company identified in this 
application is a small business concern under 40 CFR 700.43 and has 
remitted a fee of $100 in accordance with 40 CFR 700.45(b).'' in the 
exemption application.
    (iii) Each person who remits the fee identified in paragraph (b)(1) 
of this section for an exemption notice under Sec. 723.175 of this 
chapter shall include the words, ``Each company identified in this 
notice is a small business concern under 40 CFR 700.43 and has remitted 
a fee of $100 in accordance with 40 CFR 700.45(b).'' in the 
certification required in Sec. 723.175(i)(1)(x) of this chapter.
    (iv) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a MCAN for a microorganism shall include the words, 
``The company identified in this notice is a small business concern 
under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 
CFR 700.45(d),'' in the certification required in Sec. 725.25(b) of this 
chapter.
    (5)(i) Each person who remits a fee identified in paragraph (b)(2) 
of this section for a PMN, consolidated PMN, intermediate PMN, or 
significant new use notice shall write or type the words, ``The company 
named in part 1, section A has remitted the fee specified in 40 CFR 
700.45(b).'' under ``CERTIFICATION'' on page 2 of the Premanufacture 
Notice for New Chemical Substances (EPA Form 7710-25 (4-26-83)).
    (ii) Each person who remits the fee identified in paragraph (b)(2) 
of this section for an exemption application under section (5)(h)(2) of 
the Act shall include the words, ``Each company identified in this 
application has remitted a fee of $2,500 in accordance with 40 CFR 
700.45(b).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (b)(2) 
of this section for an exemption notice under Sec. 723.175 of this 
chapter shall include the words, ``Each company identified in this 
notice has remitted a fee of $2,500 in accordance with 40 CFR 
700.45(b).'' in the certification required in Sec. 723.175(i)(1)(x) of 
this chapter.
    (iv) Each person who remits a fee identified in paragraph (b)(2) of 
this section for a MCAN for a microorganism shall include the words, 
``The company identified in this notice has remitted the fee specified 
in 40 CFR 700.45(b),'' in the certification required in Sec. 725.25(b) 
of this chapter.
    (f) Fee refunds. EPA will refund any fee paid for a section 5 notice 
whenever the Agency determines:
    (1) That the chemical substance that is the subject of a PMN, 
intermediate PMN, exemption application, or exemption notice is not a 
new chemical substance as of the date of submission of the notice.
    (2) In the case of a significant new use notice, that the notice was 
not required.
    (3) The notice is incomplete under either Sec. 720.65(c) or 725.33, 
of this chapter.
    (4) That as of the date of submission of the notice: the 
microorganism that is the subject of a MCAN is not a new microorganism; 
nor is the use involving the microorganism a significant new use.

[53 FR 31252, Aug. 17, 1988, as amended at 54 FR 21429, May 18, 1989; 58 
FR 34204, June 23, 1993; 62 FR 17932, April 11, 1997]



Sec. 700.49  Failure to remit fees.

    EPA will not consider a section 5 notice to be complete unless the 
appropriate certification under Sec. 700.45(e) is included and until the 
appropriate remittance under Sec. 700.45(b) has been sent to EPA as 
provided in Sec. 700.45(e) and received by EPA. EPA will notify the 
submitter that the section 5 notice is incomplete in accordance with 
Secs. 720.65(c) and 725.33 of this chapter.

[62 FR 17932, April 11, 1997]

[[Page 8]]



PART 702--GENERAL PRACTICES AND PROCEDURES--Table of Contents




Subparts A-B  [Reserved]

                         Subpart C--Citizen Suit

Sec.
702.60  Purpose.
702.61  Service of notice.
702.62  Contents of notice.

    Authority: 15 U.S.C. 2619.

    Source: 47 FR 2773, Jan. 19, 1982, unless otherwise noted.

Subparts A-B  [Reserved]



                         Subpart C--Citizen Suit



Sec. 702.60  Purpose.

    Section 20 of the Toxic Substances Control Act (TSCA) authorizes any 
person to begin a civil action to compel performance by the 
Environmental Protection Agency (EPA) of TSCA non-discretionary acts or 
duties (section 20(a)(2)) or to restrain any violation of TSCA, or of 
any rule promulgated under sections 4, 5, or 6, or of any order issued 
under section 5 of TSCA (section 20(a)(1)). The purpose of this 
regulation is to prescribe procedures governing the giving of a notice 
of intent to file suit required by section 20(b) of TSCA as a 
prerequisite to beginning such civil actions.



Sec. 702.61  Service of notice.

    (a) Notice as a prerequisite to suit. Under section 20 of TSCA, no 
civil action may be commenced by a citizen to restrain a violation of 
TSCA, or a rule or order thereunder, unless at least 60 days in advance 
the citizen has given notice of the intent to file suit to the 
Administrator and to the person who is alleged to have committed the 
violation. No civil action may be commenced by a citizen to compel the 
Administrator to perform any non-discretionary act or duty under TSCA, 
unless at least 60 days in advance the citizen has given notice of the 
intent to file suit to the Administrator. However, in the case of an 
alleged failure by the Administrator to file an action under section 7 
of TSCA, the citizen must give notice to the Administrator only 10 days 
in advance of filing the civil action.
    (b) Method of service. Notice of intent to file suit can be either 
personally served or served by certified mail--return receipt 
requested--to persons identified in paragraph (d) of this section.
    (c) Date of service. The effective date of service of a notice given 
in accordance with this rule shall be the date of the return receipt, if 
served by mail, or the date of receipt if personally served.
    (d) Persons to be served--(1) Violations of TSCA rules or TSCA 
order. (i) If the alleged violator is a private individual or a 
corporation, notice of intent to file suit shall be served on the 
individual or the owner or managing agent of the plant, facility, or 
activity alleged to be in violation. If the alleged violator is a 
corporation, a copy of the notice shall also be sent to the registered 
agent, if any, of such corporation in the State in which such violation 
is alleged to have occurred. Notice shall also be served on the 
Administrator of the EPA.
    (ii) If the alleged violator is a State or local government entity, 
notice of intent to file suit shall be served on the head of the agency. 
Notice shall also be served on the Administrator of the EPA, and a copy 
shall be sent to the Attorney General of the United States.
    (iii) If the alleged violator is a Federal agency, notice of intent 
to file suit shall be served on the head of the agency. Notice shall 
also be served on the Administrator of the EPA, and a copy shall be sent 
to the Attorney General of the United States.
    (2) Performance of non-discretionary TSCA acts or duties. Notice of 
intent to file suit shall be served on the Administrator of the EPA and 
a copy shall be sent to the Attorney General of the United States.
    (3) Address of persons to be served. (i) EPA Administrator: 401 M 
St., SW., Washington, DC 20460. (ii) Attorney General of the United 
States: 10th and Constitution Avenue, NW., Washington, DC 20530.



Sec. 702.62  Contents of notice.

    (a) Violation of TSCA rule or TSCA order. Notice of intent to file 
suit regarding an alleged violation of TSCA

[[Page 9]]

or any rule promulgated under sections 4, 5, or 6, or an order issued 
under section 5, shall include sufficient information to permit the 
recipient to identify:
    (1) The specific provision of TSCA or of the rule or order under 
TSCA alleged to have been violated.
    (2) The activity alleged to constitute a violation.
    (3) The person or persons responsible for the alleged violation.
    (4) The location of the alleged violation.
    (5) The date or dates of the alleged violation as closely as the 
citizen is able to specify them.
    (6) The full name, address, and telephone number of the citizen 
giving notice.
    (b) Failure to act. Notice regarding an alleged failure of the 
Administrator to perform any act or duty which is not discretionary 
shall:
    (1) Identify the specific provision of TSCA which requires an act or 
creates a duty.
    (2) Describe with reasonable specificity the action taken or not 
taken by the Administrator which is alleged to constitute a failure to 
perform the act or duty.
    (3) State the full name, address, and telephone number of the 
citizen giving the notice.
    (c) Identification of Counsel. The notice shall state the name, 
address, and telephone number of the Legal Counsel, if any, representing 
the citizen giving the notice.



PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS--Table of Contents




 Subpart A--General Reporting and Recordkeeping Provisions for Section 
                    8(a) Information-Gathering Rules

Sec.
704.1  Scope.
704.3  Definitions.
704.5  Exemptions.
704.7  Confidential business information claims.
704.9  Where to send reports.
704.11  Recordkeeping.
704.13  Compliance and enforcement.

     Subpart B--Chemical-Specific Reporting and Recordkeeping Rules

704.25  11-Aminoundecanoic acid.
704.33  P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene (P-TBT) 
          and p-tert-butylbenzaldehyde (P-TBB).
704.43  Chlorinated naphthalenes.
704.45  Chlorinated terphenyl.
704.95  Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-
          (methylene)]]tetrakis-(EDTMPA) and its salts.
704.102  Hexachloronorbornadiene.
704.104  Hexafluoropropylene oxide.
704.175  4,4'-methylenebis(2-chloroaniline) (MBOCA).

    Authority: 15 U.S.C. 2607(a).



 Subpart A--General Reporting and Recordkeeping Provisions for Section 
                    8(a) Information-Gathering Rules



Sec. 704.1  Scope.

    (a) This part specifies reporting and recordkeeping procedures under 
section 8(a) of the Toxic Substances Control Act (TSCA) for 
manufacturers, importers, and processors of chemical substances and 
mixtures (hereafter collectively referred to as substances) that are 
identified in subpart B of this part. The reporting and recordkeeping 
provisions in subpart A of this part apply throughout this part unless 
revised in any other subpart.
    (b) Subpart B of this part sets out chemical-specific reporting and 
recordkeeping requirements under section 8(a) of TSCA.

[53 FR 51715, Dec. 22, 1988, as amended at 60 FR 31920, June 19, 1995]



Sec. 704.3  Definitions.

    All definitions as set forth in section 3 of TSCA apply in this 
part. In addition, the following definitions are provided for the 
purposes of this part.
    Annual means the corporate fiscal year.
    Article means a manufactured item (1) which is formed to a specific 
shape or design during manufacture, (2) which has end use function(s) 
dependent in whole or in part upon its shape or design during end use, 
and (3) which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article, and that result from a 
chemical reaction that occurs upon end use of other chemical

[[Page 10]]

substances, mixtures, or articles; except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance(s) or mixture(s).
    CAS Number means Chemical Abstracts Service Registry Number.
    Coproduct means a chemical substance produced for a commercial 
purpose during the manufacture, processing, use, or disposal of another 
chemical substance or mixture.
    Customer means any person to whom a manufacturer, importer, or 
processor directly distributes any quantity of a chemical substance, 
mixture, mixture containing the substance or mixture, or article 
containing the substance or mixture, whether or not a sale is involved.
    Domestic means within the geographical boundaries of the 50 United 
States, including the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana 
Islands, and any other territory or possession of the United States.
    Enclosed process means a manufacturing or processing operation that 
is designed and operated so that there is no intentional release into 
the environment of any substance present in the operation. An operation 
with fugitive, inadvertent, or emergency pressure relief releases 
remains an enclosed process so long as measures are taken to prevent 
worker exposure to and environmental contamination from the releases.
    EPA means the United States Environmental Protection Agency.
    Import means to import for commercial purposes.
    Import for commercial purposes means to import with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
importer, and includes the importation of any amount of a chemical 
substance or mixture. If a chemical substance or mixture containing 
impurities is imported for commercial purposes, then those impurities 
also are imported for commercial purposes.
    Import in bulk form means to import a chemical substance (other than 
as part of a mixture or article) in any quantity, in cans, bottles, 
drums, barrels, packages, tanks, bags, or other containers, if the 
chemical substance is intended to be removed from the container and the 
substance has an end use or commercial purpose separate from the 
container.
    Importer means (1) any person who imports any chemical substance or 
any chemical substance as part of a mixture or article into the customs 
territory of the United States, and includes:
    (i) The person primarily liable for the payment of any duties on the 
merchandise, or
    (ii) An authorized agent acting on his behalf (as defined in 19 CFR 
1.11).
    (2) Importer also includes, as appropriate:
    (i) The consignee.
    (ii) The importer of record.
    (iii) The actual owner if an actual owner's declaration and 
superseding bond have been filed in accordance with 19 CFR 141.20.
    (iv) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144.
    (3) For the purposes of this definition, the customs territory of 
the United States consists of the 50 States, Puerto Rico, and the 
District of Columbia.
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    Intermediate means any chemical substance that is consumed, in whole 
or in part, in chemical reactions used for the intentional manufacture 
of other chemical substances or mixtures, or that is intentionally 
present for the purpose of altering the rates of such chemical 
reactions.
    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Manufacture means to manufacture for commercial purposes.

[[Page 11]]

    Manufacture for commercial purposes means: (1) To import, produce, 
or manufacture with the purpose of obtaining an immediate or eventual 
commercial advantage for the manufacturer, and includes among other 
things, such ``manufacture'' of any amount of a chemical substance or 
mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including both 
byproducts that are separated from that other substance or mixture and 
impurities that remain in that substance or mixture. Such byproducts and 
impurities may, or may not, in themselves have commercial value. They 
are nonetheless produced for the purpose of obtaining a commercial 
advantage since they are part of the manufacture of a chemical product 
for a commercial purpose.
    Manufacturer means a person who imports, produces, or manufactures a 
chemical substance. A person who extracts a component chemical substance 
from a previously existing chemical substance or a complex combination 
of substances is a manufacturer of that component chemical substance.
    Non-isolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture. Mechanical or gravity transfer through a closed system 
is not considered to be intentional removal, but storage or transfer to 
shipping containers ``isolates'' the substance by removing it from 
process equipment in which it is manufactured.
    Own or control means ownership of 50 percent or more of a company's 
voting stock or other equity rights, or the power to control the 
management and policies of that company. A company may own or control 
one or more sites. A company may be owned or controlled by a foreign or 
domestic parent company.
    Parent company is a company that owns or controls another company.
    Person includes any individual, firm, company, corporation, joint 
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    Possession or control means in the possession or control of any 
person, or of any subsidiary, partnership in which the person is a 
general partner, parent company, or any company or partnership which the 
parent company owns or controls, if the subsidiary, parent company, or 
other company or partnership is associated with the person in the 
research, development, test marketing, or commercial marketing of the 
substance in question. Information is in the possession or control of a 
person if it is:
    (1) In the person's own files including files maintained by 
employees of the person in the course of their employment.
    (2) In commercially available data bases to which the person has 
purchased access.
    (3) Maintained in the files in the course of employment by other 
agents of the person who are associated with research, development, test 
marketing, or commercial marketing of the chemical substance in 
question.
    Process means to process for commercial purposes.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture after its manufacture for distribution in commerce 
with the purpose of obtaining an immediate or eventual commercial 
advantage for the processor. Processing of any amount of a chemical 
substance or mixture is included in this definition. If a chemical 
substance or mixture containing impurities is processed for commercial 
purposes, then the impurities also are processed for commercial 
purposes.

[[Page 12]]

    Processor means any person who processes a chemical substance or 
mixture.
    Production volume means the quantity of a substance which is 
produced by a manufacturer, as measured in kilograms or pounds.
    Propose to manufacture, import, or process means that a person has 
made a firm management decision to commit financial resources for the 
manufacture, import, or processing of a specified chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way shall be considered one site. There may be more than 
one plant on a single site. The site for a person who imports a 
substance is the site of the operating unit within the person's 
organization which is directly responsible for importing the substance 
and which controls the import transaction and may in some cases be the 
organization's headquarters office in the United States.
    Small manufacturer or importer means a manufacturer or importer that 
meets either of the following standards:
    (1) First standard. A manufacturer or importer of a substance is 
small if its total annual sales, when combined with those of its parent 
company (if any), are less than $40 million. However, if the annual 
production or importation volume of a particular substance at any 
individual site owned or controlled by the manufacturer or importer is 
greater than 45,400 kilograms (100,000 pounds), the manufacturer or 
importer shall not qualify as small for purposes of reporting on the 
production or importation of that substance at that site, unless the 
manufacturer or importer qualifies as small under standard (2) of this 
definition.
    (2) Second standard. A manufacturer or importer of a substance is 
small if its total annual sales, when combined with those of its parent 
company (if any), are less than $4 million, regardless of the quantity 
of substances produced or imported by that manufacturer or importer.
    (3) Inflation index. EPA shall make use of the Producer Price Index 
for Chemicals and Allied Products, as compiled by the U.S. Bureau of 
Labor Statistics, for purposes of determining the need to adjust the 
total annual sales values and for determining new sales values when 
adjustments are made. EPA may adjust the total annual sales values 
whenever the Agency deems it necessary to do so, provided that the 
Producer Price Index for Chemicals and Allied Products has changed more 
than 20 percent since either the most recent previous change in sales 
values or the date of promulgation of this rule, whichever is later. EPA 
shall provide Federal Register notification when changing the total 
annual sales values.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or analysis 
or chemical research on, or analysis of, such substance or another 
substance, including such research or analysis for the development of a 
product'') means quantities of a chemical substance manufactured, 
imported, or processed or proposed to be manufactured, imported, or 
processed solely for research and development that are not greater than 
reasonably necessary for such purposes.
    Substance means either a chemical substance or mixture unless 
otherwise indicated.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, article 
containing that chemical substance or mixture, or a mixture containing 
that substance, by a manufacturer or processor, to no more than a 
defined number of potential customers to explore market capability in a 
competitive situation during a predetermined testing period prior to the 
broader distribution of that chemical substance, mixture, or article in 
commerce.
    Total annual sales means the total annual revenue (in dollars) 
generated by the sale of all products of a company. Total annual sales 
must include the total annual sales revenue of all sites owned or 
controlled by that company and the total annual sales revenue of that 
company's subsidiaries and foreign or domestic parent company, if any.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

[53 FR 51715, Dec. 22, 1988]

[[Page 13]]



Sec. 704.5  Exemptions.

    A person who is subject to reporting requirements for a substance 
identified in this part is exempt from those requirements to the extent 
that the person and that person's use of the substance is described in 
this section. This section is superseded by any TSCA section 8(a) rule 
that adds to, removes, or revises the exemptions described in this 
section.
    (a) Articles. A person who imports, processes, or proposes to import 
or process a substance identified in this part solely as part of an 
article is exempt from the reporting requirements of this part with 
regard to that substance.
    (b) Byproducts. A person who manufactures, imports, or proposes to 
manufacture or import a substance identified in this part solely as a 
byproduct is exempt from the reporting requirements of this part.
    (c) Impurities. A person who manufactures, imports, processes, or 
proposes to manufacture, import, or process a substance identified in 
this part solely as an impurity is exempt from the reporting 
requirements of this part.
    (d) Non-isolated intermediate. A person who manufactures or proposes 
to manufacture a substance identified in this part solely as a non-
isolated intermediate is exempt from the reporting requirements of this 
part.
    (e) Research and development. A person who manufactures, imports, 
processes, or proposes to manufacture, import, or process a substance 
identified in this part only in small quantities solely for research and 
development is exempt from the reporting requirements of this part.
    (f) Small manufacturers and importers. Small manufacturers and 
importers are exempt from the reporting requirements of this part.

[53 FR 51717, Dec. 22, 1988]



Sec. 704.7  Confidential business information claims.

    (a) Any person submitting a notice under this rule may assert a 
business confidentiality claim covering all or any part of the notice. 
Any information covered by a claim will be disclosed by EPA only to the 
extent and by means of the procedures set forth in part 2 of this title.
    (b) If no claim accompanies the notice at the time it is submitted 
to EPA, the notice will be placed in an open file available to the 
public without further notice to the respondent.
    (c) To assert a claim of confidentiality for data contained in a 
notice, the respondent must submit two copies of the notice.
    (1) One copy of the notice must be complete. In that copy the 
respondent must indicate what data, if any, are claimed as confidential 
by marking the specific information on each page with a label such as 
``confidential'', ``proprietary'', or ``trade secret''.
    (2) If some data in the notice are claimed as confidential, the 
respondent must submit a second copy. The second copy must be complete 
except that all information claimed as confidential in the first copy 
must be deleted.
    (3) The first copy of the notice will be for internal use by EPA. 
The second copy will be placed in an open file to be available to the 
public.
    (4) Failure to furnish a second copy of the notice when information 
is claimed as confidential in the first copy will be considered a 
presumptive waiver of the claim of confidentiality. EPA will notify the 
respondent by certified mail that a finding of a presumptive waiver of 
the claim of confidentiality has been made. The respondent has 15 days 
from the date of receipt of notification to submit the required second 
copy. Failure to submit the second copy will cause EPA to place the 
first copy in the public file.
    (d) In submitting a claim of confidentiality, a person attests to 
the truth of the following four statements concerning all information 
which is claimed confidential:
    (1) My company has taken measures to protect the confidentiality of 
the information, and it intends to continue to take such measures.
    (2) The information is not, and has not been, reasonably obtainable 
without our consent by other persons (other than government bodies) by 
use of legitimate means (other than discovery based on a showing of 
special need in a judicial or quasi-judicial proceeding).

[[Page 14]]

    (3) The information is not publicly available elsewhere.
    (4) Disclosure of the information would cause substantial harm to 
our competitive position.

[48 FR 23420, May 25, 1983, as amended at 53 FR 51717, Dec. 22, 1988]



Sec. 704.9  Where to send reports.

    Reports must be submitted by certified mail to the Document Control 
Office (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, 
DC., 20460, ATT: 8(a) Reporting.

[60 FR 34463, July 3, 1995]



Sec. 704.11  Recordkeeping.

    Each person who is subject to the reporting requirements of this 
part must retain the following records for 3 years following the 
creation or compilation of the record.
    (a) A copy of each report submitted by the person in response to the 
requirements of this part.
    (b) Materials and documentation sufficient to verify or reconstruct 
the values submitted in the report.
    (c) A copy of each notice sent by the person, return receipt 
requested, to that person's customers for the purpose of notifying their 
customers of the customer's reporting obligations under this part.
    (d) All return receipts signed by the person's customers who 
received the notice described in paragraph (c) of this section.

[53 FR 51717, Dec. 22, 1988, as amended at 58 FR 34204, June 23, 1993]



Sec. 704.13  Compliance and enforcement.

    Violators of the requirements of this part may be subject to civil 
administrative penalties up to $25,000 per day of violation or criminal 
prosecution, as provided in sections 15 and 16 of TSCA. In addition, 
under section 17, EPA may seek judicial relief to compel submission of 
required information.

[53 FR 51717, Dec. 22, 1989]



     Subpart B--Chemical-Specific Reporting and Recordkeeping Rules



Sec. 704.25  11-Aminoundecanoic acid.

    (a) Definitions. (1) 11-AA means the chemical substance 11-
aminoundecanoic acid, CAS Number 2432-99-7.
    (2) Enclosed process means a process that is designed and operated 
so that there is no intentional release of any substance present in the 
process. A process with fugitive, inadvertent, or emergency pressure 
relief releases remains an enclosed process so long as measures are 
taken to prevent worker exposure to an environmental contamination from 
the releases.
    (3) Internal subunit means a subunit that is covalently linked to at 
least two other subunits. Internal subunits of polymer molecules are 
chemically derived from monomer molecules that have formed covalent 
links between two or more other molecules.
    (4) Monomer means a chemical substance that has the capacity to form 
links between two or more other molecules.
    (5) Polymer means a chemical substance that consists of at least a 
simple weight majority of polymer molecules but consists of less than a 
simple weight majority of molecules with the same molecular weight. 
Collectively, such polymer molecules must be distributed over a range of 
molecular weights wherein differences in molecular weight are primarily 
attributable to differences in the number of internal subunits.
    (6) Polymer molecule means a molecule which includes at least four 
covalently linked subunits, at least two of which are internal subunits.
    (7) Small processor means a processor that meets either the standard 
in paragraph (a)(7)(i) of this section or the standard in paragraph 
(a)(7)(ii) of this section.
    (i) First standard. A processor of a chemical substance is small if 
its total annual sales, when combined with those of its parent company, 
if any, are less than $40 million. However, if the annual processing 
volume of a particular chemical substance at any individual site owned 
or controlled by the

[[Page 15]]

processor is greater than 45,400 kilograms (100,000 pounds), the 
processor shall not qualify as small for purposes of reporting on the 
processing of that chemical substance at that site, unless the processor 
qualifies as small under paragraph (a)(7)(ii) of this section.
    (ii) Second standard. A processor of a chemical substance is small 
if its total annual sales, when combined with those of its parent 
company (if any), are less than $4 million, regardless of the quantity 
of the particular chemical substance processed by that company.
    (iii) Inflation index. EPA will use the Inflation Index described in 
the definition of small manufacturer set forth in Sec. 704.3, for 
purposes of adjusting the total annual sales values of this small 
processor definition. EPA will provide notice in the Federal Register 
when changing the total annual sales values of this definition.
    (8) Subunit means an atom or group of associated atoms chemically 
derived from corresponding reactants.
    (b) Persons who must report. Except as provided in paragraph (c) of 
this section, the following persons are subject to this section:
    (1) Persons who manufacture or propose to manufacture 11-AA:
    (i) For use as an intermediate in the manufacture of polymers in an 
enclosed process when it is expected that the 11-AA will be fully 
polymerized during the manufacturing process, or
    (ii) For use as a component in photoprocessing solutions.
    (2) Persons who import or propose to import 11-AA:
    (i) For use as an intermediate in the manufacture of polymers in an 
enclosed process when it is expected that the 11-AA will be fully 
polymerized during the manufacturing process, or
    (ii) For use as a component in photoprocessing solutions.
    (3) Persons who process or propose to process 11-AA:
    (i) For use as an intermediate in the manufacture of polymers in an 
enclosed process when it is expected that the 11-AA will be fully 
polymerized during the manufacturing process, or
    (ii) For use as a component in photoprocessing solutions.
    (c) Persons not subject to this section. The following persons are 
not subject to this section:
    (1) Small manufacturers (includes importers) as described in 
Sec. 704.3.
    (2) Small processors.
    (3) Persons described in Sec. 704.5.
    (4) Persons who, at any time during the 3-year period ending July 
22, 1986, manufactured, imported, or processed 11-AA:
    (i) For use as an intermediate in the manufacture of polymers in an 
enclosed process when it is expected that the 11-AA will be fully 
polymerized during the manufacturing process, or
    (ii) For use as a component in photoprocessing solutions.
    (d) What information to report. Persons identified in paragraph (b) 
of this section must submit a Premanufacture Notice Form (EPA Form 7710-
25).
    (e) When to report. (1) Persons who intend to manufacture, import, 
or process 11-AA for use as an intermediate in the manufacture of 
polymers in an enclosed process when it is expected that the 11-AA will 
be fully polymerized during the manufacturing process or for use as a 
component in photoprocessing solutions must notify EPA within 30 days 
after making a firm management decision to commit financial resources 
for the manufacturing, importing, or processing of 11-AA.
    (2) Persons who initiated manufacturing, importing, or processing of 
11-AA for use as an intermediate in the manufacture of polymers in an 
enclosed process when it is expected that the 11-AA will be fully 
polymerized during the manufacturing process, or for use as a component 
in photoprocessing solutions during the time period between July 22, 
1986 and July 13, 1987 must notify EPA by August 10, 1987.
    (f) Recordkeeping. Persons subject to the reporting requirements of 
this section must retain documentation of information contained in their 
reports for a period of 5 years from the date of submission of the 
report.
    (g) Where to send reports. Reports must be submitted by certified 
mail to the Document Control Office (7407), Office of Pollution 
Prevention and Toxics, U.S. Environmental Protection

[[Page 16]]

Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATT: 11-AA 
Notification.

[52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60 
FR 34463, July 3, 1995]



Sec. 704.33  P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene (P-TBT) and p-tert-butylbenzaldehyde (P-TBB).

    (a) Definitions. (1) P-TBBA means the substance p-tert-butylbenzoic 
acid, also identified as 4-(1,1-dimethylethyl)benzoic acid, CAS No. 98-
73-7.
    (2) P-TBT means the substance p-tert-butyltoluene, also identified 
as 1-(1,1-dimethylethyl)-4-methylbenzene, CAS No. 98-51-1.
    (3) P-TBB means the substance p-tert-butylbenzaldehyde, also 
identified as 4-(1,1-dimethylethyl)benzaldehyde, CAS No. 939-97-9.
    (4) Small processor means a processor that meets either the standard 
in paragraph (a)(4)(i) of this section or the standard in paragraph 
(a)(4)(ii) of this section.
    (i) First standard. A processor of a chemical substance is small if 
its total annual sales, when combined with those of its parent company, 
if any, are less than $40 million. However, if the annual processing 
volume of a particular chemical substance at any individual site owned 
or controlled by the processor is greater than 45,400 kilograms (100,000 
pounds), the processor shall not qualify as small for purposes of 
reporting on the processing of that chemical substance at that site, 
unless the processor qualifies as small under paragraph (a)(1)(ii) of 
this section.
    (ii) Second standard. A processor of a chemical substance is small 
if its total annual sales, when combined with those of its parent 
company (if any), are less than $4 million, regardless of the quantity 
of the particular chemical substance processed by that company.
    (iii) Inflation index. EPA shall use the Inflation Index described 
in the definition of small manufacturer that is set forth in Sec. 704.3, 
for purposes of adjusting the total annual sales values of this small 
processor definition. EPA shall provide Federal Register notification 
when changing the total annual sales values of this definition.
    (b) Persons who must report. Except as provided in paragraph (c) of 
this section, the following persons are subject to the reporting 
requirements of this rule; a person may become subject to this rule more 
than once, for more than one substance or under more than one of the 
criteria listed in this paragraph (b).
    (1) Persons who manufactured, imported, or processed P-TBBA, P-TBT, 
and/or P-TBB for commercial purposes during the person's latest complete 
corporate fiscal year prior to June 25, 1986. For purposes of this 
provision, processors of P-TBBA, P-TBT, and/or P-TBB shall include only 
those persons who processed the substances other than as non-isolated 
intermediates.
    (2) Persons who commence manufacture or importation of P-TBBA, P-
TBT, and/or P-TBB for commercial purposes after June 25, 1986. This 
provision is applicable to persons who cease manufacture or importation 
of P-TBBA, P-TBT, and/or P-TBB after June 25, 1986 and then subsequently 
resume manufacture or importation of the substance(s).
    (3) Persons who process P-TBBA, P-TBT, and/or P-TBB for commercial 
purposes in any way other than as a non-isolated intermediate after June 
25, 1986.
    (c) Persons not subject to this rule. In addition to the persons 
described in Sec. 704.5, small processors, as defined in paragraph 
(a)(4) of this section, are not subject to this rule.
    (d) Information to report. Persons subject to this rule as described 
in paragraph (b) of this section shall report information to EPA as 
specified in this paragraph (d). Respondents to this rule shall report 
all information that is known to or reasonably ascertainable by the 
person reporting. For purposes of importer reporting under this 
paragraph, a site is the operating unit within the person's organization 
which is directly responsible for importing the substance and which 
controls the import transaction. The import site may in some cases be 
the organization's headquarters office in the United States.
    (1) All manufacturers, importers, and processors specified in 
paragraph (b) of

[[Page 17]]

this section shall report their name and headquarters address.
    (2) All manufacturers, importers, and processors specified in 
paragraph (b) of this section shall report the name, address, and office 
telephone number (including area code) of their principal technical 
contact.
    (3) All manufacturers, importers, and processors specified in 
paragraph (b) of this section shall report the name and address of each 
site where P-TBBA, P-TBT, and/or P-TBB is manufactured, imported, or 
processed.
    (4) All manufacturers, importers, and processors specified in 
paragraph (b)(1) of this section only shall report the information 
described in this paragraph (d)(4). Respondents to this paragraph (d)(4) 
shall report separately for each substance that they manufacture, 
import, or process, and for each site at which they do so. However, if 
the information to be reported in response to this paragraph (d)(4) is 
the same for different sites, the respondent need not report separately 
for each site but need only notify EPA that the information is the same 
for each site. The information to be reported under this paragraph 
(d)(4) shall cover the respondent's latest complete corporate fiscal 
year prior to June 25, 1986. Respondents to this paragraph (d)(4) shall 
report the following information:
    (i) The total quantity (by weight) of P-TBBA, P-TBT, or P-TBB 
manufactured, imported, or processed for commercial purposes per site.
    (ii) A narrative description of the manufacturing, importing, or 
processing operation(s) involving P-TBBA, P-TBT, or P-TBB at each site.
    (iii) A narrative description of worker activities involving P-TBBA, 
P-TBT, or P-TBB at each site, including the number of workers 
potentially exposed to each substance and, if applicable, the number of 
workers potentially exposed to more than one substance.
    (iv) The potential routes of worker exposure to P-TBBA, P-TBT, or P-
TBB at each site (e.g., inhalation, ingestion, dermal absorption).
    (v) Available monitoring data from employee breathing zones with 
potential exposure to P-TBBA, P-TBT, or P-TBB at each site, including a 
description of the method of monitoring, the number of samples taken, 
and the potential number of workers similarly exposed for each worker 
job category. Respondents to this paragraph (d)(4)(v) shall submit data 
showing a range of 8-hour time weighted averages (TWAs), provided that 
the data are available in that form. Respondents also shall submit a 
calculated geometric mean of these data, with an explanation of the 
method by which the mean was derived. However, if the monitoring data 
are not available in the form of 8-hour TWAs, respondents shall submit 
raw sample data results and the duration time of sampling for each job 
category.
    (vi) A narrative description of any personal protective equipment 
and/or engineering controls used to prevent exposure to P-TBBA, P-TBT, 
or P-TBB at each site.
    (vii) A listing of the estimated quantities of P-TBBA, P-TBT, or P-
TBB released directly into air, water, or land from each site.
    (viii) A narrative description of the times during the 
manufacturing, importing, or processing operations involving P-TBBA, P-
TBT, or P-TBB when environmental release occurs at each site.
    (ix) A narrative description of any engineering controls used to 
prevent environmental release of P-TBBA, P-TBT, or P-TBB at each site.
    (x) A narrative description of all known end uses of any P-TBBA, P-
TBT, or P-TBB that is manufactured, imported, or processed by the 
respondent. The narrative need not include customer identity.
    (xi) A narrative description of the methods used at each site for 
disposing of wastes generated during the manufacture, importation, or 
processing of P-TBBA, P-TBT, or P-TBB, including the quantity and 
content of such wastes (per site), the method of disposal, and an 
identification of the disposal site(s).
    (5) All manufactureres, importers, and processors specified in 
paragraph (b) of this section shall report the information described in 
this paragraph (d)(5). Respondents to this paragraph (d)(5) shall report 
separately for each substance that they intend to manufacture, import, 
or process during the first 2 years following the date on which

[[Page 18]]

they become subject to this rule. The data reported under this paragraph 
(d)(5) shall cover that 2-year period. Respondents to this paragraph 
(d)(5) shall report separately for each site at which they intend to 
manufacture, import, or process each substance. Respondents need not 
comply with this paragraph (d)(5) if the information to be reported is 
identical to that reported by the respondent under paragraph (d)(4) of 
this section, provided that the respondent makes note of that fact to 
EPA. Respondents to this paragraph (d)(5) shall report the following 
information:
    (i) An estimate of the total quantity (by weight) of P-TBBA, P-TBT, 
or P-TBB that the respondent intends to manufacture, import, or process 
for commercial purposes per site during each of the first 2 years 
following the date on which the respondent becomes subject to this rule.
    (ii) A narrative description of the intended manufacturing, 
importing, or processing activities involving P-TBBA, P-TBT, or P-TBB at 
each site during the first 2 years following the date on which the 
respondent becomes subject to this rule. The description shall include a 
summary of the intended manufacturing, importing, or processing 
operation(s); a summary of intended worker activities involving the 
substances, including an estimate of the number of persons anticipated 
to be exposed annually to P-TBBA, P-TBT, or P-TBB (per site) during the 
2-year period, the anticipated routes of worker exposure to the 
substances (e.g., inhalation, ingestion, dermal absorption); and a 
summary of any personal protective equipment and/or engineering controls 
that the respondent intends to use to prevent exposure to the 
substances.
    (iii) A narrative description of anticipated environmental releases 
of P-TBBA, P-TBT, or P-TBB at each site from the manufacture, 
importation, or processing of these substances during the first 2 years 
following the date on which the respondent becomes subject to this rule. 
The narrative shall include the anticipated quantities of each substance 
released directly into air, water, or land, the anticipated routes of 
environmental release, and any intended engineering controls to be used 
to prevent environmental release of the substances.
    (iv) A narrative description of all anticipated end uses or P-TBBA, 
P-TBT, or P-TBB resulting from the respondent's manufacture, 
importation, or processing of the substances during the first 2 years 
following the date on which the respondent becomes subject to this rule. 
The summary need not include customer identity.
    (v) A narrative summary of the anticipated disposal of wastes 
generated from the manufacture, importation, or processing of P-TBBA, P-
TBT, or P-TBB during the first 2 years following the date on which the 
respondent becomes subject to this rule. The summary shall include the 
anticipated quantity and content of such wastes (per site), the intended 
method of disposal, and an identification of intended disposal site(s).
    (e) When to report. Persons subject to this rule must submit the 
requisite information to EPA within 60 days of becoming subject to the 
rule under the standards set forth in paragraph (b) of this section.
    (f) Certification. Persons subject to this rule must attach the 
following statement to any information submitted to EPA in response to 
this rule: ``I hereby certify that, to the best of my knowledge and 
belief, all of the attached information is complete and accurate.'' This 
statement shall be signed and dated by the company's principal technical 
contact.
    (g) Recordkeeping. Persons subject to the reporting requirements of 
this section must retain documentation of information contained in their 
reports for a period of 5 years from the date of the submission of the 
report.

[51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52 
FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]



Sec. 704.43  Chlorinated naphthalenes.

    (a) Definitions. (1) Extent of chlorination means the percent by 
weight of chlorine.
    (2) Import means to import in bulk form or as part of a mixture.
    (3) Isomeric ratio means the relative amounts of each isomeric 
chlorinated

[[Page 19]]

naphthalene that composes the chemical substance; and for each isomer 
the relative amounts of each chlorinated naphthalene designated by the 
position of the chlorine atom(s) on the naphthalene.
    (4) Polychlorinated biphenyl means any chemical substance that is 
limited to the biphenyl molecule and that has been chlorinated to 
varying degrees.
    (5) Small manufacturer means a manufacturer (including importers) 
who meets either paragraph (a)(5) (i) or (ii) of this section:
    (i) A manufacturer of a chemical substance is small if its total 
annual sales, when combined with those of its parent company (if any), 
are less than $40 million. However, if the annual production volume of a 
particular chemical substance at any individual site owned or controlled 
by the manufacturer is greater than 45,400 kilograms (100,000 pounds), 
the manufacturer shall not qualify as small for purposes of reporting on 
the production of that chemical substance at that site, unless the 
manufacturer qualifies as small under paragraph (a)(5)(ii) of this 
section.
    (ii) A manufacturer of a chemical substance is small if its total 
annual sales, when combined with those of its parent company (if any), 
are less than $4 million, regardless of the quantity of the particular 
chemical substance produced by that manufacturer.
    (iii) For imported mixtures containing a chemical substance 
identified in paragraph (b) of this section, the 45,400 kilograms 
(100,000 pounds) standard in paragraph (a)(5)(i) of this section applies 
only to the amount of the chemical substance in a mixture and not the 
other components of the mixture.
    (6) Waste means any solid liquid, semisolid, or contained gaseous 
material that results from the production of a chemical substance 
identified in paragraph (b) of this section and which is to be disposed.
    (b) Substances for which reports must be submitted.

------------------------------------------------------------------------
        CAS registry number                  Chemical substance
------------------------------------------------------------------------
   90-13-1........................  Naphthalene, 1-chloro-
   91-58-7........................  Naphthalene, 2-chloro-
 1321-64-8........................  Naphthalene, pentachloro-
 1321-65-9........................  Naphthalene, trichloro-
 1335-87-1........................  Naphthalene, hexachloro-
 1335-88-2........................  Naphthalene, tetrachloro-
 1825-30-5........................  Naphthalene, 1,5-dichloro-
 1825-31-6........................  Naphthalene, 1,4-dichloro-
 2050-69-3........................  Naphthalene, 1,2-dichloro-
 2050-72-8........................  Naphthalene, 1,6-dichloro-
 2050-73-9........................  Naphthalene, 1,7-dichloro-
 2050-74-0........................  Naphthalene, 1,8-dichloro-
 2050-75-1........................  Naphthalene, 2,3-dichloro-
 2065-70-5........................  Naphthalene, 2,6-dichloro-
 2198-75-6........................  Naphthalene, 1,3-dichloro-
 2198-77-8........................  Naphthalene, 2,7-dichloro-
 2234-13-1........................  Naphthalene, octachloro-
25586-43-0........................  Naphthalene, chloro-
32241-08-0........................  Naphthalene, heptachloro-
70776-03-3........................  Naphthalene, chloro derivatives.
------------------------------------------------------------------------

    (c) Persons who must report. (1) Persons who are manufacturing or 
importing a chemical substance identified in paragraph (b) of this 
section on October 8, 1984.
    (2) Persons who propose to import a chemical substance identified in 
paragraph (b) of this section on or after October 8, 1984.
    (3) Persons who manufacture a chemical substance identified in 
paragraph (b) of this section after October 8, 1984.
    (4) A person is required to report only once for each chemical 
substance identified in paragraph (b) of this section.
    (d) Persons exempt from reporting. (1) Small manufacturers.
    (2) Persons described in Sec. 704.5.
    (e) What information to report. Persons described in paragraph (c) 
of this section must notify EPA of current or prospective manufacture or 
import. The notice must include, to the extent that it is known to or 
reasonably ascertainable by the person making the report, the following 
information:
    (1) Company name and address.
    (2) Name, address, and telephone number of the principal technical 
contact.
    (3) For chemical substances proposed to be imported, the proposed 
date of import.
    (4) A description of the use(s) or intended use(s) for the chemical 
substance.
    (5) A description of the isomeric ratio and extent of chlorination 
of the chemical substance and the impurity level of polychlorinated 
biphenyls.
    (6) The quantity (by weight) manufactured or imported within 12 
months prior to October 8, 1984, if any, and the estimated quantity (by 
weight) to be manufactured or imported for the first

[[Page 20]]

3 years following the date of the report or the date of the intended 
start of import whichever occurs later.
    (7) The number of persons exposed to the chemical substance during 
manufacture, import, processing, distribution in commerce, use, and 
disposal.
    (8) If a manufacturer's waste contains one or more of the chemical 
substances identified in paragraph (b) of this section, the manufacturer 
must:
    (i) Provide the quantity (by weight) of the chemical substances 
identified in paragraph (b) of this section present in the waste.
    (ii) Identify the constituents of the waste and their 
concentrations,
    (iii) State the rate of waste generation as a percentage of 
production volume,
    (iv) Describe where in the manufacturing process the waste is 
generated, and
    (v) Describe the method for disposal of the waste.
    (f) When to report. (1) Persons who are manufacturing or importing a 
chemical substance identified in paragraph (b) of this section on 
October 8, 1984 must notify EPA by November 6, 1984.
    (2) Persons who propose to import a chemical substance identified in 
paragraph (b) of this section on or after October 8, 1984 must notify 
EPA by November 6, 1984, or 15 days after making the management decision 
described in Sec. 704.3, whichever is later in time.
    (3) Persons who manufacture a chemical substance identified in 
paragraph (b) of this section after October 8, 1984 must notify EPA 
within 30 days after the initial date of manufacture.

[49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. 15, 1984; 50 FR 1215, 
Jan. 10, 1985; 51 FR 19839, June 3, 1986; 52 FR 20083, May 29, 1987. 
Redesignated at 53 FR 51717, Dec. 22, 1988]



Sec. 704.45  Chlorinated terphenyl.

    (a) Definitions. (1) Chlorinated terphenyl means a chemical 
substance, CAS No. 61788-33-6, comprised of chlorinated ortho-, meta-, 
and paraterphenyl.
    (2) Extent of chlorination means the percent by weight of chlorine 
for each isomer (ortho, meta, and para).
    (3) Isomeric ratio means the ratios of ortho-, meta-, and 
parachlorinated terphenyls.
    (4) Polychlorinated biphenyl means any chemical substance that is 
limited to the biphenyl molecule that has been chlorinated to varying 
degrees.
    (5) Small manufacturer means a manufacturer (importers are defined 
as manufacturers under TSCA) who meets either of the following standards 
under this rule:
    (i) First standard. A manufacturer of an existing chemical substance 
is small if its total annual sales, when combined with those of its 
parent company (if any), are less than $40 million. However, if the 
annual production volume of a particular chemical substance at any 
individual site owned or controlled by the manufacturer is greater than 
45,400 kilograms (100,000 pounds), the manufacturer shall not qualify as 
small for purposes of reporting on the production of that chemical 
substance at the site, unless the manufacturer qualified as small under 
paragraph (a)(5)(ii) of this section.
    (ii) Second standard. A manufacturer of an existing chemical 
substance is small if its total annual sales, when combined with those 
of its parent company (if any), are less than $4 million, regardless of 
the quantity of chemicals produced by that manufacturer.
    (b) Persons who must report. Except for small manufacturers and as 
provided in Sec. 704.5, the following persons are subject to the rule:
    (1) Persons who manufacture or propose to manufacture chlorinated 
terphenyl.
    (2) Persons who import (importers) or propose to import chlorinated 
terphenyl as a chemical substance in bulk or as part of a mixture.
    (c) What information to report. Persons subject to this rule as 
described in paragraph (b) of this section must notify EPA of current or 
proposed manufacture or import of chlorinated terphenyl. The notice must 
include, to the extent that it is known to the person making the report 
or is reasonably ascertainable, the following information:
    (1) Company name and address.
    (2) Name, address, and telephone number of principal technical 
contact.
    (3) A description of the use(s) or intended use(s) for chlorinated 
terphenyl.

[[Page 21]]

    (4) A description of the isomeric ratio and extent of chlorination 
of the chlorinated terphenyl and the impurity level of polychlorinated 
biphenyls.
    (5) The quantity (by weight) manufactured or imported within 12 
months prior to the effective date of the rule, if any, and the 
estimated quantity (by weight) to be manufactured or imported for the 
first three years following the date of the report or the date of the 
intended start of production, whichever occurs later.
    (6) The proposed date for the initiation of manufacturing or 
importation of chlorinated terphenyl, if appropriate.
    (d) When to report. Persons who are manufacturing or importing 
chlorinated terphenyl on the effective date of the rule must notify EPA 
within 30 days of the effective date of the rule. Persons who propose to 
manufacture or import chlorinated terphenyl must notify EPA within 15 
days after making the management decision described in Sec. 704.3 
``Proposed to manufacture or import''.

[49 FR 11184, Mar. 26, 1984, as amended at 49 FR 32068, Aug. 10, 1984; 
50 FR 2048, Jan. 15, 1985; 52 FR 20083, May 29, 1987. Redesignated at 53 
FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]



Sec. 704.95  Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-(methylene)]]tetrakis- (EDTMPA) and its salts.

    (a) Substances for which reporting is required. The chemical 
substances for which reporting is required under this section are:

------------------------------------------------------------------------
  CAS No.                           Chemical name
------------------------------------------------------------------------
1429-50-1..  Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis
              (methylene)]] tetrakis- (EDTMPA)
15142-96-8.  Phosphonic acid, [1,2-ethanediyl-
              bis[nitrilobis(methylene)]] tetrakis-, hexasodium salt
34274-30-1.  Phosphonic acid, [1,2-ethanediyl-
              bis[nitrilobis(methylene)]] tetrakis-, potassium salt
57011-27-5.  Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis
              (methylene)]] tetrakis-, ammonium salt
67924-23-6.  Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis-[phosphonato]] (8-)]-,
              pentapotassium hydrogen, (OC-6-21)-
67969-67-9.  Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (8-)-
              N,N',O,O'',O'''',O'''''']-, pentasodium hydrogen, (OC-6-
              21)-
67989-89-3.  Cuprate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (8-)]-,
              pentapotassium hydrogen, (OC-6-21)-
68025-39-8.  Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (6-)-
              N,N',O,O'',O'''',O'''''']-, pentaammonium hydrogen, (OC-6-
              21)-
68188-96-5.  Phosphonic acid, [1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis-, tetrapotassium salt
68309-98-8.  Cadmate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (8-)]-,
              pentapotassium hydrogen, (OC-6-21)-
68901-17-7.  Phosphonic acid, [1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis-, octaammonium salt
68958-86-1.  Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (8-)]-,
              pentaammonium hydrogen, (OC-6-21)-
68958-87-2.  Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis- [phosphonato]] (8-)]-,
              pentapotassium hydrogen, (OC-6-21)-
68958-88-3.  Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
              (methylene)]] tetrakis [phosphonato]] (8-)]-, pentasodium
              hydrogen, (OC-6-21)-
------------------------------------------------------------------------

    (b) Persons who must report. Unless exempt as provided in 
Sec. 704.5, reports must be submitted by:
    (1) Persons who manufacture or import any of the substances 
identified in paragraph (a) of this section.
    (2) Persons who propose to manufacture or propose to import any of 
the substances identified in paragraph (a) of this section. For the 
purposes of importer reporting under this section, an import site is the 
operating unit within the person's organization which is directly 
responsible for importing the substance and which controls the import 
transaction; the import site may in some cases be the organization's 
headquarters office in the United States.
    (c) What information to report. Persons identified in paragraph (b) 
of this section must report to EPA, for each of the substances 
identified in paragraph (a) of this section, the following information 
to the extent known to or reasonably ascertainable by them.
    (1) Initial Report:
    (i) Name and Chemical Abstracts Service Registry Number of the 
substance for which the report is submitted.
    (ii) Company name and headquarters address.
    (iii) Name, address, and telephone number of the principal technical 
contact.
    (iv) The total quantity (by weight in pounds) of the substance 
manufactured or imported for the person's most recently completed 
corporate fiscal year.

[[Page 22]]

    (v) A description of the commercial uses of the substance during the 
person's most recently completed corporate fiscal year, including the 
production volume for each use.
    (vi) The estimated quantity (by weight in pounds) of the substance 
proposed to be manufactured or imported in the person's current 
corporate fiscal year.
    (vii) A description of the intended commercial uses of the substance 
during the person's current corporate fiscal year, including the 
estimated production volume for each use.
    (2) Follow-up Report:
    (i) Name and Chemical Abstracts Service Registry Number of the 
substance for which the report is submitted.
    (ii) Company name and headquarters address.
    (iii) Name, address, and telephone number of the principal technical 
contact.
    (iv) The estimated quantity (by weight in pounds) of the substance 
proposed to be manufactured or imported in the person's current 
corporate fiscal year.
    (v) A description of the intended commercial uses of the substance 
during the person's current corporate fiscal year, including the 
estimated production volume for each use.
    (d) When to report. (1) Persons specified in paragraph (b)(1) of 
this section who are manufacturing or importing the substance as of 
December 5, 1988 must submit an initial report described in paragraph 
(c)(1) of this section by January 3, 1989.
    (2) Persons specified in paragraph (b)(2) of this section must 
submit an initial report within 30 days after making the management 
decision described in Sec. 704.3 or by January 3, 1989, whichever is 
later.
    (3) Persons specified in paragraph (b) of this section, who 
submitted a report described in paragraph (c)(1) of this section, must 
submit a follow-up report described in paragraph (c)(2) of this section 
within 30 days of making the management decision, described at 
Sec. 704.3, to do either of the following events:
    (i) Manufacture or import the substance in a quantity 50 percent 
greater than the quantity reported in the most recently submitted 
report.
    (ii) Manufacture or import the substance for a use not reported for 
that substance in any previous report.
    (e) Certification. Persons subject to this section must attach the 
following statement to any information submitted to EPA in response to 
this section: ``I hereby certify that, to the best of my knowledge and 
belief, all of the attached information is complete and accurate.'' This 
statement must be signed and dated by the company's principal technical 
contact.
    (f) Recordkeeping. Persons subject to the reporting requirements of 
this section must retain documentation of information contained in their 
reports for a period of 5 years from the date of the submission of the 
report.

[53 FR 41337, Oct. 21, 1988, as amended at 58 FR 34204, June 23, 1993]



Sec. 704.102  Hexachloronorbornadiene.

    (a) Definitions. (1) Endrin means the pesticide 2,7:3,6-
Dimethanonaphth[2,3-b]oxirene,3,4,5,6,9,9-hexachloro-
1a,2,2a,3,6,6a,7,7a-octahydro-, (1aalpha, 2beta, 2abeta, 3alpha, 6alpha, 
6abeta, 7beta, 7aalpha)-, CAS Number 72-20-8.
    (2) HEX-BCH means the chemical substance 1,2,3,4,7,7-
hexachloronorbornadiene, CAS Number 3389-71-7.
    (3) Isodrin means the pesticide 1,4:5,8-
Dimethanonaphthalene,1,2,3,4,10,10-hexacholoro-1,4,4a,5,8,8a-hexahydro-, 
(1alpha, 4alpha, 4abeta, 5beta, 8beta, 8abeta)-, CAS Number 465-73-6.
    (4) Small business means any manufacturer, importer, or processor 
who meets either paragraph (a)(4)(i) or (ii) of this section:
    (i) A business is small if its total annual sales, when combined 
with those of its parent (if any), are less than $40 million. However, 
if the annual manufacture, importation, or processing volume of a 
particular chemical substance at any individual site owned or controlled 
by the business is greater than 45,400 kilograms (100,000 pounds), the 
business shall not qualify as small for purposes of reporting on the 
manufacture, importation, or processing of that chemical substance at 
that site, unless the business qualifies as small under paragraph 
(a)(4)(ii) of this section.

[[Page 23]]

    (ii) A business is small if its total annual sales, when combined 
with those of its parent company (if any), are less than $4 million, 
regardless of the quantity of the particular chemical substance 
manufactured, imported, or processed by that business.
    (iii) For imported and processed mixtures containing HEX-BCH, the 
45,400 kilograms (100,000 pounds) standard in paragraph (a)(4)(i) of 
this section applies only to the amount of HEX-BCH in a mixture and not 
the other components of the mixture.
    (5) 8-hour time weighted average means the cumulative exposure for 
an 8-hour work shift computed as follows:

 
                                                     Ca Ta+Cb Tb+ . . . Cn Tn
                                        E= --------------------------------------------
                                                                 8
 

Where:
    E is the equivalent exposure for the working shift.
    Ci is the concentration (i.e., parts per million) during 
any period of time (Ti) where the concentration remains 
constant.
    Ti is the duration in hours of the exposure at the 
concentration Ci.

    (6) Year means corporate fiscal year.
    (b) Persons who must report. (1) Reports must be submitted by:
    (i) Persons who are manufacturing, importing, or processing HEX-BCH 
for use as an intermediate in the production or isodrin or endrin on or 
after January 2, 1986; and
    (ii) Persons who propose to manufacture, import, or process HEX-BCH 
for use as an intermediate in the production of isodrin or endrin, on or 
after January 2, 1986.
    (2) Persons described in paragraph (b)(1) of this section who engage 
or propose to engage in more than one activity (i.e., manufacture and 
processing) must report the information required in paragraph (d) 
separately for each activity.
    (c) Persons exempt from reporting. (1) Small businesses.
    (2) Persons described in Sec. 704.5(a) and (c).
    (d) Information to report. (1) Initial reports must include, to the 
extent that it is known to or reasonably ascertainable by the person 
reporting, the following information:
    (i) Company name and address.
    (ii) Name, address, and telephone number of the principal contact.
    (iii) Name and address of plant sites where HEX-BCH is or is 
proposed to be manufactured, imported, or processed, noting for each 
plant site which activity takes or would take place at each site.
    (iv) If applicable, the intended date for initiating the 
manufacture, import, or processing of HEX-BCH.
    (v) If applicable, the actual quantity (by weight) of HEX-BCH 
manufactured, imported, or processed during the most recently concluded 
year.
    (vi) The estimated quantity (by weight) of HEX-BCH to be 
manufactured, imported, or processed each year during the first 3 years 
following the date of the report or the date of the intended start of 
manufacture, import, or processing, whichever occurs later.
    (vii) For each year described in paragraphs (d)(1) (v) and (vi) of 
this section: the number or expected number of employees exposed to HEX-
BCH during the manufacture, import, processing, distribution in 
commerce, use, and disposal; the routes of exposure; and the 8-hour time 
weighted average of exposure.
    (viii) If employees are exposed or expected to be exposed to HEX-
BCH, state for each reported route of exposure, whether personal 
protective equipment is used or expected to be used, and a description 
of the personal protective equipment.
    (ix) The actual or anticipated quantity, content, method of 
disposal, and disposal site of any wastes generated or expected to be 
generated during the manufacture, importation, or processing of HEX-BCH.
    (2) Subsequent reports must provide, to the extent known to or 
reasonably ascertainable by the person reporting, the information in 
paragraph (d)(1) of this section and a statement explaining why the 
subsequent report is required.
    (e) When to report. (1) Persons who are manufacturing, importing, or 
processing HEX-BCH on January 2, 1986, must submit an initial report to 
EPA by February 3, 1986.

[[Page 24]]

    (2) Persons who propose to manufacture, import, or process HEX-BCH 
on or after January 2, 1986, must submit an initial report to EPA by 
February 3, 1986, or 30 days after making the management decision 
described in Sec. 704.3 ``Propose to manufacture, import, or process,'' 
whichever is later in time.
    (3) Persons described in paragraph (b) of this section, who have 
submitted a report described in paragraph (d) of this section, must 
submit a subsequent report within 30 days of any of the following 
events. Based on the most recently submitted report:
    (i) The manufacture, importation, or processing of HEX-BCH begins at 
a plant site different than that reported pursuant to paragraph 
(d)(1)(iii) of this section.
    (ii) The actual quantity (by weight) of HEX-BCH manufactured, 
imported, or processed in a given year is greater than or equal to 200 
percent of the estimated value for that year reported pursuant to 
paragraph (d)(1)(vi) of this section.
    (iii) The total number of employees exposed to HEX-BCH is greater 
than 130 percent of the projected value reported pursuant to paragraph 
(d)(1)(vii) of this section.
    (iv) The route of exposures to HEX-BCH differs from that reported 
pursuant to paragraph (d)(1)(vii) of this section.
    (v) The actual 8-hour time weighted average exposure for any 
activity exceeds the projection reported pursuant to paragraph 
(d)(1)(vii) of this section by more than 100 percent.
    (vi) The method of disposal or disposal site reported pursuant to 
paragraph (d)(1)(ix) of this section has changed.
    (vii) Three years have passed since the most recent submission of a 
report and the person is still engaged in the manufacture, importation, 
or processing of HEX-BCH.
    (f) Certification of review. Each person who submits a report under 
this section must for 3 years following the submission date of the most 
recent submission, review their activities at the end of each year to 
determine whether any reportable event specified in paragraph (e)(3) of 
this section has occurred. If a review shows that none of these events 
has occurred, the person is required to certify this fact in writing.
    (g) Recordkeeping. Any person subject to the reporting requirements 
of this section must:
    (1) Retain documentation of information contained in their reports. 
This documentation must be maintained for a period of 3 years from the 
date of the submission of the report; and
    (2) Retain the certification required by paragraph (f) of this 
section for 3 years from the date of its creation.

[50 FR 47536, Nov. 19, 1985, as amended at 52 FR 20083, May 29, 1987. 
Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]



Sec. 704.104  Hexafluoropropylene oxide.

    (a) Definitions. (1) ``HFPO'' means the chemical substance 
hexafluoropropylene oxide, CAS Number 428-59-1. [Listed in TSCA 
Inventory as oxirane, trifluoro(trifluoromethyl)-]
    (2) ``Enclosed process'' means a process that is designed and 
operated so that there is no intentional release of any substance 
present in the process. A process with fugitive, inadvertent, or 
emergency pressure relief releases remains an enclosed process so long 
as measures are taken to prevent worker exposure to and environmental 
contamination from the releases.
    (3) ``Small processor'' means a processor that meets either the 
standard in paragraph (a)(3)(i) of this section or the standard in 
paragraph (a)(3)(ii) of this section.
    (i) First standard. A processor of a chemical substance is small if 
its total annual sales, when combined with those of its parent company, 
if any, are less than $40 million. However, if the annual processing 
volume of a particular chemical substance at any individual site owned 
or controlled by the processor is greater than 45,400 kilograms (100,000 
pounds), the processor shall not qualify as small for purposes of 
reporting on the processing of that chemical substance at that site, 
unless the processor qualifies as small under paragraph (a)(3)(ii) of 
this section.
    (ii) Second standard. A processor of a chemical substance is small 
if its total annual sales, when combined with those of its parent 
company (if any), are less than $4 million, regardless of

[[Page 25]]

the quantity of the particular chemical substance processed by that 
company.
    (iii) Inflation index. EPA will use the Inflation Index described in 
the definition of ``small manufacturer'' that is set forth in Sec. 704.3 
for purposes of adjusting the total annual sales values of this small 
processor definition. EPA will provide Federal Register notification 
when changing the total annual sales values of this definition.
    (b) Persons who must report. Except as provided in paragraph (c) of 
this section, the following persons are subject to this section:
    (1) Persons who manufacture or propose to manufacture HFPO for use 
as an intermediate in the manufacture of fluorinated substances in an 
enclosed process.
    (2) Persons who import or propose to import HFPO for use as an 
intermediate in the manufacture of fluorinated substances in an enclosed 
process.
    (3) Persons who process or propose to process HFPO as an 
intermediate in the manufacture of fluorinated substances in an enclosed 
process.
    (c) Persons not subject to this rule. The following persons are not 
subject to this rule:
    (1) Small processors.
    (2) Persons described in Sec. 704.5 (a) through (d).
    (3) Persons who have already submitted to EPA a completed copy of 
the Preliminary Assessment Information Manufacturer's Report (EPA Form 
7710-35, as described at Sec. 712.28 of this chapter) for HFPO are not 
required to report under this section with respect to activities 
previously reported on.
    (d) What information to report. Persons identified in paragraph (b) 
of this section must submit a Premanufacture Notice Form (EPA Form 7710-
25).
    (e) When to report. (1) Persons who are manufacturing, importing, or 
processing, or who propose to manufacture, import, or process HFPO for 
use as an intermediate in the manufacture of fluorinated substances in 
an enclosed process as of December 10, 1987, must report by February 8, 
1988.
    (2) Persons who propose to manufacture, import, or process HFPO for 
use as an intermediate in the manufacture of fluorinated substances in 
an enclosed process after December 10, 1987, must report within 30 days 
after making a firm management decision to commit financial resources 
for the manufacturing, importing, or processing of HFPO.
    (f) Recordkeeping. Persons subject to the reporting requirements of 
this section must retain documentation of information contained in their 
reports for a period of 5 years from the date of submission of the 
reports.
    (g) Where to send reports. Reports must be submitted by certified 
mail to the Document Control Office (7407), Office of Pollution 
Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 
401 M St., SW., Washington, DC., 20460, ATTN: HFPO Reporting.

[52 FR 41299, Oct. 27, 1987, as amended at 58 FR 34204, June 23, 1993; 
60 FR 16308, Mar. 29, 1995; 60 FR 31920, June 19, 1995; 60 FR 34463, 
July 3, 1995]



Sec. 704.175  4,4'-methylenebis(2-chloroaniline) (MBOCA).

    (a) Substance subject to reporting. The chemical substance 4,4'-
methylenebis(2-chloroaniline) (CAS No. 101-14-4) is subject to reporting 
under this section. The substance also is identified as 4,4'-
methylenebis(2-chlorobenzenamine) and MBOCA.
    (b) Persons who must report. Except as provided in paragraph (c) of 
this section, the following persons are subject to this rule.
    (1) Persons who propose to manufacture MBOCA in the United States on 
or after June 2, 1986.
    (2) Persons who are manufacturing MBOCA in the United States as of 
June 2, 1986.
    (3) Persons manufacturing MBOCA in the United States on or after 
June 2, 1986 who propose to change their manner or method of 
manufacturing the substance from a manner or method of manufacturing 
that previously was reported under this section.
    (c) Persons not subject to this rule. The following persons are 
exempt from the reporting requirements of this section:
    (1) Persons who import MBOCA into the customs territory of the 
United States and do not otherwise manufacture the substance in the 
United States.

[[Page 26]]

    (2) Persons who complied with the requirements of this section prior 
to June 2, 1986 and received written notification of compliance from 
EPA.
    (d) What information to report. Persons who are subject to this rule 
as described in paragraph (b) of this section must report information to 
EPA by completing the following parts of the notice form contained in 
appendix A to part 720 of this chapter: Parts I.A., I.B., I.C.1., 
I.C.3., and II.A.; also, part III as appropriate. Persons subject to the 
requirements of this section also must submit a narrative description of 
any processing and packaging of MBOCA that occurs at the manufacturing 
plant site, including the number of workers potentially exposed to MBOCA 
during on-site processing and packaging of MBOCA and a description of 
any personal protective equipment and/or engineering controls that would 
be used to prevent release of and exposure to MBOCA during on-site 
processing and packaging. Persons subject to the requirements of this 
section are not required to submit information on processing or use of 
MBOCA away from the manufacturing plant site. Respondents to this rule 
shall report all information that is known to or reasonably 
ascertainable by the person reporting.
    (e) When to report. (1) Persons specified in paragraph (b)(1) of 
this section must report by July 2, 1986 or within 30 days after making 
a firm management decision to commit financial resources for the 
manufacture of MBOCA, whichever is later in time.
    (2) Persons specified in paragraph (b)(2) of this section must 
report by July 2, 1986.
    (3) Persons specified in paragraph (b)(3) of this section must 
report within 30 days of making a firm management decision to commit 
financial resources to change their manner or method of manufacturing 
the substance from a manner or method of manufacturing that previously 
was reported under this section.

[51 FR 13223, Apr. 18, 1986, as amended at 52 FR 20083, May 29, 1987; 58 
FR 34204, June 23, 1993]



PART 707--CHEMICAL IMPORTS AND EXPORTS--Table of Contents




Subpart A  [Reserved]

         Subpart B--General Import Requirements and Restrictions

Sec.
707.20  Chemical substances import policy.

Subpart C  [Reserved]

            Subpart D--Notices of Export Under Section 12(b)

707.60  Applicability and compliance.
707.63  Definitions.
707.65  Submission to agency.
707.67  Contents of notice.
707.70  EPA notice to foreign governments.
707.72  Termination of reporting requirements.
707.75  Confidentiality.

    Authority: 15 U.S.C. 2611(b) and 2612.

    Source: 45 FR 82850, Dec. 16, 1980, unless otherwise noted.

Subpart A  [Reserved]



         Subpart B--General Import Requirements and Restrictions



Sec. 707.20  Chemical substances import policy.

    (a) Scope. (1) This statement addresses the policy of the 
Environmental Protection Agency (EPA) on importation of chemical 
substances, mixtures, and articles under section 13 of the Toxic 
Substances Control Act (TSCA; 15 U.S.C. 2601 et seq.). In particular, it 
addresses aspects of the regulation promulgated by the United States 
Customs Service (Customs), Department of the Treasury (19 CFR 12.118 
through 12.127, and 127.28 [amended]) to implement section 13 of TSCA, 
15 U.S.C. 2612. Section 13 requires the Secretary of the Treasury to 
refuse entry into the Customs territory of the United States of a 
chemical substance, mixture, or article if it does not comply with rules 
in effect under TSCA, or if it is offered for entry in violation of TSCA 
or rules or orders under TSCA.
    (2) In addition to this statement of policy, EPA will continue, as 
necessary, to address problems associated

[[Page 27]]

with imports in rulemaking and other actions under individual sections 
of TSCA, i.e., sections 4, 5, 6, 7, 8, and 12. Sections 5, 6, and 7 
apply directly to imports subject to the section 13 requirements. 
Section 12 may apply to export of a shipment that is refused entry under 
section 13. Importers may have obligations under sections 4 and 8; 
section 4 and 8 requirements for importers would not apply to individual 
chemical shipments and thus are not included under section 13 
requirements. Interested persons should refer to the records of these 
individual rulemaking actions for specific information and guidance.
    (b) Objectives. (1) TSCA is intended to be comprehensive, and assure 
protection of health and the environment from unreasonable risks 
associated with chemicals whether the chemicals are imported or produced 
domestically. This intent is manifested by the inclusion of importation 
in the Act's definition of the term ``manufacture'': ``[M]anufacture 
means to import * * *, produce, or manufacture'' (15 U.S.C. 2602(7)). 
Thus, importers are responsible for insuring that chemical importation 
complies with TSCA just as domestic manufacturers are responsible for 
insuring that chemical manufacture complies with TSCA.
    (2)(i) The section 13 rule requires importers to sign the following 
statement for each import of chemical substances subject to TSCA: ``I 
certify that all chemical substances in this shipment comply with all 
applicable rules or orders under TSCA and that I am not offering a 
chemical substance for entry in violation of TSCA or any applicable rule 
or order under TSCA.'' The certification will document that, in 
accordance with TSCA, the importer has taken the necessary steps to 
insure compliance.
    (ii) The section 13 rule requires importers of chemicals not subject 
to TSCA (e.g., pesticides) to certify that compliance with TSCA is not 
required. Importers must certify this by signing the statement: ``I 
certify that all chemicals in this shipment are not subject to TSCA.'' 
This is appropriate when a chemical import is not clearly identified as 
a pesticide or other chemical not subject to TSCA.
    (3) The United States is involved in a major effort toward 
international harmonization in the control of chemicals. At such time as 
international agreement is reached on this issue, EPA would be prepared 
to modify its policy if necessary. EPA believes that its international 
harmonization efforts in the control of chemicals will protect health 
and the environment while fulfilling its obligations under the Trade 
Agreements Act of 1979.
    (c) The section 13 rule--(1) General certification. (i) The rule 
promulgated under section 13 of TSCA by Customs, in consultation with 
EPA, implements the requirement of section 13 that chemical substances, 
mixtures, or articles not in compliance with TSCA, or whose importation 
is not in compliance with TSCA, shall be denied entry into the customs 
territory of the United States. The rule requires that importers certify 
by a statement, on the entry document or invoice, that any shipment of a 
chemical substance subject to TSCA, imported in bulk or as part of a 
mixture, complies with TSCA, and that it is not offered for entry in 
violation of TSCA or any rule or order under TSCA, or that the chemicals 
imported are not subject to TSCA.
    (ii) The certification applies to TSCA sections 5, 6, and 7.
    (iii) EPA expects that this certification will be based upon actual 
knowledge of the importer in most cases. However, EPA realizes that 
sometimes importers may not have actual knowledge of the chemical 
composition of imported mixtures. In these cases, the importer should 
attempt to discover the chemical constituents of the shipment by 
contacting another party to the transaction (e.g., his principal or the 
foreign manufacturer). This person may be able to identify the 
components of the mixture, or at least state that the substances comply 
with TSCA. The greater the effort an importer makes to learn the 
identities of the imported substances and their compliance with TSCA, 
the smaller his chance of committing a violation by importing a 
noncomplying shipment. If a shipment is ultimately determined to have 
violated TSCA, the good faith efforts of the importer to verify 
compliance, as evidenced by documents contained in

[[Page 28]]

his files, may obviate or mitigate the assessment of a civil penalty 
under section 16 of TSCA.
    (2) EPA enforcement. (i) EPA and Customs will monitor chemical 
imports to determine if shipments and their import comply with the 
certification requirements and the substantive mandates of TSCA. Customs 
will refuse entry to any shipment until such time as the certification 
is properly submitted. Customs will also detain a shipment if there are 
reasonable grounds to believe that such shipment or its import violates 
TSCA or regulations or orders thereunder. A violative shipment must 
either be brought into compliance, exported, destroyed, or voluntarily 
abandoned within the time periods prescribed in 19 CFR 12.124 of the 
section 13 rule.
    (ii) When EPA determines that a shipment should be detained, EPA 
will identify the reasons for the detention and the necessary actions 
for an importer to bring the shipment into compliance with TSCA. If EPA 
has given this information to Customs before the district director 
issues the detention notice, the information will become part of the 
detention notice. The importer should contact one of the following EPA 
regional offices for guidance as to the proper procedures to correct any 
deficiencies in the shipment.

                                Region I

John F. Kennedy Federal Building, Boston, MA 02203 (617-223-0586)

                                Region II

26 Federal Plaza, New York, NY 10278 (201-321-6669)

                               Region III

Curtis Building, 6th and Walnut Streets, Philadelphia, PA 19106 (215-
597-7668)

                                Region IV

345 Courtland Street, NE., Atlanta, GA 30365 (404-881-3864)

                                Region V

77 West Jackson Boulevard, Chicago, IL 60604 (312-353-2291)

                                Region VI

1201 Elm Street, Dallas, TX 75270 (214-767-2734)

                               Region VII

324 East 11th Street, Kansas City, MO 64106 (816-374-3036)

                               Region VIII

1860 Lincoln Street, Denver, CO 80295 (303-837-3926)

                                Region IX

215 Fremont Street, San Francisco, CA 94105 (415-974-8119)

                                Region X

1200 Sixth Avenue, Seattle, WA 98101 (206-442-2871)

    (iii) If Customs detains or refuses entry of a shipment (other than 
for failure to make the general certification) and the importer takes 
measures necessary to bring the shipment into conformity with the 
requirements of TSCA, EPA officials will reassess the shipment to 
determine its current compliance status. When a shipment is no longer in 
violation, EPA will notify the district director and the importer. The 
district director will then release the shipment. This notice will also 
serve as a determination to permit entry under 19 CFR 12.123(c) if a 
shipment is brought into compliance before the 19 CFR 12.123(c) 
decisionmaking process has been completed. If compliance is achieved 
after a 19 CFR 12.123(c) determination (adverse to the importer) has 
been made, the EPA notice to the district director will serve as a 
reversal of the decision to refuse entry.
    (3) EPA assistance. Assistance in determining whether a chemical 
shipment is in compliance with TSCA can be obtained from the Director, 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, U.S. Environmental Protection Agency, Room E-543B, 401 M 
St., SW., Washington, DC, 20460, Telephone: (202) 554-1404, TDD: (202) 
544-0551.

[48 FR 55464, Dec. 13, 1983, as amended at 60 FR 34463, July 3, 1995; 62 
FR 1834, Jan. 14, 1997]

[[Page 29]]

Subpart C  [Reserved]



            Subpart D--Notices of Export Under Section 12(b)



Sec. 707.60  Applicability and compliance.

    (a) Section 12(b) of the Toxic Substances Control Act requires any 
person who exports or intends to export a chemical substance or mixture 
to notify the Environmental Protection Agency of such exportation to a 
particular country if any of the following actions have been taken under 
the Act with respect to that chemical substance or mixture:
    (1) Data are required under section 4 or 5(b),
    (2) An order has been issued under section 5,
    (3) A rule has been proposed or promulgated under section 5 or 6, or
    (4) An action is pending, or relief has been granted under section 5 
or 7.
    (b) No notice of export will be required for articles, except PCB 
articles, unless the Agency so requires in the context of individual 
section 5, 6, or 7 actions.
    (c) Any person who exports or intends to export polychlorinated 
biphenyls (PCBs) or PCB articles, for any purpose other than disposal, 
shall notify EPA of such intent or exportation under section 12(b). PCBs 
and PCB articles have the definitions published in Sec. 761.3 of this 
title respectively.
    (d) Any person who would be prohibited by a section 5 or 6 
regulation from exporting a chemical substance or mixture, but who is 
granted an exemption by EPA to export that chemical substance or 
mixture, shall notify EPA under section 12(b) of such intent to export 
or exportation.
    (e) Failure to comply with section 12(b) as set forth in these rules 
will be considered a violation of section 15(3) of the Toxic Substances 
Control Act, and will subject the exporter to the penalty, enforcement, 
and seizure provisions of sections 16 and 17 of the Toxic Substances 
Control Act.



Sec. 707.63  Definitions.

    The definitions set forth in the Toxic Substances Control Act, 
section 3, apply for this part. In addition, the following abbreviations 
and definitions are provided for purposes of this rule:
    (a) EPA means the Environmental Protection Agency.
    (b) Exporter means the person who, as the principal party in 
interest in the export transaction, has the power and responsibility for 
determining and controlling the sending of the chemical substance or 
mixture to a destination out of the customs territory of the United 
States.
    (c) Regulated chemical means any chemical substance or mixture for 
which export notice is required under Sec. 707.60.
    (d) TSCA means the Toxic Substances Control Act.



Sec. 707.65  Submission to agency.

    (a) Exporters must notify EPA of their export or intended export of 
each regulated chemical in accordance with the following:
    (1) The notice must be in writing;
    (2)(i) The notice must be for the first export or intended export to 
a particular country in a calendar year when data are required under 
section 5(b), an order has been issued under section 5, a rule has been 
proposed or promulgated under section 5 or 6, or an action is pending or 
relief has been granted under section 5 or 7.
    (ii) The notice must be for the first export or intended export to a 
particular country when data are required under section 4.
    (3) The notice must be postmarked within seven days of forming the 
intent to export or on the date of export, whichever is earlier. A 
notice of intent to export must be based on a definite contractual 
obligation, or an equivalent intra-company agreement, to export the 
regulated chemical.
    (b) If the EPA action that prompts the notice is a proposed rule, 
the requirement to submit export notices to EPA shall begin thirty days 
after publication of the action in the Federal Register.
    (c) Notices shall be marked ``Section 12(b) Notice'' and sent to the 
Document Control Office (7407), Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, Room

[[Page 30]]

G-099, 401 M St., SW., Washington, DC., 20460.

[45 FR 82850, Dec. 16, 1980, as amended at 53 FR 12522, Apr. 15, 1988; 
58 FR 40242, July 27, 1993; 60 FR 34463, July 3, 1995]



Sec. 707.67  Contents of notice.

    The notice to EPA shall include:
    (a) The name of the regulated chemical as it appears in the section 
4, 5, 6, or 7 action. If a category is regulated, the name of the 
individual regulated chemical within that category, as well as the 
category, must be given. The name shall be that which appears in Volume 
I of the EPA Chemical Substance Inventory, or its supplements, if the 
chemical appears there.
    (b) The name and address of the exporter.
    (c) The country (countries) of import.
    (d) The date(s) of export or intended export.
    (e) The section (4, 5, 6, or 7) of TSCA under which EPA has taken 
action.



Sec. 707.70  EPA notice to foreign governments.

    (a)(1) Notice by EPA to the importing country shall be sent no later 
than 5 working days after receipt by the TSCA Document Processing Center 
of the first annual notification for each regulated chemical when data 
are required under section 5(b), an order has been issued under section 
5, a rule has been proposed or promulgated under section 5 or 6, or an 
action is pending or relief has been granted under section 5 or 7.
    (2) Notice by EPA to the importing country shall be sent no later 
than 5 working days after receipt by the TSCA Document Processing Center 
of the first notification for each regulated chemical when data are 
required under section 4.
    (b) Notices shall:
    (1) Identify the regulated chemical.
    (2) Summarize the regulatory action taken, or indicate the 
availability of data under section 4 or 5(b) of TSCA.
    (3) Identify an EPA official to contact for further information.
    (4) Include a copy of the pertinent Federal Register notice.
    (c) Notices shall be sent to the country's ambassador in Washington, 
DC, or other official designated by the foreign government, and to the 
United States Department of State.

[45 FR 82850, Dec. 16, 1980, as amended at 58 FR 40242, July 27, 1993]



Sec. 707.72  Termination of reporting requirements.

    (a) The reporting requirements of subpart D of this part are 
terminated for certain specific chemical substances and mixtures as set 
forth in this paragraph.
    (1) When data required under part 766 of this chapter have been 
submitted to EPA for a specific chemical substance produced by a 
specific process, and the data show no positive test result as defined 
in Sec. 766.3 of this chapter, reporting is no longer required by 
persons who export or intend to export that substance produced by that 
process.
    (2) [Reserved]
    (b) [Reserved]

[52 FR 21437, June 5, 1987]



Sec. 707.75  Confidentiality.

    (a) A person may assert a claim of confidentiality for any 
information which is submitted to EPA in a notice.
    (b) Any claim of confidentiality must accompany the information at 
the time it is submitted to EPA. In the notice, the submitter must 
clearly identify the information that is claimed confidential by marking 
the specific information on each page with a label such as 
``confidential business information'', ``proprietary'', or ``trade 
secret''.
    (c) Notwithstanding any claim of confidentiality, information 
outlined in Sec. 707.70 will be included in the EPA notice to the 
foreign government. With this exception, EPA will disclose information 
that is covered by a claim of confidentiality asserted in accordance 
with this section only to the extent permitted by, and in accordance 
with, the procedures set forth in TSCA and part 2 of this chapter.
    (d) If a person does not assert a claim of confidentiality for 
information at the time a notice is submitted to EPA, the Agency may 
make the information public, including placement in a public file, 
without further notice to the person.

[[Page 31]]



PART 710--INVENTORY REPORTING REGULATIONS--Table of Contents




Sec.
710.1  Scope and compliance.
710.2  Definitions.
710.3  [Reserved]
710.4  Scope of the inventory.
710.25  Chemical substances for which information must be reported.
710.26  Chemical substances for which information is not required.
710.28  Persons who must report.
710.29  Persons not subject to this subpart.
710.30  Activities for which reporting is not required.
710.32  Reporting information to EPA.
710.33  When to report.
710.35  Duplicative reporting.
710.37  Recordkeeping requirements.
710.38  Confidentiality.
710.39  How do I submit the required information for the 1998 reporting 
          cycle?

    Authority: 15 U.S.C. 2607(a).



Sec. 710.1  Scope and compliance.

    (a) This part establishes regulations governing reporting by certain 
persons who manufacture, import, or process chemical substances for 
commercial purposes under section 8(a) of the Toxic Substances Control 
Act (15 U.S.C. 2607(a)). Section 8(a) authorizes the Administrator to 
require reporting of information necessary for administration of the Act 
and requires EPA to issue regulations for the purpose of compiling an 
inventory of chemical substances manufactured or processed for a 
commercial purpose, as required by section 8(b) of the Act. Following an 
initial reporting period, EPA published an initial inventory of chemical 
substances manufactured, processed or imported for commercial purposes. 
In accordance with section 8(b), EPA periodically amends the inventory 
to include new chemical substances which are manufactured or imported 
for a commercial purpose and reported under section 5(a)(1) of the Act. 
EPA also revises the categories of chemical substances and makes other 
amendments as appropriate.
    (b) Section 15(3) of TSCA makes it unlawful for any person to fail 
or refuse to submit information required under these reporting 
regulations. In addition, section 15(3) makes it unlawful for any person 
to fail to keep, and permit access to, records required by these 
regulations. Section 16 provides that any person who violates a 
provision of section 15 is liable to the United States for a civil 
penalty and may be criminally prosecuted. Pursuant to section 17, the 
Government may seek judicial relief to compel submission of section 8(a) 
information and to otherwise restrain any violation of section 15.
    Note: As a matter of traditional Agency policy, EPA does not intend 
to concentrate its enforcement efforts on insignificant clerical errors 
in reporting.
    (c) Each person who reports under these regulations shall maintain 
records that document information reported under these regulations and, 
in accordance with the Act, permit access to, and the copying of, such 
records by EPA officials.

[42 FR 64572, Dec. 23, 1977, as amended at 45 FR 18375, Mar. 21, 1980; 
60 FR 31921, June 19, 1995]



Sec. 710.2  Definitions.

    In addition to the definitions in Sec. 704.3 in this chapter, the 
following definitions also apply to this part:
    (a) The following terms shall have the meaning contained in the 
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the 
regulations issued under such Act: Cosmetic, device, drug, food, and 
food additive. In addition, the term food includes poultry and poultry 
products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 
453 et seq.; meats and meat food products, as defined in the Federal 
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as 
defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
    (b) The term pesticide shall have the meaning contained in the 
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et 
seq., and the regulations issued thereunder.
    (c) The following terms shall have the meaning contained in the 
Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations 
issued thereunder: byproduct material, source material, and special 
nuclear material.
    (d) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.

[[Page 32]]

    (e) Administrator means the Administrator of the U.S. Environmental 
Protection Agency, any employee or authorized representative of the 
Agency to whom the Administrator may either herein or by order delegate 
his authority to carry out his functions, or any other person who shall 
by operation of law be authorized to carry out such functions.
    (f) An article is a manufactured item: (1) Which is formed to a 
specific shape or design during manufacture, (2) which has end use 
function(s) dependent in whole or in part upon its shape or design 
during end use, and (3) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the article and 
that may occur as described in Sec. 710.4(d)(5); except that fluids and 
particles are not considered articles regardless of shape or design.
    (g) Byproduct means a chemical substance produced without separate 
commercial intent during the manufacture or processing of another 
chemical substance(s) or mixture(s).
    (h) Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical; except that ``chemical substance'' does not include:
    (1) Any mixture,
    (2) Any pesticide when manufactured, processed, or distributed in 
commerce for use as a pesticide,
    (3) Tobacco or any tobacco product, but not including any derivative 
products,
    (4) Any source material, special nuclear material, or byproduct 
material,
    (5) Any pistol, firearm, revolver, shells, and cartridges, and
    (6) Any food, food additive, drug, cosmetic, or device, when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    (i) Commerce means trade, traffic, transportation, or other 
commerce: (1) Between a place in a State and any place outside of such 
State, or (2) which affects trade, traffic, transportation, or commerce 
described in paragraph (i)(1) of this section.
    (j) Distribute in commerce and distribution in commerce when used to 
describe an action taken with respect to a chemical substance or mixture 
or article containing a substance or mixture, mean to sell or the sale 
of, the substance, mixture, or article in commerce; to introduce or 
deliver for introduction into commerce, or the introduction or delivery 
for introduction into commerce of, the substance, mixture, or article; 
or to hold, or the holding of, the substance, mixture, or article after 
its introduction into commerce.
    (k) EPA means the U.S. Environmental Protection Agency.
    (l) Importer means any person who imports any chemical substance or 
any chemical substance as part of a mixture or article into the customs 
territory of the U.S. and includes:
    (1) The person primarily liable for the payment of any duties on the 
merchandise, or
    (2) An authorized agent acting on his behalf (as defined in 19 CFR 
1.11).
    (m) Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    (n) Intermediate means any chemical substance:
    (1) Which is intentionally removed from the equipment in which it is 
manufactured, and (2) which either is consumed in whole or in part in 
chemical reaction(s) used for the intentional manufacture of other 
chemical substance(s) or mixture(s), or is intentionally present for the 
purpose of altering the rate of such chemical reaction(s).
    Note: The equipment in which it was manufactured includes the 
reaction vessel in which the chemical substance was manufactured and 
other equipment which is strictly ancillary to the reaction vessel, and 
any other equipment through which the chemical substance may flow during 
a continuous flow process, but does not include tanks or other vessels 
in which the chemical substance is stored after its manufacture.
    (o) Manufacture means to produce or manufacture in the United States 
or import into the customs territory of the United States.

[[Page 33]]

    (p) Manufacture or import ``for commercial purposes'' means to 
manufacture or import:
    (1) For distribution in commerce, including for test marketing 
purposes, or
    (2) For use by the manufacturer, including for use as an 
intermediate.
    (q) Mixture means any combination of two or more chemical substances 
if the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that ``mixture'' does 
include:
    (1) Any combination which occurs, in whole or in part, as a result 
of a chemical reaction if the combination could have been manufactured 
for commercial purposes without a chemical reaction at the time the 
chemical substances comprising the combination were combined and if, 
after the effective date or premanufacture notification requirements, 
none of the chemical substances comprising the combination is a new 
chemical substance, and
    (2) Hydrates of a chemical substance or hydrated ions formed by 
association of a chemical substance with water.
    (r) New chemical substance means any chemical substance which is not 
included in the inventory compiled and published under subsection 8(b) 
of the Act.
    (s) Person means any natural or juridicial person including any 
individual, corporation, partnership, or association, any State or 
political subdivision thereof, or any municipality, any interstate body 
and any department, agency, or instrumentality of the Federal 
Government.
    (t) Process means the preparation of a chemical substance or 
mixture, after its manufacture, for distribution in commerce (1) in the 
same form or physical state as, or in a different form or physical state 
from, that in which it was received by the person so preparing such 
substance or mixture, or (2) as part of a mixture or article containing 
the chemical substance or mixture.
    (u) Process for ``commercial purposes'' means to process (1) for 
distribution in commerce, including for test marketing purposes, or (2) 
for use as an intermediate.
    (v) Processor means any person who processes a chemical substance or 
mixture.
    (w) Site means a contiguous property unit. Property divided only by 
a public right-of-way shall be considered one site. There may be more 
than one manufacturing plant on a single site. For the purposes of 
imported chemical substances, the site shall be the business address of 
the importer.
    (x) Small maufacturer or importer means a manufacturer or importer 
whose total annual sales are less than $5,000,000, based upon the 
manufacturer's or importer's latest complete fiscal year as of January 
1, 1978, except that no manufacturer or importer is a ``small 
manufacturer or importer'' with respect to any chemical substance which 
such person manufactured at one site or imported in quantities greater 
than 100,000 pounds during calendar year 1977. In the case of a company 
which is owned or controlled by another company, total annual sales 
shall be based on the total annual sales of the owned or controlled 
company, the parent company, and all companies owned or controlled by 
the parent company taken together.
    Note: The purpose of the exception to the definition is to ensure 
that manufacturing and importers report production volumes for all 
chemical substances which they manufactured at one site or imported in 
quantities equal to or greater than 100,000 pounds during calendar year 
1977.
    (y) Small quantities for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including any such research or analysis for the 
development of a product (hereinafter sometimes shortened to small 
quantities for research and development) means quantities of a chemical 
substance manufactured, imported, or processed or proposed to be 
manufactured, imported, or processed that (1) are no greater than 
reasonably necessary for such purposes and (2) after the publication of 
the revised inventory, are used by, or directly under the supervision 
of, a technically qualified individual(s).
    Note: Any chemical substances manufactured, imported or processed in 
quantities less than 1,000 pounds annually shall be presumed to be 
manufactured, imported or processed for research and development 
purposes.

[[Page 34]]

No person may report for the inventory any chemical substance in such 
quantities unless that person can certify, that the substance was not 
manufactured, imported, or processed solely in small quantities for 
research and development, as defined in this section.
    (z) State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, the Northern Mariana Islands, or any other 
territory or possession of the United States.
    (aa) Technically qualified individual means a person: (1) Who 
because of his education, training, or experience, or a combination of 
these factors, is capable of appreciating the health and environmental 
risks associated with the chemical substance which is used under his 
supervision, (2) who is responsible for enforcing appropriated methods 
of conducting scientific experimentation, analysis, or chemical research 
in order to minimize such risks, and (3) who is responsible for the 
safety assessments and clearances related to the procurement, storage, 
use, and disposal of the chemical substance as may be appropriate or 
required within the scope of conducting the research and development 
activity. The responsibilities in paragraph (aa)(3) of this section may 
be delegated to another individual, or other individuals, as long as 
each meets the criteria in paragraph (aa)(1) of this section.
    (bb) Test marketing means the distribution in commerce of no more 
than a predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture or article in commerce.
    (cc) United States, when used in the geographic sense, means all of 
the States, territories, and possessions of the United States.
    (dd) Master Inventory File means EPA's comprehensive list of 
chemical substances which constitute the Chemical Substances Inventory 
compiled under section 8(b) of the Act. It includes substances reported 
under subpart A of this part and substances reported under part 720 of 
this chapter for which a Notice of Commencement of Manufacture or Import 
has been received under Sec. 720.120 of this chapter.
    (ee) Nonisolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture.
    (ff) Site-limited means a chemical substance is manufactured and 
processed only within a site and is not distributed for commercial 
purposes as a substance or as part of a mixture or article outside the 
site. Imported substances are never site-limited.

[42 FR 64572, Dec. 23, 1977, as amended at 60 FR 31921, June 19, 1995]



Sec. 710.3  [Reserved]



Sec. 710.4  Scope of the inventory.

    (a) Chemical substances subject to these regulations. Only chemical 
substances which are manufactured, imported, or processed ``for a 
commercial purpose,'' as defined in Sec. 710.2, are subject to these 
regulations.
    (b) Naturally occurring chemical substances automatically included. 
Any chemical substance which is naturally occurring and:
    (1) Which is (i) unprocessed or (ii) processed only by manual, 
mechanical, or gravitational means; by dissolution in water; by 
flotation; or by heating solely to remove water; or
    (2) Which is extracted from air by any means, shall automatically be 
included in the inventory under the category ``Naturally Occurring 
Chemical Substances.'' Examples of such substances are: raw agricultural 
commodities; water, air, natural gas, and crude oil; and rocks, ores, 
and minerals.
    (c) Substances excluded by definition or section 8(b) of TSCA. The 
following substances are excluded from the inventory:

[[Page 35]]

    (1) Any substance which is not considered a ``chemical substance'' 
as provided in subsection 3(2)(B) of the Act and in the definition of 
``chemical substance'' in Sec. 710.2(h);
    (2) Any mixture as defined in Sec. 710.2(q);
    Note: A chemical substance that is manufactured as part of a mixture 
is subject to these reporting regulations. This exclusion applies only 
to the mixture and not to the chemical substances of which the mixture 
is comprised. The term ``mixture'' includes alloys, inorganic glasses, 
ceramics, frits, and cements, including Portland cement.
    (3) Any chemical substance which is manufactured, imported, or 
processed solely in small quantities for research and development, as 
defined in Sec. 710.2(y); and
    (4) Any chemical substance not manufactured, processed or imported 
for a commercial purpose since January 1, 1975.
    (d) Chemical substances excluded from the inventory. The following 
chemical substances are excluded from the inventory. Although they are 
considered to be manufactured or processed for a commercial purpose for 
the purpose of section 8 of the Act, they are not manufactured or 
processed for distribution in commerce as chemical substances per se and 
have no commercial purpose separate from the substance, mixture, or 
article of which they may be a part.
    Note: In addition, chemical substances excluded here will not be 
subject to premanufacture notification under section 5 of the Act.
    (1) Any impurity.
    (2) Any byproduct which has no commercial purpose.
    Note: A byproduct which has commercial value only to municipal or 
private organizations who (i) burn it as a fuel, (ii) dispose of it as a 
waste, including in a landfill or for enriching soil, or (iii) extract 
component chemical substances which have commercial value, may be 
reported for the inventory, but will not be subject to premanufacturing 
notification under section 5 of the Act if not included.
    (3) Any chemical substance which results from a chemical reaction 
that occurs incidental to exposure of another chemical substance, 
mixture, or article to environmental factors such as air, moisture, 
microbial organisms, or sunlight.
    (4) Any chemical substance which results from a chemical reaction 
that occurs incidental to storage of another chemical substance, 
mixture, or article.
    (5) Any chemical substance which results from a chemical reaction 
that occurs upon end use of other chemical substances, mixtures, or 
articles such as adhesives, paints, miscellaneous cleansers or other 
housekeeping products, fuels and fuel additives, water softening and 
treatment agents, photographic, films, batteries, matches, and safety 
flares, and which is not itself manufactured for distribution in 
commerce or for use as an intermediate.
    (6) Any chemical substance which results from a chemical reaction 
that occurs upon use of curable plastic or rubber molding compounds, 
inks, drying oils, metal finishing compounds, adhesives, or paints; or 
other chemical substances formed during manufacture of an article 
destined for the marketplace without further chemical change of the 
chemical substance except for those chemical changes that may occur as 
described elsewhere in this Sec. 710.4(d).
    (7) Any chemical substance which results from a chemical reaction 
that occurs when (i) a stabilizer, colorant, odorant, antioxidant, 
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, 
antifoamer or de-foamer, dispersant, precipitation inhibitor, binder, 
emulsifier, de-emulsifier, dewatering agent, agglomerating agent, 
adhesion promoter, flow modifier, pH neutralizer, sequesterant, 
coagulant, flocculant, fire retardant, lubricant, chelating agent, or 
quality control reagent functions as intended or (ii) a chemical 
substance, solely intended to impart a specific physicochemical 
characteristic, functions as intended.
    (8) Chemical substances which are not intentionally removed from the 
equipment in which they were manufactured.
    Note: See note to definition of ``intermediate'' at Sec. 710.2(n) 
for explanation of ``equipment in which it was manufactured.''

[42 FR 64572, Dec. 23, 1977]

[[Page 36]]



Sec. 710.25  Chemical substances for which information must be reported.

    Any chemical substance which is in the Master Inventory File at the 
beginning of a reporting period described in Sec. 710.33, unless the 
chemical substance is specifically excluded by Sec. 710.26.

[51 FR 21447, June 12, 1986]



Sec. 710.26  Chemical substances for which information is not required.

    The following categories of chemical substances are excluded from 
the reporting requirements of this subpart. However, a chemical 
substance described in paragraphs (a), (b), or (c) of this section is 
not excluded from the reporting requirements of this subpart if that 
substance is the subject of a rule proposed or promulgated under section 
4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order 
issued under section 5(e) or 5(f) of the Act, or is the subject of 
relief that has been granted under a civil action under section 5 or 7 
of the Act.
    (a) Inorganic chemical substances. Any chemical substance which does 
not contain carbon or contains carbon only in the form of carbonato 
[=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC], or 
isocyanato [-NCO] groups, or the chalcogen analogues of such groups.
    (b) Polymers. (1) Any chemical substance described with the word 
fragments ``*polym*'', ``*alkyd'', or ``*oxylated'' in the Chemical 
Abstracts Service Index or Preferred Nomenclature in the Chemical 
Substance Identities section of the 1985 edition of the Inventory or in 
the Master Inventory File, where the asterisk (*) indicates that any 
sets of characters may precede, or follow, the character string defined.
    (2) Any chemical substance which is identified in the 1985 edition 
of the Inventory or the Master Inventory File as siloxane and silicone, 
silsesquioxane, a protein (albumin, casein, gelatin, gluten, 
hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), 
rubber, or lignin. This exclusion, however, does not apply to a chemical 
substance which has been hydrolyzed, depolymerized, or chemically 
modified to the extent that the final product is no longer polymeric in 
structure.
    (c) Microorganisms. Any combination of chemical substances that is a 
living organism, such as bacteria, eimeria, fungi, and yeasts. Any 
chemical substance produced from such a living organism is reportable 
unless otherwise excluded.
    (d) Naturally occurring chemical substances. Any naturally occurring 
chemical substance, as described in Sec. 710.4(b). The applicability of 
this exclusion is determined in each case by the specific activities of 
the person who manufactures the substance in question. Some chemical 
substances can be manufactured both as described in Sec. 710.4(b) and by 
means other than those described in Sec. 710.4(b). If a person described 
in Sec. 710.28 manufactures a chemical substance by means other than 
those described in Sec. 710.4(b), the person must report regardless of 
whether the substance also could have been produced as described in 
Sec. 710.4(b). Any chemical substance that is produced from such a 
naturally occurring chemical substance described in Sec. 710.4(b) is 
reportable unless otherwise excluded.

[51 FR 21447, June 12, 1986]



Sec. 710.28  Persons who must report.

    Except as provided in Secs. 710.29 and 710.30, the following persons 
are subject to the requirements of this subpart. Persons must determine 
whether they must report under this Sec. 710.28 for each chemical 
substance that they manufacture at an individual site.
    (a) Persons subject to initial reportinq. Any person who 
manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or 
more of a chemical substance described in Sec. 710.25 at any single site 
owned or controlled by that person at any time during the person's 
latest complete corporate fiscal year before August 25, 1986.
    (b) Persons subject to recurring reporting. Any person who 
manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or 
more of a chemical substance described in Sec. 710.25 at any single site 
owned or controlled by that person at any time during the person's 
latest complete corporate fiscal year before August 25, 1990, or before 
August 25 at four-year intervals thereafter.

[[Page 37]]

    (c) Special provisions for importers. For purposes of paragraphs (a) 
and (b) of this section, the site for a person who imports a chemical 
substance described in Sec. 710.25 is the site of the operating unit 
within the person's organization which is directly responsible for 
importing the substance and which controls the import transaction. The 
import site may in some cases be the organization's headquarters in the 
U.S. (See also Sec. 710.35(b).)

[51 FR 21447, June 12, 1986]



Sec. 710.29  Persons not subject to this subpart.

    A person described in Sec. 710.28 is not subject to the requirements 
of this subpart if that person qualifies as a small manufacturer as that 
term is defined in Sec. 704.3 of this chapter. Notwithstanding this 
exclusion, a person who qualifies as a small manufacturer is subject to 
this subpart with respect to any chemical substance that is the subject 
of a rule proposed or promulgated under section 4, 5(b)(4), or 6 of the 
Act, or is the subject of an order in effect under section 5(e) of the 
Act, or is the subject of relief that has been granted under a civil 
action under section 5 or 7 of the Act.

[51 FR 21447, June 12, 1986]



Sec. 710.30  Activities for which reporting is not required.

    A person described in Sec. 710.28 is not subject to the requirements 
of this subpart with respect to any chemical substance described in 
Sec. 710.25 that the person manufactured or imported under the following 
circumstances:
    (a) The person manufactured or imported the chemical substance 
described in Sec. 710.25 solely in small quantities for research and 
development,
    (b) The person imported the chemical substance described in 
Sec. 710.25 as part of an article,
    (c) The person manufactured the chemical substance described in 
Sec. 710.25 in a manner described in Sec. 720.30(g) or (h) of this 
chapter.

[51 FR 21447, June 12, 1986]



Sec. 710.32  Reporting information to EPA.

    Any person who must report under this part must submit the 
information prescribed in this section for each chemical substance 
described in Sec. 710.25 that the person manufactured for commercial 
purposes in an amount of 10,000 pounds (4,540 kilograms) or more at a 
single site during a corporate fiscal year described in Sec. 710.28. 
(The site for a person who imports a chemical substance is the site of 
the operating unit within the person's organization which is directly 
responsible for importing the substance and which controls the import 
transaction, and may in some cases be the organization's headquarters 
office in the U.S.). A respondent to this subpart must report 
information in writing or by magnetic media as prescribed in this 
section, to the extent that such information is known to or reasonably 
ascertainable by that person. A respondent to this subpart must report 
information that applies to the specific corporate fiscal year for which 
the person is required to report.
    (a) Reporting in writing. Any person who chooses to report 
information to EPA in writing must do so by completing the reporting 
form available from EPA at the address set forth in Sec. 710.39(b). The 
form must include all information prescribed in paragraph (c) of this 
section. Persons reporting in writing must submit a separate form for 
each site for which the person is required to report.
    (b) Reporting by magnetic media. Any person who chooses to report 
information to EPA by means of magnetic media must submit the 
information prescribed in paragraph (c) of this section. Magnetic media 
submitted in response to this subpart must meet EPA specifications, as 
described in the instruction booklet available from EPA at the address 
set forth in Sec. 710.39(b).
    (c) Information to be reported. Persons reporting information under 
this subpart must report the following:
    (1) The name, company, address, city, State, Zip code, and telephone 
number of a person who will serve as technical contact for the 
respondent company, and will be able to answer questions about the 
information submitted by the company to EPA. Persons reporting by means 
of magnetic media must

[[Page 38]]

submit this information on the reporting form available from EPA at the 
address set forth in Sec. 710.39.
    (2) A certification statement signed and dated by an authorized 
official of the respondent company. Persons reporting by means of 
magnetic media must submit this information on the reporting form 
available from EPA at the address set forth in Sec. 710.39.
    (3) The specific chemical name and Chemical Abstracts Service (CAS) 
Registry Number of each chemical substance for which reporting is 
required under this subpart. A respondent to this subpart may use other 
chemical identification numbers in lieu of CAS Registry Numbers when a 
CAS Registry Number is not known to the respondent as provided in the 
instruction booklet identified in Sec. 710.39(b), including EPA-
designated Accession Numbers for confidential substances, EPA-assigned 
numbers for bona fide or Premanufacture Notification submissions, or 
Test Market Exemption Applications, or original Inventory form numbers.
    (4) The name, street address, city, State, and Zip code of each site 
at which 10,000 pounds (4,540 kilograms) or more of a chemical substance 
for which reporting is required under this subpart is manufactured or 
imported. (The site for a person who imports a chemical substance is the 
site of the operating unit within the person's organization which is 
directly responsible for importing the substance and which controls the 
import transaction, and may in some cases be the organization's 
headquarters office in the U.S.) A respondent to this subpart must 
include the appropriate Dun and Bradstreet Number for each plant site 
reported.
    (5) A statement for each substance for which information is being 
submitted indicating whether the substance is manufactured in the United 
States or imported into the United States.
    (6) A statement for each substance for which information is being 
submitted indicating whether the substance is site-limited.
    (7) The total volume (in pounds) of each subject chemical substance 
manufactured or imported at each site. This amount must be reported to 
two significant figures of accuracy provided that the reported figures 
are within 10 percent of the actual volume.

[55 FR 39587, Sept. 27, 1990, as amended at 60 FR 31921, June 19, 1995]



Sec. 710.33  When to report.

    All information reported to EPA in response to the requirements of 
this subpart must be submitted during an applicable reporting period. 
The following reporting periods are prescribed for this subpart.
    (a) Initial reporting period. The first reporting period is from 
August 25, 1986 to December 23, 1986. Any person described in 
Sec. 710.28(a) must report during this period for each chemical 
substance described in Sec. 710.25 that the person manufactured during 
the corporate fiscal year described in Sec. 710.28(a).
    (b) Recurring reporting periods. The first recurring reporting 
period is from August 25, 1990 to December 23, 1990. Subsequent 
reporting periods, except as provided in paragraph (c) of this section, 
are from August 25 to December 23 at 4-year intervals thereafter. Any 
person described in Sec. 710.28(b) must report during the appropriate 
reporting period for each chemical substance described in Sec. 710.25 
that the person manufactured during the applicable corporate fiscal year 
described in Sec. 710.28(b).
    (c) Reporting in 1998. The 1998 reporting period is from August 25, 
1998 until January 31, 1999. Any person described in Sec. 710.28(b) must 
report during this reporting period for each chemical substance 
described in Sec. 710.25 that the person manufactured during the 
applicable corporate fiscal year described in Sec. 710.28(b). This 
reporting period is applicable to 1998 reporting only.

[51 FR 21447, June 12, 1986: 51 FR 22521, June 20, 1986, as amended at 
63 FR 71600, Dec. 29, 1998]



Sec. 710.35  Duplicative reporting.

    (a) With regard to section 8(a) rules. Any person subject to the 
requirements of this part who previously has complied with reporting 
requirements of a rule under section 8(a) of the Act by submitting the 
information described

[[Page 39]]

in Sec. 710.32 for a chemical substance described in Sec. 710.25 to EPA, 
and has done so within one year of the start of a reporting period 
described in Sec. 710.33, is not required to report again on the 
manufacture of that substance at that site during that reporting period.
    (b) With regard to importers. This part requires that only one 
report be submitted on each import transaction involving a chemical 
substance described in Sec. 710.25. When two or more persons are 
involved in a particular import transaction and each person meets the 
Agency's definition of ``importer'' as set forth in Secs. 710.2(l) and 
704.3 of this chapter, they may determine among themselves who should 
submit the required report; if no report is submitted as required under 
this part, EPA will hold each such person liable for failure to report.

[51 FR 21447, June 12, 1986, as amended at 60 FR 31921, June 19, 1995]



Sec. 710.37  Recordkeeping requirements.

    Each person who is subject to the reporting requirements of this 
part must maintain records that document any information reported to 
EPA. For substances that are manufactured or imported at less than 
10,000 pounds annually, volume records must be maintained as evidence to 
support a decision not to submit a report. Records relevant to reporting 
during a reporting period described in Sec. 710.33 must be retained for 
a period of four years beginning with the effective date of that 
reporting period.

[51 FR 21447, June 12, 1986, as amended at 58 FR 34204, June 23, 1993; 
60 FR 31921, June 19, 1995]



Sec. 710.38  Confidentiality.

    (a) Any person submitting information under this part may assert a 
business confidentiality claim for the information. The procedures for 
asserting confidentiality claims are described in the instruction 
booklet identified in Sec. 710.39. Information claimed as confidential 
in accordance with this section and those instructions will be treated 
and disclosed in accordance with the procedures in part 2 of this 
chapter.
    (b) A person may assert a claim of confidentiality for the chemical 
identity of a specific chemical substance only if the identity of that 
substance is treated as confidential in the Master Inventory File as of 
the time the report is submitted for that substance under this part.
    (c) To assert a claim of confidentiality for the chemical identity 
of a specific chemical substance, the person must take the following 
steps:
    (1) The person must submit with the report detailed written answers 
to the following questions signed and dated by an authorized official.
    (i) What harmful effects to your competitive position, if any, do 
you think would result from the identity of the chemical substance being 
disclosed in connection with reporting under this part? How could a 
competitor use such information? Would the effects of disclosure be 
substantial? What is the causal relationship between the disclosure and 
the harmful effects?
    (ii) How long should confidential treatment be given? Until a 
specific date, the occurrence of a specific event, or permanently? Why?
    (iii) Has the chemical substance been patented? If so, have you 
granted licenses to others with respect to the patent as it applies to 
the chemical substance? If the chemical substance has been patented and 
therefore disclosed through the patent, why should it be treated as 
confidential?
    (iv) Has the identity of the chemical substance been kept 
confidential to the extent that your competitors do not know it is being 
manufactured or imported for a commercial purpose by anyone?
    (v) Is the fact that the chemical substance is being manufactured or 
imported for a commercial purpose available to the public, for example 
in technical journals, libraries, or State, local, or Federal agency 
public files?
    (vi) What measures have you taken to prevent undesired disclosure of 
the fact that this chemical substance is being manufactured or imported 
for a commercial purpose?
    (vii) To what extent has the fact that this chemical substance is 
manufactured or imported for commercial purposes been revealed to 
others? What

[[Page 40]]

precautions have been taken regarding these disclosures? Have there been 
public disclosures or disclosures to competitors?
    (viii) Does this particular chemical substance leave the site of 
manufacture in any form, as product, effluent, emission, etc.? If so, 
what measures have you taken to guard against discovery of its identity?
    (ix) If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the substance be 
identified by analysis of the product?
    (x) For what purpose do you manufacture or import the substance?
    (xi) Has EPA, another Federal agency, or any Federal court made any 
pertinent confidentiality determinations regarding this chemical 
substance? If so, please attach copies of such determinations.
    (2) If any of the information contained in the answers to the 
questions is asserted to contain confidential business information, the 
person must mark that information as ``trade secret,'' ``confidential,'' 
or other appropriate designation.
    (d) If no claim of confidentiality accompanies information at the 
time it is submitted to EPA under this part or if substantiation 
required under paragraph (c) of this section is not submitted with the 
reporting form, EPA may make the information available to the public 
without further notice to the submitter.

[51 FR 21447, June 12, 1986, as amended at 55 FR 39588, Sept. 27, 1990; 
60 FR 31921, June 19, 1995]



Sec. 710.39   How do I submit the required information for the 1998 reporting cycle?

    (a) Use the proper EPA form. You must use the EPA form identified as 
``Form U'' to submit written information in response to the requirements 
of this subpart. Copies of the Form U are available from EPA at the 
address set forth in paragraph (c) of this section, from the EPA 
Internet Home Page at http://www.epa.gov/opptintr/iur98, or via Fax-on-
Demand by using a faxphone to call (202) 401-0527 and selecting item 
5119.
    (b) Follow the reporting instructions. You should follow the 
detailed instructions for completing the reporting form and preparing a 
magnetic media report, which are given in the EPA publication entitled 
``Instructions for Reporting for Partial Updating of the TSCA Chemical 
Inventory Data Base,'' via the Internet or the TSCA Hotline.
    (c) Obtain the reporting package and copies of the form. EPA is 
mailing the reporting package to those companies that reported in 1994. 
Failure to receive a reporting package does not obviate or otherwise 
affect the requirement to submit a timely report. If you did not receive 
a reporting package, but are required to report, you may obtain a copy 
of the reporting package and the reporting form from EPA by submitting a 
request for this information as follows:
    (1) By phone. Call the EPA TSCA Hotline at (202) 554-1404, or TDD 
202-554-0551.
    (2) By e-mail. Send an e-mail request for this information to the 
EPA TSCA Hotline at [email protected].
    (3) By mail. Send a written request for this information to the 
following address: TSCA Hotline, Mail Code 7408, ATTN: Inventory Update 
Rule, Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    (d) Submit the completed reports. You must submit your completed 
reporting form(s) and/or magnetic media to EPA at the following address: 
Document Control Officer, Mail Code 7407, ATTN: Inventory Update Rule, 
Office of Pollution Prevention and Toxics, U.S. Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.

[63 FR 45953, Aug. 28, 1998]



PART 712--CHEMICAL INFORMATION RULES--Table of Contents




                      Subpart A--General Provisions

Sec.
712.1  Scope and compliance.
712.3  Definitions.
712.5  Method of identification of substances for reporting purposes.
712.7  Report of readily obtainable information for subparts B and C.

[[Page 41]]

712.15  Confidentiality.

 Subpart B--Manufacturers Reporting--Preliminary Assessment Information

712.20  Manufacturers and importers who must report.
712.25  Exempt manufacturers and importers.
712.28  Form and instructions.
712.30  Chemical lists and reporting periods.

    Authority: 15 U.S.C. 2607(a).

    Source: 47 FR 26998, June 22, 1982, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 712.1  Scope and compliance.

    (a) This part establishes procedures for chemical manufacturers and 
processors to report production, use, and exposure-related information 
on listed chemical substances. Subpart A establishes requirements that 
apply to all reporting under this part. Subpart B covers manufacturers' 
and processors' reporting.
    (b) Chemical substances, mixtures, and categories of substances or 
mixtures which have been recommended by the Interagency Testing 
Committee for testing consideration by the Agency but not designated for 
Agency response within 12 months, will be added to Sec. 712.30 using the 
procedure specified in Sec. 712.30(c) only to the extent that the total 
number of designated and recommended chemicals has not exceeded 50 in 
any 1 year. Additional recommended but not designated chemicals may be 
added after proposal, and consideration of public comment.

[47 FR 26998, June 22, 1982, as amended at 50 FR 34809, Aug. 28, 1985; 
60 FR 31921, June 19, 1995]



Sec. 712.3  Definitions.

    The definitions in section 3 of TSCA, 15 U.S.C. 2602, apply for this 
part. In addition, the following definitions apply:
    (a) Byproduct means any chemical substance or mixture produced 
without a separate commercial intent during the manufacture, processing, 
use, or disposal of another chemical substance or mixture.
    (b) EPA means the U.S. Environmental Protection Agency.
    (c) Import in bulk form means to import a chemical substance (other 
than as part of a mixture or article) in any quantity, in cans, bottles, 
drums, barrels, packages, tanks, bags, or other containers used for 
purposes of transportation or containment, if the chemical substance has 
an end use or commercial purpose separate from the container.
    (d) Importer means anyone who imports a chemical substance, 
including a chemical substance as part of a mixture or article, into the 
customs territory of the U.S. and includes the person liable for the 
payment of any duties on the merchandise, or an authorized agent on his 
behalf. Importer also includes, as appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20.
    (4) The transferee, if the right to withdraw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144. For the purposes of this definition, the customs territory of 
the U.S. consists of the 50 states, Puerto Rico, and the District of 
Columbia.
    (e) Impurity means a chemical substance unintentionally present with 
another chemical substance or mixture.
    (f) Intermediate means any chemical substance that is consumed, in 
whole or in part, in chemical reactions used for the intentional 
manufacture of other chemical substances or mixtures, or that is 
intentionally present for the purpose of altering the rates of such 
chemical reactions. (See also paragraph (j) of this section.)
    (g) Known to or reasonably ascertainable by means all information in 
a person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know, or could obtain without unreasonable burden.
    (h) Manufacture for commercial purposes means to import, produce, or 
manufacture with the purpose of obtaining an immediate or eventual 
commercial advantage for the manufacturer and includes, among other

[[Page 42]]

things, such ``manufacture'' of any amount of a chemical substance or 
mixture:
    (1) For commercial distribution, including for test marketing.
    (2) For use by the manufacturer, including use for product research 
and development, or as an intermediate. Manufacture for commercial 
purposes also applies to substances that are produced coincidentally 
during the manufacture, processing, use, or disposal of another 
substance or mixture, including byproducts and coproducts that are 
separated from that other substance or mixture, and impurities that 
remain in that substance or mixture. Byproducts and impurities may not 
in themselves have commercial value. They are nonetheless produced for 
the purpose of obtaining a commercial advantage since they are part of 
the manufacture of a chemical produced for a commercial purpose.
    (i) Mixture means any combination of two or more chemical substances 
if the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that mixture does 
include (1) any combination which occurs, in whole or in part, as a 
result of a chemical reaction if the combination could have been 
manufactured for commercial purposes without a chemical reaction at the 
time the chemical substances comprising the combination were combined, 
and if all of the chemical substances comprising the combination are 
included in the EPA, TSCA Chemical Substance Inventory after the 
effective date of the premanufacture notification requirement under 40 
CFR part 720, and (2) hydrates of a chemical substance or hydrated ions 
formed by association of a chemical substance with water. The term 
mixture includes alloys, inorganic glasses, ceramics, frits, and 
cements, including Portland cement.
    (j) Non-isolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture. (See also paragraph (f) of this section.)
    (k) Owned or controlled by the parent company means the parent owns 
or controls 50 percent or more of the other company's voting stock or 
other equity rights, or has the power to control the management and 
policies of the other company.
    (l) Person means any natural person, firm, company, corporation, 
joint venture, partnership, sole proprietorship, association, or any 
other business entity, any State or political subdivision thereof, any 
municipality, any interstate body, and any department, agency, or 
instrumentality of the Federal government.
    (m) Process for commercial purposes means the preparation of a 
chemical substance or mixture, after its manufacture, for distribution 
in commerce with the purpose of obtaining an immediate or eventual 
commercial advantage for the processor. Processing of any amount of a 
chemical substance or mixture is included. If a chemical or mixture 
containing impurities is processed for commercial purposes, then those 
impurities are also processed for commercial purposes.
    (n) Site means a contiguous property unit. Property divided only by 
a public right-of-way shall be considered one site. There may be more 
than one manufacturing plant on a single site.
    (o) Test marketing means distributing in commerce a limited amount 
of a chemical substance or mixture, or article containing such substance 
or mixture, to a defined number of potential customers, during a 
predetermined testing period, to explore market capability prior to 
broader distribution in commerce.
    (p) TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.




Sec. 712.5  Method of identification of substances for reporting purposes.

    (a) Report on TSCA-regulable quantities. Unless specifically 
otherwise required, respondents must report only about quantities of a 
chemical that is defined as a chemical substance under TSCA section 
3(2).
    (b) Chemicals from natural sources. A manufacturer of a chemical 
substance

[[Page 43]]

which is extracted from an ore, from oil, or from any other natural 
source must report only about the manufacturing steps for, and the uses 
of, that chemical, not about production of the natural source material 
or other crude precursors derived from the natural source material.

    For example, persons who manufacture a chemical substance such as 
``sweetened naphtha, 64741-87-3,'' but do not refine the naphtha to 
produce ``hexane, 110-54-3'' would not report on hexane. Only the 
production of ``hexane'' as an isolated product must be reported--not 
previous production of more crude, complex substances such as naphtha 
from which hexane is extracted. Thus, persons who produce crude oil, 
ores, and other crude natural materials, but do not carry them through 
further manufacturing steps that produce a listed chemical have no 
reporting responsibilities under this Part. Note, however, that any 
method of extraction, refinement, or purification of a listed chemical 
substance is considered to be manufacturing for the purposes of this 
rule.

    (c) Chemical substances as marketed. This part requires reporting 
about chemical substances as they are marketed or used in practice. The 
following preparations of a chemical substance must be reported as the 
substance itself, not as a mixture, since these preparations are 
regarded as the substance in practice.
    (1) The chemical substance in aqueous solution.
    (2) The chemical substance containing an additive (such as a 
stabilizer or other chemical) to maintain the integrity or physical form 
of the substance.
    (3) The chemical substance in any grade of purity.




Sec. 712.7  Report of readily obtainable information for subparts B and C.

    TSCA section 8(a) authorizes EPA to require persons to report 
information that is known to or reasonably ascertainable by them. For 
purposes of subpart B, however, a lesser standard applies. Companies 
must report information that is readily obtainable by management and 
supervisory employees responsible for manufacturing, processing, 
distributing, technical services, and marketing. Extensive file searches 
are not required.

[47 FR 26998, June 22, 1982, as amended at 60 FR 31921, June 19, 1995]



Sec. 712.15  Confidentiality.

    (a) Any person submitting information under this part may assert 
business confidentiality claims for the information as described in the 
pertinent reporting form and its instructions. Any information covered 
by a claim will be disclosed by EPA only as provided in the procedures 
set forth at 40 CFR part 2.
    (b) Persons must certify to the validity of a claim of 
confidentiality they make for information reported under this part, as 
specified on the reporting form.
    (c) If no claim accompanies the information at the time it is 
submitted to EPA or if certification as to the claim is not made on the 
reporting form, EPA may place the information in an open file available 
to the public without further notice to the submitter.



 Subpart B--Manufacturers Reporting--Preliminary Assessment Information



Sec. 712.20  Manufacturers and importers who must report.

    Except as described in Sec. 712.25, at the time a chemical substance 
is listed in Sec. 712.3, the following persons must submit the 
``Manufacturer's Report--Preliminary Assessment Information'' (as 
described in Sec. 712.28) for each plant site at which they manufactured 
or imported the chemical substance during the reporting period specified 
in Sec. 712.30:
    (a) Persons who manufactured one or more of the chemical substances 
listed in Sec. 712.30 for commercial purposes.
    (b) Persons who imported in bulk form one or more of the chemical 
substances listed in Sec. 712.30 for commercial purposes.



Sec. 712.25  Exempt manufacturers and importers.

    (a) Persons who manufactured or imported the chemical substance 
during the reporting period, solely for purposes of scientific 
experimentation,

[[Page 44]]

analysis, or research, including research or analysis for product 
development, are not subject to reporting under Sec. 712.20.
    (b) Persons who, during the reporting period, manufactured or 
imported fewer than 500 kilograms (1100 pounds) of the chemical 
substance at a single plant site are not subject to reporting for that 
site under Sec. 712.20.
    (c) Persons who qualify as small manufacturers or importers in 
respect to a specific chemical substance listed in Sec. 712.30 are 
exempt. However, this exemption does not apply with respect to any 
chemical in Sec. 712.30 designated by an asterisk. A manufacturer is 
qualified as small and is exempt from submitting a report under this 
subpart for a chemical substance manufactured at a particular plant site 
if both of the following criteria are met:
    (1) Total annual sales taken together of all sites owned or 
controlled by the foreign or domestic parent company were below $30 
million for the reporting period;
    (2) Total production of the listed substance for the reporting 
period was below 45,400 kilograms (100,000 pounds) at the plant site.
    (d) Persons are not subject to reporting under Sec. 712.20 if they 
manufactured or imported the chemical substance during the reporting 
period only in the following forms:
    (1) As a byproduct that was not used or sold or that was formed as 
described in 40 CFR 710.4(d) (3) through (7).
    (2) As a non-isolated intermediate.
    (3) As an impurity.

[47 FR 26998, June 22, 1982; 47 FR 28382, June 30, 1982]



Sec. 712.28  Form and instructions.

    (a) Manufacturers and importers subject to this subpart must submit 
a single EPA Form No. 7710-35, ``Manufacturer's Report--Preliminary 
Assessment Information,'' for each plant site manufacturing or importing 
a chemical substance listed in Sec. 712.30.
    (b) Reporting companies may submit their reports through individual 
plant sites or company headquarters as they choose. A separate form must 
be submitted for each plant site manufacturing the chemical substance.
    (c) Forms must be sent (preferably by certified mail) to the 
Document Control Office (7407), Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., 
SW., Washington, DC., 20460, ATTN: 8(a) PAIR Reporting.
    (d) Form 7710-35, Manufacturer's Report--Preliminary Assessment 
Information or PAIR form and instructions may be obtained by telephoning 
or writing the Environmental Assistance Division. The telephone number 
and the address of the Environmental Assistance Division is: Phone 
Number (202) 554-1404, TDD (202) 554-0551. Address: Environmental 
Assistance Division (7406), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

[47 FR 26998, June 22, 1982, as amended at 52 FR 20083, May 29, 1987; 53 
FR 12523, Apr. 15, 1988; 60 FR 31921, June 19, 1995; 60 FR 34463, July 
3, 1995]



Sec. 712.30  Chemical lists and reporting periods.

    (a)(1) Persons subject to this subpart B must submit a Preliminary 
Assessment Information Manufacturer's Report for each chemical substance 
or mixture that is listed or designated in this section.
    (2) Unless a respondent has already prepared a Manufacturer's Report 
in conformity with conditions set forth in paragraph (a)(3) of this 
section, the information in each Manufacturer's Report must cover the 
respondent's latest complete corporate fiscal year as of the effective 
date. The effective date will be 30 days after the Federal Register 
publishes a rule amendment making the substance or mixture subject to 
this subpart B.
    (3) Persons subject to this subpart B need not comply with the 
requirements of paragraph (a)(2) of this section if they meet either one 
of the following conditions:
    (i) The respondent has previously and voluntarily provided EPA with 
a Manufacturer's Report on a chemical substance or mixture subject to 
this subpart B, which contains data for a one-year period ending no more 
than three

[[Page 45]]

years prior to the effective date described in paragraph (a)(2) of this 
section. Respondents meeting this condition must notify EPA by letter of 
their desire to have the voluntary submission used in lieu of a current 
data submission and must verify the completeness and current accuracy of 
the voluntarily submitted data. Such letters must contain the following 
language: ``I hereby certify that, to the best of my knowledge and 
belief, all information entered on this form is complete and accurate. I 
agree to permit access to, and the copying of records by, a duly 
authorized representative of the EPA Administrator, in accordance with 
the Toxic Substances Control Act, to document any information reported 
on the form.'' Notification letters must be submitted prior to the 
reporting deadline.
    (ii) The respondent has previously submitted a Manufacturer's Report 
on a chemical substance or mixture subject to this subpart B to the 
Interagency Testing Committee, but not to EPA, and that Report contained 
data for a one-year period ending less than three years prior to the 
effective date described in paragraph (a)(2) of this section. 
Respondents meeting this condition must submit a copy of the 
Manufacturer's Report to EPA, and must submit an accompanying letter 
notifying EPA of the respondent's intent that the submission be used in 
lieu of a current Manufacturer's Report. The notification letter must 
verify the completeness and current accuracy of the voluntarily 
submitted data. Such a letter must contain the following language: ``I 
hereby certify that, to the best of my knowledge and belief, all 
information entered on this form is complete and accurate. I agree to 
permit access to, and the copying of records by, a duly authorized 
representative of the EPA Administrator, in accordance with the Toxic 
Substances Control Act, to document any information reported on the 
form.'' The submission must be made prior to the reporting deadline.
    (b) Except as provided in paragraph (c) of this section, chemical 
substances and designated mixtures will be added after a notice of 
proposed amendment of this subpart is published in the Federal Register. 
There will be a 30 day public comment period on each notice; after 
consideration of the comments, a final amendment will identify the 
substances and mixtures added.
    (c) Chemical substances, mixtures, and categories of substances or 
mixtures that have been added by the Interagency Testing Committee, 
established under section 4(e) of TSCA, to the section 4(e) Priority 
List, for testing consideration by the Agency, will be added to this 
section 30 days after EPA issues for publication in the Federal Register 
a rule amendment listing these chemical substances, mixtures and 
categories. A Preliminary Assessment Information--Manufacturer's Report 
must be submitted for each chemical substance and mixture within 60 days 
after the effective date of the listing. At the discretion of the 
Assistant Administrator for Prevention, Pesticides and Toxic Substances, 
a listed substance, mixture or category may be withdrawn, for good 
cause, from the rule's reporting requirements prior to the effective 
date. Any information submitted showing why a substance, mixture or 
category should be removed from the rule must be received by EPA within 
14 days after the date of publication of the notice under this 
paragraph. If a substance, mixture or category is removed, a Federal 
Register notice announcing this decision will be published no later than 
the effective date of the amendment. Any information submitted must be 
addressed to the Document Control Office (7407), Office of Pollution 
Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 
401 M St., SW., Washington, DC., 20460, ATTN: 8(a) Auto-ITC.
    (d) Manufacturers and importers of the substances listed below must 
submit a Preliminary Assessment Information Manufacturer's Report for 
each site at which they manufacture or import each substance by the 
reporting date shown in the table below. The substances are listed in 
Chemical Abstracts Service Registry Number order. Typically EPA lists 
the trivial or common name first, then, following the symbol ``- -'', 
EPA lists the substance by its TSCA Chemical Substance Inventory name. 
Whenever EPA lists a single name, the name may be either

[[Page 46]]

the TSCA Chemical Substance Inventory name, a trivial name, or a common 
name. Generally, when a single name is listed, it is the TSCA Chemical 
Substances Inventory name.

----------------------------------------------------------------------------------------------------------------
                                                                                         Effective    Reporting
            CAS No.                                    Substance                            date         date
----------------------------------------------------------------------------------------------------------------
90-30-2                         N-Phenyl-1-naphthylamine..............................      9/30/91     11/27/91
100-40-3                         4-Vinylcyclohexene...................................      1/11/90      3/12/90
108-95-5                         Thiophenol...........................................      1/26/94      3/28/94
118-79-6                         2,4,6-tribromophenol.................................      1/11/90      3/12/90
143-33-9                         Sodium cyanide.......................................     10/29/90     12/27/90
632-79-1                         Tetrabromophthalic anhydride.........................      1/11/90      3/12/90
637-92-3                         Ethyl tert-butyl ether...............................     12/28/94      2/27/95
994-05-8                         Tert-amyl methyl ether...............................     12/28/94      2/27/95
1163-19-5                        Decabromodiphenyl ether..............................      1/11/90      3/12/90
3194-55-6                        Hexabromocyclododecane...............................      1/11/90      3/12/90
3296-90-0                        Dibromoneopentyl glycol..............................      1/11/90      3/12/90
12185-10-3                      White phosphorus......................................      1/26/94      3/28/94
32534-81-9                      Pentabromodiphenyl ether..............................      1/11/90      3/12/90
32536-52-0                      Octabromodiphenyl ether...............................      1/11/90      3/12/90
32588-76-4                       Ethylene Bis-(tetrabromophthalimide).................      1/11/90      3/12/90
37853-59-1                      1,2-Bis(tribromophenoxy) ethane.......................      1/11/90      3/12/90
41291-34-3                       Ethylene(5,6-dibromonorbornane-2,3-dicarboximide)....      1/11/90      3/12/90
52907-07-0                       Ethylene bis(5,6-dibromonorbornane-2,3-dicarboximide)      1/26/94      3/28/94
57137-10-7                       Tribrominated polystyrene............................      1/11/90      3/12/90
61262-53-1                      Ethylene bis(pentabromophenoxide).....................      1/11/90      3/12/90
----------------------------------------------------------------------------------------------------------------

    (e) Manufacturers and importers of the substances listed below by 
category must submit a Preliminary Assessment Information Manufacturers 
Report for each site at which they manufacture or import each substance 
by the reporting date shown in the table below. The categories are 
listed in alphabetic order with the chemical substances within each 
category listed by ascending numerical CAS number.

----------------------------------------------------------------------------------------------------------------
                                                                                         Effective    Reporting
            CAS No.                                    Substance                            date         date
----------------------------------------------------------------------------------------------------------------
Aldehydes:
  66-77-3.....................  1-Naphthalenecarboxaldehyde...........................      9/30/91     11/27/91
  75-07-0.....................  Acetaldehyde..........................................      9/30/91     11/27/91
  75-87-6.....................  Acetaldehyde, trichloro-..............................      9/30/91     11/27/91
  78-84-2.....................  Propanal, 2-methyl-...................................      9/30/91     11/27/91
  78-85-3.....................  2-Propenal, 2-methyl-.................................      9/30/91     11/27/91
  80-54-6.....................  Benzenepropanal,4-(1,1-dimethylethyl)-.alpha.-methyl-.      9/30/91     11/27/91
  84-83-3.....................  Acetaldehyde, (1,3-dihydro-1,3, 3-trimethyl-2H-indol-2-
                                 ylidene).
  89-98-5.....................  Benzaldehyde, 2-chloro-...............................      9/30/91     11/27/91
  90-02-8.....................  Benzaldehyde, 2-hydroxy-..............................      9/30/91     11/27/91
  93-02-7.....................  Benzaldehyde, 2,5-dimethoxy-..........................      9/30/91     11/27/91
  93-53-8.....................  Benzeneacetaldehyde, .alpha.-methyl-..................      9/30/91     11/27/91
  95-01-2.....................  Benzaldehyde, 2,4-dihydroxy-..........................      9/30/91     11/27/91
  97-51-8.....................  Benzaldehyde, 2-hydroxy-5-nitro-......................      9/30/91     11/27/91
  98-01-1.....................  2-Furancarboxaldehyde.................................      9/30/91     11/27/91
  98-03-3.....................  2-Thiophenecarboxaldehyde.............................      9/30/91     11/27/91
  100-10-7....................  Benzaldehyde, 4-(dimethylamino)-......................      9/30/91     11/27/91
  100-50-5....................  3-Cyclohexene-1-carboxaldehyde........................      9/30/91     11/27/91
  100-52-7....................  Benzaldehyde..........................................      9/30/91     11/27/91
  101-39-3....................  2-Propenal, 2-methyl-3-phenyl-........................      9/30/91     11/27/91
  101-86-0....................  Octanal, 2-(phenylmethylene)-.........................      9/30/91     11/27/91
  103-95-7....................  Benzenepropanal, .alpha.-methyl-4-(1-methylethyl)-....      9/30/91     11/27/91
  104-09-6....................  Benzeneacetaldehyde, 4-methyl-........................      9/30/91     11/27/91
  104-55-2....................  2-Propenal, 3-phenyl-.................................      9/30/91     11/27/91
  104-87-0....................  Benzaldehyde, 4-methyl-...............................      9/30/91     11/27/91
  104-88-1....................  Benzaldehyde, 4-chloro-...............................      9/30/91     11/27/91
  106-23-0....................  6-Octenal, 3,7-dimethyl-..............................      9/30/91     11/27/91
  106-26-3....................  2,6-Octadienal, 3,7-dimethyl-, (Z)-...................      9/30/91     11/27/91
  106-72-9....................  5-Heptenal, 2,6-dimethyl-.............................      9/30/91     11/27/91
  107-02-8....................  2-Propenal............................................      9/30/91     11/27/91
  107-20-0....................  Acetaldehyde, chloro-.................................      9/30/91     11/27/91
  107-22-2....................  Ethanedial............................................      9/30/91     11/27/91
  107-75-5....................  Octanal, 7-hydroxy-3,7-dimethyl-......................      9/30/91     11/27/91
  110-41-8....................  Undecanal, 2-methyl-..................................      9/30/91     11/27/91

[[Page 47]]

 
  110-62-3....................  Pentanal..............................................      9/30/91     11/27/91
  111-30-8....................  Pentanedial...........................................      9/30/91     11/27/91
  111-71-7....................  Heptanal..............................................      9/30/91     11/27/91
  112-31-2....................  Decanal...............................................      9/30/91     11/27/91
  112-44-7....................  Undecanal.............................................      9/30/91     11/27/91
  112-45-8....................  10-Undecenal..........................................      9/30/91     11/27/91
  112-54-9....................  Dodecanal.............................................      9/30/91     11/27/91
  120-14-9....................  Benzaldehyde, 3,4-dimethoxy-..........................      9/30/91     11/27/91
  120-21-8....................  Benzaldehyde, 4-(diethylamino)-.......................      9/30/91     11/27/91
  120-57-0....................  1,3-Benzodioxole-5-carboxaldehyde.....................      9/30/91     11/27/91
  121-32-4....................  Benzaldehyde, 3-ethoxy-4-hydroxy-.....................      9/30/91     11/27/91
  121-33-5....................  Benzaldehyde, 4-hydroxy-3-methoxy-....................      9/30/91     11/27/91
  122-40-7....................  Heptanal, 2-(phenylmethylene)-........................      9/30/91     11/27/91
  122-78-1....................  Benzeneacetaldehyde...................................      9/30/91     11/27/91
  123-05-7....................  Hexanal, 2-ethyl-.....................................      9/30/91     11/27/91
  123-08-0....................  Benzaldehyde, 4-hydroxy-..............................      9/30/91     11/27/91
  123-11-5....................  Benzaldehyde, 4-methoxy-..............................      9/30/91     11/27/91
  123-38-6....................  Propanal..............................................      9/30/91     11/27/91
  124-13-0....................  Octanal...............................................      9/30/91     11/27/91
  124-19-6....................  Nonanal...............................................      9/30/91     11/27/91
  126-15-8....................  4a(4H)-Dibenzofurancarboxaldehyde, 1,5a,6,9,9a,9b-          9/30/91     11/27/91
                                 hexahydro-.
  135-02-4....................  Benzaldehyde, 2-methoxy-..............................      9/30/91     11/27/91
  141-27-5....................  2,6-Octadienal, 3,7-dimethyl-, (E)-...................      9/30/91     11/27/91
  143-14-6....................  9-Undecenal...........................................      9/30/91     11/27/91
  455-19-6....................  Benzaldehyde, 4-(trifluoromethyl)-....................      9/30/91     11/27/91
  505-57-7....................  02-Hexenal............................................      9/30/91     11/27/91
  552-89-6....................  Benzaldehyde, 2-nitro-................................      9/30/91     11/27/91
  590-86-3....................  Butanal, 3-methyl-....................................      9/30/91     11/27/91
  597-31-9....................  Propanal, 3-hydroxy-2,2-dimethyl-.....................      9/30/91     11/27/91
  939-97-9....................  Benzaldehyde, 4-(1,1-dimethylethyl)-..................      9/30/91     11/27/91
  1121-60-4...................  2-Pyridinecarboxaldehyde..............................      9/30/91     11/27/91
  1200-14-2...................  Benzaldehyde, 4-butyl.................................      9/30/91     11/27/91
  1331-92-6...................  2-Propenal, 3-phenyl-, monopentyl deriv...............      9/30/91     11/27/91
  1334-78-7...................  Benzaldehyde, methyl-.................................      9/30/91     11/27/91
  1423-46-7...................  3-Cyclohexene-1-carboxaldehyde, 2,4,6-trimethyl-......      9/30/91     11/27/91
  1504-74-1...................  2-Propenal, 3-(2-methoxyphenyl)-......................      9/30/91     11/27/91
  2591-86-8...................  1-Piperidinecarboxaldehyde............................      9/30/91     11/27/91
  3132-99-8...................  Benzaldehyde, 3-bromo-................................      9/30/91     11/27/91
  3268-49-3...................  Propanal, 3-(methylthio)-.............................      9/30/91     11/27/91
  3613-30-7...................  Octanal, 7-methoxy-3,7-dimethyl-......................      9/30/91     11/27/91
  4501-58-0...................  3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl-.......      9/30/91     11/27/91
  5435-64-3...................  Hexanal, 3,5,5-trimethyl-.............................      9/30/91     11/27/91
  5780-07-4...................  1,3-Benzodioxole-5-carboxaldehyde, 7-methoxy-.........      9/30/91     11/27/91
  5949-05-3...................  6-Octenal, 3,7-dimethyl-, (S)-........................      9/30/91     11/27/91
  5988-91-0...................  Octanal, 3,7-dimethyl-................................      9/30/91     11/27/91
  10031-82-0..................  Benzaldehyde, 4-ethoxy-...............................      9/30/91     11/27/91
  13586-68-0..................  2-Propenal, 3- 4-(1,1-dimethylethyl)phenyl-2-methyl-..      9/30/91     11/27/91
  17754-90-4..................  Benzaldehyde, 4-(diethylamino)-2-hydroxy-.............      9/30/91     11/27/91
  26266-68-2..................  Hexenal, 2-ethyl-.....................................      9/30/91     11/27/91
  27939-60-2..................  3-Cyclohexene-1-carboxaldehyde, dimethyl-.............      9/30/91     11/27/91
  28602-27-9..................  Benzaldehyde, (dimethylamino)-........................      9/30/91     11/27/91
  31906-04-4..................  3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4-             9/30/91     11/27/91
                                 methylpentyl)-.
  37677-14-8..................  3-Cyclohexene-1-carboxaldehyde, 4-(4-methyl-3-              9/30/91     11/27/91
                                 pentenyl)-.
  39515-51-0..................  Benzaldehyde, 3-phenoxy-..............................      9/30/91     11/27/91
  52475-86-2..................  3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-methyl-3-     9/30/91     11/27/91
                                 pentenyl)-.
  66327-54-6..................  3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-              9/30/91     11/27/91
                                 methylpentyl)-.
Alkyl-, Chloro-, and
 Hydroxymethyl Diaryl Ethers.
  3061-36-7...................  1,4-Diphenoxybenzene..................................     04/12/93     06/10/93
  3586-14-9...................  Benzene, 1-methyl-3-phenoxy-..........................     04/12/93     06/10/93
  13826-35-2..................  Benzenemethanol, 3-phenoxy-,..........................     04/12/93     06/10/93
  28299-41-4..................  Benzene, 1,1,-oxybis[methyl-..........................     04/12/93     06/10/93
  28984-89-6..................  1,1-Biphenyl, phenoxy-................................     04/12/93     06/10/93
  42874-96-4..................  2-Chloro-1-(3-methylphenoxy)-4-                            04/12/93     06/10/93
                                 (trifluoromethyl)benzene.
  50594-77-9..................  Phenol, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-,          04/12/93     06/10/93
                                 acetate.
  50789-44-1..................  Benzenemethanol, 3-phenoxy-, acetate..................     04/12/93     06/10/93
  51632-16-7..................  Benzene, 1-(bromomethyl)-3-phenoxy-...................     04/12/93     06/10/93
  61702-88-3..................  Benzene, 1,1-oxybis[(1,1,3,3-tetramethylbutyl)-.......     04/12/93     06/10/93
  63734-62-3..................  Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-     04/12/93     06/10/93
                                 ,.
  69834-19-1..................  Benzene, 1,1-oxybis[dodecyl-..........................     04/12/93     06/10/93
  72252-48-3..................  Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-     04/12/93     06/10/93
                                 , potassium salt.

[[Page 48]]

 
Alkylphenols and Alkylphenol
 Ethoxylates:.
  80-46-6.....................  4-tert-Pentylphenol...................................      3/29/96      5/29/96
  88-18-6.....................  2-tert-Butylphenol....................................      3/29/96      5/29/96
  94-06-4.....................  4-(1-Methylbutyl)phenol...............................      3/29/96      5/29/96
  98-54-4.....................  4-tert-Butylphenol....................................      3/29/96      5/29/96
  99-71-8.....................  4-sec-Butylphenol.....................................      3/29/96      5/29/96
  104-40-5....................  4-Nonylphenol.........................................      3/29/96      5/29/96
  104-43-8....................  4-Dodecylphenol.......................................      3/29/96      5/29/96
  949-13-3....................  2-Octylphenol.........................................      3/29/96      5/29/96
  1300-16-9...................  Nonylphenol (mixed isomers)...........................      3/29/96      5/29/96
  1322-69-6...................  (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers)......      3/29/96      5/29/96
  1331-57-3...................  Dodecylphenol (mixed isomers).........................      3/29/96      5/29/96
  1638-22-8...................  4-n-Butylphenol.......................................      3/29/96      5/29/96
  1806-26-4...................  4-Octylphenol.........................................      3/29/96      5/29/96
  2315-66-4...................  Decaethylene glycol 4-isooctylphenyl ether............      3/29/96      5/29/96
  2497-58-7...................  Hexaethylene glycol 4-isooctylphenyl ether............      3/29/96      5/29/96
  3180-09-4...................  2-Butylphenol.........................................      3/29/96      5/29/96
  3884-95-5...................  2-(1,1,3,3-Tetramethylbutyl)phenol....................      3/29/96      5/29/96
  9002-93-1...................  Polyethylene glycol 4-(tert-octyl)phenyl ether........      3/29/96      5/29/96
  9036-19-5...................  Polyethylene glycol mono(octyl)phenyl ether...........      3/29/96      5/29/96
  11066-49-2..................  Isononylphenol (mixed isomers)........................      3/29/96      5/29/96
  14938-35-3..................  4-Pentylphenol........................................      3/29/96      5/29/96
  17404-66-9..................  4-(1-Methyloctyl)phenol...............................      3/29/96      5/29/96
  25154-52-3..................  Nonylphenol (mixed isomers)...........................      3/29/96      5/29/96
  27178-34-3..................  tert-Butylphenol (mixed isomers)......................      3/29/96      5/29/96
  27193-28-8..................  (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers)......      3/29/96      5/29/96
  27193-86-8..................  Dodecylphenol (mixed isomers).........................      3/29/96      5/29/96
  27985-70-2..................  (1-Methylheptyl)phenol (mixed isomers)................      3/29/96      5/29/96
  29932-96-5..................  (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers)......      3/29/96      5/29/96
  30105-54-5..................  (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers)......      3/29/96      5/29/96
  31195-95-6..................  Isobutylphenol (mixed isomers)........................      3/29/96      5/29/96
  54932-78-4..................  4-(2,2,3,3-Tetramethylbutyl)phenol....................      3/29/96      5/29/96
  62744-41-6..................  (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers)......      3/29/96      5/29/96
  68987-90-6..................  Poly(oxy-1,2-ethanediyl), -(octylphenyl)-          3/29/96      5/29/96
                                 -hydroxy-, branched.
  84852-15-3..................  Branched 4-nonylphenol (mixed isomers)................      3/29/96      5/29/96
Alkyl phosphates:
  78-40-0.....................  Phosphoric acid, triethyl ester.......................     10/29/90     12/27/90
  78-42-2.....................  Phosphoric acid, tris(2-ethylhexyl)ester..............     10/29/90     12/27/90
  78-51-3.....................  Ethanol, 2-butoxy-, phosphate (3:1)...................     10/29/90     12/27/90
  107-66-4....................  Phosphoric acid, dibutyl ester........................     10/29/90     12/27/90
  126-71-6....................  Phosphoric acid, tris(2-methylpropyl) ester...........     10/29/90     12/27/90
  126-73-8....................  Phosphoric acid tributyl ester........................     10/29/90     12/27/90
  298-07-7....................  Phosphoric acid, bis(2-ethylhexyl)ester...............     10/29/90     12/27/90
  812-00-0....................  Phosphoric acid, monomethyl ester.....................     10/29/90     12/27/90
  1070-03-7...................  Phosphoric acid, mono(2-ethylhexyl)ester..............     10/29/90     12/27/90
  1498-51-7...................  Phosphorodichloridic acid, ethylester.................     10/29/90     12/27/90
  1623-15-0...................  Phosphoric acid, monobutyl ester......................     10/29/90     12/27/90
  1623-24-1...................  Phosphoric acid, mono(1-methylethyl)ester.............     10/29/90     12/27/90
  2958-09-0...................  Phosphoric acid, monooctadecyl ester..................     10/29/90     12/27/90
  3900-04-7...................  Phosphoric acid, monohexyl ester......................     10/29/90     12/27/90
  3991-73-9...................  Phosphoric acid, monooctyl ester......................     10/29/90     12/27/90
  7057-92-3...................  Phosphoric acid, didodecyl ester......................     10/29/90     12/27/90
  7332-46-9...................  Ethanol, 2-(2-butoxyethoxy)-, phosphate (3:1).........     10/29/90     12/27/90
  12645-31-7..................  Phosphoric acid, 2-ethylhexyl ester...................     10/29/90     12/27/90
  12751-23-4..................  Phosphoric acid, dodecyl ester........................     10/29/90     12/27/90
  27215-10-7..................  Phosphoric acid, diisooctyl ester.....................     10/29/90     12/27/90
Brominated flame retardants:
  74-97-5.....................  Methane, bromochloro-.................................     10/29/90     12/27/90
  87-10-5.....................  Benzamide, 3,5-dibromo-N-(4-bromophenyl)-2-hydroxy-...     10/29/90     12/27/90
  87-83-2.....................  Benzene, pentabromomethyl-............................     10/29/90     12/27/90
  87-84-3.....................  Cyclohexane,1,2,3,4,5-pentabromo-6-chloro-............     10/29/90     12/27/90
  96-13-9.....................  1-Propanol, 2,3-dibromo-..............................     10/29/90     12/27/90
  593-60-2....................  Ethene, bromo-........................................     10/29/90     12/27/90
  615-58-7....................  Phenol, 2,4-dibromo-..................................     10/29/90     12/27/90
  4162-45-2...................  Ethanol,2,2'-((1-methylethylidene)bis((2,6-dibromo-4,1-    10/29/90     12/27/90
                                 phenylene)oxy))bis-.
  25327-89-3..................  Benzene, 1,1'-(1-methylethylidene)bis(3,5-dibromo-4-(2-    10/29/90     12/27/90
                                 propenyloxy)-.
  30554-72-4..................  Cyclohexane, tetrabromodichloro-......................     10/29/90     12/27/90
  30554-73-5..................  Cyclohexane, tribromotrichloro-.......................     10/29/90     12/27/90
  36483-57-5..................  1-Propanol, 2,2-dimethyl-, tribromo deriv.............     10/29/90     12/27/90
  55205-38-4..................  2-Propenoic acid, (1-methylethylidene)bis(2,6-dibromo-     10/29/90     12/27/90
                                 4,1-phenylene) ester.

[[Page 49]]

 
  68955-41-9..................  Alkanes, C10-18, bromochloro-.........................     10/29/90     12/27/90
  69882-11-7..................  Phenol, 2,4(or 2,6)-dibromo-, homopolymer.............     10/29/90     12/27/90
  88497-56-7..................  Benzene, ethenyl-, homopolymer, brominated............     10/29/90     12/27/90
Chloralkyl phosphates.........
  34621-99-3..................  1,2-Ethanediyltetrakis(2-chloro-1-methylethylene)           6/14/93      8/12/93
                                 phosphate.
  38051-10-4..................  2,2-Bis(chloromethyl)-1,3-propanediyltetrakis(2-            6/14/93      8/12/93
                                 chloroethyl) phosphate.
  53461-82-8..................  Oxydi-2,1-ethanediyltetrakis(2-chloroethyl) phosphate.      6/14/93      8/12/93
  76649-15-5..................  2-Chloro-1-methylethylbis(2-chloropropyl) phosphate...
Cyanoacrylates:
  137-05-3....................  2-Propenoic acid, 2-cyano-, methyl ester..............      1/26/94      3/28/94
  1069-55-2...................  2-Propenoic acid, 2-cyano-, isobutyl ester............      1/26/94      3/28/94
  6197-30-4...................  2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2-ethylhexyl       1/26/94      3/28/94
                                 ester.
  6606-65-1...................  2-Propenoic acid, 2-cyano-, butyl ester...............      1/26/94      3/28/94
  7085-85-0...................  2-Propenoic acid, 2-cyano-, ethyl ester...............      1/26/94      3/28/94
  7324-02-9...................  2-Propenoic acid, 2-cyano-, 2-propenyl ester..........      1/26/94      3/28/94
  10586-17-1..................  2-Propenoic acid, 2-cyano-, 1-methylethyl ester.......      1/26/94      3/28/94
  21982-43-4..................  2-Propenoic acid, 2-cyano-, ethoxyethyl ester.........      1/26/94      3/28/94
  23023-91-8..................  2-Propenoic acid, 2-cyano-, 2,2,2-trifluoromethyl           1/26/94      3/28/94
                                 ester.
  27816-23-5..................  2-Propenoic acid, 2-cyano-, 2-methoxyethyl ester......      1/26/94      3/28/94
  64992-16-1..................  Ethanaminium, 2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-     1/26/94      3/28/94
                                 oxo-2-propenyl]oxy]-N,N,N-trimethyl-, chloride.
IRIS Chemicals:
  51-28-5.....................  2,4 Dinitrophenol.....................................      9/30/91     11/27/91
  95-65-8.....................  3,4 Dinethylphenol....................................      9/30/91     11/27/91
Isocyanates:
  91-97-4.....................  1,1'-Biphenyl, 4,4'-diisocyanato-3,3'-dimethyl-.......     10/29/90     12/27/90
  100-28-7....................  Benzene, 1-isocyanato-4-nitro-........................     10/29/90     12/27/90
  101-68-8....................  Benzene, 1,1'-methylenebis(4-isocyanato-..............     10/29/90     12/27/90
  102-36-3....................  Benzene, 1,2-dichloro-4-isocyanato-...................     10/29/90     12/27/90
  103-71-9....................  Benzene, isocyanato-..................................     10/29/90     12/27/90
  104-12-1....................  Benzene, 1-chloro-4-isocyanato-.......................     10/29/90     12/27/90
  104-49-4....................  Benzene, 1,4-diisocyanato-............................     10/29/90     12/27/90
  109-90-0....................  Ethane, isocyanato-...................................     10/29/90     12/27/90
  110-78-1....................  Propane, 1-isocyanato-................................     10/29/90     12/27/90
  111-36-4....................  Butane, 1-isocyanato-.................................     10/29/90     12/27/90
  112-96-9....................  Octadecane, 1-isocyanato-.............................     10/29/90     12/27/90
  123-61-5....................  Benzene, 1,3-diisocyanato-............................     10/29/90     12/27/90
  329-01-1....................  Benzene, 1-isocyanato-3-(trifluoromethyl)-............     10/29/90     12/27/90
  614-68-6....................  Benzene, 1-isocyanato-2-methyl-.......................     10/29/90     12/27/90
  622-58-2....................  Benzene, 1-isocyanato-4-methyl-.......................     10/29/90     12/27/90
  624-83-9....................  Methane, isocyanato-..................................     10/29/90     12/27/90
  1476-23-9...................  1-Propene, 3-isocyanato-..............................     10/29/90     12/27/90
  2422-91-5...................  Benzene, 1,1',1''-methylidynetris(4-isocyanato-.......     10/29/90     12/27/90
  2493-02-9...................  Benzene, 1-bromo-4-isocyanato-........................     10/29/90     12/27/90
  2909-38-8...................  Benzene, 1-chloro-3-isocyanato-.......................     10/29/90     12/27/90
  2949-22-6...................  Acetic acid, isocyanato-, ethyl ester.................     10/29/90     12/27/90
  3173-53-3...................  Cyclohexane, isocyanato-..............................     10/29/90     12/27/90
  4035-89-6...................  Imidodicarbonic diamide,N,N',2-tris(6-isocyanatohexyl)-    10/29/90     12/27/90
                                 .
  4098-71-9...................  Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-      10/29/90     12/27/90
                                 trimethyl-.
  4151-51-3...................  Phenol, 4-isocyanato-, phosphorothioate (3:1) (ester).     10/29/90     12/27/90
  5124-30-1...................  Cyclohexane, 1,1'-methylenebis(4-isocyanato-..........     10/29/90     12/27/90
  5873-54-1...................  Benzene, 1-isocyanato-2-((4-isocyanatophenyl)methyl)-.     10/29/90     12/27/90
  10031-75-1..................  Benzene, 1,1'-(diisocyanatomethylene)bis-.............     10/29/90     12/27/90
  15646-96-5..................  Hexane, 1,6-diisocyanato-2,4,4-trimethyl-.............     10/29/90     12/27/90
  16938-22-0..................  Hexane, 1,6-diisocyanato-2,2,4-trimethyl-.............     10/29/90     12/27/90
  25854-16-4..................  Benzene, bis(isocyanatomethyl)-.......................     10/29/90     12/27/90
  26447-40-5..................  Benzene, 1,1'-methylenebis(isocyanato-................     10/29/90     12/27/90
  26603-40-7..................  1,3,5,-Triazine-2,4,6(1H.3H,5H-trione, 1,3,5-tris(3-       10/29/90     12/27/90
                                 isocyanatomethylphenyl)-.
  26747-90-0..................  1,3-Diazetidine-2,4-dione, 1,3-bis(3-                      10/29/90     12/27/90
                                 isocyanatomethylphenyl)-.
  28178-42-9..................  Benzene, 2-isocyanato-1,3-bis(1-methylethyl)-.........     10/29/90     12/27/90
  28556-81-2..................  Benzene, 2-isocyanato-1,3-dimethyl-...................     10/29/90     12/27/90
  30674-80-7..................  2-Propenoic acid, 2-methyl-,2-isocyanatoethyl ester...     10/29/90     12/27/90
  34893-92-0..................  Benzene, 1,3-dichloro-5-isocyanato-...................     10/29/90     12/27/90
  68239-06-5..................  Cyclohexane, 2-heptyl-3,4-bis(9-isocyanatononyl)-1-        10/29/90     12/27/90
                                 pentyl-.
  73597-26-9..................  2-Propenoic acid, 2-methyl-, 2-(((((5-isocyanato-1,3,3-    10/29/90     12/27/90
                                 trimethylcyclohexyl) methyl)amino)carbonyl)oxy)ethyl
                                 ester.
Methyl ethylene glycol ethers
 and esters:
  3121-61-7...................  Ethylene glycol monomethyl ether acrylate                   1/26/94      3/28/94
  23783-42-8..................  Tetraethylene glycol monomethyl ether                       1/26/94      3/28/94
Nonylphenol ethoxylates

[[Page 50]]

 
  07311-27-5..................  Ethanol, 2-[2-[2-[2-(p-                                    11/29/96      1/27/97
                                 nonylphenoxy)ethoxy]ethoxy]ethoxy]-
  09016-45-9 and 20636-48-0...  Nonylphenol polyethylene glycol ether                      11/29/96      1/27/97
  20427-84-3..................  Ethanol, 2-[2-(p-nonylphenoxy)ethoxy]-                     11/29/96      1/27/97
  26027-38-3 and 26064-02-8...  p-Nonylphenol polyethylene glycol ether                    11/29/96      1/27/97
  26571-11-9..................  Nonylphenol octa(oxyethylene)ethanol                       11/29/96      1/27/97
  27176-93-8 and 27177-01-1...  Nonylphenoxydiglycol                                       11/29/96      1/27/97
  27177-05-5..................  Nonylphenol hepta(oxyethylene)ethanol                      11/29/96      1/27/97
  27177-08-8..................  Nonylphenolnona(oxyethylene) ethanol                       11/29/96      1/27/97
  27986-36-3..................  Nonylphenoxy ethanol                                       11/29/96      1/27/97
  37205-87-1..................  Poly(oxy-1,2-ethanediyl), alpha-(isononylphenyl)-omega-    11/29/96      1/27/97
                                 hydroxy
OSHA Chemicals in Need of
 Dermal Absorption Testing:
  60-29-7.....................  Ethyl ether...........................................      1/26/94      3/28/94
  61-82-5.....................  Amitrole..............................................      3/11/94      5/10/94
  74-96-4.....................  Ethyl bromide.........................................      3/11/94      5/10/94
  75-05-8.....................  Acetonitrile..........................................       8/4/95      10/3/95
  75-12-7.....................  Formamide.............................................       8/4/95      10/3/95
  75-15-0.....................  Carbon disulfide......................................      3/11/94      5/10/94
  75-25-2.....................  Bromoform.............................................      3/11/94      5/10/94
  75-34-3.....................  1,1-Dichloroethane....................................      3/11/94      5/10/94
  75-35-4.....................  Vinylidene chloride...................................       8/4/95      10/3/95
  75-65-0.....................  tert-Butyl alcohol....................................      1/26/94      3/28/94
  76-22-2.....................  Camphor...............................................      1/26/94      3/28/94
  77-73-6.....................  Dicyclopentadiene.....................................       8/4/95      10/3/95
  77-78-1.....................  Dimethyl sulfate......................................      3/11/94      5/10/94
  78-59-1.....................  Isophorone............................................       8/4/95      10/3/95
  78-87-5.....................  Propylene dichloride..................................       8/4/95      10/3/95
  78-92-2.....................  sec-Butyl alcohol.....................................      1/26/94      3/28/94
  79-20-9.....................  Methyl acetate........................................      1/26/94      3/28/94
  79-46-9.....................  2-Nitropropane........................................      3/11/94      5/10/94
  88-72-2.....................  o-Nitrotoluene........................................      3/11/94      5/10/94
  89-72-5.....................  o-sec-Butylphenol.....................................      3/11/94      5/10/94
  90-04-0.....................  o-Anisidine...........................................      3/11/94      5/10/94
  91-20-3.....................  Naphthalene...........................................       8/4/95      10/3/95
  92-52-4.....................  Biphenyl..............................................       8/4/95      10/3/95
  95-13-6.....................  Indene................................................      3/11/94      5/10/94
  95-49-8.....................  o-Chlorotoluene.......................................      3/11/94      5/10/94
  95-50-1.....................  o-Dichlorobenzene.....................................       8/4/95      10/3/95
  96-18-4.....................  1,2,3-Trichloropropane................................       8/4/95      10/3/95
  97-77-8.....................  Disulfiram............................................      1/26/94      3/28/94
  98-29-3.....................  t-Butylcatechol.......................................       8/4/95      10/3/95
  99-08-1.....................  m-Nitrotoluene........................................       8/4/95      10/3/95
  99-65-0.....................  m-Dinitrobenzene......................................      3/11/94      5/10/94
  99-99-0.....................  p-Nitrotoluene........................................       8/4/95      10/3/95
  100-00-5....................  p-Nitrochlorobenzene..................................      3/11/94      5/10/94
  100-01-6....................  p-Nitroaniline........................................      3/11/94      5/10/94
  100-44-7....................  Benzyl chloride.......................................      3/11/94      5/10/94
  100-25-4....................  p-Dinitrobenzene......................................      1/26/94      3/28/94
  100-63-0....................  Phenylhydrazine.......................................      3/11/94      5/10/94
  105-46-4....................  sec-Butyl acetate.....................................      1/26/94      3/28/94
  106-42-3....................  p-Xylene..............................................      1/26/94      3/28/94
  106-46-7....................  p-Dichlorobenzene.....................................       8/4/95      10/3/95
  106-49-0....................  p-Toluidine...........................................      3/11/94      5/10/94
  107-06-2....................  Ethylene dichloride...................................       8/4/95      10/3/95
  107-31-3....................  Methyl formate........................................      1/26/94      3/28/94
  107-66-4....................  Dibutyl phosphate.....................................      1/26/94      3/28/94
  108-03-2....................  1-Nitropropane........................................      1/26/94      3/28/94
  108-44-1....................  m-Toluidine...........................................      3/11/94      5/10/94
  108-87-2....................  Methylcyclohexane.....................................      1/26/94      3/28/94
  108-90-7....................  Chlorobenzene.........................................      3/11/94      5/10/94
  108-93-0....................  Cyclohexanol..........................................       8/4/95      10/3/95
  109-66-0....................  Pentane...............................................      1/26/94      3/28/94
  109-99-9....................  Tetrahydrofuran.......................................      3/11/94      5/10/94
  110-12-3....................  Methyl isoamyl ketone.................................       8/4/95      10/3/95
  110-83-8....................  Cyclohexene...........................................      1/26/94      3/28/94

[[Page 51]]

 
  111-84-2....................  Nonane................................................      1/26/94      3/28/94
  120-80-9....................  Catechol..............................................       8/4/95      10/3/95
  121-14-2....................  2,4-Dinitrotoluene....................................      3/11/94      5/10/94
  121-69-7....................  Dimethylaniline.......................................       8/4/95      10/3/95
  122-39-4....................  Diphenylamine.........................................      3/11/94      5/10/94
  123-42-2....................  Diacetone alcohol.....................................       8/4/95      10/3/95
  123-92-2....................  Isoamyl acetate.......................................      1/26/94      3/28/94
  126-99-8....................  beta-Chloroprene......................................      3/11/94      5/10/94
  127-19-5....................  Dimethyl acetamide....................................       8/4/95      10/3/95
  142-82-5....................  Heptane (n-Heptane)...................................      1/26/94      3/28/94
  150-76-5....................  p-Methoxyphenol.......................................      3/11/94      5/10/94
  287-92-3....................  Cyclopentane..........................................      1/26/94      3/28/94
  528-29-0....................  o-Dinitrobenzene......................................      3/11/94      5/10/94
  532-27-4....................  a-Chloroacetophenone..................................      1/26/94      3/28/94
  540-59-0....................  1,2-Dichloroethylene..................................      3/11/94      5/10/94
  540-88-5....................  tert-Butyl acetate....................................      1/26/94      3/28/94
  542-92-7....................  Cyclopentadiene.......................................       8/4/95      10/3/95
  626-17-5....................  m-Phthalodinitrile....................................      3/11/94      5/10/94
  628-63-7....................  n-Amyl acetate........................................      1/26/94      3/28/94
  768-52-5....................  N-Isopropylaniline....................................      3/11/94      5/10/94
  1300-73-8...................  Xylidine..............................................      3/11/94      5/10/94
  6423-43-4...................  Propylene glycol dinitrate............................      3/11/94      5/10/94
  7631-90-5...................  Sodium bisulfite......................................      1/26/94      3/28/94
  7681-57-4...................  Sodium metabisulfite..................................      1/26/94      3/28/94
  25013-15-4..................  Vinyl toluene.........................................      3/11/94      5/10/94
  34590-94-8..................  Dipropylene glycol methyl ether.......................       8/4/95      10/3/95
Propylene glycol ethers and
 esters:
  108-65-6....................  Propylene glycol monomethyl ether acetate.............      1/26/94      3/28/94
  110-98-5....................  Dipropylene glycol....................................      1/26/94      3/28/94
  770-35-4....................  1-Phenoxy-2-propanol..................................      1/26/94      3/28/94
  20324-32-7..................  1-(2-Methoxy-1-methylethoxy)-2-propanol...............      1/26/94      3/28/94
  20324-33-8..................  Tripropylene glycol methyl ether......................      1/26/94      3/28/94
  28677-93-2..................  Methoxy-1-propanol....................................      1/26/94      3/28/94
  29387-86-8..................  Propylene glycol monobutyl ether......................      1/26/94      3/28/94
  29911-28-2..................  Dipropylene glycol butyl ether........................      1/26/94      3/28/94
  42978-66-5..................  Tripropylene glycol diacrylate........................      1/26/94      3/28/94
  57018-52-7..................  Propylene glycol mono-tert-butyl ether................      1/26/94      3/28/94
  88917-22-0..................  Dipropylene glycol monomethyl ether acetate...........      1/26/94      3/28/94
Siloxanes:
  107-46-0....................  Hexamethyldisiloxane..................................     10/12/93      2/28/94
  107-50-6....................  Tetradecamethylcycloheptasiloxane.....................     10/12/93      2/28/94
  107-51-7....................  Octamethyltrisiloxane.................................     10/12/93      2/28/94
  107-52-8....................  Tetradecamethylhexasiloxane...........................     10/12/93      2/28/94
  107-53-9....................  Tetracosamethylundecasiloxane.........................     10/12/93      2/28/94
  141-62-8....................  Decamethyltetrasiloxane...............................     10/12/93      2/28/94
  141-63-9....................  Dodecamethylpentasiloxane.............................     10/12/93      2/28/94
  540-97-6....................  Dodecamethylcyclohexasiloxane.........................     10/12/93      2/28/94
  541-01-5....................  Hexadecamethylheptasiloxane...........................     10/12/93      2/28/94
  541-02-6....................  Decamethylcyclopentasiloxane..........................     10/12/93      2/28/94
  541-05-9....................  Hexamethylcyclotrisiloxane............................     10/12/93      2/28/94
  546-56-5....................  Octaphenylcyclotetrasiloxane..........................     10/12/93      2/28/94
  556-67-2....................  Octamethylcyclotetrasiloxane..........................     10/12/93      2/28/94
  556-68-3....................  Hexadecamethylcyclooctasiloxane.......................     10/12/93      2/28/94
  556-69-4....................  Octadecamethyloctasiloxane............................     10/12/93      2/28/94
  556-70-7....................  Docosamethyldecasiloxane..............................     10/12/93      2/28/94
  556-71-8....................  Octadecamethylcyclononasiloxane.......................     10/12/93      2/28/94
  999-97-3....................  Hexamethyldisilazane..................................     10/12/93      2/28/94
  2370-88-9...................  Tetramethylcyclotetrasiloxane.........................     10/12/93      2/28/94
  2374-14-3...................  Trifluoropropylmethylcyclotrisiloxane.................     10/12/93      2/28/94
  2471-08-1...................  Hexacosamethyldodecasiloxane..........................     10/12/93      2/28/94
  2471-09-2...................  Octacosamethyltridecasiloxane.........................     10/12/93      2/28/94
  2471-10-5...................  Triacontamethyltetradecasiloxane......................     10/12/93      2/28/94
  2471-11-6...................  Dotriacontamethylpentadecasiloxane....................     10/12/93      2/28/94
  2554-06-5...................  Methylvinylcyclosiloxane..............................     10/12/93      2/28/94
  2627-95-4...................  Tetramethyldivinyldisiloxane..........................     10/12/93      2/28/94
  2652-13-3...................  Eicosamethylnonasiloxane..............................     10/12/93      2/28/94
  70131-67-8..................  Siloxanes and silicones, di-Me, hydroxy-terminated....     10/12/93      2/28/94
  9004-73-3...................  Methylpolysiloxane....................................     10/12/93      2/28/94
  18766-38-6..................  Docosamethylcycloundecasiloxane.......................     10/12/93      2/28/94
  18772-36-6..................  Eicosamethylcyclodecasiloxane.........................     10/12/93      2/28/94
  18844-04-7..................  Hexatriacontamethylheptadecasiloxane..................     10/12/93      2/28/94

[[Page 52]]

 
  18919-94-3..................  Tetracosamethylcyclododecasiloxane....................     10/12/93      2/28/94
  23523-12-8..................  Hexatriacontamethylcyclooctadecasiloxane..............     10/12/93      2/28/94
  23523-14-0..................  Triacontamethylcyclopentadecasiloxane.................     10/12/93      2/28/94
  23732-94-7..................  Hexacosamethylcyclotridecasiloxane....................     10/12/93      2/28/94
  36938-50-8..................  Tetratriacontamethyl hexadecasiloxane.................     10/12/93      2/28/94
  36938-52-0..................  Octatriacontamethyl octadecasiloxane..................     10/12/93      2/28/94
  63148-62-9..................  Dimethyl silicones and siloxanes......................     10/12/93      2/28/94
  67762-90-7..................  Dimethyl silicones and siloxane, reaction products         10/12/93      2/28/94
                                 with silica.
  67762-94-1..................  Dimethylmethylvinylsiloxane...........................     10/12/93      2/28/94
  68037-59-2..................  Dimethylhydropolylsiloxane............................     10/12/93      2/28/94
  68037-74-1..................  Dimethylpolysiloxanes.................................     10/12/93      2/28/94
  68083-14-7..................  Dimethyldiphenylsiloxane..............................     10/12/93      2/28/94
  69430-24-6..................  Cyclopolydimethylsiloxane.............................     10/12/93      2/28/94
  115361-68-7.................  Dimethylmethyl 3,3,3-trifluoropropyl siloxane.........     10/12/93      2/28/94
  149050-40-8.................  Octacosamethylcyclotetradecasiloxane..................     10/12/93      2/28/94
  150026-95-2.................  Dotriacontamethylcyclohexadecasiloxane................     10/12/93      2/28/94
  150026-96-3.................  Tetratriacontamethylcycloheptadecasiloxane............     10/12/93      2/28/94
  150026-97-4.................  Octatriacontamethylcyclononadecasiloxane..............     10/12/93      2/28/94
  150026-98-5.................  Tetracontamethylcycloeicosasiloxane...................     10/12/93      2/28/94
  150026-99-6.................  Tetracontamethylnonadecasiloxane......................     10/12/93      2/28/94
  150027-00-2.................  Dotetracontamethyleicosasiloxane......................     10/12/93      2/28/94
  not available...............  Polymethyloctadecylsiloxane...........................     10/12/93      2/28/94
Substantially produced
 chemicals in need of
 subchronic tests:
  80-51-3.....................  p,p'-Oxybis(benzenesulfonylhydrazide).................      9/30/91     11/27/91
  81-84-5.....................  Naphthalenedicarboxylic anhydride.....................      9/30/91     11/27/91
  84-51-5.....................  2-Ethylanthraquinone..................................      9/30/91     11/27/91
  87-02-5.....................  7-Amino-4-hydroxy-2-naphthalenesulfonic acid..........      9/30/91     11/27/91
  90-15-3.....................  1-Naphthol............................................      9/30/91     11/27/91
  92-70-6.....................  3-Hydroxy-2-naphthoic acid............................      9/30/91     11/27/91
  94-28-0.....................  Triethylene glycol bis(2-ethylhexanoate)..............      9/30/91     11/27/91
  95-32-9.....................  2-(4-Morpholinyldithio)-benzothiazole.................      9/30/91     11/27/91
  97-88-1.....................  N-Butyl methacrylate..................................      9/30/91     11/27/91
  98-48-6.....................  1,3-Benzenedisulfonic Acid............................      9/30/91     11/27/91
  99-54-7.....................  3,4-Dichloronitrobenzene..............................      9/30/91     11/27/91
  99-63-8.....................  Isophthaloyl chloride.................................      9/30/91     11/27/91
  100-20-9....................  Terephthaloyl chloride................................      9/30/91     11/27/91
  100-29-8....................  4-Ethoxynitrobenzene..................................      9/30/91     11/27/91
  102-01-2....................  Acetoacetanilide......................................      9/30/91     11/27/91
  106-31-0....................  Butyric anhydride.....................................      9/30/91     11/27/91
  106-63-8....................  Isobutyl acrylate.....................................      9/30/91     11/27/91
  111-96-6....................  Diethylene glycol dimethyl ether......................      9/30/91     11/27/91
  112-15-2....................  Ethanol, 2-(2-ethoxyethoxy)-, acetate.................      9/30/91     11/27/91
  116-81-4....................  Bromamine acid........................................      9/30/91     11/27/91
  119-33-5....................  4-Methyl-2-nitro-phenol...............................      9/30/91     11/27/91
  121-60-8....................  4-(Acetylamino)benzenesulfonyl chloride...............      9/30/91     11/27/91
  123-54-6....................  2,4-Pentanedione......................................      9/30/91     11/27/91
  123-62-6....................  Propanoic anhydride...................................      9/30/91     11/27/91
  142-16-5....................  Bis(2-ethylhexyl)-2-butenedioate......................      9/30/91     11/27/91
  311-89-7....................  Perfluorotributylamine................................      9/30/91     11/27/91
  355-42-0....................  Perfluoro-N-hexane....................................      9/30/91     11/27/91
  594-42-3....................  Trichloromethanesulfenyl chloride.....................      9/30/91     11/27/91
  616-21-7....................  1,2-Dichlorobutane....................................      9/30/91     11/27/91
  626-17-5....................  1,3-Dicyanobenzene....................................      9/30/91     11/27/91
  760-23-6....................  3,4-Dichlorobutene....................................      9/30/91     11/27/91
  929-06-6....................  2-(2-Aminoethoxy)-ethanol.............................      6/30/92      9/28/92
  1047-16-1...................  Quinacridone..........................................      9/30/91     11/27/91
  1111-78-0...................  Ammonium carbamate....................................      9/30/91     11/27/91
  3089-11-0...................  Hexa(methoxymethyl) melamine..........................      9/30/91     11/27/91
Sulphones:
  67-71-0.....................  Dimethylsulfone.......................................      9/30/91     11/27/91
  77-79-2.....................  3-Sulfolene...........................................      9/30/91     11/27/91
  80-07-9.....................  Sulfonyl bis-(4-chlorobenzene)........................      9/30/91     11/27/91
  80-08-0.....................  4,4'-Diaminodiphenyl sulfone..........................      9/30/91     11/27/91
  80-09-1.....................  Bisphenol S...........................................      9/30/91     11/27/91
  98-30-6.....................  2-Amino-4-(methylsulfonyl)phenol......................      9/30/91     11/27/91
  126-33-0....................  Sulfolane.............................................      9/30/91     11/27/91
  127-63-9....................  Diphenylsulfone.......................................      9/30/91     11/27/91
  2580-77-0...................  2,2'-Sulfonyl bis-ethanol.............................      9/30/91     11/27/91
  3278-22-6...................  1,1'-[Methylene bis(sulfonyl)]bisethene...............      9/30/91     11/27/91

[[Page 53]]

 
  5246-57-1...................  2-[(3-Aminophenyl)sulfonyl]ethanol....................      9/30/91     11/27/91
  16588-67-3..................  3-[N-Ethyl-4-[[6-(methylsulfonyl)-2-benzothiazolyl]         9/30/91     11/27/91
                                 azo]-m-toluidino]- propionitrile.
  17557-67-4..................  6-(Methylsulfonyl)-2-benzothiazolamine................      9/30/91     11/27/91
  17601-96-6..................  2-Amino-4-[(2-hydroxyethyl) sulfonyl]phenol...........      9/30/91     11/27/91
  17688-68-5..................  4-Phenylthiomorpholine, 1,1-dioxide...................      9/30/91     11/27/91
  17741-62-7..................  4-[4-[(2,6-Dichloro-4-nitrophenyl)                          9/30/91     11/27/91
                                 azo]phenyl]thiomorpholine, 1,1-dioxide-.
  18760-44-6..................  3-(Decyloxy)tetrahydrothiophene 1,1-dioxide...........      9/30/91     11/27/91
  20018-09-1..................  1-(Diiodomethyl) sulfonyl-4-methyl benzene............      9/30/91     11/27/91
  26750-50-5..................  1,1'-[Oxybis(methylenesulfonyl)] bisethene............      9/30/91     11/27/91
  36724-43-3..................  2,2'-[Oxybis(methylenesulfonyl)]bisethanol............      9/30/91     11/27/91
  41123-59-5..................  1,1'-[Methylenebis(sulfonyl)]bis-2-chloroethane.......      9/30/91     11/27/91
  41123-69-7..................  2,2'-[Methylenebis(sulfonyl)]bisethanol...............      9/30/91     11/27/91
  41687-30-3..................  2-[(3-Nitrophenyl)sulfonyl]ethanol....................      9/30/91     11/27/91
  52218-35-6..................  2-[(6-Amino-2-naphthalenyl)sulfonyl]ethanol...........      9/30/91     11/27/91
  53061-10-2..................  1,1'-[Oxybis(methylenesulfonyl)]bis-2-chloroethane....      9/30/91     11/27/91
  63134-33-8..................  4-[[4-(Phenylmethoxy)phenyl]sulfonyl]phenol...........      9/30/91     11/27/91
----------------------------------------------------------------------------------------------------------------

(Secs 8(a) and 8(d), 90 Stat. 2027, 2029; 15 U.S.C. 2607 (a) and (d))

[47 FR 26998, June 22, 1982]

    Editorial Note: For Federal Register citations affecting 
Sec. 712.30, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.

    Effective Date Note 1: At 59 FR 14115, Mar. 25, 1994, in Sec. 712.30 
paragraph (x), the chemical substances under the category ``propylene 
glycol ethers esters'' and all related dates were stayed, effective 
March 25, 1994.
    2. At 60 FR 31921, June 19, 1995, Sec. 712.30 was amended in part by 
redesignating paragraph (x) as paragraph (e).
    3. At 63 FR 684, Jan. 7, 1998, the table in Sec. 712.30(e) was 
amended by staying the entire category ``Nonylphenol ethoxylates'', 
effective Dec. 30, 1997.



PART 716--HEALTH AND SAFETY DATA REPORTING--Table of Contents




                      Subpart A--General Provisions

Sec.
716.1  Scope and compliance.
716.3  Definitions.
716.5  Persons who must report.
716.10  Studies to be reported.
716.20  Studies not subject to the reporting requirements.
716.25  Adequate file search.
716.30  Submission of copies of studies.
716.35  Submission of lists of studies.
716.40  EPA requests for submission of further information.
716.45  How to report on substances and mixtures.
716.50  Reporting physical and chemical properties.
716.55  Confidentiality claims.
716.60  Reporting schedule.
716.65  Reporting period.

                  Subpart B--Specific Chemical Listings

716.105  Additions of substances and mixtures to which this subpart 
          applies.
716.120  Substances and listed mixtures to which this subpart applies.

    Authority: 15 U.S.C. 2607(d).

    Source: 51 FR 32726, Sept. 15, 1986, unless otherwise noted.



                       Subpart--General Provisions



Sec. 716.1  Scope and compliance.

    (a) This subpart sets forth requirements for the submission of lists 
and copies of health and safety studies on chemical substances and 
mixtures selected for priority consideration for testing rules under 
section 4(a) of the Toxic Substances Control Act (TSCA) and on other 
chemical substances and mixtures for which EPA requires health and 
safety information in fulfilling the purposes of TSCA.
    (b) Section 15(3) of TSCA makes it unlawful for any person to fail 
or refuse to submit information required under this subpart. Section 16 
provides that a violation of section 15 renders a person liable to the 
United States for a civil penalty and possible criminal prosecution. 
Under section 17, the district courts of the United States have 
jurisdiction to restrain any violation of section 15.

[[Page 54]]



Sec. 716.3  Definitions.

    The definitions in section 3 of TSCA apply to this subpart. In 
addition, the following definitions are provided for the purposes of 
this subpart:
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance(s) or mixture(s).
    Co-product means a chemical substance produced for a commercial 
purpose during the manufacture, processing, use, or disposal of another 
chemical substance(s) or mixture(s).
    Copy of study means the written presentation of the purpose and 
methodology of a study and its results.
    EPA means the United States Environmental Protection Agency.
    Health and safety study or study means any study of any effect of a 
chemical substance or mixture on health or the environment or on both, 
including underlying data and epidemiological studies, studies of 
occupational exposure to a chemical substance or mixture, toxicological, 
clinical, and ecological or other studies of a chemical substance or 
mixture, and any test performed under TSCA.
    (1) It is intended that the term health and safety study be 
interpreted broadly. Not only is information which arises as a result of 
a formal, disciplined study included, but other information relating to 
the effects of a chemical substance or mixture on health or the 
environment is also included. Any data that bear on the effects of a 
chemical substance on health or the environment would be included. 
Chemical identity is part of, or underlying data to, a health and safety 
study.
    (2) Examples are:
    (i) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; data on behavioral disorders; dermatoxicity; 
pharmacological effects; mammalian absorption, distribution, metabolism, 
and excretion; cumulative, additive, and synergistic effects; and acute, 
subchronic, and chronic effects.
    (ii) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including: Acute 
toxicity tests, chronic toxicity tests, critical life-stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular chemical substance or 
mixture on the environment, including surveys, tests, and studies of: 
Biological, photochemical, and chemical degradation; structure/activity 
relationships; air, water, and soil transport; biomagnification and 
bioconcentration; and chemical and physical properties, e.g., boiling 
point, vapor pressure, evaporation rates from soil and water, octanol/
water partition coefficient, and water solubility.
    (iv) Monitoring data, when they have been aggregated and analyzed to 
measure the exposure of humans or the environment to a chemical 
substance or mixture.
    Import means to import for commercial purposes.
    Import for commercial purposes means to import with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
importer, and includes the importation of any amount of a chemical 
substance or mixture. If a chemical substance or mixture containing 
impurities is imported for commercial purposes, then those impurities 
are also imported for commercial purposes.
    Importer means any person who imports a chemical substance, 
including a chemical substance as a part of a mixture or article, into 
the customs territory of the United States and includes the person 
primarily liable for the payment of any duties on the merchandise or an 
authorized agent acting on his behalf (as defined in 19 CFR 1.11). 
Importer also includes, as appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner, if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20.

[[Page 55]]

    (4) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144. For the purpose of this definition, the customs territory of 
the United States consists of the 50 States, Puerto Rico, and the 
District of Columbia.
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    Listed mixture means any mixture listed in Sec. 716.120.
    Manufacture means to manufacture for commercial purposes.
    Manufacture for commercial purposes means: (1) To produce, with the 
purpose of obtaining an immediate or eventual commercial advantage for 
the manufacturer, and includes among other things such ``manufacture'' 
of any amount of a chemical substance or mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including byproducts 
and impurities. Such byproducts and impurities may, or may not, in 
themselves have commercial value. They are nonetheless produced for the 
purpose of obtaining a commercial advantage since they are part of the 
manufacture of a chemical product for a commercial purpose.
    Manufacturer means a person who produces or manufactures a chemical 
substance. A person who extracts a component chemical substance from a 
previously existing chemical substance or a complex combination of 
substances is a manufacturer of that component chemical substance.
    Person includes any individual, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity, any State or political subdivision thereof, any 
municipality, any interstate body, and any department, agency, or 
instrumentality of the Federal government.
    Process means to process for commercial purposes.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture, after its manufacture, for distribution in 
commerce with the purpose of obtaining an immediate or eventual 
commercial advantage for the processor. Processing of any amount of a 
chemical substance or mixture is included. If a chemical substance or 
mixture containing impurities is processed for commercial purposes, then 
those impurities are also processed for commercial purposes.
    Propose to manufacture, import, or process means that a person has 
made a management decision to commit financial resources toward the 
manufacture, importation, or processing of a substance or mixture.
    Substance means chemical substance as defined at section 3(2)(A) of 
TSCA, 15 U.S.C. 2602(2)(A).
    TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et 
seq.).



Sec. 716.5   Persons who must report.

    (a) Except as provided in paragraphs (b) and (c) of this section, 
only those persons described in this section are required to report 
under this part. Persons who must report include manufacturers 
(including importers) who fall within the North American Industry 
Classification System (NAICS) (in effect as of January 1, 1997) 
Subsector 325 (chemical manufacturing and allied products) or Industry 
Group 32411 (petroleum refineries), who:
    (1) In the 10 years preceding the effective date on which a 
substance or mixture is added to Sec. 716.120, either had proposed to 
manufacture (including import), or had manufactured (including imported) 
the listed substance or listed mixture (including as a known byproduct), 
are required to report during the reporting period specified in 
Sec. 716.65.
    (2) As of the effective date on which a substance or mixture is 
added to Sec. 716.120, and who propose to manufacture (including 
import), or who are manufacturing (including importing) the listed 
substance or listed mixture (including as a known byproduct), are 
required to report during the reporting period specified in Sec. 716.65.

[[Page 56]]

    (3) After the effective date on which a substance or mixture is 
added to Sec. 716.120, and who propose to manufacture (including import) 
the listed substance or listed mixture (including as a known byproduct), 
are required to report during the reporting period specified in 
Sec. 716.65.
    (b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may 
require that any person who does not fall within NAICS (in effect as of 
January 1, 1997) Subsector 325 or Industry Group 32411, and who had 
proposed to manufacture (including import) or process, had manufactured 
(including imported) or processed, proposes to manufacture (including 
import) or process, or is manufacturing (including importing) or 
processing a substance or mixture listed in Sec. 716.120 must report 
under this part.
    (c) Processors and persons who propose to process a substance or 
mixture otherwise subject to the reporting requirements imposed by this 
part are not subject to this part unless EPA specifically states 
otherwise in a particular notice or rule promulgated under the authority 
of 15 U.S.C. 2607(d).

[63 FR 15773, Apr. 1, 1998]



Sec. 716.10  Studies to be reported.

    (a) In general, health and safety studies, as defined in Sec. 716.3, 
on any substance or listed mixture listed in Sec. 716.120, that are 
unpublished are reportable, i.e., must be submitted or listed. However, 
this requirement has limitations according to the nature of the material 
studied, so that:
    (1) All studies of substances and listed mixtures are reportable. 
However, in the case of physical and chemical properties, only those 
studies listed in Sec. 716.50 must be submitted.
    (2) Studies of mixtures known to contain substances or listed 
mixtures listed in Sec. 716.120 are reportable except for studies of 
physical and chemical properties and the studies exempted at 
Sec. 716.20(a)(6) (i) through (vi).
    (3) Studies of substances or listed mixtures that a person who is 
reporting has manufactured, imported, or processed or proposed to 
manufacture, import, or process only as impurities are not generally 
reportable under Sec. 716.20(a)(9).
    (4) Underlying data, such as medical or health records, individual 
files, lab notebooks, and daily monitoring records supporting studies do 
not have to be submitted initially. EPA may request underlying data 
later under Sec. 716.40.
    (b) [Reserved]



Sec. 716.20  Studies not subject to the reporting requirements.

    (a) Excluding paragraph (a)(3) of this section, the following types 
of studies are exempt from the copy and list submission requirements of 
Secs. 716.30 and 716.35.
    (1) Studies which have been published in the scientific literature.
    (2) Studies previously submitted to the EPA Office of Pollution 
Prevention and Toxics. These studies are limited to section 8(e) 
submissions, studies submitted during section 4 proceedings, studies 
submitted with premanufacture notices or significant new use notices, 
and studies submitted ``for your information'' (FYI submissions) in 
support of EPA's TSCA Existing Chemicals Program. Studies which have 
been initiated pursuant to a TSCA section 4(a) test rule, for which the 
person has submitted a letter of intent to conduct testing in accordance 
with the provisions of Sec. 790.25 of part 790 of this chapter, are 
exempt from the list submission requirements of Sec. 716.35.
    (3) Except for those studies described in paragraph (a)(2) of this 
section, studies previously submitted to any Federal agency with no 
claims of confidentiality are exempt only from the copy submission 
requirements of Sec. 716.30, and must be listed in accordance with the 
provisions of Sec. 716.35.
    (4) Studies conducted or initiated by or for another person who is 
subject to, and who will report the studies under Secs. 716.30 and 
716.35.
    (5) Studies of chemical substances which are not on the TSCA 
Chemical Substances Inventory. This exemption applies only to those 
substances within categories listed under Sec. 716.120(c).
    (6) The following types of studies when the subject of the study is 
a mixture known to contain a substance or listed mixture listed under 
Sec. 716.120.
    (i) Acute oral toxicity studies.
    (ii) Acute dermal toxicity studies.

[[Page 57]]

    (iii) Acute inhalation toxicity studies.
    (iv) Primary eye irritation studies.
    (v) Primary dermal irritation studies.
    (vi) Dermal sensitization studies.
    (vii) Physical and chemical properties.

If the substance or listed mixture is an impurity, no reporting is 
required (see paragraph (a)(9) of this section).
    (7) Analyzed aggregations of monitoring data based on monitoring 
data acquired more than 5 years preceding the date the substance or 
listed mixture was added to the list under Sec. 716.120.
    (8) Analyzed aggregations of monitoring data on mixtures known to 
contain one or more substances or listed mixtures listed in 
Sec. 716.120, when the monitoring data are not analyzed to determine the 
exposure or concentration levels of the substances or listed mixture 
listed under Sec. 716.120.
    (9) Studies on a substance or listed mixture listed under 
Sec. 716.120 that the person who is reporting has manufactured, 
imported, or processed or proposed to manufacture, import, or process 
only as an impurity. When reporting of such studies is to be required, 
that reporting will be separately proposed in the Federal Register.
    (10) Studies of chemical substances or listed mixtures previously 
submitted by trade associations in accordance with the provisions of 
Sec. 716.30.
    (b) The following types of studies on substances or listed mixtures 
listed under Sec. 716.120 are exempt from the copy and list submission 
requirements of Secs. 716.30 and 716.35.
    (1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and 
68611-64-3), studies on agronomic plant growth or damage which 
demonstrate only that the resins stimulate plant growth or cause plant 
damage when applied as a fertilizer.
    (2) For the specified chemicals in Sec. 716.120(d) under the 
category ``Siloxanes,'' acute oral, dermal, and inhalation toxicity 
studies and primary eye and dermal irritation studies.
    (3) For the listed chemicals under Sec. 716.120(d) in the category 
``OSHA Chemicals in Need of Dermal Absorption Testing,'' studies on 
ecological effects.
    (4) For the chemicals listed at Sec. 716.120 with a special 
exemption referencing this paragraph, studies on mixtures containing the 
listed substance at levels below 1 percent of the mixture, except when a 
purpose of the study includes the investigation of the effects of the 
listed substance at levels below 1 percent.
    (5) Rulemaking proceedings that add substances and mixtures to 
Sec. 716.120 will specify the types of health and/or environmental 
effects studies that must be reported and will specify the chemical 
grade/purity requirements that must be met or exceeded in individual 
studies. Chemical grade/purity requirements will be specified on a per 
chemical basis or for a category of chemicals for which reporting is 
required.

[51 FR 32726, Sept. 15, 1986, as amended at 58 FR 47649, Sept. 10, 1993; 
58 FR 68315, Dec. 27, 1993; 60 FR 34884, July 5, 1995; 63 FR 15773, Apr. 
1, 1998]



Sec. 716.25   Adequate file search.

    The scope of a person's responsibility to search records is limited 
to records in the location(s) where the required information is 
typically kept, and to records kept by the person or the person's 
individual employee(s) who is/are responsible for keeping such records 
or advising the person on the health and environmental effects of 
chemicals. Persons are not required to search for reportable information 
dated before January 1, 1977, to comply with this subpart unless 
specifically required to do so in a rule.

[63 FR 15773, Apr. 1, 1998]



Sec. 716.30  Submission of copies of studies.

    (a)(1) Except as provided in Secs. 716.5, 716.20, and 716.50, 
persons must send to EPA copies of any health and safety studies in 
their possession for the substances or mixtures listed in Sec. 716.120. 
Persons are responsible for submitting copies on only the substances or 
listed mixtures which they: Have manufactured, imported, or processed or 
proposed to manufacture, import, or process (including as known 
byproducts)

[[Page 58]]

within the 10 years preceding the effective date for reporting on the 
substances or listed mixtures; manufacture, import, or process on the 
effective date for reporting on the substances or listed mixtures; and 
propose to manufacture, import, or process following the effective date 
for reporting on the substances or listed mixtures. Persons who list 
studies as ongoing or initiated under Sec. 716.35(a) (1) and (2) must 
submit them when they are completed.
    (2) [Reserved]
    (b) Submissions under paragraph (a) of this section must be 
identified either on the face of the study or otherwise by the 
applicable chemical name and CAS number (if any) listed in 
Sec. 716.120(a) (1) and (2), and must be accompanied by a cover letter 
containing the name, job title, address and telephone number of the 
submitting official, and the name and address of the manufacturing or 
processing establishment on whose behalf the submission is made. In the 
cover letter, submitters must identify any impurity or additive known to 
have been present in the substance or listed mixtures as studied unless 
its presence is specifically noted in the study itself. The cover letter 
accompanying a study submitted by a trade association must also state 
that the submission is to satisfy reporting requirements under this 
part.
    (c) Copies of health and safety studies and the accompanying cover 
letters must be submitted, preferably by certified mail, to the Document 
Control Office (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, 
DC., 20460, ATTN: 8(d) Health and Safety Reporting Rule (Notification/
Reporting).

[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987; 
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 34463, 
July 3, 1995; 63 FR 15773, Apr. 1, 1998]



Sec. 716.35  Submission of lists of studies.

    (a) Except as provided in Secs. 716.5, 716.20, and 716.50, persons 
subject to this rule must send lists of studies to EPA for each of the 
listed substances or listed mixtures (including as a known byproduct) in 
Sec. 716.120 which they are manufacturing, importing, or processing, or 
which they propose to manufacture (including import) or process.
    (1) Ongoing studies. As of the date a person becomes subject to this 
part, a list of ongoing health and safety studies being conducted by or 
initiated for them, noting for each entry: The beginning date of the 
study, the purpose of the study, the types of data to be collected, the 
anticipated date of completion, and the name and address of the 
laboratory conducting the study.
    (2) Initiated studies. After the date a person becomes subject to 
this part, a list of studies initiated by or for them, noting for each 
entry: The beginning date of the study, the purpose of the study, the 
types of data to be collected, the anticipated date of completion, and 
the name and address of the laboratory conducting the study.
    (3) Studies which are known but without possession of copies. As of 
the date a person becomes subject to this part, a list of unpublished 
health and safety studies known to them of which they do not have 
copies. The name and address of any person known to them to possess a 
copy of the unpublished study must accompany each entry on the list. For 
purposes of this section only, an unpublished study will be considered 
to be ``known to'' a person, if the study can be discovered by a file 
search in accordance with Sec. 716.25.
    (4) Studies previously sent to Federal agencies without 
confidentiality claims. A list of unpublished studies which have been 
sent to a Federal Agency with no claims of confidentiality. The 
submission must for each study: Identify the study by title, state the 
name and address to whom the study was sent, and the month and year in 
which the study was submitted. Any study identified will be treated as 
if it were submitted under section 8(d) and will be available for public 
disclosure under section 14(b) of TSCA. Persons subject to this 
requirement may submit either a list of unpublished health and safety 
studies previously submitted to any Federal agency without claims of 
confidentiality in accordance with Sec. 716.35(a)(4), or copies of each 
such study in accordance with Sec. 716.30.

[[Page 59]]

    (b) Submission under paragraph (a) of this section must be 
identified either on the face of the study or otherwise by the 
applicable chemical name and CAS number (if any) listed in 
Sec. 716.120(a) (1) and (2), and must be accompanied by a cover letter 
containing the name, job title, address and telephone numbers of the 
submitting official, and the name and address of the manufacturing or 
processing establishment on whose behalf the submission is made.
    (c) Lists of health and safety studies should be submitted, 
preferably by certified mail, to the Document Control Office (7407), 
Office of Pollution Prevention and Toxics, U.S. Environmental Protection 
Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(d) 
Health and Safety Reporting Rule (Notification Reporting).

[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987; 
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 53 FR 46746, 
Nov. 18, 1988; 60 FR 34463, July 3, 1995; 63 FR 15774, Apr. 1, 1998]



Sec. 716.40  EPA requests for submission of further information.

    EPA may, by letter, request a person to submit or make available for 
review the following information after the initial reporting under 
Secs. 716.30 and 716.35. If the requested submissions are not made, EPA 
may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.
    (a) Submission of underlying data of the kind described in 
Sec. 716.10(a)(4) by persons who submit copies of studies under 
Sec. 716.30 or list studies under Sec. 716.35(a)(1) or 
Sec. 716.35(a)(2).
    (b) Submission of preliminary reports of ongoing studies by persons 
who list the studies under Sec. 716.35(a)(1) or Sec. 716.35(a)(2).
    (c) Submission of copies of studies by persons listed under 
Sec. 716.35(a)(3) as possessing them.



Sec. 716.45  How to report on substances and mixtures.

    Section 716.120 lists substances and mixtures, in order by Chemical 
Abstract Service Registry Number and by alphabetical order. Studies of 
listed substances and listed mixtures shall be reported as follows:
    (a) When a substance is individually listed under Sec. 716.120(a), 
studies of the substance and studies of mixtures known to contain the 
substance must be reported as studies of that substance.
    (b) When two or more substances are listed as a mixture under 
Sec. 716.120(b), studies of the listed mixture and studies of any 
mixture known to contain the listed mixture must be reported as studies 
of the listed mixture.
    (c) Studies of the following preparations of a substance must be 
reported as studies of the substance itself, not as studies of mixtures 
known to contain the substance.
    (1) The substance in aqueous solution.
    (2) The substance containing a small amount of an additive, such as 
a stabilizer, emulsifier, or other chemical added for purposes of 
maintaining the integrity or physical form of the substance.
    (3) The substance of the grade/purity specified in each rule 
promulgated under 15 U.S.C. 2607(d).

[51 FR 32726, Sept. 15, 1986, as amended at 63 FR 15774, Apr. 1, 1998]



Sec. 716.50  Reporting physical and chemical properties.

    Studies of physical and chemical properties must be reported under 
this subpart if performed for the purpose of determining the 
environmental or biological fate of a substance, and only if they 
investigated one or more of the following properties:
    (a) Water solubility.
    (b) Adsorption/desorption on particulate surfaces, e.g., soil.
    (c) Vapor pressure.
    (d) Octanol/water partition coefficient.
    (e) Density/relative density (specific gravity).
    (f) Particle size distribution for insoluble solids.
    (g) Dissociation constant.
    (h) Degradation by photochemical mechanisms--aquatic and 
atmospheric.
    (i) Degradation by chemical mechanisms--hydrolytic, reductive, and 
oxidative.
    (j) Degradation by biological mechanisms--aerobic and anaerobic.

[[Page 60]]



Sec. 716.55  Confidentiality claims.

    (a)(1) Section 14(b) of TSCA provides that EPA may not withhold from 
disclosure, on the grounds that they are confidential business 
information, health and safety studies of any substance or mixture that 
has been offered for commercial distribution (including for test 
marketing purposes and for use in research and development), any 
substance or mixture for which testinq is required under TSCA section 4, 
or any substance for which notice is required under TSCA section 5, 
except to the extent that disclosure of data from such studies would 
reveal--
    (i) Processes used in the manufacturing, importing, or processing of 
the substance or mixture, or
    (ii) The portion of a mixture comprised by any of the substances in 
the mixture.
    (2) Any respondent who wishes to assert a claim that part of a study 
should be withheld from disclosure because disclosure would reveal a 
confidential process or quantitative mixture composition should briefly 
state the basis of the claim, e.g., by saying ``reveals confidential 
mixture proportion data,'' and clearly identify the material subject to 
the claim.
    (3) Any respondent may assert a confidentiality claim for company 
name or address, financial statistics, and product codes used by a 
company. This information will not be subject to the disclosure 
requirements of section 14(b) of TSCA.
    (4) Information other than company name or address, financial 
statistics, and product codes used by a company, which is contained in a 
study, the disclosure of which would clearly be an unwarranted invasion 
of personal privacy (such as individual medical records), will be 
considered confidential by EPA as provided in Title 5, United States 
Code, section 552(b)(6).
    (b) To assert a claim of confidentiality for data contained in a 
submitted document, the respondent must submit two copies of the 
document:
    (1) One copy must be complete. In that copy, the respondent must 
indicate what data, if any, are claimed as confidential by bracketing or 
underlining the specific information. Each page containing data claimed 
as confidential must also contain a brief statement for the basis of the 
claim as well as a label such as ``confidential,'' ``proprietary,'' or 
``trade secret.''
    (2) The second copy must be complete, except that all information 
claimed as confidential in the first copy must be deleted. The second 
copy will be immediately subject to public disclosure.
    (3) Failure to furnish a second copy when information is claimed as 
confidential in the first copy will be considered a presumptive waiver 
of the claim of confidentiality. EPA will notify the respondent by 
certified mail that a finding of a presumptive waiver of the claim of 
confidentiality has been made. The respondent will be given 30 days from 
the date of his or her receipt of this notification to submit the 
required second copy. If the respondent fails to submit the second copy 
within the 30 days, EPA will place the first copy in the public file.
    (c) If no claim of confidentiality accompanies a document at the 
time it is submitted to EPA, the document will be placed in an open file 
available to the public without further notice to the respondent.



Sec. 716.60  Reporting schedule.

    (a) General requirements. Except as provided in Sec. 716.5 and 
paragraphs (b) and (c) of this section, submissions under Secs. 716.30 
and 716.35 must be postmarked on or before 60 days after the effective 
date of the listing of a substance or mixture in Sec. 716.120 or within 
60 days of proposing to manufacture (including import) or process a 
listed substance or listed mixture (including as a known byproduct) if 
first done after the effective date of the substance or mixture being 
listed in Sec. 716.120.
    (b)(1) Submission of lists of initiated studies. Persons subject to 
the listing requirements of Sec. 716.35(a)(2) must inform EPA of the 
initiated study within 30 days of its initiation.
    (2) Submission of copies of completed studies. Persons must submit 
copies of studies listed as ongoing or initiated under Sec. 716.35(a) 
(1) and (2) within 30 days of completing the study.
    (c) Requests for extensions of time. Respondents who cannot meet a 
deadline

[[Page 61]]

under this section may apply for a reasonable extension of time. 
Requests for extensions must be in writing and addressed to the 
Director, Office of Pollution Prevention and Toxics (7401), U.S. 
Environmental Protection Agency, Room E-539, 401 M St., SW., Washington, 
DC, 20460, ATTN: Section 8(d) extension. Extension requests must be 
postmarked on or before 40 days after the effective date of the listing 
of a substance or mixture in Sec. 716.120. The Director of EPA's Office 
of Pollution Prevention and Toxics will grant or deny extension 
requests.

[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July 3, 1995; 
63 FR 15774, Apr. 1, 1998]



Sec. 716.65   Reporting period.

    Unless otherwise required in a rule promulgated under 15 U.S.C. 
2607(d) relating to a listed chemical substance or listed mixture 
[hereinafter ``rule''], the reporting period for a listed chemical 
substance or listed mixture will terminate 60 days after the effective 
date on which the listed chemical substance or listed mixture is added 
to 40 CFR 716.120. EPA may require reporting for a listed chemical 
substance or listed mixture beyond the 60 day period in a rule 
promulgated under 15 U.S.C. 2607(d), however EPA will not extend any 
reporting period later than 2 years after the effective date on which a 
listed chemical substance or listed mixture is added to 40 CFR 716.120. 
After the applicable reporting period terminates, any person subject to 
the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to 
EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or 
(a)(2) must submit a copy of any such study within 30 days after its 
completion, regardless of the study's completion date.

[63 FR 15774, Apr. 1, 1998]



                  Subpart B--Specific Chemical Listings



Sec. 716.105  Additions of substances and mixtures to which this subpart applies.

    The requirements of this subpart will be extended periodically to 
cover additional substances and mixtures. Two procedures will be used to 
add substances and mixtures.
    (a) Except as provided in paragraph (b) of this section, substances 
and mixtures will be added to Sec. 716.120 after publication in the 
Federal Register of a notice of proposed amendment to this subpart. 
There will be at least a 30-day public comment period on the notice. 
After consideration of the comments, EPA will amend Sec. 716.120 by 
final rule to add the substances and listed mixtures.
    (b) Except as provided in paragraph (c) of this section, chemical 
substances, mixtures, and categories of chemical substances that have 
been added to the TSCA section 4(e) Priority List by the Interagency 
Testing Committee, established under section 4 of TSCA, will be added to 
Sec. 716.120 but only to the extent that the total number of designated 
and recommended substances, mixtures and categories of chemical 
substances has not exceeded 50 in any 1 year. The addition of such 
chemical substances, mixtures, and categories of chemical substances to 
Sec. 716.120 will be effective 30 days after publication of a notice to 
that effect in the Federal Register.
    (c) Prior to the effective date of an amendment under paragraph (b) 
of this section, the Assistant Administrator for Prevention, Pesticides 
and Toxic Substances may for good cause withdraw a chemical substance, 
mixture, or category of chemical substances from Sec. 716.120. Any 
information submitted showing why a chemical substance, mixture, or 
category of chemical substances should be withdrawn from the amendment 
must be received by EPA within 14 days after the date of publication of 
the notice under paragraph (b) of this section. If a chemical substance, 
mixture, or category of chemical substances is withdrawn, a Federal 
Register notice announcing this decision will be published no later than 
the effective date of the amendment under paragraph (b) of this section. 
Persons who wish to submit information that shows why a chemical should 
be withdrawn must address their comments, in writing to the Document 
Control Office (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room

[[Page 62]]

G-099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(d) Auto-ITC.

[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July 3, 1995]



Sec. 716.120  Substances and listed mixtures to which this subpart applies.

    Substances listed in this section appear in order by Chemical 
Abstract Service Registry Number. Chemical mixtures and categories are 
listed separately and by alphabetical order. Chemical substances listed 
within a category are provided only as examples of the category, and are 
not included on the list of substances. When a chemical substance in the 
substance or category list had been listed previously by a trivial (or 
common) name, it appears first, followed by the Chemical Abstract 
Service (CAS) name appearing in the TSCA Chemical Substance Inventory.
    (a) List of substances. The following chemical substances are 
subject to all the provisions of part 716. Manufacturers, importers, and 
processors of a listed substance are subject to the reporting 
requirements of subpart A for that substance.

----------------------------------------------------------------------------------------------------------------
                                                                                         Effective
  CAS No.                 Substance                        Special exemptions               date     Sunset date
----------------------------------------------------------------------------------------------------------------
62-74-8....  Acetic acid, fluoro-, sodium salt.  .....................................     03/07/86     03/07/96
67-63-0....  2-Propanol........................  .....................................     12/15/86     12/15/96
67-66-3....  Methane, trichloro-...............  .....................................     06/01/87     06/01/97
67-72-1....  Ethane, hexachloro-...............  .....................................     04/29/83     01/13/86
68-12-2....  Dimethyl formamide-Formamide, N,N-  .....................................      4/13/89     12/19/95
              dimethyl-.
71-55-6....  1,1,1-Trichloroethane--Ethane,      .....................................     10/04/82     10/04/92
              1,1,1-trichloro-.
74-83-9....  Methane, bromo-...................  .....................................     06/01/87     06/01/97
74-87-3....  Chloromethane--Methane, chloro-...  .....................................     10/04/82     10/04/92
74-95-3....  Methane, dibromo-.................  .....................................       6/1/87     12/19/95
74-97-5....  Methane, bromochloro-.............  .....................................       6/1/87     12/19/95
75-00-3....  Ethane, chloro-...................  .....................................     06/01/87     06/01/97
75-02-5....  Vinyl fluoride--Ethene, fluoro-...  .....................................     10/04/82     10/04/92
75-04-7....  Ethanamine........................  .....................................       6/1/87     12/19/95
75-05-8....  Acetonitrile......................  .....................................     10/04/82     10/04/92
75-09-2....  Methylene chloride--Methane,        .....................................     10/04/82     10/04/92
              dichloro-.
75-12-7....  Formamide.........................  .....................................     04/29/83     04/29/93
75-21-8....  Oxirane...........................  .....................................     10/04/82     10/04/92
75-25-2....  Methane, tribromo-................  .....................................     06/01/87     06/01/97
75-27-4....  Methane, bromodichloro-...........  .....................................       6/1/87     12/19/95
75-29-6....  Propane, 2-chloro-................  .....................................       6/1/87     12/19/95
75-34-3....  Ethane, 1,1-dichloro-.............  .....................................     06/01/87     06/01/97
75-37-6....  1,1-Difluoroethane-Ethane, 1,1-     .....................................      4/13/89     12/19/95
              difluoro-.
75-38-7....  Vinylidene fluoride--Ethene, 1,1-   .....................................     10/04/82     10/04/92
              difluoro-.
75-43-4....  Dichloromonofluoromethane-Methane,  .....................................      4/13/89     12/19/95
              dichlorofluoro-.
75-45-6....  Chlorodifluoromethane--Methane,     .....................................      4/13/89      6/30/98
              chlorodifluoro-.
75-52-5....  Nitromethane-Methane, nitro-......  .....................................      4/13/89     12/19/95
75-56-9....  Oxirane, methyl-..................  .....................................     10/04/82     10/04/92
75-68-3....  1-Chloro-1,1-difluoroethane-        .....................................      4/13/89     12/19/95
              Ethane, 1-chloro-1,1-difluoro.
75-86-5....  Propanenitrile, 2-hydroxy-2-methyl- .....................................       3/7/86     12/19/95
              .
75-88-7....  Ethane, 2-chloro- 1,1,1-trifluoro.  .....................................     10/15/90     11/09/93
76-13-1....  1,1,2-Trichloro-1,2,2-              .....................................      4/13/89     12/19/95
              trifluoroethane-Ethane, 1,1,2-
              trichloro-1,2,2-trifluoro-1.
77-47-4....  Hexachlorocyclopentadiene--1,3-     .....................................     10/04/82     10/04/92
              Cyclopentadiene, 1,2,3,4,5,5-
              hexachloro-.
77-58-7....  Dibutyltin dilaurate--Stannane,     .....................................     01/03/83     01/03/93
              dibutylbis[(1-oxododecyl)oxy]-.
78-59-1....  Isophorone--2-Cyclohexen-1-one,     .....................................     10/04/82     10/04/92
              3,5,5-trimethyl-.
78-83-1....  1-Propanol, 2-methyl-.............  .....................................     03/07/86     03/07/96
78-87-5....  1,2-Dichloropropane--Propane, 1,2-  .....................................     10/04/82     10/04/92
              dichloro-.
78-88-6....  1-Propene, 2,3-dichloro-..........  .....................................       6/1/87     12/19/95
78-93-3....  Methyl ethyl ketone--2-Butanone...  .....................................     10/04/82     10/04/92
78-97-7....  Propanenitrile, 2-hydroxy-........  .....................................       6/1/87     12/19/95
78-99-9....  Propane, 1,1-dichloro-............  .....................................       3/7/86     12/19/95
79-00-5....  Ethane, 1,1,2-trichloro-..........  .....................................     06/01/87     06/01/97
79-06-1....  Acrylamide--2-Propenamide.........  .....................................     10/04/82     10/04/92
79-24-3....  Nitroethane-Ethane, nitro-........  .....................................      4/13/89     12/19/95
79-94-7....  Tetrabromobisphenol A--Phenol,      .....................................     06/20/85     06/20/95
              4,4'-(methylethylidene)bis[2,6-
              dibromo-.
80-05-7....  Bisphenol A--Phenol, 4,4'-(1-       .....................................     06/28/84     06/28/94
              methylethylidene)bis-.
80-15-9....  Hydroperoxide, 1-methyl-1-          .....................................       3/7/86     12/19/95
              phenylethyl.
80-62-6....  Methyl methacrylate--2-Propenoic    .....................................      4/13/89      6/30/98
              acid, 2-methyl-, methyl ester.

[[Page 63]]

 
84-65-1....  Anthraquinone--9,10-                .....................................     12/28/84     11/09/93
              Anthracenedione.
85-22-3....  Pentabromoethylbenzene--Benzene,    .....................................     12/28/84     12/28/94
              pentabromoethyl-.
85-68-7....  Benzyl butyl phthalate--1,2-        .....................................     04/29/83     04/29/93
              Benzenedicarboxylic acid, butyl
              phenylmethyl ester.
86-74-8....  9H-Carbazole......................  .....................................     03/07/86     03/07/96
87-68-3....  Hexachloro-1,3-butadiene--1,3-      .....................................     10/04/82     10/04/92
              Butadiene, 1,1,2,3,4,4-hexachloro-
              .
88-04-0....  p-Chloro-m-xylenol-Phenol, 4-       .....................................     l4/13/89     12/19/95
              chloro-3,5-dimethyl-.
90-30-2....  N-Phenyl-1-naphthylamine..........  .....................................      9/30/91     12/19/95
90-42-6....  [1,1'-Bicyclohexyl]-2-one.........  .....................................     06/01/87     11/09/93
91-08-7....  Benzene, 1,3-diisocyanato-2-methyl- .....................................       6/1/87     12/19/95
              .
91-20-3....  Naphthalene.......................  .....................................     06/01/87     06/01/97
91-58-7....  Naphthalene, 2-chloro-............  .....................................     10/04/82     10/04/92
92-52-4....  1,1'-Biphenyl.....................  .....................................     04/29/83     04/29/93
92-69-3....  [1,1'-Biphenyl]-4-ol..............  .....................................       6/1/87     12/19/95
92-84-2....  10H-Phenothiazine.................  .....................................     06/01/87     06/01/97
92-87-5....  [1,1'-Biphenyl]-4,4'-diamine......  .....................................     06/01/87     06/01/97
95-14-7....  1,2,3-Benzotriazole-1H-             .....................................      4/13/89     12/19/95
              Benzotriazole.
95-47-6....  o-Xylene--Benzene, 1,2-dimethyl-..  .....................................     10/04/82     10/04/92
95-48-7....  o-Cresol--Phenol, 2-methyl-.......  .....................................     10/04/82     10/04/92
95-49-8....  2/Chlorotoluene--Benzene, 1-chloro- .....................................     04/29/83     04/29/93
              2-methyl-.
95-53-4....  Benzenamine, 2-methyl-............  .....................................       3/7/86     12/19/95
95-63-6....  1,2,4-Trimethylbenzene--Benzene,    .....................................     04/29/83     04/29/93
              1,2,4-trimethyl-.
96-18-4....  Propane, 1,2,3-trichloro-.........  .....................................     06/01/87     06/01/97
96-29-7....  2-Butanone, oxime.................  .....................................     12/15/86     12/19/95
96-37-7....  Methylcyclopentane--Cyclopentane,   .....................................     06/20/85     11/09/93
              methyl-.
97-18-7....  Phenol, 2,2'-thiobis[4,6-dichloro-  .....................................       6/1/87     12/19/95
97-23-4....  Phenol, 2,2'-methylenebis[4-chloro- .....................................       6/1/87     12/19/95
              .
97-88-1....  Butyl methacrylate-2-Propenoic      .....................................      4/13/89     12/19/95
              acid, 2-methyl-,butyl ester.
98-01-1....  2-Furancarboxaldehyde.............  .....................................     06/01/87     06/01/97
98-06-6....  Benzene, (1,1-dimethylethyl)-.....  .....................................       6/1/87     12/19/95
98-09-9....  Benzenesulfonyl chloride..........  .....................................       3/7/86     12/19/95
98-51-1....  p-tert-Butyltoluene--Benzene, 1-    .....................................     06/25/86     06/25/96
              (1,1-dimethylethyl)-4-methyl-.
98-56-6....  4-Chlorobenzotrifluoride--Benzene,  .....................................     04/29/83     04/29/93
              1-chloro-4-(trifluoromethyl)-.
98-73-7....  p-tert-Butylbenzoic acid-Benzoic    .....................................      6/25/86     12/19/95
              acid, 4-(1,1-dimethylethyl)-.
98-82-8....  Cumene--Benzene, (1-methylethyl)-.  .....................................     12/28/84     12/28/94
98-83-9....  Benzene, (1-methylethenyl)-.......  .....................................     06/01/87     11/09/93
98-95-3....  Nitrobenzene--Benzene, nitro-.....  .....................................     10/04/82     10/04/92
100-02-7...  p-Nitrophenol--Phenol, 4-nitro-...  .....................................      4/13/89      6/30/98
100-40-3...  4-Vinylcyclohexene................  .....................................      1/11/90     11/09/93
100-41-4...  Benzene, ethyl-...................  .....................................     06/19/87     06/19/97
100-48-1...  4-Pyridinecarbonitrile............  .....................................     06/01/87     06/01/87
100-54-9...  3-Pyridinecarbonitrile............  .....................................     06/01/87     12/29/88
100-70-9...  2-Pyridinecarbonitrile............  .....................................     06/01/87     11/09/93
101-68-8...  Benzene, 1,1-methylenebis[4-        .....................................     06/01/87     06/01/97
              isocyanato-.
101-77-9...  Benzenamine, 4,4-methylenebis-....  .....................................     10/04/82     10/04/92
101-84-8...  Diphenyl oxide--Benzene, 1,1'-      .....................................      4/13/89      6/30/98
              oxybis-.
102-71-6...  Triethanolamine-Ethanol, 2,2',2''-  .....................................      4/13/89     12/19/95
              nitrilotris-.
104-49-4...  Benzene, 1,4-diisocyanato-........  .....................................     06/01/87     11/09/93
104-51-8...  Benzene, butyl-...................  .....................................       6/1/87     12/19/95
104-76-7...  1-Hexanol, 2-ethyl-...............  .....................................       6/1/87     12/19/95
105-60-2...  2H-Azepin-2-one, hexahydro-.......  .....................................     06/01/87     06/01/97
106-42-3...  p-Xylene--Benzene, 1,4-dimethyl-..  .....................................     10/04/82     10/04/92
106-43-4...  Benzene, 1-chloro-4-methyl-.......  .....................................       6/1/87     12/19/95
106-44-5...  p-Cresol--Phenol, 4-methyl-.......  .....................................     10/04/82     10/04/92
106-49-0...  Benzenamine, 4-methyl-............  .....................................     03/07/86     03/07/96
106-50-3...  p-Phenylenediamine--1,4-            .....................................     10/04/82     10/04/92
              Benzenediamine.
106-51-4...  Quinone--2,5-Cyclohexadiene-1,4-    .....................................     10/04/82     10/04/92
              dione.
106-88-7...  Oxirane, ethyl-...................  .....................................     10/04/82     10/04/92
106-89-8...  Oxirane, (chloromethyl)-..........  .....................................     10/04/82     10/04/92
107-06-2...  Ethane, 1,2-dichloro-.............  .....................................     06/01/87     06/01/97
107-10-8...  1-Propanamine.....................  .....................................       3/7/86     12/19/95
107-19-7...  2-Propyn-1-ol.....................  .....................................       3/7/86     12/19/95
107-98-2...  1-Methoxy-2-propanol--2-Propanol,   .....................................      4/13/89      6/30/98
              1-methoxy-.
108-05-4...  Vinyl acetate--Acetic acid ethenyl  .....................................     02/10/86     02/10/96
              ester.
108-10-1...  Methyl isobutyl ketone--2-          .....................................     10/04/82     10/04/92
              Pentanone, 4-methyl-.
108-31-6...  Maleic anhydride--2,5-Furandione..  .....................................     09/10/84     09/10/94
108-38-3...  m-Xylene--Benzene, 1,3-dimethyl-..  .....................................     10/04/82     10/04/92

[[Page 64]]

 
108-39-4...  m-Cresol--Phenol, 3-methyl-.......  .....................................     10/04/82     10/04/92
108-60-1...  Propane, 2,2'-oxybis[1-chloro-....  .....................................       6/1/87     12/19/95
108-67-8...  1,3,5-Trimethylbenezene--Benzene,   .....................................     02/13/84     02/13/94
              1,3,5-trimethyl-.
108-86-1...  Benzene, bromo-...................  .....................................       6/1/87     12/19/95
108-88-3...  Toluene--Benzene, methyl-.........  .....................................     10/04/82     10/04/92
108-89-4...  4-Methylpyridine--Pyridine, 4-      .....................................     09/10/84     09/10/94
              methyl-.
108-94-1...  Cyclohexanone.....................  .....................................     10/04/82     10/04/92
108-95-2...  Phenol............................  .....................................     06/01/87     06/01/97
108-95-5...  Thiophenol........................  .....................................      1/26/94     12/19/95
108-98-5...  Benzenethiol......................  .....................................     03/07/86     03/07/96
108-99-6...  3-Methylpyridine--Pyridine, 3-      .....................................     09/10/84     09/10/94
              methyl-.
109-06-8...  2-Methylpyridine--Pyridine, 2-      .....................................     09/10/84     09/10/94
              methyl-.
109-77-3...  Propanedinitrile..................  .....................................       3/7/86     12/19/95
109-87-5...  Methane, Dimethoxy-...............  .....................................       6/1/87     12/19/95
109-89-7...  Ethanamine, N-ethyl-..............  .....................................     06/01/87     06/01/97
110-75-8...  Ethene, (2-chloroethoxy)-.........  .....................................       3/7/86     12/19/95
110-82-7...  Cyclohexane.......................  .....................................     12/19/85     12/19/95
110-86-1...  Pyridine..........................  .....................................     10/04/82     10/04/92
111-21-7...  Ethylene bisoxyethylene diacetate-- .....................................     01/13/84     12/29/88
              Ethanol, 2,2']-[1,2-
              ethanediylbis(oxy)]bis-,
              diacetate.
111-40-0...  Diethylenetriamine--1,2-            .....................................     04/29/83     04/29/93
              Ethanediamine, N-(2-aminoethyl)-.
111-42-2...  Diethanolamine--Ethanol, 2,2'-      .....................................      4/13/89      6/30/98
              iminobis-.
111-69-3...  Hexanedinitrile...................  .....................................       6/1/87     12/19/95
111-76-2...  2-Butoxyethanol--Ethanol, 2-butoxy- .....................................      4/13/89      6/30/98
              .
111-77-3...  Diethylene glycol monomethyl ether- .....................................      4/13/89     12/19/95
              Ethanol, 2-(2-methoxyethoxy)-.
111-90-0...  Diethylene glycol monoethyl ether-  .....................................      4/13/89     12/19/95
              Ethanol, 2-(2-ethoxyethoxy)-.
111-91-1...  Ethane, 1,1'-                       .....................................       3/7/86     12/19/95
              [methylenebis(oxy)]bis[2-chloro-.
111-92-2...  1-Butanamine, N-butyl-............  .....................................       6/1/87     12/19/95
112-35-6...  Triethyleneglycol monomethyl        .....................................     06/20/85     06/20/95
              ether--Ethanol, 2-[2-(2-
              methoxyethoxy)ethoxy]-.
112-50-5...  Triethyleneglycol monoethyl ether-- .....................................     06/20/85     06/20/95
              Ethanol, 2-[2-(2-
              ethoxyethoxy)ethoxy]-.
112-90-3...  Oleylamine--9-Octadecen-1-amine,    .....................................     01/13/84     01/13/94
              (Z)-.
115-28-6...  Chlorendic acid--Bicyclo[2.2.1]     .....................................     04/29/83     01/13/86
              hept-5-ene-2,3-dicarboxylic acid,
              1,4,5,6,7,7-hexachloro-.
115-96-8...  Ethanol, 2-chloro-, phosphate       .....................................     12/16/88     11/09/93
              (3:1).
118-79-6...  2,4,6-Tribromophenol..............  .....................................      1/11/90      6/30/98
120-20-7...  Anthracene........................  .....................................     06/01/87     06/01/97
120-32-1...  2-Benzyl-4-chlorophenol-Phenol, 4-  .....................................      4/13/89     12/19/95
              chloro-2-chlorophenol(phenyl
              methyl)-.
121-44-8...  Ethanamine, N,N-diethyl-..........  .....................................     01/13/84     01/13/94
121-47-1...  Benzenesulfonic acid, 3-amino-....  .....................................     06/01/87     12/29/88
122-09-8...  Benzeneethanamine, alpha,alpha-     .....................................       3/7/86     12/19/95
              dimethyl-.
122-66-7...  Hydrazine, 1,2-diphenyl-..........  .....................................     06/01/87     06/01/97
122-99-6...  2-Phenoxyethanol--Ethanol, 2-       .....................................     07/01/83     07/01/93
              phenoxy-.
123-31-9...  Hydroquinone--1,4-Benzenediol.....  .....................................     10/04/84     10/04/94
123-61-5...  Benzene, 1,3-diisocyanato-........  .....................................     06/01/87     11/09/93
123-72-8...  Butanal...........................  .....................................     12/16/88     12/19/95
124-16-3...  1-Butoxyethoxy-2-propanol-2-        .....................................      4/13/89     12/19/95
              Propanol, 1-(2-butoxyethoxy)-.
124-17-4...  2-(2-Butoxyethoxy)ethyl acetate--   .....................................     01/13/82     01/13/92
              Ethanol, 2-(2-butoxyethoxy)-,
              acetate.
124-48-1...  Methane, dibromochloro-...........  .....................................     06/01/87     06/01/97
126-73-8...  Phosphoric acid, tributyl ester...  .....................................     06/18/86     06/18/96
126-99-8...  Chloroprene--1,3-Butadiene, 2-      .....................................     12/28/84     12/28/94
              chloro-.
127-18-4...  Ethene, tetrachloro-..............  .....................................     06/01/87     06/01/97
128-39-2...  Phenol, 2,6-bis(1,1-dimethylethyl)- .....................................     12/19/85     11/09/93
              .
128-86-9...  2,6-Anthracenedisulfonic acid, 4,8- .....................................     12/21/87     11/09/93
              diamino-9,10-dihydro-1,5-
              dihydroxy-9,10-dioxo-.
129-00-0...  Pyrene............................  .....................................     06/01/87     06/01/97
131-17-9...  Diallyl phthalate-1,2-              .....................................      4/13/89     12/19/95
              Benzenedicarboxylic acid, di-2-
              propenyl ester.
135-98-8...  Benzene, (1-methylpropyl)-........  .....................................       6/1/87     12/19/95
137-20-2...  Soldium N-methyl-N-oleoyltaurine--  .....................................     12/28/84     12/28/94
              Ethanesulfonic acid, 2-[methyl (1-
              oxo-9-octadecenyl)amino]-, sodium
              salt, (Z)-.
137-26-8...  Thioperoxydicarbonic diamide,       .....................................       6/1/87     12/19/95
              tetramethyl-.
139-25-3...  Benzene, 1,1 \1\-methylenebis[4-    .....................................     06/01/87     11/09/93
              isocyanato-3-methyl-.
140-08-9...  Tris(2-chloroethyl)phosphite--      .....................................     04/29/83     01/13/86
              Ethanol, 2-chloro-, phosphite
              (3:1).

[[Page 65]]

 
140-66-9...  4-(1,1,3,3-Tetramethylbutyl)        .....................................     01/30/83     12/29/88
              phenol--Phenol, 4-(1,1,3,3-
              tetramethylbutyl)-.
140-88-5...  Ethyl acrylate--2-Propenoic acid,   .....................................      4/13/89      6/30/98
              ethyl ester.
141-79-7...  Mesityl oxide--3-Penten-2-one, 4-   .....................................     10/04/82     10/04/92
              methyl-.
142-28-9...  Propane, 1,3,-dichloro-...........  .....................................       3/7/86     12/19/95
142-84-7...  1-Propanamine, N-propyl-..........  .....................................     03/07/86      12/5/90
143-22-6...  Triethyleneglycol monobutyl ether-- .....................................     06/20/85     06/20/95
              Ethanol, 2-[-2-(2-
              butoxyethoxy)ethoxy]-.
143-33-9...  Sodium cyanide....................  .....................................     10/29/90     12/19/95
149-30-4...  Mercaptobenzothiazole--2(3H-        .....................................     12/28/84     12/28/94
              Benzothiazolethione.
149-57-5...  2-Ethylhexanoic acid--Hexanoic      .....................................     06/28/84     06/28/94
              acid, 2-ethyl-.
306-83-2...  Ethane, 2,2-dichloro-1,1,1-         .....................................     10/15/90     11/09/93
              trifluoro.
328-84-7...  3,4-Dichlorobenzotrifluoride--      .....................................     05/08/85     11/09/93
              Benzene, 1,2-dichloro-4-
              (trifluoromethyl)-.
354-33-6...  Ethane, pentafluoro...............  .....................................     10/15/90     11/09/93
357-57-3...  Strychnidin-10-one, 2,3-dimethoxy-  .....................................       3/7/86     12/19/95
428-59-1...  Oxirane,                            .....................................     10/04/82     10/04/92
              trifluoro(trifluoromethyl)-.
472-41-3...  Phenol, 4-(3,4-dihydro-2,2,4-       .....................................     06/01/87     12/29/88
              trimethyl-2H-1-benzopyran-4-yl)-.
506-96-7...  Acetyl bromide....................  .....................................       6/1/87     12/19/95
526-73-8...  1,2,3-Trimethylbenzene--Benzene,    .....................................     02/13/84     11/09/93
              1,2,3-trimethyl-.
530-50-7...  Hydrazine, 1,1-diphenyl-..........  .....................................       6/1/87     12/19/95
534-07-6...  2-Propanone, 1,3-dichloro-........  .....................................       6/1/87     12/19/95
540-54-5...  Propane, 1-chloro-................  .....................................       6/1/87     12/19/95
540-84-1...  Pentane, 2,2,4-trimethyl-.........  .....................................       6/1/87     12/19/95
542-75-6...  1-Propene, 1,3-dichloro-..........  .....................................     06/01/87     06/01/97
556-67-2...  Octamethylcyclotetrasiloxane--Cycl  .....................................     12/28/84     12/28/94
              otetrasiloxane, octamethyl-.
563-54-2...  1-Propene, 1,2-dichloro-..........  .....................................     03/07/86     12/29/88
563-58-6...  1-Propene, 1,1-dichloro-..........  .....................................     03/07/86     12/29/88
580-51-8...  [1,1-Biphenyl]-3-ol...............  .....................................     06/01/87     11/09/93
584-84-9...  Benzene, 2,4-diisocyanato-1-methyl- .....................................     06/01/87     06/01/97
              .
591-08-2...  Acetamide, N-(aminothioxomethyl)-.  .....................................       3/7/86     12/19/95
594-20-7...  Propane, 2,2-dichloro-............  .....................................       3/7/86     12/19/95
598-21-0...  Acetyl bromide, bromo-............  .....................................       6/1/87     12/19/95
598-31-2...  2-Propanone, 1-bromo-.............  .....................................       3/7/86     12/19/95
616-23-9...  1-Propanol, 2,3-dichloro-.........  .....................................       3/7/86     12/19/95
620-14-4...  m-Ethyltoluene--Benzene, 1-ethyl-3- .....................................     04/29/83     04/29/93
              methyl-.
622-96-8...  p-Ethyltoluene--Benzene, 1-ethyl-4- .....................................     04/29/83     04/29/93
              methyl-.
630-20-6...  Ethane, 1,1,1,2-tetrachloro-......  .....................................       6/1/87     12/19/95
632-79-1...  Tetrabromophthalic anhydride......  .....................................      1/11/90     12/19/95
637-92-3...  Ethyl-tert-butyl ether              Sec.  716.20(b)(3) applies                12/28/94      6/30/98
646-06-0...  1,3-Dioxolane.....................  .....................................     01/03/83     01/03/93
677-21-4...  Trifluoromethylethene--1-Propene,   .....................................     04/29/83     01/13/86
              3,3,3-trifluoro-.
685-91-6...  Acetamide, N,N-diethyl-...........  .....................................     06/01/87     11/09/93
692-42-2...  Arsine, diethyl-..................  .....................................       3/7/86     12/19/95
696-28-6...  Arsonous dichloride, phenyl-......  .....................................       3/7/86     12/19/95
757-58-4...  Tetraphosphoric acid, hexaethyl     .....................................       3/7/86     12/19/95
              ester.
811-97-2...  Ethane, 1,1,2-tetrafluoro-........  .....................................     10/15/90     11/09/93
812-03-3...  Propane, 1,1,1,2-tetrachloro-.....  .....................................       6/1/87     12/19/95
822-06-0...  Hexane, 1,6-diisocyanato-.........  .....................................       6/1/87     12/19/95
828-00-2...  1,3-Dioxan-4-ol, 2,6-dimethyl-,     .....................................       6/1/87     12/19/95
              acetate.
930-22-3...  Oxirane, ethenyl-.................  .....................................     10/04/82     10/04/92
939-97-9...  p-tert-Butylbenzaldehyde--          .....................................     06/25/86     11/09/93
              Benzaldehyde, 4-(1,1-
              dimethylethyl)-.
994-05-8...  Tert-amyl methyl ether              Sec.  716.20(b)(3) applies                12/28/94     06/30/98
1000-82-4..  Methylolurea--Urea,                 .....................................     07/01/83     07/01/93
              (hydroxymethyl)-.
1070-78-6..  Propane, 1,1,1,3-tetrachloro-.....  .....................................       6/1/87     12/19/95
1163-19-5..  Decabromodiphenyl ether...........  .....................................      1/11/90     06/30/98
1185-81-5..  Dibutyltin bis(lauryl mercaptide)-- .....................................     01/03/83     01/03/93
              Stannane, dibutylbis(dodecylthio).
1208-52-2..  Benzenamine, 2-[(4-                 .....................................     06/01/87     11/09/93
              aminophenyl)methyl]-.
1300-71-6..  Phenol, dimethyl-.................  .....................................       6/1/87     12/19/95
1309-64-4..  Antimony trioxide.................  .....................................     10/04/82     10/04/92
1321-38-6..  Benzene, diisocyanatomethyl-        .....................................     06/01/87     11/09/93
              (unspecified isomer).
1321-64-8..  Naphthalene, pentachloro-.........  .....................................     10/04/82     10/04/92
1321-65-9..  Naphthalene, trichloro-...........  .....................................     10/04/82     10/04/92
1331-47-1..  [1,1-Biphenyl]-4,4-diamino,         .....................................     06/01/87     11/09/93
              dichloro-.
1333-41-1..  Methyl pyridine--Pyridine, methyl-  .....................................     09/10/84     12/29/88
1335-87-1..  Naphthalene, hexachloro-..........  .....................................     10/04/82     10/04/92
1335-88-2..  Naphthalene, tetrachloro-.........  .....................................     10/04/82     10/04/92
1345-04-6..  Antimony trisulfide...............  .....................................     10/04/82     10/04/92
1464-53-5..  2,2-Bioxirane.....................  .....................................     10/04/82     10/04/92

[[Page 66]]

 
1634-04-4..  Propane, 2-methoxy-2-methyl-......  .....................................     12/15/86     12/15/96
1649-08-7..  Ethane, 1,2-dichloro-1,1-difluoro.  .....................................     10/15/90     12/19/95
1717-00-6..  Ethane, 1,1-dichloro-1-fluoro-....  .....................................     10/15/90     11/09/93
1825-30-5..  Naphthalene, 1,5-dichloro-........  .....................................     10/04/82     10/04/92
1825-31-6..  Naphthalene, 1,4-dichloro-........  .....................................     10/04/82     10/04/92
1888-71-7..  1-Propene, 1,1,2,3,3,3-hexachloro-  .....................................       3/7/87     12/19/95
2050-69-3..  Naphthalene, 1,2-dichloro-........  .....................................     10/04/82     10/04/92
2050-72-8..  Naphthalene, 1,6-dichloro-........  .....................................     10/04/82     10/04/92
2050-73-9..  Naphthalene, 1,7-dichloro-........  .....................................     10/04/82     10/04/92
2050-74-0..  Naphthalene, 1,8-dichloro-........  .....................................     10/04/82     10/04/92
2050-75-1..  Naphthalene, 2,3-dichloro-........  .....................................     10/04/82     10/04/92
2065-70-5..  Naphthalene, 2,6-dichloro-........  .....................................     10/04/82     10/04/92
2198-75-6..  Naphthalene, 1,3-dichloro-........  .....................................     10/04/82     10/04/92
2198-77-8..  Naphthalene, 2,7-dichloro-........  .....................................     10/04/82     10/04/92
2234-13-1..  Naphthalene, octachloro-..........  .....................................     10/04/82     10/04/92
2536-05-2..  Benzene, 1,1-methylenebis[2-        .....................................     06/01/87     11/09/93
              isocyanato-.
2556-36-7..  Cyclohexane, 1,4-diisocyanato.....  .....................................     06/01/87     11/09/93
2763-96-4..  3(2H)-Isoxazolone, 5-(aminomethyl)- .....................................       3/7/86      2/19/95
              .
2778-42-9..  Benzene, 1,3-bis(1-isocyanato-1-    .....................................     06/01/87     11/09/93
              methylethyl-.
2861-02-1..  2,6-Anthracenedisulfonic acid, 4,8- .....................................     12/21/87     12/19/95
              diamino-9,10-dihydro-1,5-
              dihydroxy-9,10-dioxo-, disodium
              salt
2873-89-0..  Ethane, 2-chloro-1,1,1,2-           .....................................     10/15/90     11/09/93
              tetrafluoro-.
3083-25-8..  Oxirane, (2,2,2-trichloroethyl)-..  .....................................     10/04/82     10/04/92
3173-72-6..  Naphthalene, 1,5,-diisocyanato-...  .....................................       6/1/87     12/19/95
3194-55-6..  Hexabromocyclododecane............  .....................................      1/11/90     12/19/95
3288-58-2..  Phosphorodithioic acid, O,O-        .....................................       3/7/86     12/19/95
              diethyl-S-methyl ester.
3296-90-0..  1,3-Propanediol, 2,2-               .....................................       6/1/87     12/19/95
              bis(bromomethyl)-.
3319-31-1..  Tris(2-ethylhexyl) trimellitate--   .....................................     01/03/83     01/03/93
              1,2,4-Benzenetricarboxylic acid,
              tris(2-ethylhexyl)ester.
3322-93-8..  1,2-Dibromo-4-(1,2-dibromoethyl)    .....................................     06/28/84     12/29/88
              cyclohexane--Cyclohexane, 1,2-
              dibromo-4-(1,2-dibromoethyl)-.
3389-71-7..  1,2,3,4,7,7-                        .....................................     01/13/84     01/13/94
              Hexachloronorbornadiene--Bicyclo[
              2.2.1]hepta-2,5-diene,
              1,2,3,4,7,7-hexachloro-.
3618-72-2..  Acetamide, N-[5-[bis[2-             .....................................     06/19/87     11/09/93
              (acetyloxy)ethyl]amino]-2-[(2-
              bromo-4,6-dinitrophenyl)azo]-4-
              methoxyphenyl]-.
3618-73-3..  Acetamide, N-[5-[bis[2-             .....................................     06/19/87     11/09/93
              (acetyloxy)ethyl]amino]-2-[(2-
              chloro-4,6-dinitrophenyl)azo]-4-
              methoxyphenyl]-.
3956-55-6..  Acetamide, N-[5-[bis[2-             .....................................     12/15/86     11/09/93
              (acetyloxy)ethyl]-amino]-2-[(2-
              bromo-4,6-dinitrophenyl)azo]-4-
              ethoxyphenyl.
4098-71-9..  Cyclohexane, 5-isocyanato-1-        .....................................     06/01/87     06/01/97
              (isocyanatomethyl)-1,3,3-
              trimethyl-.
4170-30-3..  2-Butenal.........................  .....................................       3/7/86     12/19/95
5124-30-1..  Cyclohexane, 1,1-methylenebis[4-    .....................................     06/01/87     06/01/97
              isocyanato-.
5131-66-8..  1-Butoxy-2-propanol-2-Propanol, 1-  .....................................      4/13/89     12/19/95
              butoxy-.
5344-82-1..  Thiourea, (2-chlorophenyl)-.......  .....................................       3/7/86     12/19/95
5873-54-1..  Benzene, 1-isocyanato-2-[4-         .....................................     06/01/87     11/09/93
              isocyanatophenyl)methyl]-.
6145-73-9..  1-Propanol, 2-chloro-, phosphate    .....................................     12/16/88     11/09/93
              (3:1).
6247-34-3..  2-Anthracenesulfonic acid, 4-[[4-   .....................................     12/21/87     11/09/93
              (acetylamino)phenyl]amino]-1-
              amino-9,10-dihydro-9,10-dioxo-.
6422-86-2..  Bis(2-ethylhexyl) terephthalate--   .....................................     01/03/83     01/03/93
              1,4-Benzenedicarboxylic acid,
              bis(2-ethylhexyl) ester.
6424-85-7..  2-Anthracenesulfonic acid, 4-[[4-   .....................................     12/21/87     12/19/95
              (acetylamino)phenyl]amino]- 1-
              amino-9,10-dihydro-9,10-dioxo-,
              monosodium salt.
7320-37-8..  Oxirane, tetradecyl-..............  .....................................     10/04/82     10/04/92
7440-28-0..  Thallium..........................  .....................................     06/01/87     06/01/97
7440-36-0..  Antimony..........................  .....................................     10/04/82     10/04/92
7440-48-4..  Cobalt............................  .....................................     06/01/87     06/01/97
7723-14-0..  White phosphorus..................  .....................................     04/12/93     06/30/98
9011-05-6..  Urea, polymer with formaldehyde...  Sec.  716.20(b)(1) applies...........     06/03/85     06/03/95
9016-87-9..  Isocyanic acid,                     .....................................       6/1/87     12/19/95
              polymethylenepolyphenylene ester.
10347-54-3.  Cyclohexane, 1,4-                   .....................................     06/01/87     06/01/87
              bis(isocyanatomethyl)-.
10436-39-2.  1-Propene, 1,1,2,3-tetrachloro-...  .....................................       6/1/87     12/19/95
12001-85-3.  Naphthenic acids, zinc salts......  .....................................       6/1/87     12/19/95
12185-10-3.  White phosphorus..................  .....................................     01/26/94     06/30/98
12217-79-7.  9,10-Anthracenedione, 1,5-diamino-  .....................................     12/21/87     11/09/93
              chloro-4,8-dihydroxy-.
13414-54-5.  Methallyl 2-nitrophenyl ether--     .....................................     02/13/84     11/09/93
              Benzene, 1-[(2-methyl-2-
              propenyl)oxy]-2-nitro-.
13414-55-6.  7-Nitro-2,2-dimethyl-2,3-dihydro-   .....................................     02/13/84     02/13/94
              benzofuran--Benzofuran, 2,3-
              dihydro-2,2-dimethyl-7-nitro-.

[[Page 67]]

 
13674-84-5.  2-Propanol, 1-chloro-, phosphate    .....................................     12/16/88     11/09/93
              (3:1).
13674-87-8.  2-Propanol, 1,3-dichloro-,          .....................................     12/16/88     12/19/95
              phosphate (3:1).
15646-96-5.  Hexane, 1,6-diisocyanato-2,4,4-     .....................................     06/01/87     11/09/93
              trimethyl-.
16938-22-0.  Hexane, 1,6-diisocyanato-2,2,4-     .....................................     06/01/87     11/09/93
              trimethyl-.
17418-58-5.  9,10-Anthracenedione, 1-amino-4-    .....................................     12/21/87     12/19/95
              hydroxy-2-phenoxy-.
18495-30-2.  Propane, 1,1,2,3-tetrachloro-.....  .....................................     06/01/87     12/29/88
18633-25-5.  Oxirane, tridecyl-................  .....................................     10/04/82     10/04/92
19660-16-3.  2-Propenoic acid, 2,3-              .....................................     06/01/87     12/29/88
              dibromopropyl ester.
21429-43-6.  Acetamide, N-[5-[bis[2-             .....................................     06/19/87     11/09/93
              (acetyloxy)ethyl]amino]-2-[(2-
              chloro-4,6-dinitrophenyl)azo]-4-
              methoxyphenyl]-.
25168-06-3.  Isopropyl phenol--Phenol, (1-       .....................................     04/13/89     11/09/93
              methylethyl)-.
25168-21-2.  Dibutyltin bis (isooctyl maleate)-- .....................................     01/03/83     01/03/93
              2-Butenoic acid, 4,4-
              [(dibutylstannylene)bis(oxy)]bis-
              [4-oxo-, diisoctyl ester, (Z,Z)-.
25498-49-1.  Tripropylene glycol monomethyl      .....................................      4/13/89     12/19/95
              ether-Propanol, [2-(2-methoxy
              methylethoxy)methylethoxy]-.
25550-14-5.  Benzene, ethylmethyl- (mixed        .....................................     04/29/83     04/29/93
              isomers).
25550-98-5.  Phosphorous acid, diisodecyl        .....................................     12/19/85     12/19/95
              phenyl ester.
25551-13-7.  Trimethylbenzene--Benzene,          .....................................     02/13/84     02/13/94
              trimethyl- (mixed isomers).
25640-78-2.  Isopropyl biphenyl--1,1-Biphenyl,   .....................................     06/28/84     11/09/93
              (1-methylethyl)-.
25852-70-4.  Monobutyltin tris (isooctyl)        .....................................     01/03/83     01/03/93
              mercapto-acetate--Acetic acid,
              2,2,2-
              [(butylstannylidyne)tris(thio)]tr
              is-, triisooctyl ester.
26447-40-5.  Benzene, 1,1-                       .....................................     06/01/87     06/01/97
              methylenebis[isocyanato-.
26471-62-5.  Benzene, 1,3-diisocyanatomethyl-..  .....................................     06/01/87     06/01/97
26530-20-1.  3(2H)-Isothiazolone, 2-octyl-.....  .....................................     06/01/87     12/29/88
26952-23-8.  1-Propene, dichloro-..............  .....................................       6/1/87     12/19/95
29385-43-1.  Tolyl triazole-1H-Benzotriazole,    .....................................      4/13/89     12/19/95
              methyl-.
32052-51-0.  Isocyanic acid,                     .....................................     06/01/87     11/09/93
              trimethylcyclohexyl ester.
32534-81-9.  Pentabromodiphenyl ether..........  .....................................      1/11/90     06/30/98
32536-52-0.  Octabromodiphenyl ether...........  .....................................      1/11/90     06/30/98
32588-76-4.  Ethylene Bis-                       .....................................      1/11/90     12/19/95
              (tetrabromophthalimide).
33125-86-9.  Phosphoric acid, 1,2-ethanediyl     .....................................     12/16/88     11/09/93
              tetrakis (2-chloroethyl) ester.
34590-94-8.  Dipropylene glycol monomethyl       .....................................      4/13/89      6/30/98
              ether--Propanol, (2-
              methoxymethylethoxy)-.
37853-59-1.  1,2-Bis(tribromophenoxy) ethane...  .....................................      1/11/90     06/30/98
38661-72-2.  Cyclohexane, 1,3-                   .....................................     06/01/87     11/09/93
              bis(isocyanatomethyl)-.
41291-34-3.  Ethylene(5,6-dibromonorbornane-2,3- .....................................      1/11/90     12/19/95
              dicarboximide).
52907-07-0.  Ethylene bis(5,6-dibromonorbornane- .....................................      1/26/94     12/19/95
              2,3-dicarboximide.
57137-10-7.  Tribrominated polystyrene.........  .....................................      1/11/90     12/19/95
61262-53-1.  Ethylene bis(pentabromophenoxide).  .....................................      1/11/90     12/19/95
61788-33-8.  Terphenyl, chlorinated............  .....................................     10/04/82     12/29/88
61789-36-4.  Calcium naphthenate--Naphthenic     .....................................     07/01/83     07/01/93
              acids, calcium salts.
61789-51-3.  Cobalt naphthenate--Naphthenic      .....................................     07/01/83     07/01/93
              acids, cobalt salts.
61790-14-5.  Lead naphthenate--Naphthenic        .....................................     07/01/83     07/01/93
              acids, lead salts.
64742-95-6.  Solvent naphtha (petroleum), light  .....................................      2/13/84      2/13/94
              arom.
68081-84-5.  Oxirane, mono[(C10-16-alkyloxy)     .....................................     10/04/82     10/04/92
              methyl] derivatives.
68122-86-1.  Imidazolium compounds, 4,5-dihydro- .....................................      6/20/88     12/19/95
              1-methyl-2-nortallow alkyl-1-(2-
              tallow amidoethyl), methyl
              sulfates.
68153-35-5.  Ethanaminium, 2-amino-N-(2-         .....................................     06/20/88     11/09/93
              aminoethyl-N-(2-hydroxyethyl)-N-
              methyl-, N,N'-ditallow acyl
              derivatives, methyl sulfates
              (salts).
68298-46-4.  7-Amino-2,2-dimethyl-2,3-           .....................................     02/13/84     12/29/88
              dihydrobenzofuran--7-
              Benzofuranamine,2,3-dihydro-2,2-
              dimethyl-.
68389-88-8.  Poly(oxy-1,2-ethanediyl), -[2-[bis(2-
              aminoethyl)methylammonio]ethyl]-
              -hydroxy-, N,N'-dicoco
              acyl derivatives, methyl sulfates
              (salts).
68389-89-9.  Poly(oxy-1,2-ethanediyl), -[2-[bis(2-
              aminoethyl)methylammonio]ethyl]-
              -hydroxy-,N,N'-
              bis(hydrogenated tallow acyl)
              derivatives, methyl sulfates
              (salts).
68410-69-5.  Poly(oxy-1,2-ethanediyl), alpha-[2- .....................................      6/20/88     12/19/95
              [bis(2-aminoethyl)
              methylammonio]ethyl]-w-hydroxy,-
              N,N'-ditallow acyl derivatives,
              methyl sulfates (salts).
68413-04-7.  Poly[oxy(methyl-1,2-ethanediyl)],   .....................................     06/20/88     11/09/93
              -[2-[bis(2-
              aminoethyl)methylammonio]
              methylethyl]--hydroxy-,
              N,N'-ditallow acyl derivatives,
              methyl sulfates (salts).

[[Page 68]]

 
68554-06-3.  Poly(oxy-1,2-ethanediyl), -[3-[bis(2-
              aminoethyl)methylammonio]-2-
              hydroxy-propyl]--
              hydroxy-, N-coco acyl
              derivatives, methyl sulfates
              (salts).
68611-64-3.  Urea, reaction products with        Sec.  716.20(b)(1) applies...........     06/03/85     11/09/93
              formaldehyde.
69009-90-1.  Diisopropyl biphenyl--1,1'-         .....................................     06/28/84     12/29/88
              Biphenyl, bis(1-methylethyl)-.
70914-09-9.  Poly(oxy-1,2-ethanediyl), -[2-[bis(2-
              aminoethyl)methylammonio]ethyl]-
              -hydroxy-, N,N'-di[C14-
              18 acyl] derivatives, methyl
              sulfates (salts).
75790-84-0.  Benzene, 2-isocyanato-4-[(4-        .....................................     06/01/87     11/09/93
              isocyanato-       phenyl)methyl]-
              1-methyl-.
75790-87-3.  Benzene, 1-isocyanato-2-[(4-        .....................................     06/01/87     11/09/93
              isocyanato-phenyl)thio]-.
----------------------------------------------------------------------------------------------------------------

    (b) [Reserved]
    (c) By category. The following categories are listed in alphabetical 
order. Chemical substances listed within a category are provided only as 
examples of the category. All chemical substances within a category are 
subject to all the provisions of part 716 for the time period from the 
effective date of the category until the sunset date. Manufacturers, 
importers, and processors of any chemical substance within a category 
are subject to the reporting requirements of subpart A for that 
category, except when the sunset date for the particular substance 
predates the sunset date for the category, or when the exemption of 
Sec. 716.20(b) of this part applies.

----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
Alkyl epoxides--including all noncyclic aliphatic         ..............  ...........     10/04/82      12/29/88
 hydrocarbons with one or more epoxy functional groups..
----------------------------------------------------------------------------------------------------------------


                                                                                                    
                                                                                                    

----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
R1=R2=R3=R4=H or alkyl. Groups R1-R4 may contain one or
 more epoxide functions.
  Oxirane, decyl-.......................................       2855-19-8  ...........     10/04/82      12/29/88
  Oxirane, 2,2-dimethyl-................................        558-30-5  ...........     10/04/82      12/29/88
  Oxirane, 2,3-dimethyl-................................       3266-23-7  ...........     10/04/82      12/29/88
  Oxirane, dodecyl......................................       3234-28-4  ...........     10/04/82      12/29/88
  Oxirane, heptadecyl-..................................      67860-04-2  ...........     10/04/82      12/29/88
  Oxirane, octyl-.......................................       2404-44-6  ...........     10/04/82      12/29/88
  Oxirane, pentadecyl-..................................      22092-38-2  ...........     10/04/82      12/29/88

[[Page 69]]

 
Alkyl phthalates--all alkyl esters of 1,2-                ..............  ...........     10/04/82      10/04/92
 benzenedicarboxylic acid (ortho-phthalic acid).........
----------------------------------------------------------------------------------------------------------------

                                                                                                    
                                                                                                    

----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
R1=R2=alkyl.
  1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester.        117-81-7  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, bis(1-methylheptyl)             131-15-7  ...........     10/04/82      10/04/92
   ester................................................
  1,2-Benzenedicarboxylic acid, bis(2-methylpropyl)              84-69-5  ...........     10/04/82      10/04/92
   ester................................................
  1,2-Benzenedicarboxylic acid, 2-butoxy-2-oxyethyl              85-70-1  ...........     10/04/82      01/13/86
   butyl ester..........................................
  1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester..         84-64-0  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, butyl 2-ethylhexyl ester         85-69-8  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, butyl octyl ester.......         84-78-6  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, decyl hexyl ester.......      25724-58-7  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, decyl octyl ester.......        119-07-3  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, dibutyl ester...........         84-74-2  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, dicyclohexyl ester......         84-61-7  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, diethyl ester...........         84-66-2  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, dihexyl ester...........         84-75-3  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, diisodecyl ester........      26761-40-0  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, diisononyl ester........      28553-12-0  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, diisooctyl ester........      27554-26-3  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, demethyl ester..........        131-11-3  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, dinonyl ester...........         84-76-4  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, dioctyl ester...........        117-84-0  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, diundecyl ester.........        119-06-2  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester.       3648-20-2  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, 2-ethylhexyl-8-                  89-13-4  ...........     10/04/82      10/04/92
   methylnonyl ester....................................
  1,2-Benzenedicarboxylic acid, hexyl isodecyl ester....      61702-81-6  ...........     10/04/82      10/04/92
  1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester.      61886-60-0  ...........     10/04/82      10/04/92
Alkyltin compounds......................................  ..............  ...........     01/03/83      12/29/88
  Dibutyltin S,S'-bis(isooctyl mercaptoacetate)--Acetic       25168-24-5  ...........     01/03/83      12/29/88
   acid, 2,2'-[(dibutylstannylene)bis(thio)]bis-,
   diisooctyl ester.....................................
  Dibutyltin S,S'-bis(isooctyl mercaptoacetate)--Acetic       26636-01-1  ...........     01/03/83      12/29/88
   acid, 2,2'-[(dimethylstannylene)bis(thio)]bis-,
   diisooctyl ester.....................................
  Mono methyltin tris(isooctylmercaptoacetate) Acetic         54849-38-6  ...........     01/03/83      12/29/88
   acid, 2,2',2''-[(methylstannylidyne)tris(thio)]tris-
   triisoacetyl ester...................................
Aniline and chloro-, bromo-, and/or nitroanilines.......  ..............  ...........     10/04/82      10/04/92
  Benzenamine...........................................         62-53-3  ...........     10/04/82      10/04/92
  Benzenamine, 4-bromo-.................................        106-40-1  ...........     10/04/82      10/04/92
  Benzenamine, 2-bromo-6-chloro-4-nitro-................         99-29-6  ...........     10/04/82      10/04/92
  Benzenamine, 2-bromo-,4,6-dinitro-....................       1817-73-8  ...........     10/04/82      10/04/92
  Benzenamine, 2-chloro-................................         95-51-2  ...........     10/04/82      10/04/92
  Benzenamine, 3-chloro-................................        108-42-9  ...........     10/04/82      10/04/92
  Benzenamine, 4-chloro-................................        106-47-8  ...........     10/04/82      10/04/92
  Benzenamine, 2-chloro-4,6-dinitro-....................       3531-19-9  ...........     10/04/82      10/04/92
  Benzenamine, 4-chloro-2,6-dinitro-....................       5388-62-5  ...........     10/04/82      10/04/92
  Benzenamine, 3-chloro-, hydrochloride.................        141-85-5  ...........     10/04/82      10/04/92
  Benzenamine, 2-chloro-4-nitro-........................        121-87-9  ...........     10/04/82      10/04/92

[[Page 70]]

 
  Benzenamine, 2-chloro-5-nitro-........................       6283-25-6  ...........     10/04/82      10/04/92
  Benzenamine, 4-chloro-2-nitro-........................         89-63-4  ...........     10/04/82      10/04/92
  Benzenamine, 4-chloro-3-nitro-........................        635-22-3  ...........     10/04/82      10/04/92
  Benzenamine, 2,6-dibromo-4-nitro-.....................        827-94-1  ...........     10/04/82      10/04/92
  Benzenamine, 2,3-dichloro-............................        608-27-5  ...........     10/04/82      10/04/92
  Benzenamine, 2,4-dichloro-............................        554-00-7  ...........     10/04/82      10/04/92
  Benzenamine, 2,5-dichloro-............................         95-82-9  ...........     10/04/82      10/04/92
  Benzenamine, 3,4-dichloro-............................         95-76-1  ...........     10/04/82      10/04/92
  Benzenamine, 3,5-dichloro-............................        626-43-7  ...........     10/04/82      10/04/92
  Benzenamine, 2,6-dichloro-4-nitro-....................         99-30-9  ...........     10/04/82      10/04/92
  Benzenamine, 2,4-dinitro-.............................         97-02-9  ...........     10/04/82      10/04/92
  Benzenamine, 2-nitro-.................................         88-74-4  ...........     10/04/82      10/04/92
  Benzenamine, 3-nitro-.................................         99-09-2  ...........     10/04/82      10/04/92
  Benzenamine, 4-nitro-.................................        100-01-6  ...........     10/04/82      10/04/92
  Benzenamine, 2,4,6-tribromo-..........................        147-82-0  ...........     10/04/82      10/04/92
  Benzenamine, 2,4,6-trichloro-.........................        634-93-5  ...........     10/04/82      10/04/92
Aryl phosphates--phosphate esters of phenol or of alkyl-  ..............  ...........     10/04/82      10/04/92
 substituted phenols. Triaryl and mixed alkyl and aryl
 esters are included but trialkyl esters are excluded...
----------------------------------------------------------------------------------------------------------------

                                                                                                    
                                                                                                    

----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
R1=phenyl, either unsubstituted or substituted with one
 or more alkyl or aralkyl groups R2=R3 alkyl; or
 phenyl, either unsubstituted or substituted with one or
 more alkyl or aralkyl groups
  Phenol, dimethyl-, phosphate (3:1)....................      25155-23-1  ...........     10/04/82      10/04/92
  Phenol, 4-(1,1-dimethylethyl)-, phosphate (3:1).......         78-33-1  ...........     10/04/82      10/04/92
  Phosphoric acid, dibutyl phenyl ester.................       2528-36-1  ...........     10/04/82      10/04/92
  Phosphoric acid, diisodecyl phenyl ester..............      51363-64-5  ...........     10/04/82      10/04/92
  Phosphoric acid, (1,1-dimethylethyl) phenyl diphenyl        56803-37-3  ...........     10/04/82      10/04/92
   ester................................................
  Phosphoric acid, 2-ethylhexyl diphenyl ester..........       1241-94-7  ...........     10/04/82      10/04/92
  Phosphoric acid, isodecyl diphenyl ester..............      29761-21-5  ...........     10/04/82      10/04/92
  Phosphoric acid, (1-methylethyl)phenyl diphenyl ester.      28108-99-8  ...........     10/04/82      10/04/92
  Phosphoric acid, methylphenyl diphenyl ester..........      25444-49-5  ...........     10/04/82      10/04/92
  Phosphoric acid, (1-methyl-l-phenylethyl)phenyl             34364-42-6  ...........     10/04/82      10/04/92
   diphenyl ester.......................................
  Phosphoric acid, triphenyl ester......................        115-86-6  ...........     10/04/82      10/04/92
  Phosphoric acid, tris(methylphenyl) ester.............       1330-78-5  ...........     10/04/82      10/04/92
  Phosphoric acid, tris(2-methylphenyl) ester...........         78-30-8  ...........     10/04/82      10/04/92
  Phosphoric acid, tris(3-methylphenyl) ester...........        563-04-2  ...........     10/04/82      10/04/92
  Phosphoric acid, tris(4-methylphenyl) ester...........         78-32-0  ...........     10/04/82      10/04/92
Asbestos--asbestiform varieties of chrysolite             ..............  ...........     10/04/82      10/04/92
 (serpentine); crocidolite (riebeckite); amosite
 (cummingtonite--grunerite); anthophyllite; tremolite;
 and actinolite.........................................
  Asbestos..............................................       1332-21-4  ...........     10/04/82      10/04/92
  Asbestiform minerals..................................      12001-29-5  ...........     10/04/82      10/04/92
  Asbestiform minerals..................................      17068-78-9  ...........     10/04/82      10/04/92
  Asbestiform minerals..................................      12172-73-5  ...........     10/04/82      10/04/92

[[Page 71]]

 
Bisazobiphenyl dyes derived from benzidine and its        ..............  ...........     10/04/82      10/04/92
 congeners, ortho-toluidine (dimethylbenzidine) and
 dianisidine (dimethoxybenzidine).......................
  Benoic acid, 2-[[2-amino-6-[[4-[(-carboxy-4-                 6739-62-4  ...........     10/04/82      10/04/92
   hydroxphenyl) azo[-3,3-dimethoxy[1,1-biphenyl]-4-
   yl]azo]-5-hydroxy-7-sulfo-1-naphthalenylazo]-5-nitro-
   , trisodium salt.....................................
  Benzoic acid, 5-[[4-[2-amino-8-hydroxy-6-sulfo-1-            2429-84-7  ...........     10/04/82      10/04/92
   naphthalenyl) azo] [1,1-biphenyl]-4-yl]-azo]-2-
   hydroxy-, disodium salt..............................
  Benzoic acid, 5-[[4-[7-amino-1-hydroxy-3-sulfo-2-            2429-82-5  ...........     10/04/82      10/04/92
   naphthalenyl)azo] [1,1-biphenyl]-4-yl]azo]-2-hydroxy-
   , disodium salt......................................
  Benzoic acid, 5-[[4-[(1-amino-4-sulfo-2-                     2429-79-0  ...........     10/04/82      10/04/92
   naphthalenyl)azo] [1,1-biphenyl]-4-yl]azo]-2-hydroxy-
   , disodium salt......................................
  Benzoic acid, 5-[[4-[[2,6-diamino-3-[[8-hydroxy-3,6-         2429-81-4  ...........     10/04/82      10/04/92
   disulfo-7-[(4-sulfo-1-naphthalenyl)azo]-2-
   naphthalenyl]azo]-5-methylphenyl]azo] [1,1-biphenyl]-
   4-yl]azo]-2-hydroxy-, tetrasodium salt...............
  Benzoic acid, 5-[[4-[(2,6-diamino-3-methyl-5-                6637-88-3  ...........     10/04/82      10/04/92
   sulfophenyl)azo]-3,3-dimethyl[1,1-biphenyl]-4-yl]azo]-
   2-hydroxy-, disodium salt............................
  Benzoic acid, 5-[[4-[[2,6-diamino-3-methyl-5-[(4-            2586-58-5  ...........     10/04/82      10/04/92
   sulfophenyl)azo]phenyl]azo][1,1-biphenyl]-4-yl]azo]-2-
   hydroxy-, disodium salt..............................
  Benzoic acid, 5-[[4-[[2,6-diamino-3-methyl-5-[(4-            6360-54-9  ...........     10/04/82      10/04/92
   sulfophenyl)azo]phenyl]azo]1,1-biphenyl]-4-yl]azo]-2-
   hydroxy-3-methly-, disodium salt.....................
  Benzoic acid, 5-[[4-[[2,4-dihydroxy-3-[(4-                   2893-80-3  ...........     10/04/82      10/04/92
   sulfophenyl)azo]phenyl]azo] [1,1-biphenyl]-4-yl]azo]-
   2-hydroxy-, disodium salt............................
  Benzoic acid, 3,3-[(3,7-disulfo-1,5-naphthalene-             8014-91-3  ...........     10/04/82      10/04/92
   diyl)bis[azo(6-hydroxy-3,1-phenylene)azo[6(or 7)-
   sulfo-4,1-naphthalenediyl]azo[1,1-biphenyl]-4,4-
   diylazo]]bis[6-hydroxy-, hexasodium salt.............
  [1,1-Biphenyl]-4,1-bis diazonium), 3,3-dimethoxy-.....      20282-70-6  ...........     10/04/82      10/04/92
  Butanamide, N,N-(3,3-dimethyl [1,1-biphenyl]-4,4-              91-96-3  ...........     10/04/82      10/04/92
   diyl)bis[3-oxo-......................................
  C.I. Direct Blue 218..................................      10401-50-0  ...........     10/04/82      10/04/92
  Cuprate(2-), [5-[[4-[[2,6-dihydroxy-3-[(2-hydroxy-5-        16071-86-6  ...........     10/04/82      10/04/92
   sulfophenyl)azo]phenyl]azo][1,1-biphenyl]-4-yl]azo]-2-
   hydroxybenzoato(4-)]-, disodium......................
  Cuprate(3-), [-[7-[[3,3-dihydroxy-4-[[1-            6656-03-7  ...........     10/04/82      10/04/92
   hydroxy-6-(phenylamino)-3-sulfo-2-naphthalenyl]azo]
   [1,1-biphenyl]-4-yl]azo]-8-hydroxy-1,6-
   naphthalenedisulfonato(7-)]]di-, trisodium...........
  Cuprate(4-), [-[[6,6-[3,3-dihydroxy[1,1-           16143-79-6  ...........     10/04/82      10/04/92
   biphenyl]-4-4-diyl)bis(azo)]bis[4-amino-5-hydroxy-1,3-
   naphthalendisulfonato]](8-)]]di-, tetrasodium........
  2-Naphthalenecarboxamide, N,N-(3,3-dimethoxy[1,1-              91-92-9  ...........     10/04/82      10/04/92
   biphenyl]-4,4-diyl)bis[3-hydroxy-....................
  1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-         2586-57-4  ...........     10/04/82      10/04/92
   [[4-[(2hydroxy-1-naphthalenyl)azo]-3,3-dimethoxy[1,1-
   biphenyl]-4-yl]azo]-, disodium salt..................
  1,3-Naphthalenedisulfonic acid, 6,6-[(3,3-                   2610-05-1  ...........     10/04/82      10/04/92
   dimethoxy[1,1-biphenyl]-4,4diyl)bis(azo)]bis[4-amino-
   5-hydroxy-, tetrasodium salt.........................
  1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-                 3530-19-6-  ...........     10/04/82      10/04/92
   ethoxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-7-hydroxy-
   , disodium salt......................................
  1,3-Naphthalenedisulfonic acid, 8-[[4'-[4-                   6358-29-8  ...........     10/04/82      10/04/92
   ethoxyphenyl)azo]-3,3'-dimethyl] [1,1'-biphenyl]-4-
   yl]azo]-7-hydroxy-, disodium salt....................
  1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4-        3567-65-5  ...........     10/04/82      10/04/92
   [[(4-methylphenyl) sulfonyl]oxy]phenyl]-azo] [1,1'-
   biphenyl]-4-yl]azo]-, disodium salt..................
  2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-(7-           2429-73-4  ...........     10/04/82      10/04/92
   amino-1-hydroxy-3-sulfo-2-naphthalenyl)-azo] [1,1'-
   biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt.......
  2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-        2429-83-6  ...........     10/04/82      10/04/92
   diamino-5-methylphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-
   5-hydroxy-6-(phenylazo)-, disodium salt..............
  2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-        1937-37-7  ...........     10/04/82      10/04/92
   diaminophenyl)azo] [1,1'-biphenyl]-4-yl]azo] 5-
   hydroxy-6-(phenylazo)-, disodium salt................

[[Page 72]]

 
  2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-           4335-09-5  ...........     10/04/82      10/04/92
   6[[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]-
   azo]-3-[(4-nitrophenyl)azo]-, disodium salt..........
  2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-         3626-28-6  ...........     10/04/82      10/04/92
   [[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo)-
   6-(phenylazo)-, disodium salt........................
  2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]-       2602-46-2  ...........     10/04/82      10/04/92
   4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium
   salt.................................................
  2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-                 2429-74-5  ...........     10/04/82      10/04/92
   dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-
   amino-4-hydroxy-, tetrasodium salt...................
  2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl-          72-57-1  ...........     10/04/82      10/04/92
   [1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-
   hydroxy-, tetrasodium salt...........................
  2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl-        2150-54-1  ...........     10/04/82      10/04/92
   [1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis-[4,5-dihydroxy-
   , tetrasodium salt...................................
  1-Naphthalenesulfonic acid, 3-[[4'[(6-amino-1-hydroxy-       6449-35-0  ...........     10/04/82      10/04/92
   3-sulfo-2-naphthalenyl)azo]-3,3'-dimethoxy[1,1'-
   biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt........
  1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-       573-58-0  ...........     10/04/82      10/04/92
   diyl-4,4'-diyl)bis(azo)]bis[(4-amino-,disodium salt..
  1-Naphthalenesulfonic acid, 3,3'-[3,3'-dimethoxy-[1,1'-      2429-71-2  ...........     10/04/82      10/04/92
   biphenyl]-4,4'-diyl)bis(azo)]bis[4-hydroxy-, disodium
   salt.................................................
  1-Naphthalenesulfonic acid, 3,3'-[(3,3'dimethyl[1,1'-         992-59-6  ...........     10/04/82      10/04/92
   biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-,disodium
   salt.................................................
Chlorinated benzenes, mono-, di-, tri-, tetra-, and       ..............  ...........     10/04/82      10/04/92
 penta-.................................................
  Benzene, chloro-......................................        108-90-7  ...........     10/04/82      10/04/92
  Benzene, 1,2-dichloro-................................         95-50-1  ...........     10/04/82      10/04/92
  Benzene, 1,3-dichloro-................................        541-73-1  ...........     10/04/82      10/04/92
  Benzene, 1,4-dichloro-................................        106-46-7  ...........     10/04/82      10/04/92
  Benzene, pentachloro-.................................        608-93-5  ...........     10/04/82      10/04/92
  Benzene, 1,2,3,4-tetrachloro-.........................        634-66-2  ...........     10/04/82      10/04/92
  Benzene, 1,2,3,5-tetrachloro-.........................        634-90-2  ...........     10/04/82      10/04/92
  Benzene, 1,2,4,5-tetrachloro-.........................         95-94-3  ...........     10/04/82      10/04/92
  Benzene, 1,2,3-trichloro-.............................         87-61-6  ...........     10/04/82      10/04/92
  Benzene, 1,2,4-trichloro-.............................        120-82-1  ...........     10/04/82      10/04/92
  Benzene, 1,3,5-trichloro-.............................        108-70-3  ...........     10/04/82      10/04/92
Chlorinated naphthalenes--chlorinated derivatives of      ..............  ...........     10/04/82      12/29/88
 naphthalene (empirical formula) C10HxCly where x=y=8...
  Naphthalene, chloro-..................................      25586-43-0  ...........     10/04/82      12/29/88
  Naphthalene, chloro derivatives.......................      70776-03-3  ...........     10/04/82      12/29/88
  Naphthalene, 1-chloro-................................         90-13-1  ...........     10/04/82      12/29/88
  Naphthalene, heptachloro-.............................      32241-08-0  ...........     10/04/82      12/29/88
Chlorinated paraffins--chlorinated paraffin oils and      ..............  ...........     10/04/82      10/04/92
 chlorinated paraffin waxes, with chlorine content of 35
 percent through 70 percent by weight...................
  Alkanes, chloro-......................................      61788-76-9  ...........     10/04/82      10/04/92
  Alkanes, C6-18, chloro-...............................      68920-70-7  ...........     10/04/82      10/04/92
  Paraffin waxes and hydrocarbon waxes, chlorinated.....      63449-39-8  ...........     10/04/82      10/04/92
Ethyltoluenes--This category consists of ethyltoluene     ..............  ...........     04/29/83      12/29/88
 (mixed isomers) and the ortho (1,2-), meta (1,3-)   and
 para (1,4-) isomers....................................
  Benzene, 1-ethyl-2-methyl-............................        611-14-3  ...........     04/29/83      12/29/88
Fluoroalkenes--This category is defined as fluroalkenes   ..............  ...........     04/29/83      04/29/93
 of the general formula: CnH2n-xFx where n   equals 2 to
 3 and X equals 1 to 6..................................
  Ethene, tetrafluoro-..................................        116-14-3  ...........     04/29/83      04/29/93
  Ethene, trifluoro-....................................        359-11-5  ...........     04/29/83      01/13/86
  1-Propene, 1,1,2,3,3,3-hexafluoro-....................        116-15-4  ...........     04/29/83      04/29/93
Glycidol (oxiranemethanol) and its derivatives..........  ..............  ...........     10/04/82      10/04/92
----------------------------------------------------------------------------------------------------------------


[[Page 73]]




----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
R=H; alkyl, alkenyl or alkynyl; aryl; acyl. where
 R=alkyl, alkenyl, alkynyl, aryl, or acyl; any
 substituents   or functional groups may be present with
 the alkyl, etc., groups
  1,2-Cyclohexanedicarboxylic acid, bis(oxiranylmethyl)        5493-45-8  ...........     10/04/82      10/04/92
   ester................................................
  Disiloxane, 1,1,3,3-tetramethyl-1,3-bis[3-                    126-80-7  ...........     10/04/82      10/04/92
   oxiranylmethoxy)propyl]-.............................
  2,4-Imidazolidinedione, 5,5-dimethyl-3-[2-                  32568-89-1  ...........     10/04/82      10/04/92
   (oxiranylmethoxy)propyl]-1-(oxiranylmethyl)-.........
  2,4-Imidazolidenedione, 3,3'-[2-(oxiranylmethoxy)-1,3-      38304-52-8  ...........     10/04/82      10/04/92
   propanediyl]bis[5,5-dimethyl-1-(oxiranyl-methyl)-....
  Neodecanoic acid, oxiranylmethyl ester................      26761-45-5  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[1,4-butanediylbis(oxymethylene)]bis....       2425-79-8  ...........     10/04/82      10/04/92
  Oxirane, (butoxymethyl)-..............................       2426-08-6  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[1,4-cyclohexanedilbis                        14228-73-0  ...........     10/04/82      10/04/92
   (methyleneoxymethylene)]bis-.........................
  Oxirane, [(2,4-dibromophenoxy)methyl]-................      20217-01-0  ...........     10/04/82      10/04/92
  Oxirane, [(1,2-dibromopropoxy)methyl]-................      35243-89-1  ...........     10/04/82      10/04/92
  Oxirane, [(1,1-dimethylethoxy)methyl]-................       7665-72-7  ...........     10/04/82      10/04/92
  Oxirane, [[4-(1,1-dimethylethyl)phenoxy]methyl]-......       3101-60-8  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[(2,2-dimethyl-1,3-                           17557-23-2  ...........     10/04/82      10/04/92
   propanediyl)bis(oxymethylene)]bis-...................
  Oxirane, [(dodecyloxy)methyl]-........................       2461-18-9  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[1,2-ethanediylbis (oxymethylene)]bis-..       2224-15-9  ...........     10/04/82      10/04/92
  Oxirane, 2,2',2'',2'''-[1,2-ethanediylidenetetrakis-         7328-97-4  ...........     10/04/82      10/04/92
   (4,1-phenyleneoxymethylene)]tetrakis-................
  Oxirane, (ethoxymethyl)-..............................       4016-11-9  ...........     10/04/82      10/04/92
  Oxirane, [[(2-ethylhexyl)oxy]methyl]-.................       2461-15-6  ...........     10/04/82      10/04/92
  Oxirane, [(hexadecyloxy)methyl]-......................      15965-99-8  ...........     10/04/82      10/04/92
  Oxirane, 2,2',2''-[1,2,6-hexanetriyltris-                   68959-23-9  ...........     10/04/82      10/04/92
   (oxymethylene)]tris-.................................
  Oxirane, (methoxymethyl)-.............................        930-37-0  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[methylenebis(phenyleneoxymethylene)]bis-     39817-09-9  ...........     10/04/82      10/04/92
   .....................................................
  Oxirane, 2,2'-[methylenebis(2,1-                            54208-63-8  ...........     10/04/82      10/04/92
   phenyleneoxymethylene)]bis-..........................
  Oxirane, [(1-methylethoxy)methyl]-....................       4016-14-2  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-[(1-methylethylidene)bis[4,1-phenyl-          71033-08-4  ...........     10/04/82      10/04/92
   eneoxy[1-(butoxymethyl)-2,1-
   ethanediyl]oxymethylene]]bis-........................
  Oxirane, 2,2'-[1-methylethylidene) bis(4,1-phenyl-           1675-54-3  ...........     10/04/82      10/04/92
   eneoxymethylene)]bis-................................
  Oxirane, 2,2'-[(1-methylethylidene)bis(4,1-phenyl-          25085-99-8  ...........     10/04/82      10/04/92
   eneoxymethylene)[bis-, homopolymer...................
  Oxirane, 2,2'-[(1-methylethylidene)bis[4,1-                 72319-24-5  ...........     10/04/82      10/04/92
   phenyleneoxy-3,1-propanediyloxy-4,1-phenylene(1-
   methylethylidene)-4,1-phenyleneoxymethylene]]bis-....
  Oxirane, [(methylphenoxy)methyl]-.....................      26447-14-3  ...........     10/04/82      10/04/92
  Oxirane, [(2-methylphenoxy)methyl]-...................       2210-79-9  ...........     10/04/82      10/04/92
  Oxirane, [[4-(1-methyl-1-phenylethyl)phenoxy]-methyl]-      61578-04-9  ...........     10/04/82      10/04/92
  Oxirane, mono[C6-C12-alkyloxy)methyl]derivatives......      68987-80-4  ...........     10/04/82      10/04/92
  Oxirane, mono[(C8-C12-alkyloxy)methyl]derivatives.....      68609-96-1  ...........     10/04/82      10/04/92
  Oxirane, mono[C10-C16-alkyloxy)methyl]derivatives.....      68081-84-5  ...........     10/04/82      10/04/92
  Oxirane, mono[(C10-C14-alkyloxy)methyl]derivatives....      68609-97-2  ...........     10/04/82      10/04/92
  Oxirane, [(4-nitrophenoxy)methyl]-....................       5255-75-4  ...........     10/04/82      10/04/92

[[Page 74]]

 
  Oxirane, [(4-nonylphenoxy)methyl]-....................       6178-32-1  ...........     10/04/82      10/04/92
  Oxirane, [(9-octadecenyloxy)methyl]-, (Z)-............      60501-41-9  ...........     10/04/82      10/04/92
  Oxirane, [(octadecyloxy)methyl]-......................      16245-97-9  ...........     10/04/82      10/04/92
  Oxirane, 2,2'-(oxiranylmethoxy)-1,3-                        13561-08-5  ...........     10/04/82      10/04/92
   phenylene]bis(methylene)]bis-........................
  Oxirane, 2,2-[[[2-oxiranylmethyoxy)                         67786-03-2  ...........     10/04/82      10/04/92
   phenyl]methylene]bis(4,1-phenyl-eneoxymethylene)]bis-
  Oxirane, 2,2-[oxybis(methylene)]bis-..................       2238-07-5  ...........     10/04/82      10/04/92
  Oxirane, (phenoxymethyl)-.............................        122-60-1  ...........     10/04/82      10/04/92
  Oxirane, 2,2-[1,3-phenylenebis (oxymethylene)]bis-....       2425-01-6  ...........     10/04/82      10/04/92
  Oxirane, 2,2-[1,4-phenylenebis (oxymethylene)]bis-....        101-90-6  ...........     10/04/82      10/04/92
  Oxirane, 2,2,21/4-[1,2,3-propanetriyl                       13236-02-7  ...........     10/04/82      10/04/92
   tris(oxymethylene)]tris-.............................
  Oxirane, [(2-propenyloxy)methyl]-.....................        106-92-3  ...........     10/04/82      10/04/92
  Oxirane, 2,2,21/4-[propylidynetris (4,1-                    68517-02-2  ...........     10/04/82      10/04/92
   phenyleneoxymethylene)]tris-.........................
  Oxirane, [(tetradecyloxy)methyl]-.....................      38954-75-5  ...........     10/04/82      10/04/92
  Oxiranecarboxylic acid, 3-methyl-3-phenyl-, ethyl              77-83-8  ...........     10/04/82      10/04/92
   ester................................................
  Poly(oxy-1,2-ethanediyl),--[4-                     69943-75-5  ...........     10/04/82      10/04/92
   oxiranylmethyoxy)benzoyl]--[[4-
   oxiranylmethoxy)benzoyl]oxy]-........................
  2-Propenoic acid, 2-methyl-, oxiranylmethyl ester.....        106-91-2  ...........     10/04/82      10/04/92
  2-Propenoic acid, oxiranylmethyl ester................        106-90-1  ...........     10/04/82      10/04/92
  Silane, [(3-chloropropyl)(dimethoxy)[3-                     71808-64-5  ...........     10/04/82      10/04/92
   (oxiranylmethoxy)propyl]-............................
  Silane, diethoxymethyl[3-(oxiranyl-methoxy)propyl]-...       2897-60-1  ...........     10/04/82      10/04/92
  Silane, ethoxydimethyl[3-(oxiranyl-methoxy)propyl]-...      17963-04-1  ...........     10/04/82      10/04/92
  Silane, trimethyoxy[3-(oxiranyl-methoxy)propyl]-......       2530-83-8  ...........     10/04/82      10/04/92
  Tetrasiloxane, 1,1,1,3,5,7,7,7-octamethyl-3,5-bis[3-        69155-42-6  ...........     10/04/82      10/04/92
   (oxiranylmethoxy)propyl]-............................
  Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[3-(oxiranyl-       7422-52-8  ...........     10/04/82      10/04/92
   methoxy)propyl]-.....................................
Halogenated alkyl epoxides--halogenated noncyclic         ..............  ...........     10/04/82      12/29/88
 aliphatic hydrocarbons with one or more epoxy
 functional groups......................................
----------------------------------------------------------------------------------------------------------------

                                                                                                    
                                                                                                    

----------------------------------------------------------------------------------------------------------------
                                                              CAS No.
                        Category                           (examples for    Special     Effective    Sunset date
                                                             category)     exemptions      date
----------------------------------------------------------------------------------------------------------------
R1=X or CnH2n=1-yXy(y=1 to 1n=1)                          ..............  ...........  ...........  ............
R2=H or X or CnH2n=1-yXy(y=0 to 2n=1)                     ..............  ...........  ...........  ............
R3=H or X or CnH2n=1-yXy(y=0 to 2n=1)                     ..............  ...........  ...........  ............
R4=H or X or CnH2n=1-yXy(y=0 to 2n=1)                     ..............  ...........  ...........  ............
X=halogen. Groups R1-R4 may contain one or more expoxide
 functions.
  Oxirane, (bromomethyl)-...............................      3132-463-7  ...........     10/04/82      12/29/88
  Oxirane, (2,2,3,3,4,4,5,5,6,6,7,7,7-                        38565-52-5  ...........     10/04/82      12/29/88
   tridecafluoroheptyl)-................................

[[Page 75]]

 
Phenylenediamines (Benzenediamines). This category is     ..............  ...........     04/29/83      04/29/93
 defined as all nitrogen unsubstituted phenylenediamines
 and their salts with zero to two substitutents on the
 ring selected from the same of different members of the
 group of halo, nitro, hydroxy, hydroxy-lower alkoxy,
 lower-alkyl, and lower alkoxy. For this purpose, the
 term ``lower'' is defined as a group containing between
 one and four carbons...................................
  1,2-Benzenediamine....................................         95-54-5  ...........     04/29/83      04/29/93
  1,3-Benzenediamine....................................        108-45-2  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-butyl-..........................       3663-23-8  ...........     04/29/83      12/29/88
  1,2-Benzenediamine, 4-butyl-..........................         95-83-0  ...........     04/29/83      04/29/83
  1,3-Benzenediamine, 4-chloro-.........................       5131-60-2  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, 2-chloro-, dihydrochloride........        615-46-3  ...........     04/29/83      12/29/88
  1,2-Benzenediamine, 5-chloro-3-nitro-.................      42389-30-0  ...........     04/29/83      12/29/88
  1,2-Benzenediamine, 4-chloro-, sulfate (1:1)..........      68459-98-3  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 4-chloro-, sulfate (1:1)..........      68239-80-5  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2-chloro-, sulfate................       6219-71-2  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2,5-dichloro-.....................      20103-09-7  ...........     04/29/83      12/29/88
  1,2-Benzenediamine, dihydrochloride...................        615-28-1  ...........     04/29/83      04/29/93
  1,3-Benzenediamine, dihydrochloride...................        541-69-5  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, dihydrochloride...................        624-18-0  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, ethanedioate (1:1)................      62654-17-5  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-ethoxy-.........................       1197-37-1  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 4-ethoxy-dihydrochloride..........      67801-06-3  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 4-ethoxy-, sulfate (1:1)..........      68015-98-5  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, ar-ethyl-ar-methyl-...............      68966-84-7  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2-methoxy.........................       5307-02-8  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-methoxy-, dihydrochloride.......        614-94-8  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 4-methoxy-, sulfate...............       6219-67-6  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 4-methoxy-, sulfate (1:1).........      39156-41-7  ...........     04/29/83      04/29/93
  Benzenediamine, ar-methyl-............................      25376-45-8  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 3-methyl-.........................       2687-25-4  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-methyl-.........................        496-72-0  ...........     04/29/83      04/29/93
  1,3-Benzenediamine, 2-methyl-.........................        823-40-5  ...........     04/29/83      04/29/93
  1,3-Benzenediamine, 4-methyl-.........................         95-80-7  ...........     04/29/83      04/29/93
  1,3-Benzenediamine, 5-methyl-.........................        108-71-4  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, 2-methyl-.........................         95-70-5  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, 2-methyl-, dihydrochloride-.......        615-45-2  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, 2-methyl-, sulfate................       6369-59-1  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, 2-methyl-, sulfate (1:1)..........        615-50-9  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-nitro-..........................         99-56-9  ...........     04/29/83      04/29/93
  1,3-Benzenediamine, 4-nitro-,.........................       5131-58-8  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, 5-nitro-,.........................       5042-55-7  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2-nitro-,.........................       5307-14-2  ...........     04/29/83      04/29/93
  1,2-Benzenediamine, 4-nitro-, dihydrochloride.........       6219-77-8  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2-nitro-, dihydrochloride.........      18266-52-9  ...........     04/29/83      12/29/88
  1,2-Benzenediamine, 4-nitro-, sulfate (1:1)...........      68239-82-7  ...........     04/29/83      12/29/88
  1,4-Benzenediamine, 2-nitro-, sulfate (1:1)...........      68239-83-8  ...........     04/29/83      12/29/88
  1,3-Benzenediamine, sulfate (1:1).....................        541-70-8  ...........     04/29/83      04/29/93
  1,4-Benzenediamine, sulfate (1:1).....................      16245-77-5  ...........     04/29/83      04/29/93
  Ethanol, 2-(2,4-diaminophenoxy)-, dihydrochloride.....      66422-95-5  ...........     04/29/83      12/29/88
  Phenol, 2,4-diamino-, dihydrochloride.................        137-09-7  ...........     04/29/83      04/29/93
  Phenol, 2,4-diamino-6-methyl-.........................      15872-73-8  ...........     04/29/83      12/29/88
  Phenol, 2,4-diamino-6-methyl-, hydrochloride..........      65879-44-9  ...........     04/29/83      12/29/88
----------------------------------------------------------------------------------------------------------------

    (d) Listed members of categories. The following categories are 
listed in alphabetical order with the chemical substances identified in 
each category also listed alphabetically. Only those chemical substances 
specifically listed within a category are subject to all provisions of 
part 716 for the time period from the effective date of the rule until 
the sunset date.

[[Page 76]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Special
                    Category                                         CAS No.                         Exemptions       Effective Date      Sunset Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aldehydes:......................................
  Acetaldehyde..................................  75-07-0......................................  .................            9/30/91            6/30/98
  Acetaldehyde, chloro-.........................  107-20-0.....................................  .................            9/30/91            6/30/98
  Acetaldehyde, (1,3-dihydro-1,3,3-trimethyl-2H-  84-83-3......................................  .................            9/30/91            6/30/98
   indol-2-ylidene).
  Acetaldehyde, trichloro-......................  75-87-6......................................  .................            9/30/91            6/30/98
  Benzaldehyde..................................  100-52-7.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 3-bromo-........................  3132-99-8....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-butyl-........................  1200-14-2....................................  .................            9/30/91           12/19/95
  Benzaldehyde, 2-chloro-.......................  89-98-5......................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-chloro-.......................  104-88-1.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-(diethylamino)-...............  120-21-8.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-(diethylamino)-2-hydroxy-.....  17754-90-4...................................  .................            9/30/91            6/30/98
  Benzaldehyde, 2,4-dihydroxy-..................  95-01-2......................................  .................            9/30/91           12/19/95
  Benzaldehyde, 2,5-dimethoxy-..................  93-02-7......................................  .................            9/30/91            6/30/98
  Benzaldehyde, 3,4-dimethoxy-..................  120-14-9.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, (dimethylamino)-................  28602-27-9...................................  .................            9/30/91           12/19/95
  Benzaldehyde, 4-(dimethylamino)-..............  100-10-7.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-ethoxy-.......................  10031-82-0...................................  .................           l9/30/91           12/19/95
  Benzaldehyde, 3-ethoxy-4-hydroxy-.............  121-32-4.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 2-hydroxy-......................  90-02-8......................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-hydroxy-......................  123-08-0.....................................  .................            9/30/91           12/19/95
  Benzaldehyde, 4-hydroxy-3-methoxy-............  121-33-5.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 2-hydroxy-5-nitro-..............  97-51-8......................................  .................            9/30/91           12/19/95
  Benzaldehyde, 2-methoxy-......................  135-02-4.....................................  .................            9/30/91           12/19/95
  Benzaldehyde, 4-methoxy-......................  123-11-5.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, methyl-.........................  1334-78-7....................................  .................            9/30/91           12/19/95
  Benzaldehyde, 4-methyl-.......................  104-87-0.....................................  .................            9/30/91            6/30/98
  Benzaldehyde, 2-nitro-........................  552-89-6.....................................  .................            9/30/91           12/19/95
  Benzaldehyde, 3-phenoxy-......................  39515-51-0...................................  .................            9/30/91            6/30/98
  Benzaldehyde, 4-(trifluoromethyl)-............  455-19-6.....................................  .................            9/30/91           12/19/95
  Benzeneacetaldehyde...........................  122-78-1.....................................  .................            9/30/91            6/30/98
  Benzeneacetaldehyde, alpha-methyl-............  93-53-8......................................  .................            9/30/91           12/19/95
  Benzeneacetaldehyde, 4-methyl-................  104-09-6.....................................  .................            9/30/91           12/19/95
  Benzenepropanal, 4-(1,1-dimethylethyl)-..-methyl-.
  Benzenepropanal, ..-methyl-4-(1-       103-95-7.....................................  .................            9/30/91            6/30/98
   methylethyl)-.
  1,3-Benzodioxole-5-carboxaldehyde.............  120-57-0.....................................  .................            9/30/91            6/30/98
  1,3-Benzodioxole-5-carboxaldehyde, 7-methoxy-.  5780-07-4....................................  .................            9/30/91           12/19/95
  Butanal, 3-methyl-............................  590-86-3.....................................  .................            9/30/91            6/30/98
  3-Cyclohexene-1-carboxaldehyde................  100-50-5.....................................  .................            9/30/91            6/30/98
  3-Cyclohexene-1-carboxaldehyde, dimethyl-.....  27939-60-2...................................  .................            9/30/91            6/30/98
  3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4- 31906-04-4...................................  .................            9/30/91            6/30/98
   methylpentyl)-.
  3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-  52475-86-2...................................  .................            9/30/91            6/30/98
   methyl-3-pentenyl)-.
  3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4-  66327-54-6...................................  .................            9/30/91            6/30/98
   methylpentyl)-.
  3-Cyclohexene-1-carboxaldehyde, 4-(4-methyl-3-  37677-14-8...................................  .................            9/30/91           12/19/95
   pentenyl)-.
  3-Cyclohexene-1-carboxaldehyde, 2,4,6-          1423-46-7....................................  .................            9/30/91           12/19/95
   trimethyl-.
  3-Cyclopentene-1-acetaldehyde, 2,2,3-trimethyl- 4501-58-0....................................  .................            9/30/91            6/30/98
   .
  Decanal.......................................  112-31-2.....................................  .................            9/30/91            6/30/98

[[Page 77]]

 
  4a(4H)-Dibenzofurancarboxaldehyde,              126-15-8.....................................  .................            9/30/91            6/30/98
   1,5a,6,9,9a,9b-hexahydro-.
  Dodecanal.....................................  112-54-9.....................................  .................            9/30/91            6/30/98
  Ethanedial....................................  107-22-2.....................................  .................            9/30/91            6/30/98
  Heptanal......................................  111-71-7.....................................  .................            9/30/91            6/30/98
  Heptanal, 2-(phenylmethylene)-................  122-40-7.....................................  .................            9/30/91            6/30/98
  5-Heptenal, 2,6-dimethyl-.....................  106-72-9.....................................  .................            9/30/91           12/19/95
  Hexanal, 2-ethyl-.............................  123-05-7.....................................  .................            9/30/91            6/30/98
  Hexanal, 3,5,5-trimethyl-.....................  5435-64-3....................................  .................            9/30/91           12/19/95
  2-Hexenal.....................................  505-57-7.....................................  .................            9/30/91           12/19/95
  Hexenal, 2-ethyl-.............................  26266-68-2...................................  .................            9/30/91            6/30/98
  1-Naphthalene carboxaldehyde..................  66-77-3......................................  .................            9/30/91           12/19/95
  Nonanal.......................................  124-19-6.....................................  .................            9/30/91            6/30/98
  2,6-Octadienal, 3,7-dimethyl-, (E)............  141-27-5.....................................  .................            9/30/91           12/19/95
  2,6-Octadienal, 3,7-dimethyl-, (Z)............  106-26-3.....................................  .................            9/30/91           12/19/95
  Octanal.......................................  124-13-0.....................................  .................            9/30/91            6/30/98
  Octanal, 3,7-dimethyl-........................  5988-91-0....................................  .................            9/30/91           12/19/95
  Octanal, 7-hydroxy-3,7-dimethyl-..............  107-75-5.....................................  .................            9/30/91            6/30/98
  Octanal, 7-methoxy-3,7-dimethyl-..............  3613-30-7....................................  .................            9/30/91            6/30/98
  Octanal, 2-(phenylmethylene)-.................  101-86-0.....................................  .................            9/30/91            6/30/98
  6-Octenal, 3,7-dimethyl-......................  106-23-0.....................................  .................            9/30/91            6/30/98
  6-Octenal, 3,7-dimethyl-, (S)-................  5949-05-3....................................  .................            9/30/91           12/19/95
  Pentanal......................................  110-62-3.....................................  .................            9/30/91            6/30/98
  Pentanedial...................................  111-30-8.....................................  .................            9/30/91            6/30/98
  1-Piperidinecarboxaldehyde....................  2591-86-8....................................  .................            9/30/91            6/30/98
  Propanal......................................  123-38-6.....................................  .................            9/30/91            6/30/98
  Propanal, 3-hydroxy-2,2-dimethyl-.............  597-31-9.....................................  .................            9/30/91            6/30/98
  2-Propenal, 2-methyl-.........................  78-85-3......................................  .................            9/30/91           12/19/95
  Propanal, 3-(methylthio)-.....................  3268-49-3....................................  .................            9/30/91            6/30/98
  2-Propenal....................................  107-02-8.....................................  .................            9/30/91            6/30/98
  2-Propenal, 3- 4-(1,1-dimethylethyl)phenyl -2-  13586-68-0...................................  .................            9/30/91            6/30/98
   methyl-.
  2-Propenal, 3-(2-methoxyphenyl)-..............  1504-74-1....................................  .................            9/30/91            6/30/98
  2-Propenal, 2-methyl-.........................  78-85-3......................................  .................            9/30/91            6/30/98
  2-Propenal, 2-methyl-3-phenyl-................  101-39-3.....................................  .................            9/30/91            6/30/98
  2-Propenal, 3-phenyl-.........................  104-55-2.....................................  .................            9/30/91            6/30/98
  2-Propenal, 3-phenyl-, monopentyl deriv.......  1331-92-6....................................  .................            9/30/91            6/30/98
  2-Pyridinecarboxaldehyde......................  1121-60-4....................................  .................            9/30/91           12/19/95
  2-Thiophene carboxaldehyde....................  98-03-3......................................  .................            9/30/91           12/19/95
  Undecanal.....................................  112-44-7.....................................  .................            9/30/91            6/30/98
  Undecanal, 2-methyl-..........................  110-41-8.....................................  .................            9/30/91            6/30/98
  9-Undecenal...................................  143-14-6.....................................  .................            9/30/91           12/19/95
  10-Undecenal..................................  112-45-8.....................................  .................            9/30/91            6/30/98
Alkyl-, Chloro-, and Hydroxymethyl Diaryl
 Ethers:.
  Benzene, 1-(bromomethyl)-3-phenoxy-...........  51632-16-7...................................  .................           04/12/93           06/30/98
  Benzenemethanol, 3-phenoxy-,..................  13826-35-2...................................  .................           04/12/93           06/30/98
  Benzenemethanol, 3-phenoxy-, acetate..........  50789-44-1...................................  .................            4/12/93           12/19/95
  Benzene, 1-methyl-3-phenoxy-..................  3586-14-9....................................  .................           04/12/93           06/30/98
  Benzene, 1,1'-oxybis[dodecyl-.................  69834-19-1...................................  .................            4/12/93           12/19/95
  Benzene, 1,1,-oxybis[methyl-..................  28299-41-4...................................  .................           04/12/93           06/30/98
  Benzene, 1,1'-oxybis[(1,1,3,3-                  61702-88-3...................................  .................            4/12/93           12/19/95
   tetramethylbutyl)-.
  Benzoic acid, 3-[2-chloro-4-                    63734-62-3...................................  .................           04/12/93           06/30/98
   (trifluoromethyl)phenoxy]-,.

[[Page 78]]

 
  Benzoic acid, 3-[2-chloro-4-                    72242-48-3...................................  .................           04/12/93           06/30/98
   (trifluoromethyl)phenoxy], potassium salt.
  1,1-Biphenyl, phenoxy-........................  28984-89-6...................................  .................           04/12/93           06/30/98
  2-Chloro-1-(3-methylphenoxy)-4-                 42874-96-4...................................  .................           04/12/93           06/30/98
   (trifluoromethyl)benzene.
  1,4-Diphenoxybenzene..........................  3061-36-7....................................  .................            4/12/93           12/19/95
  Phenol, 3-[2-chloro-4-                          50594-77-9...................................  .................           04/12/93           06/30/98
   (trifluoromethyl)phenoxy]-, acetate.
Alkyl Phosphates:...............................
  Ethanol, 2-butoxy-, phosphate (3:1)...........  78-51-3......................................  .................           10/29/90           12/19/95
  Ethanol, 2-(2-butoxyethoxy)-, phosphate (3:1).  7332-46-9....................................  .................           10/29/90           11/09/93
  Phosphoric acid, bis(2-ethylhexyl) ester......  298-07-7.....................................  .................           10/29/90           12/19/95
  Phosphoric acid, dibutyl ester................  107-66-4.....................................  .................           10/29/90           06/30/98
  Phosphoric acid, didodecyl ester..............  7057-92-3....................................  .................           10/29/90           11/09/93
  Phosphoric acid, diisooctyl ester.............  27215-10-7...................................  .................           10/29/90           11/09/93
  Phosphoric acid, dodecyl ester................  12751-23-4...................................  .................           10/29/90           11/09/93
  Phosphoric acid, 2-ethylhexyl ester...........  12645-31-7...................................  .................           10/29/90           11/09/93
  Phosphoric acid, monobutyl ester..............  1623-15-0....................................  .................           10/29/90           11/09/93
  Phosphoric acid, mono(2-ethylhexyl)ester......  1070-03-7....................................  .................           10/29/90           11/09/93
  Phosphoric acid, monohexyl ester..............  3900-04-7....................................  .................           10/29/90           11/09/93
  Phosphoric acid, monomethyl ester.............  812-00-0.....................................  .................           10/29/90           11/09/93
  Phosphoric acid, mono(1-methylethyl)ester.....  1623-24-1....................................  .................           10/29/90           11/09/93
  Phosphoric acid, monooctyl ester..............  3991-73-9....................................  .................           10/29/90           11/09/93
  Phosphoric acid, monooctadecyl ester..........  2958-09-0....................................  .................           10/29/90           11/09/93
  Phosphoric acid, triethyl ester...............  78-40-0......................................  .................           10/29/90           12/19/95
  Phosphoric acid, tris(2-ethylhexyl) ester.....  78-42-2......................................  .................           10/29/90           12/19/95
  Phosphoric acid, tris(2-methylpropyl) ester...  126-71-6.....................................  .................           10/29/90           11/09/93
  Phosphorodichloridic acid, ethyl ester........  1498-51-7....................................  .................           10/29/90           11/09/93
Alkylphenols and Alkylphenol Ethoxyates:........
  tert-Butylphenol (mixed isomers)..............  27178-34-3...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  2-Butylphenol.................................  3180-09-4....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  2-tert-Butylphenol............................  88-18-6......................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-n-Butylphenol...............................  1638-22-8....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-sec-Butylphenol.............................  99-71-8......................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-tert-Butylphenol............................  98-54-4......................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Decaethylene glycol 4-isoctylphenyl ether.....  2315-66-4....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-Dodecylphenol...............................  104-43-8.....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Dodecylphenol (mixed isomers).................  1331-57-3....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Dedecylphenol (mixed isomers).................  27193-86-8...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies

[[Page 79]]

 
  Hexaethylene glycol 4-isoctylphenyl ether.....  2497-58-7....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Isobutylphenol (mixed isomers)................  31195-95-6...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Isononylphenol (mixed isomers)................  11066-49-2...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-(1-Methylbutyl)phenol.......................  94-06-4......................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  (1-Methylheptyl)phenol (mixed isomers)........  27985-70-2...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-(1-Methyloctyl)phenol.......................  17404-66-9...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Nonylphenol (mixed isomers)...................  1300-16-9....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
                                                  25154-52-3...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-Nonylphenol.................................  104-40-5.....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Branched 4-nonylphenol (mixed isomers)........  84852-15-3...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  2-Octylphenol.................................  949-13-3.....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-Octylphenol.................................  1806-26-4....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-Pentylphenol................................  14938-35-3...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-tert-Pentylphenol...........................  80-46-6......................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Polyethylene glycol mono(octyl)phenyl ether...  9036-19-5....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Polyethylene glycol 4-(tert-octyl)phenyl ether  9002-93-1....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  Poly(oxy-1,2-ethanediyl), -            68987-90-6...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
   (octylphenyl)--hydroxy-, branched.                                                          ) applies
  2-(1,1,3,3-Tetramethylbutyl)phenol............  3884-95-5....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  (1,1,3,3-Tetramethylbutyl)phenol (mixed         1322-69-6....................................  Sec.  716.20(b)(4            3/29/96            6/30/98
   isomers).                                                                                             ) applies
                                                  27193-28-8...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
                                                  29932-96-5...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
                                                  30105-54-5...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
                                                  62744-41-6...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
  4-(2,2,3,3-Tetramethylbutyl)phenol............  54932-78-4...................................  Sec.  716.20(b)(4            3/29/96            6/30/98
                                                                                                         ) applies
Brominated flame retardants:....................
  Alkanes, C10-18, bromochloro-.................  68955-41-9...................................  .................           10/29/90           12/19/95

[[Page 80]]

 
  Benzamide, 3,5-dibromo-N-(4-bromophenyl)-2-     87-10-5......................................  .................           10/29/90           12/19/95
   hydroxy-.
  Benzene, ethenyl-, homopolymer, brominated....  88497-56-7...................................  .................           10/29/90           11/09/93
  Benzene, 1,1'-(1-methylethylidene)bis (3,5-     25327-89-3...................................  .................           10/29/90           11/09/93
   dibromo-4-(2-propenyloxy)-.
  Benzene, pentabromomethyl-....................  87-83-2......................................  .................           10/29/90           12/19/95
  Cyclohexane, 1,2,3,4,5-pentabromo-6-chloro-...  87-84-3......................................  .................           10/29/90           12/19/95
  Cyclohexane, tetrabromodichloro-..............  30554-72-4...................................  .................           10/29/90           12/19/95
  Cyclohexane, tribromotrichloro-...............  30554-73-5...................................  .................           10/29/90           12/19/95
  Ethanol, 2,2'-((1-methylethylidene)bis ((2,6-   4162-45-2....................................  .................           10/29/90           12/19/95
   dibromo-4,1-phenylene)oxy)) bis-.
  Ethene, bromo-................................  593-60-2.....................................  .................           10/29/90           06/30/98
  Phenol, 2,4-dibromo-..........................  615-58-7.....................................  .................           10/29/90           12/19/95
  Phenol, 2,4(or 2,6)-dibromo-,homopolymer......  69882-11-7...................................  .................           10/29/90           12/19/95
  1-Propanol, 2,3-dibromo-......................  96-13-9......................................  .................           10/29/90           12/19/95
  1-Propanol, 2,2-dimethyl-,tribromo deriv......  36483-57-5...................................  .................           10/29/90           12/19/95
  2-Propenoic acid,(1-methylethylidene)bis (2,6-  55205-38-4...................................  .................           10/29/90           12/19/95
   dibromo-4,1-phenylene) ester.
Chloroalkyl phosphates:.........................
  2,2-Bis(chloromethyl)-1,3-                      38051-10-4...................................  .................            6/14/93           12/19/95
   propanediyltetrakis(2-chloroethyl) phosphate.
  2-Chloro-1-methylethylbis(2-chloropropyl)       76649-15-5...................................  .................            6/14/93           12/19/95
   phosphate-.
  1,2-Ethanediyl tetrakis(2-chloro-1-             34621-99-3...................................  .................            6/14/93           12/19/95
   methylethylene) phosphate.
  Oxydi-2,1-ethanediyltetrakis(2-choloroethyl)    53461-82-8...................................  .................            6/14/93           12/19/95
   phosphate.
Cyanoacrylates:.................................
  2-Propenoic acid, 2-cyano-, methyl ester......  137-05-3.....................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-, isobutyl ester....  1069-55-2....................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2-     6197-30-4....................................  .................            1/26/94           12/19/95
   ethylhexyl ester.
  2-Propenoic acid, 2-cyano-, butyl ester.......  6606-65-1....................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-, ethyl ester.......  7085-85-0....................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-, 2-propenyl ester..  7324-02-9....................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-, 1-methylethyl       10586-17-1...................................  .................            1/26/94           12/19/95
   ester.
  2-Propenoic acid, 2-cyano-, ethoxy ethyl ester  21982-43-4...................................  .................            1/26/94           12/19/95
  2-Propenoic acid, 2-cyano-, 2,2,2-              23023-91-8...................................  .................            1/26/94           12/19/95
   trifluoromethyl ester.
  2-Propenoic acid, 2-cyano-, 2-methoxyethyl      27816-23-5...................................  .................            1/26/94           12/19/95
   ester.
  Ethanaminium, 2-[[2-cyano-3-[4-                 64992-16-1...................................  .................            1/26/94           12/19/95
   (diethylamino)phenyl]-1-oxo-2-propenyl]oxy]-
   N,N,N-trimethyl-, chloride.
IRIS Chemicals:.................................
  3,4-Dimethylphenol............................  95-65-8......................................  .................            9/30/91           12/19/95
  2,4-Dinitrophenol.............................  51-28-5......................................  .................            9/30/91           12/19/95
Isocyanates:....................................
  Acetic acid, isocyanato-, ethyl ester.........  2949-22-6....................................  .................           10/29/90           11/09/93
  Benzene, bis(isocyanatomethyl)-...............  25854-16-4...................................  .................           10/29/90           11/09/93
  Benzene, 1-bromo-4-isocyanato-................  2493-02-9....................................  .................           10/29/90           11/09/93
  Benzene, 1-chloro-3-isocyanato-...............  2909-38-8....................................  .................           10/29/90           11/09/93
  Benzene, 1-chloro-4-isocyanato-...............  104-12-1.....................................  .................           10/29/90           06/30/98
  Benzene, 1,2-dichloro-4-isocyanato-...........  102-36-3.....................................  .................           10/29/90           06/30/98
  Benzene, 1,3-dichloro-5-isocyanato-...........  34893-92-0...................................  .................           10/29/90           11/09/93
  Benzene, 1,1'-(diisocyanatomethylene)bis-.....  10031-75-1...................................  .................           10/29/90           11/09/93
  Benzene, isocyanato-..........................  103-71-9.....................................  .................           10/29/90           06/30/98
  Benzene, 2-isocyanato-1,3-bis(1-methylethyl)-.  28178-42-9...................................  .................           10/29/90           11/09/93
  Benzene, 2-isocyanato-1,3-dimethyl-, ester....  28556-81-2...................................  .................           10/29/90           11/09/93

[[Page 81]]

 
  Benzene, 1-isocyanato-2-methyl-...............  614-68-6.....................................  .................           10/29/90           11/09/93
  Benzene, 1-isocyanato-4-methyl-...............  622-58-2.....................................  .................           10/29/90           11/09/93
  Benzene, 1-isocyanato-4-nitro-................  100-28-7.....................................  .................           10/29/90           11/09/93
  Benzene, 1-isocyanato-3-(trifluoromethyl)-....  329-01-1.....................................  .................           10/29/90           06/30/98
  Benzene, 1,1',1''-methylidynetris(4-isocyanato- 2422-91-5....................................  .................           10/29/90           11/09/93
   .
  Butane, 1-isocyanato-.........................  111-36-4.....................................  .................           10/29/90           06/30/98
  Cyclohexane, 2-heptyl-3,4-bis (9-               68239-06-5...................................  .................           10/29/90           11/09/93
   isocyanatononyl)-1-pentyl-.
  Cyclohexane, isocyanato-......................  3173-53-3....................................  .................           10/29/90           11/09/93
  1,3-Diazetidine-2,4-dione, 1,3-bis(3-           26747-90-0...................................  .................           10/29/90           11/09/93
   isocyanato methylphenyl)-.
  Ethane, isocyanato-...........................  109-90-0.....................................  .................           10/29/90           12/19/95
  Imidodicarbonic diamide, N,N'-2-tris(6-         4035-89-6....................................  .................           10/29/90           11/09/93
   isocyanatohexyl)-.
  Methane, isocyanato-..........................  624-83-9.....................................  .................           10/29/90           12/19/95
  Octadecane, 1-isocyanato-.....................  112-96-9.....................................  .................           10/29/90           11/09/93
  Phenol, 4-isocyanato-, phosphorothioate (3:1)   4151-51-3....................................  .................           10/29/90           11/09/93
   (ester).
  Propane, 1-isocyanato-........................  110-78-1.....................................  .................           10/29/90           11/09/93
  1-Propene, 3-isocyanato-......................  1476-23-9....................................  .................           10/29/90           11/09/93
  2-Propenoic acid, 2-methyl-, 2-                 30674-80-7...................................  .................           10/29/90           12/19/95
   isocyanatoethyl ester.
  2-Propenoic acid, 2-methyl-2-(((((5-isocyanato- 73597-26-9...................................  .................           10/29/90           11/09/93
   1,3,3-trimethylcyclohexyl)methyl)amino)
   carbonyl)oxy)ethyl ester.
  1,3,5,-Triazine-2,4,6(1H.3H.5H-trione, 1,3,5-   26603-40-7...................................  .................           10/29/90           11/09/93
      tris(3-isocyanatomethylphenyl)-.
Methyl ethylene glycol ethers and esters:.......
  Ethylene glycol monomethy ether acrylate......  3121-61-7....................................  .................            1/26/94           12/19/95
  Tetraethylene glycol monomethyl ether.........  23783-42-8...................................  .................            1/26/94           12/19/95
OSHA Chemicals in Need of Dermal Absorption
 Testing:.
  Amitrole......................................  61-82-5......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  n-Amyl acetate................................  628-63-7.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  o-Anisidine...................................  90-04-0......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Benzyl chloride...............................  100-44-7.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  sec-Butyl acetate.............................  105-46-4.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  tert-Butyl acetate............................  540-88-5.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  sec-Butyl alcohol.............................  78-92-2......................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  tert-Butyl alcohol............................  75-65-0......................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  t-Butylcatechol...............................  98-29-3......................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  o-sec-butylphenol.............................  89-72-5......................................  .................            3/11/94            6/30/98
  Camphor.......................................  76-22-2......................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Carbon disulfide..............................  75-15-0......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Catechol......................................  120-80-9.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply

[[Page 82]]

 
  a-Chloroacetophenone..........................  532-27-4.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Chlorobenzene.................................  108-90-7.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  o-Chlorotoluene...............................  95-49-8......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Cyclohexene...................................  110-83-8.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Cyclohexanol..................................  108-93-0.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Cyclopentadiene...............................  542-92-7.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Cyclopentane..................................  287-92-3.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Diacetone alcohol.............................  123-42-2.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Dibutyl phosphate.............................  107-66-4.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  1,2-Dichloroethylene..........................  540-59-0.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Dicylcopentadiene.............................  77-73-6......................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Dimethyl acetamide............................  127-19-5.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Dimethylaniline...............................  121-69-7.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Dimethyl sulfate..............................  77-78-1......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  m-Dinitrobenzene..............................  99-65-0......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  o-Dinitrobenzene..............................  528-29-0.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  p-Dinitrobenzene..............................  100-25-4.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  2,4-Dinitrotoluene............................  121-14-2.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Diphenylamine.................................  122-39-4.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Disulfiram....................................  97-77-8......................................  Sec.  716.20(b)(3            1/26/94            1/26/94
                                                                                                         ) applies
  Ethyl bromide.................................  74-96-4......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Ethyl ether...................................  60-29-7......................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Heptane (n-Heptane)...........................  142-82-5.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies

[[Page 83]]

 
  Indene........................................  95-13-6......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Isoamyl acetate...............................  123-92-2.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  N-Isopropylaniline............................  768-52-5.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  p-Methoxyphenol...............................  150-76-5.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Methyl acetate................................  79-20-9......................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Methylcyclohexane.............................  108-87-2.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Methyl formate................................  107-31-3.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Methyl isoamyl ketone.........................  110-12-3.....................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  p-Nitroaniline................................  100-01-6.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  p-Nitrochlorobenzene..........................  100-00-5.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  1-Nitropropane................................  108-03-2.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  2-Nitropropane................................  79-46-9......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  m-Nitrotoluene................................  99-08-1......................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  o-Nitrotoluene................................  88-72-2......................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  p-Nitrotoluene................................  99-99-0......................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Nonane........................................  111-84-2.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Pentane.......................................  109-66-0.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Phenylhydrazine...............................  100-63-0.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Propylene glycol dinitrate....................  6423-43-4....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Sodium bisulfite..............................  7631-90-5....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Sodium metabisulfite..........................  7681-57-4....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Tetrahydrofuran...............................  109-99-9.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  m-Toluidine...................................  108-44-1.....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
  Vinylidene chloride...........................  75-35-4......................................  Sec.  716.20(b)(3             8/4/95            6/30/98
                                                                                                      ) and (b)(4)
                                                                                                             apply
  Vinyl toluene.................................  25013-15-4...................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies

[[Page 84]]

 
  p-Xylene......................................  106-42-3.....................................  Sec.  716.20(b)(3            1/26/94            6/30/98
                                                                                                         ) applies
  Xylidine......................................  1300-73-8....................................  Sec.  716.20(b)(3            3/11/94            6/30/98
                                                                                                         ) applies
Nonylphenol ethoxylates
  alpha-(p-Nonylphenol)-omega-                    NA                                             Sec.  716.20(b)(4           11/29/96           11/29/06
   hydroxypoly(oxyethylene).                                                                             ) applies
  Decaethylene glycol, isononylphenyl ether.....  65455-72-3                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Ethanol, 2-[2-(p-nonylphenoxy)ethoxy]-........  20427-84-3                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Ethanol, 2-[2-[2-[2-(p-nonylphenoxy)            07311-27-5                                     Sec.  716.20(b)(4           11/29/96           11/29/06
   ethoxy]ethoxy]ethoxy]-.                                                                               ) applies
  Nonoxynol-2...................................  NA                                             Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonoxynol-3...................................  NA                                             Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonoxynol-7...................................  NA                                             Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenol hepta(oxyethylene)ethanol.........  27177-05-5                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenol octa(oxyethylene)ethanol..........  26571-11-9                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenol polyethylene glycol ether.........  09016-45-9, 20636-48-0, 26027-38-3, 26064-02-  Sec.  716.20(b)(4           11/29/96           11/29/06
                                                   8, 27177-01-1, 37205-87-1, 127087-87-0                ) applies
  Nonylphenol polyethylene glycol ether.........  27177-08-8                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenolnona(oxyethylene) ethanol..........  27986-36-3                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenoxy ethanol..........................  27176-93-8                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenoxydiglycol..........................  68412-54-4                                     Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Nonylphenoxypolyoxyethanol....................  152143-22-1, 26027-38-3                        Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  p-Nonylphenol polyethylene glycol ether.......  27986-36-3, 37205-87-1, 98113-10-1             Sec.  716.20(b)(4           11/29/96           11/29/06
                                                                                                         ) applies
  Poly(oxy-1,2-ethanediyl), alpha-                37205-87-1                                     Sec.  716.20(b)(4           11/29/96           11/29/06
   (isononylphenyl)-omega-hydroxy.                                                                       ) applies
  Poly(oxy-1,2-ethanediyl), alpha-(2-             51938-25-1                                     Sec.  716.20(b)(4           11/29/96           11/29/06
   nonylphenyl)-omega-hydroxy.                                                                           ) applies
Propylene glycol ethers and esters:.............
  Dipropylene glycol............................  110-96-5.....................................  .................            1/26/94           12/19/95
  Dipropylene glycol butyl ether................  29911-28-2...................................  .................            1/26/94           12/19/95
  Dipropylene glycol monomethyl ether acetate...  88917-22-0...................................  .................            1/26/94           12/19/95

[[Page 85]]

 
  1-(2-Methoxy-1-methylethoxy)-2-propanol.......  20324-32-7...................................  .................            1/26/94           12/19/95
  Methoxy-1-propanol............................  28677-93-2...................................  .................            1/26/94           12/19/95
  1-Phenoxy-2-propanol..........................  770-35-4.....................................  .................            1/26/94           12/19/95
  Propylene glycol monobutyl ether..............  29387-86-8...................................  .................            1/26/94           12/19/95
  Propylene glycol monomethyl ether acetate.....  108-65-6.....................................  .................            1/26/94           12/19/95
  Propylene glycol mono-tert-butyl ether........  57018-52-7...................................  .................            1/26/94           12/19/95
  Tripropylene glycol diacrylate................  42978-66-5...................................  .................            1/26/94           12/19/95
  Tripropylene glycol methyl ether..............  20324-33-8...................................  .................            1/26/94           12/19/95
Siloxanes:......................................
  Cyclopolydimethylsiloxane.....................  69430-24-6...................................                              10/12/93           06/30/98
  Decamethylcyclopentasiloxane..................  541-02-6.....................................                              10/12/93           06/30/98
  Decamethyltetrasiloxane.......................  141-62-8.....................................                              10/12/93           06/30/98
  Dimethyldiphenylsiloxane......................  68083-14-7...................................                              10/12/93           06/30/98
  Dimethylhydropolylsiloxane....................  68037-59-2...................................                              10/12/93           06/30/98
  Dimethylmethyl 3,3,3-trifluoropropyl siloxane.  115361-68-7..................................                              10/12/93           06/30/98
  Dimethylmethylvinylsiloxane...................  67762-94-1...................................                              10/12/93           06/30/98
  Dimethylpolysiloxanes.........................  68037-74-1...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Dimethyl silicones and siloxanes..............  63148-62-9...................................                              10/12/93           06/30/98
  Dimethyl silicones and siloxane, reaction       67762-90-7...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
   products with silica.                                                                                 ) applies
  Docosamethylcycloundecasiloxane...............  18766-38-6...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Docosamethyldecasiloxane......................  556-70-7.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Dodecamethylcyclohexasiloxane.................  540-97-6.....................................                              10/12/93           06/30/98
  Dodecamethylpentasiloxane.....................  141-63-9.....................................                              10/12/93           06/30/98
  Dotetracontamethyleicosasiloxane..............  150027-00-2..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Dotriacontamethylcyclohexadecasiloxane........  150026-95-2..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Dotriacontamethylpentadecasiloxane............  2471-11-6....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Eicosamethylcyclodecasiloxane.................  18772-36-6...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Eicosamethylnonasiloxane......................  2652-13-3....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Hexacosamethylcyclotridecasiloxane............  23732-94-7...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Hexacosamethyldodecasiloxane..................  2471-08-1....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Hexadecamethylcyclooctasiloxane...............  556-68-3.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Hexadecamethylheptasiloxane...................  541-01-5.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Hexamethylcyclotrisiloxane....................  541-05-9.....................................                              10/12/93           06/30/98
  Hexamethyldisilazane..........................  999-97-3.....................................                              10/12/93           06/30/98
  Hexamethyldisiloxane..........................  107-46-0.....................................                              10/12/93           06/30/98
  Hexatriacontamethylcyclooctadecasiloxane......  23523-12-8...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies

[[Page 86]]

 
  Hexatriacontamethylheptadecasiloxane..........  18844-04-7...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Methylpolysiloxane............................  9004-73-3....................................                              10/12/93           06/30/98
  Methylvinylcyclosiloxane......................  2554-06-5....................................                              10/12/93           06/30/98
  Siloxanes and silicones, di-Me, hydroxy-        70131-67-8...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
   terminated.                                                                                           ) applies
  Octacosamethylcyclotetradecasiloxane..........  149050-40-8..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Octacosamethyltridecasiloxane.................  2471-09-2....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Octadecamethylcyclononasiloxane...............  556-71-8.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Octadecamethyloctasiloxane....................  556-69-4.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Octamethyltrisiloxane.........................  107-51-7.....................................                              10/12/93           06/30/98
  Octaphenylcyclotetrasiloxane..................  546-56-5.....................................                              10/12/93           06/30/98
  Octatriacontamethylcyclononadecasiloxane......  150026-97-4..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Octatriacontamethyloctadecasiloxane...........  36938-52-0...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Polymethyloctadecylsiloxane...................  not available................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetracontamethylcycloeicosasiloxane...........  150026-98-5..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetracontamethylnonadecasiloxane..............  150026-99-6..................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetracosamethylcyclododecasiloxane............  18919-94-3...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetracosamethylundecasiloxane.................  107-53-9.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetradecamethylcycloheptasiloxane.............  107-50-6.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetradecamethylhexasiloxane...................  107-52-8.....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Tetramethylcyclotetrasiloxane.................  2370-88-9....................................                              10/12/93           06/30/98
  Tetramethyldivinyldisiloxane..................  2627-95-4....................................                              10/12/93           06/30/98
  Tetratriacontamethylcycloheptadecasiloxane....  150026-96-3..................................                              10/12/93           06/30/98
  Tetratriacontamethylhexadecasiloxane..........  36938-50-8...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Triacontamethylcyclopentadecasiloxane.........  23523-14-0...................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Triacontamethyltetradecasiloxane..............  2471-10-5....................................  Sec.  716.20(b)(2           10/12/93           06/30/98
                                                                                                         ) applies
  Trifluoropropylmethylcyclotrisiloxane.........  2374-14-3....................................                              10/12/93           06/30/98
 
Substantially produced chemicals in need of
 subchronic tests:.
  Acetoacetanilide..............................  102-01-2.....................................  .................            9/30/91           12/19/95

[[Page 87]]

 
  4-(Acetylamino)benzenesulfonyl chloride.......  121-60-8.....................................  .................            9/30/91            6/30/98
  2-(2-Aminoethoxy)-ethanol.....................  929-06-6.....................................  .................            6/30/92            6/30/98
  7-Amino-4-hydroxy-2-naphthalenesulfonic acid..  87-02-5......................................  .................            9/30/91           12/19/95
  Ammonium carbamate............................  1111-78-0....................................  .................            9/30/91           12/19/95
  1,3-Benzenedisulfonic acid....................  98-48-6......................................  .................            9/30/91           12/19/95
  Bis(2-ethylhexyl)-2-butenedioate..............  142-16-5.....................................  .................            9/30/91           12/19/95
  Bromamine acid................................  116-81-4.....................................  .................            9/30/91           12/19/95
  Butyric anhydride.............................  106-31-0.....................................  .................            9/30/91           12/19/95
  Ethanol, 2-(2-ethoxyethoxy)-, acetate.........  112-15-2.....................................  .................            9/30/91            6/30/98
  1,2-Dichlorobutane............................  616-21-7.....................................  .................            9/30/91           12/19/95
  3,4-Dichlorobutene............................  760-23-6.....................................  .................            9/30/91           12/19/95
  3,4-Dichloronitrobenzene......................  99-54-7......................................  .................            9/30/91            6/30/98
  1,3-Dicyanobenzene............................  626-17-5.....................................  .................            9/30/91            6/30/98
  Diethylene glycol dimethyl ether..............  111-96-6.....................................  .................            9/30/91            6/30/98
  4-Ethoxynitrobenzene..........................  100-29-8.....................................  .................            9/30/91            6/30/98
  2-Ethylanthraquinone..........................  84-51-5......................................  .................            9/30/91           12/19/95
  Hexa(methoxymethyl) melamine..................  3089-11-0....................................  .................            9/30/91            6/30/98
  3-Hydroxy-2-naphthoic acid....................  92-70-6......................................  .................            9/30/91           12/19/95
  Isobutyl acrylate.............................  106-63-8.....................................  .................            9/30/91           12/19/95
  Isophthaloyl chloride.........................  9-63-8.......................................  .................            9/30/91           12/19/95
  4-Methyl-2-nitro-phenol.......................  119-33-5.....................................  .................            9/30/91            6/30/98
  2-(4-Morpholinyldithio)-benzothiazole.........  95-32-9......................................  .................            9/30/91           12/19/95
  Naphthalenedicarboxylic anhydride.............  81-84-5......................................  .................            9/30/91            6/30/98
  1-Naphthol....................................  90-15-3......................................  .................            9/30/91           12/19/95
  p,p'-Oxybis(benzenesulfonylhydrazide).........  80-51-3......................................  .................            9/30/91            6/30/98
  2,4-Pentanedione..............................  123-54-6.....................................  .................            9/30/91           12/19/95
  Perfluoro-N-hexane............................  355-42-0.....................................  .................            9/30/91           12/19/95
  Perfluorotributylamine........................  311-89-7.....................................  .................            9/30/91           12/19/95
  Propanoic anhydride...........................  123-62-6.....................................  .................            9/30/91           12/19/95
  Quinacridone..................................  1047-16-1....................................  .................            9/30/91           12/19/95
  Terephthaloyl chloride........................  100-20-9.....................................  .................            9/30/91  .................
  Trichloromethanesulfenyl chloride.............  594-42-3.....................................  .................            9/30/91            6/30/98
  Triethylene glycol bis(2-ethylhexanoate)......  94-28-0......................................  .................            9/30/91           12/19/95
Sulphones:......................................
  2-Amino-4-[(2-hydroxyethyl) sulfonyl]phenol...  17601-96-6...................................  .................            9/30/91           12/19/95
  2-Amino-4-(methylsulfonyl)phenol..............  98-30-6......................................  .................            9/30/91           12/19/95
  2-[(6-Amino-2-naphthalenyl) sulfonyl]ethanol..  52218-35-6...................................  .................            9/30/91           12/19/95
  2-[(3-Aminophenyl)sulfonyl]ethanol............  5246-57-1....................................  .................            9/30/91           12/19/95
  Bisphenol S...................................  80-09-1......................................  .................            9/30/91           12/19/95
  3-(Decyloxy)tetrahydrothiophene 1,1-dioxide...  18760-44-6...................................  .................            9/30/91           12/19/95
  4,4'-Diaminodiphenyl sulfone..................  80-08-0......................................  .................            9/30/91           12/19/95
  4-[4-[(2,6-Dichloro-4-nitrophenyl)azo]phenyl]   17741-62-7...................................  .................            9/30/91           12/19/95
   thiomorpholine, 11,1-dioxide.
  1-(Diiodomethyl)sulfonyl-4-methyl benzene.....  20018-09-1...................................  .................            9/30/91           12/19/95
  Dimethylsulfone...............................  67-71-0......................................  .................            9/30/91           12/19/95
  Diphenylsulfone...............................  127-63-9.....................................  .................            9/30/91           12/19/95
  3-[N-Ethyl-4-[[6-(methylsulfonyl)-2-            16588-67-3...................................  .................            9/30/91           12/19/95
   benzothiazolyl]azo]-m-toluidino]propionitrile.
  1,1'-[Methylenebis(sulfonyl)]bis-2-             41123-59-5...................................  .................            9/30/91           12/19/95
   chloroethane.
  2,2'-[Methylenebis(sulfonyl)]bisethanol.......  41123-69-7...................................  .................            9/30/91           12/19/95
  1,1'-[Methylenebis(sulfonyl)]bisethene........  3278-22-6....................................  .................            9/30/91           12/19/95
  6-Methylsulfonyl)-2-benzothiazolamine.........  17557-67-4...................................  .................            9/30/91           12/19/95

[[Page 88]]

 
  2-[(3-Nitrophenyl)sulfonyl]ethanol............  41687-30-3...................................  .................            9/30/91           12/19/95
  1,1'-[Oxybis(methylenesulfonyl)]bis-2-          53061-10-2...................................  .................            9/30/91           12/19/95
   chloroethane.
  2,2'-[Oxybis(methylenesulfonyl)] bisethanol...  36724-43-3...................................  .................            9/30/91           12/19/95
  1,1'-[Oxybis(methylenesulfonyl)] bisethene....  26750-50-5...................................  .................            9/30/91           12/19/95
  4-[[4-(Phenylmethoxy)phenyl]sulfonyl] phenol..  63134-33-8...................................  .................            9/30/91           12/19/95
  4-Phenylthiomorpholine, 1,1-dioxide...........  17688-68-5...................................  .................            9/30/91           12/19/95
  Sulfolane.....................................  126-33-0.....................................  .................            9/30/91           12/19/95
  3-Sulfolene...................................  77-79-2......................................  .................            9/30/91           12/19/95
  Sulfonyl bis(4-chlorobenzene).................  80-07-9......................................  .................            9/30/91           12/19/95
  2,2'-Sulfonyl bisethanol......................  2580-77-0                                      .................            9/30/91           12/19/95
--------------------------------------------------------------------------------------------------------------------------------------------------------

[53 FR 38645, Sept. 30, 1988; 53 FR 45656, Nov. 10, 1988, as amended at 
53 FR 46281, Nov. 16, 1988; 53 FR 49966, Dec. 12, 1988; 54 FR 617, Jan. 
9, 1989; 54 FR 8488, Feb. 28, 1989; 54 FR 51134, Dec. 12, 1989; 55 FR 
35631, Aug. 31, 1990; 55 FR 36640, Sept. 6, 1990; 55 FR 39774, Sept. 28, 
1990; 55 FR 39784, Sept. 28, 1990; 56 FR 42693, Aug. 29, 1991; 56 FR 
49146, Sept. 27, 1991; 57 FR 29034, June 30, 1992; 58 FR 13559, Mar. 12, 
1993; 58 FR 28515, May 14, 1993; 58 FR 42678, Aug. 11, 1993; 58 FR 
47649, Sept. 10, 1993; 58 FR 68315, 68321, Dec. 27, 1993; 59 FR 5960, 
Feb. 9, 1994; 59 FR 22519, May 2, 1994; 59 FR 60719, Nov. 28, 1994; 60 
FR 34884, July 5, 1995; 60 FR 48662, Sept. 20, 1995; 61 FR 7425, Feb. 
28, 1996; 61 FR 14596, Apr. 2, 1996; 61 FR 55875, Oct. 29, 1996; 63 FR 
15774, Apr. 1, 1998]

  Effective Date Notes: 1. At 59 FR 14115, Mar. 25, 1994, in 
Sec. 716.120 paragraph (d), the chemical substances under the category 
``propylene glycol ethers and esters'' and all related dates, was stayed 
effective March 25, 1994.

  2. At 63 FR 684, Jan. 7, 1998, the table in Sec. 716.120(d) was 
amended by staying the entire category ``Nonylphenol ethoxylates'', 
effective Dec. 30, 1997.

[[Page 89]]



PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT--Table of Contents




                      Subpart A--General Provisions

Sec.
717.1  Scope and compliance.
717.3  Definitions.
717.5  Persons subject to this part.
717.7  Persons not subject to this part.
717.10  Allegations subject to this part.
717.12  Significant adverse reactions that must be recorded.
717.15  Recordkeeping requirements.
717.17  Inspection and reporting requirements.
717.19  Confidentiality.

    Authority: 15 U.S.C. 2607(c).

    Source: 48 FR 38187, Aug. 22, 1983, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 717.1  Scope and compliance.

    Section 8 (c) of the Toxic Substances Control Act (TSCA) requires 
manufacturers, processors, and distributors of chemical substances and 
mixtures:
    (a) To keep ``records of significant adverse reactions to health or 
the environment, as determined by the Administrator by rule, alleged to 
have been caused by the substance or mixture.''
    (b) To ``permit inspection and submit copies of such records'', upon 
request of any designated representative of the Administrator. This rule 
implements section 8(c) of TSCA. It describes the records to be kept and 
prescribes the conditions under which certain firms must submit or make 
the records available to a duly designated representative of the 
Administrator.



Sec. 717.3  Definitions.

    The definitions set forth in section 3 of TSCA and the following 
definitions apply to this part:
    (a) Allegation means a statement, made without formal proof or 
regard for evidence, that a chemical substance or mixture has caused a 
significant adverse reaction to health or the environment.
    (b) Firm or company means any person, that is subject to this part, 
as defined in Sec. 717.5.
    (c)(1) Known human effects means a commonly recognized human health 
effect of a particular substance or mixture as described either in:
    (i) Scientific articles or publications abstracted in standard 
reference sources.
    (ii) The firm's product labeling or material safety data sheets 
(MSDS).
    (2) However, an effect is not a ``known human effect'' if it:
    (i) Was a significantly more severe toxic effect than previously 
described.
    (ii) Was a manifestation of a toxic effect after a significantly 
shorter exposure period or lower exposure level than described.
    (iii) Was a manifestation of a toxic effect by an exposure route 
different from that described.
    (d) Manufacture or process means to manufacture or process for 
commercial purposes.
    (e)(1) Manufacture for commercial purposes means to import, produce, 
or manufacture with the purpose of obtaining an immediate or eventual 
commercial advantage for the manufacturer, and includes, among other 
things, such ``manufacture'' of any amount of a chemical substance or 
mixture:
    (i) For distribution in commerce, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    (2) Manufacture for commercial purposes also applies to substances 
that are produced coincidentally during the manufacture, processing, 
use, or disposal of another substance or mixture, including both 
byproducts that are separated from that other substances or mixture and 
impurities that remain in that substance or mixture. Such byproducts and 
impurities may, or may not, in themselves have commercial value. They 
are nonetheless produced for the purpose of obtaining a commercial 
advantage since they are part of the manufacture of a chemical product 
for a commercial purpose.
    (f) Person includes any individual, firm, company, corporation, 
joint venture, partnership, sole proprietorship,

[[Page 90]]

association, or any other business entity, any State or political 
subdivision thereof, and any department, agency, or instrumentally of 
the Federal Government.
    (g) Process for commercial purposes means the preparation of a 
chemical substance or mixture, after its manufacture, for distribution 
in commerce with the purpose of obtaining an immediate or eventual 
commercial advantage for the processor. Processing of any amount of a 
chemical substance or mixture is included. If a chemical substance or 
mixture containing impurities is processed for commercial purposes, then 
those impurities are also processed for commercial purposes.
    (h) Retailer means a person who distributes in commerce a chemical 
substance, mixture, or article to ultimate purchasers who are not 
commercial entities.
    (i) Significant adverse reactions are reactions that may indicate a 
substantial impairment of normal activities, or long-lasting or 
irreversible damage to health or the environment.
    (j) Site means a contiguous property unit. Property divided only by 
a public right-of-way is considered one site. There may be multiple 
manufacturing, processing, or distribution activities occurring within a 
single site.
    (k) Substance means a chemical substance or mixture unless otherwise 
indicated.



Sec. 717.5  Persons subject to this part.

    (a) Manufacturers. (1) All manufacturers of chemical substances are 
subject to this part except as provided in Sec. 717.7(a). If manufacture 
of a chemcial substance occurs at any site owned or controlled by a firm 
then that firm is subject to this part.
    (2) A manufacturer must collect:
    (i) Any allegation identifying a chemical substance it manufactures 
and any allegation identifying the operations in the manufacture of any 
chemical substance it manufactures.
    (ii) Any allegation identifying any of its own processing or 
distribution in commerce activities with respect to any chemical 
substance it manufactures.
    (iii) Any allegation identifying emissions, effluents, or other 
discharges from activities described in this paragraph.
    (iv) Any allegation identifying a substance produced coincidentally 
during processing, use, storage or disposal of a chemical substance it 
manufactures.
    (3) For the purpose of this part, owned or controlled means 
ownership of 50 percent or more of a firm's voting stock or other equity 
rights, or the power to control the management and policies of that 
firm.
    (b) Processors. (1) A person who processes chemical substances, who 
is not also a manufacturer of those chemical substances, is subject to 
this part if (i) the person processes chemical substances to produce 
mixtures, or (ii) the person repackages chemical substances or mixtures.
    (2) As a processor subject to this part such person must collect:
    (i) Any allegation identifying any mixture it produces and 
distributes in commerce and any allegation identifying any chemical 
substance or mixture it repackages and distributes in commerce.
    (ii) Any allegation identifying any of its own further processing or 
distribution in commerce activities of the products described in 
paragraph (b)(2)(i) of this section.
    (iii) Any allegation identifying emissions, effluents, or other 
discharges from activities described in this paragraph.
    (iv) Any allegation identifying a substance produced coincidentally 
during the processing, use, storage or disposal of the products 
described in paragraph (b)(2)(i) of this section.
    (c) SIC code. SIC codes applicable to this part are published in 
Standard Industrial Classification Manual--1972 and the 1977 Supplement. 
This manual and supplement may be obtained from the U.S. Government 
Printing Office, Washington, D.C. 20402--stock number 4101-0006 and 
stock number 003-005-0170-0 respectively. Where there is a conflict 
between the SIC code use of a term and the definition of that term in 
this part, the definition in this part applies.

[48 FR 38187, Aug 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985]

[[Page 91]]



Sec. 717.7  Persons not subject to this part.

    (a) Manufacturers. (1) Persons or site activities are exempt from 
this part if the means by which they manufacture a chemical substance 
solely involves mining or other solely extractive functions, e.g., those 
companies or sites within a company whose sole function is to mine 
mineral ores, extract petroleum or natural gas, quarry non-metallic 
minerals (including extraction of salts from seawater or brines), mine 
or otherwise extract coal, or separate gases from the atmosphere. This 
exemption may include, but is not necessarily limited to, firms engaged 
in activities as described in SIC Division B--Mining and SIC Code 2813--
Industrial Gases.
    (2) A person is not subject to this part if the chemical substances 
that person causes to be produced are limited to:
    (i) Chemical substances that result from chemical reactions that 
occur incidental to exposure of another chemical substance, mixture, or 
article to environmental factors such as air, moisture, microbial 
organisms, or sunlight.
    (ii) Chemical substances that result from chemical reactions that 
occur incidental to storage or disposal of other chemical substances, 
mixtures, or articles.
    (iii) Chemical substances that result from chemical reactions that 
occur upon end use of other chemical substances, mixtures, or articles 
such as adhesives, paints, miscellaneous cleaners or other housekeeping 
products, fuel additives, water softening and treatment agents, 
photographic films, batteries, matches, or safety flares, and that are 
not themselves manufactured or imported for distribution in commerce for 
use as chemical intermediates.
    (iv) Chemical substances that result from chemical reactions that 
occur upon use of curable plastic or rubber molding compounds, inks, 
drying oils, metal finishing compounds, adhesives, or paints, or other 
chemical substance formed during the manufacture of an article destined 
for the marketplace without further chemical change of the chemical 
substance.
    (v) Chemical substances that result from chemical reactions that 
occur when (A) a stabilizer, colorant, odorant, antioxidant, filler, 
solvent, carrier, surfactant, plasticizer, corrosion inhibitor, 
antifoamer or defoamer, dispersant, precipitation-inhibitor, binder, 
emulsifier, deemulsifier, dewatering agent, agglomerating agent, 
adhesion promoter, flow modifier, pH adjuster, sequestrant, coagulant, 
flocculant, fire retardant, lubricant, chelating agent, or quality 
control reagent functions as intended, or (B) a chemical substance, 
which is intended solely to impart a specific physicochemical 
characteristic, functions as intended.
    (b) [Reserved]
    (c) Sole distributors. A person solely engaged in the distribution 
of chemical substances is exempt from this part, unless such person is 
also a manufacturer or processor subject to this part. For example, a 
``distributor'' who repackages chemical substances or mixtures is 
considered to be a processor and, thus, is not a sole distributor. Sole 
distributors may include, but are not limited to, those firms that 
distribute chemical substances as described in the wholesale trade SIC 
codes 5161--Chemicals and Allied Products, 5171--Petroleum Bulk Stations 
and Terminals, and 5172--Petroleum and Petroleum Products Wholesalers, 
Except Bulk Stations and Terminals.
    (d) Retailers. A person who is a retailer is exempt from this part 
unless such person is also a manufacturer or a processor subject to this 
part.

[48 FR 38187, Aug 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985]



Sec. 717.10  Allegations subject to this part.

    (a) Allegations subject to this part are those allegations received 
on or after November 21, 1983 by persons subject to this part.
    (b) Allegations subject to this part are those that:
    (1) Are submitted either in writing and are signed by the alleger, 
or are submitted orally. In the case of an oral allegation, the firm 
must transcribe the allegation into written form, or it must inform the 
alleger that such allegation may be subject to this part and request 
that the alleger submit such

[[Page 92]]

allegation to the firm in writing and signed.
    (2) Implicate a substance that caused the stated significant adverse 
reaction by one of the following:
    (i) Naming the specific substance.
    (ii) Naming a mixture that contains a specific substance.
    (iii) Naming an article that contains a specific substance.
    (iv) Naming a company process or operation in which substances are 
involved.
    (v) Identifying an effluent, emission, or other discharge from a 
site of manufacturing, processing or distribution of a substance.
    (c) Allegations subject to this part may be made to a firm by any 
person, such as an employee of the firm, individual consumer, a neighbor 
of the firm's plant, another firm on behalf of its employees or an 
organization on behalf of its members.
    (d) EPA intends that firms should, to the maximum practical extent, 
provide allegers with information regarding the ultimate disposition of 
their allegations. For example, firms could provide a brief notice to 
the alleger stating that a record was created under this part based upon 
their allegation, or that a record was not created and briefly explain 
the reasons why not.



Sec. 717.12  Significant adverse reactions that must be recorded.

    (a) Except as provided in paragraph (b) of this section, significant 
adverse reactions to human health that must be recorded include but are 
not limited to:
    (1) Long-lasting or irreversible damage, such as cancer or birth 
defects.
    (2) Partial or complete impairment of bodily functions, such as 
reproductive disorders, neurological disorders or blood disorders.
    (3) An impairment of normal activities experienced by all or most of 
the persons exposed at one time.
    (4) An impairment of normal activities which is experienced each 
time an individual is exposed.
    (b) Firms are not required to record significant adverse reactions 
that are known human effects as defined in Sec. 717.3(c).
    (c) Except as provided in paragraph (d) of this section, significant 
adverse reactions to the environment that must be recorded, even if 
restricted to the environs of a plant or disposal site, include but are 
not limited to:
    (1) Gradual or sudden changes in the composition of animal life or 
plant life, including fungal or microbial organisms, in an area.
    (2) Abnormal number of deaths of organisms (e.g., fish kills).
    (3) Reduction of the reproductive success or the vigor of a species.
    (4) Reduction in agricultural productivity, whether crops or 
livestock.
    (5) Alterations in the behavior or distribution of a species.
    (6) Long lasting or irreversible contamination of components of the 
physical environment, especially in the case of ground water, and 
surface water and soil resources that have limited self-cleansing 
capability.
    (d) Firms are not required to record a significant adverse reaction 
to the environment if the alleged cause of that significant adverse 
reaction can be directly attributable to an accidental spill or other 
accidental discharge, emission exceeding permitted limits, or other 
incident of environmental contamination that has been reported to the 
Federal Government under any applicable authority.

[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 
FR 34204, June 23, 1993]



Sec. 717.15  Recordkeeping requirements.

    (a) Establishment and location of records. A firm subject to this 
part shall establish and maintain records of significant adverse 
reactions alleged to have been caused by chemical substances or mixtures 
manufactured or processed by the firm. Such records shall be kept at the 
firm's headquarters or at any other appropriate location central to the 
firm's chemical operations.
    (b) Content of records. The record shall consist of the following:
    (1) The original allegation as received.
    (2) An abstract of the allegation and other pertinent information as 
follows:
    (i) The name and address of the plant site which received the 
allegation.

[[Page 93]]

    (ii) The date the allegation was received at that site.
    (iii) The implicated substance, mixture, article, company process or 
operation, or site discharge.
    (iv) A description of the alleger (e.g., ``company employee,'' 
``individual consumer,'' ``plant neighbor''). If the allegation involves 
a health effect, the sex and year of birth of the individual should be 
recorded, if ascertainable.
    (v) A description of the alleged health effect(s). The description 
must relate how the effect(s) became known and the route of exposure, if 
explained in the allegation.
    (vi) A description of the nature of the alleged environmental 
effect(s), identifying the affected plant and/or animal species, or 
contaminated portion of the physical environment.
    (3) The results of any self-initiated investigation with respect to 
an allegation. (EPA does not require persons subject to this part to 
investigate allegations received, and no provision of this part shall be 
construed to imply that EPA recommends, encourages or requires such 
investigation.)
    (4) Copies of any further required records or reports relating to 
the allegation. For example, if an employee allegation results in a 
requirement for the firm to record the case on Occupational Safety and 
Health Form 101 or appropriate substitute (see 29 CFR part 1904 for 
requirements under the Occupational Safety and Health Act of 1970), a 
copy of that OSHA record must be included in the allegation record.
    (c) File structure. Records must be retrievable by the alleged cause 
of the significant adverse reaction, which cause may be one of the 
following:
    (1) A specific chemical identity.
    (2) A mixture.
    (3) An article.
    (4) A company process or operation.
    (5) A site emission, effluent or other discharge.
    (d) Retention period. Records of significant adverse reactions to 
the health of employees shall be retained for a period of 30 years from 
the date such reactions were first reported to or known by the person 
maintaining such records. This provision requires persons subject to 
this part to retain for 30 years an employee health related allegation, 
arising from any employment related exposure, whether or not such 
allegation was submitted by or on the behalf of that recordkeeper's own 
employee. Any other record of significant adverse reactions shall be 
maintained for a period of five years from the date the information 
contained in the record was first reported to or known by the person 
maintaining the record.
    (e) Transfer of records. (1) If a firm ceases to do business, the 
successor must receive and keep all the records that must be kept under 
this part.
    (2) If a firm ceases to do business and there is no successor to 
receive and keep the records for the prescribed period, these records 
must be transmitted to EPA. See Sec. 717.17(c) for the address to which 
such records must be sent.

[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 
FR 34204, June 23, 1993]



Sec. 717.17  Inspection and reporting requirements.

    (a) Inspection. Firms must make records of allegations available for 
inspection by any duly designated representative of the Administrator.
    (b) Reporting. Each person who is required to keep records under 
this part must submit copies of those records to the Agency as required 
by the EPA Administrator or appropriate designee. EPA will notify those 
responsible for reporting by letter or will announce any such 
requirements for submitting copies of records by a notice in the Federal 
Register. Such letter or notice will be signed by the Administrator or 
appropriate designee, and will specify which records or portion of 
records must be submitted. The reporting period will be specified by the 
letter or notice but in no case will such reporting period be less than 
45 days from the date of the letter or the effective date of the notice.
    (c) How to report. When required to report, firms must submit copies 
of records (preferably by certified mail) to the Document Control Office 
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, Room G-099, 401 M St., SW.,

[[Page 94]]

Washington, DC., 20460, ATTN: 8(c) Allegations.

[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 
FR 20084, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 
23, 1993; 60 FR 34464, July 3, 1995]



Sec. 717.19  Confidentiality.

    (a) Any person submitting copies of records may assert a business 
confidentiality claim covering all or part of the submitted information. 
Any information covered by a claim will be disclosed by EPA only as 
provided in procedures set forth at part 2 of this title.
    (b) If no claim accompanies a document at the time it is submitted 
to EPA, the document will be placed in an open file available to the 
public without further notice to the respondent.
    (c) To asset a claim of confidentiality for information contained in 
a submitted record, the respondent must submit two copies of the 
document.
    (1) One copy must be complete. In that copy, the respondent must 
indicate what information, if any, is claimed as confidential by marking 
the specific information on each page with a label such as 
``confidential'', ``proprietary'', or ``trade secret'' and briefly state 
the basis of the claim.
    (2) If some information is claimed as confidential, the respondent 
must submit a second copy of the record. The second copy must be 
complete, except that all information claimed as confidential in the 
first copy must be deleted.
    (3) The first copy will be for internal use by EPA. The second copy 
will be placed in an open file to be available to the public.
    (4) Failure to furnish a second copy when information is claimed as 
confidential in the first copy will be considered a presumptive waiver 
of the claim of confidentiality. EPA will notify the respondent by 
certified mail that a finding of a presumptive waiver of the claim of 
confidentiality has been made. The respondent will be given 30 days from 
the date of receipt of notification to submit the required second copy. 
If the respondent fails to submit the second copy within the 30 days, 
EPA will place the first copy in the public file.



PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents




                      Subpart A--General Provisions

Sec.
720.1  Scope.
720.3  Definitions.

                        Subpart B--Applicability

720.22  Persons who must report.
720.25  Determining whether a chemical substance is on the Inventory.
720.30  Chemicals not subject to notification requirements.
720.36  Exemption for research and development.
720.38  Exemptions for test marketing.

                         Subpart C--Notice Form

720.40  General.
720.45  Information that must be included in the notice form.
720.50  Submission of test data and other data concerning the health and 
          environmental effects of a substance.
720.57  Imports.

                    Subpart D--Disposition of Notices

720.60  General.
720.62  Notice that notification is not required.
720.65  Acknowledgment of receipt of a notice; errors in the notice; 
          incomplete submissions; false and misleading statements.
720.70  Notice in the Federal Register.
720.75  Notice review period.
720.78  Recordkeeping.

       Subpart E--Confidentiality and Public Access to Information

720.80  General provisions.
720.85  Chemical identity.
720.87  Categories or proposed categories of uses of a new chemical 
          substance.
720.90  Data from health and safety studies.
720.95  Public file.

            Subpart F--Commencement of Manufacture or Import

720.102  Notice of commencement of manufacture or import.

                  Subpart G--Compliance and Inspections

720.120  Compliance.
720.122  Inspections.

    Authority: 15 U.S.C. 2604, 2607, and 2613.

    Source: 48 FR 21742, May 13, 1983, unless otherwise noted.

[[Page 95]]



                      Subpart A--General Provisions



Sec. 720.1  Scope.

    This part establishes procedures for the reporting of new chemical 
substances by manufacturers and importers under section 5 of the Toxic 
Substances Control Act, 15 U.S.C. 2604. This part applies to 
microorganisms only to the extent provided by part 725 of this chapter. 
The rule defines the persons and chemical substances subject to the 
reporting requirements, prescribes the contents of section 5 notices, 
and establishes procedures for submitting notices. The rule also 
establishes EPA policy regarding claims of confidentiality for, and 
public disclosure of, various categories of information submitted in 
connection with section 5 notices.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 62 
FR 17932, April 11, 1997]



Sec. 720.3  Definitions.

    (a)(1) For the purposes of this part, the terms cosmetic, device, 
drug, food, and food additive have the meanings contained in the Federal 
Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations 
issued under it. In addition, the term ``food'' includes poultry and 
poultry products, as defined in the Poultry Products Inspection Act, 21 
U.S.C. 453 et seq.; meats and meat food products, as defined in the 
Federal Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg 
products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 
et seq.
    (2) The term pesticide has the meaning contained in the Federal 
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and 
the regulations issued under it.
    (3) The terms byproduct material, source material, and special 
nuclear material have the meanings contained in the Atomic Energy Act of 
1954, 42 U.S.C 2014 et seq. and the regulations issued under it.
    (b) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.
    (c) Article means a manufactured item (1) which is formed to a 
specific shape or design during manufacture, (2) which has end use 
function(s) dependent in whole or in part upon its shape or design 
during end use, and (3) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the article and 
that may occur as described in Sec. 720.36(g)(5), except that fluids and 
particles are not considered articles regardless of shape or design.
    (d) Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance or mixture.
    (e) Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical, except that ``chemical substance'' does not include:
    (1) Any mixture.
    (2) Any pesticide when manufactured, processed, or distributed in 
commerce for use as a pesticide.
    (3) Tobacco or any tobacco product.
    (4) Any source material, special nuclear material, or byproduct 
material.
    (5) Any pistol, firearm, revolver, shells, or cartridges.
    (6) Any food, food additive, drug, cosmetic, or device, when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    (f) Commerce means trade, traffic, transportation, or other commerce 
(1) between a place in a State and any place outside of such State, or 
(2) which affects trade, traffic, transportation, or commerce between a 
place in a State and any place outside of such State.
    (g) Customs territory of the United States means the 50 States, 
Puerto Rico, and the District of Columbia.
    (h) Director means the Director of the EPA Office of Pollution 
Prevention and Toxics.
    (i) Distribute in commerce means to sell in commerce, to introduce 
or deliver for introduction into commerce, or to hold after introduction 
into commerce.
    (j) EPA means the U.S. Environmental Protection Agency.

[[Page 96]]

    (k) Health and safety study or study means any study of any effect 
of a chemical substance or mixture on health or the environment or on 
both, including underlying data and epidemiological studies, studies of 
occupational exposure to a chemical substance or mixture, toxicological, 
clinical, and ecological, or other studies of a chemical substance or 
mixture, and any test performed under the Act. Chemical identity is 
always part of a health and safety study.
    (1) Not only is information which arises as a result of a formal, 
disciplined study included, but other information relating to the 
effects of a chemical substance or mixture on health or the environment 
is also included. Any data that bear on the effects of a chemical 
substance on health or the environment would be included.
    (2) Examples include:
    (i) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; data on behavioral disorders; dermatoxicity; 
pharmacological effects; mammalian absorption, distribution, metabolism, 
and excretion; cumulative, additive, and synergistic effects; acute, 
subchronic, and chronic effects; and structure/activity analyses.
    (ii) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including: Acute 
toxicity tests, chronic toxicity tests, critical life stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular chemical substance or 
mixture on the environment, including surveys, tests, and studies of: 
Biological, photochemical, and chemical degradation; air, water, and 
soil transport; biomagnification and bioconcentration; and chemical and 
physical properties, e.g., boiling point, vapor pressure, evaporation 
rates from soil and water, octanol/water partition coefficient, and 
water solubility.
    (iv) Monitoring data, when they have been aggregated and analyzed to 
measure the exposure of humans or the environment to a chemical 
substance or mixture.
    (v) Any assessments of risk to health and the environment resulting 
from the manufacture, processing, distribution in commerce, use, or 
disposal of the chemical substance.
    (l) Importer means any person who imports a chemical substance, 
including a chemical substance as part of a mixture or article, into the 
customs territory of the United States. ``Importer'' includes the person 
primarily liable for the payment of any duties on the merchandise or an 
authorized agent acting on his or her behalf. The term also includes, as 
appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20; or
    (4) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144. (See ``principal importer.'')
    (m) Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    (n) Intermediate means any chemical substance that is consumed, in 
whole or in part, in chemical reactions used for the intentional 
manufacture of another chemical substance(s) or mixture(s), or that is 
intentionally present for the purpose of altering the rates of such 
chemical reactions.
    (o) Inventory means the list of chemical substances manufactured or 
processed in the United States that EPA compiled and keeps current under 
section 8(b) of the Act.
    (p) Known to or reasonably ascertainable by means all information in 
a person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    (q) Manufacture means to produce or manufacture in the United States 
or import into the customs territory of the United States.
    (r) Manufacture or import for commercial purposes means:
    (1) To import, produce, or manufacture with the purpose of obtaining 
an

[[Page 97]]

immediate or eventual commercial advantage for the manufacturer or 
importer, and includes, among other things, ``manufacture'' of any 
amount of a chemical substance or mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development or as an intermediate.
    (2) The term also applies to substances that are produced 
coincidentally during the manufacture, processing, use, or disposal of 
another substance or mixture, including byproducts that are separated 
from that other substance or mixture and impurities that remain in that 
substance or mixture. Byproducts and impurities without separate 
commercial value are nonetheless produced for the purpose of obtaining a 
commercial advantage, since they are part of the manufacture of a 
chemical substance for commercial purposes.
    (s) Manufacture solely for export means to manufacture or import for 
commercial purposes a chemical substance solely for export from the 
United States under the following restrictions on activities in the 
United States:
    (1) Distribution in commerce is limited to purposes of export or 
processing solely for export as defined in Sec. 721.3 of this chapter.
    (2) The manufacturer or importer, and any person to whom the 
substance is distributed for purposes of export or processing solely for 
export (as defined in Sec. 721.3 of this chapter), may not use the 
substance except in small quantities solely for research and development 
in accordance with Sec. 720.36.
    (t) Manufacturer means a person who imports, produces, or 
manufactures a chemical substance. A person who extracts a component 
chemical substance from a previously existing chemical substance or a 
complex combination of substances is a manufacturer of that component 
chemical substance. A person who contracts with a manufacturer to 
manufacture or produce a chemical substance is also a manufacturer if 
(1) the manufacturer manufactures or produces the substance exclusively 
for that person, and (2) that person specifies the identity of the 
substance and controls the total amount produced and the basic 
technology for the plant process.
    (u) Mixture means any combination of two or more chemical substances 
if the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except ``mixture'' does include 
(1) any combination which occurs, in whole or in part, as a result of a 
chemical reaction if the combination could have been manufactured for 
commercial purposes without a chemical reaction at the time the chemical 
substances comprising the combination were combined, and if all of the 
chemical substances comprising the combination are not new chemical 
substances, and (2) hydrates of a chemical substance or hydrated ions 
formed by association of a chemical substance with water, so long as the 
nonhydrated form is itself not a new chemical substance.
    (v) New chemical substance means any chemical substance which is not 
included on the Inventory.
    (w) Nonisolated intermediate means any intermediate that is not 
intentionally removed from the equipment in which it is manufactured, 
including the reaction vessel in which it is manufactured, equipment 
which is ancillary to the reaction vessel, and any equipment through 
which the chemical substance passes during a continuous flow process, 
but not including tanks or other vessels in which the substance is 
stored after its manufacture.
    (x) Person means any natural person, firm, company, corporation, 
joint-venture, partnership, sole proprietorship, association, or any 
other business entity, any State or political subdivision thereof, any 
municipality, any interstate body, and any department, agency or 
instrumentality of the Federal Government.
    (y) Possession or control means in possession or control of the 
submitter, or of any subsidiary, partnership in which the submitter is a 
general partner, parent company, or any company or partnership which the 
parent company owns or controls, if the subsidiary, parent company, or 
other company or partnership is associated with the submitter in the 
research, development,

[[Page 98]]

test marketing, or commercial marketing of the chemical substance in 
question. (A parent company owns or controls another company if the 
parent owns or controls 50 percent or more of the other company's voting 
stock. A parent company owns or controls any partnership in which it is 
a general partner). Information is included within this definition if it 
is:
    (1) In files maintained by submitter's employees who are:
    (i) Associated with research, development, test marketing, or 
commercial marketing of the chemical substance in question.
    (ii) Reasonably likely to have such data.
    (2) Maintained in the files of other agents of the submitter who are 
associated with research, development, test marketing, or commercial 
marketing of the chemical substance in question in the course of their 
employment as such agents.
    (z) Principal importer means the first importer who, knowing that a 
new chemical substance will be imported rather than manufactured 
domestically, specifies the identity of the chemical substance and the 
total amount to be imported. Only persons who are incorporated, 
licensed, or doing business in the United States may be principal 
importers.
    (aa) Process means the preparation of a chemical substance or 
mixture, after its manufacture, for distribution in commerce (1) in the 
same form or physical state as, or in a different form or physical state 
from, that in which it was received by the person so preparing such 
substance or mixture, or (2) as part of a mixture or article containing 
the chemical substance or mixture.
    (bb) Processor means any person who processes a chemical substance 
or mixture.
    (cc) Small quantities solely for research and development (or 
``small quantities solely for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including such research or analysis for the 
development of a product'') means quantities of a chemical substance 
manufactured, imported, or processed or proposed to be manufactured, 
imported, or processed solely for research and development that are not 
greater than reasonably necessary for such purposes.
    (dd) State means any State of the United States and the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, the Northern Mariana Islands, and any other 
territory or possession of the United States.
    (ee) Technically qualified individual means a person or persons (1) 
who, because of education, training, or experience, or a combination of 
these factors, is capable of understanding the health and environmental 
risks associated with the chemical substance which is used under his or 
her supervision, (2) who is responsible for enforcing appropriate 
methods of conducting scientific experimentation, analysis, or chemical 
research to minimize such risks, and (3) who is responsible for the 
safety assessments and clearances related to the procurement, storage, 
use, and disposal of the chemical substance as may be appropriate or 
required within the scope of conducting a research and development 
activity.
    (ff) Test data means data from a formal or informal test or 
experiment, including information concerning the objectives, 
experimental methods and materials, protocols, results, data analyses, 
recorded observations, monitoring data, measurements, and conclusions 
from a test or experiment.
    (gg) Test marketing means the distribution in commerce of no more 
than a predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor, to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture, or article in commerce.
    (hh) United States, when used in the geographic sense, means all of 
the States.

[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986]

[[Page 99]]



                        Subpart B--Applicability



Sec. 720.22  Persons who must report.

    (a)(1) Any person who intends to manufacture a new chemical 
substance in the United States for commercial purposes must submit a 
notice unless the substance is excluded under Sec. 720.30.
    (2) If a person contracts with a manufacturer to manufacture or 
produce a new chemical substance, and (i) the manufacturer manufactures 
or produces the substance exclusively for that person, and (ii) that 
person specifies the identity of the substance, and controls the total 
amount produced and the basic technology for the plant process, that 
person must submit the notice. If it is unclear who must report, EPA 
should be contacted to determine who must submit the notice.
    (3) Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a notice.
    (b)(1) Any person who intends to import a new chemical substance 
into the United States for commercial purposes must submit a notice, 
unless the substance is excluded under Sec. 720.30 or unless the 
substance is imported as part of an article.
    (2) When several persons are involved in an import transaction, the 
notice must be submitted by the principal importer. If no one person 
fits the principal importer definition in a particular transaction, the 
importer should contact EPA to determine who must submit the notice for 
that transaction.



Sec. 720.25  Determining whether a chemical substance is on the Inventory.

    (a) A new chemical substance is any chemical substance that is not 
currently listed on the Inventory.
    (b)(1) A chemical substance is listed in the public portion of the 
Inventory by a specific chemical name (either a Chemical Abstracts (CA) 
Index Name or a CA Preferred Name) and a Chemical Abstracts Service 
(CAS) Registry Number if its identity is not confidential. If its 
identity is confidential, it is listed in the public portion of the 
Inventory by a TSCA Accession Number and a generic chemical name that 
masks the specific substance identity. The confidential substance is 
listed by its specific chemical name only in the confidential portion of 
the Inventory, which is not available to the public. A person who 
intends to manufacture or import a chemical substance not listed by 
specific chemical name in the public portion of the Inventory may ask 
EPA whether the substance is included in the confidential Inventory. EPA 
will answer such an inquiry only if EPA determines that the person has a 
bona fide intent to manufacture or import the chemical substance for 
commercial purposes.
    (2) To establish a bona fide intent to manufacture or import a 
chemical substance, the person who proposes to manufacture or import the 
substance must submit to EPA:
    (i) Except as provided in paragraphs (b)(3) (i) and (ii) of this 
section, the specific chemical identity of the substance that the person 
intends to manufacture or import, using the currently, correct CA name 
for the substance and the other correct chemical identity information in 
accordance with Secs. 720.45(a) (1), (2), and (3).
    (ii) A signed statement that the person intends to manufacture or 
import that chemical substance for commercial purposes.
    (iii)(A) A brief description of the research and development 
activities conducted to date related to the substance, including the 
year in which the person first started to conduct research or 
development activity on the substance, and the general types of research 
and development activities conducted thus far (e.g., synthesis, 
substance isolation/purification, formulating, product development, 
process development, end-use application, toxicity testing, etc.). The 
person must also indicate whether any pilot plant or production-scale 
plant evaluations have been conducted involving the manufacture or 
processing of the substance.
    (B) If an importer is unable to provide the information requested in 
paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer 
or supplier, the following information shall be submitted:

[[Page 100]]

    (1) A brief statement indicating how long the substance has been in 
commercial use outside of the United States.
    (2) The name of a country in which it has been commercially used.
    (3) Whether the importer believes that the substance has already 
been used commercially, in any country, for the same purpose or 
application that the importer is intending.
    (iv) A specific description of the major intended application or use 
of the substance.
    (v) An infrared spectrum of the substance, or alternative spectra or 
other data which identify the substance if infrared analysis is not 
suitable for the substance or does not yield a reasonable amount of 
structural information. When using alternative spectra or instrumental 
analysis, the person must submit a spectrum or instrumental readout for 
the substance.
    (vi) The estimated date (month/year) in which the person intends to 
submit a Premanufacture Notice (PMN) for this substance if EPA informs 
the notice submitter that the substance is not on the Inventory.
    (vii) The address of the facility under the control of the submitter 
at which the manufacture or processing of the substance would most 
likely occur. For an imported substance, the facility under the control 
of the importer at which processing of the substance would likely occur, 
if any.
    (viii)(A) For substances intended to be manufactured in the United 
States, a description of the most probable manufacturing process that 
would be used by the submitter to produce the substance for non-exempt 
commercial purposes.
    (B) For substances intended to be imported, a brief description of 
how the submitter is most likely to process or use the substance for a 
commercial purpose. If the substance is not expected to be processed or 
used at any facility under the importer's control, a statement to this 
effect must be included along with a description of how the substance 
will be processed or used at sites controlled by others, if this 
information is known or reasonably ascertainable.
    (3)(i) If an importer cannot provide the chemical identity 
information required by paragraph (b)(2) (i) and (v) of this section 
because it is claimed confidential by its foreign manufacturer or 
supplier, the foreign manufacturer or supplier must supply the required 
information directly to EPA in accordance with Sec. 720.45(a) (1), (2), 
and (3) and reference the importer's notice. If the appropriate 
supporting document from the foreign party is not received within 30 
days after EPA receives the importer's notice, the notice will be 
considered incomplete.
    (ii) If a manufacturer cannot provide all of the required 
information in accordance with Sec. 720.45(a) (1), (2), and (3) because 
the new chemical substance is manufactured using a reactant that has a 
specific chemical identity claimed as confidential by its supplier, the 
notice must contain chemical identity information that is as complete as 
known by the manufacturer. In addition, a letter of support for the 
notice must then be sent to EPA by the chemical supplier of the 
confidential reactant, providing the specific chemical identity of the 
proprietary reactant. The letter of support must reference the 
manufacturer's notice. If the appropriate supporting document from the 
supplier is not received within 30 days after EPA receives the 
manufacturer's notice, the notice will be considered incomplete.
    (4) EPA will review the information submitted by the proposed 
manufacturer or importer under this paragraph to determine whether it 
has a bona fide intent to manufacture or import the chemical substance. 
If necessary, EPA will compare this information either to the 
information requested for the confidential chemical substance under 
Sec. 710.7(e)(2)(v) of this chapter or the information requested under 
Sec. 720.85(b)(3)(iii).
    (5) If the proposed manufacturer or importer has shown a bona fide 
intent to manufacture or import the substance, and provide sufficient 
unambiguous chemical identity information so

[[Page 101]]

EPA can make a conclusive determination of the chemical substance's 
Inventory status, EPA will search the confidential Inventory and inform 
the proposed manufacturer or importer whether the chemical substance is 
on the confidential Inventory.
    (6) If the chemical substance is found on the confidential 
Inventory, EPA will notify the person(s) who originally reported the 
chemical substance that another person has demonstrated a bona fide 
intent to manufacture or import the substance and therefore was told 
that the chemical substance is on the Inventory.
    (7) A disclosure of a confidential chemical identity to a person 
with a bona fide intent to manufacture or import the particular chemical 
substance will not be considered a public disclosure of confidential 
business information under section 14 of the Act.
    (8) EPA will answer an inquiry on whether a particular chemical 
substance is on the confidential Inventory within 30 days after receipt 
of a complete submission under paragraph (b)(2) of this section.
    (9) If the required chemical identity information has not been 
reported correctly or completely in the notice (except as provided under 
paragraph (b)(3)(ii) of this section) or if any other required data or 
information has been omitted or is incomplete, EPA will consider the 
whole notice to be incomplete. As soon as an incomplete notice is 
identified as such by EPA, the Agency will immediately return the notice 
directly to the submitter. The submitter must then resubmit the whole, 
completed bona fide notice to EPA in order to have the Agency perform 
the desired Inventory search and respond to the notice.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 
FR 16309, Mar. 29, 1995]



Sec. 720.30  Chemicals not subject to notification requirements.

    The following substances are not subject to the notification 
requirements of this part:
    (a) Any substance which is not a ``chemical substance'' as defined 
in Sec. 720.3(e).
    (b) Any mixture as defined in Sec. 720.3(u).1
---------------------------------------------------------------------------

    \1\ A new chemical substance that is manufactured or imported as 
part of a mixture is subject to the requirements of this part. This 
exclusion applies only to a mixture as a whole and not to any chemical 
substances which are part of the mixture.
---------------------------------------------------------------------------

    (c) Any new chemical substance which will be manufactured or 
imported in small quantities solely for research and development under 
Sec. 720.36.
    (d) Any new chemical substance which will be manufactured or 
imported solely for test-marketing purposes under an exemption granted 
under Sec. 720.38.
    (e) Any new chemical substance manufactured solely for export if, 
when the substance is distributed in commerce:
    (1) The substance is labeled in accordance with section 12(a)(1)(B) 
of the Act.
    (2) The manufacturer knows that the person to whom the substance is 
being distributed intends to export it or process it solely for export 
as defined in Sec. 721.3 of this chapter.
    (f) Any new chemical substance which is manufactured or imported 
under the terms of a rule promulgated under section 5(h)(4) of the Act.
    (g) Any byproduct if its only commercial purpose is for use by 
public or private organizations that (1) burn it as a fuel, (2) dispose 
of it as a waste, including in a landfill or for enriching soil, or (3) 
extract component chemical substances from it for commercial purposes. 
(This exclusion only applies to the byproduct; it does not apply to the 
component substances extracted from the byproduct.)
    (h) The chemical substances described below: (Although they are 
manufactured for commercial purposes under the Act, they are not 
manufactured for distribution in commerce as chemical substances per se 
and have no commercial purpose separate from the substance, mixture, or 
article of which they are a part.)
    (1) Any impurity.
    (2) Any byproduct which is not used for commercial purposes.
    (3) Any chemical substance which results from a chemical reaction 
that occurs incidental to exposure of another chemical substance, 
mixture, or article

[[Page 102]]

to environmental factors such as air, moisture, microbial organisms, or 
sunlight.
    (4) Any chemical substance which results from a chemical reaction 
that occurs incidental to storage or disposal of another chemical 
substance, mixture, or article.
    (5) Any chemical substance which results from a chemical reaction 
that occurs upon end use of another chemical substance, mixture, or 
article such as an adhesive, paint, miscellaneous cleanser or other 
housekeeping product, fuel additive, water softening and treatment 
agent, photographic film, battery, match, or safety flare, and which is 
not itself manufactured or imported for distribution in commerce or for 
use as an intermediate.
    (6) Any chemical substance which results from a chemical reaction 
that occurs upon use of curable plastic or rubber molding compounds, 
inks, drying oils, metal finishing compounds, adhesives, or paints, or 
any other chemical substance formed during the manufacture of an article 
destined for the marketplace without further chemical change of the 
chemical substance except for those chemical changes that occur as 
described elsewhere in this paragraph.
    (7) Any chemical substance which results from a chemical reaction 
that occurs when (i) a stabilizer, colorant, odorant, antioxidant, 
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, 
antifoamer or defoamer, dispersant, precipitation inhibitor, binder, 
emulsifier, deemulsifier, dewatering agent, agglomerating agent, 
adhesion promoter, flow modifier, pH neutralizer, sequesterant, 
coagulant, flocculant, fire retardant, lubricant, chelating agent, or 
quality control reagent functions as intented, or (ii) a chemical 
substance, which is intended solely to impart a specific physiochemical 
characteristic, functions as intended.
    (8) Any nonisolated intermediate.
    (i) Any chemical substance which is manufactured solely for non-
commercial research and development purposes. Non-commercial research 
and development purposes include scientific experimentation, research, 
or analysis conducted by academic, government, or independent not-for-
profit research organizations (e.g., universities, colleges, teaching 
hospitals, and research institutes), unless the activity is for eventual 
commercial purposes.

[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986]



Sec. 720.36  Exemption for research and development.

    (a) This part does not apply to a chemical substance if the 
following conditions are met:
    (1) The chemical substance is manufactured or imported only in small 
quantities solely for research and development.
    (2) The manufacturer or importer notifies all persons in its employ 
or to whom it directly distributes the chemical substance, who are 
engaged in experimentation, research, or analysis on the chemical 
substance, including the manufacture, processing, use, transport, 
storage, and disposal of the substance associated with research and 
development activities, of any risk to health, identified under 
paragraph (b) of this section, which may be associated with the 
substance. The notification must be made in accordance with paragraph 
(c) of this section.
    (3) The chemical substance is used by, or directly under the 
supervision of, a technically qualified individual.
    (b)(1) To determine whether notification under paragraph (a)(2) of 
this section is required, the manufacturer or importer must review and 
evaluate the following information to determine whether there is reason 
to believe there is any potential risk to health which may be associated 
with the chemical substance:
    (i) Information in its possession or control concerning any 
significant adverse reaction by persons exposed to the chemical 
substance which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer or importer by a 
supplier or any other person concerning a health risk believed to be 
associated with the substance.
    (iii) Health and environmental effects data in its possession or 
control concerning the substance.

[[Page 103]]

    (iv) Information on health effects which accompanies any EPA rule or 
order issued under sections 4, 5, or 6 of the Act that applies to the 
substance and of which the manufacturer or importer has knowledge.
    (2) When the research and development activity is conducted solely 
in a laboratory and exposure to the chemical substance is controlled 
through the implementation of prudent laboratory practices for handling 
chemical substances of unknown toxicity, and any distribution, except 
for purposes of disposal, is to other such laboratories for further 
research and development activity, the information specified in 
paragraph (b)(1) of this section need not be reviewed and evaluated. 
(For purposes of this paragraph, a laboratory is a contained research 
facility where relatively small quantities of chemical substances are 
used on a non-production basis, and where activities involve the use of 
containers for reactions, transfers, and other handling of substances 
designed to be easily manipulated by a single individual.)
    (c)(1) The manufacturer or importer must notify the persons 
identified in paragraph (a)(2) of this section by means of a container 
labeling system, conspicuous placement of notices in areas where 
exposure may occur, written notification to each person potentially 
exposed, or any other method of notification which adequately informs 
persons of health risks which the manufacturer or importer has reason to 
believe may be associated with the substance, as determined under 
paragraph (b)(1) of this section.
    (2) If the manufacturer or importer distributes a chemical substance 
manufactured or imported under this section to persons not in its 
employ, the manufacturer or importer must in written form:
    (i) Notify those persons that the substance is to be used only for 
research and development purposes.
    (ii) Provide the notice of health risks specified in paragraph 
(c)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer or importer.
    (d) A chemical substance is not exempt from reporting under this 
part if any amount of the substance, including as part of a mixture, is 
processed, distributed in commerce, or used, for any commercial purpose 
other than research and development, except where the chemical substance 
is processed, distributed in commerce, or used only as an impurity or as 
part of an article.
    (e) Quantities of the chemical substance, or of mixtures or articles 
containing the chemical substance, remaining after completion of 
research and development activities may be:
    (1) Disposed of as a waste in accordance with applicable Federal, 
state, and local regulations, or
    (2) Used for the following commercial purposes:
    (i) Burning it as a fuel.
    (ii) Reacting or otherwise processing it to form other chemical 
substances for commercial purposes, including extracting component 
chemical substances.
    (f) Quantities of research and development substances existing 
solely as impurities in a product or incorporated into an article, in 
accordance with paragraph (d) of this section, and quantities of 
research and development substances used solely for commercial purposes 
listed in paragraph (e) of this section, are not subject to the 
requirements of paragraphs (a), (b), and (c) of this section, once 
research and development activities have been completed.
    (g) A person who manufactures or imports a chemical substance in 
small quantities solely for research and development is not required to 
comply with the requirements of this section if the person's exclusive 
intention is to perform research and development activities solely for 
the purpose of determining whether the substance can be used as a 
pesticide.

[51 FR 15102, Apr. 22, 1986]



Sec. 720.38  Exemptions for test marketing.

    (a) Any person may apply for an exemption to manufacture or import a 
new chemical substance for test marketing. EPA may grant the exemption 
if the person demonstrates that the chemical substance will not present 
an unreasonable risk to injury to health or the environment as a result 
of the test marketing.

[[Page 104]]

    (b) Persons applying for a test-marketing exemption should provide 
the following information:
    (1) All existing data regarding health and environmental effects of 
the chemical substance, including physical/chemical properties or, in 
the absence of such data, a discussion of toxicity based on structure-
activity relationships (SAR) and relevant data on chemical analogues.
    (2) The maximum quantity of the chemical substance which the 
applicant will manufacture or import for test marketing.
    (3) The maximum number of persons who may be provided the chemical 
substance during test marketing.
    (4) The maximum number of persons who may be exposed to the chemical 
substance as a result of test marketing, including information regarding 
duration and route of such exposures.
    (5) A description of the test-marketing activity, including its 
length and how it can be distinguished from full-scale commercial 
production and research and development.
    (c) In accordance with section 5(h)(6) of the Act, after EPA 
receives an application for exemption under this section, the Agency 
will file with the Office of the Federal Register a notice containing a 
summary of the information provided in the application, to the extent it 
has not been claimed confidential.
    (d) No later than 45 days after EPA receives an application, the 
Agency will either approve or deny the application. Thereafter, EPA will 
publish a notice in the Federal Register explaining the reasons for 
approval or denial.
    (e) In approving an application for exemption, EPA may impose any 
restrictions necessary to ensure that the substance will not present an 
unreasonable risk of injury to health and the environment as a result of 
test marketing.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]



                         Subpart C--Notice Form



Sec. 720.40  General.

    (a) Use of the notice form; electronic submissions. (1) Each person 
who is required by subpart B of this part to submit a notice must 
complete, sign, and submit a notice containing the information in the 
form and manner specified in this paragraph. The information submitted 
and all attachments (unless the attachment appears in the open 
scientific literature) must be in English. All information submitted 
must be true and correct.
    (2) Information may be submitted on paper, or electronically, as 
follows:
    (i) Information submitted on paper must be submitted in the form and 
manner set forth in EPA Form No. 7710-25, which is available from the 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Information which is not submitted on the EPA Form No. 7710-25 
or a photocopy thereof (e.g., on a form created by commercial form-
making software) must be in a format pre-approved by the Agency.
    (ii) Information may be submitted electronically (on magnetic or 
other media) pursuant to an EPA published format for electronic 
submissions. Such submissions must comply with this format and all other 
media specifications published by EPA. Persons submitting electronically 
must still complete and submit on paper the Certification and Submitter 
Identification sections of Form 7710-25.
    (b) When to submit a notice. Each person who is required to submit a 
notice must submit the notice at least 90 calendar days before 
manufacture or import of the new chemical substance for commercial 
purposes begins.
    (c) Where to submit a notice. Each person who submits a notice must 
submit it to the address listed on the notice form.
    (d) General notice requirements. (1) Each person who submits a 
notice must provide the information described in Sec. 720.45 and 
specified on the notice form, to the extent such information is

[[Page 105]]

known to or reasonably ascertainable by the person. In accordance with 
Sec. 720.50, the notice must also include any test data in the person's 
possession or control, and descriptions of other data which are known to 
or reasonably ascertainable by the person and which concern the health 
and environmental effects of the new chemical substance.
    (2) A person who submits a notice to EPA under this part must 
provide EPA with an original and two complete copies of the notice, 
including all test data and any other information attached to the notice 
form. If information is claimed as confidential pursuant to Sec. 720.80, 
a sanitized copy must also be provided.
    (e) Agency or joint submissions. (1) A manufacturer or importer may 
designate an agent to submit the notice. Both the manufacturer or 
importer and the agent must sign the certification on the form.
    (2) A manufacturer or importer may authorize another person, (e.g., 
a foreign manufacturer or supplier, or a toll manufacturer) to report 
some of the information required in the notice to EPA on its behalf. If 
separate portions of a joint notice are not submitted together, the 
submitter should indicate which information will be supplied by another 
person and identify that person. The other person must submit the 
information on the appropriate part of the notice form. The manufacturer 
or importer and any other person supplying the information must sign the 
certification provided on their respective notice forms.
    (3) If EPA receives a submission which does not include information 
required by this rule, which the submitter indicates that it has 
authorized another person to provide, the notice review period will not 
begin until EPA receives that information.
    (f) New information. During the notice review period, if the 
submitter possesses, controls, or knows of new information that 
materially adds to, changes, or otherwise makes significantly more 
complete the information included in the notice, the submitter must that 
information to the address listed on the notice form within ten days of 
receiving the new information, but no later than five days before the 
end of the notice review period. The new submission must clearly 
identify the submitter and the notice to which the new information is 
related. If the new information becomes available during the last five 
days of the notice review period, the submitter must immediately inform 
its EPA contract for that notice by telephone.
    (g) Chemical substances subject to a section 4 test rule. (1) Except 
as provided in paragraph (g)(3) of this section, if (i) A person intends 
to manufacture or import a new chemical substance which is subject to 
the notification requirements of this part, and (ii) The chemical 
substance is subject to a test rule promulgated under section 4 of the 
Act before the notice is submitted, section 5(b)(1) of the Act requires 
the person to submit the test data required by the testing rule with the 
notice. The person must submit the data in the form and manner specified 
in the test rule and in accordance with Sec. 720.50. If the person does 
not submit the test data, the submission is incomplete and EPA will 
follow the procedures in Sec. 720.65.
    (2) If EPA has granted the submitter an exemption under section 4(c) 
of the Act from the requirement to conduct tests and submit data, the 
submitter may not submit a notice until EPA receives the test data.
    (3) If EPA has granted the submitter an exemption under section 4(c) 
of the Act and if another person previously has submitted the test data 
to EPA, the exempted person may either submit the test data or provide 
the following information as part of the notice:
    (i) The name, title, and address of the person who submitted the 
test data to EPA.
    (ii) The date the test data were submitted to EPA.
    (iii) A citation for the test rule.
    (iv) A description of the exemption and a reference identifying it.
    (h) Chemical substances subject to a section 5(b)(4) rule. (1) If a 
person (i) intends to manufacture or import a new chemical substance 
which is subject to the notification requirements of this part and which 
is subject to a rule issued under section 5(b)(4) of the Act; and (ii) 
is not required by a rule issued under section 4 of the Act to submit

[[Page 106]]

test data for the substance before the submission of a notice, the 
person must submit to EPA data described in paragraph (h)(2) of this 
section at the time the notice is submitted.
    (2) Data submitted under paragraph (h)(1) of this section must be 
data which the person submitting the notice believes show that the 
manufacture, processing, distribution in commerce, use and disposal of 
the substance, or any combination of such activities, will not present 
an unreasonable risk of injury to health or the environment.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 
FR 16309, Mar. 29, 1995]



Sec. 720.45  Information that must be included in the notice form.

    Each person who submits a notice must include the information 
specified in the notice form to the extent it is known to or reasonably 
ascertainable by the submitter. However, no person is required to 
include information which relates solely to exposure of human or 
ecological populations outside of the United States. The notice form 
requires the following information relating to the manufacture, 
processing, distribution in commerce, use, and disposal of the new 
chemical substance:
    (a)(1) The specific chemical identity of the substance that the 
person intends to manufacture or import, which includes the following:
    (i) The currently correct Chemical Abstracts (CA) name for the 
substance, based on the Ninth Collective Index (9CI) of CA nomenclature 
rules and conventions, and consistent with listings for similar 
substances in the Inventory. For each substance having a chemical 
composition that can be represented by a specific, complete chemical 
structure diagram (a Class 1 substance), a CA Index Name must be 
provided. For each chemical substance that cannot be fully represented 
by a complete, specific chemical structure diagram (a Class 2 
substance), or if the substance is a polymer, a CA Index Name or CA 
Preferred Name must be provided (whichever is appropriate based on CA 
9CI nomenclature rules and conventions). In addition, for a Class 2 
substance, the notice must identify the immediate chemical precursors 
and reactants by specific chemical name and Chemical Abstracts Service 
Registry Number (CASRN), if the number is available. Tradenames or 
generic names of chemical precursors or reactants are not acceptable as 
substitutes for specific chemical names.
    (ii) The currently correct CASRN for the substance if a CASRN 
already exists for the substance.
    (iii) For a Class 1 substance and for any Class 2 substance for 
which a definite molecular formula is known or reasonably ascertainable, 
the correct molecular formula.
    (iv) For a Class 1 substance, a complete, correct chemical structure 
diagram; for a Class 2 substance or polymer, a correct representative or 
partial chemical structure diagram, as complete as can be known, if one 
can be reasonably ascertained.
    (2) For a polymer, the submitter must also report the following:
    (i) The specific chemical name and CASRN, if the number is 
available, of each monomer and other reactant used, at any weight 
percent, to manufacture the polymer. Tradenames or generic names of 
chemical reactants or monomers are not acceptable as substitutes for 
specific chemical names.
    (ii) The typical percent by weight of each monomer and other 
reactant in the polymer (weight of the monomer or other reactant 
expressed as a percentage of the weight of the polymeric chemical 
substance manufactured), and the maximum residual amount of each monomer 
present in the polymer.
    (iii) For monomers and other reactants used at 2 weight percent or 
less (based on the dry weight of the polymer manufactured), indicate on 
the PMN form any such monomers and other reactants that should be 
included as part of the polymer description on the Inventory, where the 
weight percent is based on either (A) the weight of monomer or other 
reactant actually charged to the reaction vessel, or (B) the minimum 
weight of monomer or other reactant required in theory to account for 
the actual weight of monomer or other reactant molecules or fragments 
chemically incorporated (chemically combined) in the polymeric substance 
manufactured.

[[Page 107]]

    (iv) For a determination that 2 weight percent or less of a monomer 
or other reactant is incorporated (chemically combined) in a polymeric 
substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of 
this section, analytical data or appropriate theoretical calculations 
(if it can be documented that analytical measurement is not feasible or 
not necessary) to support this determination must be maintained at the 
site of manufacture or import of the polymer.
    (v) Measured or estimated values of the minimum number-average 
molecular weight of the polymer and the amount of low molecular weight 
species below 500 and below 1,000 molecular weight, with a description 
of how the measured or estimated values were obtained.
    (3) The person must use one of the following two methods to develop 
or obtain the specified chemical identity information reported under 
paragraphs (a) (1) and (2) of this section and must identify the method 
used in the notice:
    (i) Method 1. Obtain the correct chemical identity information 
required by paragraphs (a) (1) and (2) of this section directly from the 
Chemical Abstracts Service (CAS), specifically from the CAS Registry 
Services Inventory Expert Service, prior to submitting a notice to EPA. 
A copy of the chemical identification report obtained from CAS must be 
submitted with the notice.
    (ii) Method 2. Obtain the correct chemical identity information 
required by paragraphs (a) (1) and (2) from any source. The notice will 
be incomplete according to Sec. 720.65(c)(1)(vi) if the person uses 
Method 2 and any chemical identity information is determined to be 
incorrect by EPA.
    (4) If an importer submitting the notice cannot provide all the 
information specified in paragraphs (a) (1) and (2) of this section 
because it is claimed as confidential by the foreign supplier of the 
substance, the importer must have the foreign supplier follow the 
procedures in paragraph (a)(3) of this section and provide the correct 
chemical identity information specified in paragraphs (a) (1) and (2) of 
this section directly to EPA in a joint submission or as a letter of 
support to the notice, which clearly references the importer's notice 
and PMN User Fee Identification Number. The statutory review process 
will commence upon receipt of both the notice and the complete, correct 
information.
    (5) If a manufacturer cannot provide all the information specified 
in paragraphs (a) (1) and (2) of this section because the new chemical 
substance is manufactured using a reactant having a specific chemical 
identity claimed as confidential by its supplier, the manufacturer must 
submit a notice directly to EPA containing all the information known by 
the manufacturer about the chemical identity of the reported substance 
and its proprietary reactant. In addition, the manufacturer must ensure 
that the supplier of the confidential reactant submit a letter of 
support directly to EPA providing the specific chemical identity of the 
confidential reactant, including the CAS number, if available, and the 
appropriate PMN or exemption number, if applicable. The letter of 
support must reference the manufacturer's name and PMN User Fee 
Identification Number under Sec. 700.45(c)(3) of this chapter. The 
statutory review period will commence upon receipt of both the notice 
and the letter of support.
    (b) The impurities anticipated to be present in the substance by 
name, CAS Registry number, and weight percent of the total substance.
    (c) Known synonyms or trade names of the new chemical substance.
    (d) A description of the byproducts resulting from the manufacture, 
processing, use, and disposal of the new chemical substance.
    (e) The estimated maximum amount to be manufactured or imported 
during the first year of production and the estimated maximum amount to 
be manufactured or imported during any 12-month period during the first 
three years of production.
    (f) A description of intended categories of use by function and 
application, the estimated percent of production volume devoted to each 
category of use, and the percent of the new substance in the formulation 
for each commercial or consumer use.
    (g) For sites controlled by the submitter:

[[Page 108]]

    (1) The identity of sites where the new substance will be 
manufactured, processed, or used.
    (2) A process description of each manufacture, processing, and use 
operation which includes a diagram of the major unit operations and 
chemical conversions, the identity and entry point of all feedstocks, 
and the points of release of the new chemical substance.
    (3) Worker exposure information, including worker activities, 
physical form of the new substance to which workers may be exposed, the 
number of workers, and the duration of activities.
    (4) Information on release of the new substance to the environment, 
including the quantity and media of release and type of control 
technology used.
    (h) For sites not controlled by the submitter, a description of each 
type of processing and use operation involving the new chemical 
substance, including identification of the estimated number of 
processing or use sites, situations in which worker exposure to and/or 
environmental release of the new chemical substance will occur, the 
number of workers exposed and the duration of exposure, and controls 
which limit worker exposure and environmental release.

[48 FR 21742, May 13, 1983, as ameneded at 60 FR 16310, Mar. 29, 1995]



Sec. 720.50  Submission of test data and other data concerning the health and environmental effects of a substance.

    (a) Test data on the new chemical substance in the possession or 
control of the submitter. (1) Except as provided in paragraph (d) of 
this section, each notice must contain all test data in the submitter's 
possession or control which are related to the effects on health or the 
environment of any manufacture, processing, distribution in commerce, 
use, or disposal of the new chemical substance or any mixture or article 
containing the new chemical substance, or any combination of such 
activities. This includes test data concerning the new chemical 
substance in a pure, technical grade, or formulated form.
    (2) A full report or standard literature citation must be submitted 
for the following types of test data:
    (i) Health effects data.
    (ii) Ecological effects data.
    (iii) Physical and chemical properties data.
    (iv) Environmental fate characteristics.
    (v) Monitoring data and other test data related to human exposure to 
or environmental release of the chemical substance.
    (3)(i) If the data do not appear in the open scientific literature, 
the submitter must provide a full report. A full report includes the 
experimental methods and materials, results, discussion and data 
analysis, conclusions, references, and the name and address of the 
laboratory that developed the data.
    (ii) If the data appear in the open scientific literature, the 
submitter need only provide a standard literature citation. A standard 
literature citation includes author, title, periodical name, date of 
publication, volume, and page numbers.
    (4)(i) If a study, report, or test is incomplete when a person 
submits a notice, the submitter must identify the nature and purpose of 
the study; name and address of the laboratory developing the data; 
progress to date; types of data collected; significant preliminary 
results; and anticipated completion date.
    (ii) If a test or experiment is completed before the notice review 
period ends, the person must submit the study, report, or test to the 
address listed on the notice form, as specified in paragraph (a)(3)(i) 
of this section, within ten days of receiving it, but no later than five 
days before the end of the review period. If the test or experiment is 
completed during the last five days of the review period, the submitter 
must immediately inform its EPA contact for that notice by telephone.
    (5) For test data in the submitter's possession or control which are 
not listed in paragraph (a)(2) of this section, a person is not required 
to submit a complete report. The person must submit a summary of the 
data. If EPA so requests, the person must submit a full report within 
ten days of the request, but no later than five days before the end of 
the review period.

[[Page 109]]

    (6) All test data described by paragraph (a) are subject to these 
requirements, regardless of their age, quality, or results.
    (b) Other data concerning the health and environmental effects of 
the new chemical substance that are known to or reasonably ascertainable 
by the submitter. (1) Except as provided in paragraph (d) of this 
section, any person who submits a notice must describe the following 
data, including any data from a health and safety study, if the data are 
related to the effects on health or the environment of any manufacture, 
processing, distribution in commerce, use, or disposal of the new 
chemical substance, of any mixture or article containing the new 
chemical substance, or of any combination of such activities:
    (i) Any data, other than test data, in the submitter's possession or 
control.
    (ii) Any data, including test data, which are not in the submitter's 
possession or control, but which are known to or reasonably 
ascertainable by the submitter. For the purposes of this section, data 
are known to or reasonably ascertainable by the submitter if the data 
are known to any of its employees or other agents who are associated 
with the research and development, test marketing, or commercial 
marketing of the substance.
    (2) Data that must be described include data concerning the new 
chemical substance in a pure, technical grade, or formulated form.
    (3) The description of data reported under this paragraph must 
include:
    (i) If the data appear in the open scientific literature, a standard 
literature citation, which includes the author, title, periodical name, 
date of publication, volume, and pages.
    (ii) If the data are not contained in the open scientific 
literature, a description of the type of data and summary of the 
results, if available, and the names and addresses of persons the 
submitter believes may have possession or control of the data.
    (4) All data described by this paragraph are subject to these 
requirements, regardless of their age, quality, or results; and 
regardless of whether they are complete at the time the notice is 
submitted.
    (c) [Reserved]
    (d) Data that need not be submitted--(1) Data previously submitted 
to EPA. (i) A person need not submit any data previously submitted to 
EPA with no claims of confidentiality if the notice includes the office 
or person to whom the data were submitted, the date of submission, and, 
if appropriate, a standard literature citation as specified in paragraph 
(a)(3)(ii) of this section.
    (ii) For data previously submitted to EPA with a claim of 
confidentiality, the person must resubmit the data with the notice and 
any claim of confidentiality, under Sec. 720.80.
    (2) Efficacy data. This part does not require submission of any data 
related solely to product efficacy. This does not exempt a person from 
submitting any of the data specified in paragraph (a), (b), or (c) of 
this section.
    (3) Non-U.S. exposure data. This part does not require submission of 
any data which relates only to exposure of humans or the environment 
outside the United States. This does not exclude nonexposure data such 
as data on health effects (including epidemiological studies), 
ecological effects, physical and chemical properties, or environmental 
fate characteristics.

[48 FR 21742, May 13, 1983, as amended at 51 FR 15102, Apr. 22, 1986]



Sec. 720.57  Imports.

    (a) Except as otherwise provided in this section, the provisions of 
this subpart C apply to each person who submits a notice for a new 
chemcial substance which he or she intends to import for a commercial 
purpose. In addition, each importer must comply with this section.
    (b) EPA will hold the principal importer, or the importer that EPA 
determines must submit the notice when there is no principal importer 
under Sec. 720.22(b)(2), liable for complying with this part, for 
completing the notice form and for the completeness and truthfulness of 
all information which it submits.

[[Page 110]]



                    Subpart D--Disposition of Notices



Sec. 720.60  General.

    This subpart establishes procedures that EPA will follow in 
reviewing notices.



Sec. 720.62  Notice that notification is not required.

    When EPA receives a notice, EPA will review it to determine whether 
the chemical substance is subject to the requirements of this part. If 
EPA determines that the chemical substance is not subject to these 
requirements, EPA will notify the submitter that section 5 of the Act 
does not prevent the manufacture or import of the substance and that the 
submission is not a notice under this part.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]



Sec. 720.65  Acknowledgment of receipt of a notice; errors in the notice; incomplete submissions; false and misleading statements.

    (a) Notification to submitter. EPA will acknowledge receipt of each 
notice by sending the submitter a letter that identifies the 
premanufacture notice number assigned to the new chemical substance and 
the date on which the review period begins. The review period will begin 
on the date the notice is received by the Office of Pollution Prevention 
and Toxics Document Control Officer. The acknowledgment does not 
constitute a finding by EPA that the notice, as submitted, is in 
compliance with this part.
    (b) Errors in the notice. (1) Within 30 days of receipt of the 
notice, EPA may request that the submitter remedy errors in the notice. 
The following are examples of such errors:
    (i) Failure to date the notice form.
    (ii) Typographical errors that cause data to be misleading or 
answers to any questions to be unclear.
    (iii) Contradictory information.
    (iv) Ambiguous statements or information.
    (2) In the request to correct the notice, EPA will explain the 
action which the submitter must take to correct the notice.
    (3) If the submitter fails to correct the notice within 15 days of 
receipt of the request, EPA may extend the notice period under section 
(5)(c) of the Act, in accordance with Sec. 720.75(c).
    (c) Incomplete submissions. (1) A submission is not complete, and 
the notification period does not begin, if:
    (i) The wrong person submits the notice form.
    (ii) The submitter does not sign the notice form.
    (iii) Some or all of the information in the notice or the 
attachments are not in English, except for published scientific 
literature.
    (iv) The submitter does not use the notice form.
    (v) The submitter does not provide information that is required by 
section 5(d)(1) (B) and (C) of the Act and Sec. 720.50.
    (vi) The submitter does not provide information required on the 
notice form and by Sec. 720.45 or indicate that it is not known to or 
reasonably ascertainable by the submitter.
    (vii) The submitter does not submit a second copy of the submission 
with all confidential information deleted for the public file, as 
required by Sec. 720.80(b)(2).
    (viii) The submitter does not include any information required by 
section 5(b)(1) of the Act and pursuant to a rule promulgated under 
section 4 of the Act, as required by Sec. 720.40(g).
    (ix) The submitter does not submit data which the submitter believes 
show that the chemical substance will not present an unreasonable risk 
of injury to health or the environment, if EPA has listed the chemical 
substance under section 5(b)(4) of the Act, as required in 
Sec. 720.40(h).
    (2)(i) If EPA receives an incomplete submission, the Director, or 
his or her delegate, will notify the submitter within 30 days of receipt 
that the submission is incomplete and that the notice review period will 
not begin until EPA receives a complete notice.
    (ii) If EPA obtains additional information during the notice review 
period that indicates the original submission was incomplete, the 
Director, or his or her delegate, may declare the submission incomplete 
within 30 days after EPA obtains the additional information and so 
notify the submitter.

[[Page 111]]

    (3) The notification that a submission is incomplete under paragraph 
(c)(2) (i) or (ii) of this section will include:
    (i) A statement of the basis of EPA's determination that the 
submission is incomplete.
    (ii) The requirements for correcting the incomplete submission.
    (iii) Information on procedures under paragraph (c)(4) of this 
section for filing objections to the determination or requesting 
modification of the requirements for completing the submission.
    (4) Within ten days after receipt of notification by EPA that a 
submission is incomplete, the submitter may file written objections 
requesting that EPA accept the submission as a complete notice or modify 
the requirements necessary to complete the submission.
    (5)(i) EPA will consider the objections filed by the submitter. The 
Director, or his or her delegate, will determine whether the submission 
was complete or incomplete, or whether to modify the requirements for 
completing the submission. EPA will notify the submitter in writing of 
EPA's response within ten days of receiving the objections.
    (ii) If the Director, or his or her delegate, determines, in 
response to the objection, that the submission was complete, the notice 
review period will be deemed suspended on the date EPA declared the 
notice incomplete, and will resume on the date that the notice is 
declared complete. The submitter need not correct the notice as EPA 
originally requested. If EPA can complete its review within 90 days from 
the date of the original submission, the Director, or his or her 
delegate, may inform the submitter that the running of the review period 
will resume on the date EPA originally declared it incomplete.
    (iii) If the Director, or his or her delegate, modifies the 
requirements for completing the submission or concurs with EPA's 
original determination, the notice review period will begin when EPA 
receives a complete notice.
    (d) Materially false or misleading statements. If EPA discovers at 
any time that person submitted materially false or misleading statements 
in the notice, EPA may find that the notice was incomplete from the date 
it was submitted, and take any other appropriate action.



Sec. 720.70  Notice in the Federal Register.

    (a) Filing of Federal Register notice. In accordance with section 
5(d)(2) of the Act, after EPA receives a notice, EPA will file with the 
Office of the Federal Register a notice including the information 
specified in paragraph (b) of this section.
    (b) Contents of notice. (1) In the public interest, the specific 
chemical identity listed in the notice will be published in the Federal 
Register unless the submitter has claimed chemical identity 
confidential. If the submitter claims confidentiality, a generic name 
will be published in accordance with Sec. 720.85(a)(3).
    (2) The categories of use of the new chemical substance will be 
published as reported in the notice unless this information is claimed 
confidential. If confidentiality is claimed, the generic information 
which is submitted under Sec. 720.87(b) will be published.
    (3) A list of data submitted in accordance with Sec. 720.50(a) will 
be published. In addition, for test data submitted in accordance with 
Sec. 720.40(g), a summary of the data will be published.
    (4) The submitter's identity will be published, unless the submitter 
has claimed it confidential.



Sec. 720.75  Notice review period.

    (a) Length of notice review period. The notice review period 
specified in section 5(a) of the Act runs for 90 days from the date the 
Document Control Officer for the Office of Pollution Prevention and 
Toxics receives a complete notice, or the date EPA determines the notice 
is complete under Sec. 720.65(c), unless the Agency extends the period 
under section 5(c) of TSCA and paragraph (c) of this section.
    (b) Suspension of the running of the notice review period. (1) A 
submitter may voluntarily suspend the running of the notice review 
period if the Director or his or her delegate agrees. If the Director 
does not agree, the review period will continue to run, and EPA will 
notify the submitter. A submitter may

[[Page 112]]

request a suspension at any time during the notice review period. The 
suspension must be for a specified period of time.
    (2) A request for suspension may be made in writing to the Document 
Control Office (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, 
DC., 20460. The suspension also may be made orally, including by 
telephone, to the submitter's EPA contact for that notice. EPA will send 
the submitter a written confirmation that the suspension has been 
granted.
    (i) An oral request may be granted for 15 days only. To obtain a 
longer suspension, the Document Control Officer for the Office of 
Pollution Prevention and Toxics must receive written confirmation of the 
oral request. The notice review period is suspended as of the date of 
the oral request.
    (ii) If the submitter has not made a previous oral request, the 
running of the notice review period is suspended as of the date of 
receipt of the written request by the Document Control Officer for the 
Office of Pollution Prevention and Toxics.
    (c) Extension of notice review period. (1) At any time during the 
notice review period, EPA may determine that good cause exists to extend 
the notice review period specified in paragraph (a) of this section.
    (2) If EPA makes such a determination, EPA will:
    (i) Notify the submitter that EPA is extending the notice review 
period for a specified length of time, and state the reasons for the 
extension.
    (ii) Issue a notice for publication in the Federal Register which 
states that EPA is extending the notice review period and gives the 
reasons for the extension.
    (3) The initial extension may be for a period of up to 90 days. If 
the initial extension is for less than 90 days, EPA may make additional 
extensions. However, the total period of extensions may not exceed 90 
days for any notice.
    (4) The following are examples of situations in which EPA may find 
that good cause exists for extending the notice review period:
    (i) EPA has reviewed the notice and determined that there is a 
significant possibility that the chemical substance will be regulated 
under section 5(e) or section 5(f) of the Act, but EPA is unable to 
initiate regulatory action within the initial 90-day period.
    (ii) EPA has reviewed the submission and is seeking additional 
information.
    (iii) EPA has received significant additional information during the 
notice review period.
    (iv) The submitter has failed to correct a notice after receiving 
EPA's request under Sec. 720.65(b).
    (d) Notice of expiration of notice review period. EPA will notify 
the submitter that the notice review period has expired or that EPA has 
completed its review of the notice. Expiration of the review period does 
not constitute EPA approval or certification of the new chemical 
substance, and does not mean that EPA may not take regulatory action 
against the substance in the future. After expiration of the statutory 
notice review period, in the absence of regulatory action by EPA under 
section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or 
import the chemical substance even if the submitter has not received 
notice of expiration.
    (e) Withdrawal of a notice by the submitter. (1) A submitter may 
withdraw a notice during the notice review period. A statement of 
withdrawal must be made in writing to the Document Control Office 
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460. 
The withdrawal is effective upon receipt of the statement by the 
Document Control Officer.
    (2) If a manufacturer or importer which withdrew a notice later 
resubmits a notice for the same chemical substance, a new notice review 
period begins.

[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 58 
FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995]



Sec. 720.78  Recordkeeping.

    (a) Any person who submits a notice under this part must retain 
documentation of information in the notice, including (1) other data, as 
defined in

[[Page 113]]

Sec. 720.50(b), in the submitter's possession or control; and (2) 
records of production volume for the first three years of production or 
import, the date of commencement of manufacture or import, and 
documentation of this information. This information must be retained for 
five years from the date of commencement of manufacture of import.
    (b)(1) Persons who manufacture or import a chemical substance under 
Sec. 720.36 must retain the following records:
    (i) Copies of, or citations to, information reviewed and evaluated 
under Sec. 720.36(b)(1) to determine the need to make any notification 
of risk.
    (ii) Documentation of the nature and method of notification under 
Sec. 720.36(c)(1) including copies of any labels or written notices 
used.
    (iii) Documentation of prudent laboratory practices used instead of 
notification and evaluation under Sec. 720.36(b)(2).
    (iv) The names and addresses of any persons other than the 
manfacturer or importer to whom the substance is distributed, the 
identity of the substance to the extent known, the amount distributed, 
and copies of the notifications required under Sec. 720.36(c)(2). These 
records are not required when substances are distributed as impurities 
or incorporated into an article, in accordance with paragraph (d) of 
this section.
    (2) A person who manufactures or imports a chemical substance under 
Sec. 720.36 and who manufactures or imports the substance in quantities 
greater than 100 kilograms per year must retain records of the identity 
of the substance to the extent known, the production volume of the 
substance, and the person's disposition of the substance. The person is 
not required to maintain records of the disposition of products 
containing the substance as an impurity or of articles incorporating the 
substances.
    (3) Records under this paragraph must be retained for 5 years after 
they are developed.
    (c) Any person who obtains a test-marketing exemption under this 
part must retain documentation of information in the application and 
documentation of compliance with any restrictions imposed by EPA when it 
granted the application. This information must be retained for five 
years from the final date of manufacture or import under the exemption.

[48 FR 21742, May 13, 1983; 48 FR 33872, July 26, 1983, as amended at 51 
FR 15102, Apr. 22, 1986; 58 FR 34204, June 23, 1993]



       Subpart E--Confidentiality and Public Access to Information



Sec. 720.80  General provisions.

    (a) A person may assert a claim of confidentiality for any 
information which he or she submits to EPA under this part.
    (b) Any claim of confidentiality must accompany the information when 
it is submitted to EPA.
    (1)(i) For information submitted on the notice form, the claim(s) 
must be asserted on the form in the manner prescribed on the notice 
form.
    (ii) When a person submits information in an attachment, the 
claim(s) must be asserted in the attachment as described on the notice 
form.
    (2) If any information is claimed as confidential, the person must 
submit, in addition to the copies specified by Sec. 720.40, a sanitized 
copy of the notice form (or electronic submission) and any attachments.
    (i) The original and two copies of the notice, specified at 
Sec. 720.40 (or electronic submission) and attachments must be complete. 
The submitter must designate that information which is claimed as 
confidential in the manner prescribed on the notice form (or in EPA's 
electronic submission instructions).
    (ii) The sanitized copy must be complete except that all information 
claimed as confidential in the original must be deleted. EPA will place 
this sanitized copy in the public file.
    (iii) If the person does not provide the sanitized copy, or 
information in a health and safety study (except information claimed as 
confidential in accordance with Sec. 720.90), the submission will be 
deemed incomplete and the notice review period will not begin until EPA 
receives the sanitized copy or the health and safety study information 
is included, in accordance with Sec. 720.65(c)(1)(vii).

[[Page 114]]

    (c) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent permitted 
by the Act, this subpart, and part 2 of this title.
    (d) If a notice submitter does not assert a claim of confidentiality 
for information at the time it is submitted to EPA, EPA may make the 
information public and place it in the public file without further 
notice to the submitter.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 
FR 16311, Mar. 29, 1995]



Sec. 720.85  Chemical identity.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import. (1)(i) A person who submits information to EPA 
under this part may assert a claim of confidentiality for the chemical 
identity of the new chemical substance. This claim will apply only to 
the period prior to the commencement of manufacture or import for 
commercial purposes. A submitter may assert this claim only if the 
submitter believes that public disclosure prior to commencement of 
manufacture or import of the fact that anyone intends to manufacture or 
import the specific chemical substance for commercial purposes would 
reveal confidential business information.
    (ii) If the notice includes a health and safety study concerning the 
new chemical substance and if the claim for confidentiality with respect 
to the chemical identity is denied in accordance with Sec. 720.90(c), 
EPA will deny a claim asserted under this paragraph.
    (2) Any person who asserts a claim of confidentiality for chemical 
identity under this paragraph must provide one of the following items at 
the time the notice is submitted:
    (i) The generic name which was accepted by EPA in the prenotice 
consultation conducted under paragraph (a)(3) of this section.
    (ii) One generic name that is only as generic as necessary to 
protect the confidential chemical identity of the particular chemical 
substance. The name should reveal the specific chemical identity to the 
maximum extent possible. The generic name will be subject to EPA review 
and approval at the time a notice of commencement is submitted.
    (3)(i) Any person who intends to assert a claim of confidentiality 
for the chemical identity of a new chemical substance may seek a 
determination by EPA of an appropriate generic name for the substance 
before submitting a notice. For this purpose, the person should submit 
to EPA:
    (A) The chemical identity of the substance.
    (B) A proposed generic name(s) which in only as generic as necessary 
to protect the confidential chemical identity of the new chemical 
substance. The name(s) should reveal the chemical identity of the 
substance to the maximum extent possible.
    (ii) Within 30 days, EPA will inform the submitter either that one 
of the proposed generic names is adequate or that none is adequate and 
further consultation is necessary.
    (4) If a submitter claims chemical identity to be confidential under 
this paragraph, and if the submitter complies with paragraph (a)(2) of 
this section, EPA will issue for publication in the Federal Register 
notice described in Sec. 720.70 the generic name proposed by the 
submitter or one agreed upon by EPA and the submitter.
    (b) Claims applicable to the period after commencement of 
manufacture or import. (1) Any claim of confidentiality under paragraph 
(a) of this section is applicable only until the substance is 
manufactured or imported for commercial purposes and becomes eligible 
for inclusion on the Inventory. To maintain the confidential status of 
the chemical identity when the substance is added to the Inventory, a 
submitter must reassert the confidentiality claim and substantiate the 
claim in the notice of commencement of manufacture required uner 
Sec. 720.102. A submitter may not claim the chemical indentity 
confidential for the period after commencement of manufacture or import 
unless the submitter claimed the chemical identity confidential for the 
period prior to commencement of manufacture or import under paragraph 
(a) of this section.
    (2)(i) A person who believes that public disclosure of the fact that 
anyone

[[Page 115]]

manfactures or imports the new chemical substance for commercial 
purposes would reveal confidential business information may assert a 
claim of confidentiality under this paragraph.
    (ii) If the notice includes a health and safety study concerning the 
new chemical substance, and if the claim for confidentiality with 
respect to the chemical identity is denied in accordance with 
Sec. 720.90(c), EPA will deny a claim asserted under this paragraph.
    (3) Any person who asserts a confidentiality claim for chemical 
identity must:
    (i) Comply with the requirements of paragraph (a)(3) of this section 
regarding submission of a generic name.
    (ii) Agree that EPA may disclose to a person with a bona fide intent 
to manufacture or import the chemical substance the fact that the 
particular chemical substance is included on the confidential Inventory 
for purposes of notification under section 5(a)(1)(A) of the Act.
    (iii) Have available for the particular chemical substance, and 
agree to furnish to EPA upon request:
    (A) An elemental analysis.
    (B) Either an X-ray diffraction pattern (for inorganic substances), 
a mass spectrum (for most other substances), or an infrared spectrum of 
the particular chemical substance, or if such data do not resolve 
uncertainties with respect to the identity of the chemical substance, 
additional or alternative spectra or other data to identify the chemical 
substance.
    (iv) Provide a detailed written substantiation of the claim, by 
answering the following questions:
    (A) What harmful effects to your competitive position, if any, do 
you think would result if EPA publishes on the Inventory the identity of 
the chemical substance? How could a competitor use such information 
given the fact that the identity of the substance otherwise would appear 
on the Inventory of chemical substances with no link between the 
substance and your company or industry? How substantial would the 
harmful effects of disclosure be? What is the casual relationship 
between the disclosure and the harmful effects?
    (B) For what period of time should confidential treatment be given? 
Until a specific date, the occurrence of a specific event, or 
permanently? Why?
    (C) Has the chemical substance been patented? If so, have you 
granted licenses to others with respect to the patent as it applies to 
the chemical substance? If the chemical substance has been patented and 
therefore disclosed through the patent, why should it be treated as 
confidential for purposes of the Inventory?
    (D) Has the identity of the chemical substance been kept 
confidential to the extent that your competitors do not know it is being 
manufactured on imported for a commercial purpose by anyone?
    (E) Is the fact that someone is manufacturing or importing this 
chemical substance for commercial purposes available to the public, 
e.g., in technical journals or other publications; in libraries; or in 
State, local, or Federal agency public files?
    (F) What measures have you taken to prevent undesired disclosure of 
the fact that you are manufacturing or importing this substance for a 
commercial purpose?
    (G) To what extent has the fact that you are manufacturing or 
importing this chemical substance for a commercial purpose been 
disclosed to others? What precautions have you taken in regard to these 
disclosures? Has this information been disclosed to the public or to 
competitors?
    (H) In what form does this particular chemical substance leave the 
site of manufacture, e.g., as part of a product; in an effluent or 
emission stream? If so, what measures have you taken to guard against 
discovery of its identity?
    (I) If the chemical substance leaves the site of manufacture in a 
product that is available to either the public or your competitors, can 
they identify the substance by analyzing the product?
    (J) For what purpose do you manufacture or import the substance?
    (K) Has EPA, another Federal agency, or any Federal court made any 
pertinent confidentiality determinations regarding this chemical 
substance? If so, copies of such determinations must be included in the 
substantiation.
    (L) If the notice includes a health and safety study concerning the 
new chemical substance, the submitter

[[Page 116]]

must also answer the questions in Sec. 720.90(b)(2).
    (4) If the submitter does not meet the requirements of this 
paragraph, EPA will deny the claim of confidentiality.
    (5)(i) EPA will publish a generic name on the public Inventory if:
    (A) The submitter asserts a claim of confidentiality in accordance 
with this paragraph.
    (B) No claim for confidentiality of the specific chemical identity 
as part of a health and safety study has been denied in accordance with 
part 2 of this title or Sec. 720.90.
    (ii) Publication of a generic name on the public Inventory does not 
create a category for purposes of the Inventory. Any person who has a 
bona fide intent to manufacture or import a chemical substance which is 
described by a generic name on the public Inventory may submit an 
inquiry to EPA under Sec. 720.25(b) to determine whether the particular 
chemical substance is included on the confidential Inventory.
    (iii) Upon receipt of a request described in Sec. 720.25(b), EPA may 
require the submitter which originally asserted confidentiality for a 
chemical substance to submit to EPA the information listed in paragraph 
(b)(3)(iii) of this section.
    (iv) Failure to submit any of the information required under 
paragraph (b)(3)(iii) of this section within ten days of a request by 
EPA under this paragraph is a waiver of the original submitter's 
confidentiality claim. In this event, EPA may place the specific 
chemical identity on the public Inventory without further notice to the 
original submitter.
    (6) If a submitter asserts a claim of confidentiality under this 
paragraph, EPA will examine the generic chemical name proposed by the 
submitter.
    (i) If EPA determines that the generic name proposed by the 
submitter is only as generic as necessary to protect the confidential 
identity of the particular chemical substance, EPA will place that 
generic name on the public Inventory.
    (ii) If EPA determines that the generic name proposed by the 
submitter is more generic than necessary to protect the confidential 
identity, EPA will propose in writing, for review by the submitter, an 
alternative generic name that will reveal the chemical identity of the 
chemical substance to the maximum extent possible.
    (iii) If the generic name proposed by EPA is acceptable to the 
submitter, EPA will place that generic name on the public Inventory.
    (iv) If the generic name proposed by EPA is not acceptable to the 
submitter, the submitter must explain in detail why disclosure of that 
generic name would reveal confidential business information and propose 
another generic name which is only as generic as necessary to protect 
the confidential identity. If EPA does not receive a response from the 
submitter within 30 days after the submitter receives the proposed name, 
EPA will place EPA's chosen generic name on the public Inventory. If the 
submitter does provide the information requested, EPA will review the 
response. If the submitter's proposed generic name is acceptable, EPA 
will publish that generic name on the public Inventory. If the 
submitter's proposed generic name is not acceptable, EPA will notify the 
submitter of EPA's choice of a generic name. Thirty days after this 
notification, EPA will place the chosen generic name on the public 
Inventory.



Sec. 720.87  Categories or proposed categories of uses of a new chemical substance.

    (a) A person who submits information to EPA under this part on the 
categories or proposed categories of use of a new chemical substance may 
assert a claim of confidentiality for this information.
    (b) A submitter that asserts such a claim must:
    (1) Report the categories or proposed categories of use of the 
chemical substance.
    (2) Provide, in nonconfidential form, a description of the uses that 
is only as generic as necessary to protect the confidential business 
information. The generic use description will be included in the Federal 
Register notice described in Sec. 720.70.
    (c) The person must submit the information required by paragraph (b) 
of this section in the manner specified in the notice form.

[[Page 117]]



Sec. 720.90  Data from health and safety studies.

    (a) Information other than specific chemical identity. Except as 
provided in paragraph (b) of this section, EPA will deny any claim of 
confidentiality with respect to information included in a health and 
safety study, unless the information would disclose confidential 
business information concerning:
    (1) Processes used in the manufacture or processing of a chemical 
substance or mixture.
    (2) In the case of a mixture, the portion of the mixture comprised 
by any of the chemical substances in the mixture.
    (3) Information which is not in any way related to the effects of a 
substance on human health or the environment, such as the name of the 
submitting company, cost or other financial data, product development or 
marketing plans, and advertising plans, for which the person submits a 
claim of confidentiality in accordance with Sec. 720.80.
    (b) Specific chemical identity--(1) Claims applicable to period 
prior to commencement of manufacture. A claim of confidentiality for the 
period prior to commencement of manufacture or import for the chemical 
identity of a chemical substance for which a health and safety study was 
submitted must be asserted in conjunction with a claim asserted under 
Sec. 720.85(a).
    (2) Claims applicable to period after commencement of manufacture or 
import for commercial purposes. To maintain the confidential status of 
the chemical identity of a chemical substance for which a health and 
safety study was submitted after commencement of manufacture or import, 
the claim must be reasserted and substantiated in conjunction with a 
claim under Sec. 720.85(b). In addition to the questions set forth in 
Sec. 720.85(b)(3)(iv) of this part, the submitter must answer the 
following questions:
    (i) Would disclosure of the chemical identity disclose processes 
used in the manufacture or processing of a chemical substance or 
mixture? Describe how this would occur. In responding to the question in 
Sec. 720.85(b)(3)(iv)(A), explain what harmful competitive effects would 
occur from disclosure of this process information.
    (ii) Would disclosure of the chemical identity disclose the portion 
of a mixture comprised by any of the substances in the mixture? Describe 
how this would occur. In responding to the question in 
Sec. 720.85(b)(3)(iv)(A), explain what harmful competitive effects would 
occur from disclosure of this information.
    (iii) Do you assert that disclosure of the chemical identity is not 
necessary to interpret any of the health and safety studies you have 
submitted? If so, explain how a less specific identity would be 
sufficient to interpret the studies.
    (c) Denial of confidentiality claim. EPA will deny a claim of 
confidentiality for chemical identity under paragraph (b) of this 
section, unless:
    (1) The information would disclose processes used in the manufacture 
or processing of a chemical substance or mixture.
    (2) In the case of a mixture, the information would disclose the 
portion of the mixture comprised by any of the substances in the 
mixture.
    (3) The specific chemical identity is not necessary to interpret a 
health and safety study.
    (d) Use of generic names. When EPA discloses a health and safety 
study containing a specific chemical identity, which the submitter has 
claimed confidential, and if the Agency has not denied the claim under 
paragraph (c) of this section, EPA will identify the chemical substance 
by the generic name selected under Sec. 720.85.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]



Sec. 720.95  Public file.

    All information submitted with a notice, including any health and 
safety study and other supporting documentation, will become part of the 
public file for that notice, unless such materials are claimed 
confidential. In addition, EPA may add materials to the public file, 
subject to subpart E of this part. Any of the nonconfidential material 
described in this subpart will be available for public inspection in the 
Non-Confidential Information Center

[[Page 118]]

(NCIC) (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room B-607 NEM, 401 M Street, SW., 
Washington, DC, 20460, between the hours of 12 p.m. and 4 p.m. weekdays 
excluding legal holidays.

[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 60 
FR 16311, Mar. 29, 1995; 60 FR 34464, July 3, 1995]



            Subpart F--Commencement of Manufacture or Import



Sec. 720.102  Notice of commencement of manufacture or import.

    (a) Applicability. Any person who commences the manufacture or 
import of a new chemical substance for a nonexempt commercial purpose 
for which that person previously submitted a section 5(a) notice under 
this part must submit a notice of commencement of manufacture or import.
    (b) When to report. (1) If manufacture or import for commercial 
purposes begins on or after the effective date of this rule, the 
submitter must submit the notice to EPA on, or no later than 30 calendar 
days, after the first day of such manufacture or import.
    (2) If manufacture or import for commercial purposes began or will 
begin before the effective date of this rule, the submitter must submit 
the notice by the effective date of this rule.
    (c) Information to be reported on form. (1) The notice must be 
submitted on EPA (Form 7710-56), which is available from the 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. The form must be signed and dated by an authorized official. 
All information specified on the form must be provided. The notice must 
contain the following information:
    (i) The specific chemical identity of the PMN substance.
    (ii) A generic chemical name (if the chemical identity is claimed as 
confidential by the submitter).
    (iii) The premanufacture notice (PMN) number assigned by EPA.
    (iv) The date of commencement for the submitter's manufacture or 
import for a non-exempt commercial purpose (indicating whether the 
substance was initially manufactured in the United States or imported). 
The date of commencement is the date of completion of non-exempt 
manufacture of the first amount (batch, drum, etc.) of new chemical 
substance identified in the submitter's PMN. For importers, the date of 
commencement is the date the new chemical substance clears United States 
customs.
    (v) The name and address of the submitter.
    (vi) The name of the authorized official.
    (vii) The name and telephone number of a technical contact in the 
United States.
    (viii) The address of the site where commencement of manufacture 
occurred.
    (ix) Clear indications of whether the chemical identity, submitter 
identity, and/or other information are claimed as confidential by the 
submitter.
    (2) If the submitter claims the chemical identity confidential, and 
wants the identity to be listed on the confidential portion of the 
Inventory, the claim must be reasserted and substantiated in accordance 
with Sec. 720.85(b). Otherwise, EPA will list the specific chemical 
identity on the public Inventory. Submitters who did not claim the 
chemical identity, submitter identity, or other information to be 
confidential in the PMN cannot claim this information as confidential in 
the notice of commencement.
    (d) Where to submit. Notices of commencement of manufacture or 
import should be submitted to the Document Control Office (7407), Office 
of Pollution Prevention and Toxics, U.S. Environmental Protection 
Agency, Room G-099, 401 M St., SW., Washington, DC., 20460.

(Approved by the Office of Management and Budget under control number 
2070-0012)

[48 FR 21742, May 13, 1983, as amended at 48 FR 41140, Sept. 13, 1983; 
51 FR 15103, Apr. 22, 1986; 53 FR 12523, Apr. 15, 1988; 60 FR 16311, 
Mar. 29, 1995; 60 FR 34464, July 3, 1995]

[[Page 119]]



                  Subpart G--Compliance and Inspections



Sec. 720.120  Compliance.

    (a) Failure to comply with any provision of this part is a violation 
of section 15 of the Act (15 U.S.C 2614).
    (b) A person who manufactures or imports a new chemical substance 
before a notice is submitted and the notice review period expires is in 
violation of section 15 of the Act even if that person was not requied 
to submit the notice under Sec. 720.22.
    (c) Using for commercial purposes a chemical substance or mixture 
which a person knew or had reason to know was manufactured, processed, 
or distributed in commerce in violation of section 5 of this rule is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (d) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (e) Failure or refusal to permit entry or inspection as required by 
section 11 is a violation of section 15 of the Act (15 U.S.C. 2614).
    (f) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who 
submit materially misleading or false information in connection with the 
requirements of any provision of this rule may be subject to penalties 
calculated as if they never filed their notices.
    (g) EPA may seek to enjoin the manufacture or processing of a 
chemical substance in violation of this rule or act to seize any 
chemical substance manufactured or processed in violation of this rule 
or take other actions under the authority of section 7 of this Act (15 
U.S.C. 2606) or section 17 or this Act (15 U.S.C. 2616).



Sec. 720.122  Inspections.

    EPA will conduct inspections under section 11 of the Act to assure 
compliance with section 5 of the Act and this rule, to verify that 
information submitted to EPA under this rule is true and correct, and to 
audit data submitted to EPA under this rule.



PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES--Table of Contents




                      Subpart A--General Provisions

Sec.
721.1  Scope and applicability.
721.3  Definitions.
721.5  Persons who must report.
721.11  Applicability determination when the specific chemical identity 
          is confidential.
721.20  Exports and imports.
721.25  Notice requirements and procedures.
721.30  EPA approval of alternative control measures.
721.35  Compliance and enforcement.
721.40  Recordkeeping.
721.45  Exemptions.
721.47  Conditions for research and development exemption.

                 Subpart B--Certain Significant New Uses

721.50  Applicability.
721.63  Protection in the workplace.
721.72  Hazard communication program.
721.80  Industrial, commercial, and consumer activities.
721.85  Disposal.
721.90  Release to water.
721.91  Computation of estimated surface water concentrations: 
          Instructions.

                  Subpart C--Recordkeeping Requirements

721.100  Applicability.
721.125  Recordkeeping requirements.

 Subpart D--Expedited Process for Issuing Significant New Use Rules for 
 Selected Chemical Substances and Limitation or Revocation of Selected 
                        Significant New Use Rules

721.160  Notification requirements for new chemical substances subject 
          to section 5(e) orders.
721.170  Notification requirements for selected new chemical substances 
          that have completed premanufacture review.
721.185  Limitation or revocation of certain notification requirements.

    Subpart E--Significant New Uses for Specific Chemical Substances

721.225  2-Chloro-N-methyl-N-substituted acetamide (generic name).
721.267  N-[2-[(substituted dinitrophenyl)azo]diallylamino-4-substituted 
          phenyl] acetamide (generic name).
721.275  Halogenated-N-(2-propenyl)-N-(substituted phenyl) acetamide.
721.285  Acetamide, N-[4-(pentyloxy)phenyl]-, acetamide, N-[2-nitro-4-

[[Page 120]]

          (pentyloxy)phenyl]-, and acetamide, N-[2-amino-4-
          (pentyloxy)phenyl]-.
721.305  Di-substituted acetophenone (generic).
721.320  Acrylamide-substituted epoxy.
721.323  Substituted acrylamide.
721.336  Perfluoroalkylethyl acrylate copolymer (generic name).
721.405  Polyether acrylate.
721.430  Oxo-substituted aminoalkanoic acid derivative.
721.435  Alkylphenylpolyetheralkanolamines (generic).
721.445  Substituted ethyl alkenamide.
721.450  Hydrofluorochloroalkene (generic).
721.484  Fluorinated acrylic copolymer (generic name).
721.505  Halogenated acrylonitrile.
721.520  Alanine, N-(2-carboxyethyl)-N- alkyl-, salt.
721.524  Alcohols, C6-12, ethoxylated, reaction product with 
          maleic anhydride.
721.530  Substituted aliphatic acid halide (generic name).
721.536  Halogenated phenyl alkane.
721.537  Organosilane ester.
721.538  Phenol, 4-(1,1-dimethylethyl)-, homopolymer.
721.539  Poly(oxy-1,2-ethanediyl), -sulfo--[1-[(4-
          nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, 
          ammonium salts.
721.540  Alkylphenoxypolyalkoxyamine (generic name).
721.550  Alkyl alkenoate, azobis-.
721.555  Alkyl amino nitriles (generic).
721.558  Salt of a fatty alkylamine derivative (generic).
721.562  Substituted alkylamine salt.
721.575  Substituted alkyl halide.
721.600  3-Alkyl-2-(2-anilino)vinyl thiazolinium salt (generic name).
721.625  Alkylated diarylamine, sulfurized (generic name).
721.630  Salt of a modified tallow alkylenediamine (generic).
721.639  Amine aldehyde condensate.
721.640  Amine substituted metal salts.
721.641  Alkylpoly(oxyalkylene)amine.
721.642  Amines, N-(C14-18 and C16-18 unsaturated 
          alkyl)] dipropylene-tri-, tripropylenetetra-, and 
          tetrapropylenepenta-.
721.643  Ethoxylated alcohol, phosphated, amine salt.
721.646  Aminofluoran derivative (generic name).
721.650  11-Aminoundecanoic acid.
721.655  Ethoxylated alkyl quaternary ammonium compound.
721.715  Trisubstituted anthracene.
721.720  Alkoxylated fatty acid amide, alkylsulfate salt.
721.750  Aromatic amine compound.
721.757  Polyoxyalkylene substituted aromatic azo colorant.
721.775  Brominated aromatic compound (generic name).
721.785  Halogenated alkane aromatic compound (generic name).
721.805  Benzenamine, 4,4'-[1,3-phenylenebis(1-methylethyl 
          idene)]bis[2,6-dimethyl-.
721.825  Certain aromatic ether diamines.
721.840  Alkyl substituted diaromatic hydrocarbons.
721.875  Aromatic nitro compound.
721.925  Substituted aromatic (generic).
721.950  Sodium salt of an alkylated, sulfonated aromatic (generic 
          name).
721.977  Aryloxyarene.
721.980  Sodium salt of azo acid dye.
721.981  Substituted naphtholoazo-substituted naphthalenyl-substituted 
          azonaphthol chromium complex.
721.982  Calcium, bis(2,4-pentanedionato-O,O').
721.987  Dialkylaminophenyl imino pyrazole acid ester (generic).
721.988  Pyrazolone azomethine dye (generic).
721.1000  Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-
          (trifluoromethyl)-.
721.1025  Benzenamine, 4-chloro-2-methyl-; benzenamine, 4-chloro-2-
          methyl-, hydrochloride; and benzenamine, 2-chloro-6-methyl-.
721.1050  Benzenamine, 2,5-dibutoxy-4-(4-morpholinyl)-, sulfate.
721.1068  Benzenamine, 4-isocyanato-N,N-bis(4-isocyanatophenyl)-2,5-
          dimethoxy-.
721.1075  Benzenamine, 4-(1-methylbutoxy)-, hydrochloride.
721.1105  Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-methylethyl)]-.
721.1120  Benzenamine, 4,4'-[1,4-phenylenebis(1-
          methylethylidene)]bis[2,6- dimethyl-.
721.1150  Substituted polyglycidyl benzenamine.
721.1155  1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl)-and 
          Bis(dimethylamino substituted)carbomonocycle.
721.1187  Bis(imidoethylene) benzene.
721.1193  Benzene, 2-bromo-1,4-dimethoxy-.
721.1210  Benzene, (2-chloroethoxy)-.
721.1225  Benzene, 1,2-dimethyl-, polypropene derivatives, sulfonated, 
          potassium salts.
721.1300  [(Dinitrophenyl)azo]-[2,4-diamino-5-methoxybenzene] 
          derivatives.
721.1325  Benzene, 1-(1-methylbutoxy)-4-        nitro-.
721.1350  Benzene, (1-methylethyl)(2-        phenylethyl)-.
721.1372  Substituted nitrobenzene.
721.1375  Disubstituted nitrobenzene (generic name).
721.1425  Pentabromoethylbenzene.
721.1430  Pentachlorobenzene.
721.1435  1,2,4,5-Tetrachlorobenzene.
721.1440  1,3,5-Trinitrobenzene.

[[Page 121]]

721.1450  1,3-Benzenediamine, 4-(1,1-dimethylethyl)-ar-methyl.
721.1500  1,2-Benzenediamine, 4-ethoxy, sulfate.
721.1550  Benzenediazonium, 4-(dimethylamino)-, salt with 2-hydroxy-5-
          sulfobenzoic acid (1:1).
721.1555  Substituted phenyl azo substituted benzenediazonium salt.
721.1568  Substituted benzenediazonium.
721.1580  Disubstituted benzene ether, polymer with substituted phenol 
          (generic).
721.1612  Substituted 2-nitro- and 2-aminobenzesulfonamide.
721.1625  Alkylbenzene sulfonate, amine salt.
721.1630  1,2-Ethanediol bis(4-methylbenzenesulfonate); 2,2-oxybis-
          ethane bis(4-methylbenzenesulfonate); ethanol, 2,2'-
          [oxybis(2,1-ethanediyl oxy)]bis-, bis(4-
          methylbenzenesulfonate); ethanol, 2,2'-[oxybis (2,1-ethane 
          diyloxy)] bis-, bis(4-methylbenzenesulfonate); ethanol, 2,2'-
          [[1-[(2-propenyloxy) methyl]-1,2-ethanediyl] bis(oxy)]bis-, 
          bis(4-methylbenzene sulfonate); and ethanol, 2-[1-[[2-[2-[[(4-
          methylphenyl)sulfonyl] oxy]ethoxy] ethoxy]methyl]-2-(2-
          propenyloxy)ethoxy]-, 4-methylbenzenesulfonate.
721.1637  1,2-Propanediol, 3-(2-propenyloxy)-, bis(4-methylbenzene 
          sulfonate); 2-propanol, 1-[2-[[(4-methylphenyl)sulfonyl] 
          oxy]ethoxy]-3-(2-propenyloxy)-4-methylbenzenesulfonate; and 2-
          propanol, 1-[2-[2-[[(4-methylphenyl)sulfonyl]oxy] 
          ethoxy]ethoxy]-3-(2-propenyloxy)-, 4-methylbenzenesulfonate.
721.1640  3,6,9,12,-Tetraoxatetradecane-1,14-diol, bis(4-
          methylbenzenesulfonate; 3,6,9,13-tetraoxahexadec-15-ene-1,11-
          diol, bis(4-methylbenzenesulfonate); 3,6,9,12,16-
          pentaoxanonadec-18-ene-1,14-diol, bis(4-methyl 
          benzenesulfonate); and 3,6,9,12-tetraoxatetradecane-1,14-diol, 
          7-[(2-propenyloxy)methyl]-, bis(4-methylbenzenesulfonate).
721.1643  Benzenesulfonic acid, amino substituted phenylazo-.
721.1645  Benzenesulfonic acid, 4-methyl-, reaction products with 
          oxirane mono[(C10-16-alkyloxy)methyl] derivatives 
          and 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine.
721.1650  Alkylbenzenesulfonic acid and sodium salts.
721.1660  Benzidine-based chemical substances.
721.1675  Disulfonic acid rosin amine salt of a benzidine derivative 
          (generic name).
721.1700  Halonitrobenzoic acid, substituted (generic name).
721.1705  Benzoic acid, 3-amino-, diazotized, coupled with 6-amino-4-
          hydroxy-2-naphthalenesulfonic acid, diazotized, (3-
          aminophenyl)phosphonic acid and diazotized 2,5-
          diethoxybenzenamine.
721.1710  Methoxy benzoic acid derivative (generic).
721.1725  Benzoic acid, 3,3'-methylenebis [6 amino-, di-2-propenyl 
          ester.
721.1728  Benzoic acid, 2-(3-phenylbutylidene)amino-, methyl ester.
721.1732  Nitrobenzoic acid octyl ester.
721.1734  Substituted benzonitrile (generic).
721.1735  Alkylbisoxyalkyl (substituted-1,1-dimethylethylphenyl) 
          benzotriazole (generic name).
721.1738  Substituted benzotriazole (generic name).
721.1745  Ethoxybenzothiazole disulfide.
721.1750  1H-Benzotriazole, 5-(pentyloxy)- and 1H-benzotriazole, 5-
          (pentyloxy)-, sodium and potassium salts.
721.1755  Methylenebisbenzotriazole.
721.1760  Substituted benzotriazole derivatives.
721.1765  2-Substituted benzotriazole.
721.1775  6-Nitro-2(3H)-benzoxazolone.
721.1790  Polybrominated biphenyls.
721.1800  3,3',5,5'-Tetramethylbiphenyl-4,4'-diol.
721.1805  Substituted bisaniline.
721.1820  Bisphenol derivative.
721.1825  Bisphenol A, epichlorohydrin, polyalkylenepolyol and 
          polyisocyanato derivative.
721.1850  Toluene sulfonamide bisphenol A epoxy adduct.
721.1875  Boric acid, alkyl and substituted alkyl esters (generic name).
721.1900  Substituted bromothiophene.
721.1907   Butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-
          diyl)bisazobis N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-3-
          oxo-.
721.1920  1,4-Bis(3-hydroxy-4-benzoylphenoxy)butane.
721.1925  Substituted carboheterocyclic butane tetracarboxylate.
721.1930  Butanoic acid, antimony (3=) salt.
721.1950  2-Butenedioic acid (Z), mono(2-((1-oxopropenyloxy)ethyl) ester 
          .
721.2025  Substituted phenylimino carbamate derivative.
721.2075  Carbamodithioic acid, methyl-, compound with methanamine 
          (1:1).
721.2077  Substituted carbazate (generic).
721.2078  1-Piperidinecarboxylic acid, 2-[(dichloro-hydroxy-
          carbomonocycle)hydrazono]-, methyl ester (generic).
721.2079  Dichloro, hydroxy, hydrazino-carbomonocycle (generic).
721.2081  Dichloro, hydroxy, hydrazino-carbomonocycle-monohydrochloride 
          (generic).
721.2083  Polysubstituted carbomonocyclic hydroxylamine (generic).
721.2084  Carbon oxyfluoride (Carbonic difluoride).
721.2085  Hydroxyalkylquinoline dioxoindandialkylcarboxamide.

[[Page 122]]

721.2086  Coco acid triamine condensate, polycarboxylic acid salts.
721.2088  Carboxylic acids, (C6-C9) branched and linear.
721.2089  Tetrasubstituted aminocarboxylic acid.
721.2091  Chloroalkane.
721.2092  3-Methylcholanthrene.
721.2094  N,N'-di(alkyl heteromonocycle)amino chlorotriazine.
721.2095  Chromate(3), bis 2-[[substituted-3-[(5-sulfo-1-
          napthalenyl)azo]phenyl]azo]substituted monocycle, trisodium 
          (generic name).
721.2097  Azo chromium complex dyestuff preparation (generic name).
721.2120  Cyclic amide.
721.2122  Substituted phenyl azo substituted sulfo carbopolycycle.
721.2140  Carbopolycyclicol azoalkylaminoalkylcarbomonocyclic ester, 
          halogen acid salt.
721.2145  Ceteareth-25 sorbate.
721.2175  Salt of cyclodiamine and mineral acid.
721.2222  Cyclohexanamine, N,N-dimethyl-, compd. with alpha-isotridecyl-
          omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.
721.2250  1,4-Cyclohexanediamine, cis- and trans-.
721.2260  1,2-Cyclohexanedicarboxylic acid, 2,2-bis[[[[2-
          [(oxiranylmethoxy) carbonyl]cyclohexy]carbonyl]oxy]methyl]-
          1,3-propanediyl bis(oxiranylmethyl) ester.
721.2270  Aliphatic dicarboxylic acid salt.
721.2275  N,N,N',N'-Tetrakis(oxiranyl methyl)-1,3-cyclohexane 
          dimethanamine.
721.2280  Cyclopropanecarboxaldehyde.
721.2287  DDT (Dichlorodiphenyltrichloroethane).
721.2340  Dialkenylamide (generic name).
721.2345  Alkyletherpropyl dialkylamines.
721.2350  Alkyltri, tetra, and pentaamines.
721.2355  Diethylstilbestrol.
721.2380  Disubstituted diamino anisole.
721.2410  Alkoxylated alkyldiethylenetriamine, alkyl sulfate salts.
721.2420  Alkoxylated dialkyldiethylenetriamine, alkyl sulfate salt.
721.2475  Dimetridazole.
721.2480  Isoalkyldimethylamine (generic).
721.2485  1,3-Dioxolane, 2-ethenyl-.
721.2520  Alkylated diphenyls.
721.2527  Substituted diphenylazo dye (generic name).
721.2532  Substituted diphenylmethane (generic).
721.2535  Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer, Bu 
          alc.-blocked.
721.2540  Diphenylmethane diisocyanate     (MDI) modified.
721.2560  Alkylated diphenyl oxide (generic name).
721.2565  Alkylated sulfonated diphenyl oxide, alkali and amine salts.
721.2570  Alkylated diphenyls (generic).
721.2575  Disubstituted diphenylsulfone.
721.2580  C.I. Disperse Red 152 (generic).
721.2585  Sodium salts of dodecylphenol (generic).
721.2600  Epibromohydrin.
721.2625  Reaction product of alkanediol and epichlorohydrin.
721.2675  Perfluoroalkyl epoxide (generic name).
721.2725  Trichlorobutylene oxide.
721.2800  Erionite fiber.
721.2805  Acrylate ester.
721.2825  Alkyl ester (generic name).
721.2900  Substituted aminobenzoic acid ester (generic name).
721.2920  tert-Amyl peroxy alkylene ester (generic name).
721.2925  Brominated aromatic ester.
721.2950  Carboxylic acid glycidyl esters.
721.3000  Dicarboxylic acid monoester.
721.3020  1,1-Dimethylpropyl peroxyester (generic name).
721.3031  Boric acid (H3BO3), zinc salt (2=3).
721.3032  Boric acid (H3BO2), zinc salt.
721.3034  Methylamine esters.
721.3063  Substituted phenyl azo substituted phenyl esters (generic 
          name).
721.3080  Substituted phosphate ester (generic).
721.3085  Brominated phthalate ester.
721.3100  Oligomeric silicic acid ester compound with a 
          hydroxylalkylamine.
721.3140  Vinyl epoxy ester.
721.3152  Ethanaminium, N-ethyl-2-hydroxy-N,N-bis(2-hydroxyethyl)-, 
          diester with C12-18 fatty acids, ethyl sulfates 
          (salts).
721.3155  3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.
721.3160  1-Chloro-2-bromoethane.
721.3180  Ethane, 2-chloro-1,1,1,2-tetrafluoro-.
721.3220  Pentachloroethane.
721.3248  Ethane, 1,2,2-trichlorodifluoro-.
721.3260  Ethanediimidic acids.
721.3320  Ethanol, 2-amino-, compound with N-hydroxy-N-
          nitrosobenzenamine (1:1).
721.3340  Ethanol, 2,2'-(hexylamino)bis-.
721.3350  N-Nitrosodiethanolamine.
721.3360  Substituted ethanolamine.
721.3364  Aliphatic ether.
721.3374  Alkylenediolalkyl ether.
721.3380  Anilino ether.
721.3420  Brominated arylalkyl ether.
721.3430  4-Bromophenyl phenyl ether.
721.3435  Butoxy-substituted ether alkane.
721.3437  Dialkyl ether.
721.3440  Haloalkyl substituted cyclic ethers.
721.3460  Diglycidyl ether of disubstituted carbopolycyle (generic 
          name).
721.3465  Stilbene diglycidyl ether.
721.3480  Halogenated biphenyl glycidyl ethers.
721.3485  Hydrofluorocarbon alkyl ether.
721.3486  Polyglycerin mono(4-nonylphenyl) ether.

[[Page 123]]

721.3488  Poly(oxy-1,2-ethanediyl), alpha substituted-omega-hydroxy-, 
          C16-20 alkyl ethers.
721.3500  Perhalo alkoxy ether.
721.3520  Aliphatic polyglycidyl ether.
721.3550  Dipropylene glycol dimethyl ether.
721.3560  Derivative of tetrachloroethylene.
721.3565  Ethylenediamine, substituted, sodium salt.
721.3620  Fatty acid amine condensate, polycarboxylic acid salts.
721.3625  Fatty acid amine salt (generic name).
721.3627  Branched synthetic fatty acid.
721.3628  Fatty acids, C(14-18)- unsaturated, branched and linear, 
          methyl and butyl esters.
721.3629  Triethanolamine salts of fatty acids.
721.3635  Octadecanoic acid, ester with 1,2-propanediol, phosphate, 
          anhydride with silicic acid (H4SiO4).
721.3680  Ethylene oxide adduct of fatty acid ester with 
          pentaerythritol.
721.3700  Fatty acid, ester with styrenated phenol, ethylene oxide 
          adduct.
721.3720  Fatty amide.
721.3740  Bisalkylated fatty alkyl amine oxide
721.3760  Fluorene-containing diaromatic amines.
721.3764  Fluorene substituted aromatic amine.
721.3790  Polyfluorocarboxylates.
721.3800  Formaldehyde, condensated polyoxyethylene fatty acid, ester 
          with styrenated phenol, ethylene oxide adduct.
721.3815  Furan, 2-(ethoxymethyl)- tetrahydro-.
721.3840  Tetraglycidalamines (generic      name).
721.3860  Glycol monobenzoate.
721.3880  Polyalkylene glycol substituted acetate.
721.3900  Alkyl polyethylene glycol phosphate, potassium salt.
721.4000  Polyoxy alkylene glycol amine.
721.4040    Glycols, polyethylene-, 3-sulfo-2-hydroxypropyl-p-(1,1,3,3-
          tetramethylbutyl)phenyl ether, sodium salt.
721.4060  Alkylene glycol terephthalate and substituted benzoate esters 
          (generic name).
721.4080  MNNG (N-methyl-N'-nitro-N-nitrosoguanidine).
721.4085  Guanidine, pentaethyl-.
721.4090  Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-, 
          bromide.
721.4095  Quaternary ammonium alkyltherpropyl trialkylamine halides.
721.4097  7-Oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl ester.
721.4098  Substituted heteroaromatic-2[[4-(dimethylamino) phenyl]azo]-3-
          methyl-, salts (generic).
721.4100  Tris(disubstituted alkyl) heterocycle.
721.4110  Allyloxysubstituted heterocycle.
721.4128  Dimethyl-3-substituted heteromonocycle.
721.4133  Dimethyl-3-substituted heteromonocyclic amine.
721.4140  Hexachloronorbornadiene.
721.4155  Hexachloropropene.
721.4158  Hexadecanoic acid, ethenyl ester.
721.4160  Hexafluoropropylene oxide.
721.4180  Hexamethylphosphoramide.
721.4200  Substituted alkyl peroxyhexane carboxylate (mixed isomers) 
          (generic name).
721.4215  Hexanedioic acid, diethenyl ester.
721.4240  Alkyl peroxy-2-ethyl hexanoate.
721.4250  Hexanoic acid, 2-ethyl-, ethenyl ester.
721.4255  1,4,7,10,13,16-Hexaoxacyclooctadecane, 2-[(2-propenyl 
          oxy)methyl]-.
721.4257  Hydrazine, (2-fluorophenyl).
721.4259  Aliphatic polyisocyanate homopolymer.
721.4260  Hydrazine, [4-(1-methylbutoxy)phenyl]-, monohydrochloride.
721.4270  Nitrophenoxylalkanoic acid substituted thiazino hydrazide 
          (generic name).
721.4280  Substituted hydrazine.
721.4300  Hydrazinecarboxamide, N,N'-1,6-hexanediylbis [2,2-dimethyl-].
721.4320  Hydrazinecarboxamide, N,N'-(methylenedi-4,1-phenylene)bis 
          [2,2-dimethyl-.
721.4340  Substituted thiazino hydrazine salt (generic name).
721.4360  Certain hydrogen containing chlorofluorocarbons.
721.4380  Modified hydrocarbon resin.
721.4390  Trisubstituted hydroquinone        diester.
721.4420  Substituted hydroxylamine.
721.4460  Amidinothiopropionic acid hydrochloride.
721.4462  Hydrochlorofluorocarbon.
721.4463  Hydrochlorofluorocarbon.
721.4464  Mixture of hydrofluoro alkanes and hydrofluoro alkene.
721.4465  Hydrofluoroalkane.
721.4466  3-Hydroxy-1,1-dimethylbutyl derivative.
721.4467  Quaternary ammonium hydroxide.
721.4468  1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
721.4469  Imidazolethione.
721.4470  2,4-Imidazolidinedione, bromochloro-5,5-dimethyl-.
721.4473  Dialkylamidoimidazoline.
721.4476  Substituted imines.
721.4480  2-Imino-1,3-thiazin-4-one-5,6-dihydromonohydrochloride.
721.4484  Halogenated indane (generic name).
721.4490  Capped aliphatic isocyanate.
721.4494  Polycyclic isocyanate.
721.4497  Aliphatic polyisocyanates (generic name).

[[Page 124]]

721.4500  Isopropylamine distillation residues and ethylamine 
          distillation residues.
721.4520  Isopropylidene, bis(1,1-dimethylpropyl) derivative.
721.4550  Diperoxy ketal.
721.4568  Methylpolychloro aliphatic ketone.
721.4585  Lecithins, phospholipase A2-hydrolyzed.
721.4587  Lithium manganese oxide (LiMn204) (generic name).
721.4589  Propanedioic acid, [(4-methoxyphenyl)methylene]-, 
          bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).
721.4590  Mannich-based adduct.
721.4594  Substituted azo metal complex dye.
721.4596  Diazo substituted carbomonocyclic metal complex.
721.4600  Recovered metal hydroxide.
721.4620  Dialkylamino alkanoate metal salt.
721.4660  Alcohol, alkali metal salt.
721.4663  Fluorinated carboxylic acid alkali metal salts.
721.4668  Hydrated alkaline earth metal salts of metalloid oxyanions.
721.4680  Metal salts of complex inorganic oxyacids (generic name).
721.4685  Substituted purine metal salt (generic name).
721.4700  Metalated alkylphenol copolymer (generic name).
721.4720  Disubstituted phenoxazine, chlorometalate salt.
721.4740  Alkali metal nitrites.
721.4794  Polypiperidinol-acrylate methacrylate.
721.4820  Methane, bromodifluoro-.
721.4840  Substituted triphenylmethane.
721.4880  Methanol, trichloro-, carbonate (2:1).
721.4885  Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-
          tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy) 
          phenyl]phenyl-.
721.4925  Methyl n-butyl ketone.
721.5050  2,2'-[(1-Methylethylidene)bis[4,1-phenyloxy[1-(butoxymethyl)-
          (2,1-ethanediyl]oxymethylene]]bisoxirane, reaction product 
          with a diamine.
721.5075  Mixed methyltin mercaptoester sulfides.
721.5175  Mitomycin C.
721.5192  Substituted 1,6-dihydroxy naphthalene.
721.5200  Disubstituted phenylazo trisubstituted naphthalene.
721.5225  Naphthalene,1,2,3,4-tetrahydro(1-phenylethyl) (specific name).
721.5250  Trimethyl spiropolyheterocyclic naphthalene compound.
721.5255  2-Naphthalenol, mono and dioctyl derivs.
721.5275  2-Napthalenecarboxamide-N-aryl-3-hydroxy-4-arylazo (generic 
          name).
721.5276  2-Napthalenol, heptyl-1-[[(4-phenylazo)phenyl]azo]-, ar', 
          ar''-Me derivs.
721.5278  Substituted naphthalenesulfonic acid, alkali salt.
721.5279  2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-4-[(3-
          butoxy-2-hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-
          biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt.
721.5280  2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled 
          with diazotized 4-butylbenzenamine, diazotized 4,4'-
          cyclohexylidenebis[benzenamine] and m-phenylenediamine, sodium 
          salt.
721.5281  2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-
          sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-
          (phenylamino)-, sodium salt, compd. With 2,2',2"-nitrilotris 
          [ethanol] (9CI).
721.5282  Trisodium chloro [(trisubstituted heteromonocycle amino) 
          propylamino]triazinylamino hydroxyazo naphthalenetrisulfonate.
721.5285  Ethoxylated substituted naphthol.
721.5290  Phenylazoalkoxy naphthylamines (generic).
721.5300  Neodecaneperoxoic acid, 1,1,3,3-tetramethylbutyl ester.
721.5310  Neononanoic acid, ethenyl ester.
721.5325  Nickel acrylate complex.
721.5330  Nickel salt of an organo compound containing nitrogen.
721.5350  Substituted nitrile (generic name).
721.5356  Ethanol, 2,2'2"-nitrilotris-, compound with alpha-2,4,6-tris 
          (1-phenylethyl)phenyl]-omega-hydroxypoly (oxy-1,2-ethanediyl) 
          phosphate.
721.5360  Substituted nitrobenezene (generic).
721.5375  Nitrothiophenecarboxylic acid, ethyl ester, 
          bis[[[[(substituted)] amino]alkylphenyl]azo] (generic name).
721.5385  Octanoic acid, hydrazide.
721.5400  3,6,9,12,15,18,21-Heptaoxatetratriaoctanoic acid, sodium salt.
721.5425  -Olefin sulfonate, potassium salts.
721.5450  -Olefin sulfonate, sodium salt.
721.5460  Organosolv lignin.
721.5475  1-Oxa-4-azaspiro[4.5]decane, 4-dichloroacetyl-.
721.5500  7-Oxabicyclo[4.1.0]heptane, 3-ethenyl, homopolymer, ether with 
          2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), epoxidized.
721.5525  Substituted spiro oxazine.
721.5540  1H,3H,5H-oxazolo [3,4-c] oxazole, dihydro-7a-methyl-.
721.5545  3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyl-oxazolidine.
721.5547  Antimony double oxide.
721.5548  Mixed metal oxide (generic).
721.5549  Lithiated metal oxide.
721.5550  Substituted dialkyl oxazolone (generic name).
721.5575  Oxirane, 2,2'-(1,6-hexanediylbis (oxymethylene)) bis-.

[[Page 125]]

721.5580  Oxirane, 2,2'-[methylenebis[(2,6-dimethyl-4,1-
          phenylene)oxymethylene]]bis-.
721.5600  Substituted oxirane.
721.5625  Oxiranemethanamine, N,N'-[methylenebis(2-ethyl-4,1-
          phenylene)]bis[N-(oxiranylmethyl)]-.
721.5645  Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
721.5650  Pentanediol light residues.
721.5700  Pentanenitrile, 3-amino-.
721.5708  2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.
721.5710  Phenacetin.
721.5740  Phenol, 4,4'-methylenebis (2,6-dimethyl-.
721.5760  Phenol, 4,4'-[methylenebis (oxy-2,1-ethanediylthio)]bis-.
721.5763  Methylenebisbenzotriazolyl phenols.
721.5769  Mixture of nitrated alkylated phenols.
721.5775  Phenol, 5-amino-2,4-dicholoro-, hydrochloride.
721.5780  Phenol, 4,4'-(oxybis(2,1-ethanediylthio)bis-.
721.5800  Sulfurized alkylphenol.
721.5820  Aminophenol.
721.5840  Ethylated aminophenol.
721.5860  Methylphenol, bis(substi-tuted)alkyl.
721.5867  Substituted phenol.
721.5880  Sulfur bridged substituted phenols (generic name).
721.5900  Trisubstituted phenol (generic name).
721.5913  Phenothiazine derivative.
721.5915  Polysubstituted phenylazopolysubstitutedphenyl dye.
721.5920  Phenyl(disubstitutedpolycyclic).
721.5930  Phenylenebis[imino (chlorotriazinyl)-imino (substituted 
          napthyl)azo (substituted phenyl)azo, sodium salt (generic 
          name).
721.5960  N,N'-Bis(2-(2-(3-alkyl)thiazoline) vinyl)-1,4-phenylenediamine 
          methyl sulfate double salt (generic name).
721.5965  Substituted S-phenylthiazole (generic).
721.5970  Phosphated polyarylphenol ethoxylate, potassium salt.
721.5980  Dialkyl phosphorodithioate phosphate compounds.
721.5995  Polyalkyl phosphate.
721.6000  Tris (2,3-dibromopropyl) phosphate.
721.6020  Phosphine, dialkylyphenyl.
721.6045  Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- (9CI).
721.6060  Alkylaryl substituted phosphite.
721.6070  Alkyl phosphonate ammonium salts.
721.6075  Phosphonic acid, 1,1-methylenebis-tetrakis(1-methylethyl) 
          ester.
721.6078  Substituted ethoxyethylamine phosphonate.
721.6080  Phosphonium salt (generic name).
721.6085  Phosphonocarboxylate salts.
721.6090  Phosphoramide.
721.6097  Phosphoric acid derivative (generic name).
721.6100  Phosphoric acid, C6-12-alkyl esters, compounds with 
          2-(dibutylamino) ethanol.
721.6110  Alkyldi(alkyloxyhydroxypropyl) derivative, phosphoric acid 
          esters, potassium salts.
721.6120  Phosphoric acid, 1,2-ethanediyl tetrakis(2-chloro-1-
          methylethyl) ester.
721.6140  Dialkyldithiophosphoric acid, aliphatic amine salt.
721.6160  Piperazinone, 1,1',1"-[1,3,5-triazine-2,4,6-
          triyltris[(cyclohexylimino)-2,1-ethanediyl]]tris-[3,3,4,5,5-
          pentamethyl]-.
721.6165  Polysubstituted piperidine.
721.6170  Siloxanes and silicones, Me hydrogen, reaction products with 
          2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.
721.6175  2-Piperdinone, 1,3-dimethyl-.
721.6176  2-Piperdinone, 1,5-dimethyl-.
721.6186  Polyamine dithiocarbamate.
721.6193  Polyalkylene polyamine.
721.6200  Fatty acid polyamine condensate, phosphoric acid ester salts.
721.6220  Aryl sulfonate of a fatty acid mixture, polyamine condensate.
721.6440  Polyamine ureaformaldehyde condensate (specific name).
721.6470  Polyaminopolyacid.
721.6475  Alkyl polycarboxylic acids, esters with ethoxylated fatty 
          alcohols.
721.6477  Alkyl polycarboxylic acids, esters with ethoxylated fatty 
          alcohols, reaction products with maleic anhydride.
721.6485  Hydroxy terminated polyester.
721.6490  Alkyl phenyl polyetheramines.
721.6495  Aliphatic polyisocyanate.
721.6498  Modified polyisocyanates (generic).
721.6505  Polymers of C13C15 oxoalcohol 
          ethoxolates.
721.6520  Acrylamide, polymer with substituted alkylacrylamide salt 
          (generic name).
721.6540  Acrylamide, polymers with tetraalkyl ammonium salt and 
          polyalkyl, aminoalkyl methacrylamide salt.
721.6560  Acrylic acid, polymer with substituted ethene.
721.6620  Alkanaminium, polyalkyl-[(2-methyl-1-oxo-2-propenyl)oxy] salt, 
          polymer with acrylamide and substituted alkyl methacrylate.
721.6660  Polymer of alkanepolyol and 
          polyalkylpolyisocyanatocarbomonocycle, acetone oxime-blocked 
          (generic name).
721.6680  Alkanoic acid, butanediol and cyclohexanealkanol polymer 
          (generic name).
721.6820  Polymer of substituted aryl olefin.
721.6900  Polymer of bisphenol A diglycidal ether, substituted alkenes, 
          and butadiene.

[[Page 126]]

721.6920  Butyl acrylate, polymer with substituted methyl styrene, 
          methyl methacrylate, and substituted silane.
721.6980  Dimer acids, polymer with polyalkylene glycol, bisphenol A-
          diglycidyl ether, and alkylenepolyols polyglycidyl ethers 
          (generic name).
721.7000  Polymer of disodium maleate, allyl ether, and ethylene oxide.
721.7020  Distillates (petroleum), C(3-6), polymers with styrene and 
          mixed terpenes (generic name).
721.7046  Formaldehyde, polymer with substituted phenols, glycidyl 
          ether.
721.7160  2-Oxepanone, polymer with 4,4'-(1-methylethylidene)bisphenol 
          and 2,2-[(1-methylethylidene)bis(4,1-
          phenyleneoxymethylene)]bisoxirane, graft.
721.7200  Perfluoroalkyl aromatic carbamate modified alkyl methacrylate 
          copolymer.
721.7210  Epoxidized copolymer of phenol and substituted phenol.
721.7220  Polymer of substituted phenol, formaldehyde, epichlorohydrin, 
          and disubstituted benzene.
721.7260  Polymer of polyethylenepolyamine and alkanediol diglycidyl 
          ether.
721.7280  1,3-Propanediamine, N,N'-1,2-ethanediylbis-, polymer with 
          2,4,6-trichloro-1,3,5-triazine, reaction products with N-
          butyl-2,2,6,6-tetramethyl-4-piperidinamine.
721.7285  Amines, N-cocoalkyltrimethylenedi-, citrates.
721.7286  Amines, N-tallowalkyltripropylenetetra-, citrates.
721.7375  Potassium salt of polyolefin acid.
721.7378  Substituted polyoxyethylene.
721.7440  Polyalkylenepolyol alkylamine. (generic name).
721.7450  Aromatic amine polyols.
721.7480  Isocyanate terminated polyols.
721.7500  Nitrate polyether polyol (generic name).
721.7600  Alkyl(heterocyclicyl) phenylazohetero monocyclic polyone 
          (generic name).
721.7620  Alkyl(heterocyclicyl) phenylazohetero monocyclic polyone, 
          ((alkylimidazolyl) methyl) derivative (generic name).
721.7655  Alkylsulfonium salt.
721.7700  Poly(oxy-1,2-ethanediyl), -hydro--
          (oxiranylmethoxy)-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-
          propanediol (3:1).
721.7710  Polyepoxy polyol.
721.7720  Poly(oxy-1,2-ethanediyl), ,'-[(1-
          methylethylidene) di-4,1-phenylene] bis [-
          (oxiranylmethoxy)-.
721.7770  Alkylphenoxypoly(oxyethylene) sulfuric acid ester, substituted 
          amine salt.
721.7780  Poly[oxy(methyl-1,2-ethanediyl)], ,'-(2,2-
          dimethyl-1,3-propanediyl)bis[-(oxiranymethoxy)-.
721.7785  Substituted alkyl aminomethylene polyphosphonic acid, salt 
          (generic).
721.8079  Isophorone diisocyanate neopentyl glycol adipate polyurethane 
          prepolymer.
721.8082  Polyester polyurethane acrylate.
721.8090  Polyurethane polymer.
721.8095  Silylated polyurethane.
721.8100  Potassium N,N-bis (hydroxyethyl) cocoamine oxide phosphate, 
          and potassium N,N-bis (hydroxyethyl) tallowamine oxide 
          phosphate.
721.8153  Di-substituted propanedione (generic).
721.8155  Propanenitrile, 3-[amino, N-tallowalkyl] dipropylenetri- and 
          tripropylenetri- and propanenitrile, 3-[amino, 
          (C14-18 and C16-18 unsaturated alkyl)] 
          trimethylenedi-, dipropylenetri-, and tripropylenetetra-.
721.8160  Propanoic acid, 2,2-dimethyl-, ethenyl ester.
721.8170  Propanol, [2-(1,1-dimethylethoxy)methylethoxy]-.
721.8225  2-Propenamide, N-[3-dimethylamino)propyl]-.
721.8250  1-Propanol, 3,3'-oxybis[2,2-bis(bromomethyl)-.
721.8350  2-Propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl ester.
721.8450  2-Propenoic acid, 2-methyl-, 2-[3-(2H-benzotriazol-2-yl)-4-
          hydroxyphenyl]ethyl ester.
721.8500  2-Propenoic acid, 2-methyl-, 7-oxabicyclo [4.1.0]hept-3-
          ylmethyl ester.
721.8654  2-Propenoic acid 3-(trimethoxy silyl)propyl ester.
721.8660  Propionic acid methyl ester (generic).
721.8670  Alkylcyano substituted pyridazo benzoate.
721.8673  [(Disubstituted phenyl)]azo dihydro hydroxy alkyl oxo alkyl-
          substituted-pyridines (generic name).
721.8675  Halogenated pyridines.
721.8700  Halogenated alkyl pyridine.
721.8750  Halogenated substituted pyridine.
721.8775  Substituted pyridines.
721.8780  Substituted pyridine azo substituted phenyl.
721.8825  Substituted methylpyridine and substituted 2-phenoxypyridine.
721.8850  Disubstituted halogenated pyridinol.
721.8875  Substituted halogenated pyridinol.
721.8900  Substituted halogenated pyridinol, alkali salt.
721.8965  1H-Pyrole-2, 5-dione, 1-(2,4,6-tribromophenyl)-.
721.9000  N-Nitrosopyrrolidine.
721.9005  2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.
721.9010  2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.
721.9075  Quaternary ammonium salt of fluorinated alkylaryl amide.
721.9080  Nitro methyl quinoline.
721.9100  Substituted quinoline.
721.9220  Reaction products of secondary alkyl amines with a substituted

[[Page 127]]

          benzenesulfonic acid and sulfuric acid (generic name).
721.9265  Reaction product of dichlorobenzidine and substituted 
          alkylamide.
721.9270  Reaction product of epoxy with anhydride and glycerol and 
          glycol.
721.9280  Reaction product of ethoxylated fatty acid oils and a phenolic 
          pentaerythritol tetraester.
721.9285  Reaction products of formalin (37%) with amine C12.
721.9300  Reaction products of substituted hydroxyalkanes and 
          polyalkylpolyisocyanatocarbomonocycle.
721.9400  Reaction product of phenolic pentaerythritol tetraesters with 
          fatty acid esters and oils, and glyceride triesters.
721.9460  Tall oil fatty acids, reaction products with polyamines, alkyl 
          substituted.
721.9470  Reserpine.
721.9480  Resorcinol, formaldehyde substituted carbomonocycle resin.
721.9488  Substituted resorcinols.
721.9490  Coco alklydimethyl amine salts (generic).
721.9492  Polymers of styrene, cyclohexyl methacrylate and substituted 
          methacrylate.
721.9495  Acrylosilane resins.
721.9497  Trifunctional ketoximino silane.
721.9499  Modified silicone resin.
721.9500  Silane, (1,1-dimethylethoxy) dimethoxy(2-methyl propyl)-.
721.9503  Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
          heptadecafluorodecyl)trimethoxy-.
721.9505  Silanes substituted macrocycle polyethyl.
721.9507  Polyester silane.
721.9515  Aminofunctional alkoxy alkyl siloxane.
721.9516  Siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl Me, 
          di-Me, reaction products with polyethylene-polypropylene 
          glycol Bu glycidal ether.
721.9517  Siloxanes and silicones, de-Me, 3-[4-[[[3-(dimethyl amino) 
          propyl] amino]carbonyl]-2-oxo-1-pyrrolidinyl] propyl Me.
721.9518  Sinorhizobuim meliloti strain RMBPC-2.
721.9526  Sodium perthiocarbonate.
721.9527  Bis(1,2,2,6,6-pentamethyl-4-piperidin-4-ol) ester of 
          cycloaliphatic spiroketal.
721.9530  Bis(2,2,6,6-tetramethylpiperidinyl) ester of cycloalkyl 
          spiroketal.
721.9540  Polysulfide mixture.
721.9545  Substituted phenyl azo substituted sulfocarbopolycle, sodium 
          salt.
721.9550  Sulfonamide.
721.9570  Halophenyl sulfonamide salt.
721.9575  Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-
          4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl] propyl]azo]-2-
          naphthalenesulfonato(3-)]-, trisodium (9CI).
721.9576  Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
          (aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-
          sulfonato (3-)]-, trisodium (9CI).
721.9577  Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
          (aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalene 
          sulfonato (3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-
          hydroxy-7-[[2-hydroxy-1-[(phenylamino) carbonyl]-1-
          propenyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI).
721.9580  Ethyl methanesulfonate.
721.9595  Alkyl benzene sulfonic acids and alkyl sulfates, amine salts 
          (generic).
721.9620  Aromatic sulfonic acid compound with amine.
721.9630  Polyfluorosulfonic acid salt.
721.9635  Terpene residue distillates.
721.9650  Tetramethylammonium salts of alkylbenzenesulfonic acid.
721.9656  Thiaalkanethiol.
721.9657  Disubstituted thiadiazole.
721.9658  Thiadiazole derivative.
721.9659  Disubstituted thiadiazosulfone.
721.9660  Methylthiouracil.
721.9661  Diphenol tars (generic).
721.9662  Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).
721.9663  Poly(oxy-1,2-ethanediyl), alpha, alpha'-[thiobis (1-oxo-3,1-
          propanediyl)]bis [omega-hydroxy-,bis (C11-15 and 
          C11-15-isoalkyl) ethers.
721.9664  9H-Thioxanthen-9-one,2,4-diethyl.
721.9665  Organotin catalysts.
721.9668   Organotin lithium compound.
721.9675  Titanate [Ti6 O13 (2-)], dipotassium.
721.9680  Alkaline titania silica gel (generic name).
721.9685  Mixed trialkylamines (generic).
721.9700  Monosubstituted alkoxyaminotrazines (generic name).
721.9717  Azo monochloro triazine reactive dye.
721.9719  Tris carbamoyl triazine (generic).
721.9720  Disubstituted alkyl triazines (generic name).
721.9730  1,3,5-Triazin-2-amine, 4-dimethylamino-6-substituted-.
721.9740  Brominated triazine derivative.
721.9750  2-Chloro-4,6-bis(substituted)-1,3,5-triazine, dihydrochloride.
721.9800  Poly(substituted triazinyl) piperazine (generic name).
721.9820  Substituted triazole.
721.9825  Phenyl substituted triazolinones.
721.9830  1-Tridecyn-3-ol, 3-methyl.
721.9840  Tungstate (W12(OH)2O386-) hexasodium (9CI).
721.9850  2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-
          bis[2,4,6-tris(1,1-dimethylethyl)phenoxy]-.
721.9892  Alkylated urea.

[[Page 128]]

721.9900  Urea, condensate with poly[oxy(methyl-1,2ethanediyl)]-
          - (2-aminomethylethyl)--(2-aminoethylethoxy) 
          (generic name).
721.9920  Urea, (hexahydro-6-methyl-2-oxopyrimidinyl)-.
721.9925  Aminoethylethylene urea methacrylamide.
721.9928  Urea, tetaethyl-.
721.9930  Urethane.
721.9957  N-Nitroso-N-methylurethane.
721.9969  3,6-Bis(dialkylamino) -9-[2-alkoxycarbonyl) phenyl]-xanthylium 
          salt (generic).
721.9970  o-Xylene compound (generic name).
721.9973  Zirconium dichlorides (generic).

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).



                      Subpart A--General Provisions



Sec. 721.1  Scope and applicability.

    (a) This part identifies uses of chemical substances, except for 
microorganisms regulated under part 725 of this chapter, which EPA has 
determined are significant new uses under the authority of section 
5(a)(2) of the Toxic Substances Control Act. In addition, it specifies 
procedures for manufacturers, importers, and processors to report on 
those significant new uses. This subpart A contains general provisions 
applicable to this part. subpart B of this part identifies generic 
requirements for certain significant new uses cross referenced in 
specific provisions of subpart E of this part. subpart C of this part 
identifies generic reporting requirements for certain significant new 
uses cross referenced in specific provisions of subpart E of this part. 
subpart E of this part identifies chemical substances and their 
significant new uses.
    (b) This subpart A contains provisions governing submission and 
review of notices for the chemical substances and significant new uses 
identified in subpart E of this part. The provisions of this subpart A 
apply to the chemical substances and significant new uses identified in 
subpart E of this part, except to the extent that they are specifically 
modified or supplanted by specific requirements in subpart E of this 
part. In the event of a conflict between the provisions of this subpart 
A and the provisions of subpart E of this part, the provisions of 
subpart E of this part shall govern.
    (c) The provisions of part 720 of this chapter apply to this part 
721. For purposes of this part 721, wherever the phrase ``new chemical 
substance'' appears in part 720 of this chapter, it shall mean the 
chemical substance subject to this part 721. In the event of a conflict 
between the provisions of part 720 of this chapter and the provisions of 
this part 721, the provisions of this part 721 shall govern.

[53 FR 28358, July 27, 1988, as amended at 62 FR 17932, Apr. 11, 1997]



Sec. 721.3  Definitions.

    The definitions in section 3 of the Act, 15 U.S.C. 2602, and 
Sec. 720.3 of this chapter apply to this part. In addition, the 
following definitions apply to this part:
    Acutely toxic effects A chemical substance produces acutely toxic 
effects if it kills within a short time period (usually 14 days):
    (1) At least 50 percent of the exposed mammalian test animals 
following oral administration of a single dose of the test substance at 
25 milligrams or less per kilogram of body weight (LD50).
    (2) At least 50 percent of the exposed mammalian test animals 
following dermal administration of a single dose of the test substance 
at 50 milligrams or less per kilogram of body weight (LD50).
    (3) At least 50 percent of the exposed mammalian test animals 
following administration of the test substance for 8 hours or less by 
continuous inhalation at a steady concentration in air at 0.5 milligrams 
or less per liter of air (LC50).
    CAS Number means Chemical Abstracts Service Registry Number assigned 
to a chemical substance on the Inventory.
    Chemical name means the scientific designation of a chemical 
substance in accordance with the nomenclature system developed by the 
International Union of Pure and Applied Chemistry or the Chemical 
Abstracts Service's rules of nomenclature, or a name which will clearly 
identify a chemical substance for the purpose of conducting a hazard 
evaluation.
    Chemical protective clothing means items of clothing that provide a 
protective barrier to prevent dermal contact

[[Page 129]]

with chemical substances of concern. Examples can include, but are not 
limited to: full body protective clothing, boots, coveralls, gloves, 
jackets, and pants.
    Commercial use means the use of a chemical substance or any mixture 
containing the chemical substance in a commercial enterprise providing 
saleable goods or a service to consumers (e.g., a commercial dry 
cleaning establishment or painting contractor).
    Common name means any designation or identification such as code 
name, code number, trade name, brand name, or generic chemical name used 
to identify a chemical substance other than by its chemical name.
    Consumer means a private individual who uses a chemical substance or 
any product containing the chemical substance in or around a permanent 
or temporary household or residence, during recreation, or for any 
personal use or enjoyment.
    Consumer product means a chemical substance that is directly, or as 
part of a mixture, sold or made available to consumers for their use in 
or around a permanent or temporary household or residence, in or around 
a school, or in recreation.
    Customer means any person to whom a manufacturer, importer, or 
processor distributes any quantity of a chemical substance, or of a 
mixture containing the chemical substance, whether or not a sale is 
involved.
    Director of the Office of Pollution Prevention and Toxics means the 
Director of the EPA Office of Pollution Prevention and Toxics or any EPA 
employee delegated by the Office Director to carry out the Office 
Director's functions under this part.
    Employer means any manufacturer, importer, processor, or user of 
chemical substances or mixtures.
    Environmentally transformed A chemical substance is 
``environmentally transformed'' when its chemical structure changes as a 
result of the action of environmental processes on it.
    Facility means all buildings, equipment, structures, and other 
stationary items which are located on a single site or on contiguous or 
adjacent sites and which are owned or operated by the same person (or by 
any person which controls, is controlled by, or under common control 
with such person).
    Identity means any chemical or common name used to identify a 
chemical substance or a mixture containing that substance.
    Immediate use A chemical substance is for the ``immediate use'' of a 
person if it is under the control of, and used only by, the person who 
transferred it from a labeled container and will only be used by that 
person within the work shift in which it is transferred from the labeled 
container.
    Impervious Chemical protective clothing is ``impervious'' to a 
chemical substance if the substance causes no chemical or mechanical 
degradation, permeation, or penetration of the chemical protective 
clothing under the conditions of, and the duration of, exposure.
    Manufacturing stream means all reasonably anticipated transfer, 
flow, or disposal of a chemical substance, regardless of physical state 
or concentration, through all intended operations of manufacture, 
including the cleaning of equipment.
    Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water and used in metal machining 
operations for the purpose of cooling, lubricating, or rust inhibition.
    MSDS means material safety data sheet, the written listing of data 
for the chemical substance as required under Sec. 721.72(c).
    NIOSH means the National Institute for Occupational Safety and 
Health of the U.S. Department of Health and Human Services.
    Non-enclosed process means any equipment system (such as an open-top 
reactor, storage tank, or mixing vessel) in which a chemical substance 
is manufactured, processed, or otherwise used where significant direct 
contact of the bulk chemical substance and the workplace air may occur.
    Non-industrial use means use other than at a facility where chemical 
substances or mixtures are manufactured, imported, or processed.
    Personal protective equipment means any chemical protective clothing 
or device placed on the body to prevent contact with, and exposure to, 
an identified chemical substance or substances

[[Page 130]]

in the work area. Examples include, but are not limited to, chemical 
protective clothing, aprons, hoods, chemical goggles, face splash 
shields, or equivalent eye protection, and various types of respirators. 
Barrier creams are not included in this definition.
    Powder or dry solid form means a state where all or part of the 
substance would have the potential to become fine, loose, solid 
particles.
    Principal importer means the first importer who, knowing that a 
chemical substance will be imported for a significant new use rather 
than manufactured in the United States, specifies the chemical substance 
and the amount to be imported. Only persons who are incorporated, 
licensed, or doing business in the United States may be principal 
importers.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture containing the chemical substance, after 
manufacture of the substance, for distribution in commerce with the 
purpose of obtaining an immediate or eventual commercial advantage for 
the processor. Processing of any amount of a chemical substance or 
mixture containing the chemical substance is included in this 
definition. If a chemical substance or mixture containing impurities is 
processed for commercial purposes, the impurities also are processed for 
commercial purposes.
    Process solely for export means to process for commercial purposes 
solely for export from the United States under the following 
restrictions on activity in the United States: Processing must be 
performed at sites under the control of the processor; distribution in 
commerce is limited to purposes of export; and the processor may not use 
the chemical substance except in small quantities solely for research 
and development.
    Process stream means all reasonably anticipated transfer, flow, or 
disposal of a chemical substance, regardless of physical state or 
concentration, through all intended operations of processing, including 
the cleaning of equipment.
    Recipient means any person who purchases or otherwise obtains a 
chemical substance directly from a person who manufacturers, imports, or 
processes the substance.
    Serious acute effects means human injury or human disease processes 
that have a short latency period for development, result from short-term 
exposure to a chemical substance, or are a combination of these factors 
and which are likely to result in death or severe or prolonged 
incapacitation.
    Serious chronic effects means human injury or human disease 
processes that have a long latency period for development, result from 
long-term exposure to a chemical substance, or are a combination of 
these factors and which are likely to result in death or severe or 
prolonged incapacitation.
    Short-term test indicative of carcinogenic potential means either 
any limited bioassay that measures tumor or preneoplastic induction, or 
any test indicative of interaction of a chemical substance with DNA 
(i.e., positive response in assays for gene mutation, chromosomal 
aberrations, DNA damage and repair, or cellular transformation).
    Short-term test indicative of the potential to cause a 
developmentally toxic effect means either any in vivo preliminary 
development toxicity screen conducted in a mammalian species, or any in 
vitro developmental toxicity screen, including any test system other 
than the intact pregnant mammal, that has been extensively evaluated and 
judged reliable for its ability to predict the potential to cause 
developmentally toxic effects in intact systems across a broad range of 
chemicals or within a class of chemicals that includes the substance of 
concern.
    Significant adverse environmental effects means injury to the 
environment by a chemical substance which reduces or adversely affects 
the productivity, utility, value, or function of biological, commercial, 
or agricultural resources, or which may adversely affect a threatened or 
endangered species. A substance will be considered to have the potential 
for significant adverse environmental effects if it has one of the 
following:
    (1) An acute aquatic EC50 of 1 mg/L or less.
    (2) An acute aquatic EC50 of 20 mg/L or less where the 
ratio of aquatic

[[Page 131]]

vertebrate 24-hour to 48-hour EC50 is greater than or equal 
to 2.0.
    (3) A Maximum Acceptable Toxicant Concentration (MATC) of less than 
or equal to 100 parts per billion (100 ppb).
    (4) An acute aquatic EC50 of 20 mg/L or less coupled with 
either a measured bioconcentration factor (BCF) equal to or greater than 
1,000x or in the absence of bioconcentration data a log P value equal to 
or greater than 4.3.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way is one site. There may be more than one 
manufacturing plant on a single site.
    Site-limited intermediate means an intermediate manufactured, 
processed, and used only within a site and not distributed in commerce 
other than as an impurity or for disposal. Imported intermediates cannot 
be ``site-limited.''
    Spray application means any method of projecting a jet of vapor of 
finely divided liquid onto a surface to be coated; whether by compressed 
air, hydraulic pressure, electrostatic forces, or other methods of 
generating a spray.
    Use stream means all reasonably anticipated transfer, flow, or 
disposal of a chemical substance, regardless of physical state or 
concentration, through all intended operations of industrial, 
commercial, or consumer use.
    Waters of the United States has the meaning set forth in 40 CFR 
122.2.
    Work area means a room or defined space in a workplace where a 
chemical substance is manufactured, processed, or used and where 
employees are present.
    Workplace means an establishment at one geographic location 
containing one or more work areas.

[53 FR 28358, July 27, 1988, as amended at 54 FR 31306, July 27, 1989; 
58 FR 63516, Dec. 1, 1993]



Sec. 721.5  Persons who must report.

    (a) The following persons must submit a significant new use notice 
as specified under the provisions of section 5(a)(1)(B) of the Act, part 
720 of this chapter, and Sec. 721.25:
    (1) A person who intends to manufacture, import, or process for 
commercial purposes a chemical substance identified in a specific 
section in subpart E of this part, and intends to engage in a 
significant new use of the substance identified in that section.
    (2) A person who intends to manufacture, import, or process for 
commercial purposes a chemical substance identified in a specific 
section in subpart E of this part, and intends to distribute the 
substance in commerce. A person described in this paragraph is not 
required to submit a significant new use notice if that person can 
document one or more of the following as to each recipient of the 
substance from that person:
    (i) That the person has notified the recipient, in writing, of the 
specific section in subpart E of this part which identifies the 
substance and its designated significant new uses.
    (ii) That the recipient has knowledge of the specific section in 
subpart E of this part which identifies the substance and its designated 
significant new uses.
    (iii) That the recipient cannot undertake any significant new use 
described in the specific section in subpart E of this part.
    (b) A person described in paragraph (a)(2) of this section must 
submit a significant new use notice if that person has knowledge at the 
time of commercial distribution of the substance identified in the 
specific section in subpart E of this part that a recipient intends to 
engage in a designated significant new use of that substance without 
submitting a notice under this part.
    (c) A person who processes a chemical substance identified in a 
specific section in subpart E of this part for a significant new use of 
that substance is not required to submit a significant new use notice if 
that person can document each of the following:
    (1) That the person does not know the specific chemical identity of 
the chemical substance being processed.
    (2) That the person is processing the chemical substance without 
knowledge that the substance is identified in subpart E of this part.
    (d)(1) If at any time after commencing distribution in commerce of a 
chemical substance identified in a specific section in subpart E of this 
part a person described in paragraph (a)(2) of this section has 
knowledge that a recipient of the substance is engaging in

[[Page 132]]

a significant new use of that substance designated in that section 
without submitting a notice under this part, the person is required to 
cease supplying the chemical substance to that recipient and to submit a 
significant new use notice for that chemical substance and significant 
new use, unless the person is able to document each of the following:
    (i) That the person has notified the recipient and EPA enforcement 
authorities (at the address in paragraph (d)(1)(iii) of this section), 
in writing within 15 working days of the time the person develops 
knowledge that the recipient is engaging in a significant new use, that 
the recipient is engaging in a significant new use without submitting a 
significant new use notice.
    (ii) That, within 15 working days of notifying the recipient as 
described in paragraph (d)(1)(i) of this section, the person received 
from the recipient, in writing, a statement of assurance that the 
recipient is aware of the terms of the applicable section in subpart E 
of this part and will not engage in the significant new use.
    (iii) That the person has promptly provided EPA enforcement 
authorities with a copy of the recepient's statement of assurance 
described in paragraph (d)(1)(ii) of this section. The copy must be sent 
to the Office of Enforcement and Compliance Assurance, Office of 
Compliance (2224A), U.S. Environmental Protection Agency, Ariel Rios, 
1200 Pennsylvania Ave., N.W., Washington, DC, 20044.
    (2) If EPA notifies the manufacturer, importer, or processor that 
the recipient is engaging in a significant new use after providing the 
statement of assurance described in paragraph (d)(1)(ii) of this section 
and without submitting a notice under this part, the manufacturer, 
importer, or processor shall immediately cease distribution to that 
recipient until the manufacturer, importer, or processor or the 
recipient has submitted a significant new use notice under this part and 
the notice review period has ended.
    (3) If, after receiving a statement of assurance from a recipient 
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or 
processor has knowledge that the recipient is engaging in a significant 
new use without submitting a notice under this part, the manufacturer, 
importer, or processor must immediately cease distributing the substance 
to that recipient and notify EPA enforcement authorities at the address 
identified in paragraph (d)(1)(iii) of this section. The manufacturer, 
importer, or processor may not resume distribution to that recipient 
until any one of the following has occurred:
    (i) The manufacturer, importer, or processor has submitted a 
significant new use notice under this part and the notice review period 
has ended.
    (ii) The recipient has submitted a significant new use notice under 
this part and the notice review period has ended.
    (iii) The manufacturer, importer, or processor has received notice 
from EPA enforcement authorities that it may resume distribution to that 
recipient.
    (e) Any significant new use notice relating to import of a substance 
must be submitted by the principal importer.

[53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]



Sec. 721.11  Applicability determination when the specific chemical identity is confidential.

    (a) A person who intends to manufacture, import, or process a 
chemical substance which is described by a generic chemical name is 
subpart E of this part may ask EPA whether the substance is subject to 
the requirements of this part. EPA will answer such an inquiry only if 
EPA determines that the person has a bona fide intent to manufacture, 
import, or process the chemical substance for commercial purposes.
    (b) To establish a bona fide intent to manufacture, import, or 
process a chemical substance, the person who intends to manufacture, 
import, or process the chemical substance must submit the following 
information in writing to the Document Control Office (7407), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room G-099, 401 M St., SW., Washington, DC., 20460, ATTN: SNUR Bonafide 
submissions.
    (1) The specific chemical identity of the chemical substance that 
the person

[[Page 133]]

intends to manufacture, import, or process.
    (2) A signed statement that the person intends to manufacture, 
import, or process the chemical substance for commercial purposes.
    (3) A description of the research and development activities 
conducted to date, and the purpose for which the person will 
manufacture, import, or process the chemical substance.
    (4) An elemental analysis.
    (5) Either an X-ray diffraction pattern (for inorganic substances), 
a mass spectrum (for most other substances), or an infrared spectrum of 
the particular chemical substance, or, if such data do not resolve 
uncertainties with respect to the identity of the chemical substance, 
additional or alternative spectra or other data to identify the 
substance.
    (c) If an importer or processor cannot provide all the information 
required in paragraph (b) of this section because it is claimed as 
confidential business information by the importer's or processor's 
manufacturer or supplier, the manufacturer or supplier may supply the 
information directly to EPA.
    (d) EPA will review the information submitted by the manufacturer, 
importer, or processor under paragraph (b) of this section to determine 
whether than person has shown a bona fide intent to manufacture, import, 
or process the chemical substance. If necessary, EPA will compare this 
information either to the information requested for the confidential 
chemical substance under Sec. 710.7(e)(2)(v) of this chapter or the 
information requested under Sec. 720.85(b)(3)(iii) of this chapter.
    (e) If the manufacturer, importer, or processor has shown a bona 
fide intent to manufacture, import, or process the substance and has 
provided sufficient unambiguous chemical identity information to enable 
EPA to make a conclusive determination as to the identity of the 
substance, EPA will inform the manufacturer, importer, or processor 
whether the chemical substance is subject to this part and, if so, which 
section in subpart E of this part applies.
    (f) A disclosure to a person with a bona fide intent to manufacture, 
import, or process a particular chemical substance that the substance is 
subject to this part will not be considered public disclosure of 
confidential business information under section 14 of the Act.
    (g) EPA will answer an inquiry on whether a particular chemical 
substance is subject to this part within 30 days after receipt of a 
complete submission under paragraph (b) of this section.

[53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]



Sec. 721.20  Exports and imports.

    Persons who intend to export a chemical substance identified in 
subpart E of this part, or in any proposed rule which would amend 
subpart E of this part, are subject to the export notification 
provisions of section 12(b) of the Act. The regulations that interpret 
section 12(b) appear at 40 CFR part 707. Persons who import a substance 
identified in a specific section in subpart E of this part are subject 
to the import certification requirements under section 13 of the Act, 
which are codified at 19 CFR 12.118 through 12.127 and 127.28. The EPA 
policy in support of the import certification requirements appears at 40 
CFR part 707.

[53 FR 28360, July 27, 1988]



Sec. 721.25  Notice requirements and procedures.

    (a) Each person who is required to submit a significant new use 
notice under this part must submit the notice at least 90 calendar days 
before commencing manufacture, import, or processing of a chemical 
substance identified in subpart E of this part for a significant new 
use. The submitter must comply with any applicable requirement of 
section 5(b) of the Act, and the notice must include the information and 
test data specified in section 5(d)(1) of the Act. The notice must be 
submitted on EPA Form 7710-25, and must comply with the requirements of 
part 720 of this chapter, except to the extent that they are 
inconsistent with this part 721.
    (b) If two or more persons are required to submit a significant new 
use notice for the same chemical substance and significant new use 
identified in

[[Page 134]]

subpart E of this part, they may submit a joint notice to EPA. Persons 
submitting a joint notice must individually complete the certification 
section of part I of the required notification form. Persons who are 
required to submit individually, but elect to submit jointly, remain 
individually liable for the failure to submit required information which 
is known to or reasonably ascertainable by them and test data in their 
possession or control.
    (c) EPA will process the notice in accordance with the procedures of 
part 720 of this chapter, expect to the extent they are inconsistent 
with this part 721.
    (d) Any person submitting a significant new use notice in response 
to the requirements of this part 721 shall not manufacture, import, or 
process a chemical substance identified in subpart E of this part for a 
significant new use until the notice review period, including all 
extensions and suspensions, has expired.

[53 FR 28360, July 27, 1988, as amended at 60 FR 16311, Mar. 29, 1995]



Sec. 721.30  EPA approval of alternative control measures.

    (a) In certain sections of subpart E of this part, significant new 
uses for the identified substances are described as the failure to 
establish and implement programs providing for the use of either: 
specific measures to control worker exposure to or release of substances 
which are identified in such sections, or alternative measures to 
control worker exposure or environmental release which EPA has 
determined provide substantially the same degree of protection as the 
specified control measures. Persons who manufacture, import, or process 
a chemical substance identified in such sections and who intend to 
employ alternative measures to control worker exposure or environmental 
release must submit a request to EPA for a determination of equivalency 
before commencing manufacture, import, or processing involving the 
alternative control measures.
    (b) A request for a determination of equivalency must be submitted 
in writing to the Document Control Office (7407), Office of Pollution 
Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 
401 M St., SW., Washington, DC., 20460; ATTN: SNUR Equivalency 
Determination, and must contain:
    (1) The name of the submitter.
    (2) The specific chemical identity of the substance.
    (3) The citation for the specific section in subpart E of this part 
which pertains to the substance for which the request is being 
submitted.
    (4) A detailed description of the activities involved.
    (5) The specifications of the alternative worker exposure control 
measures or environmental release control measures.
    (6) An analysis justifying why such alternative control measures 
provide substantially the same degree of protection as the specific 
control measures identified in the specific section in subpart E of this 
part which pertains to the substance for which the request is being 
submitted.
    (7) The data and information described in Sec. 720.50 (a) and (b) of 
this chapter unless such data and information have already been 
submitted to the Office of Pollution Prevention and Toxics, EPA.
    (c) Requests for determinations of equivalency will be reviewed by 
EPA within 45 days. Determinations under this paragraph will be made by 
the Director, Office of Pollution Prevention and Toxics, or designee. 
Notice of the results of such determinations will be mailed to the 
submitter.
    (d) If EPA notifies the submitter under paragraph (c) of this 
section that EPA has determined that the alternative control measures 
provide substantially the same degree of protection as the specified 
control measures identified in the specified section of subpart E of 
this part which pertains to the substance for which the request is being 
submitted, the submitter may commence manufacture, import, or processing 
in accordance with the specifications for alternative worker exposure 
control measures or environmental release control measures identified in 
the submitter's request, and may alter any corresponding notification to 
workers to reflect such alternative controls. Deviations from the

[[Page 135]]

activities described in the EPA notification constitute a significant 
new use and are subject to the requirements of this part.

[53 FR 28360, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]



Sec. 721.35  Compliance and enforcement.

    (a) Failure to comply with any provision of this part is a violation 
of section 15(1) of the Act (15 U.S.C. 2614).
    (b) Using for commercial purposes a chemical substance which a 
person knew or had reason to know was manufactured, imported, or 
processed in violation of this part is a violation of section 15(2) of 
the Act (15 U.S.C. 2614).
    (c) Failure or refusal to permit access to or copying of records, as 
required by section 11 of the Act, is a violation of section 15(3) of 
the Act (15 U.S.C. 2614).
    (d) Failure or refusal to permit entry or inspection, as required by 
section 11 of the Act, is a violation of section 15(4) of the Act.
    (e) Violators of the Act or of this part may be subject to the civil 
and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for 
each violation. The submission of false or misleading information in 
connection with the requirement of any provision of this part may 
subject persons to penalties calculated as if they never filed a notice.
    (f) Under the authority of sections 7 and 17 of the Act, EPA may:
    (1) Seek to enjoin the manufacture, import, or processing of a 
chemical substance in violation of this part.
    (2) Act to seize any chemical substance which is being manufactured, 
imported, or processed in violation of this part.
    (3) Take any other appropriate action.

[53 FR 28361, July 27, 1988]




Sec. 721.40  Recordkeeping.

    Any person subject to the requirements of this part must retain 
documentation of information contained in that person's significant new 
use notice. This documentation must be maintained for a period of 5 
years from the date of the submission of the significant new use notice.

[53 FR 28361, July 27, 1988]




Sec. 721.45  Exemptions.

    The persons identified in Sec. 721.5 are not subject to the 
notification requirements of Sec. 721.25 for a chemical substance 
identified in subpart E of this part, unless otherwise specified in a 
specific section in subpart E, if:
    (a) The person has applied for and has been granted an exemption for 
test marketing the substance for a significant new use identified in 
subpart E of this part in accordance with section 5(h)(1) of the Act and 
Sec. 720.38 of this chapter.
    (b) The person manufactures, imports, or processes the substance for 
a significant new use identified in subpart E of this part in small 
quantities solely for research and development in accordance with 
Sec. 721.47.
    (c) The person has applied for and been granted an exemption under 
section 5(h)(5) of the Act.
    (d) The person manufactures, imports, or processes the substance 
only as an impurity.
    (e) The person manufactures, imports, or processes the substance 
only as a byproduct which is used only by public or private 
organizations that (1) burn it as a fuel, (2) dispose of it as a waste, 
including in a landfill or for enriching soil, or (3) extract component 
chemical substances from it for commercial purposes.
    (f) The person imports or processes the substance as part of an 
article.
    (g) The person manufactures or processes the substance solely for 
export and, when distributing the substance in commerce, labels the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (h) The person submits a significant new use notice for the 
substance prior to the promulgation date of the section in subpart E of 
this part which identifies the substance, and the person receives 
written notification of compliance from EPA prior to the effective date 
of such section. The notice submitter must comply with any applicable 
requirement of section 5(b) of the

[[Page 136]]

Act. The notice must include the information and test data specified in 
section 5(d)(1) of the Act and must be submitted on the notice form in 
Appendix A to part 720 of this chapter. For purposes of this exemption, 
the specific section in subpart E of this part which identifies the 
substance and Secs. 721.1, 721.3, 721.11, 721.35, and 721.40 apply; 
after the effective date of the section in subpart E of this part which 
identifies the substance, Sec. 721.5 applies and Sec. 721.20 continues 
to apply. EPA will provide the notice submitter with written 
notification of compliance only if one of the following occurs:
    (1) EPA is unable to make the finding that the activities described 
in the significant new use notice will or may present an unreasonable 
risk of injury to health or the environment under reasonably foreseeable 
circumstances.
    (2) EPA and the person negotiate a consent order under section 5(e) 
of the Act, such order to take effect on the effective date of the 
section in subpart E of this part which identifies the substance.
    (i) The person is operating under the terms of a consent order 
issued under section 5(e) of the Act applicable to that person. If a 
provision of such section 5(e) order is inconsistent with a specific 
significant new use identified in subpart E of this part, abiding by the 
provision of the section 5(e) order exempts the person from submitting a 
significant new use notice for that specific significant new use.

[53 FR 28361, July 27, 1988]




Sec. 721.47  Conditions for research and development exemption.

    (a) A person who manufactures, imports, or processes a chemical 
substance identifies in subpart E of this part for a significant new use 
identified in subpart E of this part is not subject to the notification 
requirements of Sec. 721.25 if the following conditions are met:
    (1) The person manufactures, imports, or processes the substance for 
the significant new use in small quantities solely for research and 
development.
    (2) The manufacturer, importer, or processor notifies all persons in 
its employ or to whom it directly distributes the chemical substance, 
who are engaged in experimentation, research, or analysis on the 
chemical substance, including the manufacture, processing, use, 
transport, storage, and disposal of the substance associated with 
research and development activities, of any risk to health, identified 
under paragraph (b) of this section, which may be associated with the 
substance. The notification must be made in accordance with paragraph 
(c) of this section.
    (3) The chemical substance is used by, or directly under the 
supervision of, a technically qualified individual.
    (b)(1) To determine whether notification under paragraph (a)(2) of 
this section is required, the manufacturer, importer, or processor must 
review and evaluate the following information to determine whether there 
is reason to believe there is any risk to health which may be associated 
with the chemicals substance:
    (i) Information in its possession or control concerning any 
significant adverse reaction by persons exposed to the chemical 
substance which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer, importer, or 
processor by a supplier or any other person concerning a health risk 
believed to be associated with the substance.
    (iii) Health and environmental effects data in its possession or 
control concerning the substance.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under section 4, 5, or 6 of the Act that applies to the 
substance and of which the manufacturer, importer, or processor has 
knowledge.
    (2) When the research and development activity is conducted solely 
in a laboratory and exposure to the chemical substance is controlled 
through the implementation of prudent laboratory practices for handling 
chemical substances of unknown toxicity, and any distribution, except 
for purposes of disposal, is to other such laboratories for further 
research and development activity, the information specified in 
paragraph (b)(1) of this section need not be reviewed and evaluated. 
(For

[[Page 137]]

purposes of this paragraph (b)(2), a laboratory is defined as a 
contained research facility where relatively small quantities of 
chemical substances are used on a pro-production basis, and where 
activities involve the use of containers for reactions, transfers, and 
other handling of substances designed to be easily manipulated by a 
single individual).
    (c)(1) The manufacturer, importer, or processor must notify the 
persons identified in paragraph (a)(2) of this section by means of a 
container labeling system, conspicuous placement of notices in areas 
where exposure may occur, written notification to each person 
potentially exposed, or any other method of notification which 
adequately informs persons of health risks which the manufacturer, 
importer, or processor has reason to believe may be associated with the 
substance, as determined under paragraph (b)(1) of this section.
    (2) If the manufacturer, importer, or processor distributes a 
chemical substance manufactured, imported, or processed under this 
section to persons not in its employ, the manufacturer, importer, or 
processor must in written form:
    (i) Notify those persons that the substance is to be used only for 
research and development purposes.
    (ii) Provide the notice of health risks specified in paragraph 
(c)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer, importer, or processor.
    (d) Quantities of the chemical substance, or of mixtures or articles 
containing the chemical substance, remaining after completion of 
research and development activities may be:
    (1) Disposed of as a waste in accordance with applicable Federal, 
State, and local regulations, to the extent the disposal activity is not 
identified as a significant new use for the substance in subpart E of 
this part, or
    (2) Used for a commercial purpose, to the extent the use is not 
identified as a significant new use of the substance in subpart E of 
this part.
    (e)(1) Persons who manufacture, import, or process a chemical 
substance under this section must retain the following records:
    (i) Copies of or citations to information reviewed and evaluated 
under paragraph (b)(1) of this section to determine the need to make any 
notification of risk.
    (ii) Documentation of the nature and method of notification under 
paragraph (c)(1) of this section including copies of any labels or 
written notices used.
    (iii) Documentation of prudent laboratory practices used instead of 
notification and evaluation under paragraph (b)(2) of this section.
    (iv) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the substance, the amount distributed, and 
copies of the notifications required under paragraph (c)(2) of this 
section.
    (2) [Reserved]

[53 FR 28361, July 27, 1988, as amended at 58 FR 34204, June 23, 1993]



                 Subpart B--Certain Significant New Uses

    Source: 54 FR 31308, July 27, 1989, unless otherwise noted.



Sec. 721.50  Applicability.

    This subpart B identifies certain significant new uses of chemical 
substances identified in subpart E of this part. The provisions of this 
subpart B apply only when referenced as applying to a chemical substance 
identified in subpart E of this part.




Sec. 721.63  Protection in the workplace.

    (a) Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of the substance is 
any manner or method of manufacturing, importing, or processing 
associated with any use of the substance without establishing a program 
whereby:
    (1) Each person who is reasonably likely to be dermally exposed in 
the work area to the chemical substance through direct handling of the 
substance or through contact with equipment on which the substance may 
exist, or because the substance becomes airborne in the form listed in

[[Page 138]]

paragraph (a)(6) of this section, and cited in subpart E of this part 
for the chemical substance, is provided with, and is required to wear, 
personal protective equipment that provides a barrier to prevent dermal 
exposure to the substance in the specific work area where it is selected 
for use. Each such item of personal protective equipment must be 
selected and used in accordance with 29 CFR 1910.132 and 1910.133.
    (2) In addition to any other personal protective equipment selected 
in paragraph (a)(1) of this section, the following items are required:
    (i) Gloves.
    (ii) Full body chemical protective clothing.
    (iii) Chemical goggles or equivalent eye protection.
    (iv) Clothing which covers any other exposed areas of the arms, 
legs, and torso. Clothing provided under this paragraph need not be 
tested or evaluated under the requirements of paragraph (a)(3) of this 
section.
    (3) The employer is able to demonstrate that each item of chemical 
protective clothing, including gloves, selected provides an impervious 
barrier to prevent dermal exposure during normal and expected duration 
and conditions of exposure within the work area by any one or a 
combination of the following:
    (i) Testing the material used to make the chemical protective 
clothing and the construction of the clothing to establish that the 
protective clothing will be impervious for the expected duration and 
conditions of exposure. The testing must subject the chemical protective 
clothing to the expected conditions of exposure, including the likely 
combinations of chemical substances to which the clothing may be exposed 
in the work area.
    (ii) Evaluating the specifications from the manufacturer or supplier 
of the chemical protective clothing, or of the material used in 
construction of the clothing, to establish that the chemical protective 
clothing will be impervious to the chemical substance alone and in 
likely combination with other chemical substances in the work area.
    (4) Each person who is reasonably likely to be exposed to the 
chemical substance by inhalation in the work area in one or more of the 
forms listed in paragraph (a)(6) of this section and cited in subpart E 
of this part for the chemical substance, is provided with, and is 
required to wear, at a minimum, a NIOSH- approved respirator from one of 
the categories listed in paragraph (a)(5) of this section, and the 
respirator is used in accordance with 29 CFR 1910.134 and 30 CFR part 
11.
    (5) The following NIOSH approved respirators meet the minimum 
requirements for paragraph (a)(4) of this section:
    (i) Category 19C Type C supplied-air respirator operated in pressure 
demand or other positive pressure mode and equipped with a full 
facepiece.
    (ii) Category 19C Type C supplied-air respirator operated in 
pressure demand or continuous flow mode and equipped with a tight-
fitting facepiece.
    (iii) Category 19C Type C supplied-air respirator operated in 
pressure demand or continuous flow mode and equipped with a hood or 
helmet or tight-fitting facepiece.
    (iv) Category 21C air-purifying respirator equipped with a full 
facepiece and high efficiency particulate filters.
    (v) Category 21C powered air-purifying respirator equipped with a 
tight-fitting facepiece and high efficiency particulate filters.
    (vi) Category 21C powered air-purifying respirator equipped with a 
loose-fitting hood or helmet and high efficiency particulate filters.
    (vii) Category 21C air-purifying respirator equipped with a high 
efficiency particulate filter including disposable respirators.
    (viii) Category 23C air-purifying respirator equipped with a full 
facepiece and combination cartridges approved for paints, lacquers, and 
enamels. (Approval label may preclude use for some paints, lacquers, or 
enamels.)
    (ix) Category 23C powered air-purifying respirator equipped with a 
tight-fitting facepiece and combination cartridges approved for paints, 
lacquers, and enamels. (Approval label may preclude use for some paints, 
lacquers, or enamels.)
    (x) Category 23C powered air-purifying respirator equipped with a 
loose-fitting hood or helmet and combination

[[Page 139]]

cartridges approved for paints, lacquers, and enamels. (Approval label 
may preclude use for some paints, lacquers, or enamels.)
    (xi) Category 23C air-purifying respirator equipped with combination 
cartridges approved for paints, lacquers, and enamels, including 
disposable respirators. (Approval label may preclude use for some 
paints, lacquers, or enamels.)
    (xii) Category 23C air-purifying respirator equipped with a full 
facepiece and organic gas/vapor cartridges.
    (xiii) Category 23C powered air-purifying respirator equipped with a 
tight-fitting facepiece and organic gas/vapor cartridges.
    (xiv) Category 23C powered air-purifying respirator equipped with a 
loose-fitting hood or helmet and organic gas/vapor cartridges.
    (xv) Category 23C air-purifying respirator equipped with organic 
gas/vapor cartridges, including disposable respirators.
    (6) When cited in subpart E of this part for a substance, the 
following airborne form(s) of the substance apply to paragraphs (a) (1) 
and (4) of this section:
    (i) Dust.
    (ii) Mist.
    (iii) Fume.
    (iv) Smoke.
    (v) Vapor.
    (vi) Gas.
    (b) If a substance identified in subpart E of this part is present 
in the work area only as a mixture, an employer is exempt from the 
provisions of this section if the concentration of the substance in the 
mixture does not exceed a concentration set in subpart E of this part. 
The exemption does not apply if the employer has reason to believe that 
during intended use or processing in the work area, the substance in the 
mixture may be concentrated above the level set in subpart E of this 
part.
    (c)(1) If at any time after commencing distribution in commerce of a 
chemical substance that is identified in subpart E of this part as 
subject to this section, the person has knowledge that a recipient of 
the substance is engaging in an activity that is not consistent with the 
implementation of a program specified in paragraph (a) of this section, 
the person is considered to have knowledge that the recipient is 
engaging in a significant new use and is required to follow the 
procedures in Sec. 721.5(d) unless the person is able to document the 
following:
    (i) That the person has notified the recipient in writing within 15 
working days of the time the person first has knowledge that the 
recipient is engaging in an activity that is not consistent with the 
implementation of a program specified in paragraph (a) of this section, 
and that the person has knowledge of the failure of implementation.
    (ii) That within 15 working days of notifying the recipient that the 
recipient is engaging in an activity that is not consistent with the 
implementation of a program specified in paragraph (a) of this section 
the person has received from the recipient, in writing, a statement of 
assurance that the recipient has established the program required under 
paragraph (a) of this section, and will take appropriate measures to 
avoid activities that are inconsistent with implementation of the 
program required under paragraph (a) of this section.
    (2) If, after receiving a statement of assurance from a recipient 
under paragraph (c)(1)(ii) of this section, a manufacturer, importer, or 
processor has knowledge that the recipient is engaging in an activity 
that is not consistent with the implementation of the program specified 
in paragraph (a) of this section, that person is considered to have 
knowledge that the person is engaging in a significant new use and is 
required to follow the procedures in Sec. 721.5(d).




Sec. 721.72  Hazard communication program.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of that substance 
is any manner or method of manufacture, import, or processing associated 
with any use of that substance without establishing a hazard 
communication program as described in this section.
    (a) Written hazard communication program. Each employer shall 
develop and

[[Page 140]]

implement a written hazard communication program for the substance in 
each workplace. The written program will, at a minimum, describe how the 
requirements of this section for labels, MSDSs, and other forms of 
warning material will be satisfied. The employer must make the written 
hazard communication program available, upon request, to all employees, 
contractor employees, and their designated representatives. The employer 
may rely on an existing hazard communication program, including an 
existing program established under the Occupational Health and Safety 
Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), 
to comply with this paragraph provided that the existing hazard 
communication program satisfies the requirements of this paragraph. The 
written program shall include the following:
    (1) A list of each substance identified in subpart E of this part as 
subject to this section known to be present in the work area. The list 
must be maintained in the work area and must use the identity provided 
on the appropriate MSDS for each substance required under paragraph (c) 
of this section. The list may be compiled for the workplace or for 
individual work areas.
    (2) The methods the employer will use to inform employees of the 
hazards of non-routine tasks involving the substance, for example, the 
cleaning of reactor vessels, and the hazards associated with the 
substance contained in unlabeled pipes in their work area.
    (3) The methods the employer will use to inform contractors of the 
presence of the substance in the employer's workplace and of the 
provisions of this part applicable to the substance if employees of the 
contractor work in the employer's workplace and are reasonably likely to 
be exposed to the substance while in the employer's workplace.
    (b) Labeling. (1) Each employer shall ensure that each container of 
the substance in the workplace is labeled in accordance with this 
paragraph (b)(1).
    (i) The label shall, at a minimum, contain the following 
information:
    (A) A statement of health hazard(s) and precautionary measure(s) for 
the substance, if any, identified in subpart E of this part or by the 
employer.
    (B) The identity by which the substance may be commonly recognized.
    (C) A statement of environmental hazard(s) and precautionary 
measure(s) for the substance, if any, identified in subpart E of this 
part or by the employer.
    (D) A statement of exposure and precautionary measure(s), if any, 
identified in subpart E of this part or by the employer.
    (ii) The employer may use signs, placards, process sheets, batch 
tickets, operating procedures, or other such written materials in lieu 
of affixing labels to individual stationary process containers, as long 
as the alternative method identifies the containers to which it is 
applicable and conveys information specified by paragraph (b)(1)(i) of 
this section. Any written materials must be readily accessible to the 
employees in their work areas throughout each work shift.
    (iii) The employer need not label portable containers into which the 
substance is transferred from labeled containers, and which are intended 
only for the immediate use of the employee who performs the transfer.
    (iv) The employer shall not remove or deface an existing label on 
incoming containers of the substance unless the container is immediately 
relabeled with the information specified in paragraph (b)(1)(i) of this 
section.
    (2) Each employer shall ensure that each container of the substance 
leaving its workplace for distribution in commerce is labeled in 
accordance with this paragraph.
    (i) The label shall, at a minimum, contain the following 
information:
    (A) The information required under paragraph (b)(1)(i) of this 
section.
    (B) The name and address of the manufacturer or a responsible party 
who can provide additional information on the substance for hazard 
evaluation and any appropriate emergency procedures.
    (ii) The label shall not conflict with the requirements of the 
Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and 
regulations issued under that Act by the Department of Transportation.

[[Page 141]]

    (3) The label, or alternative forms of warning, shall be legible and 
prominently displayed.
    (4) The label, or alternative forms of warning, shall be in English; 
however, the information may be repeated in other languages.
    (5) If the label or alternative form of warning is to be applied to 
a mixture containing a substance identified in subpart E of this part as 
subject to this section in combination with another substance identified 
in subpart E of this part and/or a substance defined as a ``hazardous 
chemical'' under the Occupational Safety and Health Administration 
(OSHA) Hazard Communication Standard (29 CFR 1900.1200), the employer 
may prescribe on the label, MSDS, or alternative form of warning, the 
measures to control worker exposure or environmental release which the 
employer determines provide the greatest degree of protection. However, 
should these control measures differ from the applicable measures 
required under subpart E of this part, the employer must seek a 
determination of equivalency for such alternative control measures 
pursuant to Sec. 721.30 before prescribing them under this paragraph.
    (c) Material safety data sheets. (1) Each employer must obtain or 
develop a MSDS for the substance.
    (2) Each MSDS shall contain, at a minimum, the following 
information:
    (i) The identity used on the container label of the substance under 
this section, and, if not claimed confidential, the chemical and common 
name of the substance. If the chemical and common name are claimed 
confidential, a generic chemical name must be used.
    (ii) Physical and chemical characteristics of the substance known to 
the employer (such as vapor pressure, flash point).
    (iii) The physical hazards of the substance known to the employer, 
including the potential for fire, explosion, and reactivity.
    (iv) The potential human and environmental hazards as specified in 
subpart E of this part for the substance.
    (v) Signs and symptoms of exposure, and any medical conditions which 
are expected to be aggravated by exposure to the substance known to the 
employer.
    (vi) The primary routes of exposure to the substance.
    (vii) Precautionary measures to control worker exposure and/or 
environmental release identified in subpart E of this part for the 
substance, or alternative control measures which EPA has determined 
under Sec. 721.30 provide substantially the same degree of protection as 
the identified control measures.
    (viii) Any generally applicable precautions for safe handling and 
use of the substance which are known to the employer, including 
appropriate hygienic practices, protective measures during repair and 
maintenance of contaminated equipment, and procedures for response to 
spills and leaks.
    (ix) Any generally applicable control measures which are known to 
the employer, such as appropriate engineering controls, work practices, 
or personal protective equipment.
    (x) Emergency first aid procedures known to the employer.
    (xi) The date of preparation of the MSDS or of its last revision.
    (xii) The name, address, and telephone number of the individual 
preparing or distributing the MSDS, or a responsible party who can 
provide additional information on the substance for hazard evaluation 
and any appropriate emergency procedures.
    (3) If no relevant information is found or known for any given 
category on the MSDS, the employer must mark the MSDS to indicate that 
no applicable information was found.
    (4) Where multiple mixtures containing the substance have similar 
compositions (i.e., the chemical ingredients are essentially the same, 
but the specific composition varies from mixture to mixture) and similar 
hazards, the employer may prepare one MSDS to apply to all of these 
multiple mixtures.
    (5) If the employer becomes aware of any significant new information 
regarding the hazards of the substance or ways to protect against the 
hazards, this new information must be added to the MSDS within 3 months 
from the time the employer becomes aware of the new information. If the 
substance

[[Page 142]]

is not currently being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to the 
MSDS before the substance is reintroduced into the workplace.
    (6) The employer must ensure that persons receiving the substance 
from the employer are provided an appropriate MSDS with their initial 
shipment and with the first shipment after an MSDS is revised. The 
employer may either provide the MSDS with the shipped containers or send 
it to the person prior to or at the time of shipment.
    (7) The employer must maintain a copy of the MSDS in its workplace, 
and must ensure that it is readily accessible during each work shift to 
employees when they are in their work areas.
    (8) The MSDS may be kept in any form, including as operating 
procedures, and may be designed to cover groups of substances in a work 
area where it may be more appropriate to address the potential hazards 
of a process rather than individual substances. However, in all cases, 
the required information must be provided for each substance and must be 
readily accessible during each work shift to employees when they are in 
their work areas.
    (9) The MSDS must be printed in English; however, the information 
may be repeated in other languages.
    (d) Employee information and training. Each employer must ensure 
that employees are provided with information and training on the 
substance identified in subpart E of this part. This information and 
training must be provided at the time of each employee's initial 
assignment to a work area containing the substance and whenever the 
substance subject to this section is introduced into the employee's work 
area for the first time.
    (1) Information provided to employees under this paragraph shall 
include:
    (i) The requirements of this section.
    (ii) Any operations in the work area where the substance is present.
    (iii) The location and availability of the written hazard 
communication program required under paragraph (a) of this section, 
including the list of substances identified in subpart E of this part as 
subject to this section, and MSDSs required by paragraph (c) of this 
section.
    (2) Training provided to employees shall include:
    (i) Methods and observations that may be used to detect the presence 
or release of the substance in or from an employee's work area (such as 
monitoring conducted by the employer, continuous monitoring devices, 
visual appearance, or odor of the substance when being released).
    (ii) The potential human health and environmental hazards of the 
substance as specified in subpart E of this part.
    (iii) The measures employees can take to protect themselves and the 
environment from the substance, including specific procedures the 
employer has implemented to protect employees and the environment from 
exposure to the substance, including appropriate work practices, 
emergency procedures, personal protective equipment, engineering 
controls, and other measures to control worker exposure and/or 
environmental release required under subpart E of the part, or 
alternative control measures which EPA has determined under Sec. 721.30 
provide substantially the same degree of protection as the specified 
control measures.
    (iv) The requirements of the hazard communication program developed 
by the employer under this section, including an explanation of the 
labeling system and the MSDS required by this section and guidance on 
obtaining and using appropriate hazard information.
    (e) Low concentrations in mixtures. If a substance identified in 
subpart E of this part is present in the work area only as a mixture, an 
employer is exempt from the provisions of this section if the 
concentration of the substance in the mixture does not exceed a 
concentration set in subpart E of this part. The exemption does not 
apply if the employer has reason to believe that during intended use or 
processing in the work area, the substance in the mixture may be 
concentrated above the level set in subpart E of this part.
    (f) Existing hazard communication program. The employer need not 
take additional actions if existing programs and procedures satisfy the 
requirements of this section.

[[Page 143]]

    (g) Human health, environmental hazard, exposure, and precautionary 
statements. Whenever referenced in subpart E of this part for a 
substance, the following human health and environmental hazard, 
exposure, and precautionary statements shall appear on each label as 
specified in paragraph (b) of this section and the MSDS as specified in 
paragraph (c) of this section. Additional statements may be included as 
long as they are true and do not alter the meaning of the required 
statements.
    (1) Human health hazard statements: This substance may cause:
    (i) Skin irritation.
    (ii) Respiratory complications.
    (iii) Central nervous system effects.
    (iv) Internal organ effects.
    (v) Birth defects.
    (vi) Reproductive effects.
    (vii) Cancer.
    (viii) Immune system effects.
    (ix) Developmental effects.
    (2) Human health hazard precautionary statements: When using this 
substance:
    (i) Avoid skin contact.
    (ii) Avoid breathing substance.
    (iii) Avoid ingestion.
    (iv) Use respiratory protection.
    (v) Use skin protection.
    (3) Environmental hazard statements: This substance may be:
    (i) Toxic to fish.
    (ii) Toxic to aquatic organisms.
    (4) Environmental hazard precautionary statements: Notice to users:
    (i) Disposal restrictions apply.
    (ii) Spill clean-up restrictions apply.
    (iii) Do not release to water.
    (5) Each human health or environmental hazard precautionary 
statement identified in subpart E of this part for the label on the 
substance container must be followed by the statement, ``See MSDS for 
details.''
    (h) Human health, environmental hazard exposure and precautionary 
statements. (1) Whenever referenced in subpart E of this part for a 
substance, the following human health, environmental hazard, exposure, 
and precautionary statements shall appear on each label as specified in 
paragraph (b) of this section. Additional statements may be included as 
long as they are true and do not alter the meaning of the required 
statements.
    (i) Precautionary statements. (A) The health effects of this 
chemical substance have not been determined.
    (B) When using this substance, use skin protection.
    (C) Use respiratory protection when there is a reasonable likelihood 
of exposure in the work area from dust, mist, or smoke from spray 
application.
    (D) Chemicals similar in structure to this substance have been found 
to cause cancer in laboratory animals.
    (ii) Human health hazard statements. This substance may cause:
    (A) Skin irritation
    (B) Respiratory complications
    (C) Central nervous system effects
    (D) Internal organ effects
    (E) Birth defects
    (F) Reproductive effects
    (G) Cancer
    (H) Immune system effects
    (I) Developmental effects
    (iii) Human health hazard precautionary statements. When using this 
substance:
    (A) Avoid skin contact
    (B) Avoid breathing substance
    (C) Avoid ingestion
    (D) Use respiratory protection
    (E) Use skin protection
    (iv) Environmental hazard statements. This substance may be:
    (A) Toxic to fish
    (B) Toxic to aquatic organisms
    (v) Environmental hazard precautionary statements. Notice to Users:
    (A) Disposal restrictions apply
    (B) Spill clean-up restrictions apply
    (C) Do not release to water.
    (vi) Additional statements. Each human health or environmental 
precautionary statement identified in subpart E of this part for the 
label on the substance container must be followed by the statement, 
``See MSDS for details.''
    (2) Whenever referenced in subpart E of this part for a substance, 
the following human health, environmental hazard, exposure, and 
precautionary statements shall appear on each MSDS as specified in 
paragraph (c) of this section. Additional statements may be included as 
long as they are true and do not alter the meaning of the required 
statements.

[[Page 144]]

    (i) Precautionary statements. (A) The health effects of this 
chemical substance have not been determined.
    (B) When using this substance, use skin protection.
    (C) Use respiratory protection when there is a reasonable likelihood 
of exposure in the work area from dust, mist, or smoke from spray 
application.
    (D) Chemicals similar in structure to this substance have been found 
to cause cancer in laboratory animals.
    (ii) Human health hazard statements. This substance may cause:
    (A) Skin irritation
    (B) Respiratory complications
    (C) Central nervous system effects
    (D) Internal organ effects
    (E) Birth defects
    (F) Reproductive effects
    (G) Cancer
    (H) Immune system effects
    (I) Developmental effects
    (iii) Human health hazard precautionary statements. When using this 
substance:
    (A) Avoid skin contact
    (B) Avoid breathing substance
    (C) Avoid ingestion
    (D) Use respiratory protection
    (E) Use skin protection
    (iv) Environmental hazard statements. This substance may be:
    (A) Toxic to fish
    (B) Toxic to aquatic organisms
    (v) Environmental hazard precautionary statements. Notice to Users:
    (A) Disposal restrictions apply
    (B) Spill clean-up restrictions apply
    (C) Do not release to water.

[54 FR 31308, July 27, 1989, as amended at 55 FR 45996, Oct. 31, 1990; 
58 FR 34204, June 23, 1993]




Sec. 721.80  Industrial, commercial, and consumer activities.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of the substance 
is:
    (a) Use in non-enclosed processes.
    (b) Any manner or method of manufacture in non-enclosed processes 
associated with any use.
    (c) Any manner or method of processing in non-enclosed processes 
associated with any use.
    (d) Use beyond the site of manufacture or import.
    (e) Processing beyond the site of manufacture or import.
    (f) Any manner or method of manufacture (excluding import) of the 
substance associated with any use.
    (g) Use other than as an intermediate.
    (h) Use other than as a site-limited intermediate.
    (i) Use as an intermediate where the concentration of the 
intermediate substance in the product intended for distribution in 
commerce exceeds the concentration specified in subpart E of this part 
for the substance.
    (j) Use other than as described in the premanufacture notice 
referenced in subpart E of this part for the substance.
    (k) Use other than allowed by the section 5(e) consent order 
referenced in subpart E of this part for the substance.
    (l) Non-industrial use.
    (m) Commercial use.
    (n) Non-commercial use.
    (o) Use in a consumer product.
    (p) Aggregate manufacture and importation volume for any use greater 
than that specified in subpart E of this part for the substance.
    (q) Aggregate manufacture and importation volume for any use greater 
than that allowed by the section 5(e) consent order referenced in 
subpart E of this part for the substance.
    (r) Aggregate manufacture and importation volume for any use greater 
than that specified in subpart E of this part for the substance unless 
the manufacturer or importer has submitted the results of the health or 
environmental effects studies identified in subpart E of this part for 
the substance and those studies comply with the procedures and criteria 
for developing and evaluating data identified in subpart E of this part 
for the substance.
    (s) Annual manufacture and importation volume for any use greater 
than that specified in subpart E of this part for the substance.
    (t) Annual manufacture and importation volume for any use greater 
than that allowed by the section 5(e) consent order referenced in 
subpart E of this part for the substance.
    (u) Annual manufacture and importation volume for any use greater 
than

[[Page 145]]

that specified in subpart E of this part for the substance unless the 
manufacturer or importer has submitted the results of the health or 
environmental effects studies identified in subpart E of this part for 
the substance and those studies comply with the procedures and criteria 
for developing and evaluating data identified in subpart E of this part 
for the substance.
    (v) Use in the form of:
    (1) A powder.
    (2) A solid.
    (3) A liquid.
    (4) A gas.
    (w) Any manner or method of manufacture of the substance in the 
following form associated with any use:
    (1) A powder.
    (2) A solid.
    (3) A liquid.
    (4) A gas.
    (x) Any manner or method of processing of the substance in the 
following form associated with any use:
    (1) A powder.
    (2) A solid.
    (3) A liquid.
    (4) A gas.
    (y) Use involving an application method that generates:
    (1) A vapor, mist, or aerosol.
    (2) A dust.




Sec. 721.85  Disposal.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of the substance is 
any method of:
    (a) Disposal of the process stream associated with any use of the 
substance or with any manner or method of manufacturing associated with 
any use of the substance other than by the following. This provision 
does not supercede any applicable Federal, State, or local laws and 
regulations.
    (1) Incineration.
    (2) Landfill.
    (3) Deep well injection.
    (b) Disposal of the process stream associated with any use or with 
any manner or method of processing associated with any use other than by 
the following. This provision does not supercede any applicable Federal, 
State, or local laws and regulations.
    (1) Incineration.
    (2) Landfill.
    (3) Deep well injection.
    (c) Disposal of the use stream associated with any use, other than 
by the following. This provision does not supercede any applicable 
Federal, State, or local laws and regulations.
    (1) Incineration.
    (2) Landfill.
    (3) Deep well injection.
    (d) Disposal of the substance associated with any use of the 
substance, or with any manner or method of manufacture or processing in 
association with any use. This provision does not supercede any 
applicable Federal, State, or local laws and regulations.




Sec. 721.90  Release to water.

    Whenever a substance is identified in subpart E of this part as 
being subject to this section, a significant new use of the substance 
is:
    (a) Any predictable or purposeful release of a manufacturing stream 
associated with any use of the substance, from any site:
    (1) Into the waters of the United States.
    (2) Into the waters of the United States without application of one 
or more of the following treatment technologies as specified in subpart 
E of this part either by the discharger or, in the case of a release 
through publicly-owned treatment works, by a combination of treatment by 
the discharger and the publicly-owned treatment works:
    (i) Chemical precipitation and settling.
    (ii) Biological treatment (activated sludge or equivalent) plus 
clarification.
    (iii) Steam stripping.
    (iv) Resin or activated carbon adsorption.
    (v) Chemical destruction or conversion.
    (vi) Primary wastewater treatment.
    (3) Into the waters of the United States without primary wastewater 
treatment, and secondary wastewater treatment as defined in 40 CFR part 
133.
    (4) Into the waters of the United States if the quotient from the 
following formula:

[[Page 146]]



 
 number of kilograms/day/site released
----------------------------------------
 receiving stream flow (million liters/    X  1000 = N parts per billion
                  day)
 


exceeds the level specified in subpart E of this part when calculated 
using the methods described in Sec. 721.91. In lieu of calculating the 
above quotient, monitoring or alternative calculations may be used to 
predict the surface water concentration which will result from the 
intended release of the substance, if the monitoring procedures or 
calculations have been approved for such purpose by EPA. EPA will review 
and act on written requests to approve monitoring procedures or 
alternative calculations within 90 days after such requests are 
received. EPA will inform submitters of the disposition of such requests 
in writing, and will explain the reasons therefor when they are denied.
    (b) Any predictable or purposeful release of a process stream 
containing the substance associated with any use of the substance from 
any site:
    (1) Into the waters of the United States.
    (2) Into the waters of the United States without application of one 
or more of the following treatment technologies as specified in subpart 
E of this part either by the discharger or, in the case of a release 
through publicly-owned treatment works, by a combination of treatment by 
the discharger and the publicly-owned treatment works:
    (i) Chemical precipitation and settling.
    (ii) Biological treatment (activated sludge or equivalent) plus 
clarification.
    (iii) Steam stripping.
    (iv) Resin or activated carbon adsorption.
    (v) Chemical destruction or conversion.
    (vi) Primary wastewater treatment.
    (3) Into the waters of the United States without primary wastewater 
treatment, and secondary wastewater treatment as defined in 40 CFR part 
133.
    (4) Into the waters of the United States if the quotient from the 
following formula:

 
 number of kilograms/day/site released
----------------------------------------           1000 = N parts per
 receiving stream flow (million liters/    X            billion
                  day)
 


exceeds the level specified in subpart E of this part when calculated 
using the methods described in Sec. 721.91. In lieu of calculating the 
above quotient, monitoring or alternative calculations may be used to 
predict the surface water concentration which will result from the 
intended release of the substance, if the monitoring procedures or 
calculations have been approved for such purpose by EPA. EPA will review 
and act on written requests to approve monitoring procedures or 
alternative calculations within 90 days after such requests are 
received. EPA will inform submitters of the disposition of such requests 
in writing, and will explain the reasons therefor when they are denied.
    (c) Any predictable or purposeful release of a use stream containing 
the substance associated with any use of the substance from any site:
    (1) Into the waters of the United States.
    (2) Into the waters of the United States without application of one 
or more of the following treatment technologies as specified in subpart 
E of this part either by the discharger or, in the case of a release 
through publicly-owned treatment works, by a combination of treatment by 
the discharger and the publicly-owned treatment works:
    (i) Chemical precipitation and settling.
    (ii) Biological treatment (activated sludge or equivalent) plus 
clarification.
    (iii) Steam stripping.
    (iv) Resin or activated carbon adsorption.
    (v) Chemical destruction or conversion.
    (vi) Primary wastewater treatment.
    (3) Into the waters of the United States without primary wastewater 
treatment, and secondary wastewater treatment as defined in 40 CFR part 
133.
    (4) Into the waters of the United States if the quotient from:

[[Page 147]]



 
 number of kilograms/day/site released
----------------------------------------
 receiving stream flow (million liters/    X  1000 = N parts per billion
                  day)
 


exceeds the level specified in subpart E of this part, when calculated 
using the methods described in Sec. 721.91. In lieu of calculating the 
above quotient, however, monitoring or alternative calculations may be 
used to predict the surface water concentration expected to result from 
intended release of the substance, if the monitoring procedures or 
calculations have been approved for such purpose by EPA. EPA will review 
and act on written requests to approve monitoring procedures or 
alternative calculations within 90 days after such requests are 
received. EPA will inform submitters of the disposition of such requests 
in writing, and will explain the reasons therefor when they are denied.



Sec. 721.91  Computation of estimated surface water concentrations: Instructions.

    These instructions describe the use of the equation specified in 
Sec. 721.90(a)(4) and (b)(4) to compute estimated surface water 
concentrations which will result from release of a substance identified 
in subpart E of this part. The equation shall be computed for each site 
using the stream flow rate appropriate for the site according to 
paragraph (b) of this section, and the highest number of kilograms 
calculated to be released for that site on a given day according to 
paragraph (a) of this section. Two variables shall be considered in 
computing the equation, the number of kilograms released, and receiving 
stream flow.
    (a) Number of kilograms released. (1) To calculate the number of 
kilograms of substance to be released from manufacturing, processing, or 
use operations, as specified in the numerator of the equation, develop a 
process description diagram which describes each manufacturing, 
processing, or use operation involving the substance. The process 
description must include the major unit operation steps and chemical 
conversions. A unit operation is a functional step in a manufacturing, 
processing, or use operation where substances undergo chemical changes 
and/or changes in location, temperature, pressure, physical state, or 
similar characteristics. Include steps in which the substance is 
formulated into mixtures, suspensions, solutions, etc.
    (2) Indicate on each diagram the entry point of all feedstocks 
(e.g., reactants, solvents, and catalysts) used in the operation. 
Identify each feedstock and specify its approximate weight regardless of 
whether the process is continuous or batch.
    (3) Identify all release points from which the substance or wastes 
containing the substance will be released into air, land, or water. 
Indicate these release points on the diagram. Do not include accidental 
releases or fugitive emissions.
    (4) For releases identified in the diagram that are destined for 
water, estimate the amount of substance that will be released before the 
substance enters control technology. The kilograms of substance released 
may be estimated based on:
    (i) The mass balance of the operation, i.e., totaling inputs and 
outputs, including wastes for each part of the process such that outputs 
equal inputs. The amount released to water may be the difference between 
the amount of the substance in the starting material (or formed in a 
reaction) minus the amount of waste material removed from each part of 
the process and not released to water and the amount of the substance in 
the final product.
    (ii) Physical properties such as water solubility where a known 
volume of water being discharged is assumed to contain the substance at 
concentrations equal to its solubility in water. This approach is 
particularly useful where the waste stream results from separation of 
organic/water phases or filtration of the substance from an aqueous 
stream to be discharged.
    (iii) Measurements of flow rates of the process/use stream and known 
concentrations of the substance in the stream.
    (5) After releases of a substance to water are estimated for each 
operation on a site, total the releases of the substance to water from 
all operations at that site. The value (number of kilograms) specified 
in the numerator of

[[Page 148]]

the equation should reflect total kilograms of substance released to 
water per day from all operations at a single site.
    (6) Use the highest expected daily release of the substance for each 
site.
    (b) Receiving stream flow. (1) The receiving stream flow shall be 
expressed in million liters per day (MLD). The flow rate data to be used 
must be for the point of release on the water body that first receives 
release of the substance whether by direct discharge from a site, or by 
indirect discharge through a Publicly-Owned Treatment Works (POTW) for 
each site. The flow rate reported shall be the lowest 7-day average 
stream flow with a recurrence interval of 10 years (7-Q-10). If the 7-Q-
10 flow rate is not available for the actual point of release, the 
stream flow rate should be used from the U.S. Geological Survey (USGS) 
gauging station that is nearest the point of release that is expected to 
have a flow rate less than or equal to the receiving stream flow at the 
point of release.
    (2) Receiving stream flow data may be available from the National 
Pollutant Discharge Elimination System (NPDES) permit for the site or 
the POTW releasing the substance to surface water, from the NPDES 
permit-writing authority for the site or the POTW, or from USGS 
publications, such as the water-data report series.
    (3) If receiving stream flow data are not available for a stream, 
either the value of 10 MLD or the daily flow of wastewater from the site 
or the POTW releasing the substance must be used as an assumed minimum 
stream flow. Similarly, if stream flow data are not available because 
the location of the point of release of the substance to surface water 
is a lake, estuary, bay, or ocean, then the flow rate to be used must be 
the daily flow of wastewater from the site or the POTW releasing the 
substance to surface water. Wastewater flow data may be available from 
the NPDES permit or NPDES authority for the site or the POTW releasing 
the substance to water.



                  Subpart C--Recordkeeping Requirements



Sec. 721.100  Applicability.

    This subpart C identifies certain additional recordkeeping 
requirements applicable to manufacturers, importers, and processors of 
substances identified in subpart E of this part for each specific 
substance. The provisions of this subpart C apply only when referenced 
in subpart E of this part for a substance and significant new use 
identified in that subpart E. If the provisions in this subpart C 
conflict with general provisions of subpart A of this part, the 
provisions of this subpart C shall apply.

[54 FR 31313, July 27, 1989]



Sec. 721.125  Recordkeeping requirements.

    At the time EPA adds a substance to subpart E of this part, EPA will 
specify appropriate recordkeeping requirements which correspond to the 
significant new use designations for the substance selected from subpart 
B of this part. Each manufacturer, importer, and processor of the 
substance shall maintain the records for 5 years from the date of their 
creation. In addition to the records specified in Sec. 721.40, the 
records whose maintenance this section requires may include the 
following:
    (a) Records documenting the manufacture and importation volume of 
the substance and the corresponding dates of manufacture and import.
    (b) Records documenting volumes of the substance purchased in the 
United States by processors of the substance, names and addresses of 
suppliers, and corresponding dates of purchase.
    (c) Records documenting the names and addresses (including shipment 
destination address, if different) of all persons outside the site of 
manufacture, importation, or processing to whom the manufacturer, 
importer, or processor directly sells or transfers the substance, the 
date of each sale or transfer, and the quantity of the substance sold or 
transferred on such date.
    (d) Records documenting establishment and implementation of a 
program

[[Page 149]]

for the use of any applicable personal protective equipment required 
under Sec. 721.63.
    (e) Records documenting the determinations required by Sec.  
721.63(a)(3) that chemical protective clothing is impervious to the 
substance.
    (f) Records documenting establishment and implementation of the 
hazard communication program required under Sec. 721.72.
    (g) Copies of labels required under Sec. 721.72(b).
    (h) Copies of material safety data sheets required under Sec.  
721.72(c).
    (i) Records documenting compliance with any applicable industrial, 
commercial, and consumer use limitations under Sec.  721.80.
    (j) Records documenting compliance with any applicable disposal 
requirements under Sec. 721.85, including the method of disposal, 
location of disposal sites, dates of disposal, and volume of the 
substance disposed. Where the estimated disposal volume is not known to 
or reasonably ascertainable by the manufacturer, importer, or processor, 
that person must maintain other records which demonstrate establishment 
and implementation of a program that ensures compliance with any 
applicable disposal requirements.
    (k) Records documenting establishment and implementation of 
procedures that ensure compliance with any applicable water discharge 
limitations under Sec. 721.90.

[54 FR 31313, July 27, 1989]



 Subpart D--Expedited Process for Issuing Significant New Use Rules for 
 Selected Chemical Substances and Limitation or Revocation of Selected 
                        Significant New Use Rules

    Source: 54 FR 31314, July 27, 1989, unless otherwise noted.



Sec. 721.160  Notification requirements for new chemical substances subject to section 5(e) orders.

    (a) Selection of substances. (1) In accordance with the expedited 
process specified in this section, EPA will issue significant new use 
notification requirements and other specific requirements for each new 
chemical substance that is the subject of a final order issued under 
section 5(e) of the Act, except for an order that prohibits manufacture 
and import of the substance, unless EPA determines that significant new 
use notification requirements are not needed for the substance.
    (2) If EPA determines that significant new use notification 
requirements are not needed for a substance that is subject to a final 
order issued under section 5(e) of the Act, except for an order that 
prohibits manufacture or import of the substance, EPA will issue a 
notice in the Federal Register explaining why the significant new use 
requirements are not needed.
    (b) Designation of requirements. (1) The significant new use 
notification and other specific requirements will be based on and be 
consistent with the provisions included in the final order issued for 
the substance under section 5(e) of the Act. EPA may also designate 
additional activities as significant new uses which will be subject to 
notification. Designation of additional activities as significant new 
uses will be done in accordance with the criteria and procedures under 
Sec. 721.170, or through a separate rulemaking proceeding.
    (2) Significant new use requirements and other specific requirements 
designated under this section will be listed in subpart E of this part. 
For each substance, subpart E will identify:
    (i) The chemical name.
    (ii) The activities designated as significant new uses.
    (iii) Other specific requirements applicable to the substance, 
including recordkeeping requirements or any other requirements included 
in the final section 5(e) order.
    (c) Procedures for issuing significant new use rules. (1) EPA will 
issue significant new use rules under this section by one of the 
following three processes: direct final rulemaking, interim final 
rulemaking, or notice and comment rulemaking. EPA will use the direct 
final rulemaking process to issue significant new use rules unless it 
determines that, in a particular case, one of the other processes is 
more appropriate.

[[Page 150]]

    (2) Federal Register documents issued to propose or establish 
significant new uses under this section will contain the following:
    (i) The chemical identity of the substance or, if its specific 
identity is claimed confidential, an appropriate generic chemical name 
and an accession number assigned by EPA.
    (ii) The premanufacture notice number.
    (iii) The CAS number, where available and not claimed confidential.
    (iv) A summary of EPA's findings under section 5(e)(1)(A) of the Act 
for the final order issued under section 5(e).
    (v) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (vi) Any modifications of subpart A of this part applicable to the 
specific substance and significant new uses.
    (vii) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (3) Direct final rulemaking. (i) When EPA uses the direct final 
rulemaking procedure to issue a significant new use rule, it will issue 
a final rule in the Federal Register following its decision to develop a 
significant new use rule under this section for a specific new chemical 
substance.
    (ii) The Federal Register document will state that, unless written 
notice is received by EPA within 30 days of publication that someone 
wishes to submit adverse or critical comments, the rule will be 
effective 60 days from the date of publication. The written notice of 
intent to submit adverse or critical comments should state which SNUR(s) 
will be the subject of the adverse or critical comments, if several 
SNURs are established through the direct final rule. If notice is 
received within 30 days that someone wishes to submit adverse or 
critical comments, the section(s) of the direct final rule containing 
the SNUR(s) for which a notice of intent to comment was received will be 
withdrawn by EPA issuing a document in the final rule section of the 
Federal Register, and a proposal will be published in the proposed rule 
section of the Federal Register. The proposal will establish a 30-day 
comment period.
    (iii) If EPA, having considered any timely comments submitted in 
response to the proposal, decides to establish notification requirements 
under this section, EPA will issue a final rule adding the substance to 
subpart E of this part and designating the significant new uses subject 
to notification.
    (4) Notice and comment rulemaking. (i) When EPA uses a notice and 
comment procedure to issue a significant new use rule, EPA will issue a 
proposal in the Federal Register following its decision to develop a 
significant new use rule under this section for a specific new chemical 
substance. Persons will be given 30 days to comment on whether EPA 
should establish notification requirements for the substance under this 
part.
    (ii) If EPA, having considered any timely comments, decides to 
establish notification requirements under this section, EPA will issue a 
final rule adding the substance to subpart E of this part and 
designating the significant new uses subject to notification.
    (5) Interim final rulemaking. (i) When EPA uses the interim final 
rulemaking procedure to issue a significant new use rule, EPA will issue 
an interim final rule in the final rule section of the Federal Register 
following its decision to develop a significant new use rule for a 
specific new chemical substance. The document will state EPA's reasons 
for using the interim final rulemaking procedure.
    (A) The significant new use rule will take effect on the date of 
publication.
    (B) Persons will be given 30 days from the date of publication to 
submit comments.
    (ii) Interim final rules issued under this section shall cease to be 
in effect 180 days after publication unless, within the 180-day period, 
EPA issues a final rule in the Federal Register responding to any 
written comments received during the 30-day comment period specified in 
paragraph (c)(5)(i)(B) of this section and promulgating final

[[Page 151]]

significant new use notification requirements and other requirements for 
the substance.
    (d) Schedule for issuing significant new use rules. (1) Unless EPA 
determines that a significant new use rule should not be issued under 
this section, EPA will issue a proposed rule, a direct final rule, or an 
interim final rule within 180 days of receipt of a valid notice of 
commencement under Sec. 720.102 of this chapter for any substance for 
which the notice of commencement was received on or after October 10, 
1989.
    (2) Unless EPA determines that a significant new use rule should not 
be issued under this section, EPA will issue a proposed rule, a direct 
final rule, or an interim final rule within 1 year of October 10, 1989, 
for any substance for which the valid notice of commencement under 
Sec. 720.102 of this chapter was received before October 10, 1989.
    (3) If EPA receives adverse or critical significant comments 
following publication of a proposed or interim final rule, EPA will 
either withdraw the rule or issue a final rule addressing the comments 
received.



Sec. 721.170  Notification requirements for selected new chemical substances that have completed premanufacture review.

    (a) Selection of substances. In accordance with the expedited 
process specified in this section, EPA may issue significant new use 
notification and recordkeeping requirements for any new chemical 
substance for which a premanufacture notice has been submitted under 
part 720 of this chapter if EPA determines that activities other than 
those described in the premanufacture notice may result in significant 
changes in human exposure or environmental release levels and/or that 
concern exists about the substance's health or environmental effects.
    (b) Concern criteria. EPA may determine that concern exists about a 
substance's health or environmental effects if EPA makes any one of the 
following findings:
    (1)(i) The substance may cause carcinogenic effects because the 
substance:
    (A) Has been shown by valid test data to cause carcinogenic effects 
in humans or in at least one species of laboratory animal.
    (B) Has been shown to be a possible carcinogen based on the weight 
of the evidence in short-term tests indicative of the potential to cause 
carcinogenic effects.
    (C) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
substance that has been shown by test data to cause carcinogenic effects 
in humans or in at least one species of laboratory animal, provided that 
if there is more than one such analogue, the greatest weight will be 
given to the relevant data for the most appropriate analogues.
    (D) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be metabolized 
in humans or transformed in the environment to a substance which may 
have the potential to cause carcinogenic effects under the criteria in 
paragraphs (b)(1)(i) (A), (B), or (C) of this section.
    (ii) No substance may be regulated based on a finding under 
paragraph (b)(1) of this section unless EPA has also made the finding 
under Sec. 721.170(c)(2)(ii).
    (2) The substance has been shown by valid test data to cause acutely 
toxic effects in at least one species of laboratory animal or is closely 
analogous, based on toxicologically relevant similarities in molecular 
structure and physical properties, to another substance that has been 
shown by valid test data to cause acutely toxic effects in at least one 
species of laboratory animal, provided that if there is more than one 
such analogue, the greatest weight will be given to the relevant data 
for the most appropriate analogues.
    (3) The substance may cause serious chronic effects, serious acute 
effects, or developmentally toxic effects under reasonably anticipated 
conditions of exposure because the substance:
    (i) Has been shown by valid test data to cause serious chronic 
effects, serious acute effects, or developmentally toxic effects in 
humans or in at least one species of laboratory animal at dose

[[Page 152]]

levels that could be of concern under reasonably anticipated conditions 
of exposure.
    (ii) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
chemical substance that has been shown by valid test data to cause 
serious chronic effects, serious acute effects, or developmentally toxic 
effects in humans or in at least one species of laboratory animal at 
dose levels that could be of concern under reasonably anticipated 
conditions of exposure, provided that if there is more than one such 
analogue, the greatest weight will be given to the relevant data for the 
most appropriate analogues.
    (iii) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be metabolized 
in humans or transformed in the environment to a substance which may 
have the potential to cause serious chronic effects, serious acute 
effects, or developmentally toxic effects under the criteria in 
paragraph (b)(3) (i) and (ii) of this section.
    (iv) Has been shown to potentially cause developmentally toxic 
effects based on the weight of the evidence in short-term tests 
indicative of the potential to cause developmentally toxic effects.
    (4) The substance may cause significant adverse environmental 
effects under reasonably anticipated conditions of release because the 
substance:
    (i) Has been shown by valid test data to cause significant adverse 
environmental effects at dose levels that could be of concern under 
reasonably anticipated conditions of release.
    (ii) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
substance that has been shown by valid test data to cause significant 
adverse environmental effects at dose levels that could be of concern 
under reasonably anticipated conditions of release, provided that if 
there is more than one such analogue, the greatest weight will be given 
to the relevant data for the most appropriate analogues.
    (iii) Has been determined, based on calculations using the 
substance's physical and chemical properties, to be potentially able to 
cause significant adverse environmental effects at dose levels that 
could be of concern under reasonably anticipated conditions of release.
    (iv) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be 
environmentally transformed to a substance which may have the potential 
to cause significant adverse environmental effects under the criteria in 
paragraph (b)(4) (i), (ii), and (iii) of this section.
    (5) Concern exists about the health or environmental effects of one 
or more impurities or byproducts of the substance because the impurity 
or byproduct meets one or more of the criteria in paragraph (b) (1) 
through (4) of this section and either:
    (i) The impurity or byproduct is a new chemical substance and may be 
present in concentrations that could cause adverse health or 
environmental effects under reasonably anticipated conditions of 
exposure or release.
    (ii) Reasonably anticipated manufacture, processing, or use 
activities involving the substance for which a premanufacture notice has 
been submitted may result in significantly increased human exposure to 
or environmental release of the impurity or byproduct compared to 
exposure or release levels resulting from existing activities involving 
the impurity or byproduct.
    (c) Designation of requirements. (1) When EPA decides to establish 
significant new use reporting requirements under this section, EPA may 
designate as a significant new use any one or more of the activities set 
forth in subpart B of this part. In addition, EPA may designate specific 
recordkeeping requirements described under subpart C of this part that 
are applicable to the substance.
    (2) EPA may designate as a significant new use only those activities 
that (i) are different from those described in the premanufacture notice 
for the substance, including any amendments, deletions, and additions of 
activities to the premanufacture notice, and (ii)

[[Page 153]]

may be accompanied by changes in exposure or release levels that are 
significant in relation to the health or environmental concerns 
identified under paragraph (b) of this section.
    (d) Procedures for issuing significant new use rules. (1) 
Significant new use requirements designated under this section will be 
listed in subpart E of this part. For each substance, subpart E of this 
part will identify:
    (i) The chemical name.
    (ii) The activities designated as significant new uses, which may 
include one or more of the activities described in paragraph (c) of this 
section.
    (iii) Other specific requirements applicable to the substance.
    (2) When EPA determines that a substance is a candidate for a 
significant new use rule under this section, it will notify the person 
that submitted the premanufacture notice for the substance no later than 
7 calendar days before the expiration of the notice review period under 
Sec. 720.75 of this chapter. In providing this notice, EPA will describe 
the health or environmental concerns identified under paragraph (b) of 
this section and the activities under consideration for designation as 
significant new uses. Such notice may be by telephone, but in this event 
will be confirmed in writing no later than 30 days after completion of 
the notice review period.
    (3) Federal Register documents issued to propose or establish 
significant new uses under this section will contain the following:
    (i) The chemical identity of the substance or, if its specific 
identity is claimed confidential, an appropriate generic chemical name 
and an accession number assigned by EPA.
    (ii) The premanufacture notice number.
    (iii) The CAS number, where available and not claimed confidential.
    (iv) A summary of the basis for action under this section.
    (v) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (vi) Any modifications of subpart A of this part applicable to the 
specific substance and significant new uses.
    (vii) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (4) EPA will issue significant new use rules under this section by 
one of the following three processes: direct final rulemaking, interim 
final rulemaking, or notice and comment rulemaking. EPA will use the 
direct final rulemaking process to issue significant new use rules 
unless it determines that, in a particular case, one of the other 
processes is more appropriate.
    (i)(A) When EPA uses the direct final rulemaking procedure to issue 
a significant new use rule it will issue a direct final rule in the 
final rule section of the Federal Register following its decision to 
develop a significant new use rule under this section for a specific new 
chemical substance.
    (B) The Federal Register document will state that, unless written 
notice is received by EPA within 30 days after the date of publication 
that someone wishes to submit adverse or critical comments, the SNUR 
will be effective 60 days from date of publication. The written notice 
of intent to submit adverse or critical comments should state which 
SNUR(s) will be the subject of the adverse or critical comments, if 
several SNURs are established through the direct final rule. If notice 
is received within 30 days after the date of publication that someone 
wishes to submit adverse or critical comments, the section(s) of the 
direct final rule containing the SNUR(s) for which a notice of intent to 
comment was received will be withdrawn by EPA issuing a document in the 
final rule section of the Federal Register, and EPA will issue a 
proposed rule in the proposed rule section of the Federal Register. The 
proposed rule will establish a 30-day comment period.
    (C) If EPA, having considered any timely comments submitted in 
response to the proposal, decides to establish notification requirements 
under this section, EPA will issue a final rule adding the substance to 
subpart E of this part and designating the

[[Page 154]]

significant new uses subject to notification.
    (ii)(A) When EPA uses a notice and comment procedure to issue a 
significant new use rule, EPA will issue a proposed rule in the Federal 
Register following its decision to develop a significant new use rule 
under this section for a specific new chemical substance. Persons will 
be given 30 days to comment on whether EPA should establish notification 
requirements for the substance under this part.
    (B) If EPA, having considered any timely comments, decides to 
establish notification requirements under this section, EPA will issue a 
final rule adding the substance to subpart E of this part and 
designating the significant new uses subject to notification.
    (iii)(A) When EPA uses the interim final rulemaking procedure to 
issue a significant new use rule, EPA will issue an interim final rule 
in the final rule section of the Federal Register following its decision 
to develop a significant new use rule for a specific new chemical 
substance. The document will state EPA's reasons for using the interim 
final rulemaking procedure.
    (1) The significant new use rule will take effect on the date of 
publication.
    (2) Persons will be given 30 days from the date of publication to 
submit comments.
    (B) An interim final rule issued under this section shall cease to 
be in effect 180 days after publication unless, within the 180-day 
period, EPA issues a final rule in the Federal Register responding to 
any written comments received during the 30-day comment period specified 
in paragraph (d)(4)(iii)(A)(2) of this section and promulgating final 
significant new use notification requirements and other requirements for 
the substance.
    (e) Schedule for issuing significant new use rules. (1) EPA will 
issue a proposed rule, an interim final rule, or a direct final rule 
within 270 days of receipt of the notice of commencement under 
Sec. 720.102 of this chapter for any substance for which the notice of 
commencement was received on or after October 10, 1989.
    (2) If EPA receives adverse or critical comments within the 
designated comment period following publication of a proposed rule or an 
interim final rule, EPA will either withdraw the rule or issue a final 
rule addressing the comments received.

[54 FR 31314, July 27, 1989, as amended at 60 FR 16316, Mar. 29, 1995]



Sec. 721.185  Limitation or revocation of certain notification requirements.

    (a) Criteria for modification or revocation. EPA may at any time 
modify or revoke significant new use notification requirements for a 
chemical substance which has been added to subpart E of this part using 
the procedures under Sec. 721.160 or Sec. 721.170. Such action may be 
taken under this section if EPA makes one of the following 
determinations, unless other information shows that the requirements 
should be retained:
    (1) Test data or other information obtained by EPA provide a 
reasonable basis for concluding that activities designated as 
significant new uses of the substance will not present an unreasonable 
risk of injury to human health or the environment.
    (2) EPA has promulgated a rule under section 4 or 6 of the Act, or 
EPA or another agency has taken action under another law for the 
substance that eliminates the need for significant new use notification 
under section 5(a)(2) of the Act.
    (3) EPA has received significant new use notices for some or all of 
the activities designated as significant new uses of the substance and, 
after reviewing such notices, concluded that there is no need to require 
additional notice from persons who propose to engage in identical or 
similar activities.
    (4) EPA has examined new information, or has reexamined the test 
data or other information or analysis supporting its decision to add the 
substance to subpart E of this part under Sec. 721.170 and has concluded 
that the substance does not meet the criteria under Sec. 721.170(b).
    (5) For a substance added to subpart E of this part under 
Sec. 721.160, EPA has examined new information, or has reexamined the 
test data or other information or analysis supporting its finding under 
section 5(e)(1)(A)(ii)(I) of the Act, and has concluded that a rational 
basis no longer exists for the findings that activities involving the 
substance

[[Page 155]]

may present an unreasonable risk of injury to human health or the 
environment required under section 5(e)(1)(A) of the Act.
    (6) For a substance added to subpart E of this part under 
Sec. 721.160, certain activities involving the substance have been 
designated as significant new uses pending the completion of testing, 
and adequate test data developed in accordance with applicable 
procedures and criteria have been submitted to EPA.
    (b) Procedures for limitation or revocation. Modification or 
revocation of significant new use notification requirements for a 
substance that has been added to subpart E of this part using the 
procedures described under Sec. 721.160 or Sec. 721.170 may occur either 
at EPA's initiative or in response to a written request.
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a substance that has 
been added to subpart E of this part using the procedures described in 
Sec. 721.160 or Sec. 721.170 by writing to the Director of the Office of 
Pollution Prevention and Toxics and stating the basis for such request. 
All requests should be sent to the Document Control Office (7407), 
Office of Pollution Prevention and Toxics, U.S. Environmental Protection 
Agency, Room G-099, 401 M St., SW., Washington, DC., 20460. ATTN: 
Request to amend significant new use rule. The request must be 
accompanied by information sufficient to support the request.
    (2) The Director of the Office of Pollution Prevention and Toxics 
will consider the request, make a determination whether to initiate 
rulemaking to modify the requirements, and notify the requester of that 
determination by certified letter. If the request is denied, the letter 
will explain why EPA has concluded that the significant new use 
notification requirements for that substance should remain in effect.
    (3) If EPA concludes that significant new use notification 
requirements for a substance should be limited or revoked, EPA will 
propose the changes in the Federal Register, briefly describe the 
grounds for the action, and provide interested parties an opportunity to 
comment.

[54 FR 31314, July 27, 1989, as amended at 58 FR 34204, June 23, 1993; 
60 FR 34464, July 3, 1995]



    Subpart E--Significant New Uses for Specific Chemical Substances



Sec. 721.225  2-Chloro-N-methyl-N-substituted acetamide (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-chloro-N-methyl-N-substituted 
acetamide (PMN P-84-393) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 1.0 percent), (f), 
(g)(1)(iv), (g)(2)(i), and (g)(2)(v). The provisions of Sec. 721.72(d) 
requiring employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDSs are not required under 
Sec. 721.72 (a) and (c), respectively. The provision of Sec. 721.72(g) 
requiring placement of specific information on an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements as specified in 
Sec. 721.125 (a) through (g) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions

[[Page 156]]

of Sec. 721.185 apply to this significant new use rule.

[55 FR 32412, Aug. 9, 1990, as amended at 57 FR 20424, May 13, 1992. 
Redesignated at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.267  N-[2-[(substituted dinitrophenyl)azo]diallylamino-4- substituted phenyl] acetamide (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as N-[2-
[(substituted dinitrophenyl)azo]diallylamino-4-substituted phenyl] 
acetamide (PMN P-95-513) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63734, Dec. 2, 1996]



Sec. 721.275  Halogenated-N-(2-propenyl)-N-(substituted phenyl) acetamide.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated-N-(2-propenyl)-N-(substituted phenyl) acetamide (P-83-1085) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (e), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25988, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.285  Acetamide, N-[4-(pentyloxy)phenyl]-, acetamide, N-[2-nitro-4-(pentyloxy)phenyl]-, and acetamide, N-[2-amino-4-(pentyloxy)phenyl]-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as acetamide, N-[4-
(pentyloxy)phenyl]- (PMN P-92-31), acetamide, N-[2-nitro-4-
(pentyloxy)phenyl]- (PMN P-92-32), and acetamide, N-[2-amino-4-
(pentyloxy)phenyl]- (PMN P-92-33) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are: (i) Industrial, commercial, and 
consumer activities. Requirements as specified in Sec. 721.80(h).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 90 ppb for PMNs P-92-31 and P-92-
32, and N = 30 ppb for P-92-33). When calculating the surface water 
concentrations according to the instructions in Sec. 721.90(a)(4), the 
statement that the amount of the substance that will be released will be 
calculated before the substance enters control technology does not 
apply. Instead, if the waste stream containing the substance will be 
treated before release, then the amount of the substance reasonably 
likely to be removed from the waste stream by such treatment may be 
subtracted in calculating the number of kilograms released. No more than 
25 percent removal efficiency may be attributed to such treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 157]]

this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51702, Oct. 4, 1993]



Sec. 721.305  Di-substituted acetophenone (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as di-
substituted acetophenone (PMN P-97-93) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) 
(concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(2)(i), (g)(2)(v). The following statement shall appear on each 
label as specified in Sec. 721.72(b) and the MSDS as specified in 
Sec. 721.72(c): This substance is expected to be dermally absorbed and 
may cause effects to the liver, kidney, adrenal glands, and the heart.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44574, Aug. 20, 1998]



Sec. 721.320  Acrylamide-substituted epoxy.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
acrylamide-substituted epoxy (PMN P-92-660) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(2)(iv), 
(a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (b) (concentration set 
at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), 
(g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51681, Oct. 4, 1993]



Sec. 721.323  Substituted acrylamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted acrylamide (PMN P-90-1687) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1),

[[Page 158]]

(a)(2)(iii), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (b) (concentration 
set at 0.1 percent), and (c). Section 721.63 (a)(5)(i), (a)(5)(ii), and 
(a)(5)(iii) apply to manufacturing operations only; 
Sec. 721.63(a)(5)(ix), (a)(5)(x), and (a)(5)(xi) apply to processing and 
use operations only.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(ii) (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), and (g)(5). The following additional statement shall appear 
on each label and MSDS as required by this paragraph: This substance may 
cause nervous system effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51702, Oct. 4, 1993]



Sec. 721.336  Perfluoroalkylethyl acrylate copolymer (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
perfluoroalkylethyl acrylate copolymer (PMN P-94-241) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63734, Dec. 2, 1996]



Sec. 721.405  Polyether acrylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyether acrylate (PMN P-95-666) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3419, Jan. 22, 1998]



Sec. 721.430  Oxo-substituted aminoalkanoic acid derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as oxo-
substituted amino alkanoic acid derivative (PMN No. P-92-692) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iv), 
(a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a) through (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii),

[[Page 159]]

(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (a)(2), and (a)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32236, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.435  Alkylphenylpolyetheralkanolamines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkylphenylpolyetheralkanolamines (PMNs P-97-880/881/882) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44574, Aug. 20, 1998]



Sec. 721.445  Substituted ethyl alkenamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted ethyl alkenamide (PMN No. P-86-1315) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(iv), (g)(2)(v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Use other 
than polymerizing all residual materials from the manufacture, 
processing, and equipment rinsing of the PMN substance so that no 
monomers of the PMN substance are released to the environment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32236, June 8, 1993]



Sec. 721.450  Hydrofluorochloroalkene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydrofluorochloroalkene (PMN P-97-593) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a),

[[Page 160]]

(b), (c) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44574, Aug. 20, 1998]



Sec. 721.484  Fluorinated acrylic copolymer (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
fluorinated acrylic copolymer (PMN P-95-1208) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), (x)(1), and (y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63735, Dec. 2, 1996]



Sec. 721.505  Halogenated acrylonitrile.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated acrylonitrile, (PMN P-90-299) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), 
(g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), and (g)(5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.125 (a) through (h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 15792, Apr. 17, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.520  Alanine, N-(2-carboxyethyl)-N-alkyl-, salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alanine, 
N-(2-carboxyethyl)-N- alkyl-, salt (P-89-336) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), (c)(4) (where N = 100). The requirement of 40 CFR 
721.91(a)(4) that the amount of the substance estimated to be released 
to water is calculated before entering control technology is not 
retained. Instead, if the waste stream containing the PMN substance will 
be treated using biological treatment (activated sludge or equivalent) 
plus clarification, then the amount of PMN substance reasonably likely 
to be removed from the waste stream by such treatment may be subtracted 
in calculating the number of kilograms released. No more than 90 percent 
removal efficiency may be attributed to such treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 161]]

this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance as specified in Sec. 721.125 (a), (b), (c), (f), (g), 
(h), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15789, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.524  Alcohols, C6-12, ethoxylated, reaction product with maleic anhydride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alcohols, C6-12, ethoxylated, reaction product with maleic 
anhydride (PMN P-88-1108) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 300).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3419, Jan. 22, 1998]



Sec. 721.530  Substituted aliphatic acid halide (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance substituted aliphatic acid halide 
(PMN P-84-491) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), 
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f) and 
(g)(1)(vii), (g)(2)(i) through (g)(2)(v), and (g)(4)(i). The provisions 
of Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a) and (c), respectively. The provision of 
Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1) and (c)(1). (In lieu of incineration, persons subject to this 
section may dispose of wastes containing the substance by chemically 
treating liquid wastes so that the first hydrolysis product is less than 
10 ppm prior to discharge or purifying the waste stream so that the 
first hydrolysis product is less than 10 ppm. Those purified waste 
streams may be reused or sold. All of the substance removed by these 
processes must be incinerated or treated and released as described in 
this paragraph (a)(2)(iv).)
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e) through 
(f), (i) and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 162]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32412, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.536  Halogenated phenyl alkane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated phenyl alkane (PMN P-89-867) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply once the 
substance has been incorporated into a resin.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (6)(i), (b) 
(concentration set at 0.1 percent), and (c). As an alternative to the 
respiratory requirements in this section, manufacturers, importers, and 
processors may use the New Chemical Exposure Limits provisions, 
including sampling and analytical methods which have previously been 
approved by EPA for this substance, found in the 5(e) consent order for 
this substance. As an alternative to the respiratory requirements in 
this section manufacturers, importers, and processors may use the New 
Chemical Exposure Limits provisions, including sampling and analytical 
methods which have previously been approved by EPA for this substance, 
found in the 5(e) consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(g)(1)(vii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) [Reserved]
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51681, Oct. 4, 1993]



Sec. 721.537  Organosilane ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
organosilane ester (PMN P-96-1661/P-95-1654) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(r) (370,000 kilogram (kg)) (90-day subchronic 
inhalation study in rats-(40 CFR 799.9346) (62 FR 43828, August 15, 
1997) (FRL-5719-5). A person may not manufacture or import the substance 
beyond the aggregate production volume limit, unless that person 
conducts this study on the substance and submits all final reports and 
underlying data in accordance with the procedures and criteria specified 
in paragraphs (a)(2)(i)(A), (a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) 
of this section.
    (A) Each study required to be performed pursuant to this section 
must be scientifically valid. Scientific valid means that the study was 
conducted according to:
    (1) The test guidelines specified in paragraph (a)(2)(i) of this 
section.
    (2) An EPA-approved protocol.
    (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.
    (4) Using methodologies generally accepted at the time the study is 
initiated.
    (5) Any deviation from these requirements must be approved in 
writing by EPA.
    (B) Before starting to conduct any of the studies in paragraph 
(a)(2)(i) of this section, the person must obtain approval of test 
protocols from EPA by

[[Page 163]]

submitting written protocols. EPA will respond to the person within 4 
weeks of receiving the written protocols. Published test guidelines 
specified in paragraph (a)(2)(i) of this section (e.g., 40 CFR part 797 
or part 798) provide general guidance for development of test protocols, 
but are not themselves acceptable protocols.
    (C) The person shall:
    (1) Conduct each study in good faith with due care.
    (2) Promptly furnish to EPA the results of any interim phase of each 
study.
    (3) Submit, in triplicate (with an additional sanitized copy, if 
confidential business information is involved), the final report of each 
study and all underlying data (``the report and data'') to EPA no later 
than 14 weeks prior to exceeding the applicable production volume limit. 
The final report shall contain the contents specified in 40 CFR 792.185.
    (D)(1) Except as described in paragraph (a)(2)(i)(D)(2) of this 
section, if, within 6 weeks of EPA's receipt of a test report and data, 
the person receives written notice that EPA finds that the data 
generated by a study are scientifically invalid, the person is 
prohibited from further manufacture and import of the PMN substance 
beyond the applicable production volume limit.
    (2) The person may continue to manufacture and import the PMN 
substance beyond the applicable production limit only if so notified, in 
writing, by EPA in response to the person's compliance with either of 
the following paragraphs (a)(2)(i)(D)(2)(i) or (a)(2)(i)(D)(2)(ii) of 
this section.
    (i) The person may reconduct the study. If there is sufficient time 
to reconduct the study and submit the report and data to EPA at least 14 
weeks before exceeding the production limit as required by paragraph 
(a)(2)(i)(C)(3) of this section, the person shall comply with paragraph 
(a)(2)(i)(C)(3) of this section. If there is insufficient time for the 
person to comply with paragraph (a)(2)(ii)(C)(3) of this section, the 
person may exceed the production limit and shall submit the report and 
data in triplicate to EPA within a reasonable period of time, all as 
specified by EPA in the notice described in paragraph (a)(2)(i)(D)(1) of 
this section. EPA will respond to the person in writing, within 6 weeks 
of receiving the person's report and data.
    (ii) The person may, within 4 weeks of receiving from EPA the notice 
described in paragraph (a)(2)(i)(D)(1) of this section, submit to EPA a 
written report refuting EPA's finding. EPA will respond to the person in 
writing, within 4 weeks of receiving the person's report.
    (E) The person is not required to conduct a study specified in 
paragraph (a)(2)(i) of this section if notified in writing by EPA that 
it is unnecessary to conduct that study.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3419, Jan. 22, 1998]



Sec. 721.538  Phenol, 4-(1,1-dimethyl- ethyl)-, homopolymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 4-(1,1-
dimethylethyl)-, homopolymer (PMN P-95-243; CAS No. 30813-81-1) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(3) of this section.
    (2) High moleculation weight exemption. A batch of the chemical 
substance may be exempt from the provisions of this rule if the average 
number molecular weight of the substance is greater than 1,000 and the 
low molecular weight species below 1,000 and 500 are less than 25 
percent and 10 percent, respectively. To be eligible for this exemption, 
the batch must be individually measured.
    (3) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (d), (f), (g)(3)(i), (g)(4)(i), and (g)(5). The 
label and material safety data

[[Page 164]]

sheet (MSDS) as required by this paragraph shall also include the 
following statement: This substance is toxic to aquatic invertebrate.
    (ii) Industrial, commercial, and consumer activites. Requirements as 
specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) and (b)(4) (N = 9). When calculating the surface water 
concentrations according to the instructions in Sec. 721.91, the 
statement that the amount of the substance that will be released will be 
calculated before the substance enters control technology does not 
apply. Instead, if the waste stream containing the substance will be 
treated using primary and secondary wastewater treatment with control of 
suspended solids, before release, then the amount of the substance 
reasonably likely to be removed from the waste stream by such treatment 
may be subtracted in calculating the number of kilograms released. No 
more than 95 percent removal efficiency may be attributed to such 
treatment. These requirements do not apply to the sites specifically 
exempted in the TSCA section 5(e) consent order for this substance.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3420, Jan. 22, 1998]



Sec. 721.539  Poly(oxy-1,2-ethanediyl), -sulfo--[1-[(4-nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, ammonium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Poly(oxy-1,2-
ethanediyl), -sulfo--[1-[(4-nonylphenoxy)methyl]-2-
(2-propenyloxy)ethoxy]-, branched, ammonium salts (PMN P-96-1240; CAS 
No. 184719-88-8) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3420, Jan. 22, 1998]



Sec. 721.540  Alkylphenoxypolyalkoxyamine (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
akylphenoxypolyalkoxyamine (PMN P-86-1489) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (f), and (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (ii) Release to water. Section 721.90 (a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (f), (g), (h), and (k).
    (2) Limitations or revocation of certain requirements. The 
provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 26097, June 26, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.550  Alkyl alkenoate, azobis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 165]]

chemical substance identified generically as alkyl alkenoate, azobis- 
(PMN P-88-2470) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), 
(a)(6)(ii), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 1.0 percent), (f), 
(g)(1)(iii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), and (g)(5). 
The provisions of Sec. 721.72(d) requiring employees to be provided with 
information on the location and availability of a written hazard 
communication program and MSDSs do not apply when the written program 
and MSDS are not required under Sec. 721.72 (a) and (c), respectively. 
The provision of Sec. 721.72(g) requiring placement of specific 
information on an MSDS does not apply when an MSDS is not required under 
Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), (g), 
and (h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46771, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.555  Alkyl amino nitriles (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
amino nitriles (PMNs P-96-1674 and P-96-1675) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(iii), (a)(4), (a)(5)(i), (a)(6)(ii),(a)(6)(v), and 
(c). A full face shield is required if splashing or spraying occurs.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph 
shall include the following statement: Ocular exposure may cause death.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (l).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 65709, Nov. 30, 1998]



Sec. 721.558  Salt of a fatty alkylamine derivative (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a salt 
of a fatty alkylamine derivative (PMN P-96-1426) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 166]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.562  Substituted alkylamine salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted alkylamine salt (PMN P-85-941) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 70).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45080, Aug. 30, 1995]



Sec. 721.575  Substituted alkyl halide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted alkyl halide (PMN P-83-1222) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), 
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and 
(g)(2)(v). The provisions of Sec. 721.72(d) requiring employees to be 
provided with information on the location and availability of a written 
hazard communication program and MSDSs do not apply when the written 
program and MSDS are not required under Sec. 721.72 (a), and (c), 
respectively. The provisions of Sec. 721.72(g) requiring placement of 
specific information on a label and MSDS do not apply when a label and 
MSDS are not required under Sec. 721.72 (b), and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(h).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), and (f).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46772, Nov. 6, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.600  3-Alkyl-2-(2-anilino)vinyl thiazolinium salt (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 3-alkyl-
2-(2-anilino)vinylthiazolinium salt (PMN P-84-1007) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
(a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (concentration set at 1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e), (f) [concentration set at 1 
percent], (g)(1)(iii), (g)(1) (may be lethal if inhaled or in contact 
with eyes), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). 
The provision of Sec. 721.72(d) requiring that employees be provided 
with information on the location and availability of MSDSs does not 
apply when an MSDS is not required under Sec. 721.72(c). The provision 
of Sec. 721.72(g) requiring placement of

[[Page 167]]

specific information on an MSDS does not apply when an MSDS in not 
required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26102, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.625  Alkylated diarylamine, sulfurized (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylated diarylamine, sulfurized (PMN P-89-506) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26099, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.630  Salt of a modified tallow alkylenediamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a salt 
of a modified tallow alkylenediamine (PMN P-96-1425) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.639  Amine aldehyde condensate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an amine 
aldehyde condensate (PMN P-94-1810) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45080, Aug. 30, 1995]

[[Page 168]]



Sec. 721.640  Amine substituted metal salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as amine 
substituted metal salts (PMNs P-96-1337/1338/1339) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 4).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3421, Jan. 22, 1998]



Sec. 721.641  Alkylpoly(oxyalkylene)amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
alkylpoly(oxyalkylene)amine (PMN P-96-1430) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3421, Jan. 22, 1998]



Sec. 721.642  Amines, N-(C14-18 and C16-18 unsaturated alkyl)] dipropylene-tri-, tripropylenetetra-, and tetrapropylenepenta-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances amines, N-(C14-18 and 
C16-18 unsaturated alkyl)] dipropylenetri-, (PMN P-94-1244), 
tripropylenetetra- (PMN P-94-1245), and tetrapropylenepenta- (PMN P-94-
1246) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11041, Mar. 1, 1995]



Sec. 721.643  Ethoxylated alcohol, phosphated, amine salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as an ethoxylated 
alcohol, phosphated, amine salt (PMN P-96-1478) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 8).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 169]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3421, Jan. 22, 1998]



Sec. 721.646  Aminofluoran derivative (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aminofluoran derivative (PMN P-95-512) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63735, Dec. 2, 1996]



Sec. 721.650  11-Aminoundecanoic acid.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 11-aminoundecanoic acid, CAS Number 2432-99-
7, is subject to reporting under this section for the significant new 
use described in paragraph (a)(2) of this section.
    (2) The significant new use is any use other than as.
    (i) An intermediate in the manufacture of polymers in an enclosed 
process when it is expected that the 11-aminoundecanoic acid will be 
fully polymerized during the manufacturing process, or
    (ii) A component in photoprocessing solutions.
    (b) Specific requirements. The provisions of Subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Definitions. In addition to the definitions in Sec. 721.3, the 
following definitions apply to this section:
    (i) Enclosed process means a process that is designed and operated 
so that there is no intentional release of any substance present in the 
process. A process with fugitive, inadvertent, or emergency pressure 
relief releases remains an enclosed process so long as measures are 
taken to prevent worker exposure to and environmental contamination from 
the releases.
    (ii) Internal subunit means a subunit that is covalently linked to 
at least two other subunits. Internal subunits of polymer molecules are 
chemically derived from monomer molecules that have formed covalent 
links between two or more other molecules.
    (iii) Monomer means a chemical substance that has the capacity to 
form links between two or more other molecules.
    (iv) Polymer means a chemical substance that consists of at least a 
simple weight majority of polymer molecules but consists of less than a 
simple weight majority of molecules with the same molecular weight. 
Collectively, such polymer molecules must be distributed over a range of 
molecular weights wherein differences in molecular weight are primarly 
attributable to differences in the number of internal subunits.
    (v) Polymer molecule means a molecule which includes at least four 
covalently linked subunits, at least two of which are internal subunits.
    (vi) Subunit means an atom or group of associated atoms chemically 
derived from corresponding reactants.
    (2) [Reserved]

[52 FR 19865, May 28, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993]



Sec. 721.655  Ethoxylated alkyl quaternary ammonium compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
ethoxylated alkyl quaternary ammonium compound (PMN P-96-573) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.

[[Page 170]]

    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3421, Jan. 22, 1998]



Sec. 721.715  Trisubstituted anthracene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trisubstituted anthracene (PMN P-91-689) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (a)(4), 
(a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), 
(b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (First limit set at 500 kg; second limit 
set at 25,000 kg).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27481, May 27, 1994]



Sec. 721.720  Alkoxylated fatty acid amide, alkylsulfate salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkoxylated fatty acid amide, alkylsulfate salt (PMN P-97-136) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(l).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.750  Aromatic amine compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance aromatic amine compound (PMN P-86-
334) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent) and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(iv), (g)(1)(vii), (g)(2)(i) through (g)(2)(iii), and (g)(2)(v). 
The provisions of Sec. 721.72(d) requiring employees to be provided with 
information on the location and availability of a written hazard 
communication program and MSDSs do not apply when

[[Page 171]]

the written program and MSDS are not required under Sec. 721.72 (a) and 
(c), respectively. The provisions of Sec. 721.72(g) requiring placement 
of specific information on a label and MSDS do not apply when a label 
and MSDS are not required under Sec. 721.72 (b) and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e) and (f).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 39899, Sept. 28, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.757  Polyoxyalkylene substituted aromatic azo colorant.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyoxyalkylene substituted aromatic azo colorant (PMN P-92-1131) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (w)(1) and (w)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51681, Oct. 4, 1993]



Sec. 721.775  Brominated aromatic compound (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
brominated aromatic compound (PMN P-84-824) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
(a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(1), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), and (g)(2)(v). The provision of Sec. 721.72(d) requiring 
that employees be provided with information on the location and 
availability of MSDSs does not apply when an MSDS is not required under 
Sec. 721.72(c). The provision of Sec. 721.72(g) requiring placement of 
specific information on an MSDS does not apply when an MSDS in not 
required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (j) (use as an additive flame retardant for 
plastics) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (g), (i), and (k).
    (2) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (3) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26098, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]

[[Page 172]]



Sec. 721.785  Halogenated alkane aromatic compound (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
halogenated alkane aromatic compound (PMN P-94-1747) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (6)(i), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(g)(1)(vii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activites. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63735, Dec. 2, 1996]



Sec. 721.805  Benzenamine, 4,4'-[1,3-phenylenebis(1-methylethyl idene)]bis[2,6-dimethyl-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance benzenamine, 4,4'-[1,3-
phenylenebis(1-methyl ethylidene)]bis[2,6-dimethyl- (CAS Registry Number 
2716-12-3; PMN P-86-501) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(xv), 
(a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication. Requirements as specified in Sec. 721.72 
(a), (b)(2), (c), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), (c)(1), (a)(2), (b)(2), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(vi), (b)(2)(vi), and (c)(2)(vi).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125 (a) through (k) are applicable to 
manufacturers, importers, and processors of these substances .
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 31330, July 15, 1992, as amended at 58 FR 29946, May 24, 1993; 58 
FR 34204, June 23, 1993]



Sec. 721.825  Certain aromatic ether diamines.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The following chemical substances are subject to 
reporting under this section for the significant new uses described in 
paragraphs (a)(2), (a)(3), and (a)(4) of this section: Benzenamine, 
4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis- (CAS Number 94148-67-1, 
Premanufacture notice (PMN) P-85-335); 1,2,4,5-benzenetetracarboxylic 
acid, diethyl ester, compound with 4,4'-[[1,1'-biphenyl]-2,5-
diylbis(oxy)]bis[benzenamine] (1:1) (PMN P-85-336); and 1,2,4,5-
benzenetetracarboxylic acid, 1,4-diethyl ester, compound with 4,4'-
[[1,1'-

[[Page 173]]

biphenyl]-2,5-diylbis(oxy)]bis[benzenamine] (1:1), polymer with 4,4'-
[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis[benzenamine]-1,5-diethyl-1,2,4,5-
benzenetetra carboxylate (1:1), reaction products with phthalic 
anhydride (PMN P-86-1153).
    (2) The significant new use for P-85-335 is: Manufacture, import, or 
processing in a quantity of 100,000 pounds per year, or greater, for any 
use.
    (3) The significant new use for P-85-336 is: Any use.
    (4) The significant new use for P-86-1153 is: Manufacture, import, 
or processing in a quantity of 225,000 pounds per year, or greater, for 
any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except Sec. 721.5(a)(2). A person who intends to manufacture, import, or 
process for commercial purposes a substance identified in paragraph 
(a)(3) of this section and intends to distribute the substance in 
commerce must submit a significant new use notice.
    (2) [Reserved]

[59 FR 43296, Aug. 23, 1994]



Sec. 721.840  Alkyl substituted diaromatic hydrocarbons.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an alkyl 
substituted diaromatic hydrocarbons (PMN P-91-710) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46464, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.875  Aromatic nitro compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance aromatic nitro compound (PMN P-86-
335) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(vii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(iv), (g)(1)(vii), and (g)(2)(i) through (g)(2)(v). The provisions 
of Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a) and (c), respectively. The provisions of 
Sec. 721.72(g) requiring placement of specific information on a label 
and MSDS do not apply when a label and MSDS are not required under 
Sec. 721.72 (b) and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), and (f).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 39899, Sept. 28, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]

[[Page 174]]



Sec. 721.925  Substituted aromatic     (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted aromatic (PMN P-84-954) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vii), (g)(2)(i), and (g)(2)(v). The provision of Sec. 721.72(d) 
requiring that employees be provided with information on the location 
and availability of MSDSs does not apply when an MSDS is not required 
under Sec. 721.72(c). The provisions of Sec. 721.72(g) requiring 
placement of specific information on a label and MSDS do not apply when 
a label and MSDS are not required under Sec. 721.72 (b) and (c), 
respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (level set at 0.25 ppm).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26098, June 26, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.950  Sodium salt of an alkylated, sulfonated aromatic (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a sodium 
salt of an alkylated, sulfonated aromatic (PMN P-84-591) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (j) (use as a dye leveler) and (q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26098, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.977  Aryloxyarene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aryloxyarene (PMN P-92-314) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and 
(g)(5). The label and MSDS as required by this paragraph shall also 
include the following statement: This substance may be toxic to sediment 
organisms.
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.

[[Page 175]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.980  Sodium salt of azo acid dye.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a sodium 
salt of azo acid dye (PMN P-95-633) is subject to eporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.981  Substituted naphtholoazo-substituted naphthalenyl-substituted azonaphthol chromium complex.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted naphtholoazo-substituted naphthalenyl-substituted 
azonaphthol chromium complex (PMN P-93-1631) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(2), (w)(2), and (x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.982  Calcium, bis(2,4-pentanedionato-O,O').

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance calcium, bis(2,4-pentanedionato-
O,O') (PMN P-93-214, CAS no. 19372-44-2) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply if the 
substance is embedded or encapsulated in a plastic matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set a 1.0 
percent); and (c). As an alternative to the respiratory requirements in 
this section, manufacturers, importers, and processors may use the New 
Chemical Exposure Limits provisions, including sampling and analytical 
methods which have previously been approved by EPA for this substance, 
found in the 5(e) consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (d), (f) through (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27482, May 27, 1994]

[[Page 176]]



Sec. 721.987  Dialkylaminophenyl imino pyrazole acid ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dialkylaminophenyl imino pyrazole acid ester (PMN P-98-45) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.988  Pyrazolone azomethine dye (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
pyrazolone azomethine dye (PMN P-98-91) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.1000  Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 3-
chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (P-86-83) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), and (g)(2)(v). The 
provision of Sec. 721.72(d) requiring that employees be provided with 
information on the location and availability of MSDSs does not apply 
when an MSDS is not required under Sec. 721.72(c). The provision of 
Sec. 721.72(g) requiring placement of specific information in an MSDS or 
label does not apply when an MSDS and label are not required under 
Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 720.80(h).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(3), (b)(1), (b)(3), (c)(1), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (f), (i), and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 25989, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]


[[Page 177]]





Sec. 721.1025  Benzenamine, 4-chloro-2-methyl-; benzenamine, 4-chloro-2-methyl-, hydrochloride; and benzenamine, 2-chloro-6-methyl-.

    (a) Chemical substances and significant new use subject to 
reporting. (1) The chemical substances benzenamine, 4-chloro-2-methyl- 
(CAS Number 95-69-2); benzenamine, 4-chloro-2-methyl-, hydrochloride 
(CAS Number 3165-93-3); and benzenamine, 2-chloro-6-methyl- (CAS Number 
87-63-8) are subject to reporting under this section for the significant 
new use described in paragraph (a)(2) of this section.
    (2) The significant new use is: Any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph:
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes a substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[54 FR 12447, Mar. 27, 1989; 54 FR 17707, Apr. 25, 1989. Redesignated at 
58 FR 29946, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1050  Benzenamine, 2,5-dibutoxy-4-(4-morpholinyl)-, sulfate.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 2,5-
dibutoxy-4-(4-morpholinyl), sulfate (PMN P-90-1809; CAS number 130169-
66-3) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i) and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in 
Sec. 721.90(a)(1), unless the substance is released to the Passaic 
Valley Sewerage Commission publicly-owned treatment works (NPDES Number 
NJ0021016) which discharges to the New York Bay.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), (f) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44061, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.1068  Benzenamine, 4-isocyanato-N,N-bis(4-isocyanatophenyl)-2,5-dimethoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 4-
isocyanato-N,N- bis(4-isocyanatophenyl)-2,5-dimethoxy- (PMN P-92-168) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(5)(vii), (a)(6)(ii), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (22,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.

[[Page 178]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1075  Benzenamine, 4-(1-methylbutoxy)-, hydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 4-(1-
methylbutoxy)-, hydrochloride (PMN P-90-559) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Modifications or revocation of certain notification 
requirements. The provisions of Sec. 721.185 apply to this section.

[57 FR 44062, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1105  Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-methylethyl)]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 4,4'-
methylenebis[2-methyl-6-(1-methylethyl)]- (PMN P-96-93; CAS No. 16298-
38-7) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.1120  Benzenamine, 4,4'-[1,4-phenylenebis(1-methylethylidene)]bis[2,6-dimethyl-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance benzenamine, 4,4'-[1,4-
phenylenebis(1-methylethylidene)]bis- (CAS Registry Number 2716-10-1; 
PMN P-86-503) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec. 721.72 
(a), (b)(2), (c), (d), (e) (concentration set at 1.0 percent), (f), 
(g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), (c)(1), (a)(2), (b)(2), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(vi), (b)(2)(vi), and (c)(2)(vi).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), (j), and 
(k) are applicable to manufacturers, importers, and processors of these 
substances .

[[Page 179]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 31330, July 15, 1992, as amended at 58 FR 29946, May 24, 1993; 58 
FR 34204, June 23, 1993]



Sec. 721.1150  Substituted polyglycidyl    benzenamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance, referred to by 
premanufacture notice number and its generic chemical name, is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section: Substituted polyglycidyl 
benzeneamine, P-83-394.
    (2) The significant new uses are:
    (i) Use in spray applications.
    (ii) Manufacture or processing without establishing a program 
whereby:
    (A) During all stages of manufacture and processing of the 
substance, and during response to emergencies and spills involving the 
substance, any person employed by or under the control of the 
manufacturer or processor who may potentially be dermally exposed to the 
substance wears:
    (1) Gloves which cover the arm up to the elbow and which have been 
determined to be impervious to the substance under conditions of 
exposure (gloves may be determined to be impervious by standard testing 
methods or by reliance on the manufacturer's specifications for those 
gloves selected);
    (2) A face shield of at least 8 inches in length; and
    (3) Clothing which covers any other exposed areas of the arms, legs, 
and torso.
    (B) All workers described in paragraph (a)(ii)(A) of this section 
are informed in writing, or by presenting the information as part of a 
training program in a safety meeting where attendance is recorded, of 
the following: To avoid all contact with this substance; that 
structurally similar chemicals have been found to cause cancer, 
reproductive effects, kidney and liver effects in laboratory animals, 
and allergic reactions in humans; that this substance is a severe skin 
and eye irritant; and that the use of impervious gloves, face shields 
and other clothing to cover exposed areas of the arms, the legs, and the 
torso is required.
    (C) A label is affixed to each container of the substance or of a 
formulation containing the substance which (in a print size no smaller 
than ten point type) contains, at a minimum, the following information:

WARNING: CONTACT WITH SKIN AND EYES IS HARMFUL

--Severe skin and eye irritant.
--Similar chemicals cause cancer, reproductive effects, and kidney and 
liver changes in laboratory animals. They have also caused allergic 
reactions in humans.
--Prevent all contact with skin, eyes, and clothing.
--Wear impervious gloves, face shield, and protective clothing. Promptly 
remove and wash contaminated non-impervious clothing before re-use.
--Wash thoroughly after handling and before eating, drinking, or 
smoking.

STORAGE INSTRUCTIONS:

--Keep closure tight and upright to prevent leakage.
--Keep container closed during shipment and when not in use.
--In case of spillage absorb with sand or vermiculite and flush with 
plenty of water.

FIRST AID:

--In case of eye contact, immediately flush with plenty of water and get 
immediate medical attention.
--In case of skin contact, immediately wash with soap and water and get 
immediate medical attention.

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. In addition to the requirements of Sec. 721.17, 
manufacturers, importers, and processors of the chemical substance 
identified in paragraph (a)(1) of this section must maintain the 
following records for five years from their creation:
    (i) The names of persons informed, the date they are informed, and 
the means by which they are informed in accordance with paragraph 
(a)(2)(ii)(B) of this section.
    (ii) The names of any transferee and the dates of any transfers of 
containers which are labeled in accordance with paragraph (a)(2)(ii)(C) 
of this section.

[[Page 180]]

    (iii) The method used to determine that the protective gloves are 
impervious to the substance and date and the results of that 
determination.
    (2) [Reserved]

[49 FR 43653, Oct. 31, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.1155  1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl)-and Bis(dimethylamino substituted)carbomonocycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1,4-
benzenediol, 2-(1,1,3,3-tetramethylbutyl)- and Bis (dimethylamino 
substituted)carbomonocycle (PMN P-96-92) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3422, Jan. 22, 1998]



Sec. 721.1187  Bis(imidoethylene) benzene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance bis(imidoethylene)benzene (PMN P-
93-1447) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11041, Mar. 1, 1995]



Sec. 721.1193  Benzene, 2-bromo-1,4-dimethoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, 2-bromo-
1,4-dimethoxy- (PMN P-95-17, CAS No. 25245-34-5) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45081, Aug. 30, 1995]



Sec. 721.1210  Benzene, (2-chloroethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, (2-
chloroethoxy)- (PMN P-87-1471) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:

[[Page 181]]

    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3) (applies to 
gloves only), (a)(4), (a)(5)(iii), (a)(6)(v), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), 
(g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(j).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1) and (c)(1). Disposal other than as described in the 
premanufacture notice referenced in paragraph (a)(1) of this section.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44062, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.1225  Benzene, 1,2-dimethyl-, polypropene derivatives, sulfonated, potassium salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, 1,2-
dimethyl-, polypropene derivatives, sulfonated, potassium salts (PMN P-
89-711) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent, 
and (f). The following environmental hazard statement shall appear on 
each label as specified in Sec. 721.72(b) of this section and the MSDS 
as specified in Sec. 721.72(c) of this section: EPA is requiring aquatic 
toxicity testing and fate testing for a substance in this product. These 
requirements are based on EPA's determination that the substance causes 
toxicity to fish and aquatic organisms based on data on the substance 
and similar sulfonate compounds. EPA has further determined that 
discharge of this substance may cause toxicity to fish and aquatic 
organisms at concentrations as low as 25 ppb. Water releases of the 
substance are subject to an EPA Significant New Use Rule (SNUR) under 40 
CFR part 721 which requires that EPA be notified 90 days prior to use 
resulting in surface water concentrations in excess of this level.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 25 ppb). The requirement of 40 CFR 
721.91(a)(4) that the amount of the substance estimated to be released 
to water is calculated before entering control technology is not 
retained. If the waste stream containing the substance will be treated 
using biological treatment (activated sludge or equivalent) plus 
clarification, then the amount of substance reasonably likely to be 
removed from the waste stream by such treatment may be subtracted in 
calculating the number of kilograms released. No more than 50 percent 
removal efficiency may attributed to such treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance: Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and 
(k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 182]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15789, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1300  [(Dinitrophenyl)azo]-[2,4-diamino-5-methoxybenzene] derivatives.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
[(dinitrophenyl)azo]-[2,4-diamino-5-methoxybenzene] derivatives (P-83-
817 and P-83-818) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and 
(x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25990, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1325  Benzene, 1-(1-methylbu-    toxy)-4-nitro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, 1-(1-
methylbutoxy)-4-nitro- (PMN P-90-560) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(6)(i), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (p) (production limit set at 43,000 
kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Modifications or revocation of certain notification 
requirements. The provisions of Sec. 721.185 apply to this section.

[57 FR 44062, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1350  Benzene, (1-methylethyl)(2-phenylethyl)-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, (1-
methylethyl)(2-phenylethyl)-, (PMN P-88-894) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) 
(concentration set at 1.0 percent), and (c). However, the personal 
protective clothing required in paragraph (a)(2)(iv) must be tested or 
evaluated under the requirements of paragraph (a)(3). Furthermore, the 
imperviousness of gloves required under paragraph (a)(2)(i) may not be 
demonstrated according to paragraph (a)(3)(ii), but rather must be 
tested according to paragraph (a)(3)(i) with the following additional 
requirements: There must be no permeation of the PMN substance greater 
than 16 ppb after 8 hours of testing in accordance with the American 
Society for Testing and Materials (ASTM) F739-85 ``Standard Test Method 
for Resistance of Protective Clothing Materials to Permeation by Liquids 
or Gases.'' Gloves may not be used for a time period longer than they 
are actually tested and must be replaced at the end of each work shift.

[[Page 183]]

    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(2)(i), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), 
(g)(4)(i) and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q). In addition, a significant use of the 
substance is any manner or method of manufacturing, processing, or use 
other than as an insulating oil for capacitors or transformers.
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), (c)(1), (a)(2), (b)(2), (c)(2), (a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40210, Aug. 13, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1372  Substituted nitrobenzene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a substituted 
nitrobenzene (PMN P-92-1125) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 50 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1375  Disubstituted nitrobenzene (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance disubstituted nitrobenzene (PMN P-
84-860) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f) and 
(g)(1)(vii), (g)(2)(i), (g)(2)(v). The provisions of Sec. 721.72(d) 
requiring employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDS are not required under 
Sec. 721.72 (a) and (c), respectively. The provision of Sec. 721.72(g) 
requiring placement of specific information on an MSDS does not apply 
when a MSDS in not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e), (f) and 
(i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 32416, Aug. 9, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]

[[Page 184]]



Sec. 721.1425  Pentabromoethylbenzene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance pentabromoethylbenzene (CAS Number 85-22-3) 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph:
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[54 FR 18286, Apr. 28, 1989. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1430  Pentachlorobenzene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance pentachlorobenzene (CAS No. 608-93-5) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.1435  1,2,4,5-Tetrachlorobenzene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 1,2,4,5-tetrachlorobenzene (CAS No. 95-94-3) 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.1440  1,3,5-Trinitrobenzene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 1,3,5-trinitrobenzene (CAS No. 95-35-4) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.1450  1,3-Benzenediamine, 4-(1,1-dimethylethyl)-ar-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance, referred to by its PMN 
number and chemical name, is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section: 
P-85-929; 1,3-Benzenediamine, 4-(l,1-dimethylethyl)-ar-methyl.
    (2) The significant new uses are:

[[Page 185]]

    (i) Use other than for applications where the substance will be 
completely reacted (cured or used as a chemical intermediate).
    (ii) Any method of disposal other than by landfill, incineration, or 
for wastewater from vent scrubbers, steam vacuum ejectors, pad washings, 
equipment washouts, and stormwater runoffs, wastewater treatment in 
permitted industrial wastewater treatment facilities. Each method of 
disposal must meet all applicable local, State, and Federal laws and 
regulations.
    (iii) Any manner or method of manufacturing, importing, or 
processing without establishing a program whereby:
    (A) Any person who may be exposed dermally to the substance wears:
    (1) Gloves which have been determined to be impervious to the 
substance under the conditions of exposure, including the duration of 
exposure. This determination is made either by testing the gloves under 
the conditions of exposure or by evaluating the specifications provided 
by the manufacturer of the gloves. Testing or evaluation of 
specifications includes consideration of permeability, penetration, and 
potential chemical and mechanical degradation by the substance and 
associated chemical substances.
    (2) Clothing which covers any other exposed areas of the arms, legs, 
and torso.
    (3) Chemical safety goggles or equivalent eye protection.
    (B) Any person who may be exposed to the substance through 
inhalation during manufacture, in addition to the dermal protective 
equipment described in paragraph (a)(2)(iii)(A) of this section, wears 
at a minimum, a National Institute for Occupational Safety and Health 
approved, category 23C respirator, organic vapor type. Use of the 
respirator must be according to 29 CFR 1910.134 and 30 CFR part 11. If a 
full-face type respirator is selected and worn, the chemical safety 
goggles requirement in paragraph (a)(2)(iii)(A)(3) of this section is 
waived.
    (C)(1) All persons who may be exposed to the substance are informed, 
in writing, and by presenting the information as part of a training 
program in safety meetings at which attendance is recorded, by means of 
the following statement:

    WARNING: Avoid all contact. Chemicals similar in structure to 
[insert appropriate name] have been found to cause chronic organ and 
systemic effects and cancer in laboratory animals. To protect yourself, 
you must wear chemical safety goggles or equivalent eye protection, 
impervious gloves, and protective clothing while handling this material.

    (2) During manufacture, the warning statement in paragraph 
(a)(2)(iii)(C)(1) of this section shall include the additional following 
statement:

    Respirators are required during clean-up or loading of bulk 
material.

    (D) All persons that receive the PMN substance are notified by means 
of a Material Safety Data Sheet (``MSDS'') which includes, at a minimum, 
the language specified in paragraph (a)(2)(iii)(C)(1) of this section, 
and specifies the requirements for protective equipment in paragraph 
(a)(2)(iii)(A) and (a)(2)(iii)(B) of this section.
    (E) Each container of the substance distributed in commerce has 
affixed to it a label which includes a Warning Statement which consists, 
at a minimum, of the language specified in paragraph (a)(2)(iii)(C)(1) 
of this section. The first word of the Warning Statement is capitalized, 
and the type size of the first word is no smaller than 6-point type for 
a label 5 square inches or less in area, 10-point type for a label above 
5 but no greater than 10 square inches in area, 12-point type for a 
label above 10 but no greater than 15 square inches in area, 14-point 
type for a label above 15 but no greater than 30 square inches in area, 
or 18-point type for a label over 30 square inches in area. The type 
size of the remainder of the Warning Statement is no smaller than 6-
point type. All required label text is of sufficient prominence, and is 
placed with such conspicuousness relative to other label text and 
graphic material, to ensure that the Warning Statement is read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (iv) Manufacturing and importing the substance for any use at 
greater than

[[Page 186]]

the aggregrate volumes allowed under the consent order issued for 
Premanufacture Notice P-85-929, without submitting to EPA the 
corresponding scientifically valid toxicity test data required under 
that order, developed according to EPA's Good Laboratory Practice 
standards at 40 CFR part 792 and EPA's testing guidelines at 40 CFR 
798.2650 and 798.3300.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Determining whether a use is a significant new use. (i) Any 
person who intends to manufacture or import the substance identified in 
paragraph (a)(1) of this section shall, before commencing any 
manufacture or import, submit to EPA the information required under 
Sec. 721.11(b).
    (ii) EPA will review this information to determine whether the 
person has a bona fide intent to manufacture or import the substance. If 
EPA determines that the person has a bona fide intent to manufacture or 
import the substance, EPA will tell the person the specific production 
volumes which would constitute a significant new use under paragraph 
(a)(2)(iv) of this section.
    (iii) A disclosure to a person with a bona fide intent to 
manufacture or import the substance of the specific production volumes 
which would constitute a significant new use under paragraph (a)(2)(iv) 
of this section will not be considered public disclosure of confidential 
business information under section 14 of the Act.
    (2) Recordkeeping. In addition to the requirements of Sec. 721.40, 
manufacturers, importers, and processors must maintain the following 
records for 5 years after the date they are created:
    (i) Any determination that gloves are impervious to the substance.
    (ii) Names of persons who have attended safety meetings in 
accordance with paragraph (a)(2)(iii)(C) of this section, the dates of 
such meetings, and copies of any written information provided in 
accordance with paragraph (a)(2)(iii)(C) of this section.
    (iii) Copies of any MSDSs used.
    (iv) Names and addresses of all persons to whom the substance is 
sold or transferred including shipment destination address if different, 
the date of each transfer, and the quantity of substance sold or 
transferred on such date.
    (v) Copies of any labels used.
    (vi) Any names used for the substance and the corresponding dates of 
use.
    (vii) Quantities of the substance manufactured or imported, with the 
corresponding dates of manufacture or import.
    (viii) Quantities of the substance purchased in the United States by 
processors of the substance, names and addresses of suppliers, and 
corresponding dates of purchase.
    (ix) Information on disposal of the substance, including dates waste 
material is disposed of, location of disposal sites, volume of disposed 
solid material, estimated volume of any disposed liquid wastes 
containing the substance, and method of disposal.

[55 FR 20795, May 21, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1500  1,2-Benzenediamine,       4-ethoxy, sulfate.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The following chemical substance referred to by its chemical name is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section: 1,2-benzenediamine, 4-
ethoxy, sulfate, PMN P-83-105.
    (2) The significant new use is: Manufacture, import, or processing 
in powder or dry solid form.
    (b) [Reserved]

(Sec. 5, Pub. L. 94-469, 90 Stat. 2012 (15 U.S.C. 2604))

[49 FR 43061, Oct. 26, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.1550  Benzenediazonium, 4-(dimethylamino)-, salt with 2-hydroxy-5-sulfobenzoic acid (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenediazonium, 4-
(dimethylamino)-, salt with 2-hydroxy-5-sulfobenzoic acid (1:1) (CAS No. 
124737-31-1) (P-90-1366) is

[[Page 187]]

subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), 
(a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), 
(a)(6)(i), (a)(6)(ii), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 
(g)(3)(ii), and (g)(5). In addition, the following human health hazard 
statement shall appear on each label as specified at Sec. 721.72(b) and 
the MSDS as specified at Sec. 721.72(c). Additional statements may be 
included as long as they are true and do not alter the meaning of the 
required statement. Human health hazard statements: This substance may 
cause severe acute toxicity and death or serious neurotoxic effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (volume set at 31,000 kg).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 80 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this substance 
as specified in Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40211, Aug. 13, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1555  Substituted phenyl azo substituted benzenediazonium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted phenyl azo substituted benzenediazonium salt (PMN P-92-652) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and 
(g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1568  Substituted benzenediazonium.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted benzenediazonium (PMN P-93-533) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(h).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1580  Disubstituted benzene ether, polymer with substituted phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
disubstituted benzene ether, polymer with substituted phenol (PMN

[[Page 188]]

P-98-155) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.1612  Substituted 2-nitro- and 2-aminobenzesulfonamide.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted 2-nitro- and 2-aminobenzenesulfonamide (PMNs P-88-1937 and 
P-88-1938) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a) through (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5). The following additional statements shall appear on each label 
and MSDS required by this paragraph: This substance may be toxic to 
terrestrial organisms and plants. Notice to user: Release to water 
restrictions apply.
    (ii) Disposal. Requirements as specified in Sec. 721.85. A 
significant new use of these substances is any release of the substances 
to land.
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 100 ppb for P-88-1937 and N = 10 
ppb for P-88-1938). When calculating the surface water concentrations 
according to the instructions in Sec. 721.91(a)(4), the statement that 
the amount of the substances that will be released will be calculated 
before the substances enter control technology does not apply. Instead, 
if the waste stream containing the PMN substances will be treated before 
release, the amount of the PMN substances reasonably likely to be 
removed from the waste stream by treatment may be subtracted in 
calculating the number of kilograms released. No more than 50 percent 
removal efficiency may be attributed to such treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (j), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27482, May 27, 1994]



Sec. 721.1625  Alkylbenzene sulfonate,     amine salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylbenzene sulfonate, amine salt (PMN P-90-456) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), (c)(1).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 19242, Apr. 25, 1991; 56 FR 29903, July 1, 1991. Redesignated at 
58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993]

[[Page 189]]



Sec. 721.1630  1,2-Ethanediol bis(4-methylbenzenesulfonate); 2,2-oxybis-ethane bis(4-methylbenzenesulfonate); ethanol, 2,2'-[oxybis(2,1-ethanediyl oxy)]bis-,
 
          bis(4-methylbenzenesulfonate); ethanol, 2,2'-[oxybis (2,1-
          ethane diyloxy)] bis-, bis(4-methylbenzenesulfonate); ethanol, 
          2,2'-[[1-[(2-propenyloxy) methyl]-1,2-ethanediyl] 
          bis(oxy)]bis-, bis(4-methylbenzene sulfonate); and ethanol, 2-
          [1-[[2-[2-[[(4-methylphenyl)sulfonyl] oxy]ethoxy] 
          ethoxy]methyl]-2-(2-propenyloxy)ethoxy]-, 4-
          methylbenzenesulfonate.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances 1,2-ethanediol bis(4-
methylbenzenesulfonate) (PMN P-93-1193, CAS no. 6315-52-2), 2,2-oxybis-
ethane bis(4-methylbenzenesulfonate) (PMN P-93-1194, CAS no. 7460-82-4), 
ethanol, 2,2'-[oxybis(2,1-ethanediyloxy)]bis-, bis(4-methylbenzene-
sulfonate) (PMN P-93-1195, CAS no. 19249-03-7), ethanol, 2,2'-
[oxybis(2,1-ethanediyloxy)] bis-, bis(4-methylbenzene sulfonate) (PMN P-
93-1196, CAS no. 37860-51-8), ethanol, 2,2'-[[1-[(2-propenyloxy) 
methyl]-1,2-ethanediyl]bis(oxy)]bis-, bis(4-methylbenzene sulfonate) 
(PMN P-93-1203, CAS no. 114719-15-2), and ethanol, 2-[1-[[2-[2- [[(4-
methylphenyl) sulfonyl] oxy]ethoxy] ethoxy]methyl]-2-(2-
propenyloxy)ethoxy]-, 4-methylbenzenesulfonate (PMN P-93-1204, CAS no. 
124029-00-1) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27482, May 27, 1994]



Sec. 721.1637  1,2-Propanediol, 3-(2-propenyloxy)-, bis(4-methylbenzene sulfonate); 2-propanol, 1-[2-[[(4-methylphenyl)sulfonyl] oxy]ethoxy]-3-(2-propenyloxy)-

          4-methylbenzenesulfonate; and 2-propanol, 1-[2-[2-[[(4-
          methylphenyl)sulfonyl]oxy] ethoxy]ethoxy]-3-(2-propenyloxy)-, 
          4-methylbenzenesulfonate.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances 1,2-propanediol, 3-(2-
propenyloxy)-, bis(4-methylbenzenesulfonate) (PMN P-93-1198, CAS no. 
114719-19-6), 2-propanol, 1-[2-[[(4-methylphenyl)sulfonyl]oxy]ethoxy]-3-
(2-propenyloxy)-4-methylbenzenesulfonate (PMN P-93-1199, CAS no. 124213-
39-4), and 2-propanol, 1-[2-[2-[[(4-methylphenyl)sulfonyl]oxy] 
ethoxy]ethoxy]-3-(2-propenyloxy)-, 4-methylbenzenesulfonate (PMN P-93-
1200, CAS no. 124028-99-5) are subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27482, May 27, 1994]

[[Page 190]]



Sec. 721.1640  3,6,9,12,-Tetraoxatetradecane-1,14-diol, bis(4-methylbenzenesulfonate; 3,6,9,13-tetraoxahexadec-15-ene-1,11-diol, bis(4-methylbenzenesulfonate);
 
          3,6,9,12,16-pentaoxanonadec-18-ene-1,14-diol, bis(4-methyl 
          benzenesulfonate); and 3,6,9,12-tetraoxatetradecane-1,14-diol, 
          7-[(2-propenyloxy)methyl]-, bis(4-methylbenzenesulfonate).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances 3,6,9,12-tetraoxatetradecane-
1,14-diol, bis(4-methylbenzenesulfonate (PMN P-93-1197, CAS no. 41024-
91-3), 3,6,9,13-tetraoxahexadec-15-ene-1,11-diol, bis(4-
methylbenzenesulfonate) (PMN P-93-1201), 3,6,9,12,16-pentaoxanonadec-18-
ene-1,14-diol, bis(4-methyl benzenesulfonate) (PMN P-93-1202), and 
3,6,9,12-tetraoxatetradecane-1,14-diol, 7-[(2-propenyloxy)methyl]-, 
bis(4-methylbenzenesulfonate) (PMN P-93-1205) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27483, May 27, 1994]



Sec. 721.1643  Benzenesulfonic acid, amino substituted phenylazo-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
benzenesulfonic acid, amino substituted phenylazo- (PMN P-95-86) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(w)(1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45081, Aug. 30, 1995]



Sec. 721.1645  Benzenesulfonic acid, 4-methyl-, reaction products with oxirane mono[(C10-16-alkyloxy)methyl] derivatives and 2,2,4(or 2,4,4)-
          trimethyl-1,6-hexanediamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance benzenesulfonic acid, 4-methyl-, 
reaction products with oxirane mono[(C10-16-alkyloxy)methyl] 
derivatives and 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine (PMN P-93-
1047, CAS no. 147170-38-5) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27483, May 27, 1994]



Sec. 721.1650  Alkylbenzenesulfonic acid and sodium salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The

[[Page 191]]

chemical substances identified generically as alkyl benzenesulfonic acid 
and sodium salts (PMNs P-88-1783, P-88-2231, P-88-2237, and P-88-2530) 
are subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer are provided an MSDS as described in 
Sec. 721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44062, Sept. 23, 1993, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.1660  Benzidine-based chemical substances.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The benzidine-based chemical substances listed in table 1 
of this section are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are any use other than as a reagent to 
test for hydrogen peroxide in milk; a reagent to test for hydrogen 
sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; a 
reagent for detecting blood; an analytical standard; and also for Colour 
Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as an indicator 
dye.
    (b) List of substances. The following table 1 lists the benzidine-
based chemical substances covered by this section.

                                  Table 1.--Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
                CAS number                       C.I. name          C.I. number             Chemical Name
----------------------------------------------------------------------------------------------------------------
92-87-5                                             Benzidine                0N/A   [1,1'-Biphenyl]-4,4'-diamine
 
531-85-1                                      Benzidine  2HCL                 N/A   [1,1'-Biphenyl]-4,4'-
                                                                                     diamine, dihydrochloride
 
573-58-0                                         C.I. Direct Red 28         22120   1-Naphthalenesulfonic acid,
                                                                                     3,3'-[[1,1'-biphenyl]-4,4'-
                                                                                     diylbis(azo)]bis[4-amino-,
                                                                                             disodium salt
 
1937-37-7                                   C.I. Direct Black               30235   2,7-Naphthalenedisulfonic
                                                           38                        acid, 4-amino-3-[[4'-[(2,
                                                                                      4-diaminophenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-5-
                                                                                       hydroxy-6-(phenylazo)-,
                                                                                     disodium salt
 

[[Page 192]]

 
2302-97-8                                        C.I. Direct Red 44         22500   1-Naphthalenesulfonic acid,
                                                                                     8,8'-[[1,1'-biphenyl]     -
                                                                                     4,4'-diylbis(azo)]bis[7-
                                                                                     hydroxy-, disodium salt
 
2429-73-4                                   C.I. Direct Blue 2              22590   2,7-Naphthalenedisulfonic
                                                                                     acid, 5-amino-3-[[4'-
                                                                                     [(7-amino-1-hydroxy-3-sulfo-
                                                                                     2-naphthalenyl)azo]  [1,1'-
                                                                                     biphenyl]-4-yl]azo]-4-
                                                                                     hydroxy-,
                                                                                     trisodium salt
 
2429-79-0                                   C.I. Direct Orange              22130   Benzoic acid, 5-[[4'-[(1-
                                                            8                        amino-4-sulfo-2-
                                                                                     naphthalenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-, disodium salt
 
2429-81-4                                   C.I. Direct Brown               35660   Benzoic acid, 5-[[4'-[[2,6-
                                                           31                        diamino-3-[[8-hydroxy-3,6-
                                                                                     disulfo-7-[(4-sulfo-1-
                                                                                     naphthalenyl)azo]-2-
                                                                                     naphthalenyl]azo]-5-
                                                                                     methylphenyl]azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-,
                                                                                     tetrasodium salt
 
2429-82-5                                   C.I. Direct Brown               22311   Benzoic acid, 5-[[4'-[(7-
                                                            2                        amino-1-hydroxy-3-sulfo-  2-
                                                                                     naphthalenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-, disodium salt
 
2429-83-6                                   C.I. Direct Black               30245   2,7-Naphthalenedisulfonic
                                                            4                        acid, 4-amino-3-[[4'-[(2,4-
                                                                                     diamino-5-
                                                                                     methylphenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-5-
                                                                                     hydroxy-6-(phenylazo)-,
                                                                                      disodium salt
 
2429-84-7                                        C.I. Direct Red 1          22310   Benzoic acid, 5-[[4'-[(2-
                                                                                     amino-8-hydroxy-6-sulfo-  1-
                                                                                     naphthalenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-, disodium salt
 
2586-58-5                                   C.I. Direct Brown               30110   Benzoic acid, 5-[[4'-[[2,6-
                                                          1:2                        diamino-3-methyl-5-[(4-
                                                                                     sulfophenyl)azo]phenyl]azo]
                                                                                     [1,1'-biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-, disodium salt
 
2602-46-2                                   C.I. Direct Blue 6              22610   2,7-Naphthalenedisulfonic
                                                                                     acid, 3,3'-[[1,1'-
                                                                                     biphenyl]-4,4'-
                                                                                     diylbis(azo)]bis[5-amino-4-
                                                                                       hydroxy-, tetrasodium
                                                                                     salt
 
2893-80-3                                   C.I. Direct Brown               30140   Benzoic acid, 5-[[4'-[[2,4-
                                                            6                        dihydroxy-3-
                                                                                     [(4-
                                                                                     sulfophenyl)azo]phenyl]azo]
                                                                                     [1,1'-biphenyl]-4-
                                                                                     yl]azo]-2-hydroxy-,
                                                                                     disodium salt
 
3530-19-6                                        C.I. Direct Red 37         22240   1,3-Naphthalenedisulfonic
                                                                                     acid, 8-[[4'-[(4-ethoxy
                                                                                     phenyl)azo][1,1'-biphenyl]-
                                                                                     4-yl]azo]-7-hydroxy-,
                                                                                     disodium salt
 
3567-65-5                                          C.I. Acid Red 85         22245   1,3-Naphthalenedisulfonic
                                                                                     acid, 7-hydroxy-8-    [[4'-
                                                                                     [[4-[[(4-
                                                                                     methylphenyl)sulfonyl]oxy]p
                                                                                     henyl]  azo][1,1'-biphenyl]-
                                                                                     4-yl]azo]-, disodium salt
 
3626-28-6                                   C.I. Direct Green               30280   2,7-Naphthalenedisulfonic
                                                            1                        acid, 4-amino-5-
                                                                                        hydroxy-3-[[4'-[(4-
                                                                                     hydroxyphenyl)azo][1,1'-
                                                                                      biphenyl]-4-yl]azo]-6-
                                                                                     (phenylazo)-, disodium salt
 
3811-71-0                                   C.I. Direct Brown               30045   Benzoic acid, 5-[[4'-[[2,4-
                                                            1                        diamino-5-[(4-
                                                                                     sulfophenyl)azo]phenyl]azo]
                                                                                     [1,1'-biphenyl]-4-yl]  azo]-
                                                                                     2-hydroxy-, disodium salt
 

[[Page 193]]

 
4335-09-5                                   C.I. Direct Green               30295   2,7-Naphthalenedisulfonic
                                                            6                        acid, 4-amino-5-
                                                                                     hydroxy-6-[[4'-[(4-
                                                                                     hydroxyphenyl)azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-3-[(4-
                                                                                     nitrophenyl)azo]-, disodium
                                                                                     salt
 
6358-80-1                                   C.I. Acid Black 94              30336   2,7-Naphthalenedisulfonic
                                                                                     acid, 4-amino-5-
                                                                                     hydroxy-3-[[4'-[[4-hydroxy-
                                                                                     2-[(2-methylphenyl)
                                                                                     amino]phenyl]azo][1,1'-
                                                                                     biphenyl]-4-yl]azo]-6-[(4-
                                                                                     sulfophenyl)azo]-,
                                                                                     trisodium salt
 
6360-29-8                                   C.I. Direct Brown               31725   Benzoic acid, 5-[[4'-[[4-[(4-
                                                           27                        amino-7-sulfo-1-
                                                                                     naphthalenyl)azo]-6-sulfo-1-
                                                                                     naphthalenyl]azo]    [1,1'-
                                                                                     biphenyl]-4-yl]azo]-2-
                                                                                     hydroxy-,
                                                                                     trisodium salt
 
6360-54-9                                   C.I. Direct Brown               30120   Benzoic acid, 5-[[4'-[[2,6-
                                                          154                        diamino-3-methyl-5-[(4-
                                                                                     sulfophenyl)azo]phenyl]azo]
                                                                                     [1,1'-biphenyl]-4-yl]  azo]-
                                                                                     2-hydroxy-3-methyl-,
                                                                                     disodium salt
 
8014-91-3                                   C.I. Direct Brown               36300   Benzoic acid, 3,3'-[(3,7-
                                                           74                        disulfo-1,5-
                                                                                     naphthalenediyl)bis[azo(6-
                                                                                     hydroxy-3,1-
                                                                                     phenylene)azo[6(or7)-sulfo-
                                                                                     4,1-
                                                                                     naphthalenediyl]azo[1,1'-
                                                                                     biphenyl]-4,4'-
                                                                                     diylazo]]bis[6-hydroxy-,
                                                                                     hexasodium salt
 
16071-86-6                                  C.I. Direct Brown               30145   Cuprate(2-), [5-[[4'-[[2,6-
                                                           95                        dihydroxy-3-[(2-hydroxy-
                                                                                     5-
                                                                                     sulfophenyl)azo]phenyl]azo]
                                                                                     [1,1'-biphenyl] -4-yl]azo]-
                                                                                     2-hydroxybenzoato(4-)]-,
                                                                                     disodium
----------------------------------------------------------------------------------------------------------------



[61 FR 52295, Oct. 7, 1996]



Sec. 721.1675  Disulfonic acid rosin amine salt of a benzidine derivative (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disulfonic acid rosin amine salt of a benzidine derivative (PMN P-87-
1337) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 33304, Aug. 15, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1700  Halonitrobenzoic acid, substituted (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance halonitrobenzoic acid, substituted 
(PMN P-86-1098) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through

[[Page 194]]

(a)(5)(vii), (a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b), (c), (d), (e) (concentration set at 1.0 percent), (f) 
and (g)(1)(vi), (g)(2)(i) through (g)(2)(v), and (g)(5). The provision 
of Sec. 721.72(d) requiring that employees to be provided with 
information on the location and availability of a written hazard 
communication program does not apply when the written program is not 
required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e) through (g) 
and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32416, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1705  Benzoic acid, 3-amino-, diazotized, coupled with 6-amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3-aminophenyl)phosphonic acid and 
          diazotized 2,5-diethoxybenzenamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as benzoic 
acid, 3-amino-, diazotized, coupled with 6-amino-4-hydroxy-2-
naphthalenesulfonic acid, diazotized, (3-amino-phenyl)phosphonic acid 
and diazotized 2,5-diethoxybenzenamine (PMN P-96-1216; CAS No. 163879-
69-4) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3423, Jan. 22, 1998]



Sec. 721.1710  Methoxy benzoic acid derivative (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
methoxy benzoic acid derivative (PMN P-98-24) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 40).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44575, Aug. 20, 1998]



Sec. 721.1725  Benzoic acid, 3,3'-methylenebis [6 amino-, di-2-propenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance, referred to by its CAS 
Number and chemical name, is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section: 
61386-02-5, Benzoic acid, 3,3'-

[[Page 195]]

methylenebis [6 amino-, di-2-propenyl ester.
    (2) The significant new uses are: (i) Any use other than the use 
described in Premanufacture Notice P-82-438.
    (ii) Any manner or method of manufacturing or processing the 
substance for the use described in Premanufacture Notice P-82-438 
different than the manner or method described in Premanufacture Notice 
P-82-438.
    (b) Special provisions. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Determining whether a specific use is subject to this rule. (i) 
A person who intends to manufacture, import, or process the chemical 
substance identified in paragraph (a)(1) of this section may ask EPA 
whether the use for which the person intends to manufacture, import, or 
process the substance is a significant new use under paragraph (a)(2)(i) 
of this section. EPA will answer such an inquiry only if EPA determines 
that the person has a bona fide intent to manufacture, import, or 
process the chemical substance.
    (ii) To establish a bona fide intent to manufacture, import, or 
process the chemical substance, the person must submit to EPA:
    (A) All materials and statements required under Sec. 721.6.
    (B) The specific use for which the person intends to manufacture, 
import, or process the chemical substance.
    (iii) EPA will review the information submitted by the person under 
this paragraph to determine whether the person has a bona fide intent to 
manufacture, import, or process the chemical substance.
    (iv) If EPA determines that the person has a bona fide intent to 
manufacture, import, or process the chemical substance, EPA will tell 
the person whether the use for which the person intends to manufacture, 
import, or process the substance is a significant new use under 
paragraph (a)(2)(i) of this section. If EPA tells the person that the 
intended use is not a significant new use under paragraph (a)(2)(i) of 
this section, EPA will tell the person what activities would constitute 
a significant new use under paragraph (a)(2)(ii) of this section.
    (v) A disclosure to a person with a bona fide intent to manufacture, 
import, or process the chemical substance of the significant new uses 
subject to this section will not be considered public disclosure of 
confidential business information under section 14 of the Act.
    (vi) EPA will answer an inquiry on whether a particular use is 
subject to this section within 30 days after receipt of a complete 
submission under paragraph (b)(1) of this section.
    (2) [Reserved]

[51 FR 16687, May 6, 1986. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.1728  Benzoic acid, 2-(3-phenylbutylidene)amino-, methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzoic acid, 2-(3-
phenylbutylidene)amino-, methyl ester (PMN P-85-1211) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(p) (10,600 kg).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1732  Nitrobenzoic acid octyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as nitrobenzoic acid 
octyl ester (PMN P-93-343) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.

[[Page 196]]

    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 1 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51682, Oct. 4, 1993]



Sec. 721.1734  Substituted benzonitrile (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted benzonitrile (PMN P-97-1029) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), 
(a)(5)(v), and (a)(6)(v).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44576, Aug. 20, 1998]



Sec. 721.1735  Alkylbisoxyalkyl (substituted-1,1-dimethylethylphenyl) benzotriazole (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkylbisoxyalkyl (substituted-1,1-
dimethylethylphenyl) benzotriazole (PMN P-86-1771) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(vii), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 1.0 percent), 
(f) and (g)(1)(iv), (g)(2)(i) through (g)(2)(v), and (g)(5). The 
provision of Sec. 721.72(d) requiring that employees be provided with 
information on the location and availability of a written hazard 
communication program does not apply when the written program is not 
required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) (light stabilizer for polymers) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e) through 
(g), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 21413, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1738  Substituted benzotriazole (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted benzotriazole (PMN P-94-1744) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.

[[Page 197]]

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(6)(i), 
(b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0%), (f), 
(g)(1)(iv), (g)(1)(vi), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125(a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63736, Dec. 2, 1996]



Sec. 721.1745  Ethoxybenzothiazole disulfide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
ethoxybenzothiazole disulfide (PMN P-90-1384) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i) through (vii), (a)(6)(i), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44063, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1750  1H-Benzotriazole, 5-(pentyloxy)- and 1H-benzotriazole, 5-(pentyloxy)-, sodium and potassium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances 1H-benzotriazole, 5-(pentyloxy)- 
(PMN P-92-34, CAS no. 133145-29-6), 1H-benzotriazole, 5-(pentyloxy)-, 
sodium salt (PMN P-92-35), and 1H-benzotriazole, 5-(pentyloxy)- , 
potassium salt (PMN P-92-36) are subject to reporting for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these 
substances is any manner or method of manufacture, import, or processing 
associated with any use of these substances without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for these substances, the employer becomes aware that 
these substances may present a risk of injury to the environment, the 
employer must incorporate this new information, and any information on 
methods for protecting against such risk, into a MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If these substances are not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substances are 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received these substances from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section

[[Page 198]]

within 90 days from the time the employer becomes aware of the new 
information.
    (ii) Industrial, commercial consumer activities. Requirements as 
specified in Sec. 721.80(p) (limit set at 9,500 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of these substances, as specified in Sec. 721.125 (a), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 32237, June 8, 1993]



Sec. 721.1755  Methylenebisbenzotriazole.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance methylenebisbenzotriazole (P-93-
578) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. During both manufacture and use of 
the substance, requirements as specified in Sec. 721.63 (a)(4), 
(a)(6)(i), (b) (concentration set at 1.0 percent) and (c). During 
manufacture of the PMN substance Sec. 721.63(a)(5)(i); during use of the 
PMN substance Sec. 721.63 (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
(a)(5)(vi), and (a)(5)(vii).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 11041, Mar. 1, 1995]



Sec. 721.1760  Substituted benzotriazole derivatives.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted benzotriazole derivatives (PMNs P-93-374 and P-93-375) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(2)(i), (g)(2)(v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (v)(1), (w)(1), and (x)(1).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of these 
substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11041, Mar. 1, 1995]



Sec. 721.1765  2-Substituted benzotriazole.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
substituted benzotriazole

[[Page 199]]

(PMN P-90-335) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), (c)(4), (where N = 80 ). However, contrary to 
Sec. 721.91(a)(4), if the waste stream containing the PMN substance will 
be treated using biological treatment (activated sludge or equivalent) 
plus clarification, then the amount of PMN substance reasonably likely 
to be removed from the waste stream by such treatment may be subtracted 
in calculating the number of kilograms released. No more than 75 percent 
removal efficiency may be attributed to such treatment.
    (b) Special requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19235, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993; 60 FR 30468, June 9, 1995; 63 
FR 45955, Aug. 28, 1998]



Sec. 721.1775  6-Nitro-2(3H)-benzoxazolone.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance 6-nitro-2(3H)-benzoxazolone (PMN 
P-84-963) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vii), (g)(2)(i), (g)(2)(ii), and (g)(2)(v). The provisions of 
Sec. 721.72(g) requiring placement of specific information on a label 
and MSDS do not apply when a label and MSDS are not required under 
Sec. 721.72 (b) and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (v)(1), (w)(1), (x)(1), and (y)(2).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (d), (e), (f), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26100, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1790  Polybrominated biphenyls.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as 1,1'-(Biphenyl, 
4,4'-dibromo- (CAS No. 92-86-4); 1,1'-(Biphenyl, 2-bromo- (CAS No. 2052-
07-5); 1,1'-(Biphenyl, 3-bromo- (CAS No. 2113-57-7); 1,1'-(Biphenyl, 
2,2', 3,3', 4,4', 5,5', 6,6'-decabromo- (CAS No. 13654-09-6); 
Nonabromobiphenyl (CAS No. 27753-52-2); Octabromobiphenyl (CAS No. 
27858-07-7); and

[[Page 200]]

Hexabromobiphenyl (CAS No. 36355-01-8) are subject to reporting under 
this section for the significant new uses described in paragraph 
(a)(1)(i) of this section.
    (i) The significant new use is: Any use.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes a substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (B) [Reserved]
    (2) The chemical substance identified as 1,1'-(Biphenyl, 4-bromo- 
(CAS No. 92-66-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2)(i) of this section.
    (i) The significant new uses are:
    (A) Industrial, commercial, and consumer activites. Requirements as 
specified in Sec. 721.80 (f), (j), and (s) (10,000 kilograms).
    (B) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (C) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (b) [Reserved]

[63 FR 45955, Aug. 28, 1998]



Sec. 721.1800  3,3',5,5'-Tetramethylbiphenyl-4,4'-diol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as 3,3',5,5'-
tetramethylbiphenyl-4,4'-diol (PMN P-88-972) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) 
(concentration set at 1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1 percent), 
(f), (g)(1)(iv), (g)(1)(ix), (g)(2)(ii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) (monomer for epoxy resins and 
engineering plastics or an antioxidizing agent for lubricating oils) and 
(p) (level set at 42,000 kg and 366,000 kg).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 33308, Aug. 15, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1805  Substituted bisaniline.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted bisaniline (PMN P-96-1410) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 4).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 201]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3423, Jan. 22, 1998]



Sec. 721.1820  Bisphenol derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bisphenol derivative (PMN No. P-92-509) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), 
(a)(6)(ii), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1) (systemic effects--depression in body weight gain and blood 
effects), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (when in dust or mist 
form), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (d), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32237, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.1825  Bisphenol A, epichlorohydrin, polyalkylenepolyol and polyisocyanato derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bisphenol A, epichlorohydrin, polyalkylenepolyol and polyisocyanato 
derivative (PMN P-89-750) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), 
(a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f) and (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q) (The production limit applies to 
the aggregate production volume of both P-89-750 and P-89-760. P-89-760 
is the preferred substance for use in performing these tests. Results 
from such testing can be used to evaluate the toxicity of P-89-750 as 
well).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii) (Oil and grease separation may be used as an alternative 
treatment), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f), 
(g), (h), (i), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 202]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46772, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1850  Toluene sulfonamide bisphenol A epoxy adduct.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as toluene 
sulfonamide bisphenol A epoxy adduct (PMN P-90-113) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows. (A) If, as a result of the test data required 
under the section 5(e) consent order for this substance, the employer 
becomes aware that this substance may present a risk of injury to human 
health, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.125 (a), (c), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15791, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1875  Boric acid, alkyl and substituted alkyl esters (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance boric acid, alkyl and substituted 
alkyl esters (PMN P-86-1252) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 0.1 percent], 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (d), (e) [concentration set at 0.1 percent], (f), and 
(g)(1)(i), (g)(1)(iv), (g)(1)(vii), (g)(1)(viii), and (g)(1)(ix), 
(g)(2)(i) and (g)(2)(v), (g)(4)(i) and (g)(4)(iii), and (g)(5). The 
provisions of Sec. 721.72(d) requiring employees to be provided with 
information on the location and availability of a written hazard 
communication program and MSDSs do not apply when the written program 
and MSDS are not required under Sec. 721.72 (a) and (c), respectively. 
The provision of Sec. 721.72(g) requiring placement of specific 
information on a MSDS does not apply when a MSDS was not required under 
Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(b)(1).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).

[[Page 203]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26108, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1900  Substituted bromothiophene.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted bromothiophene (P-83-769) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), 
(a)(5)(v), and (a)(6)(i).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(D) and (g)(2)(iv). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), (d), (f), and (g).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25990, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.1907   Butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-diyl)bisazobis N-2,3-dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
butanamide, 2,2'-[3'dichloro[1,1'-biphenyl]-4,4'-diyl)bisazobis N-2,3-
dihydro-2-oxo-1H-benximdazol-5-yl)-3-oxo- (PMN P-93-1111) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5). The following 
additional statements shall appear on each label and Material Safety 
Data Sheet (MSDS) as specified by this paragraph: This substance 
decomposes in polymers or sheet metal coatings at temperatures greater 
than 280  deg.C to give 3,3' DCB a suspect human carcinogen.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(f) and processing or use at temperatures 
above 280  deg.C.
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(b)(1) and (c)(1). When the substance is processed or used as a colorant 
for dyeing plastics, this section does not apply.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 5742, Feb. 4, 1998]



Sec. 721.1920  1,4-Bis(3-hydroxy-4-benzoylphenoxy)butane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-bis(3-hydroxy-4-
benzoylphenoxy)butane (PMN P-93-483) is subject to reporting under this 
section for the significant

[[Page 204]]

new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 1 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51683, Oct. 4, 1993]



Sec. 721.1925  Substituted carboheterocyclic butane tetracarboxylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted butane tetracarboxylate (PMN P-90-440) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, and specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19242, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.1930  Butanoic acid, antimony (3=) salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as butanoic acid, 
antimony (3=) salt (PMN P-94-1143; CAS No. 53856-17-0) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(v), 
and (g)(5). The label and MSDS as required by this paragraph shall also 
include the following statement: This substance may cause neurologic 
effects. This substance may cause cardiovascular effects. This substance 
may cause ocular irritation.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (675,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3423, Jan. 22, 1998]



Sec. 721.1950  2-Butenedioic acid (Z), mono(2-((1-oxopropenyloxy)ethyl) ester .

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-butenedioic acid 
(Z), mono(2-((1-oxopropenyloxy)ethyl) ester (PMN P-

[[Page 205]]

85-543) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(xi), (a)(6)(i), (a)(6)(ii), 
(a)(6)(iv), (a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 0.1 percent), 
(f) (g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v) and (g)(5). The provision of Sec. 721.72(d) 
requiring that employees to be provided with information on the location 
and availability of a written hazard communication program does not 
apply when the written program is not required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance: Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44063, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2025  Substituted phenylimino   carbamate derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted phenylimino carbamate derivative (PMN P-91-487) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46464, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2075  Carbamodithioic acid, methyl-, compound with methanamine (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbamodithioic acid, methyl-, compound with methanamine (1:1) (P-84-
1042), is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vii), (g)(1)(vi), and (g)(2)(i). The provision of 
Sec. 721.72(d) requiring that employees be provided with information on 
the location and availability of MSDSs does not apply when an MSDS is 
not required under Sec. 721.72(c). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 720.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(2), 
(b)(2), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable

[[Page 206]]

to manufacturers, importers, and processors of this substance, as 
specified in Sec. 721.125 (a) through (g), (i), and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 25990, June 5, 1991. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2077  Substituted carbazate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted carbazate (PMN P-97-267) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph 
shall include the following statements: Overexposure to this material 
may cause severe acute toxicity including death. This concern is 
particularly true with respect to direct contact to the eyes. Exposure 
to the eyes may cause severe acute toxicity including death.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (a), (b), (c), and (j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 65710, Nov. 30, 1998]



Sec. 721.2078  1-Piperidinecarboxylic acid, 2-[(dichloro-hydroxy-carbomonocycle)hydrazono]-, methyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 1-
piperidinecarboxylic acid, 2-[(dichloro-hydroxy-carbomonocycle) 
hydrazono]-, methyl ester (PMN P-96-756) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (l), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44576, Aug. 20, 1998]



Sec. 721.2079  Dichloro, hydroxy, hydrazino-carbomonocycle (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dichloro, hydroxy, hydrazino-carbomonocycle (PMN P-96-757) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4),

[[Page 207]]

(a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (l), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44576, Aug. 20, 1998]



Sec. 721.2081  Dichloro, hydroxy, hydrazino-carbomonocycle-monohydrochloride (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
dichloro, hydroxy, hydrazino-carbomonocycle-monohydrochloride (PMN P-96-
758) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (l), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44576, Aug. 20, 1998]



Sec. 721.2083  Polysubstituted carbomonocyclic hydroxylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and (a)(6)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (d) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44576, Aug. 20, 1998]



Sec. 721.2084  Carbon oxyfluoride (Carbonic difluoride).

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance carbon oxyfluoride (CAS No. 353-50-4), also 
referred to as carbonic difluoride, is subject to reporting under this 
section for the significant new use described in paragraph (a)(2) of 
this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.

[[Page 208]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.2085  Hydroxyalkylquinoline dioxoindandialkylcarboxamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydroxyalkylquinoline dioxoindandialkylcarboxamide (PMN P-94-682) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11042, Mar. 1, 1995]



Sec. 721.2086  Coco acid triamine condensate, polycarboxylic acid salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as coco acid triamine 
condensate, polycarboxylic acid salts. (PMN P-92-446) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in 
Sec. 721.90(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46464, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2088  Carboxylic acids, (C6-C9) branched and linear.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
carboxylic acids, (C6-C9) branched and linear (PMNs P-93-313, 314, 315, 
and 316) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii) 
and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 300 ppb for P-93-313, 314, and 315 
and N = 50 ppb for P-93-316).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (f), (g), (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11042, Mar. 1, 1995]



Sec. 721.2089  Tetrasubstituted aminocarboxylic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
tetrasubstituted aminocarboxylic acid (PMN P-85-619) is subject to 
reporting under this section

[[Page 209]]

for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(vii), (g)(2)(iii), 
(g)(3)(ii), (g)(4)(ii), (g)(4)(iii), and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (h) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45081, Aug. 30, 1995]



Sec. 721.2091  Chloroalkane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
chloroalkane (PMN P-96-273) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3423, Jan. 22, 1998]



Sec. 721.2092  3-Methylcholanthrene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 3-methylcholanthrene (CAS No. 56-49-5) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.2094  N,N'-di(alkyl heteromonocycle)amino chlorotriazine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as N,N'-
di(alkyl heteromonocycle)amino chlorotriazine (PMN P-93-1369) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i) (this respirator meets the minimum 
requirement for persons exposed via inhalation during manufacture), 
(a)(5)(ii), (a)(5)(iv), (a)(5)(v) (these three respirators meet the 
minimum requirements for persons exposed via inhalation during 
processing and use), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 210]]

this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3424, Jan. 22, 1998]



Sec. 721.2095  Chromate(3-), bis 2-[[substituted-3-[(5-sulfo-1-naphthalenyl)azo] phenyl]azo]substituted monocycle, trisodium (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
chromate(3-), bis 2-[[substituted-3-[(5-sulfo-1-naphthalenyl) 
azo]phenyl]azo]substituted monocycle, trisodium (PMN P-95-1242) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (w)(1), and (y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63736, Dec. 2, 1996]



Sec. 721.2097  Azo chromium complex dyestuff preparation (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an azo 
chromium complex dyestuff preparation (PMN P-95-240) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and 
(x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63736, Dec. 2, 1996]



Sec. 721.2120  Cyclic amide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a cyclic amide (PMN 
P-92-131) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 70 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46465, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2122  Substituted phenyl azo substituted sulfo carbopolycycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted phenyl azo substituted sulfo carbopolycycle (PMN P-96-702) 
is subject to reporting under

[[Page 211]]

this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(r) (204,000 kg) (activated sludge adsorption 
isotherm- OPPTS 835.1110 test guideline (public draft; 61 FR 16486, 
April 15, 1996) (FRL-5363-1), daphnid acute toxicity-Sec. 797.1300, fish 
acute toxicity-Sec. 797.1400, murine immune allergic response study 
(Toxicology and Applied Pharmacology 112:190-197 (1992)). A person may 
not manufacture or import the substance beyond the following aggregate 
production volume limits, unless that person conducts the following 
corresponding studies on the substance and submits all final reports and 
underlying data in accordance with the procedures and criteria specified 
in paragraphs (a)(2)(i)(A), (a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) 
of this section.
    (A) Each study required to be performed pursuant to this section 
must be scientifically valid. Scientifically valid means that the study 
was conducted according to:
    (1) The test guidelines specified in paragraph (a)(2)(i) of this 
section.
    (2) An EPA-approved protocol.
    (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.
    (4) Using methodologies generally accepted at the time the study is 
initiated.
    (5) Any deviation from these requirements must be approved in 
writing by EPA.
    (B) Before starting to conduct any of the studies in paragraph 
(a)(2)(i) of this section, the person must obtain approval of test 
protocols from EPA by submitting written protocols. EPA will respond to 
the person within 4 weeks of receiving the written protocols. Published 
test guidelines specified in paragraph (a)(2)(i) of this section (e.g., 
40 CFR part 797 or part 798) provide general guidance for development of 
test protocols, but are not themselves acceptable protocols.
    (C) The person shall:
    (1) Conduct each study in good faith with due care.
    (2) Promptly furnish to EPA the results of any interim phase of each 
study.
    (3) Submit, in triplicate (with an additional sanitized copy, if 
confidential business information is involved), the final report of each 
study and all underlying data (``the report and data'') to EPA no later 
than 14 weeks prior to exceeding the applicable production volume limit. 
The final report shall contain the contents specified in 40 CFR 792.185.
    (D)(1) Except as described in paragraph (a)(2)(i)(D)(2) of this 
section, if, within 6 weeks of EPA's receipt of a test report and data, 
the person receives written notice that EPA finds that the data 
generated by a study are scientifically invalid, the person is 
prohibited from further manufacture and import of the PMN substance 
beyond the applicable production volume limit.
    (2) The person may continue to manufacture and import the PMN 
substance beyond the applicable production limit only if so notified, in 
writing, by EPA in response to the person's compliance with either of 
the following paragraph (a)(2)(i)(D)(2)(i) or (a)(2)(i)(D)(2)(ii) of 
this section.
    (i) The person may reconduct the study. If there is sufficient time 
to reconduct the study and submit the report and data to EPA at least 14 
weeks before exceeding the production limit as required by paragraph 
(a)(2)(i)(C)(3) of this section, the person shall comply with paragraph 
(a)(2)(i)(C)(3) of this section. If there is insufficient time for the 
person to comply with paragraph (a)(2)(i)(C)(3) of this section, the 
person may exceed the production limit and shall submit the report and 
data in triplicate to EPA within a reasonable period of time, all as 
specified by EPA in the notice described in paragraph (a)(2)(i)(D)(1) of 
this section. EPA will respond to the person in writing, within 6 weeks 
of receiving the person's report and data.
    (ii) The person may, within 4 weeks of receiving from EPA the notice 
described in paragraph (a)(2)(i)(D)(1) of this section, submit to EPA a 
written report refuting EPA's finding. EPA will

[[Page 212]]

respond to the person in writing, within 4 weeks of receiving the 
person's report.
    (E) The person is not required to conduct a study specified in 
paragraph (a)(2)(i) of this section if notified in writing by EPA that 
it is unnecessary to conduct that study.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3424, Jan. 22, 1998]



Sec. 721.2140  Carbopolycyclicol azoalkylaminoalkylcarbomonocyclic ester, halogen acid salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
carbopolycyclicol azoalkylaminoalkylcarbomonocyclic ester, halogen acid 
salt (PMN P-88-1682) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4) and (c)(4) (where N = 1 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44063, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.2145  Ceteareth-25 sorbate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ceteareth-25 sorbate (PMN P-96-941) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provision of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2175  Salt of cyclodiamine and mineral acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a salt 
of cyclodiamine and mineral acid (PMN P-91-838) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 213]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46465, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2222  Cyclohexanamine, N,N-dimethyl-, compd. with alpha-isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclohexanamine, 
N,N-dimethyl-, compd. with alpha-isotridecyl-omega-hydroxypoly(oxy-1,2-
ethanediyl) phosphate (PMN P-96-1176; CAS No. 164383-18-0) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2250  1,4-Cyclohexanediamine, cis- and trans-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as 1,4-
cyclohexanediamine, cis- and trans- (PMNs P-87-1881 and P-87-1882; CAS 
numbers 15827-56-2 and 2615-25-0) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44064, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2260  1,2-Cyclohexanedicarboxylic acid, 2,2-bis[[[[2-[(oxiranylmethoxy) carbonyl]cyclohexy]carbonyl] oxy]methyl]-1,3-propanediyl bis(oxiranylmethyl) 
          ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 1,2-cyclohexanedicarboxylic acid, 
2,2-bis[[[[2-[(oxiranylmethoxy) carbonyl] cyclohexy]carbonyl] 
oxy]methyl]-1,3-propanediyl bis(oxiranylmethyl) ester (PMN P-92-471) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(4), (a)(5)(ii), 
(a)(5)(viii), (a)(5)(ix), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(ii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.

[[Page 214]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51702, Oct. 4, 1993]



Sec. 721.2270  Aliphatic dicarboxylic acid salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic dicarboxylic acid salt (PMN P-92-1352) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 1,000 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51683, Oct. 4, 1993]



Sec. 721.2275  N,N,N',N'-Tetrakis(oxiranyl- methyl)-1,3-cyclohexane dimethanamine.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as N,N,N',N'-
tetrakis(oxiranylmethyl)-1,3-cyclohexanedimethanamine (P-84-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(ii), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), and (g)(2)(v).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25991, June 5, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2280  Cyclopropanecarboxaldehyde.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
cyclopropanecarboxaldehyde (PMN P-96-33) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(xii), 
(a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b) (concentration set at 1.0 
percent), and (c). Each person who is reasonsonably likely to be exposed 
by inhalation to the PMN substance in vapor form during loading of rail 
cars is provided with, and is required to wear, at a minimum, a National 
Institute for Occupational Safety and Health (NIOSH) approved category 
19C Type C supplied-air respirator operated in pressure demand or other 
positive pressure mode and equipped with a full facepiece with an 
assigned protection factor (APF) of 200. As an alternative to the 
respiratory requirements in this section, manufacturers, importers, and 
processors may use the new chemical exposure limits provisions, 
including sampling and analytical methods which have previously been 
approved by EPA for this substance, found in the TSCA section 5(e) 
consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii),

[[Page 215]]

(g)(1)(iv), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activites. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2287  DDT (Dichlorodiphenyltrichloroethane).

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance DDT (dichlorodiphenyltrichloroethane) (CAS 
No. 50-29-3) is subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.2340  Dialkenylamide (generic    name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
dialkenylamide (P-87-502) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), 
(a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2) and (c)(1), (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26099, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2345  Alkyletherpropyl dialkylamines.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as alkyletherpropyl 
dialkylamines (PMNs P-96-1510/1511/1512/1513/1514) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 216]]

(b), (c), and (k) are applicable to manufacturers, importers, and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2350  Alkyltri, tetra, and pentaamines.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkyltri, tetra, and pentaamines (PMNs P-96-406/407/408) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2355  Diethylstilbestrol.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance diethylstilbestrol (CAS No. 56-53-1) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63516, Dec. 1, 1993]



Sec. 721.2380  Disubstituted diamino anisole.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance referred to by its 
premanufacture notice number and generic chemical name is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section: P-83-822, disubstituted diamino 
anisole.
    (2) The significant new uses are:
    (i) Use other than as an intermediate.
    (ii) Manufacture, import, or processing for use as an intermediate 
without establishing a program whereby:
    (A) Persons employed by or under the control of the manufacturer, 
importer, or processor who may be exposed to the substance (including 
those persons involved in maintenance, packaging, and storage 
operations) wear protective gloves determined to be impervious to the 
substance by testing the gloves under the conditions of exposure or by 
evaluating the specifications provided by the manufacturer of the 
gloves, and
    (B) Packages containing the substance (including those storing the 
substance between manufacturing or importing and processing stages) are 
labeled to indicate that the substance should be handled only while 
using gloves determined to be impervious to the substance.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. In addition to the requirements of Sec. 721.17, 
manufacturers, importers, and processors of the chemical substance 
identified in paragraph (a)(1) of this section must maintain the 
following records for 5 years from their creation:
    (i) The results of any determination that gloves are impervious.
    (ii) The names of persons required to wear gloves.
    (iii) Copies of labels described in paragraph (a)(2)(ii)(B) of this 
section.

[[Page 217]]

    (2) [Reserved]

[50 FR 34465, Aug. 26, 1985. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.2410  Alkoxylated alkyldiethylenetriamine, alkyl sulfate salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkoxylated dialkyldiethylenetriamine, alkyl sulfate salts (PMN P-94-
325, 326, and 327) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11042, Mar. 1, 1995]



Sec. 721.2420  Alkoxylated dialkyldiethylenetriamine, alkyl    sulfate salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkoxylated dialkyldiethylenetriamine, alkyl sulfate salt (PMN P-91-288) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46465, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2475  Dimetridazole.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dimetridazole (P-90-1308) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5) (iii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v) and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44064, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.2480  Isoalkyldimethylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isoalkyldimethylamine (PMN

[[Page 218]]

P-96-1320) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2485  1,3-Dioxolane, 2-ethenyl-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-Dioxolane, 2-
ethenyl- (PMN P-96-1006; CAS No. 3984-22-3) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3)(i), (a)(4), 
(a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b) 
(concentration set at 1.0 percent), and (c). The imperviousness of each 
item pursuant to (a)(2)(i) and (a)(2)(ii) must be demonstrated by actual 
testing under (a)(3)(i) and not by manufacturer specifications. 
Permeation testing shall be conducted according to the ASTM F739 
``Standard Test Method for Resistance of Protective Clothing Materials 
to Permeation by Liquids or Gases.'' Results shall be recorded as a 
cumulative permeation rate as a function of time, and shall be 
documented in accordance with ASTM F739 using the format specified in 
ASTM F1194-89 ``Guide for Documenting the Results of Chemical Permeation 
Testing on Protective Clothing Materials.'' Gloves may not be used for a 
time period longer than they are actually tested and must be replaced at 
the end of each work shift. The manufacturer, importer, or processor 
must submit all test data to the Agency and must receive written Agency 
approval for each type of glove tested prior to use of such gloves.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(2)(ii), (g)(2)(iii), and (g)(5). The 
following statements shall appear on each label as specified in 
Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): This 
substance may cause fatality. When using this substance avoid dermal 
contact. When using this substance use respiratory protection or 
engineering and process controls to mitigate respiratory exposure. When 
using this substance use dermal protection to prevent dermal exposure.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), and (h) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2520  Alkylated diphenyls.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkylated diphenyls (PMN Nos. P-90-237, P-90-248, and P-90-249) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 1 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 219]]

(b), (c), and (k) are applicable to manufacturers, importers, and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32237, June 8, 1993]



Sec. 721.2527  Substituted diphenylazo dye (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted diphenylazo dye (PMN P-95-514) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63736, Dec. 2, 1996]



Sec. 721.2532  Substituted diphenylmethane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted diphenylmethane (PMN P-97-4) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2535  Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer, Bu alc.-blocked.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzene, 1,1'-
methylanebis[4-isocyanato-, homopolymer, Bu alc.-blocked (PMN P-95-1386; 
CAS No. 186321-98-2) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3425, Jan. 22, 1998]



Sec. 721.2540  Diphenylmethane diisocyanate (MDI) modified.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
diphenylmethane diisocyanate (MDI) modified (PMN P-92-294) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), 
(y)(1), and (y)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 220]]

this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46465, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2560  Alkylated diphenyl oxide (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkylated diphenyl oxide (PMN P-
84-1079) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 1.0 percent], 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) [concentration set at 1.0 percent], 
(f), and (g)(1)(vi) and (g)(1)(ix), (g)(2)(i) and (g)(2)(v), and (g)(5). 
The provision of Sec. 721.72(d) requiring that employees be provided 
with information on the location and availability of MSDSs does not 
apply when a MSDS was not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g). The term intermediate as used in 
Sec. 721.80(g) is defined as an intermediate for making sulfonated 
surfactants.
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26109, June 26, 1990, as amended at 57 FR 54305, Nov. 18, 1992. 
Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 
23, 1993]



Sec. 721.2565  Alkylated sulfonated diphenyl oxide, alkali and amine salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as alkylated 
sulfonated diphenyl oxide, alkali salt (PMN P-93-352) and alkylated 
sulfonated diphenyl oxide, amine salt (PMN P-93-353) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 20 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51683, Oct. 4, 1993]



Sec. 721.2570  Alkylated diphenyls (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkylated diphenyls (PMNs P-97-869/870/871) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 221]]

this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2575  Disubstituted diphenylsulfone.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disubstituted diphenylsulfone (PMN P-92-1119) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63(a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iv), 
(a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(vi), (g)(1)(vii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5). 
The following additional statements shall appear on each label and MSDS 
as required by this paragraph: This substance may cause blood effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (o), and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51683, Oct. 4, 1993]



Sec. 721.2580  C.I. Disperse Red 152 (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as C.I. 
disperse red 152 (PMN P-97-820) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2585  Sodium salts of dodecylphenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as sodium 
salts of dodecylphenol (PMNs P-97-1060/1061/1062) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.

[[Page 222]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44577, Aug. 20, 1998]



Sec. 721.2600  Epibromohydrin.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance epibromohydrin, CAS Number 3132-64-7, [Listed 
in TSCA Inventory as oxirane,(bromoethyl)-] is subject to reporting 
under this section for the significant new use described in paragraph 
(a)(2) of this section.
    (2) The significant new use is any use.
    (b) Special requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[52 FR 41300, Oct. 27, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.2625  Reaction product of alkanediol and epichlorohydrin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as reaction 
product of alkanediol and epichlorohydrin (PMN P-89-760) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), 
(a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), and (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l), and (q). (The production limit applies 
to the aggregate production volume of both P-89-750 and P-89-760. 
Results from testing this substance can be used to evaluate the toxicity 
P-89-750 as well.)
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii) (Oil and grease separation may be used as an alternative 
treatment.), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f), 
(g), (h), (i), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46772, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2675  Perfluoroalkyl epoxide (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkyl epoxide (PMN P-86-562) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) and (g)(2)(v). The provision of 
Sec. 721.72(d) requiring that employees be provided with information on 
the location and availability of MSDSs does not apply when an MSDS is 
not required under Sec. 721.72(c). The provision

[[Page 223]]

of Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (v) Release to water. Sec. 721.90 (a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (g), (i), (j), and 
(k).
    (2) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (3) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 26099, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2725  Trichlorobutylene oxide.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance trichlorobutylene oxide (TCBO), CAS Number 
3083-25-8, [Listed in TSCA Inventory as oxirane, (2,2,2-trichloroethyl)-
] is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is any use.
    (b) Special requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[52 FR 41300, Oct. 27, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.2800  Erionite fiber.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance, erionite fiber (CAS No. 66733-21-9 (when an 
exact molecular formula is known) and 12510-42-8 (when an exact 
molecular formula is not known)), is subject to reporting under this 
section for the significant new use described in paragraph (a)(2) of 
this section.
    (2) The significant new use is: Any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by the following paragraphs:
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) Exemptions. Section 721.45 applies to this section except for 
Sec. 721.45(f). A person who intends to import or process the substance 
identified in paragraph (a)(1) of this section as part of an article is 
subject to the notification provisions of Sec. 721.25.

[56 FR 56472, Nov. 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.2805  Acrylate ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
acrylate ester (PMN P-96-824) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 224]]

this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3426, Jan. 22, 1998]



Sec. 721.2825  Alkyl ester (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkyl ester (PMN P-84-968) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent) and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). The 
provision of Sec. 721.72(d) requiring that employees to be provided with 
information on the location and availability of a written hazard 
communication program does not apply when the written program is not 
required under Sec. 721.72(a). The provision of Sec. 721.72(g) requiring 
placement of specific information on a label does not apply when a label 
is not required under Sec. 721.72(b).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e), (f), (i) 
and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32414, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2900  Substituted aminobenzoic acid ester (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance substituted aminobenzoic acid 
ester (PMN P-84-951) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) (concentration set at 0.1 percent), 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vii) and (g)(2)(v). The provisions of Sec. 721.72(d) requiring 
employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDS are not required under 
Sec. 721.72 (a) and (c), respectively. The provision of Sec. 721.72(g) 
requiring placement of specific information on a MSDS does not apply 
when a MSDS in not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e), (f), and 
(i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 225]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32415, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2920  tert-Amyl peroxy alkylene ester (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance tert-amyl peroxy alkylene ester 
(PMN P-85-1180) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) (concentration set at 1.0 percent), 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 1.0 percent), 
(f) and (g)(1)(vii), (g)(2)(i), (g)(2)(v), (g)(4)(i), and (g)(5). The 
provision of Sec. 721.72(d) requiring that employees to be provided with 
information on the location and availability of a written hazard 
communication program does not apply when the written program is not 
required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2) and (a)(3), (b)(1), (b)(2) and (b)(3).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(vi), (b)(2)(vi) and (c)(2)(vi).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32413, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.2925  Brominated aromatic ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
brominated aromatic ester (PMN P-95-1128) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(1), (g)(3)(ii), (g)(4)(iii), 
and (g)(5).
    (ii) [Reserved]
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3426, Jan. 22, 1998]



Sec. 721.2950  Carboxylic acid glycidyl esters.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid glycidyl ester (PMN P-92-776) is subject to reporting 
under this section for the significant new uses described in this 
paragraph.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), 
(a)(5)(v), (a)(5)(vi), (a)(5)(vii),

[[Page 226]]

(a)(6)(i), (b) (concentration set at 0.1 percent), and (c). As an 
alternative to the respiratory requirements in this section, 
manufacturers, importers, and processors may use the New Chemical 
Exposure Limits provisions, including sampling and analytical methods 
which have previously been approved by EPA for this substance, found in 
the 5(e) consent order for this substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (C) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (2) The chemical substance identified as carboxylic acid glycidyl 
ester (PMN P-92-777) is subject to reporting under this section for the 
significant new uses described in this paragraph.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i) 
(Sec. 721.63(a)(5)(i) applies only during processing operations), 
(a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c). As an 
alternative to the respiratory requirements in this section, 
manufacturers, importers, and processors may use the New Chemical 
Exposure Limits provisions, including sampling and analytical methods 
which have previously been approved by EPA for this substance, found in 
the 5(e) consent order for this substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(vi), (g)(1)(vii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (C) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (b) [Reserved]

[59 FR 27483, May 27, 1994]



Sec. 721.3000  Dicarboxylic acid       monoester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance referred to by its 
premanufacture notice number and its generic chemical name is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section: dicarboxylic acid monoester, P-83-255.
    (2) The significant new uses are:
    (i) Any manufacture in the United States for commercial purposes.
    (ii) Failure to require the use of gloves determined to be 
impervious to the substance, and/or failure to require the use of 
clothing to prevent dermal contact for any person involved in any 
processing or use operation where dermal contact may occur. (Gloves may 
be determined to be impervious to the substance either by testing the 
gloves under the conditions of use or by relying on the manufacturer's 
specifications.)

[[Page 227]]

    (iii) Distribution in commerce by any person, including importers, 
processors, and distributors, without affixing to each container of any 
formulation containing the substance a label that includes, in letters 
no smaller than 10 point type, the following statements:

    WARNING! HARMFUL IF INHALED OR ABSORBED THROUGH THE SKIN. MAY CAUSE 
REPRODUCTIVE EFFECTS.

--Do not get in eye, on skin, or clothing.
--Do not breathe (vapor, mist, spray, dust).
--Use with adequate ventilation.
--Wear impervious gloves and protective equipment to prevent contact or 
exposure.
--Promptly remove contaminated non-imprevious clothing, wash before 
reuse.
--Discard contaminated leather shoes.
--Wash thoroughly after handling, and before eating, drinking, or 
smoking.
--Keep container closed.
    FIRST AID: In case of contact.
    EYES: Immediately flush with water for at least 15 minutes.
    SKIN: Promptly wash thoroughly with mild soap and water.
    INHALATION: Remove to fresh air. If breathing is difficult, give 
oxygen.
    INGESTION: If conscious, give water and induce vomiting.

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. In addition to the requirements of Sec. 721.17, 
importers and processors of the chemical substance identified in 
paragraph (a)(1) of this section must maintain the following records for 
five years from their creation:
    (i) The names of persons required to wear protective clothing.
    (ii) The name and address of each person to whom the substance is 
sold or transferred and the date of such sale or transfer.
    (2) [Reserved]

[49 FR 43064, Oct. 26, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.3020  1,1-Dimethylpropyl peroxyester (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 1,1-dimethylpropyl peroxyester 
(PMN P-85-680) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), and (a)(6)(v), (b) 
[concentration set at 0.1 percent], and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) [concentration set at 0.1 
percent], (f), and (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and 
(g)(2)(v), and (g)(4)(i).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(3) and 
(b)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26111, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3031  Boric acid (H3BO3), zinc salt (2=3).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as boric acid 
(H3BO3), zinc salt (2=3) (PMN P-97-552; CAS No. 
10192-46-8) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 228]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.3032  Boric acid (H3BO2), zinc salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as boric acid 
(H3BO2), zinc salt (PMN P-97-553; CAS No. 14720-
55-9) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.3034  Methylamine esters.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylamine esters (PMN P-94-982) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11042, Mar. 1, 1995]



Sec. 721.3063  Substituted phenyl azo substituted phenyl esters (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted phenyl azo substituted phenyl esters (PMNs P-95-655, P-95-
782 and P-95-871) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(w)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[61 FR 63736, Dec. 2, 1996]



Sec. 721.3080  Substituted phosphate ester (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted phosphate ester (PMN P-85-730) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at

[[Page 229]]

0.1 percent), (f), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Release to water. Section 721.90 (a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26100, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3085  Brominated phthalate ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
brominated phthalate ester (PMN P-90-581) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (ii) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of these substances without providing risk 
notification as follows.
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a MSDS as 
described in Sec. 721.72(c) within 90 days from the time the employer 
becomes aware of the new information. If this substance is not being 
manufactured, imported, processed, or used in the employer's workplace, 
the employer must add the new information to an MSDS before the 
substances are reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received the substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3426, Jan. 22, 1998]



Sec. 721.3100  Oligomeric silicic acid ester compound with a hydroxylalkylamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
oligomeric silicic acid ester compound with a hydroxylalkylamine (PMN P-
91-118) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(a).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a),

[[Page 230]]

(b), (c), and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46465, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3140  Vinyl epoxy ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance vinyl epoxy ester (PMN P-85-527) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent) and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(vii), (g)(2)(i) through (g)(2)(iii), (g)(2)(v), 
(g)(4)(i), and (g)(5). The provision of Sec. 721.72(d) requiring that 
employees to be provided with information on the location and 
availability of a written hazard communication program does not apply 
when the written program is not required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) (as an injection molding coating), and 
(y).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(2), 
(b)(2), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), (g), 
(h), and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 39900, Sept. 28, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3152  Ethanaminium, N-ethyl-2-hydroxy-N,N-bis(2-hydroxyethyl)-, diester with C12-18 fatty acids, ethyl sulfates (salts).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance ethanaminium, N-ethyl-2-hydroxy-
N,N-bis(2-hydroxyethyl)-, diester with C12-18 fatty acids, 
ethyl sulfates (salts) (P-94-24) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a material 
safety data sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received, this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (1,900,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 231]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 45081, Aug. 30, 1995]



Sec. 721.3155  3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3,8-dioxa-4,7-
disiladecane, 4,4,7,7-tetraethoxy- (PMN P-95-1326; CAS No. 16068-37-4) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3426, Jan. 22, 1998]



Sec. 721.3160  1-Chloro-2-bromoethane.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 1-chloro-2-bromoethane (CAS No. 107-04-0) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[53 FR 2845, Feb. 2, 1988. Redesignated at 58 FR 29946, May 24, 1993, as 
amended at 58 FR 34204, June 23, 1993]



Sec. 721.3180  Ethane, 2-chloro-1,1,1,2-    tetrafluoro-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as ethane, 2-chloro-
1,1,1,2-tetrafluoro- (CAS number 2837-89-0) (PMN P-88-1763) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent; 
concentration is set at 0.1 percent if new information requires a hazard 
statement on the MSDS for cancer pursuant to Sec. 721.72(c)(5)), (f), 
and (g)(5). The following additional human hazard precautionary 
statement shall appear on the MSDS as specified in Sec. 721.72(c):

    Inhalation of high concentrations of vapor is harmful and may cause 
heart irregularities, unconsciousness, or death. Intentional misuse can 
be fatal. Vapor reduces oxygen available for breathing and is heavier 
than air. Liquid contact causes frostbite. The effects in animals from 
single exposure by inhalation include central nervous system effects, 
anesthesia, and decreased blood pressure. Cardiac sensitization occurred 
in dogs exposed to a concentration of 2.5 percent in air and given an 
intravenous epinephrine challenge. Repeated exposures produced increased 
liver weights, anesthetic effects, irregular respiration, poor 
coordination, and nonspecific effects such as decreased body weight 
gain. However, no irreversible effects were seen as evidenced by 
histopathologic evaluation. As part of an extensive toxicology program, 
halogenated chlorofluorocarbon-124 will be tested in subchronic, 
developmental, and chronic/cancer studies. Avoid breathing high 
concentration of vapor. Use with sufficient ventilation to keep employee 
exposure below recommended

[[Page 232]]

limits. Avoid contact of liquid with skin and eyes. Wear chemical splash 
goggles and lined butyl gloves. Do NOT allow product to contact open 
flame or electrical heating elements because dangerous decomposition 
products may form.


The following additional human health hazard precautionary statements 
shall appear on each label as specified in Sec. 721.72(b):

    Inhalation of high concentrations of this substance in vapor form 
may cause:
    (a) Heart irregularities.
    (b) Unconsciousness.
    (c) Death.

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q). In addition it is a significant new use 
to use this substance as a blowing agent in the manufacture of 
structural insulation foams for commercial or consumer purposes or to 
use for commercial or consumer purposes structural insulation foams made 
using this substance.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Processors of this substance are not subject to this section if 
they only service, repair, maintain, or sell products that contain the 
substance.
    (2) Notwithstanding Sec. 721.45(f), importers of structural 
insulation foams made using this substance are subject to notification 
requirements.
    (3) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance: Sec. 721.125 (a), (b), (c), and (f) through (i).
    (4) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (5) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 32446, July 22, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3220  Pentachloroethane.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance pentachloroethane, CAS Number 76-01-7, is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[51 FR 32079, Sept. 9, 1986. Redesignated at 53 FR 2845, Feb. 2, 1988 
and correctly redesignated at 56 FR 29903, July 1, 1991. Further 
redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 34204, 
June 23, 1993]



Sec. 721.3248  Ethane, 1,2,2-       trichlorodifluoro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethane, 1,2,2-
trichlorodifluoro- (CAS No. 354-21-2, PMN No. P-92-595) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32237, June 8, 1993]



Sec. 721.3260  Ethanediimidic acids.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as ethanediimidic 
acids (PMNs P-90-1472

[[Page 233]]

and P-90-1473), are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e), (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(4)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1) and (b)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44065, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.3320  Ethanol, 2-amino-, compound with N-hydroxy-N-nitrosobenzenamine (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanol, 2-amino-, 
compound with N-hydroxy-N-nitrosobenzenamine (1:1) (P-86-542), is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), and (g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 720.80(k) (monomer stabilizer).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 25990, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3340  Ethanol, 2,2'-       (hexylamino)bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanol, 2,2'-
(hexylamino)bis- (PMN P-91-1346) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125 (a), (b), (c), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 31968, July 20, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3350  N-Nitrosodiethanolamine.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance N-

[[Page 234]]

nitrosodiethanolamine (CAS No. 1116-54-7) is subject to reporting under 
this section for the significant new use described in paragraph (a)(2) 
of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.3360  Substituted ethanolamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted ethanolamine (PMN P-91-490) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2), 
(y)(1), and (y)(2).
    (ii) Release to water. Requirements as specified in 
Sec. 721.90(a)(4), (b)(4), and (c)(4) (N = 1 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3364  Aliphatic ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
aliphatic ether (PMN P-93-1381) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27484, May 27, 1994]



Sec. 721.3374  Alkylenediolalkyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as an alkylenediolalkyl 
ether (PMN P-93-362) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51684, Oct. 4, 1993]



Sec. 721.3380  Anilino ether.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as anilino 
ether (P-83-910) is subject to reporting under this section for

[[Page 235]]

the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(D) and (g)(2)(v). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), (d), (f), and (g).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25989, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3420  Brominated arylalkyl ether.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
brominated arylalkyl ether (P-83-906) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(D) and (g)(2)(v). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), (d), (f), and (g).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25990, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3430  4-Bromophenyl phenyl ether.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance 4-bromophenyl phenyl ether (CAS No. 101-55-3) 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.3435  Butoxy-substituted ether alkane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as butoxy-
substituted ether alkane (PMN P-92-755) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) 
(concentration set at 1.0 percent), and (c). In addition, the employer 
must be able to demonstrate that the gloves selected for handling the 
chemical substance provide an impervious barrier to prevent dermal 
exposure during normal and expected duration and conditions of exposure 
within the work area by testing the material used to make the gloves and 
the construction of the gloves to establish that they will be impervious 
for the expected duration and conditions of exposure. The testing

[[Page 236]]

must subject the gloves to the expected conditions of exposure, 
including the likely combinations of chemical substances to which the 
gloves may be exposed in the work area. There must be no permeation of 
the gloves by the chemical substance (or an EPA-approved analogue) 
greater than 0.16  g/cm2/min after 8 h of testing in 
accordance with the most recent versions of the American Society for 
Testing and Materials (ASTM) F739 ``Standard Test Method for Resistance 
of Protective Clothing Materials to Permeation by Liquids or Gases'' and 
ASTM F1194 ``Guide for Documenting the Results of Chemical Permeation 
Testing of Protective Clothing Materials.'' The employer must submit all 
test data to the Agency and must receive written Agency approval of the 
test results for each type of glove tested prior to use of such gloves. 
Nitrile gloves with a minimum thickness of 0.5588 mm have already been 
tested and found to satisfy the terms of this section. Gloves 
contaminated with the PMN substance shall be disposed of after every 
work shift.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). In addition, the 
human health hazard statements shall include a statement that this 
substance may cause systemic toxicity and blood effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and records documenting compliance with the 
glove permeability testing requirements of this section are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51684, Oct. 4, 1993]



Sec. 721.3437  Dialkyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as dialkyl 
ether (PMN P-93-1308) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 180 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11042, Mar. 1, 1995]



Sec. 721.3440  Haloalkyl substituted cyclic ethers.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances haloalkyl substituted cyclic 
ethers (PMN P-85-368 and P-85-369) are subject to reporting under this 
section for the significant new uses described in this paragraph.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii) 
and (a)(6)(v) and (a)(6)(vi), (b) [concentration set at 1.0 percent], 
and (c).
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) [concentration set at 1.0 percent], (f), and 
(g)(1)(iii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv) and (g)(2)(v), and 
(g)(5). The provision of Sec. 721.72(d) requiring that employees be 
provided with information on the location and availability of MSDSs does 
not apply when a MSDS was not required under Sec. 721.72(c). The 
provisions of Sec. 721.72(g) requiring placement of specific information 
on a label and MSDS do not apply when a label and MSDS are not

[[Page 237]]

required under Sec. 721.72 (b) and (c), respectively.
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(k).
    (D) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2), (b)(1) and (b)(2), and (c)(1) and (c)(2).
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of the 
substances, as specified in Sec. 721.125 (a) through (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (C) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (2) The chemical substance haloalkyl substituted cyclic ether (PMN 
P-85-367) is subject to reporting under this section for the significant 
new uses described in this paragraph.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
and (a)(6)(v) and (a)(6)(vi), (b) [concentration set at 0.1 percent], 
and (c).
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) [concentration set at 0.1 percent], (f), and 
(g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv) and 
(g)(2)(v), and (g)(5). The provision of Sec. 721.72(d) requiring that 
employees be provided with information on the location and availability 
of MSDSs does not apply when a MSDS was not required under 
Sec. 721.72(c). The provisions of Sec. 721.72(g) requiring placement of 
specific information on a label and MSDS do not apply when a label and 
MSDS are not required under Sec. 721.72 (b) and (c), respectively.
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(k).
    (D) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1) and (b)(2), and (c)(1) and (c)(2).
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (C) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (b) [Reserved]

[55 FR 26109, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3460  Diglycidyl ether of disubstituted carbopolycyle (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance diglycidyl ether of disubstituted 
carbopolycyle (PMN P-88-837) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5) (vii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b), (c), (d), (e) (concentration set at 0.1 percent), (f) 
and (g)(1)(iv) through (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), 
(g)(2)(v) and (g)(5). The provision of Sec. 721.72(d) requiring that 
employees to be provided with information on the location and 
availability of a written hazard communication program does not apply 
when the written program is not required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable

[[Page 238]]

to manufacturers, importers, and processors of this substance, as 
specified in Sec. 721.125 (a) through (c) and (e) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32415, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3465  Stilbene diglycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as stilbene diglycidyl 
ether (PMN P-96-1427) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), 
(a)(5)(v), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c). 
As an alternative to the respiratory protection requirements of this 
section, manufacturers, importers, and processors of this substance may 
follow the terms of the new chemical exposure limits section in the TSCA 
section 5(e) consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ii), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), (g)(2)(v), and (g)(5). The label and MSDS as required by 
this paragraph shall also include the following statement: When using 
this substance use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.5 
milligram (mg)/meter (m3).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3426, Jan. 22, 1998]



Sec. 721.3480  Halogenated biphenyl    glycidyl ethers.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
halogenated biphenyl glycidyl ethers (PMNs P-90-1844, P-90-1845, and P-
90-1846) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) 
(concentration set at 0.1 percent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), 
(g)(i)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 
(g)(3)(ii) and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44065, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3485  Hydrofluorocarbon alkyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 239]]

chemical substance identified generically as a hydrofluorocarbon alkyl 
ether (PMN P-95-1578) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. Non-
spray uses are exempt from the provisions of this rule.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), and (a)(6)(v).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3427, Jan. 22, 1998]



Sec. 721.3486  Polyglycerin mono(4-nonylphenyl) ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyglycerin mono(4-nonylphenyl) ether (PMN P-94-2230) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]



Sec. 721.3488  Poly(oxy-1,2-ethanediyl), alpha substituted-omega-hydroxy-, C16-20 alkyl ethers.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
poly(oxy-1,2-ethanediyl), alpha substituted-omega-hydroxy-, 
C16-20 alkyl ethers (PMN P-87-323) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (N = 20).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3427, Jan. 22, 1998]



Sec. 721.3500  Perhalo alkoxy ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as perhalo 
alkoxy ether (PMN P-83-1227) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), 
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communicatiom program. Requirements as specified in 
Sec. 721.72 (d), (e) (concentration set at 1.0 percent), (f), 
(g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The 
provisions of Sec. 721.72(d) requiring employees to be provided with 
information on the location and availability of a written hazard 
communication program and MSDSs do not apply when the written program 
and MSDS are not required under Sec. 721.72 (a), and (c), respectively.

[[Page 240]]

The provisions of Sec. 721.72(g) requiring placement of specific 
information on a label and MSDS do not apply when a label and MSDS are 
not required under Sec. 721.72 (b), and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(h).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), and (f).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46772, Nov. 6, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3520  Aliphatic polyglycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance aliphatic polyglycidyl ether (PMN 
P-89-1036) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5) (vii), 
(a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(3)(ii), 
(g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c) through (i), and 
(k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 39900, Sept. 28, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3550  Dipropylene glycol dimethyl ether.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as dipropylene glycol 
dimethyl ether (PMN P-93-507; CAS No. 111109-77-4) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. This class 2 substance is exempt from 
the notification requirements of this rule if it contains less than 5 
percent by weight of the specific isomer, propane, 2,2'-oxybis[1-
methoxy- (CAS No. 189354-80-1), which is one of the possible products of 
the manufacturing process for PMN P-93-507.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements specified in Sec. 721.125 (a), (b), (c), (d), and (e) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[62 FR 59583, Nov. 4, 1997; 62 FR 63035, Nov. 26, 1997]



Sec. 721.3560  Derivative of tetrachloroethylene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The following chemical substance referred to

[[Page 241]]

by its premanufacture notice number and generic chemical name is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section: Derivative of tetrachloroethylene, 
P-82-684.
    (2) The significant new uses are: (i) Manufacture or processing 
without requiring use of the following by persons employed by or under 
the control of the manufacturer or processor who are involved in, and in 
the immediate area of, any operation where dermal contact and/or 
inhalation of the substance may occur:
    (A) A respirator, approved by the National Institute for 
Occupational Safety (NIOSH) to provide protection against dusts having 
an air contamination level not less than 0.05 mg per cubic meter of air 
and fitted according to procedures established by the Occupational 
Safety and Health Administration and Mine Safety and Health 
Administration regulations and set forth at 29 CFR 1910.134, and 30 CFR 
part 11, respectively, and
    (B) Gloves which are determined to be impervious to the substance 
under the conditions of potential exposure (gloves must be determined to 
be impervious to the substance either by testing the gloves under the 
conditions of exposure, including the duration of exposure, or by 
evaluating the data and specifications supplied by the glove 
manufacturer or others, in the context of the conditions of exposure 
including the duration of exposure, associated chemical substances, 
chemical and mechanical stresses, and potential durations of exposures.
    (ii) Manufacture or processing without requiring that any container 
of the substance or of a formulation containing the substance be:
    (A) Packaged to prevent any leakage of the substance to the 
environment.
    (B) Labeled on the package that the substance should be handled only 
while using NIOSH approved respirators and impervious gloves.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. In addition to the requirements of Sec. 721.17, 
manufacturers and processors of the substance identified in paragraph 
(a)(1) of this section must maintain the following records for five 
years from the date of their creation:
    (i) The names of persons required to wear protective equipment in 
accordance with paragraph (a)(2) of this section.
    (ii) The names and addresses of any person to whom the substance is 
sold or transferred and the dates of such sale or transfer.
    (iii) Records of respirator fit tests for each person required to 
wear a respirator in accordance with paragraph (a)(2) of this section.
    (iv) The method for determining that the gloves described in 
paragraph (a)(2) of this section are impervious to the substance, the 
date(s) of such determination, and the results of that determination.
    (2) [Reserved]

(Secs. 5, 8, Pub. L. 94-469, 90 Stat. 2012 (15 U.S.C. 2604, 2607))

[49 FR 42932, Oct. 25, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29947, May 24, 1993]



Sec. 721.3565  Ethylenediamine, substituted, sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ethylenediamine, substituted, sodium salt (PMN P-97-328) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3427, Jan. 22, 1998]

[[Page 242]]



Sec. 721.3620  Fatty acid amine condensate, polycarboxylic acid salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a fatty acid amine 
condensate, polycarboxylic acid salts. (PMN P-92-445) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3625  Fatty acid amine salt (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acid amine salt (PMN P-88-1889) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (f), and (g)(3)(ii). The provisions of 
Sec. 721.72(g) would require the following warning language on the 
label: Minimize releases to the environment.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (f), (g), (h), 
(i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33305, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3627  Branched synthetic fatty acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
branched synthetic fatty acid (PMN P-94-422) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (g), and (l).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11043, Mar. 1, 1995]



Sec. 721.3628  Fatty acids, C(14-18)-unsaturated, branched and linear, methyl and butyl esters.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances fatty acids, C(14-18) 
unsaturated, branched and linear, methyl and butyl esters (P-94-1634/35/
36/37/38/39) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is

[[Page 243]]

any manner or method of manufacture, import, or processing associated 
with any use of this substance without providing risk notification as 
follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63737, Dec. 2, 1996]



Sec. 721.3629  Triethanolamine salts of fatty acids.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
triethanolamine salts of fatty acids (PMN Nos. P-92-156, P-92-157, and 
P-92-159) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of these 
substances is any manner or method of manufacture, import, or processing 
associated with any use of these substances without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for these substances, the employer becomes aware that 
these substances may present a risk of injury to human health, the 
employer must incorporate this new information, and any information on 
methods for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If these substances are not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substances are 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received these substances from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 244]]

(h), and (i) are applicable to manufacturers, importers, and processors 
of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32238, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.3635  Octadecanoic acid, ester with 1,2-propanediol, phosphate, anhydride with silicic acid (H4SiO4).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octadecanoic acid, 
ester with 1,2-propanediol, phosphate, anhydride with silicic acid 
(H4SiO4) (PMN P-96-1520; CAS No. 177771-31-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and (g)(5). 
The following statement shall appear on each label as specified in 
Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): Do not 
release into the environment in quantities that allow surface water 
concentrations to exceed 6 ppb.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (15 months).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 6).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.3680  Ethylene oxide adduct of fatty acid ester with pentaerythritol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as ethylene 
oxide adduct of fatty acid ester with pentaerythritol (PMN P-91-442) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3700  Fatty acid, ester with styrenated phenol, ethylene oxide adduct.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acid, ester with styrenated phenol, ethylene oxide adduct (P-90-364) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 400 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a),

[[Page 245]]

(b), (c), (f), (g), (h), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44065, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3720  Fatty amide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a fatty 
amide (PMN P-91-87) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3740  Bisalkylated fatty alkyl amine oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bisalkylated fatty alkyl amine oxide (PMN P-90-643) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 80 ppb).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19238, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.3760  Fluorene-containing diaromatic amines.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
fluorene-containing diaromatic amines (PMN P-88-998 and P-88-999) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]



Sec. 721.3764   Fluorene substituted aromatic amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
fluorene substituted aromatic amine (PMN P-91-43) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at 
1.0 percent),

[[Page 246]]

and (c). However, these requirements do not apply after the PMN 
substance is adhered onto film or incorporated into prepreg form (resin 
impregnated substrate).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5) during 
manufacture.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[62 FR 42692, Aug. 8, 1997]



Sec. 721.3790  Polyfluorocarboxylates.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
polyfluorocarboxylates (PMNs P-94-322 and P-94-323) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11043, Mar. 1, 1995]



Sec. 721.3800  Formaldehyde, condensated polyoxyethylene fatty acid, ester with styrenated phenol, ethylene oxide adduct.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
formaldehyde, condensated polyoxyethylene fatty acid, ester with 
styrenated phenol, ethylene oxide adduct (PMN P-90-360) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4) and (c)(4) (where N = 400 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44066, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3815  Furan, 2-(ethoxymethyl)- tetrahydro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance furan, 2-(ethoxymethyl) 
tetrahydro- (P-93-721) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:

[[Page 247]]

    (A) If, as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125 (a), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 11043, Mar. 1, 1995]



Sec. 721.3840  Tetraglycidalamines    (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
tetraglycidalamines (PMN P-86-500 and P-86-502) are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5) (vi), 
(a)(6)(i), (a)(5)(xi) and (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c). The respirator required under Sec. 721.63 (a)(5)(vi) 
is applicable only when the PMN substance is in the form of a dust. The 
respirator required under Sec. 721.63 (a)(5)(xi) is applicable only when 
the PMN substance is in the form of a mist.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), 
(g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (o).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2) and (c)(1), (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(vi), (b)(2)(vi) and (c)(2)(vi).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 26101, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.3860  Glycol monobenzoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 
glycol monobenzoate (P-90-1357) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is

[[Page 248]]

any manner or method of manufacture, import, or processing associated 
with any use of this substance without providing risk notification as 
follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40211, Aug. 13, 1991, as amended at 56 FR 46729, Sept. 16, 1991. 
Redesignated and amended at 58 FR 29946, May 24, 1993; 58 FR 34204, June 
23, 1993]



Sec. 721.3880  Polyalkylene glycol substituted acetate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyalkylene glycol substituted acetate (PMN P-91-1269) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to the environment, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer, or who have received this substance from 
the employer within 5 years from the date the employer becomes aware of 
this new information described in paragraph (a)(2)(i)(A) of this 
section, are provided an MSDS as described in Sec. 721.72(c) containing 
the information required under paragraph (a)(2)(i)(A) of this section 
within 90 days from the time the employer becomes aware of the new 
information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 249]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44066, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.3900  Alkyl polyethylene glycol phosphate, potassium salt.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
polyethylene glycol phosphate, potassium salt (P-90-481), is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows.
    (A) If, as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into a Material Safety Data Sheet 
(MSDS) as described in Sec. 721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, imported, processed, or used in the employer's 
workplace, the employer must add the new information to an MSDS before 
the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.125 (a), (c), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15792, Apr. 17, 1991; 56 FR 29903, July 1, 1991. Redesignated and 
amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4000  Polyoxy alkylene glycol amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polyoxy 
alkylene glycol amine (PMN P-91-1372) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified at Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125 (a), (b), (c), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 31968, July 20, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4040    Glycols, polyethylene-, 3-sulfo-2-hydroxypropyl-p-(1,1,3,3-tetramethylbutyl)phenyl ether,   sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycols, 
polyethylene-, 3-sulfo-2-hydroxypropyl-p-(1,1,3,3-tetramethyl

[[Page 250]]

butyl)phenyl ether, sodium salt (P-90-1565) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into an MSDS as 
described at Sec. 721.72(c) within 90 days from the time the employer 
becomes aware of the new information. If this substance is not being 
manufactured, imported, processed, or used in the employer's workplace, 
the employer must add the new information to an MSDS before the 
substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (volume set at 1,115,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40212, Aug. 13, 1991, as amended at 56 FR 46729, Sept. 16, 1991. 
Redesignated at 58 FR 29946, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4060  Alkylene glycol terephthalate and substituted benzoate esters (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkylene 
glycol terephthalate and substituted benzoate esters (PMN P-89-596) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c) and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26101, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4080  MNNG (N-methyl-N'-nitro-N-nitrosoguanidine).

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance MNNG (N-methyl-N'-nitro-N-nitrosoguanidine) 
(CAS No. 70-25-7) is subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000

[[Page 251]]

pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.4085  Guanidine, pentaethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as guanidine, 
pentaethyl- (PMN P-94-1018; CAS No. 13439-89-9) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3427, Jan. 22, 1998]



Sec. 721.4090  Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-, bromide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanaminium, N-
[bis(diethylamino)-methylene]-N-ethyl-, bromide (PMN P-94-1019; CAS No. 
89610-32-2) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3427, Jan. 22, 1998]



Sec. 721.4095  Quaternary ammonium alkyltherpropyl trialkylamine halides.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
quaternary ammonium alkyltherpropyl trialkylamine halides (PMNs P-96-
1280/81/1504/1505/1506/1507/1508) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4097  7-Oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 7-
oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl ester (PMN P-98-101) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 252]]

    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.4098  Substituted heteroaromatic-2[[4-(dimethylamino) phenyl]azo]-3-methyl-, salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted heteroaromatic-2[[4-(dimethylamino)phenyl]azo]-3-methyl-, 
salts (PMNs P-97-582 and P-97-583) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.4100  Tris(disubstituted alkyl) heterocycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tris(disubstituted alkyl) heterocycle (P-90-142) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iv), (a)(6)(i), (b) (concentration set at 0.1 
percent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(2)(iv), (g)(5). The hazard 
communication requirements do not apply when the chemical substance is 
present in a plastic, an elastomer, a rubber matrix, or in a solution.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q). Any amount of the PMN substance imported 
in a plastic, an elastomer, a rubber matrix, or in a solution, such that 
inhalation is precluded, shall not be included in the production limit 
calculations.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (f), (g), 
(h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40212, Aug. 13, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4110  Allyloxysubstituted heterocycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
allyloxysubstituted heterocycle (PMN P-93-1471) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 70 ppb).

[[Page 253]]

    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11043, Mar. 1, 1995]



Sec. 721.4128  Dimethyl-3-substituted heteromonocycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dimethyl-3-substituted heteromonocycle (PMN No. P-91-1322) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), 
(a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (d) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32238, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.4133  Dimethyl-3-substituted heteromonocyclic amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dimethyl-3-substituted heteromonocycle (PMN No. P-91-1323) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(2)(iv), 
(a)(3), (a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (concentration set at 
1.0 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(iii), (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (d) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32238, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.4140  Hexachloronorbornadiene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 1,2,3,4,7,7-
hexachloronorbornadiene, CAS Number 3389-71-7, is subject to reporting 
under

[[Page 254]]

this section for the significant new use described in paragraph (a)(2) 
of this section.
    (2) The significant new use is: Use other than as an intermediate in 
the production of isodrin or endrin.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Definitions. In addition to the definitions in Sec. 721.3, the 
following definitions apply:
    (i) ``Endrin'' means the pesticide 2,7:3,6-Dimethanonaphth[2,3-
b]oxirene, 3,4,5,6,9,9-hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-, (1a 
alpha, 2beta,2abeta,3alpha,6alpha,6abeta, 7beta,7aalpha)-, CAS Number 
72-20-8.
    (ii) ``Isodrin'' means the pesticide 1,4:5,8-Dimethano-
naphthalene,1,2,3,4,10,10-hexachloro-1,4,4a,5,8,8a-hexahydro-, (1alpha, 
4alpha, 4abeta, 5beta, 8beta, 8abeta)-, CAS Number 465-73-6.
    (2) [Reserved]

[50 FR 47538, Nov. 19, 1985. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.4155  Hexachloropropene.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance hexachloropropene (CAS No. 1888-71-7) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.4158  Hexadecanoic acid, ethenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexadecanoic acid, 
ethenyl ester (PMN P-97-302; CAS No. 693-38-9) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i) and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4160  Hexafluoropropylene oxide.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance hexafluoropropylene oxide (HFPO), CAS Number 
428-59-1 [Listed in TSCA Inventory as oxirane, 
trifluoro(trifluoromethyl)-] is subject to reporting under this section 
for the significant new use described in paragraph (a)(2) of this 
section.
    (2) The significant new use is any use other than as an intermediate 
in the manufacture of fluorinated substances in an enclosed process.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Definitions. In addition to the definitions in Sec. 721.3, the 
following definitions apply to this section:
    (i) Enclosed process means a process that is designed and operated 
so that there is no intentional release of any substance present in the 
process. A process with fugitive, inadvertent, or emergency relief 
releases remains an enclosed process so long as measures are taken to 
prevent worker exposure to and environmental contamination from the 
releases.

[[Page 255]]

    (ii) [Reserved]
    (2) [Reserved]

[52 FR 41300, Oct. 27, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.4180  Hexamethylphosphoramide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance hexamethylphosphomide, CAS Number 
680-31-9, is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new use is: Any use.
    (b) Special provisions. The provisions of subpart A of the part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a signficant new use notice.
    (2) [Reserved]

[51 FR 9453, Mar. 19, 1986. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.4200  Substituted alkyl peroxyhexane carboxylate (mixed isomers) (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance substituted alkyl peroxyhexane 
carboxylate (mixed isomers) (PMN-86-1493) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 0.1 percent], 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) [concentration set at 0.1 
percent], (f), and (g)(1)(i) and (g)(1)(vii), (g)(2)(i) and (g)(2)(v), 
and (g)(4)(i).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) and (b)(1) and (b)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) [concern level of 5 ppb], (b)(4) [concern level of 5 ppb], and 
(c)(4) [concern level of 5 ppb].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26111, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4215  Hexanedioic acid, diethenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexanedioic acid, 
diethenyl ester (PMN P-90-1564) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply once the 
substance has been incorporated into a polymer matrix with the level of 
residual monomer below 0.1 percent.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i), (There must 
be no permeation of the PMN substance greater than 0.05  g/
min. cm2 after 8 hours of testing in accordance 
with the most current version of the American Society for Testing and 
Materials (ASTM) F739 ``Standard Test Method for Resistance of 
Protective Clothing Materials to Permeation by Liquids or Gases.'' For 
conditions of exposure which are intermittent, gloves may be tested in 
accordance with the most current version

[[Page 256]]

of ASTM F1383 ``Standard Test Method for Resistance of Protective 
Clothing Materials to Permeation by Liquids or Gases Under Conditions of 
Intermittent Contact,'' provided the contact time in testing is greater 
than or equal to the expected duration of dermal contact, and the purge 
time used in testing is less than or equal to the expected duration of 
noncontact during the intermittent cycle of dermal exposure in the 
workplace. If ASTM F1383 is used for testing, manufacturers, importers, 
and processors must submit to the Agency a description of worker 
activities involving the PMN substance which includes daily frequencies 
and durations of potential worker exposures. The results of all glove 
permeation testing must be reported in accordance with the most current 
version of ASTM F1194 ``Guide for Documenting the Results of Chemical 
Permeation Testing of Protective Clothing Materials.'' Manufacturers, 
importers, and processors must submit all test data to the Agency and 
must receive written Agency approval for each type of glove tested prior 
to use of such gloves. The following gloves have been tested in 
accordance with the ASTM F739 method and found by EPA to satisfy the 
requirements for continuous use: North/B-161-R/Butyl rubber gloves 
(These gloves are acceptable for the solid form of the substance only.), 
0.04 cm thick; and Ansell Edmont/4H/PE/EVOH/PE Laminate gloves, 0.006 cm 
thick. (Gloves may not be used for a time period longer than they are 
actually tested and must be replaced at the end of each work shift.), 
(a)(2)(ii) (With the exception of laboratory activities, full body 
chemical protective clothing is required for any worker activity in 
which the substance is reasonably likely to contact the worker in the 
following state(s): Open liquid pool or solid of greater than 5 kg; 
liquid spray or splash; mist; aerosol dust; or any worker activity which 
have potential for contact with the PMN chemical for more than 10 min/h. 
At a minimum, a chemical protective apron is required for any worker 
activity with potential for contact with the PMN chemical which is not 
covered by this paragraph)), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii) 
(if cartridge service life testing is not available), (a)(5)(xii) or 
(a)(5)(xiii) (if data on cartridge service life testing has been 
reviewed and approved in writing by EPA), (a)(6)(i), (a)(6)(ii), 
(a)(6)(iv), and (a)(6)(v). As an alternative to the respiratory 
requirements in this section, manufacturers, importers, and processors 
may use the New Chemical Exposure Limits provisions, including sampling 
and analytical methods which have previously been approved by EPA for 
this substance, found in the 5(e) consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (h)(1)(vi) (The following additional statements shall appear on 
each label required by this paragraph: The health effects of this 
material have not been fully determined but are currently being tested. 
EPA is concerned however, that this material may have serious chronic 
health and environmental effects. When using this material, use eye and 
skin protection, which includes gloves which have been determined to be 
impervious to this substance. Use respiratory protection, unless 
workplace airborne concentrations are maintained at or below an 8-h time 
weighted average (TWA) of 1 ppm, when there is a likelihood of exposure 
in the work area from dust, mist, smoke or vapors.), (h)(2)(ii)(F), 
(h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), (h)(2)(iii)(B), 
(h)(2)(iii)(C), (h)(2)(iii)(E), (h)(2)(iv)(A), (h)(2)(iv)(B). The 
following additional statements shall appear on each MSDS required by 
this paragraph: This substance may cause moderate skin irritation. This 
substance may cause neurotoxicity. When using this substance, use 
respiratory protection, unless workplace airborne concentrations are 
maintained at or below an 8-h TWA of 1 ppm.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 80 ppb). When calculating the 
surface water concentrations according to the instructions in 
Sec. 721.91(a)(4), the statement that the amount of the substance that 
will be released will be calculated before the

[[Page 257]]

substance enters control technology does not apply. Instead, if the 
waste stream containing the substance will be treated before release, 
then the amount of the substance reasonably likely to be removed from 
the waste stream by such treatment may be subtracted in calculating the 
number of kilograms released. No more than 75 percent removal efficiency 
may be attributed to such treatment. In addition, when the substance is 
released in combination with the substances hexanoic acid, 2-ethyl-, 
ethenyl ester, neononanoic acid, ethenyl ester, and propanoic acid, 2,2-
dimethyl-, ethenyl ester, the quotient from the formula referenced in 
this section shall not exceed the average of the quotient applicable to 
the other substances weighted by the proportion of each substance 
present in the total daily amount released.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance. Manufacturers, importers, 
and processors of the substance must document that the PMN substance has 
been incorporated into a polymer matrix with the level of residual 
monomer below 0.1 percent if this section does not apply as described in 
paragraph (a)(1) of this section.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51703, Oct. 4, 1993].



Sec. 721.4240  Alkyl peroxy-2-ethyl hexanoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
peroxy-2-ethyl hexanoate (PMN P-86-1492) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e)[concentration set at 0.1 percent], (f), 
(g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5). The provisions of 
Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a), and (c), respectively. The provision of 
Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(3) (on-site only), (b)(3) (on-site only), and (c)(3) (on-site only).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), (g), 
(h), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46773, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4250  Hexanoic acid, 2-ethyl-, ethenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexanoic acid, 2-
ethyl-, ethenyl ester (PMN P-91-826) is subject to reporting under this 
section for the significant

[[Page 258]]

new uses described in paragraph (a)(2) of this section. The requirements 
of this section do not apply once the substance has been incorporated 
into a polymer matrix with the level of residual monomer below 0.1 
percent.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i) (There must 
be no permeation of the substance greater than 0.02  g/
min. cm2 after 8 hours of testing in accordance 
with the most current version of the American Society for Testing and 
Materials (ASTM) F739 ``Standard Test Method for Resistance of 
Protective Clothing Materials to Permeation by Liquids or Gases.'' For 
conditions of exposure which are intermittent, gloves may be tested in 
accordance with the most current version of ASTM F1383 ``Standard Test 
Method for Resistance of Protective Clothing Materials to Permeation by 
Liquids or Gases Under Conditions of Intermittent Contact,'' provided 
the contact time in testing is greater than or equal to the expected 
duration of dermal contact, and the purge time used in testing is less 
than or equal to the expected duration of noncontact during the 
intermittent cycle of dermal exposure in the workplace. If ASTM F1383 is 
used for testing, manufacturers, importers, and processors must submit 
to the Agency a description of worker activities involving the substance 
which includes daily frequencies and durations of potential worker 
exposures. The results of all glove permeation testing must be reported 
in accordance with the most current version of ASTM F1194 ``Guide for 
Documenting the Results of Chemical Permeation Testing of Protective 
Clothing Materials.'' Manufacturers, importers, and processors must 
submit all test data to the Agency and must receive written Agency 
approval for each type of glove tested prior to use of such gloves. The 
following gloves have been tested in accordance with the ASTM F739 
method and found by EPA to satisfy the requirements for continuous use: 
North/F101/Vitron gloves, 0.03 cm thick; and Ansell/Edmont/4H/PE/EVOH/PE 
Laminate gloves, 0.006 cm thick.(Gloves may not be used for a time 
period longer than they are actually tested and must be replaced at the 
end of each work shift.), (a)(2)(ii) (With the exception of laboratory 
activities, full body chemical protective clothing is required for any 
worker activity in which the substance is reasonably likely to contact 
the worker in the following state(s): Open liquid pool or solid of 
greater than 5 kg; liquid spray or splash; mist; aerosol dust; or any 
worker activity which have potential for contact with the PMN chemical 
for more than 10 min/h. At a minimum, a chemical protective apron is 
required for any worker activity with potential for contact with the PMN 
chemical which is not covered by this paragraph), (a)(2)(iii), (a)(3), 
(a)(4), (a)(5)(iii) (if cartridge service life testing is not 
available), (a)(5)(xii) or (a)(5)(xiii) (if data on cartridge service 
life testing has been reviewed and approved in writing by EPA), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), and (a)(6)(v). As an alternative to 
the respiratory requirements in this section, manufacturers, importers, 
and processors may use the New Chemical Exposure Limits provisions, 
including sampling and analytical methods which have previously been 
approved by EPA for this substance, found in the 5(e) consent order for 
this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (h)(1)(vi) (The following additional statements shall appear on 
each label required by this paragraph: The health effects of this 
material have not been fully determined but are currently being tested. 
EPA is concerned however, that this material may have serious chronic 
health and environmental effects. When using this material, use eye and 
skin protection, which includes gloves which have been determined to be 
impervious to this substance. Use respiratory protection, unless 
workplace airborne concentrations are maintained at or below an 8-h time 
weighted average (TWA) of 1 ppm, when there is a likelihood of exposure 
in the work area from dust, mist, smoke or vapors.), (h)(2)(ii)(F), 
(h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), (h)(2)(iii)(B), 
(h)(2)(iii)(C), (h)(2)(iii)(E), (h)(2)(iv)(A), (h)(2)(iv)(B). The 
following additional statements shall appear on each MSDS required by 
this paragraph:

[[Page 259]]

This substance may cause moderate skin irritation. This substance may 
cause neurotoxicity. When using this substance, use respiratory 
protection, unless workplace airborne concentrations are maintained at 
or below an 8-h TWA of 1 ppm.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 7 ppb). When calculating the 
surface water concentrations according to the instructions in 
Sec. 721.91(a)(4), the statement that the amount of the substance that 
will be released will be calculated before the substance enters control 
technology does not apply. Instead, if the waste stream containing the 
substance will be treated before release, then the amount of the 
substance reasonably likely to be removed from the waste stream by such 
treatment may be subtracted in calculating the number of kilograms 
released. No more than 75 percent removal efficiency may be attributed 
to such treatment. In addition, when the substance is released in 
combination with the substances hexanedioic acid, diethenyl ester, 
neononanoic acid, ethenyl ester, and propanoic acid, 2,2-dimethyl-, 
ethenyl ester, the quotient from the formula referenced in this section 
shall not exceed the average of the quotient applicable to the other 
substances weighted by the proportion of each substance present in the 
total daily amount released.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance. Manufacturers, importers, 
and processors of the substance must document that the substance has 
been incorporated into a polymer matrix with the level of residual 
monomer below 0.1 percent if this section does not apply as described in 
paragraph (a)(1) of this section.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51704, Oct. 4, 1993, as amended at 58 FR 68311, Dec. 27, 1993]



Sec. 721.4255  1,4,7,10,13,16-Hexaoxacyclooctadecane, 2-[(2-propenyl oxy)methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 1,4,7,10,13,16-
hexaoxacyclooctadecane, 2-[(2-propenyloxy)methyl]- (PMN P-93-1208, CAS 
no. 84812-04-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27484, May 27, 1994]



Sec. 721.4257  Hydrazine, (2-fluorophenyl).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hydrazine, (2-
fluorophenyl) (PMN P-95-2101; CAS No. 2368-80-1) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 260]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4259  Aliphatic polyisocyanate homopolymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
aliphatic polyisocyanate homopolymer (PMN P-96-1239) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4260  Hydrazine, [4-(1-methylbutoxy)phenyl]-, monohydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hydrazine, [4-(1-
methylbutoxy)phenyl]-, monohydrochloride (PMN P-90-558; CAS number 
124993-63-1) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5). 
In addition, the following human health hazard statement shall appear on 
each label and MSDS required by this section: This substance may cause 
eye irritation.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (p) (production limit set at 15,500 
kg).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Modification or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44066, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4270  Nitrophenoxylalkanoic acid substituted thiazino hydrazide (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance nitrophenoxylalkanoic acid 
substituted thiazino hydrazide (PMN P-88-270) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(vii), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b), (c), (d), (e) (concentration set at 1.0 percent), (f) 
and (g)(1)(iv) (also acute toxicity), (g)(2)(i) through (g)(2)(v), 
(g)(4)(i) and (g)(5). The provision of Sec. 721.72(d) requiring that 
employees to be provided with information on the location and 
availability of a written hazard communication program does

[[Page 261]]

not apply when the written program is not required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g) (industrial intermediates only).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1) and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 32415, Aug. 9, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4280  Substituted hydrazine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted hydrazine (PMN P-90-594) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2), (g)(3), (g)(4)(i), (g)(4)(iii), 
and (g)(5). In addition, the human health hazard statement shall include 
mutagenicity.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40213, Aug. 13, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4300  Hydrazinecarboxamide, N,N'-1,6-hexanediylbis        [2,2-dimethyl-].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
hydrazinecarboxamide, N,N'-1,6-hexanediylbis [2,2-dimethyl- (P-87-1192)] 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), 
(a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set a 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(3), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (k) (any application which, if there 
are releases to water or discharges to land, will not result in releases 
to facilities with a National Pollutant Discharge Elimination System 
permit), and (l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(b)(4), (c)(4), (where N = 30).
    (A) Selling or transferring the substance to any person for use 
where the substance is released to surface waters without notifying in 
writing the parties listed in subparagraph (B) of the identities of all 
such persons. Such notification shall be sent within 15 days of the date 
of the first sale or transfer and shall contain the following 
information:

[[Page 262]]

    (1) The name and address (including shipment destination address, if 
different) of the person to whom the substance is sold or transferred.
    (2) The date on which sale or transfer commenced.
    (3) The chemical identity of the substance.
    (4) The name of the stream or river into which the specific buyer or 
transferee is expected to discharge the substance.
    (5) Notification that the substance is subject to a Significant New 
Use Rule issued under section 5 of the Toxic Substances Control Act.
    (6) A summary of the water release restrictions contained in 
paragraph (a)(iv) of this section.
    (7) A request that the party notify the following office of any 
information which indicates that the in-stream concentration of the PMN 
substance specified in paragraph (a)(iv) of this section has been 
exceeded: Chief, New Chemicals Branch, Chemical Control Division (7405), 
Office of Pollution Prevention and Toxics, U.S. Environmental Protection 
Agency, Room E-447, 401 M St., SW., Washington, DC, 20460.
    (B) The parties to be notified are as follows.
    (1) The Director, Water Management Division (or, in the case of 
Regions 5 and 10, Water Division) at the headquarters of the EPA region 
in which the specific buyer or transferee is located.
    (2) The Agency, Department, or Office of the State or U.S. Territory 
with jurisdiction over point source water discharges in the State or 
Territory in which the specific buyer or transferee is located (EPA is 
available for consultation regarding the identity and address of the 
appropriate Agency, etc.)
    (3) The Publicly Owned Treatment Works (POTW) authority, if any, 
expected to receive the discharge of the PMN substance from the specific 
buyer or transferee.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance as specified in Sec. 721.125 (a), (b), (c), (d), (f), 
(g), (h), (i), and records documenting notification to parties 
identified in Sec. 721.90.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15792, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995]



Sec. 721.4320  Hydrazinecarboxamide, N,N'-(methylenedi-4,1-phenylene)bis [2,2-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance hydrazinecarboxamide, N,N'-
(methylenedi-4,1-phenylene)bis[2,2-dimethyl- (PMN P-88-522) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii) through (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(iv) (and blood effects), (g)(1)(vii), (g)(2)(iv), (g)(2)(v), 
(g)(4)(iii), and (g)(5). The provisions of Sec. 721.72(d) requiring 
employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDS are not required under 
Sec. 721.72 (a) and (c), respectively. The provision of Sec. 721.72(g) 
requiring placement of specific information on an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 263]]

this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), (g), 
(h), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46773, Nov. 6, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4340  Substituted thiazino hydrazine salt (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance substituted thiazino hydrazine 
salt (PMN P-88-63) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii) through (a)(5)(vii), and 
(a)(6)(i), (b) [concentration set at 0.1 percent], and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) [concentration set at 0.1 
percent], (f), and (g)(1)(iv) and (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), and (g)(2)(v), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (l).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) and (b)(1) and (b)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 26112, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4360  Certain hydrogen containing chlorofluorocarbons.

    (a) Chemical substances and significant new uses subject to 
reporting.
    (1) The chemical substances ethane, 2-chloro-1,1,1-trifluoro- (CAS 
Number 75-88-7) and ethane, 1,2-dichloro-1,1-difluoro- (CAS Number 1649-
08-7) are subject to reporting under this section for the significant 
new use described in paragraph (a)(2) of this section.
    (2) The significant new use is: Use other than as an intermediate.
    (b) [Reserved]

[55 FR 35632, Aug. 31, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4380  Modified hydrocarbon resin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
modified hydrocarbon resin (P-91-1418) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.

[[Page 264]]

    (B) The employer must ensure that persons who will receive this 
substance from the employer, or who have received the substance from the 
employer within 5 years from the date the employer becomes aware of the 
information described in paragraph (a)(2)(i)(A) of this section, are 
provided an MSDS as described in Sec. 721.72(c) containing the 
information required under paragraph (a)(2)(i)(A) of this section within 
90 days from the time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.4390  Trisubstituted hydroquinone diester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trisubstituted hydroquinone diester (PMN No. P-92-329) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 
and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4) (where N = 30 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (j), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32239, June 8, 1993]



Sec. 721.4420  Substituted hydroxylamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted hydroxylamine (PMN P-84-492) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communicatiom program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vii), and (g)(2)(i) through (g)(2)(iii). The provisions of 
Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a), and (c), respectively. The provision of 
Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) (chemically treated liquid wastes must contain no more than 10 
ppm of the substance prior to discharge), (b)(4) (chemically treated 
liquid wastes must contain no more than 10 ppm of the substance prior to 
discharge), and (c)(4) (chemically treated liquid wastes must contain no 
more than 10 ppm of the substance prior to discharge).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 265]]

    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), and 
(j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46773, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4460  Amidinothiopropionic acid hydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
amidinothiopropionic acid hydrochloride (PMN P-91-102) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4462  Hydrochlorofluorocarbon.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydrochlorofluorocarbon (PMN P-95-1317) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4463  Hydrochlorofluorocarbon.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydrochlorofluorocarbon (PMN P-94-1453) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]



Sec. 721.4464  Mixture of hydrofluoro alkanes and hydrofluoro alkene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as a 
mixture of hydrofluoro alkanes and hydrofluoro alkene (PMNs P-96-945/
946/947/948) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).

[[Page 266]]

    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified as in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4465  Hydrofluoroalkane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydrofluoroalkane (PMN P-96-1288) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(h).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3428, Jan. 22, 1998]



Sec. 721.4466  3-Hydroxy-1,1-dimethylbutyl derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 3-
hydroxy-1,1-dimethylbutyl derivative (PMN P-86-1491) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2).
    (v) Release to water. Requirements as specified in 
Sec. 721.90(a)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]



Sec. 721.4467  Quaternary ammonium hydroxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
quaternary ammonium hydroxide (PMN P-95-1806) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]

[[Page 267]]



Sec. 721.4468  1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H-imidazole, 2-
ethyl-4,5-dihydro-4-methyl- (PMN P-97-217; CAS No. 931-35-1) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 40).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]



Sec. 721.4469  Imidazolethione.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
imidazolethione (PMNs P-91-1131 and P-90-564) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. Formulations or mixtures containing the PMN 
substance in concentrations at or below 10 percent by weight or volume 
are exempt from the provisions of this rule.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS as 
required by this paragraph shall also include the following statements: 
This substance may cause thyroid cancer. This substance may cause 
thyroid effects.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), and (h) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]



Sec. 721.4470  2,4-Imidazolidinedione, bromochloro-5,5-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2,4-imidazolidinedione, 
bromochloro-5,5-dimethyl- (PMN P-94-34) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(3), (w)(3), and (x)(3).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11043, Mar. 1, 1995]



Sec. 721.4473  Dialkylamidoimidazoline.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
dialkylamidoimidazoline (PMN P-94-1864) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:

[[Page 268]]

    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(h).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45082, Aug. 30, 1995]



Sec. 721.4476  Substituted imines.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted imines (PMNs P-95-1557/1558) are subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3429, Jan. 22, 1998]



Sec. 721.4480  2-Imino-1,3-thiazin-4-one-5,6-dihydromonohydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-imino-1,3-thiazin-
4-one-5,6-dihydromonohydrochloride (PMN P-91-101) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), 
and (x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46466, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4484  Halogenated indane (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
halogenated indane (PMN P-94-351) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to P-94-351 
after incorporation into a plastic, resin matrix, or pelletized so 
humans are not reasonally likely to be exposed.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements during manufacture as 
specified in Sec. 721.63 (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(5(vii), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements during manufacture 
as specified in Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(vii), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.

[[Page 269]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63737, Dec. 2, 1996, as amended at 62 FR 27694, May 21, 1997]



Sec. 721.4490  Capped aliphatic isocyanate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a capped 
aliphatic isocyanate (PMN P-86-1146) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(xi), (a)(6)(v), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (d), (e) (concentration set at 0.1 percent), (f), 
(h)(1)(ii)(G), (h)(1)(iii)(A), (h)(1)(iii)(B), (h)(1)(iii)(D), and 
(h)(1)(iii)(E).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(h).
    (iv) Disposal. Requirements as specified in Sec. 721.90 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b) through (g), (i), and (j) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51685, Oct. 4, 1993]



Sec. 721.4494  Polycyclic isocyanate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a polycyclic 
isocyanate (PMN P-94-437) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), 
(a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), (b) (concentration set 
at 1.0%), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). In 
addition the following human health and environmental hazard and 
precautionary statements shall appear on each label as specified in 
paragraph (b) of this section and the MSDS as specified in paragraph (c) 
of this section: This substance may cause skin sensitization. This 
substance may cause pulmonary sensitization.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63737, Dec. 2, 1996]



Sec. 721.4497  Aliphatic polyisocyanates (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
aliphatic polyisocyanates (P-91-1210 and P-92-714) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. Non-spray uses are exempt from the 
provisions of this rule.
    (2) The significant new uses are:

[[Page 270]]

    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), 
(a)(5)(ii), (a)(5)(iii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), 
(a)(5)(xi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 
1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, and 
processors who implement the product stewardship provisions of the 
section 5(e) consent order for these substances are exempt from the 
requirements of Secs. 721.63 and 721.72.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (h) are applicable to manufacturers, importers, 
and processors of this substance. Manufacturers, importers, and 
processors who implement the product stewardship provisions or keep 
records as required by the section 5(e) consent order for these 
substances are exempt from the requirements of Sec. 721.125.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Applicability of Sec. 721.5. The provisions of Sec. 721.5 do not 
apply to manufacturers, importers, and processors, implementing the 
product stewardship provisions in the section 5(e) consent order for 
these substances.

[61 FR 63737, Dec. 2, 1996]



Sec. 721.4500  Isopropylamine distillation residues and ethylamine distillation residues.

    (a) Chemical substances and significant new use subject to 
reporting. (1) The following chemical substances referred to by their 
Chemical Abstracts Service (CAS) register numbers and chemical names are 
subject to reporting under this section for the significant new use 
identified in paragraph (a)(2) of this section: CAS No. 79771-08-7, 
isopropylamine distillation residues, and CAS No. 79771-09-98, 
ethylamine distillation residues.
    (2) The significant new use is use in metalworking fluids.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Notice Requirements and Procedures. Section 721.10 applies to 
this section, except persons submitting a notice must complete only 
Parts I and III of the notice form.
    (2) [Reserved]


(Sec. 5, Pub. L. 94-469, 90 Stat. 2012 (15 U.S.C. 2604))

[49 FR 46378, Nov. 26, 1984. Redesignated at 51 FR 23539, June 30, 1986, 
and 53 FR 2845, Feb. 2, 1988. Further redesignated at 58 FR 29946, May 
24, 1993, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4520  Isopropylidene, bis(1,1-    dimethylpropyl) derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as isopropylidene, 
bis(1,1-dimethylpropyl) derivative (PMN P-85-648) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3) (applies to 
gloves only), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[[Page 271]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.4550  Diperoxy ketal.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as diperoxy 
ketal (PMN-92-1394) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Hazard communication program. 
Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (f), 
(g)(3)(ii), (g)(4)(iii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51705, Oct. 4, 1993]



Sec. 721.4568  Methylpolychloro aliphatic ketone.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylpolychloro aliphatic ketone (PMN No. P-91-1321) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), 
(a)(6)(ii), (a)(6)(iii), (a)(6)(v), (b) (concentration set at 0.1 
percent), and (c). The employer is able to demonstrate that the gloves 
selected for handling P-91-1321 provide an impervious barrier to prevent 
dermal exposure during normal and expected duration and conditions of 
exposure within the work area by testing the material used to make the 
gloves and the construction of the gloves to establish that they will be 
impervious for the expected duration and conditions of exposure. The 
testing must subject the gloves to the expected conditions of exposure, 
including the likely combinations of chemical substances to which the 
gloves may be exposed in the work area. There must be no permeation of 
P-91-1321 greater than 0.017 mg/cm2/min after 8 h of testing 
in accordance with the most recent versions of the American Society for 
Testing and Materials (ASTM) F739 ``Standard Test Method for Resistance 
of Protective Clothing Materials to Permeation by Liquids or Gases'' and 
ASTM F1194 ``Guide for Documenting the Results of Chemical Permeation 
Testing of Protective Clothing Materials.'' The employer must submit all 
test data to the Agency and must receive written Agency approval of the 
test results for each type of glove tested prior to use of such gloves. 
Neoprene gloves with a minimum thickness of 1.50 mm have already been 
tested and found to satisfy the terms of this rule. Nitrile gloves with 
a minimum thickness of 0.61 mm also satisfy the terms of this rule, as 
long as the duration of exposure to P-91-1321 is less than 2 h per work 
shift. If the duration of exposure is longer than 2 h, nitrile gloves 
shall be discarded and replaced every 2 h. Unless otherwise indicated, 
gloves contaminated with P-91-1321 shall be disposed of after every work 
shift.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iv) Release to water. Requirements as specified in 
Sec. 721.90(a)(1), (b)(1), (c)(1).

[[Page 272]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (d) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32239, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.4585  Lecithins, phospholipase A2-hydrolyzed.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
lecithins, phospholipase A2-hydrolyzed (PMN P-93-333) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), and (g)(3)(ii).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[59 FR 27484, May 27, 1994]



Sec. 721.4587  Lithium manganese oxide (LiMn204) (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as lithium 
manganese oxide (LiMn204) (P-96-175) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of these substances without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for these substances, the employer becomes aware that 
these substances may present a risk of injury to human health or the 
environment the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If 
these substances are not being manufactured, imported, processed, or 
used in the employer's workplace, the employer must add the new 
information to an MSDS before the substances are reintroduced into the 
workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received their substances from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 273]]

(h), and (i) are applicable to manufacturers, importers, and processors 
of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63738, Dec. 2, 1996]



Sec. 721.4589  Propanedioic acid, [(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanedioic acid, 
[(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) 
ester (9CI) (PMN P-95-1411; CAS No. 147783-69-5) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b) 
(concentration set at 1.0 percent), and (c). As an alternative to the 
respiratory protection requirements of this section, manufacturers, 
importers, and processors of this substance may follow the terms of the 
new chemical exposure limits section in the TSCA section 5(e) consent 
order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(iv), (g)(1)(vi), 
(g)(1)(viii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3429, Jan. 22, 1998]



Sec. 721.4590  Mannich-based adduct.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a 
Mannich-based adduct (PMN P-93-66) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are: (i) Industrial, commercial, and 
consumer activities. Requirements as specified in Sec. 721.80(h).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 8 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51705, Oct. 4, 1993]



Sec. 721.4594  Substituted azo metal complex dye.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted azo metal complex dye (PMN P-94-499) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 274]]

    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11044, Mar. 1, 1995]



Sec. 721.4596  Diazo substituted carbomonocyclic metal complex.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a diazo 
substituted carbomonocyclic metal complex (PMN P-94-1039) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11044, Mar. 1, 1995]



Sec. 721.4600  Recovered metal hydroxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
recovered metal hydroxide (PMN P-91-809) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to the environment, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer, or who have received this substance from 
the employer within 5 years from the date the employer becomes aware of 
the new information described under paragraph (a)(2)(i)(A) of this 
section, are provided an MSDS as described in Sec. 721.72(c) containing 
the information required under paragraph (a)(2)(i)(A) of this section 
within 90 days from the time the employer becomes aware of the new 
information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44067, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.4620  Dialkylamino alkanoate   metal salt.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dialkylamino alkanoate metal salt (P-90-274), is subject to reporting

[[Page 275]]

under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows. (A) If, as a result of the test data required 
under the section 5(e) consent order for this substance, the employer 
becomes aware that this substance may present a risk of injury to human 
health, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (production limit set at 573,300 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.125 (a), (c), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 15789, Apr. 17, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4660  Alcohol, alkali metal salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alcohol, 
alkali metal salt (PMN P-91-151) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 5 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40213, Aug. 13, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4663  Fluorinated carboxylic acid alkali metal salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as fluorinated 
carboxylic acid alkali metal salts (PMNs P-95-979/980/981) are subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(2), (w)(2), and (x)(2).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4), (N = 100 ppb for P-95-979), (N = 30 ppb for 
P-95-980), and (N = 3 ppb for P-95-981).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.

[[Page 276]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63738, Dec. 2, 1996]



Sec. 721.4668  Hydrated alkaline earth metal salts of metalloid oxyanions.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hydrated alkaline 
earth metal salts of metalloid oxyanions (PMN P-94-1557) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(5)(vii), (a)(5)(viii), (a)(6)(i), (b), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(vi), (g)(1)(ix), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[61 FR 63738, Dec. 2, 1996]



Sec. 721.4680  Metal salts of complex inorganic oxyacids (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as metal 
salts of complex inorganic oxyacids (PMNs P-89-576 and P-89-577) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33305, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.4685  Substituted purine metal salt (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted purine metal salt (PMN P-95-175) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 8)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.4700  Metalated alkylphenol copolymer (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance metalated alkylphenol copolymer 
(PMN P-87-723)

[[Page 277]]

is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(C), (b)(1)(ii), (b)(1)(iii), (b)(1)(iv), (b)(2), 
(c)(1), (f), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(j) (industrial coating material).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(3), (b)(1), (b)(3), (c)(1), and (c)(3).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 32416, Aug. 9, 1990, as amended at 57 FR 20424, May 13, 1992. 
Redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 34204, 
June 23, 1993]



Sec. 721.4720  Disubstituted phenoxazine, chlorometalate salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disubstituted phenoxazine, chlorometalate salt (PMN P-90-0002) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4740  Alkali metal nitrites.

    (a) Chemical substances and significant new use subject to 
reporting. (1) The category of chemical substances which are nitrites of 
the alkali metals (Group IA in the periodic classification of chemical 
elements) lithium, sodium, potassium, rubidium, cesium, and francium, is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Use as an ingredient in metalworking 
fluids (as defined in 40 CFR 721.3) containing amines.
    (b) [Reserved]

[58 FR 27944, May 12, 1993, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4794  Polypiperidinol-acrylate methacrylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polypiperidinol-acrylate methacrylate (PMN P-88-1304) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 1.0 percent), 
(f), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), 
(g)(2)(v). The following additional statement shall appear on each label 
and MSDS required by this paragraph: This substance may cause acute and 
chronic toxicity.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).

[[Page 278]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27484, May 27, 1994]



Sec. 721.4820  Methane, bromodifluoro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as methane, 
bromodifluoro- is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(ii), (g)(2)(iii), and (g)(5). In addition, the following 
statements shall appear on the label and MSDS: This substance may cause 
cardiotoxicity. Evacuate area before the concentration of this substance 
in the area reaches 1 percent. Residential use is prohibited due to 
cardiotoxic dangers. General consumer use is prohibited, with the 
exception of outdoor automotive use and outdoor marine use. Following 
discharge and evacuation, use protective gear (self-contained breathing 
apparatus) before reentering an area in which the airborne concentration 
of the PMN substance exceeds 1 percent.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k) (Use in portable fire extinguishers 
intended for consumer use except for outdoor automotive use and outdoor 
marine use; use in fire extinguisher units with an Underwriters 
Laboratory (UL) rating of less than 5BC; use in other than rechargeable 
fire extinguisher units; use in occupied areas from which personnel 
cannot be evacuated before the concentration of the PMN substance 
exceeds 1 percent or egress cannot occur within 30 seconds; or use 
without protective gear (self-contained breathing apparatus) being made 
available in the event that, following discharge of the PMN substance 
and evacuation of the area, personnel must reenter an area in which the 
airborne concentration of the PMN substance exceeds 1 percent.)
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (f) through 
(i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19238, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993; 59 FR 39296, Aug. 2, 1994]



Sec. 721.4840  Substituted triphenylmethane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted triphenylmethane (PMN P-87-1553) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), (x)(1) and (y)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40216, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]

[[Page 279]]



Sec. 721.4880  Methanol, trichloro-, carbonate (2:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as methanol, trichloro-
, carbonate (2:1) (CAS No. 32315-10-9) (PMN P-90-1535) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(5). The following additional human hazard 
precautionary statement shall appear on the label: This substance may 
react to form phosgene gas. When using this substance, handle with 
extreme caution.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (f), (g), and 
(h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40213, Aug. 13, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.4885  Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy) phenyl]phenyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as methanone, [5-[[3-
(2H-benzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-
tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy)phenyl]phenyl- 
(PMN P-96-942; CAS No.162245-07-0) is subject to the reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c). As an 
alternative to the respiratory protection requirements of this section, 
manufacturers, importers, and processors of this substance may follow 
the terms of the new chemical exposure limits section in the TSCA 
section 5(e) consent order for this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), 
(g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3430, Jan. 22, 1998]



Sec. 721.4925  Methyl n-butyl ketone.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance methyl n-butyl ketone, CAS Number 591-78-6, 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the

[[Page 280]]

substance in commerce must submit a significant new use notice.
    (2) [Reserved]

[52 FR 11825, Apr. 13, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.5050  2,2'-[(1-Methylethylidene)bis[4,1-phenyloxy[1-(butoxymethyl)-(2,1-ethanediyl]oxymethylene]]bisoxirane, reaction product with a diamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2,2'-
[(1-methylethylidene)bis[4,1-phenyloxy[1-(butoxymethyl)-(2,1-
ethanediyl]oxymethylene]]bisoxirane, reaction product with a diamine 
(PMN P-91-934), is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5075  Mixed methyltin mercaptoester sulfides.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as mixed 
methyltin mercaptoester sulfides (PMN P-92-177) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), 
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(3)(i), (g)(3)(ii), 
(g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) (only in a facility permitted to landfill Resources Conservation 
and Recovery Act (RCRA) hazardous wastes with the landfill operated in 
accordance with subtitle C of RCRA).
    (iv) [Reserved]
    (v) Release to water. Requirements as specified in Sec. 721.90(a)(4) 
(where N = 2 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f) through (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51685, Oct. 4, 1993]



Sec. 721.5175  Mitomycin C.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance mitomycin C (CAS No. 5007-7) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]

[[Page 281]]



Sec. 721.5192  Substituted 1,6-dihydroxy naphthalene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted 1,6-dihydroxy naphthalene (PMN P-87-1036) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (k), and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2).
    (v) Release to water. Requirements as specified in 
Sec. 721.90(a)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 45083, Aug. 30, 1995]



Sec. 721.5200  Disubstituted phenylazo trisubstituted naphthalene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disubstituted phenylazo trisubstituted naphthalene (PMN P-91-328) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (g), (v)(1), (w)(1), (x)(1), and (y)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5225  Naphthalene,1,2,3,4-tetra- hydro(1-phenylethyl) (specific    name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance naphthalene,1,2,3,4-tetrahydro(1-
phenylethyl) (PMN P-85-1331) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (e) [concentration set at 1.0 percent], (f), 
and (g)(3)(i) and (g)(3)(ii), (g)(4)(i) and (g)(4)(iii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a) (1) and 
(2), (b)(1) and (b)(2), and (c)(1) and (c)(2).
    (iv) [Reserved]
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 282]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26110, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 62 FR 42692, Aug. 8, 
1997]



Sec. 721.5250  Trimethyl spiropolyheterocyclic naphthalene compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trimethyl spiropolyheterocyclic naphthalene compound (PMN P-91-1456) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125 (a), (b), (c), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 31968, July 20, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5255  2-Naphthalenol, mono and dioctyl derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-naphthalenol, mono 
and dioctyl derivs (PMN P-95-1288) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 1). When calculating the surface 
water concentrations according to the instructions in Sec. 721.91, the 
statement that the amount of the substance that will be released will be 
calculated before the substance enters control technology does not 
apply. Instead, if the waste stream containing the substance will be 
treated before release, then the amount of the substance reasonably 
likely to be removed from the waste stream by such treatment may be 
subtracted in calculating the number of kilograms released. No more than 
90 percent removal efficiency may be attributed to such treatment.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3430, Jan. 22, 1998]



Sec. 721.5275  2-Napthalenecarboxamide-N-aryl-3-hydroxy-4-arylazo (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-naphthalenecarboxamide-N-aryl-3-
hydroxy-4-arylazo (PMN P-87-1265) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii) through (a)(5)(vii), and (a)(6)(i), (b) 
[concentration set at 0.1 percent], and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) [concentration set at 0.1 percent], 
(f), and (g)(1)(i), (g)(1)(v), and (g)(1)(vii), and (g)(2)(ii) and 
(g)(2)(iv).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable

[[Page 283]]

to manufacturers, importers, and processors of this substance, as 
specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26110, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5276  2-Naphthalenol, heptyl-1-[[(4-phenylazo)phenyl]azo]-, ar',ar''-Me derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-naphthalenol, 
heptyl-1-[[(4-phenylazo)phenyl] azo]-, ar',ar''-Me derivs (PMN P-95-538) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.5278  Substituted naphthalenesulfonic acid, alkali salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted naphthalenesulfonic acid, alkali salt (PMN P-95-85) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45083, Aug. 30, 1995]



Sec. 721.5279  2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-4-[(3-butoxy-2-hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-5-
          hydroxy-6-(phenylazo)-, disodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,7-
naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-4-[(3-butoxy-2-
hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-
5-hydroxy-6-(phenylazo)-, disodium salt (PMN P-97-131; CAS No. 103580-
64-9) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 40).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3430, Jan. 22, 1998]

[[Page 284]]



Sec. 721.5280  2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with diazotized 4-butylbenzenamine, diazotized 4,4'-cyclohexylidenebis[benzenamine] 
          and m-phenylenediamine, sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,7-
naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with diazotized 
4-butylbenzenamine, diazotized 4,4'-cyclohexyl-idenebis[benzenamine] and 
m-phenylenediamine, sodium salt (PMN P-97-193; CAS No. 182238-09-1) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3430, Jan. 22, 1998]



Sec. 721.5281  2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-(phenylamino)-, sodium salt, compd. 
          With 2,2',2"-nitrilotris [ethanol] (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-sulfophenyl)azo]-2-
methoxy-5-methylphenyl]azo]-4-hydroxy-7-(phenylamino)-, sodium salt, 
compd. With 2,2',2"-nitrilotris [ethanol] (9CI) (PMN P-95-1235; CAS No. 
94213-53-3) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3430, Jan. 22, 1998]



Sec. 721.5282  Trisodium chloro [(trisubstituted heteromonocycle amino) propylamino]triazinylamino hydroxyazo naphthalenetrisulfonate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
trisodium chloro[(trisubstituted heteromonocycleamino) 
propylamino]triazinyl aminohydroxyazo naphthalenetrisulfonate (PMN P-94-
2177) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45083, Aug. 30, 1995]

[[Page 285]]



Sec. 721.5285  Ethoxylated substituted naphthol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
ethoxylated substituted naphthol (PMN P-88-2484) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 200 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51685, Oct. 4, 1993]



Sec. 721.5290  Phenylazoalkoxy naphthylamines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
phenylazoalkoxy napthylamines (PMNs P-97-42 and P-97-43) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 50 for P-97-42) (N = 40 for P-97-43).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44578, Aug. 20, 1998]



Sec. 721.5300  Neodecaneperoxoic acid, 1,1,3,3-tetramethylbutyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as neodecaneperoxoic 
acid, 1,1,3,3-tetramethylbutyl ester (PMN P-89-764; CAS number 51240-95-
0) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (b), (c), and (l).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements . Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44068, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5310  Neononanoic acid, ethenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as neononanoic acid, 
ethenyl ester (PMN P-92-129) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply once the 
substance has been incorporated into a polymer matrix with the level of 
residual monomer below 0.1 percent.

[[Page 286]]

    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i) (There must 
be no permeation of the substance greater than 0.02  g/
min. cm2 after 8 hours of testing in accordance 
with the most current version of the American Society for Testing and 
Materials (ASTM) F739 ``Standard Test Method for Resistance of 
Protective Clothing Materials to Permeation by Liquids or Gases.'' For 
conditions of exposure which are intermittent, gloves may be tested in 
accordance with the most current version of ASTM F1383 ``Standard Test 
Method for Resistance of Protective Clothing Materials to Permeation by 
Liquids or Gases Under Conditions of Intermittent Contact,'' provided 
the contact time in testing is greater than or equal to the expected 
duration of dermal contact, and the purge time used in testing is less 
than or equal to the expected duration of noncontact during the 
intermittent cycle of dermal exposure in the workplace. If ASTM F1383 is 
used for testing, manufacturers, importers, and processors must submit 
to the Agency a description of worker activities involving the substance 
which includes daily frequencies and durations of potential worker 
exposures. The results of all glove permeation testing must be reported 
in accordance with the most current version of ASTM F1194 ``Guide for 
Documenting the Results of Chemical Permeation Testing of Protective 
Clothing Materials.'' Manufacturers, importers, and processors must 
submit all test data to the Agency and must receive written Agency 
approval for each type of glove tested prior to use of such gloves. The 
following gloves have been tested in accordance with the ASTM F739 
method and found by EPA to satisfy the requirements for continuous use: 
North/F101/Vitron gloves, 0.03 cm thick; and Ansell/Edmont/4H/PE/EVOH/PE 
Laminate gloves, 0.006 cm thick. Gloves may not be used for a time 
period longer than they are actually tested and must be replaced at the 
end of each work shift.), (a)(2)(ii) (With the exception of laboratory 
activities, full body chemical protective clothing is required for any 
worker activity in which the substance is reasonably likely to contact 
the worker in the following state(s): Open liquid pool or solid of 
greater than 5 kg; liquid spray or splash; mist; aerosol dust; or any 
worker activity which have potential for contact with the substance for 
more than 10 min/h. At a minimum, a chemical protective apron is 
required for any worker activity with potential for contact with the 
substance which is not covered by this paragraph), (a)(2)(iii), (a)(3), 
(a)(4), (a)(5)(iii) (if cartridge service life testing is not 
available), (a)(5)(xii) or (a)(5)(xiii) (if data on cartridge service 
life testing has been reviewed and approved in writing by EPA), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), and (a)(6)(v). As an alternative to 
the respiratory requirements in this section, manufacturers, importers, 
and processors may use the New Chemical Exposure Limits provisions, 
including sampling and analytical methods which have previously been 
approved by EPA for this substance, found in the 5(e) consent order for 
this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (h)(1)(vi) (The following additional statements shall appear on 
each label required by this paragraph: The health effects of this 
material have not been fully determined but are currently being tested. 
EPA is concerned however, that this material may have serious chronic 
health and environmental effects. When using this material, use eye and 
skin protection, which includes gloves which have been determined to be 
impervious to this substance. Use respiratory protection, unless 
workplace airborne concentrations are maintained at or below an 8-h time 
weighted average (TWA) of 1 ppm, when there is a likelihood of exposure 
in the work area from dust, mist, smoke or vapors.), (h)(2)(ii)(F), 
(h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), (h)(2)(iii)(B), 
(h)(2)(iii)(C), (h)(2)(iii)(E), (h)(2)(iv)(A), (h)(2)(iv)(B) (The 
following additional statements shall appear on each MSDS required by 
this paragraph: This substance may cause moderate skin irritation. This 
substance may cause neurotoxicity. When using this substance, use 
respiratory protection,

[[Page 287]]

unless workplace airborne concentrations are maintained at or below an 
8-h TWA of 1 ppm.)
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 5 ppb). When calculating the 
surface water concentrations according to the instructions in 
Sec. 721.91(a)(4), the statement that the amount of the substance that 
will be released will be calculated before the substance enters control 
technology does not apply. Instead, if the waste stream containing the 
substance will be treated before release, then the amount of the 
substance reasonably likely to be removed from the waste stream by such 
treatment may be subtracted in calculating the number of kilograms 
released. No more than 75 percent removal efficiency may be attributed 
to such treatment. In addition, when the substance is released in 
combination with the substances hexanedioic acid, diethenyl ester, 
hexanoic acid, 2-ethyl-, ethenyl ester, and propanoic acid, 2,2-
dimethyl-, ethenyl ester, the quotient from the formula referenced in 
this section shall not exceed the average of the quotient applicable to 
the other substances weighted by the proportion of each substance 
present in the total daily amount released.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance. Manufacturers, importers, 
and processors of the substance must keep records documenting that the 
PMN substance has been incorporated into a polymer matrix with the level 
of residual monomer below 0.1 percent if this section does not apply as 
described in paragraph (a)(1) of this section.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51705, Oct. 4, 1993, as amended at 58 FR 68311, Dec. 27, 1993]



Sec. 721.5325  Nickel acrylate complex.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance nickel acrylate complex (PMN P-85-
1034) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(i) through (g)(2)(iii), (g)(2)(v), 
(g)(4)(i), and (g)(5). The provision of Sec. 721.72(d) requiring that 
employees to be provided with information on the location and 
availability of a written hazard communication program does not apply 
when the written program is not required under Sec. 721.72(a).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (e), (f), (g), 
and (h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 39901, Sept. 28, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]

[[Page 288]]



Sec. 721.5330  Nickel salt of an organo compound containing nitrogen.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as nickel 
salt of an organo compound containing nitrogen (PMN P-92-686) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(ii), (g)(1)(vii), 
(g)(1)(viii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), 
and (g)(5). The following additional statements shall appear on each 
label and MSDS as required by this paragraph: This substance may cause 
skin sensitization. This substance may cause blood effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (b), (c), and (k).
    (iv) Disposal. Requirements as specified in Sec. 721.85(a)(2) 
(landfill operated in accordance with subtitle C of the Resource 
Conservation and Recovery Act (RCRA) to receive nickel wastes), 
Sec. 721.85(b)(2) (landfill operated in accordance with subtitle C of 
RCRA to receive nickel wastes), and Sec. 721.85(c)(2) (landfill operated 
in accordance with subtitle C of RCRA to receive nickel wastes).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 40 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51685, Oct. 4, 1993]



Sec. 721.5350  Substituted nitrile (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted nitrile (PMN P-83-603) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5) (iii), 
(a)(6)(v), (b) (concentration set at 1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(1), (d), (e) (concentration set at 1 percent), (f), 
(g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), and (g)(4)(i). The provision of 
Sec. 721.72(d) requiring that employees be provided with information on 
the location and availability of MSDSs does not apply when an MSDS was 
not required under Sec. 721.72(c). The provision of Sec. 721.72(g) 
requiring placement of specific information on an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (level set at 1 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (g), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33305, Aug. 15, 1990; 55 FR 52275, Dec. 21, 1990. Redesignated 
and amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 34204, June 23, 
1993]

[[Page 289]]



Sec. 721.5356  Ethanol, 2,2'2"-nitrilotris-, compound with alpha-2,4,6-tris (1-phenylethyl)phenyl]-omega-hydroxypoly (oxy-1,2-ethanediyl) phosphate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanol, 2,2'2"-
nitrilotris-, compound with alpha-[2,4,6-tris(1-phenylethyl)phenyl]-
omega-hydroxypoly (oxy-1,2-ethanediyl) phosphate (PMN P-98-185) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f) and (j) (pesticide inert).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44579, Aug. 20, 1998]



Sec. 721.5360  Substituted nitrobenezene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted nitrobenezene (PMN P-97-1028) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), 
(a)(5)(v), and (a)(6)(v).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44579, Aug. 20, 1998]



Sec. 721.5375  Nitrothiophenecarboxylic acid, ethyl ester, bis[[[[(substituted)] amino]alkyl-phenyl]azo] (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance nitrothiophenecarboxylic acid, 
ethyl ester, bis [[[[(substituted)]amino]alkylphenyl]azo] (PMN P-87-304) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f), (k), (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26110, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5385  Octanoic acid, hydrazide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octanoic acid, 
hydrazide (PMN P-92-1086) is subject to reporting under this

[[Page 290]]

section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1), (a)(3), (a)(4), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(ii), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(b)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (j) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51706, Oct. 4, 1993]



Sec. 721.5400  3,6,9,12,15,18,21-Heptaoxatetratriaoctanoic acid, sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3,6,9,12,15,18,21-
heptaoxatetratriaoctanoic acid, sodium salt is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new use is:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 19237, Apr. 25, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5425  -Olefin sulfonate, potassium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as an -olefin 
sulfonate, potassium salt (PMN P-91-100) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40215, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5450  -Olefin sulfonate, sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
-olefin sulfonate, sodium salt (PMN P-88-2210) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with

[[Page 291]]

any use of this substance without providing risk notification as 
follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer are provided an MSDS as described in 
Sec. 721.72(c) containing the information required under paragraph 
(a)(1)(i)(A) within 90 days from the time the employer becomes aware of 
the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44068, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.5460  Organosolv lignin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as an organosolv lignin 
(PMN P-95-1584; CAS No. 8068-03-9) is subject to reporting under this 
section for the significant new use described in paragraph (a)(2) of 
this section.
    (2) The significant new use is any manufacture, processing, or use 
of the substance with a number average molecular weight less than 700 
daltons.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and records documenting compliance with the 
designated molecular weight requirements are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 65710, Nov. 30, 1998]



Sec. 721.5475  1-Oxa-4-azaspiro[4.5]decane, 4-dichloroacetyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-oxa-4-
azaspiro[4.5]decane, 4-dichloroacetyl- (PMN P-86-1648, CAS number 71526-
07-3) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3) (applies to 
gloves only), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 1.0 
percent), (f), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (j) are applicable to manufacturers, importers, 
and processors of this substance.

[[Page 292]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44068, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.5500  7-Oxabicyclo[4.1.0]heptane, 3-ethenyl, homopolymer, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), epoxidized.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 7-oxabicyclo[4.1.0] heptane, 3-
ethenyl, homopolymer, ether with 2-ethyl-2(hydroxymethyl)-1,3-
propanediol (3:1), epoxidized (PMN P-88-1898) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(viii), 
(a)(5)(ix), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 39902, Sept. 28, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5525  Substituted spiro oxazine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted spiro oxazine (PMN P-92-283) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125 (a), (b), (c), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 31969, July 20, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5540  1H,3H,5H-oxazolo [3,4-c] oxazole, dihydro-7a-methyl-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H,3H,5H-oxazolo 
[3,4-c] oxazole, dihydro-7a-methyl- (PMN P-91-1324) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(iii) and (a)(3).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 500 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements

[[Page 293]]

specified in Sec. 721.125 (a), (b), (c), (d), (e), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 26691, May 18, 1995]



Sec. 721.5545  3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyl-oxazolidine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 3-(dichloroacetyl)-
5-(2-furanyl)-2,2-dimethyloxazolidine (PMN P-93-1694) (CAS no. 121776-
57-6) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b) 
(concentration set at 0.1%), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1%), (f), 
(g)(1)(iv), (g)(1)(vii), (g)(1)(ix), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 
(g)(3)(i), (g)(3)(ii), and (g)(5).
    (iii) Industrial, commercial, and consumer activites. Requirements 
as specified in Sec. 721.80 (b), (c), (k) (as a seed safener), and (o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.5547  Antimony double oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
antimony double oxide (PMNs P-95-677 and P-95-724) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(3)(ii), and (g)(5). The 
label and MSDS as required by this paragraph shall also include the 
following statements: These substances may cause lung toxicity. When 
using these substances avoid any applications of these substances which 
could cause inhalation exposures. When using these substances keep in 
liquid form only.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), 
(x)(2), (y)(1), and (y)(2). Manufacturing, processing or use in any form 
which could cause inhalation exposures.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3431, Jan. 22, 1998]



Sec. 721.5548  Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a mixed 
metal oxide (PMN P-97-956) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), and (a)(6)(i).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (d) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 294]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44579, Aug. 20, 1998]



Sec. 721.5549  Lithiated metal oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
lithiated metal oxide (LiNiO2) (PMN P-96-19; CAS No. 12031-
65-1) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(iv), 
(b) (concentration set at 0.1 percent), and (c). As an alternative to 
the respiratory requirements listed here, a manufacturer, importer, or 
processor may choose to follow the new chemical exposure limit (NCEL) 
provisions listed in the TSCA section 5(e) consent order for this 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f) (g)(1)(iv), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)4)(i), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 30).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125(a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3431, Jan. 22, 1998]



Sec. 721.5550  Substituted dialkyl oxazolone (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted dialkyl oxazolone (PMN P-86-1634) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(xi), (a)(6)(v), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(iii), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33306, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5575  Oxirane, 2,2'-(1,6-hexanediylbis (oxymethylene)) bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2,2'-(1,6-
hexanediylbis(oxymethylene))bis- (PMNs P-88-2179 and P-89-539) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 295]]

    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1),(a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), (a)(6)(ii), 
and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii), (b)(1), and (c)(1). The following may be used as an 
alternative to the technologies in Sec. 721.90(a)(2)(ii): Oil and grease 
separation.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (k).
    (2) Limitation of revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19238, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5580  Oxirane, 2,2'-[methylenebis[(2,6-dimethyl-4,1-phenylene)oxymethylene]]bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2,2'-
[methylenebis[(2,6-dimethyl-4,1-phenylene)oxymethylene]]bis- (PMN P-97-
1011; CAS No. 93705-66-9) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set 
at 0.1 percent), and (c). As an alternative to the respiratory 
requirements listed here, a manufacturer, importer, or processor may 
choose to follow the new chemical exposure limit (NCEL) provisions 
listed in the TSCA section 5(e) consent order for this substance. The 
NCEL is 0.35 milligram/meter3 (mg/m3).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44579, Aug. 20, 1998]



Sec. 721.5600  Substituted oxirane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted oxirane (PMN P-83-1157) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i) through (a)(5)(iii), 
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (d), (e) (concentration set at 0.1 percent), (f), 
(g)(1)(ii), (g)(1)(vii), (g)(2)(i),

[[Page 296]]

(g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The provisions of Sec. 721.72(d) 
requiring employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDS are not required under 
Sec. 721.72 (a) and (c), respectively. The provisions of Sec. 721.72(g) 
requiring placement of specific information on a label and MSDS do not 
apply when a label and MSDS are not required under Sec. 721.72 (b) and 
(c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(h).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f), 
and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46774, Nov. 6, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5625  Oxiranemethanamine, N,N'-[methylenebis(2-ethyl-4,1-phenylene)]bis[N-(oxiranylmethyl)]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxiranemethanamine, 
N,N'-[methylenebis(2-ethyl-4,1-phenylene)]bis[N-(oxiranylmethyl)]- (PMN 
P-91-411; CAS number 130728-76-6) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (o), and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44070, Sept. 23, 1992. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5645  Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pentane 
1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638 and SNUN P-97-79; CAS No. 
138495-42-8) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j) and uses other than as described in the 
significant new use notice.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3431, Jan. 22, 1998]



Sec. 721.5650  Pentanediol light residues.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
pentanediol light residues

[[Page 297]]

(PMN P-95-1750) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3431, Jan. 22, 1998]



Sec. 721.5700  Pentanenitrile, 3-amino-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pentanenitrile, 3-
amino- (PMN P-91-222; CAS number 75405-06-0) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), during both drumming and 
transfer of the substance requirements as specified in Sec. 721.63 
(a)(5)(i), (a)(5)(ii), and (a)(5)(iii) apply, and during transfer (but 
not drumming) of the substance, requirements as specified in Sec. 721.63 
(a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), and (a)(5)(xv) apply following 
submittal by the company, and written approval by the EPA, of the 
results of cartridge service life testing performance in accordance with 
Interim Recommendations for Determining Organic Vapor Cartridge Service 
Life for Category 23C Respirators (available through the TSCA Assistance 
Office), or equivalent, which demonstrates the effectiveness of the 
organic vapor cartridge, (a)(6)(v), (b) (concentration set at 1.0 
percent), and (c). The requirements specified in Sec. 721.63(a) (4) and 
(5) apply only during drumming activities and during transfer of liquid 
PMN substance from a process vessel into a tank, truck, or rail car.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44069, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.5708  2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-Pentene, 
1,1,1,2,3,4,4,5,5,5-decafluoro- (PMN P-95-637; CAS No.72804-49-0) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3431, Jan. 22, 1998]

[[Page 298]]



Sec. 721.5710  Phenacetin.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance phenacetin (CAS No. 62-442) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.5740  Phenol, 4,4'-methylenebis (2,6-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Phenol, 4,4'-
methylenebis (2,6-dimethyl- (PMNs P-88-864, P-90-211, and P-94-921; CAS 
No. 5384-21-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), 
(a)(6)(i), (b) (concentration set at 1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1 percent), 
(f), (g)(1)(iv), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and 
(g)(5). The label and MSDS as required by this paragraph shall also 
include the following statements: This substance may cause blood 
effects. This substance may cause chronic effects.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (l), and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33306, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 63 FR 45956, Aug. 28, 
1998]



Sec. 721.5760  Phenol, 4,4'-[methylenebis (oxy-2,1-ethanediylthio)]bis-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance phenol, 4,4'-[methylenebis(oxy 
2,1-ethanediylthio)]bis- (PMN P-87-1760) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (f), (g)(3)(ii), and (g)(4)(iii). The provision of 
Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS is not required under Sec. 721.72(c).
    (ii) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Recordkeeping requirements specified in Sec. 721.125 (a), 
(b), (c), (f), (g), and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 33306, Aug. 15, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]

[[Page 299]]



Sec. 721.5763  Methylenebisbenzotriazolyl phenols.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylenebisbenzotriazolyl phenols (P-94-1042) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(6)(i), (b) (concentration set at 1.0 percent), 
and (c). Requirements as specified in Sec. 721.63(a)(5)(i) apply during 
manufacture of the PMN substance. Requirements as specified in 
Sec. 721.63 (a)(5)(iii) through (a)(5)(vii) apply during use of the PMN 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.575(b)(1) apply to this section.

[60 FR 45083, Aug. 30, 1995]



Sec. 721.5769  Mixture of nitrated alkylated phenols.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a mixture of 
nitrated alkylated phenols (PMN P-93-987) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45083, Aug. 30, 1995]



Sec. 721.5775  Phenol, 5-amino-2,4-dicholoro-, hydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 5-amino-2,4-
dicholoro-, hydrochloride (PMN P-98-198) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(i), (w)(i), and (x)(i).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44579, Aug. 20, 1998]



Sec. 721.5780  Phenol, 4,4'-(oxybis(2,1-    ethanediylthio)bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance phenol, 4,4'-(oxybis(2,1-
ethanediylthio)bis- (PMN P-89-651) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:

[[Page 300]]

    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(6)(i), (b) 
(concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(ix), (g)(2)(iv), and (g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(r) (82,000 kg; 141,000 kg; and 272,000 kg 
with testing required at each interval).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 39902, Sept. 28, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5800  Sulfurized alkylphenol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance described generically as 
sulfurized alkylphenol (PMN P-89-708) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer are provided an MSDS as described in 
Sec. 721.72(c) containing the information required under paragraph 
(a)(1)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125 (a), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 4578, Feb. 6, 1992. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5820  Aminophenol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aminophenol (P-83-909) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(D) and (g)(2)(v). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to

[[Page 301]]

this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), (d), (f), and (g).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25989, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5840  Ethylated aminophenol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ethylated aminophenol (P-83-908) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(1)(i)(D) and (g)(2)(v). The provision of Sec. 721.72(g) 
requiring placement of specific information in an MSDS does not apply 
when an MSDS is not required under Sec. 721.72(c).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a), (b), (c), (d), (f), and (g).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25989, June 5, 1991. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5860  Methylphenol, bis(substi-   tuted)alkyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylphenol, bis(substituted)alkyl (P-84-417) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 1.0 
percent), (f), (g)(1)(ii), (g)(1)(iv), (g)(2)(i), and (g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 720.80 (k) (antioxidant/stabilizer for polymers) 
and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 25991, June 5, 1991. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5867   Substituted phenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted phenol (PMNs P-89-1125, P-91-87, P-92-41, P-92-511, P-94-
1527, and P-94-1755) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j) (ingredient in a photoresist formulation).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 302]]

(b), (c), and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 23679, Apr. 30, 1998]



Sec. 721.5880  Sulfur bridged substituted phenols (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance sulfur bridged substituted phenols 
(PMN P-89-396) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv) (specifically liver and blood effects), (g)(2)(i), 
(g)(2)(v), and (g)(5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The recordkeeping requirements as 
specified in Sec. 721.125 (a) and (c) through (h) are applicable to 
manufacturers and importers of this substance. Any statements requiring 
processors to keep records in Sec. 721.125 do not apply.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32417, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 59 FR 40260, Aug. 8, 
1994]



Sec. 721.5900  Trisubstituted phenol (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance trisubstituted phenol (PMN P-85-
605) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii) through (a)(5)(vii) and 
(a)(6)(i), (b) [concentration set at 0.1 percent], and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) [concentration set at 0.1 percent], (f), 
(g)(1)(vii), and (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The 
provision of Sec. 721.72(d) requiring that employees be provided with 
information on the location and availability of MSDSs does not apply 
when a MSDS was not required under Sec. 721.72(c). The provisions of 
Sec. 721.72(g) requiring placement of specific information on a label 
and MSDS do not apply when a label and MSDS are not required under 
Sec. 721.72 (b) and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26111, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.5913  Phenothiazine derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
phenothiazine derivative (PMN P-96-813) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]

[[Page 303]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, and importers 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3432, Jan. 22, 1998]



Sec. 721.5915  Polysubstituted phenylazopolysubstitutedphenyl dye.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polysubstituted phenylazopolysubstitutedphenyl dye (PMN P-93-658) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Industrial, commercial and 
consumer activities. Requirements as specified in Sec. 721.80 (w)(1), 
(w)(2), (x)(1), and (x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51706, Oct. 4, 1993]



Sec. 721.5920  Phenyl(disubstitutedpolycyclic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phenyl(disubstitutedpolycyclic) (PMN P-92-1337) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are: (i) Release to water. Requirements 
as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (where N = 10 
ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51706, Oct. 4, 1993]



Sec. 721.5930  Phenylenebis[imino  (chlorotriazinyl)imino(substituted naphthyl)azo(substituted phenyl)azo, sodium salt (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phenylenebis[imino  (chlorotriazinyl)imino(substituted naphthyl)azo 
(substituted phenyl) azo, sodium salt (PMN P-95-274) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.5960  N,N'-Bis(2-(2-(3-alkyl)thia- zoline) vinyl)-1,4-phenylenediamine methyl sulfate double salt (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as N,N'-
Bis(2-(2-(3-alkyl)thiazoline)vinyl)-1,4-phenylenediamine methyl sulfate 
double salt (PMN P-84-913) is subject to reporting under

[[Page 304]]

this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), 
(a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (concentration set at 1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e), (f) (concentration set at 1 
percent), (g)(1)(iii), (g)(1), (may be lethal if inhaled or in contact 
with eyes), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5). 
The provision of Sec. 721.72(d) requiring that employees be provided 
with information on the location and availability of MSDSs does not 
apply when an MSDS is not required under Sec. 721.72(c). The provision 
of Sec. 721.72(g) requiring placement of specific information on an MSDS 
does not apply when an MSDS in not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26098, June 26, 1990. Redesignated at 58 FR 29946, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.5965  Substituted S-phenylthiazole (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted s-phenylthiazole (PMN P-97-1046) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44580, Aug. 20, 1998]



Sec. 721.5970  Phosphated polyarylphenol ethoxylate, potassium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphated polyarylphenol ethoxylate, potassium salt (PMN P-93-1222) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in 
Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 600 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.5980  Dialkyl phosphorodithioate phosphate compounds.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as dialkyl 
phosphorodithioate phosphate compounds (P-90-1642 through 1649) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 305]]

    (i) Hazard communication program. A significant new use of these 
substances is any manner or method of manufacture, import, or processing 
associated with any use of these substances without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for these substances, the employer becomes aware that any 
of these substances may present a risk of injury to human health, the 
employer must incorporate this new information, and any information on 
methods for protecting against such risk, into an MSDS as described at 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If these substances are not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before these substances are 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, these substances from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40214, Aug. 13, 1991, as amended at 56 FR 46729, Sept. 16, 1991. 
Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 
34204, June 23, 1993]



Sec. 721.5995  Polyalkyl phosphate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyalkyl phosphate (PMN P-95-1772) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Releases to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3432, Jan. 22, 1998]



Sec. 721.6000  Tris (2,3-dibromopropyl)   phosphate.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance tris (2,3-dibromopropyl) phosphate (CAS 
Number 126-72-7) is subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new use is: Any use.
    (b) Special provisions. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[52 FR 2703, Jan. 26, 1987. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]

[[Page 306]]



Sec. 721.6020  Phosphine, dialkylyphenyl.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphine dialkylphenyl (P-83-1023) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), 
(a)(6)(i), (b) (concentration set at 1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (d), (e) (concentration set at 1 percent), (f), 
(g)(1)(iii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and 
(g)(2)(v). The provision of Sec. 721.72(d) requiring that employees be 
provided with information on the location and availability of MSDSs does 
not apply when an MSDS is not required under Sec. 721.72(c). The 
provision of Sec. 721.72(g) requiring placement of specific information 
in an MSDS does not apply when an MSDS is not required under 
Sec. 721.72(c).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(2); 
(b)(2); and (c)(2).
    (iv) Release to Water. Requirements as specified in Sec. 721.90 
(a)(3), (b)(3), and (c)(3).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (g), (i), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 25991, June 5, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6045  Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphinothioic 
acid, bis(2,4,4-trimethylpentyl)- (9CI) (PMN P-96-1652; CAS No. 132767-
86-3) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 10). When calculating the surface water 
concentrations according to the instructions in Sec. 721.91, the 
statement that the amount of the substance that will be released will be 
calculated before the substance enters control technology does not 
apply. Instead, if the waste stream containing the substance will be 
treated using carbon adsorption treatment before release, then the 
amount of the substance reasonably likely to be removed from the waste 
stream by such treatment may be subtracted in calculating the number of 
kilograms released. No more than 99 percent removal efficiency may be 
attributed to such treatment.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3432, Jan. 22, 1998]



Sec. 721.6060  Alkylaryl substituted    phosphite.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylaryl substituted phosphite (PMN P-91-899) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance

[[Page 307]]

may present a risk of injury to human health, the employer must 
incorporate this new information, and any information on methods for 
protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125(a) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 31969, July 20, 1992, as amended at 58 FR 29946, May 24, 1993; 58 
FR 34204, June 23, 1993]



Sec. 721.6070  Alkyl phosphonate ammonium salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
phosphonate ammonium salts (PMNs P-93-725 and P-93-726) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Release to water. Requirements 
as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (where N = 400 
ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51707, Oct. 4, 1993]



Sec. 721.6075  Phosphonic acid, 1,1-methylenebis-tetrakis(1-methylethyl) ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphonic acid, 
1,1-methylenebis-tetrakis(1-methylethyl) ester (PMN P-95-168) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS required by 
this paragraph shall also include the following statement: This 
substance may cause mutagenicity.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (h) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3432, Jan. 22, 1998]



Sec. 721.6078  Substituted ethoxyethylamine phosphonate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 308]]

chemical substance identified generically as a substituted 
ethoxyethylamine phosphonate (PMN P-95-1950) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3433, Jan. 22, 1998]



Sec. 721.6080  Phosphonium salt (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance phosphonium salt (PMN Number P-84-
820) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 1.0 percent], 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (d), (e) [concentration set at 1.0 percent], (f), and 
(g)(1)(iii) and (g)(2)(i) and (g)(2)(v). The provision of Sec. 721.72(d) 
requiring that employees be provided with information on the location 
and availability of MSDSs does not apply when a MSDS was not required 
under Sec. 721.72(c). The provisions of Sec. 721.72(g) requiring 
placement of specific information on a label and MSDS do not apply when 
a label and MSDS are not required under Sec. 721.72(b) and (c), 
respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26111, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.6085  Phosphonocarboxylate salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
phosphonocarboxylate salts (PMNs P-93-722, P-93-723, and P-93-724) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Release to water. Requirements 
as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (where N = 1000 
ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51707, Oct. 4, 1993]



Sec. 721.6090  Phosphoramide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphoramide (P-89-538) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 309]]

    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described under 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51686, Oct. 4, 1993]



Sec. 721.6097  Phosphoric acid derivative (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
phosphoric acid derivative (PMN P-95-284) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.6100  Phosphoric acid, C6-12-alkyl esters, compounds with 2-(dibutylamino) ethanol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as phosphoric acid, 
C6-12-alkyl esters, compounds with 2-(dibutylamino)ethanol 
(PMN P-90-384) are subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 700 ppb).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c) and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions

[[Page 310]]

of Sec. 721.185 apply to this significant new use rule.

[56 FR 19239, Apr. 25, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6110  Alkyldi(alkyloxyhydroxypropyl) derivative, phosphoric acid esters, potassium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkyldi(alkyloxyhydroxypropyl) derivative, phosphoric acid esters, 
potassium salts (PMN P-91-818) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f) and (o).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45084, Aug. 30, 1995]



Sec. 721.6120  Phosphoric acid, 1,2-ethanediyl tetrakis(2-chloro-1-methylethyl) ester.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphoric acid, 
1,2-ethanediyl tetrakis(2-chloro-1-methylethyl) ester (PMN P-861263) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(6)(v), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(iii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), and (g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k) (use other than as a flame retardant for 
polyurethane foams).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 33307, Aug. 15, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6140  Dialkyldithiophosphoric acid, aliphatic amine salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
dialkyldithiophosphoric acid, aliphatic amine salt (P-90-1839) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the

[[Page 311]]

new information to an MSDS before the substance is reintroduced into the 
workplace.
    (B) The employer must ensure that persons will receive this 
substance from the employer are provided an MSDS as described in 
Sec. 721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44069, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.6160  Piperazinone, 1,1',1"-[1,3,5-  triazine-2,4,6-triyltris[(cyclohexylimino)-2,1-ethanediyl]]tris-[3,3,4,5,5-pentamethyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as piperazinone, 
1,1',1"-[1,3,5-triazine-2,4,6-triyltris [(cyclohexylimino)-2,1-
ethanediyl]]tris-[3,3,4,5,5-pentamethyl]- (PMN P-89-589; CAS number 
130277-45-1) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iv) through (vii), (a)(6)(i), (b) 
(concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d) (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iv), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (d), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44069, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.6165  Polysubstituted piperidine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polysubstituted piperdine (PMN P-93-568) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 30).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3433, Jan. 22, 1998]



Sec. 721.6170  Siloxanes and silicones, Me hydrogen, reaction products with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as

[[Page 312]]

siloxanes and silicones, Me hydrogen, reaction products with 2,2,6,6-
tetramethyl-4-(2-propenyloxy)piperdine (PMN P-95-1891; CAS No. 182635-
99-0) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3433, Jan. 22, 1998]



Sec. 721.6175  2-Piperdinone, 1,3-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-Piperdinone, 1,3-
dimethyl- (PMN P-97-520; CAS No. 1690-76-2) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44580, Aug. 20, 1998]



Sec. 721.6176  2-Piperdinone, 1,5-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as 2-Piperdinone, 1,5-
dimethyl- (PMN P-97-521; CAS No. 86917-58-0) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44580, Aug. 20, 1998]



Sec. 721.6186  Polyamine dithiocarbamate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyamine dithiocarbamate (PMN No. P-91-1328) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 50 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32239, June 8, 1993]



Sec. 721.6193  Polyalkylene polyamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a 
polyalkylene polyamine (PMN P-89-963) is subject to reporting under this 
section for the significant new

[[Page 313]]

uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(4) (users minimize 
release to water), and (g)(5) are applicable to manufacturers and 
importers.
    (ii) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers and importers of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[62 FR 64740, Dec. 9, 1997]



Sec. 721.6200  Fatty acid polyamine condensate, phosphoric acid ester salts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as fatty acid 
polyamine condensate, phosphate ester salts (PMNs P-90-1984 and P-90-
1985) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6220  Aryl sulfonate of a fatty acid mixture, polyamine condensate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an aryl 
sulfonate of a fatty acid mixture, polyamine condensate (PMN P-91-584) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46467, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6440  Polyamine ureaformaldehyde condensate (specific name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance polyamine ureaformaldehyde 
condensate (PMN P-87-1456) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) [concern level of 1 ppb], (b)(4) [concern level of 1 ppb], and 
(c)(4) [concern level of 1 ppb].
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions

[[Page 314]]

of Sec. 721.185 apply to this significant new use rule.

[55 FR 26112, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6470  Polyaminopolyacid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyaminopolyacid (PMN No. P-92-491) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 500 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32240, June 8, 1993]



Sec. 721.6475  Alkyl polycarboxylic acids, esters with ethoxylated fatty alcohols.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
polycarboxylic acids, esters with ethoxylated fatty alcohols (PMNs P-96-
554/555/556/557/558/559) are subject to reporting under this section for 
the significant new uses described in paragraph (a)(1)(i) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Chemical substance and significant new uses subject to 
reporting. The chemical substances identified generically as alkyl 
polycarboxylic acids, esters with ethoxylated fatty alcohols (PMN P-96-
560/561/564/565) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (i) The significant new uses are:
    (A) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (B) [Reserved]
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3433, Jan. 22, 1998]



Sec. 721.6477  Alkyl polycarboxylic acids, esters with ethoxylated fatty alcohols, reaction products with maleic anhydride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
polycarboxylic acids, esters with ethoxylated fatty alcohols, reaction 
products with maleic anhydride (PMNs P-96-399/400/401/402/403/404) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 315]]

(b), (c), and (k) are applicable to manufacturers, importers, and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.6485  Hydroxy terminated polyester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
hydroxy terminated polyester (PMN P-95-1213) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.6490  Alkyl phenyl polyetheramines.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
phenyl polyetheramines (PMNs P-95-1650/1651/1652/1653) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.6495  Aliphatic polyisocyanate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
aliphatic polyisocyanate (PMN P-95-1347) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.6498  Modified polyisocyanates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as modified 
polyisocyanates (PMN P-96-1428) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(viii), 
(a)(5)(ix), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c). 
As an alternative to the respiratory requirements listed here, a 
manufacturer, importer, or processor may choose to follow the NCEL 
provisions listed in the TSCA section 5(e) consent order for this 
substance. The NCEL is 0.05 mg/m3.

[[Page 316]]

    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), and (g)(5). The following statements shall appear on each label as 
specified in Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): 
Warnings. Exposure to diisocyanates may cause the following human health 
effects: Skin irritation and allergic reactions, respiratory irritation, 
respiratory sensitization, and lung toxicity; some diisocyanates also 
may cause cancer. The likelihood that these effects will occur depends 
on a number of factors; among them, the level of exposure, frequency of 
exposure, part of the body exposed, and sensitivity of the exposed 
individual. Symptoms of allergic reaction and respiratory sensitization 
include rashes, cough, shortness of breath, asthma, chest tightness and 
other breathing difficulties. There is uncertainty as to the mechanism 
by which sensitization occurs. In sensitized individuals, exposure to 
even small amounts of diisocyanates (below government-recommended 
workplace exposure levels) may cause allergic respiratory reactions like 
asthma and severe breathing difficulties. It is especially important to 
note that contact with skin may lead to respiratory sensitization or 
cause other allergic reactions. In some cases, the effects of 
diisocyanate exposure may be immediate and life-threatening; in others, 
the effects may be delayed and occur hours after the exposure has ended. 
Repeated or prolonged exposure to diisocyanates may also cause 
irritation to eyes, skin, respiratory tract and lungs, as well as 
adverse chronic lung effects, like decreased lung capacity and function. 
Individuals experiencing shortness of breath, tightness in the chest or 
other problems breathing should seek immediate medical attention. When 
using this substance the following protective measures should be used: 
In workplaces where individuals handle diisocyanates or coatings or 
other formulations that contain them, an industrial hygiene and safety 
program should be operative. Important components of this program 
include: Hazard communication and training on safe handling practices; 
use of efficient and well-maintained application equipment, engineering 
controls and personal protective equipment; housekeeping procedures 
including spill prevention and cleanup practices; and, if feasible, 
means to measure airborne levels of polyisocyanates and diisocyanates. 
During spray applications, workers should take precautions to avoid 
breathing vapors, mists or aerosols. Inhalation exposures should be 
limited to < 0.05 mg/m3 as an 8-hour time-weighted average 
(TWA) for combined polyisocyanates and diisocyanates. Engineering 
controls should serve as the first, most effective means of reducing 
airborne polyisocyanate and diisocyanate concentrations; an appropriate 
National Institute for Occupational Safety and Health/Mine Safety and 
Health Administration (NIOSH/MSHA) approved respirator should be used as 
a secondary tool to lower exposures. Currently, downdraft spray booths 
and high-volume low-pressure (HVLP) spray guns appear to offer the most 
efficient technology to reduce inhalation exposures; a maintenance 
program should always be used to ensure optimal operating efficiencies. 
To limit dermal contact, individuals should wear impermeable gloves, 
protective clothing and goggles or glasses with side shields.
    (iii) Industrial, commercial, and consumer activites. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44580, Aug. 20, 1998]



Sec. 721.6505  Polymers of C13C15 oxoalcohol ethoxolates.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
polymers of C13C15 oxoalcohol

[[Page 317]]

ethoxolates (PMNs P-96-950/951) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.6520  Acrylamide, polymer with substituted alkylacrylamide salt (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
acrylamide, polymer with substituted alkylacrylamide salt (PMN P-87-794) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(p) (limit set at 216,700 kg).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Recordkeeping requirements specified in Sec. 721.125 (a), 
(b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 33303, Aug. 15, 1990. Redesignated at 55 FR 52276, Dec. 21, 1990. 
Further redesignated at 58 FR 29946, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.6540  Acrylamide, polymers with tetraalkyl ammonium salt and polyalkyl, aminoalkyl methacrylamide salt.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
acrylamide, polymers with tetraalkyl ammonium salt and polyalkyl, amino 
alkyl methacrylamide salt (PMNs P-88-2100 and P-88-2169) are subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46468, Oct. 8, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6560  Acrylic acid, polymer with substituted ethene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as acrylic 
acid, polymer with substituted ethene (PMN P-91-521) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 200 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.

[[Page 318]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 46468, Oct. 8, 1992, as amended at 53 FR 34204, June 23, 1993]



Sec. 721.6620  Alkanaminium, polyalkyl-[(2-methyl-1-oxo-2-propenyl)oxy] salt, polymer with acrylamide and substituted alkyl methacrylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanaminium, polyalkyl-[(2-methyl-1-oxo-2-propenyl)oxy] salt, polymer 
with acrylamide and substituted alkyl methacrylate (PMN P-87-252) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(p) (production limit set at 680,000 kg).
    (ii) Release to water. Requirements as specified in Sec. 721.85 
(a)(4), (b)(4) and (c)(4) (concentration set at 40 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (j) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44070, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.6660  Polymer of alkanepolyol and polyalkylpolyisocyanatocarbomonocycle, acetone oxime-blocked (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polymer of alkanepolyol and polyalkylpolyisocyanatocarbomonocy- cle, 
acetone oxime-blocked (PMN P-88-1658) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26100, June 26, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.6680  Alkanoic acid, butanediol and cyclohexanealkanol polymer (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkanoic acid, butanediol, and 
cyclohexanealkanol polymer (PMN P-89-672) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows.
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into a Material Safety Data Sheet 
(MSDS) as described in Sec. 721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being

[[Page 319]]

manufactured, imported, processed, or used in the employer's workplace, 
the employer must add the new information to an MSDS before the 
substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q) (293,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (h) and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32417, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.6820  Polymer of substituted aryl olefin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of substituted aryl olefin (PMN P-85-612) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply once the 
substance has been encapsulated into a plastic matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (a)(4), 
(a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (b) (concentration set 
at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(2), (g)(4), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), (c)(2), and any disposal associated with 
any use, or with manufacturing or processing associated with any use 
other than by means of recycling.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125 (a) through (j) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 39295, Aug. 2, 1994]



Sec. 721.6900  Polymer of bisphenol A diglycidal ether, substituted alkenes, and butadiene.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as polymer 
of bisphenol A diglycidal ether, substituted alkenes, and butadiene 
(PMNs P-90-244 and P-90-245) are subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements

[[Page 320]]

are applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 15791, Apr. 17, 1991. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.6920  Butyl acrylate, polymer with substituted methyl styrene, methyl methacrylate, and substituted silane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as butyl acrylate, 
polymer with substituted methyl styrene, methyl methacrylate, and 
substituted silane (PMN P-91-272) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(ii), 
(a)(5)(viii), (a)(5)(ix), (a)(6)(ii), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 per cent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (volume set at 90,000 kg), (volume set at 
512,000 kg), (volume set at 1,235,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44070, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]



Sec. 721.6980  Dimer acids, polymer with polyalkylene glycol, bisphenol A-diglycidyl ether, and alkylenepolyols polyglycidyl ethers (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance dimer acids, polymer with 
polyalkylene glycol, bisphenol A-diglycidyl ether, and alkylenepolyols 
polyglycidyl ethers (PMN P-86-628) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 0.1 percent], 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (d), (e) [concentration set at 0.1 percent], 
(f), and (g)(1)(vi) and (g)(1)(vii), (g)(2)(i) and (g)(2)(v), (g)(4)(i), 
and (g)(5). The provision of Sec. 721.72(d) requiring that employees be 
provided with information on the location and availability of MSDSs does 
not apply when a MSDS was not required under Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) and (y).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) and (b)(1) and (b)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 321]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26109, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7000  Polymer of disodium maleate, allyl ether, and ethylene oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polymer of disodium maleate, allyl ether, and ethylene oxide (P-91-1086) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.125 (a), (h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44071, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.7020  Distillates (petroleum), C(3-6), polymers with styrene and mixed terpenes (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance distillates (petroleum), C(3-6), 
polymers with styrene and mixed terpenes (PMN P-89-676) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows.
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into a Material Safety Data Sheet 
(MSDS) as described in Sec. 721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, imported, processed, or used in the employer's 
workplace, the employer must add the new information to an MSDS before 
the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the

[[Page 322]]

time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (h) and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32414, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, May 
24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7046  Formaldehyde, polymer with substituted phenols, glycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
polymer with substituted phenols, glycidyl ether (PMN P-93-955) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply once the substance is a component of a highly 
densified tablet formulation of an epoxy molding compound.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(6)(i), (b) (concentration set at 
0.1 percent), and (c). Requirements as specified in Sec. 721.63 
(a)(5)(i) apply during manufacturing only. Requirements as specified in 
Sec. 721.63(a)(5)(i) through (a)(5)(vii) apply during processing for 
workers exposed greater than 17 days per year or during use.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
(g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (b), (l), and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 45084, Aug. 30, 1995, as amended at 62 FR 42692, Aug. 8, 1997]



Sec. 721.7160  2-Oxepanone, polymer with 4,4'-(1-methylethylidene)bisphenol and 2,2-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxi- rane, graft.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-oxepanone, polymer with 4,4'(1-
methylethylidene)bisphenol and 2,2-[(1-methylethylidene) bis(4,1-
phenyleneoxymethylene)]bisoxirane, graft (PMN P-88-2582) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i),(a)(5)(ii), (a)(5)(iii), 
(a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(ii), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).

[[Page 323]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33306, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7200  Perfluoroalkyl aromatic carbamate modified alkyl methacrylate copolymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkyl aromatic carbamate modified alkyl methacrylate copolymer 
(PMN P-87-1555) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements asspecified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent 
for cancer; 1.0 percent for other effects), (f), (g)(1)(ii), (g)(2)(ii), 
and (g)(5). In addition, the following human health hazard statement 
shall appear on each label and MSDS required by this section: This 
substance may cause lung effects.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (o) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44071, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.7210  Epoxidized copolymer of phenol and substituted phenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as epoxidized copolymer 
of phenol and substituted phenol (PMN P-91-598) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
once the substance is a component of a highly densified tablet 
formulation of an epoxy molding compound.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(6)(i), 
(b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a) through (e) (concentration set at 0.1 percent), (f), 
(g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44071, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993; 62 FR 42692, Aug. 8, 1997]

[[Page 324]]



Sec. 721.7220  Polymer of substituted phenol, formaldehyde, epichlorohydrin, and disubstituted benzene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of substituted phenol, formaldehyde, epichlorohydrin, and disubstituted 
benzene (PMN P-89-1104) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(v), (g)(4)(i), and 
(g)(5). The following additional human hazard precautionary statement 
shall appear on each label as specified in Sec. 721.72(b): Disposal 
restrictions apply.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in 
Sec. 721.90(c)(2)(v), or diatomaceous earth filtration.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19242, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7260  Polymer of polyethylenepolyamine and alkanediol diglycidyl ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of polyethylenepolyamine and alkanediol diglycidyl ether (PMN P-89-810) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows.
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) which includes a written listing of safety data 
for this substance within 90 days from the time the employer becomes 
aware of the new information. If this substance is not being 
manufactured, imported, processed, or used in the employer's workplace, 
the employer must add the new information to an MSDS before the 
substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS 
containing a written listing of safety data for this chemical and the 
information required under paragraph (a)(2)(i)(A) within 90 days from 
the time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (2,000,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 325]]

    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (c), and (h) (In addition, 
each manufacturer, importer and processor of this substance shall 
maintain for five years from the date of their creation, copies of 
material safety data sheets required under paragraph (a)(2)(i)(A) of 
this section).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46774, Nov. 6, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.7280  1,3-Propanediamine, N,N'-1,2-ethanediylbis-, polymer with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-2,2,6,6-tetramethyl-4-
          piperidinamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-propanediamine, 
N, N'-1,2-ethanediylbis-, polymer with 2,4,6-trichloro-1,3,5-triazine, 
reaction products with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine (PMN 
P-89-632) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), 
(a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a) through (f), (g)(1)(iv), (g)(1)(viii), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33308, Aug. 15, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 60 FR 65582, Dec. 20, 
1995]



Sec. 721.7285  Amines, N-cocoalkyltrimethylenedi-, citrates.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as amines, N-
cocoalkyltrimethylenedi-, citrates. (PMN P-93-880; CAS No. 189120-63-6) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and 
(g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44581, Aug. 20, 1998]



Sec. 721.7286  Amines, N-tallowalkyltripropylenetetra-, citrates.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as amines, N-
tallowalkyltripropylenetetra-, citrates (PMN P-93-881; CAS No. 189120-
62-5) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a),

[[Page 326]]

(b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44581, Aug. 20, 1998]



Sec. 721.7375  Potassium salt of polyolefin acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
potassium salt of polyolefin acid (PMN P-97-417) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.7378  Substituted polyoxyethylene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted polyoxyethylene (PMN P-93-1654) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j) (use as an emulsifier for paint and 
adhesives).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3434, Jan. 22, 1998]



Sec. 721.7440  Polyalkylenepolyol alkylamine. (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyalkylenepolyol alkylamine (PMN P-89-483) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(ix), (g)(2)(i), 
(g)(2)(iii), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[[Page 327]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 33307, Aug. 15, 1990, as amended at 55 FR 52276, Dec. 21, 1990. 
Redesignated and amended at 58 FR 29946, 29947, May 24, 1993; 58 FR 
34204, June 23, 1993]



Sec. 721.7450  Aromatic amine polyols.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
aromatic amine polyols (PMNs P-93-212 and P-93-213) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51686, Oct. 4, 1993]



Sec. 721.7480  Isocyanate terminated    polyols.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
isocyanate terminated polyols (P-90-404, P-90-405, and P-90-406) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), 
(a)(5)(iii), (a)(6)(ii), (b) (concentration set at 1.0 percent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5). The following additional human health 
hazard statements shall appear on each label and MSDS required by this 
paragraph: The substance may cause eye irritation, lung effects, dermal 
sensitization, pulmonary sensitization, or systemic effects.

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (volume set at 245,000 kg; aggregate 
manufacture and import volume for PMNs P-90-404, P-90-405, and P-90-406 
combined).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this substance 
as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 40214, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.7500  Nitrate polyether polyol (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance nitrate polyether polyol (PMN P88-
2540) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows.
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into a Material Safety Data Sheet 
(MSDS) as described in Sec. 721.72(c) within 90 days from the time the 
employer becomes aware of the new information. If this substance is not 
being manufactured, imported, processed, or used in the employer's 
workplace, the

[[Page 328]]

employer must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) within 90 days from the time the employer becomes 
aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (h) and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32418, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7600  Alkyl(heterocyclicyl) phenylazohetero monocyclic polyone (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkyl (heterocyclicyl) 
phenylazohetero monocyclic polyone (PMN P-85-1370) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(vii), 
(a)(6)(i) through (a)(6)(iii), (b) (concentration set at 1.0 percent), 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (d), (e) (concentration set at 1.0 percent), (f) and 
(g)(1)(ix), (g)(2)(i) through (g)(2)(v) and (g)(4). The provisions of 
Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a) and (c), respectively.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g) (as intermediates to manufacture dyes for 
coloring pulp or paper only) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1) and (c)(1).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(iv), (b)(2)(iv) and (c)(2)(iv).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (f), (i), (j) and 
(k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 32418, Aug. 9, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.7620  Alkyl(heterocyclicyl) phenylazohetero monocyclic polyone, ((alkylimidazolyl) methyl) derivative (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance alkyl (heterocyclicyl) 
phenylazohetero monocyclic polyone, ((alkylimidazolyl) methyl) 
derivative (PMN P-86-136) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv) through (a)(5)(vii), 
(a)(6)(i), (a)(6)(ii) and (a)(6)(iii), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) (concentration set at 1.0 percent), (f) and 
(g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and (g)(2)(v). The

[[Page 329]]

provisions of Sec. 721.72(d) requiring employees to be provided with 
information on the location and availability of a written hazard 
communication program and MSDSs do not apply when the written program 
and MSDS are not required under Sec. 721.72 (a) and (c), respectively. 
The provision of Sec. 721.72(g) requiring placement of specific 
information on an MSDS does not apply when an MSDS is not required under 
Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g), (k) and (q). The term intermediate as 
used in Sec. 721.80(g) is defined as intermediate for manufacture of 
dyes for coloring pulp or paper.
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1) and (c)(1).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2), (b)(2) and (c)(2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (e), (f), (i) 
and (j).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32418, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7655  Alkylsulfonium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylsulfonium salt (PMN P-93-1166) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 50 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.7700  Poly(oxy-1,2-ethanediyl), -hydro--(oxiranylmethoxy)-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl),-hydro--(oxiranylmethoxy)-, ether with 2-
ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-88-2188) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), 
(a)(6)(ii), and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii), (b)(1), and (c)(1). The following may be used as alternative 
to the technologies in Sec. 721.90(a)(2)(ii): Oil and grease separation.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable

[[Page 330]]

to manufacturers, importers, and processors of this substance: 
Sec. 721.125 (a) through (k).
    (2) Limitation of revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19240, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7710  Polyepoxy polyol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyepoxy polyol (PMN P-93-364) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.7720  Poly(oxy-1,2-ethanediyl), ,'-[(1-methylethylidene) di-4,1-phenylene] bis [-(oxiranylmethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), ,'-[(1-methylethylidene) di-4,1-
phenylene] bis [-(oxiranylmethoxy)- (PMN P-88-2181) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), 
(a)(6)(ii), and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii), (b)(1), and (c)(1). The following may be used as an 
alternative to the technologies in Sec. 721.90(a)(2)(ii): Oil and grease 
separation.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (k).
    (2) Limitation of revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19240, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7770  Alkylphenoxypoly(oxyethylene) sulfuric acid ester, substituted amine salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkyl 
phenoxypoly(oxyethylene) sulfuric acid ester, substituted amine salt 
(PMN P-92-396) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Hazard communication program. 
Requirements as specified in Sec. 721.72 (a), (b), (c), (d), (f), 
(g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

[[Page 331]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k).
    (iii) Release to water. Requirements as specified in 
Sec. 721.90(a)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51707, Oct. 4, 1993]



Sec. 721.7780  Poly[oxy(methyl-1,2-ethanediyl)], ,'-(2,2-dimethyl-1,3-propanediyl)bis[-(oxiranymethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-
ethanediyl)], ,,'-(2,2-dimethyl-1,3-
propanediyl)bis[-(oxiranymethoxy)- (PMN P-88-2180) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(ix), 
(a)(6)(ii), and (b) (concentration set at 0.1 percent).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1), 
(b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(2)(ii), (b)(1), and (c)(1). The following may be used as an 
alternative to the technologies in Sec. 721.90(a)(2)(ii): Oil and grease 
separation.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (k).
    (2) Limitation of revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19239, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.7785  Substituted alkyl aminomethylene polyphosphonic acid, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted alkylamino methylene polyphosphonic acid, salt (PMN P-97-
1095) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44581, Aug. 20, 1998]



Sec. 721.8079  Isophorone diisocyanate neopentyl glycol adipate polyurethane prepolymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
isophorone diisocyanate neopentyl glycol adipate polyurethane

[[Page 332]]

prepolymer (PMN P-94-1743) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. Non-spray uses are exempt from the provisions of this rule.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(viii), 
(a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), 
and (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, and 
processors who implement the product stewardship provisions of the TSCA 
section 5(e) consent order for these substances are exempt from the 
requirements of Sec. 721.63 and Sec. 721.72.
    (iii) Industrial, commercial and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance. Manufacturers, importers, and 
processors who implement the product stewardship provisions and keep 
records as required by the TSCA section 5(e) consent order for these 
substances are exempt from the requirements of Sec. 721.125.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.
    (4) Applicability of Sec. 721.5. The provisions of Sec. 721.5 do not 
apply to manufacturers, importers, and processors, implementing the 
product stewardship provisions in the TSCA section 5(e) consent order 
for this substance.

[63 FR 3435, Jan. 22, 1998]



Sec. 721.8082  Polyester polyurethane acrylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyester polyurethane acrylate (PMN P-93-498) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51686, Oct. 4, 1993]



Sec. 721.8090  Polyurethane polymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polyurethane polymer (P-94-47) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(viii) through 
(a)(5)(xi), (a)(6)(ii), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i) through (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a)

[[Page 333]]

through (i) are applicable to manufacturers, importers, and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 45084, Aug. 30, 1995]



Sec. 721.8095  Silylated polyurethane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
silylated polyurethane (PMN P-95-1356) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3435, Jan. 22, 1998]



Sec. 721.8100  Potassium N,N-bis (hydroxyethyl) cocoamine oxide phosphate, and potassium N,N-bis (hydroxyethyl) tallowamine oxide phosphate.

    (a) Chemical substances and significant new use subject to 
reporting. (1) The following chemical substances, identified by their 
chemical names and CAS Number are subject to reporting under this part 
for the significant new use identified in paragraph (a)(2) of this 
section: Potassium N,N-bis (hydroxyethyl) cocoamine oxide phosphate (CAS 
Number 855712-26-1), and potassium N,N-bis (hydroxyethyl) tallowamine 
oxide phosphate (CAS Number 855712-27-2).
    (2) The significant new use is: Use in a consumer product at 
concentrations greater than five percent by weight.
    (b) Specific Requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Definitions. In addition to the definitions in Sec. 721.3, the 
following definitions apply to this section:
    ``Consumer'' means any natural person who uses products for personal 
rather than business purposes.
    ``Consumer product'' means any chemical substance which is directly, 
or as part of a mixture, sold or made available to consumers for their 
use in or around a permanent or temporary household or residence, in or 
around a school, or in recreation.
    (2) Persons who must report. The provisions of Sec. 721.5 apply to 
determine persons who must report under this section, except 
Sec. 721.5(a)(2) does not apply to a person who intends to distribute 
either of the substances in commerce as part of a mixture at 
concentrations of five percent or less by weight of the mixture.
    (3) Notice requirements and procedures. Section 721.10 applies to 
this section, except a person submitting a notice must complete only 
Parts I and II of the notice form.

[49 FR 35018, Sept. 5, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.8153  Di-substituted propanedione (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as di-
substituted propanedione (PMN P-97-94) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b) 
(concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0

[[Page 334]]

percent), (f), (g)(2)(i), (g)(2)(v). The following statement shall 
appear on each label as specified in Sec. 721.72(b) and the MSDS as 
specified in Sec. 721.72(c): This substance is expected to be dermally 
absorbed and may cause effects to the liver, kidney, adrenal glands, and 
the heart.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44581, Aug. 20, 1998]



Sec. 721.8155  Propanenitrile, 3-[amino, N-tallowalkyl] dipropylenetri- and tripropylenetri- and propanenitrile, 3-[amino, (C14-18 and
 
          C16-18 unsaturated alkyl)] trimethylenedi-, 
          dipropylenetri-, and tripropylenetetra-.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as propanenitrile, 3-
[amino, N-tallowalkyl] dipropylenetri- (PMN P-94 1238), propanenitrile, 
3-[amino, N-tallowalkyl] tripropylenetri- (PMN P-94-1239), 
propanenitrile, 3-[amino, (C14-18 and C16-18 
unsaturated alkyl)] trimethylenedi- (PMN P-94-1241), propanenitrile, 3-
[amino, (C14-18 and C16-18 unsaturated alkyl)] 
dipropylenetri- (PMN P-94-1242), and propanenitrile, 3-[amino, 
(C14-18 and C16-18 unsaturated alkyl)] 
tripropylenetetra- (PMN P-94-1243) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11044, Mar. 1, 1995]



Sec. 721.8160  Propanoic acid, 2,2-dimethyl-, ethenyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanoic acid, 2,2-
dimethyl-, ethenyl ester (PMN P-89-1058) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply once the 
substance has been incorporated into a polymer matrix with the level of 
residual monomer below 0.1 percent.
    (2) The significant new uses are: (i) Protection in the workplace. 
Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(i) (There must 
be no permeation of the substance greater than 0.02  g/
min. cm2 after 8 hours of testing in accordance 
with the most current version of the American Society for Testing and 
Materials ASTM F739 ``Standard Test Method for Resistance of Protective 
Clothing Materials to Permeation by Liquids or Gases.'' For conditions 
of exposure which are intermittent, gloves may be tested in accordance 
with the most current version of ASTM F1383 ``Standard Test Method for 
Resistance of Protective Clothing Materials to Permeation by Liquids or 
Gases Under Conditions of Intermittent Contact,'' provided the contact 
time in testing is greater than or equal to the expected duration of 
dermal contact, and the purge time used in testing is less than or equal 
to the expected duration of noncontact during the intermittent cycle of 
dermal exposure in the workplace. If ASTM F1383 is used for testing, 
manufacturers, importers, and processors must submit to

[[Page 335]]

the Agency a description of worker activities involving the substance 
which includes daily frequencies and durations of potential worker 
exposures. The results of all glove permeation testing must be reported 
in accordance with the most current version of ASTM F1194 ``Guide for 
Documenting the Results of Chemical Permeation Testing of Protective 
Clothing Materials.'' Manufacturers, importers, and processors must 
submit all test data to the Agency and must receive written Agency 
approval for each type of glove tested prior to use of such gloves. The 
following gloves have been tested in accordance with the ASTM F739 
method and found by EPA to satisfy the requirements for continuous use: 
Ansell Edmont/15-554/PVA, 0.08 cm thick; and Ansell Edmont/4h/PE/EVOH/PE 
laminate gloves, 0.006 cm thick. Gloves may not be used for a time 
period longer than they are actually tested and must be replaced at the 
end of each work shift. The following gloves have been tested in 
accordance with the ASTM 1383 method and found by EPA to satisfy the 
requirements for intermittent use: North/B-161-R/Butyl rubber gloves, 
0.04 cm thick, time period tested 2 min/h. The gloves listed may not be 
used for a time period longer than they are actually tested and must be 
replaced at the end of each work shift unless based on its review of 
data from the ASTM 1383 method, the company's personal protective 
equipment required under this paragraph, and other appropriate 
information, the Agency approves, in writing, a time period of greater 
duration.), (a)(2)(ii) (With the exception of laboratory activities, 
full body chemical protective clothing is required for any worker 
activity in which the substance is reasonably likely to contact the 
worker in the following state(s): Open liquid pool or solid of greater 
than 5 kg; liquid spray or splash; mist; aerosol dust; or any worker 
activity which has the potential for contact with the substance for more 
than 10 min/h. At a minimum, a chemical protective apron is required for 
any worker activity with potential for contact with the substance which 
is not covered by this paragraph), (a)(2)(iii), (a)(3), (a)(4), 
(a)(5)(iii) (if cartridge service life testing is not available), 
(a)(5)(xii) or (a)(5)(xiii) (if data on cartridge service life testing 
has been reviewed and approved in writing by EPA), (a)(6)(i), 
(a)(6)(ii), (a)(6)(iv), and (a)(6)(v). As an alternative to the 
respiratory requirements in this section, manufacturers, importers, and 
processors may use the New Chemical Exposure Limits provisions, 
including sampling and analytical methods which have previously been 
approved by EPA for this substance, found in the 5(e) consent order for 
this substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (h)(1)(vi) (The following additional statements shall appear on 
each label required by this paragraph: The health effects of this 
material have not been fully determined but are currently being tested. 
EPA is concerned however, that this material may have serious chronic 
health and environmental effects. When using this material, use eye and 
skin protection, which includes gloves which have been determined to be 
impervious to this substance. Use respiratory protection, unless 
workplace airborne concentrations are maintained at or below an 8-h time 
weighted average (TWA) of 1 ppm, when there is a likelihood of exposure 
in the work area from dust, mist, smoke or vapor), (h)(2)(ii)(F), 
(h)(2)(ii)(G), (h)(2)(ii)(I), (h)(2)(iii)(A), (h)(2)(iii)(B), 
(h)(2)(iii)(C), (h)(2)(iii)(E), (h)(2)(iv)(A), (h)(2)(iv)(B). The 
following additional statements shall appear on each MSDS required by 
this paragraph: This substance may cause moderate skin irritation. This 
substance may cause neurotoxicity. When using this substance, use 
respiratory protection, unless workplace airborne concentrations are 
maintained at or below an 8-h TWA of 1 ppm.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 40 ppb). When calculating the 
surface water concentrations according to the instructions in 
Sec. 721.91, the statement in paragraph (a)(4) that the amount of the 
substance that will be released will be calculated before

[[Page 336]]

the substance enters control technology does not apply. Instead, if the 
waste stream containing the substance will be treated before release, 
then the amount of the substance reasonably likely to be removed from 
the waste stream by such treatment may be subtracted in calculating the 
number of kilograms released. No more than 75 percent removal efficiency 
may be attributed to such treatment. In addition, when the substance is 
released in combination with the substances hexanedioic acid, diethenyl 
ester, hexanoic acid, 2-ethyl-, ethenyl ester, and neononanoic acid, 
ethenyl ester, the quotient from the formula referenced in this section 
shall not exceed the average of the quotient applicable to the other 
substances weighted by the proportion of each substance present in the 
total daily amount released.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance. Manufacturers, importers, 
and processors of the substance must document that the substance has 
been incorporated into a polymer matrix with the level of residual 
monomer below 0.1 percent if this section does not apply as described in 
paragraph (a)(1) of this section.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 51707, Oct. 4, 1993]



Sec. 721.8170  Propanol, [2-(1,1-dimethylethoxy)methylethoxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance propanol, [2-(1,1-
dimethylethoxy)methylethoxy]- (CAS no. 132739-31-2) (P-93-193) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If, as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into a Material 
Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within 90 days 
from the time the employer becomes aware of the new information. If this 
substance is not being manufactured, imported, processed, or used in the 
employer's workplace, the employer must add the new information to an 
MSDS before the substance is reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified in Sec. 721.125(a), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[60 FR 11044, Mar. 1, 1995]

[[Page 337]]



Sec. 721.8225  2-Propenamide, N-[3-di-   methylamino)propyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenamide, N-[3-
dimethylamino)propyl]- (PMN P-86-1602) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(ii), (b) (concentration set 
at 0.1 percent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(v), (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (o) and (q).
    (iv) Release to water. Requirements as specified in 
Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 300 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i) and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40215, Aug. 13, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.8250  1-Propanol, 3,3'-oxybis[2,2-bis(bromomethyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-propanol, 3,3'-
oxybis[2,2-bis(bromomethyl)]- (PMN P-87-1273) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63(a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3)(applies to gloves 
only), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), 
(a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements asspecified in 
Sec. 721.72(a), (b)(2), (c), (d), (e) (concentration set at 0.1 
percent), (f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), and (g)(5). In addition, 
the human health hazard statement shall include a statement that this 
substance may cause acute and chronic toxicity.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (p). In addition, use other than as 
a flame retardant additive is a significant new use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (i), and (j) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44072, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.8350  2-Propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-propenoic acid, 7-
oxabicyclo[4.1.0]hept-3-ylmethyl ester (PMN P-89-31) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(xv), (a)(6)(i), 
(a)(6)(ii), (a)(6)(iv), (b) (concentration set at 0.1 percent), and (c).

[[Page 338]]

    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(o).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46774, Nov. 6, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 62 FR 42692, Aug. 8, 1997]



Sec. 721.8450  2-Propenoic acid, 2-methyl-, 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 2-
methyl-, 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl ester, (PMN 
P-90-333) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), (c)(4), ( where N = 80 ). However, contrary to 
Sec. 721.91(a)(4), if the waste stream containing the PMN substance will 
be treated using biological treatment (activated sludge or equivalent) 
plus clarification, then the amount of PMN substance reasonably likely 
to be removed from the waste stream by such treatment may be subtracted 
in calculating the number of kilograms released. No more than 75 percent 
removal efficiency may be attributed to such treatment.
    (b) Special requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 19241, Apr. 25, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 60 FR 30468, June 9, 
1995; 63 FR 45956, Aug. 28, 1998]



Sec. 721.8500  2-Propenoic acid, 2-methyl-, 7-oxabicyclo [4.1.0]hept-3-ylmethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-propenoic acid, 2-methyl-, 7-
oxabicyclo[4.1.0]hept-3-ylmethyl ester (PMN P-89-30) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(viii), (a)(5)(xv), (a)(6)(i), 
(a)(6)(ii), (a)(6)(iv), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(vi), (g)(1)(vii), (g)(2)(i) through (g)(2)(v), 
and (g)(5).

[[Page 339]]

    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 46775, Nov. 6, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.8654  2-Propenoic acid 3-(trimethoxy silyl)propyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-propenoic acid 3-
(trimethoxysilyl)propyl ester (PMN P-93-1235) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.8660  Propionic acid methyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
propionic acid methyl ester (PMN P-97-370) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f) and (j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44581, Aug. 20, 1998]



Sec. 721.8670  Alkylcyano substituted pyridazo benzoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkylcyano substituted pyridazo benzoate (PMN P-94-1129) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11044, Mar. 1, 1995]



Sec. 721.8673  [(Disubstituted phenyl)]azo dihydro hydroxy alkyl oxo alkyl-substituted-pyridines (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
[(disubstituted phenyl)]azo

[[Page 340]]

dihydro hydroxy alkyl oxo alkyl-substituted-pyridines (PMN P-95-510/511) 
are subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[61 FR 63739, Dec. 2, 1996]



Sec. 721.8675  Halogenated pyridines.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated pyridine (PMN P-83-1163) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(1)(i) of 
this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contain residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 0.2 ppb). Where 
primary, secondary, and tertiary waste treatment will occur, or 
treatment in a lined, self-contained solar evaporation pond where UV 
light will degrade the substance, the number of kilograms per day per 
site is calculated after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (2) The chemical substances identified generically as halogenated 
pyridines (PMN P-85-216, P-85-1184) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(4)(i) of 
this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).

[[Page 341]]

    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 0.2 ppb). Where 
primary, secondary, and tertiary waste treatment will occur, or 
treatment in a lined, self-contained solar evaporation pond where UV 
light will degrade the substance, the number of kilograms per day per 
site is calculated after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (b) [Reserved]

[56 FR 23769, May 23, 1991; 56 FR 29903, July 1, 1991. Redesignated at 
58 FR 29947, May 24, 1993, as amended at 58 FR 34204, June 23, 1993; 59 
FR 66747, Dec. 28, 1994]



Sec. 721.8700  Halogenated alkyl pyridine.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated alkyl pyridine (PMN P-83-237) is subject to reporting under 
this section for the significant new uses described in paragraph 
(a)(1)(i) of this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 10 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (2) The chemical substance identified generically as halogenated 
alkyl pyridine (PMN P-83-1162) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2)(i) of 
this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a) (1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during

[[Page 342]]

manufacturing, processing, or use of the chemical substance which 
contain residual amounts of the chemical substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b) , (c), (d), (f), (g)(1)(iv), (g)(1)(vii), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), 
(g)(4)(i), and (g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 0.2 ppb). Where 
primary, secondary, and tertiary waste treatment will occur, or 
treatment in a lined, self-contained solar evaporation pond where UV 
light will degrade the substance, the number of kilograms per day per 
site is calculated after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (b) [Reserved]

[56 FR 23771, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994]



Sec. 721.8750  Halogenated substituted   pyridine.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halogenated substituted pyridine (PMN P-86-838) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), 
(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 1 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 23769, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994]



Sec. 721.8775  Substituted pyridines.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted pyridine (PMN P-84-1219) is subject to reporting under this 
section for the significant new

[[Page 343]]

uses described in paragraph (a)(1)(i) of this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 10 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (2) The chemical substances identified generically as substituted 
pyridines (PMNs P-85-236 and P-85-706) are subject to reporting under 
this section for the significant new uses described in paragraph 
(a)(2)(i) of this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 0.2 ppb). Where 
primary, secondary, and tertiary waste treatment will occur, or 
treatment in a lined, self-contained solar evaporation pond where UV 
light will degrade the substance, the number of kilograms per day per 
site is calculated after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) The chemical substance identified generically as substituted 
pyridine (PMN P-85-36) is subject to reporting

[[Page 344]]

under this section for the significant new uses described in paragraph 
(a)(3)(i) of this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contain residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), 
(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 10 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (4) The chemical substance identified generically as substituted 
pyridine (PMN P-85-1184) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(4)(i) of this 
section.
    (i) The significant new uses are:
    (A) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), 
(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (C) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (D) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 1.3 ppb). Where 
primary, secondary, and tertiary waste treatment will occur or treatment 
in a lined, self-contained solar evaporation pond where UV light will 
degrade the substance, the number of kilograms per day per site is 
calculated after wastewater treatment.
    (ii) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (A) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (B) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[[Page 345]]

    (b) [Reserved]

[56 FR 23770, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66747, Dec. 28, 1994]



Sec. 721.8780  Substituted pyridine azo substituted phenyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted pyridine azo substituted phenyl (PMNs P-96-767 and P-96-773) 
are subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers and importers 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3435, Jan. 22, 1998]



Sec. 721.8825  Substituted methylpyridine and substituted 2-phenoxypyridine.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The following chemical substances, referred to by their 
PMN numbers and generic chemical names, are subject to reporting under 
this section for the significant new uses described in paragraphs (a)(2) 
and (3) of this section: Substituted methylpyridine (P-83-24, P-83-49, 
and P-83-272) and substituted 2-phenoxypyridine (P-83-23 and P-83-75).
    (2) The significant new uses for P-83-49 and P-83-272 are 
manufacture or processing without:
    (i) Requiring use of the following personal protective equipment for 
persons involved in any operation where dermal contact and/or inhalation 
of the substances may occur, and where local exhaust ventilation is 
present at the site of the operation:
    (A) Chemical cartridge respirator, approved by the National 
Institute for Occupational Safety and Health for protection from organic 
vapors, and used and fitted according to 29 CFR 1910.134 and 30 CFR part 
11.
    (B) Chemical worker gloves and aprons or other equivalent personal 
protective clothing determined to be impervious to the particular 
substance in its conditions of use. (Equipment may be determined to be 
impervious either by testing under the conditions of use, including the 
duration of exposure, or by evaluating the specifications supplied by 
the supplier of the equipment.)
    (ii) Requiring use of the following personal protective equipment 
for persons involved in and in the immediate area of any operation where 
dermal contact and/or inhalation of the substance may occur, and where 
local exhaust ventilation is not present at the site of the operation:
    (A) Full facepiece, positive pressure air-supplied respirator, 
approved by the Bureau of Mines, Department of the Interior or by the 
National Institute of Occupational Safety and Health fitted according to 
procedures established at 29 CFR 1910.134.
    (B) Chemical worker gloves and aprons, or other equivalent personal 
protective clothing determined to be impervious to the particular 
substance in its conditions of use. (Equipment may be determined to be 
impervious either by testing under the conditions of use, including the 
duration of exposure, or by evaluating the specifications supplied by 
the supplier of the equipment.)
    (iii) Notifying in writing, each employee required to use protective 
equipment that these chemical substances may present a hazard of liver, 
kidney, and nervous system toxicity unless the specified protective 
equipment is used.
    (3) The significant new uses for P-83-23, P-83-24, and P-83-75 are 
manufacture or processing without:
    (i) Requiring the use of the following personal protective equipment 
for persons involved in any operation where dermal contact may occur:
    (A) Chemical goggles.
    (B) Chemical worker gloves and aprons, or other equivalent personal 
protective clothing determined to be impervious to the particular 
substance in its conditions of use. (Equipment

[[Page 346]]

may be determined to be impervious either by testing under the 
conditions of use, including the duration of exposure, or by evaluating 
the specifications supplied by the supplier of the equipment.)
    (ii) Notifying in writing, each employee required to use protective 
equipment that these chemical substances may present a hazard of liver, 
kidney, and nervous system toxicity unless the specified protective 
equipment is used.
    (b) Specific requirements. In addition to the general provisions of 
subpart A of this part, the following specific requirements apply.
    (1) Recordkeeping. In addition to the requirements of Sec. 721.17, 
manufacturers, importers, and processors of the chemical substances 
identified in paragraph (a) of this section must maintain the following 
records for five years from the date of their creation:
    (i) The names of persons required to wear protective clothing and/or 
equipment.
    (ii) Records of respirator fit tests for each person required to 
wear a respirator.
    (iii) The names and addresses of persons to whom any of these 
substances are sold or transferred and the date of such sale or 
transfer.
    (2) [Reserved]

[49 FR 50400, Dec. 28, 1984. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.8850  Disubstituted halogenated pyridinol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disubstituted halogenated pyridinol (PMN P-88-1274) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 44 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 23771, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994]



Sec. 721.8875  Substituted halogenated  pyridinol.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted halogenated pyridinol (PMN P-88-1273) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 347]]

    (i) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 44 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Sec. 721.125 (a) through (h), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 23772, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994]



Sec. 721.8900  Substituted halogenated  pyridinol, alkali salt.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted halogenated pyridinols, alkali salts (PMNs P-88-1271 and P-
88-1272) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. The general requirements as 
specified in Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), 
(a)(3), (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), 
(a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), 
and (c) apply in all cases except that Sec. 721.63(a)(2)(ii) does not 
apply for reactor sampling operations where enclosed vented sample boxes 
are used. In addition Sec. 721.63(a)(2)(iv) applies for processing of 
any byproduct generated during manufacturing, processing, or use of the 
chemical substance which contains residual amounts of the chemical 
substance.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and 
(g)(5).
    (iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). The following additional 
disposal methods also apply: Chemical destruction or, where necessary to 
ensure complete destruction of the substance, chemical destruction and 
carbon adsorption.
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (concentration set at 44 ppb). Where primary, 
secondary, and tertiary waste treatment will occur, or treatment in a 
lined, self-contained solar evaporation pond where UV light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable

[[Page 348]]

to manufacturers, importers, and processors of this substance: 
Sec. 721.125 (a) through (h), (j), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 23772, May 23, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993; 59 FR 66748, Dec. 28, 1994]



Sec. 721.8965  1H-Pyrole-2, 5-dione, 1-(2,4,6-tribromophenyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H-pyrole-2, 5-
dione, 1-(2,4,6-tribromophenyl)-, (PMN No. P-90-159) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(iii) for employees likely to have ocular exposure, 
(a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b) 
(concentration set at 0.1 percent by weight or volume), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) concentration set at 0.1 percent by 
weight or volume, (f), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), 
(g)(1)(vii), (g)(1)(ix) (corrosion to the eyes), (g)(2)(iii), 
(g)(2)(iv)( use chemical goggles), (g)(3)(ii), (g)(4)(i), (g)(4)(iii) 
(except the dewatering step during polymerization of acrylonitrile/
butadiene/styrene), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (a), (c), (f), (k) (any use in a system 
other than as flame retardant in styrenic, polyolefin elastomer, and 
thermoset systems), (l), and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (b)(1) (by 
industrial incinerator), (b)(2), (c)(1), and (c)(2). Dispose of the PMN 
substance by industrial incinerator or landfill.
    (v) Release to water. Requirements as specified in Sec. 721.90 
(b)(1) and (c)(1). Section 721.90 (c)(1) does not apply to releases of 
the PMN substance during the dewatering step of the polymerization 
reactions from use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (d), and (f) through (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32240, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.9000  N-Nitrosopyrrolidine.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance N-nitrosopyrrolidine (CAS No. 930-55-2) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.9005  2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-pyrrolidinone, 
1,1'-(2-methyl-1,5-pentanediyl)bis- (PMN P-93-761; CAS No. 146453-62-5) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i) (There must be no permeation of the PMN 
substance greater than 0.08 grams (g)/minutes (min) centimeter

[[Page 349]]

(cm2) after 8 hours of testing in accordance with the most 
current version of the American Society for Testing and Materials (ASTM) 
F739 ``Standard Test Method for Resistance of Protective Clothing 
Materials to Permeation by Liquids or Gases.'' The results of all glove 
permeation testing must be reported in accordance with the most current 
version of (ASTM) F1194 ``Guide for Documenting the Results of Chemical 
Permeation Testing of Protective Clothing Materials.'' Manufacturers, 
importers, and processors must submit such glove test data to the Agency 
and must receive written Agency approval for each type of glove tested 
prior to use of such gloves. The following gloves have been tested in 
accordance with the ASTM F739 method and found to satisfy the 
requirements for use by EPA: Ansell Edmond/8-352/Neoprene rubber, 0.097 
cm thick. Gloves may not be used for a time period longer than they are 
actually tested and must be replaced at the end of each work shift), 
(a)(2)(ii), (a)(2)(iii), (a)(3), (b) (concentration set at 1.0 percent), 
and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(l)(iii), (g)(l)(iv), (g)(2)(i), (g)(2)(iii), (g)(2)(v), and 
(g)(5). The label and MSDS as required by this paragraph shall also 
include the following statement: This substance is expected to enhance 
the absorption of other chemicals into skin or other materials.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (o), (q), and (k) (use other than as a heat 
transfer fluid).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 3435, Jan. 22, 1998]



Sec. 721.9010  2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-pyrrolidone, 1-
ethenyl-3-ethylidene-, (E)- (PMN P-96-1536; CAS No. 153954-47-3) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(2)(i) and (a)(3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3436, Jan. 22, 1998]



Sec. 721.9075  Quaternary ammonium salt of fluorinated alkylaryl amide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternary ammonium salt of fluorinated alkylaryl amide (PMN No. P-92-
688) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 350]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[58 FR 32241, June 8, 1993]



Sec. 721.9080  Nitro methyl quinoline.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as nitro 
methyl quinoline (PMN P-96-1319) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and (a)(6)(i).
    (ii) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (j) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3436, Jan. 22, 1998]



Sec. 721.9100  Substituted quinoline.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted quinoline (PMN P-93-1183) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(c).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.9220  Reaction products of secondary alkyl amines with a substituted benzenesulfonic acid and sulfuric acid (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
reaction products of secondary alkyl amines with a substituted 
benzenesulfonic acid and sulfuric acid (PMNs P-89-703, P-89-755, and P-
89-756) are subject to reporting under this section for significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Uses as 
specified in Sec. 721.80(q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of these 
substances: Recordkeeping requirements specified in Sec. 721.125 (a), 
(b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 17381, Apr. 24, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9265  Reaction product of dichlorobenzidine and substituted alkylamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 351]]

chemical substance identified generically as a reaction product of 
dichlorobenzidine and substituted alkylamide (PMN P-95-1282) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e), (f), and (g)(5). The label and MSDS 
as required by this paragraph shall also include the following 
statements: At temperatures above 200  deg.C, this substance decomposes 
to produce a suspect human carcinogen, 3',3' dichlorobenzidine. Do not 
heat above 200  deg.C or 392  deg.F.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(f) and processing or use of the PMN 
substance at temperatures above 200  deg.C.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3436, Jan. 22, 1998]



Sec. 721.9270  Reaction product of epoxy with anhydride and glycerol and glycol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as reaction 
product of epoxy with anhydride and glycerol and glycol (PMN P-96-1233) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), (x)(1) and (y)(2).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3436, Jan. 22, 1998]



Sec. 721.9280  Reaction product of ethoxylated fatty acid oils and a phenolic pentaerythritol tetraester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
reaction product of ethoxylated fatty acid oils and a phenolic 
pentaerythritol tetraester (PMN P-92-63) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who have received, or will 
receive, this substance from the employer are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
employer becomes aware of the new information.

[[Page 352]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44072, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9285  Reaction products of formalin (37%) with amine C12.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as reaction 
products of formalin (37%) with amine C12 (PMN P-95-535) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3436, Jan. 22, 1998]



Sec. 721.9300  Reaction products of substituted hydroxyalkanes and polyalkylpolyisocyanatocarbomono- cycle.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as reaction 
products of substituted hydroxyalkanes and polyal- 
kylpolyisocyanatocarbomonocycle (PMN P-91-75) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protecting against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance from the employer are provided an MSDS as described in 
Sec. 721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (volume set at 433,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[57 FR 44073, Sept. 23, 1992, as amended at 58 FR 34204, June 23, 1993]

[[Page 353]]



Sec. 721.9400  Reaction product of phenolic pentaerythritol tetraesters with fatty acid esters and oils, and glyceride triesters.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
Reaction product of phenolic pentaerythritol tetraesters with fatty acid 
esters and oils, and glyceride triesters (PMNs P-91-1231, -1232, -1233, 
-1234, and -1235) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, the employer 
must incorporate this new information, and any information on methods 
for protectintg against such risk, into an MSDS as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive this 
substance, or who have received this substance from the employer within 
5 years from the date the employer becomes aware of the new information 
described in section (a)(2)(i)(A) of this subparagraph, are provided an 
MSDS as described in Sec. 721.72(c) containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (h), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.575(b)(1) apply to this section.

[57 FR 44073, Sept. 23, 1992, as amended by 58 FR 34204, June 23, 1993]



Sec. 721.9460  Tall oil fatty acids, reaction products with polyamines, alkyl substituted.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as tall oil 
fatty acids, reaction products with polyamines, alkyl substituted (PMN 
P-91-225) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), 
and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q) and any use in a manner that will result 
in overspray over or into waters of the United States.
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), (c)(1), or use in any manner that will result in 
overspray over or into waters of the United States.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a), (b), (c), and (f) through (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[[Page 354]]

    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44074, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9470  Reserpine.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance reserpine (CAS No. 50-555) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.9480  Resorcinol, formaldehyde substituted carbomonocycle resin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance resorcinol, formaldehyde 
substituted carbomonocycle resin (PMN P-89-769) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i) through 
(a)(5)(iii), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i) through (g)(1)(iv), blood effects), and eye effects, 
(g)(1)(ix), (g)(2)(i) (avoid eye contact as well) through (g)(2)(v), 
(g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (k) (use other than as an additive in 
rubber) and (q).
    (iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 39905, Sept. 28, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9488  Substituted resorcinols.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted resorcinols (PMNs P-95-1103, P-95-1104, and P-96-1235) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 9).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9490  Coco alklydimethyl amine salts (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as coco 
alkyldimethyl amine

[[Page 355]]

salts (PMNs P-98-412/414/415/416/417) are subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9492  Polymers of styrene, cyclohexyl methacrylate and substituted methacrylate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
polymers of styrene, cyclohexyl methacrylate and substituted 
methacrylate (PMNs P-97-143/144) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(f).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9495  Acrylosilane resins.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as acrylosilane resins 
(PMNs P-95-1024/1040) are subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(l).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63740, Dec. 2, 1996]



Sec. 721.9497  Trifunctional ketoximino silane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
trifunctional ketoximino silane (PMNs P-95-605 and P-95-606) are subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to 
manufacturers, importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9499  Modified silicone resin.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 356]]

chemical substance identified generically as a modified silicone resin 
(PMN P-96-1649) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 5).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9500  Silane, (1,1-dimethylethoxy) dimethoxy(2-methyl propyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance silane, (1,1-dimethylethoxy) 
dimethoxy (2-methylpropyl)- (PMN P-89-906) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iv) through (a)(5)(vii), (a)(6)(i) through 
(a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (f), (g), 
(h), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 46775, Nov. 6, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9503  Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl)trimethoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as silane, 
(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl) trimethoxy- 
(PMN P-97-264; CAS No. 83048-65-1) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xv), 
(a)(6)(ii), and (a)(6)(v).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 10).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9505  Silanes substituted macrocycle polyethyl.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as silanes 
substituted macrocycle polyethyl (PMNs P-93-1423, 1424, 1425, and 1426) 
are subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:

[[Page 357]]

    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11045, Mar. 1, 1995]



Sec. 721.9507  Polyester silane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a polyester silane 
(P-95-1022) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial and consumer activities. Requirements as 
specified in Sec. 721.80(l).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63740, Dec. 2, 1996]



Sec. 721.9515  Aminofunctional alkoxy alkyl siloxane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
aminofunctional alkoxy alkyl siloxane (PMN P-96-346) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9516  Siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl Me, di-Me, reaction products with polyethylene-polypropylene glycol Bu glycidal ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl Me, di-Me, 
reaction products with polyethylene-polypropylene glycol Bu glycidyl 
ether (PMN P-97-740; CAS No. 189354-73-2) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9517  Siloxanes and silicones, de-Me, 3-[4-[[[3-(dimethyl amino) propyl] amino]carbonyl]-2-oxo-1-pyrrolidinyl] propyl Me.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 358]]

chemical substance identified as siloxanes and silicones, de-Me, 3-[4-
[[[3-(dimethylamino) propyl]amino] carbonyl]-2-oxo-1-pyrrolidinyl]propyl 
Me (PMN P-97-332) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9518   Sinorhizobium meliloti strain RMBPC-2.

    (a) Microorganism and significant new uses subject to reporting. (1) 
The microorganism identified as Sinorhizobium meliloti strain RMBPC-2 
(PMN P-92-403) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Commercial activities before submitting a TSCA section 5(a) 
notice. For any manufacturer or importer who has not previously 
submitted a premanufacture notice or significant new use notice for this 
microorganism, the significant new use is any use.
    (ii) Commercial activities after submitting a TSCA section 5(a) 
notice. For any manufacturer or importer who has previously submitted a 
premanufacture notice or a significant new use notice for this 
microorganism, the significant new use is manufacture, import, or 
processing greater than a maximum production volume of 500,000 lbs in 
any consecutive 12-month period.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture or 
import this substance for commercial purposes must have submitted a 
premanufacture notice or submit a significant new use notice.
    (2) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers and importers 
of this substance.
    (3) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 29648, June 1, 1998]



Sec. 721.9526  Sodium perthiocarbonate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as sodium 
perthiocarbonate (PMN P-94-2166) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45084, Aug. 30, 1995]



Sec. 721.9527  Bis(1,2,2,6,6-pentamethyl-4-piperidin-4-ol) ester of cycloaliphatic spiroketal.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bis(1,2,2,6,6-pentamethyl-4-piperidin-4-ol) ester of cycloaliphatic 
spiroketal (PMN No. P-91-1361) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:

[[Page 359]]

    (i) Protection in the workplace. For manufacturing workers only, 
requirements as specified in Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), 
and (b) (concentration set at 1.0 percent). For processing/use workers 
only, requirements as specified in Sec. 721.63(a)(4), (a)(5)(iv), 
(a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) (concentration set at 
1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(3)(ii), (g)(4)(iii), and (g)(5). The following additional statements 
shall appear on each label and MSDS required by this paragraph: This 
substance may cause systemic effects, eye irritation.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (d), (f) through (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32241, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.9530  Bis(2,2,6,6-tetramethylpiperidinyl) ester of cycloalkyl spiroketal.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bis(2,2,6,6-tetramethyl piperidinyl) ester of cycloalkyl spiroketal (PMN 
P-88-0083) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. For the manufacturing workers only, 
requirements as specified in Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), 
and (b) (concentration set at 1.0 percent). For the processing/use 
workers only, requirements as specified in Sec. 721.63 (a)(4), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) 
(concentration set at 1.0 per cent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 
(g)(3)(ii), (g)(4)(iii), and (g)(5). The following additional human 
health hazard statements shall appear on each label and MSDS required by 
this paragraph: This substance may cause: systemic effects, eye 
irritation.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(l).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (f), (g), 
(h), (i), and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[56 FR 40215, Aug. 13, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.9540  Polysulfide mixture.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
polysulfide mixture (PMN P-93-1043) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:

[[Page 360]]

    (A) If, as a result of the test data required under the section 5(e) 
consent order for this substance, the employer becomes aware that this 
substance may present a risk of injury to human health, or the 
environment, the employer must incorporate this new information, and any 
information on methods for protecting against such risk, into the 
applicable Material Safety Data Sheet (MSDS) as described in 
Sec. 721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
imported, processed, or used in the employer's workplace, the employer 
must add the new information to an MSDS before the substance is 
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive, or who 
have received this substance from the employer within 5 years from the 
date the employer becomes aware of the new information described in 
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as 
described in Sec. 721.72(c) containing the information required under 
paragraph (a)(2)(i)(A) of this section within 90 days from the time the 
Company becomes aware of the new information. Requirements as specified 
in Sec. 721.72 (a), (b), (c), (d), (f), and (g)(4)(iii).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(p) (153,000 kg).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements specified 
in Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 11045, Mar. 1, 1995]



Sec. 721.9545  Substituted phenyl azo substituted sulfocarbopolycle, sodium salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
substituted phenyl azo substituted sulfocarbopolycle, sodium salt (PMN 
P-96-1263) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3437, Jan. 22, 1998]



Sec. 721.9550  Sulfonamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a 
sulfonamide (PMN P-90-1732) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (a)(4), 
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(6)(i), (b) 
(concentration set at 1.0 percent) and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).

[[Page 361]]

    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44074, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9570  Halophenyl sulfonamide   salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
halophenyl sulfonamide salt (PMN P-90-1730) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 
and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (g) and (q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Recordkeeping requirements as 
specified at Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are 
applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 31970, July 20, 1992, as amended at 58 FR 29946, May 24, 1993; 58 
FR 34204, June 23, 1993]



Sec. 721.9575  Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl] propyl]azo]-2-naphthalenesulfonato(3-
          )]-, trisodium (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as chromate(3-), bis[3-
[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-
[(phenylamino)carbonyl] propyl]azo]-2-naphthalene sulfonato(3-)]-, 
trisodium (9CI) (PMN P-95-1575; CAS No. 119535-63-6) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9576  Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium 
          (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as chromate(3-), bis[7-
[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-
hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium (9CI) (PMN P-95-1576;

[[Page 362]]

CAS No. 118716-62-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9577  Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalene sulfonato (3-)]-,-[[5-

          (aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-hydroxy-
          1-[(phenylamino) carbonyl]-1-propenyl]azo]-2-
          naphthalenesulfonato(3-)]-, trisodium (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as chromate(3-), bis[7-
[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxy phenyl] azo]-
4-hydroxy-2-naphthalenesulfonato (3-)]-,-[[5-(aminosulfonyl) -2-
hydroxyphenyl]azo]-4-hydroxy-7-[[2-hydroxy-1-[(phenylamino) carbonyl]-1-
propenyl]azo]-2-naphthalene sulfonato(3-)]-, trisodium (9CI) (PMN P-95-
1577; CAS No. 118716-61-3) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9580  Ethyl methanesulfonate.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance ethyl methanesulfonate (CAS No. 62-50-0) is 
subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63518, Dec. 1, 1993]



Sec. 721.9595  Alkyl benzene sulfonic acids and alkyl sulfates, amine salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
benzene sulfonic acids and alkyl sulfates, amine salts (PMNs P-97-296/
297/298/299) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.

[[Page 363]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9620  Aromatic sulfonic acid compound with amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as aromatic 
sulfonic acid compound with amine (PMN P-93-832) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are: (i) Release to water. Requirements 
as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (where N = 30 
ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51709, Oct. 4, 1993]



Sec. 721.9630  Polyfluorosulfonic acid salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyfluorosulfonic acid salt (P-90-587) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(y) (1) and (2).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements are applicable to manufacturers, importers, and processors 
of this substance, as specified in Sec. 721.100 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[56 FR 15793, Apr. 17, 1991. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.9635  Terpene residue distillates.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as terpene 
residue distillates (PMN P-96-897) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 10).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9650  Tetramethylammonium salts of alkylbenzenesulfonic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tetramethylammonium salts of alkylbenzenesulfonic acid (PMN P-92-1364) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 80 ppb).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 364]]

(b), (c), and (k) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51687, Oct. 4, 1993]



Sec. 721.9656  Thiaalkanethiol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
thiaalkanethiol (PMN P-94-1487) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii)  [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45084, Aug. 30, 1995]



Sec. 721.9657  Disubstituted thiadiazole.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
disubstituted thiadiazole (PMN P-97-314) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (a),(b), (c), and (j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9658  Thiadiazole derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as a thiadiazole 
derivative (PMN P-94-1631) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (a), (c), (f), (v)(1), (w)(1), and (x)(1).
    (ii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where n = 90).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[60 FR 45085, Aug. 30, 1995]



Sec. 721.9659  Disubstituted thiadiazosulfone.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
disubstituted thiadiazosulfone (PMN P-97-304) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (a),(b), (c), and (j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 365]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3438, Jan. 22, 1998]



Sec. 721.9660  Methylthiouracil.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance methylthiouracil (CAS No. 56-04-2) is subject 
to reporting under this section for the significant new use described in 
paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63517, Dec. 1, 1993]



Sec. 721.9661  Diphenol tars (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as diphenol 
tars (PMN P-97-813) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9662  Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as thieno[3,4-b]-1,4-
dioxin, 2,3-dihydro- (9CI) (PMN P-95-1825; CAS No. 126213-50-1) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(2)(i).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(f).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3439, Jan. 22, 1998; 63 FR 9441, Feb. 25, 1998]



Sec. 721.9663  Poly(oxy-1,2-ethanediyl), alpha, alpha'-[thiobis (1-oxo-3,1-propanediyl)]bis [omega-hydroxy-,bis (C11-15 and 
          C11-15-isoalkyl) ethers.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), alpha, alpha'-[thiobis (1-oxo-3,1-propanediyl)]bis [omega-
hydroxy-,bis(C11-15 and C11-15-isoalkyl) ethers 
(PMN P-97-497; CAS No. 174254-18-3) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]

[[Page 366]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44582, Aug. 20, 1998]



Sec. 721.9664  9H-Thioxanthen-9-one,2,4-diethyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 9H-thioxanthen-9-
one,2,4-diethyl (PMN P-96-1315; CAS No. 82799-44-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3439, Jan. 22, 1998]



Sec. 721.9665  Organotin catalysts.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
organotin catalysts (PMNs P-93-853, P-93-854, P-93-855, P-93-856, P-93-
857, and P-93-858) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Industrial, commercial and 
consumer activities. Requirements as specified in Sec. 721.80 (v)(1), 
(v)(2), (w)(1), (w)(2), (x)(1), and (x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51709, Oct. 4, 1993]



Sec. 721.9668   Organotin lithium compound.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as an 
organotin lithium compound (PMN P-93-1119) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 9450, Feb. 25, 1998]



Sec. 721.9675  Titanate [Ti6 O13 (2-)], dipotassium.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as titanate 
[Ti6 O13 (2-)], dipotassium (CAS No. 12056-51-8) 
(PMN P-90-0226) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a),

[[Page 367]]

(b), (c), (d), (f), (g)(1)(ii), (g)(1)(vii), (g)(2)(ii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (f), (l), and (q). In addition, a 
significant new use of the substance is importation of the PMN substance 
if:
    (A) Manufactured by other than the method described in 
premanufacture notice P-90-226.
    (B) The bulk density measurements of the PMN substance in the pure 
form are less than 0.4 g/cm3 or greater than 0.6 g/
cm3. The bulk density of each shipment must be verified, by 
lot, prior to clearing U.S. customs.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this substance 
as specified in Sec. 721.125 (a), (b), (c), (f), (g), (h), and (i). In 
addition, records shall be kept identifying the foreign supplier and 
documenting, by lot, for each shipment, the method of manufacture and 
bulk density measurements.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[56 FR 40215, Aug. 13, 1991. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9680  Alkaline titania silica gel (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkaline titania silica gel (PMN P-95-529) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[61 FR 63740, Dec. 2, 1996]



Sec. 721.9685  Mixed trialkylamines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as mixed 
trialkylamines (PMNs P-97-943/944/945/946/947/948) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44583, Aug. 20, 1998]



Sec. 721.9700  Monosubstituted alkoxyaminotrazines (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance monosubstituted 
alkoxyaminotrazines (PMN P-86-1043) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(1)(i) of 
this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1) and (a)(3), (b) [concentration set at 0.1 percent], 
and (c).

[[Page 368]]

    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) [concentration set at 0.1 percent], (f), 
and (g)(1)(iv), (g)(1)(vii), and (g)(1)(viii), (g)(2)(i) and (g)(2)(v), 
(g)(4)(xi), and (g)(5). The provisions of Sec. 721.72(d) requiring 
employees to be provided with information on the location and 
availability of a written hazard communication program and MSDSs do not 
apply when the written program and MSDS are not required under 
Sec. 721.72 (a) and (c), respectively. The provision of Sec. 721.72(g) 
requiring placement of specific information on a MSDS does not apply 
when a MSDS is not required under Sec. 721.72(c).
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(k).
    (D) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) and (b)(1) and (b)(2).
    (E) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) [concern level of 10 ppb], (b)(4) [concern level of 10 ppb], and 
(c)(4) [concern level of 10 ppb].
    (ii) [Reserved]
    (2) The chemical substance monosubstituted alkoxyaminotrazines (PMN 
P-86-1044) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2)(i) of this section.
    (i) The significant new uses are:
    (A) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iii) through (a)(5)(vii), and 
(a)(6)(i), (b) [concentration set at 0.1 percent], and (c).
    (B) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (d), (e) [concentration set at 0.1 percent], (f), 
and (g)(1)(iv), (g)(1)(vii), and (g)(1)(viii), (g)(2)(i), (g)(2)(ii), 
(g)(2)(iv), and (g)(2)(v), (g)(4)(xi), and (5). The provisions of 
Sec. 721.72(d) requiring employees to be provided with information on 
the location and availability of a written hazard communication program 
and MSDSs do not apply when the written program and MSDS are not 
required under Sec. 721.72 (a) and (c), respectively. The provision of 
Sec. 721.72(g) requiring placement of specific information on a MSDS 
does not apply when a MSDS in not required under Sec. 721.72(c).
    (C) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(k).
    (D) Disposal. Requirements as specified in Sec. 721.85 (a)(1) and 
(a)(2) and (b)(1) and (b)(2).
    (E) Release to water. Requirements as specified in Sec. 721.90 
(a)(4) [concern level of 1 ppb], (b)(4) [concern level of 1 ppb], and 
(c)(4) [concern level of 1 ppb].
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26108, June 26, 1990. Redesignated and amended at 58 FR 29946, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9717  Azo monochloro triazine reactive dye.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an azo 
monochloro triazine reactive dye (PMN P-96-238) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (v)(2), (w)(2), and (x)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3439, Jan. 22, 1998]

[[Page 369]]



Sec. 721.9719  Tris carbamoyl triazine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as tris 
carbamoyl triazine (PMN P-95-1098) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 40).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable 
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[63 FR 44583, Aug. 20, 1998; 63 FR 62956, Nov. 10, 1998]



Sec. 721.9720  Disubstituted alkyl triazines (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
disubstituted alkyl triazines (PMNs P-85-932 and P-85-933) are subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(6)(i), (b) 
(concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b)(1), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), and 
(g)(2)(v). The provision of Sec. 721.72(d) requiring that employees be 
provided with information on the location and availability of MSDSs does 
not apply when an MSDS is not required under Sec. 721.72(c). The 
provision of Sec. 721.72(g) requiring placement of specific information 
on an MSDS does not apply when an MSDS is not required under 
Sec. 721.72(c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(g).
    (iv) Release to water. Sec. 721.90 (a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (i) and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[55 FR 26101, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.9730  1,3,5-Triazin-2-amine, 4-dimethylamino-6-substituted-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances generically identified as 1,3,5-
triazin-2-amine, 4-dimethylamino-6-substituted- (PMN Nos. P-92-343 and 
P-92-344) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (a)(4), 
(a)(5)(i), (a)(6)(i), (b) (concentration set at 0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), 
(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).

[[Page 370]]

    (iv) Disposal. Requirements as specified in Sec. 721.85 as thus 
amended: It is a significant new use to dispose of the process or use 
stream associated with any use of the substance or with any manner or 
method of manufacturing associated with any use of the substance by 
landfill.
    (v) Release to water. Requirements as specified in Sec. 721.90(a)(4) 
(where N = 1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[58 FR 32241, June 8, 1993, as amended at 58 FR 29946, May 24, 1993]



Sec. 721.9740  Brominated triazine derivative.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
brominated triazine derivative (PMN P-91-403) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(4), (a)(5)(iv), (a)(6)(i), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(2)(iv), and (g)(5). The 
hazard communication requirements do not apply when the chemical 
substance is present in a plastic, elastomer, rubber matrix, or in 
solution.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in section 721.80(q). Any amount of the PMN substance 
imported in a plastic, elastomer, rubber matrix, or in a solution, such 
that inhalation is precluded, shall not be included in the production 
limit calculations.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (d) and (f) through (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44075, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9750  2-Chloro-4,6-bis(substituted)-1,3,5-triazine, dihydrochloride.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
chloro-4,6-bis(substituted)-1,3,5-triazine, dihydrochloride (PMN P-91-
659) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 
and (g)(5). The following additional statements shall appear on each 
label and MSDS required by this paragraph: This substance may be toxic 
to terrestrial organisms and plants. Notice to users: Release to water 
restrictions apply.
    (ii) Disposal. Requirements as specified in Sec. 721.85. A 
significant new use of this substance is any release of this substance 
to land.
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 10 ppb).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a),

[[Page 371]]

(b), (c), (f), (g), (h), (j), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[59 FR 27485, May 27, 1994]



Sec. 721.9800  Poly(substituted triazinyl) piperazine (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance poly(substituted triazinyl) 
piperazine (PMN P-88-436) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec. 721.72 (b)(2), (c), (e) (concentration set at 1.0 percent), (f), 
(g)(1) (statement-health effects not fully determined), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), and (g)(5). The requirements of this paragraph 
shall not apply when the PMN substance is encapsulated in a polymeric 
matrix.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a) through (c), (g), and (h).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 32419, Aug. 9, 1990. Redesignated and amended at 58 FR 29946, 
29947, May 24, 1993; 58 FR 34204, June 23, 1993; 63 FR 45956, Aug. 28, 
1998]



Sec. 721.9820  Substituted triazole.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a 
substituted triazole (PMN P-90-1731) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (a)(4), 
(a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b) (concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(v), (g)(1)(vi), (g)(1)(vii), 
(g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), 
(g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (iv) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (where N = 12).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (k) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44075, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9825  Phenyl substituted triazolinones.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as phenyl 
substituted triazolinones (PMNs P-93-204, P-94-1870, P-94-1871, P-94-
1872, P-94-1873, and P-94-1874) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), 
(a)(5)(v), (a)(5)(vi), (a)(6)(i),

[[Page 372]]

(b) (concentration set at 1.0 percent), and (c). The imperviousness of 
the gloves selected pursuant to (a)(2)(i) of this section must be 
demonstrated by actual testing under (a)(3)(i) of this section and not 
by manufacturer specifications. In addition, there must be no permeation 
of the chemical substance greater than 15 g/day-cm2 
as a daily cumulative total when tested in accordance with the most 
current version of the American Society for Testing and Materials (ASTM) 
F739 ``Standard Test Method for Resistance of Protective Clothing 
Materials to Permeation by Liquids or Gases'' or ASTM F1383 ``Standard 
Test Method for Resistance of Protective Clothing Materials to 
Permeation by Liquids or Gases Under Conditions of Intermittent 
Contact.''
    (A) For conditions of exposure which are intermittent, gloves may be 
tested in accordance with the most current version of ASTM F1383 
``Standard Test Method for Resistance of Protective Clothing Materials 
to Permeation by Liquids or Gases Under Conditions of Intermittent 
Contact,'' provided the contact time in testing is greater than or equal 
to the expected duration of dermal contact, and the purge time used in 
the testing is less than or equal to the expected duration of non-
contact during the intermittent cycle of dermal exposure in the 
workplace. If ASTM F1383 is used for testing, the company must submit to 
the Agency a description of worker activities involving the chemical 
substance which includes daily frequencies and durations of potential 
worker exposures.
    (B) The results of all glove permeation testing must be reported in 
accordance with the most current version of (ASTM) F1194 ``Guide for 
Documenting the Results of Chemical Permeation Testing of Protective 
Clothing Materials.'' The company must submit all test data to the 
Agency and must receive written Agency approval for each type of glove 
tested prior to use of such gloves. Gloves must be discarded and 
replaced with such frequency as to ensure that they will reliably 
provide an impervious barrier to the chemical substances under normal 
and expected conditions of exposure within the work area. Gloves that 
have been damaged or are defective shall not be used. For PMNs P-94-1871 
through P-94-1874, EPA has approved North Safety Butyl Rubber gloves (32 
mils thick). For P-93-204 and P-94-1870, EPA has approved North Safety 
Butyl Rubber gloves (32 mils thick) only if used in combination with a 
chemical-resistant glove that has been demonstrated (EPA review not 
required) impermeable to the solvent, e.g., North Silvershield gloves 
and North 4H gloves.
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), 
(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 5 for all the chemical substances 
subject to the provisions of this rule combined). However, contrary to 
the requirements specified in Sec. 721.91, if the waste stream 
containing the chemical substances will be treated using activated 
carbon adsorption, then the amount of chemical substances reasonably 
likely to be removed from the waste stream by such treatment may be 
subtracted in calculating the number of kilograms released. No more than 
the following percent removal efficiencies may be attributed to such 
treatment for each PMN: P-93-204, 99 percent; P-94-1870, 98 percent; P-
94-1871, 97 percent; P-94-1872, 92 percent; P-94-1873, 90 percent; P-94-
1874, 73 percent.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (k) are 
applicable to manufacturers, importers, and processors of these 
substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3439, Jan. 22, 1998]



Sec. 721.9830  1-Tridecyn-3-ol, 3-methyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-tridecyn-3-ol, 3-
methyl (PMN P-96-236;

[[Page 373]]

CAS No. 100912-15-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Worker protection. Requirements as specified in Sec. 721.63 
(a)(1), (a)(2)(i), and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(f).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3440, Jan. 22, 1998]



Sec. 721.9840  Tungstate (W12(OH)2O386-) hexasodium (9CI).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tungstate 
(W12(OH)2O386-) hexasodium (9CI) (PMN P-96-1177; CAS No. 12141-67-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3440, Jan. 22, 1998]



Sec. 721.9850  2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-  bis[2,4,6-tris(1,1-dimethylethyl)phenoxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,4,8,10-tetraoxa-
3,9-diphosphaspiro[5.5]undecane, 3,9-bis[2,4,6-tris(1,1-
dimethylethyl)phenoxy]- (PMN P-91-65; CAS number 126505-35-9) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), 
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(vi), (g)(1)(ix), (g)(2)(i) through (v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. Requirements as specified in 
Sec. 721.125 (a) through (h) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[57 FR 44075, Sept. 23, 1992, as amended at 58 FR 29946, May 24, 1993; 
58 FR 34204, June 23, 1993]



Sec. 721.9892  Alkylated urea.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
alkylated urea (PMN P-93-1649) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:

[[Page 374]]

    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(iii), (g)(1)(ix), (g)(2)(i), (g)(2)(iii), (g)(2)(v), and 
(g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80 (l) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) through (i) are applicable to manufacturers, importers, 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.575(b)(1) apply to this section.

[60 FR 45085, Aug. 30, 1995]



Sec. 721.9900  Urea, condensate with poly[oxy(methyl-1,2-ethanediyl)]-- (2-aminomethylethyl)--(2-aminoethylethoxy) (generic name).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance urea, condensate with 
poly[oxy(methyl-1,2-ethanediyl)]--(2-aminomethylethyl)-
-(2-aminoethylethoxy) (PMN P-84-482) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance: Recordkeeping requirements specified in Sec. 721.125 (a), 
(b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this section.

[55 FR 26102, June 26, 1990. Redesignated and amended at 58 FR 29947, 
May 24, 1993; 58 FR 34204, June 23, 1993]



Sec. 721.9920  Urea, (hexahydro-6-methyl-2-oxopyrimidinyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance urea, (hexahydro-6-methyl-
2oxopyrimidinyl)- (PMN P-89-303) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(p) (level set at 1,975,000 and 2,200,000 kg).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), (c), and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this significant new use rule.

[55 FR 26102, June 26, 1990. Redesignated at 58 FR 29947, May 24, 1993, 
as amended at 58 FR 34204, June 23, 1993]



Sec. 721.9925  Aminoethylethylene urea methacrylamide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an 
aminoethylethylene urea methacrylamide (PMN P-89-1038) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are: (i) Industrial, commercial and 
consumer activities. Requirements as specified in Sec. 721.80(f).
    (ii) [Reserved]

[[Page 375]]

    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a) and (i) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[58 FR 51709, Oct. 4, 1993]



Sec. 721.9928  Urea, tetraethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as urea, tetraethyl- 
(PMN P-94-1017; CAS No. 1187-03-7) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(r) (445,000 kg) (a dermal developmental 
toxicity study in mice and rats and either a chromosome aberration assay 
in mice (40 CFR 798.5385) or a micronucleus assay in mice (40 CFR 
798.5395)). A person may not manufacture or import the substance beyond 
the following aggregate production volume limits, unless that person 
conducts the following corresponding studies on the substance and 
submits all final reports and underlying data in accordance with the 
procedures and criteria specified in paragraphs (a)(2)(i)(A), 
(a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) of this section.
    (A) Each study required to be performed pursuant to this section 
must be scientifically valid. Scientific valid means that the study was 
conducted according to:
    (1) The test guidelines specified in paragraph (a)(2)(i) of this 
section.
    (2) An EPA-approved protocol.
    (3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.
    (4) Using methodologies generally accepted at the time the study is 
initiated.
    (5) Any deviation from these requirements must be approved in 
writing by EPA.
    (B) Before starting to conduct any of the studies in paragraph 
(a)(2)(i) of this section, the person must obtain approval of test 
protocols from EPA by submitting written protocols. EPA will respond to 
the person within 4 weeks of receiving the written protocols. Published 
test guidelines specified in paragraph (a)(2)(i) of this section (e.g., 
40 CFR part 797 or part 798) provide general guidance for development of 
test protocols, but are not themselves acceptable protocols.
    (C) The person shall:
    (1) Conduct each study in good faith with due care.
    (2) Promptly furnish to EPA the results of any interim phase of each 
study.
    (3) Submit, in triplicate (with an additional sanitized copy, if 
confidential business information is involved), the final report of each 
study and all underlying data (``the report and data'') to EPA no later 
than 14 weeks prior to exceeding the applicable production volume limit. 
The final report shall contain the contents specified in 40 CFR 792.185.
    (D)(1) Except as described in paragraph (a)(2)(ii)(D)(2) of this 
section, if, within 6 weeks of EPA's receipt of a test report and data, 
the person receives written notice that EPA finds that the data 
generated by a study are scientifically invalid, the person is 
prohibited from further manufacture and import of the PMN substance 
beyond the applicable production volume limit.
    (2) The person may continue to manufacture and import the PMN 
substance beyond the applicable production limit only if so notified, in 
writing, by EPA in response to the person's compliance with either of 
the following paragraph (a)(2)(ii)(D)(2)(i) or (a)(2)(ii)(D)(2)(ii) of 
this section.
    (i) The person may reconduct the study. If there is sufficient time 
to reconduct the study and submit the report and data to EPA at least 14 
weeks before exceeding the production limit as required by paragraph 
(a)(2)(ii)(C)(3) of this section, the person shall comply with paragraph 
(a)(2)(ii)(C)(3) of this

[[Page 376]]

section. If there is insufficient time for the person to comply with 
paragraph (a)(2)(ii)(C)(3) of this section, the person may exceed the 
production limit and shall submit the report and data in triplicate to 
EPA within a reasonable period of time, all as specified by EPA in the 
notice described in paragraph (a)(2)(ii)(D)(1) of this section. EPA will 
respond to the person in writing, within 6 weeks of receiving the 
person's report and data.
    (ii) The person may, within 4 weeks of receiving from EPA the notice 
described in paragraph (a)(2)(ii)(D)(1) of this section, submit to EPA a 
written report refuting EPA's finding. EPA will respond to the person in 
writing, within 4 weeks of receiving the person's report.
    (E) The person is not required to conduct a study specified in 
paragraph (a)(2)(i) of this section if notified in writing by EPA that 
it is unnecessary to conduct that study.
    (iii) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 3440, Jan. 22, 1998]



Sec. 721.9930  Urethane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance urethane, CAS Number 51-79-6, is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Any use.
    (b) Special provisions. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Persons who must report. Section 721.5 applies to this section 
except for Sec. 721.5(a)(2). A person who intends to manufacture, 
import, or process for commercial purposes the substance identified in 
paragraph (a)(1) of this section and intends to distribute the substance 
in commerce must submit a significant new use notice.
    (2) [Reserved]

[51 FR 9453, Mar. 19, 1986. Redesignated at 53 FR 2845, Feb. 2, 1988. 
Further redesignated at 58 FR 29947, May 24, 1993, as amended at 58 FR 
34204, June 23, 1993]



Sec. 721.9957  N-Nitroso-N-methylurethane.

    (a) Chemical substance and significant new use subject to reporting. 
(1) The chemical substance N-nitroso-N-methylurethane (CAS No. 615-53-2) 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) The significant new use is: Manufacture, import, or processing 
of 10,000 pounds or more per year per facility for any use.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers, importers, and processors of this 
substance, as specified in Sec. 721.125 (a), (b), and (c).
    (2) [Reserved]

[58 FR 63518, Dec. 1, 1993]



Sec. 721.9969  3,6-Bis(dialkylamino) -9-[2-alkoxycarbonyl) phenyl]-xanthylium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 3,6-
bis(dialkylamino) -9-[2-alkoxycarbonyl) phenyl]-xanthylium salt (PMN P-
97-854) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80 (f) and (j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 377]]

    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44583, Aug. 20, 1998]



Sec. 721.9970  o-Xylene compound (generic name).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as an o-
xylene compound (PMN P-95-1030) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements as 
specified in Sec. 721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[61 FR 63740, Dec. 2, 1996]



Sec. 721.9973  Zirconium dichlorides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
zirconium dichlorides (PMNs P-97-179/181/189/769/775/781/782/783) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(4), (b)(4), and (c)(4) (N = 20).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in 
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[63 FR 44583, Aug. 20, 1998]



PART 723--PREMANUFACTURE NOTIFICATION EXEMPTIONS--Table of Contents




Subpart A  [Reserved]

                     Subpart B--Specific Exemptions

Sec.
723.50  Chemical substances manufactured in quantities of 10,000 
          kilograms or less per year, and chemical substances with low 
          environmental releases and human exposures.
723.175  Chemical substances used in or for the manufacture or 
          processing of instant photographic and peel-apart film 
          articles.
723.250  Polymers.

    Authority: 15 U.S.C. 2604.

Subpart A  [Reserved]



                     Subpart B--Specific Exemptions



Sec. 723.50  Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and 
          human exposures.

    (a) Purpose and scope. (1) This section grants an exemption from the 
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic 
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
    (i) Chemical substances manufactured in quantities of 10,000 
kilograms or less per year.
    (ii) Chemical substances with low environmental releases and human 
exposures.
    (2) To manufacture a new chemical substance under the terms of this 
exemption a manufacturer must:
    (i) Submit a notice of intent to manufacture 30 days before 
manufacture begins, as required under paragraph (e) of this section.

[[Page 378]]

    (ii) Comply with all other provisions of this section.
    (3) This section does not apply to microorganisms subject to part 
725 of this chapter.
    (b) Definitions. The following definitions apply to this subpart.
    (1) Act means the Toxic Substances Control Act (15 U.S.C. 2601 et 
seq).
    (2) Consumer means a private individual who uses a chemical 
substance or any product containing the chemical substance in or around 
a permanent or temporary household or residence, during recreation, or 
for any personal use or enjoyment.
    (3) Environment has the same meaning as in section 3 of the Act (15 
U.S.C. 2602).
    (4) Environmental transformation product means any chemical 
substance resulting from the action of environmental processes on a 
parent compound that changes the molecular identity of the parent 
compound.
    (5) Metabolite means a chemical entity produced by one or more 
enzymatic or nonenzymatic reactions as a result of exposure of an 
organism to a chemical substance.
    (6) Serious acute effects means human disease processes or other 
adverse effects that have short latency periods for development, result 
from short-term exposure, or are a combination of these factors and that 
are likely to result in death, severe or prolonged incapacitation, 
disfigurement, or severe or prolonged loss of the ability to use a 
normal bodily or intellectual function with a consequent impairment of 
normal activities.
    (7) Serious chronic effects means human disease processes or other 
adverse effects that have long latency periods for development, result 
from long-term exposure, are long-term illnesses, or are a combination 
of these factors and that are likely to result in death, severe or 
prolonged incapacitation, disfigurement, or severe or prolonged loss of 
the ability to use a normal bodily or intellectual function with a 
consequent impairment of normal activities.
    (8) Significant environmental effects means:
    (i) Any irreversible damage to biological, commercial, or 
agricultural resources of importance to society;
    (ii) Any reversible damage to biological, commercial, or 
agricultural resources of importance to society if the damage persists 
beyond a single generation of the damaged resource or beyond a single 
year; or
    (iii) Any known or reasonably anticipated loss of members of an 
endangered or threatened species. Endangered or threatened species are 
those species identified as such by the Secretary of the Interior in 
accordance with the Endangered Species Act, as amended (16 U.S.C. 1531).
    (9) Site means a contiguous property unit. Property divided only by 
a public right-of-way is one site. There may be more than one 
manufacturing plant on a single site.
    (10) The terms byproduct, EPA, importer, impurity, known to or 
reasonably ascertainable, manufacture, manufacturer, new chemical 
substance, person, possession or control, and test data have the same 
meanings as in Sec. 720.3 of this chapter.
    (c) Exemption categories. Except as provided in paragraph (d) of 
this section, this exemption applies to:
    (1) Any manufacturer of a new chemical substance manufactured in 
quantities of 10,000 kilograms or less per year under the terms of this 
exemption.
    (2) Any manufacturer of a new chemical substance satisfying all of 
the following low environmental release and low human exposure 
eligibility criteria:
    (i) Consumers and the general population. For exposure of consumers 
and the general population to the new chemical substance during all 
manufacturing, processing, distribution in commerce, use, and disposal 
of the substance:
    (A) No dermal exposure.
    (B) No inhalation exposure (except as described in paragraph 
(c)(2)(iv) of this section.
    (C) Exposure in drinking water no greater than a 1 milligram per 
year (estimated average dosage resulting from drinking water exposure in 
streams from the maximum allowable concentration level from ambient 
surface

[[Page 379]]

water releases established under paragraph (c)(2)(iii) of this section 
or a higher concentration authorized by EPA under paragraph (c)(2)(iii) 
of this section).
    (ii) Workers. For exposure of workers to the new chemical substance 
during all manufacturing, processing, distribution in commerce, use and 
disposal of the substance:
    (A) No dermal exposure (this criterion is met if adequate dermal 
exposure controls are used in accordance with applicable EPA guidance).
    (B) No inhalation exposure (this criterion is considered to be met 
if adequate inhalation exposure controls are used in accordance with 
applicable EPA guidance).
    (iii) Ambient surface water. For ambient surface water releases, no 
releases resulting in surface water concentrations above 1 part per 
billion, calculated using the methods prescribed in Secs. 721.90 and 
721.91, unless EPA has approved a higher surface water concentration 
supported by relevant and scientifically valid data submitted to EPA in 
a notice under paragraph (e) of this section on the substance or a close 
structural analogue of the substance which demonstrates that the new 
substance will not present an unreasonable risk of injury to aquatic 
species or human health at the higher concentration.
    (iv) Incineration. For ambient air releases from incineration, no 
releases of the new chemical substance above 1 microgram per cubic meter 
maximum annual average concentration, calculated using the formula:

    (kg/day of release after treatment) multiplied by (number of release 
days per year) multiplied by (9.68  x  10-6) micrograms per 
cubic meter.

    (v) Land or groundwater. For releases to land or groundwater, no 
releases to groundwater, to land, or to a landfill unless the 
manufacturer has demonstrated to EPA's satisfaction in a notice under 
paragraph (e) of this section that the new substance has negligible 
groundwater migration potential.
    (d) Chemical substances that cannot be manufactured under this 
exemption. A new chemical substance cannot be manufactured under this 
section, notwithstanding satisfaction of the criterion of paragraphs 
(c)(1) or (c)(2) of this section, if EPA determines, in accordance with 
paragraph (g) of this section, that the substance, any reasonably 
anticipated metabolites, environmental transformation products, or 
byproducts of the substance, or any reasonably anticipated impurities in 
the substance may cause, under anticipated conditions of manufacture, 
processing, distribution in commerce, use, or disposal of the new 
chemical substance:
    (1) Serious acute (lethal or sublethal) effects.
    (2) Serious chronic (including carcinogenic and teratogenic) 
effects.
    (3) Significant environmental effects.
    (e) Exemption notice. (1) A manufacturer applying for an exemption 
under either paragraph (c)(1) or (c)(2) of this section must submit an 
exemption notice to the EPA at least 30 days before manufacture of the 
new chemical substance begins. The notice must be sent in writing to: 
TSCA Document Control Officer (7407), Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., 
SW., Washington, DC 20460. The date of submission will be the date on 
which the notice is received by the TSCA Document Control Officer. EPA 
will acknowledge the receipt of the notice by letter. The letter will 
identify the date on which the review period begins. The notice shall be 
submitted using EPA Form No. 7710-25 (``the PMN form''), which may be 
obtained from EPA by writing the Environmental Assistance Division, 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC. 20460, or by calling 
the TSCA Assistance Information Service at (202) 554-1404; TDD (202) 
554-0551; online service modem (202) 554-5603.
    (2) The notice shall contain the information described below, 
pursuant to the referenced provisions of Sec. 720.45.
    (i) Manufacturer identity.
    (ii) Chemical identity (Sec. 720.45(a)).
    (iii) Impurities (Sec. 720.45(b)).
    (iv) Known synonyms or trade names (Sec. 720.45(c)).
    (v) Byproducts (Sec. 720.45(d)).

[[Page 380]]

    (vi) Production volume (Sec. 720.45(e)). (A) Manufacturers 
submitting an exemption application under paragraph (c)(1) of this 
section will be assumed to be manufacturing at an annual production 
volume of 10,000 kilograms. Manufacturers who intend to manufacture an 
exempted substance at annual volumes of less than 10,000 kilograms and 
wish EPA to conduct its risk assessment based upon such lesser annual 
production level rather than a 10,000-kilograms level, may so specify by 
writing the lesser annual production volume in the appropriate box on 
the PMN form and marking the adjacent binding option box. Manufacturers 
who opt to specify annual production levels below 10,000 kilograms and 
who mark the production volume binding option box shall not manufacture 
more than the specific annual amount of the exempted substance unless a 
new exemption notice for a higher (up to 10,000 kgs) manufacturing 
volume is submitted and approved pursuant to this section.
    (B) Manufacturers submitting an exemption under paragraph (c)(2) of 
this section shall list the estimated maximum amount to be manufactured 
during the first year of production and the estimated maximum amount to 
be manufactured during any 12-month period during the first 3 years of 
production.
    (vii) Description of intended categories of use (Sec. 720.45(f)).
    (viii) For manufacturer-controlled sites, the manufacturer shall 
supply identity of manufacturing sites, process descriptions, and worker 
exposure and environmental release information (Sec. 720.45(g)); for 
sites not controlled by the manufacturer, processing and use operation 
descriptions, estimated number of processing and use sites, and worker 
exposure/environmental release information (Sec. 720.45(h)). A 
manufacturer applying for an exemption under paragraph (c)(1) of this 
section need not provide information on worker exposure and 
environmental release referenced in paragraphs (e)(2)(viii) of this 
section if such information is not known or not readily available to the 
manufacturer. To assist in reporting this information, manufacturers may 
obtain a copy of EPA's Guidance for Reporting Occupational Exposure and 
Environmental Release Information under 40 CFR 723.50, available from 
the Environmental Assistance Division at the address listed in paragraph 
(e)(1) of this section. Where worker exposure and environmental release 
information is not supplied by the manufacturer, EPA will generally 
apply ``bounding estimates'' (i.e., exposure estimates higher than those 
incurred by persons in the population with the highest exposure) to 
account for uncertainties in actual exposure and release scenarios.
    (ix) Type and category of notice. The manufacturer must clearly 
indicate on the first page of the PMN form that the submission is a 
``TSCA section 5(h)(4) exemption notice,'' and must indicate whether the 
notice is being submitted under paragraph (c)(1) or (c)(2) of this 
section. Manufacturers of chemical substances that qualify for an 
exemption under both paragraph (c)(1) and (c)(2) of this section may 
apply for either exemption, but not both.
    (x) Test data (Sec. 720.50).
    (xi) Certification. In addition to the certifications required in 
EPA form 7710-25, the following certifications shall be included in 
notices under this section. The manufacturer must certify that:
    (A) The manufacturer intends to manufacture or import the new 
chemical substance for commercial purposes, other than in small 
quantities solely for research and development, under the terms of this 
section.
    (B) The manufacturer is familiar with the terms of this section and 
will comply with those terms.
    (C) The new chemical substance for which the notice is submitted 
meets all applicable exemption conditions.
    (D) For substances manufactured under paragraph (c)(1) of this 
section, the manufacturer intends to commence manufacture of the 
exempted substance for commercial purposes within 1 year of the date of 
the expiration of the 30-day review period.
    (xii) Sanitized copy of notice. (A) The manufacturer must make all 
claims of confidentiality in accordance with paragraph (l) of this 
section. If any information is claimed confidential, the manufacturer 
must submit a second copy of the notice, with all information

[[Page 381]]

claimed as confidential deleted, in accordance with paragraph (l)(3) of 
this section.
    (B) If the manufacturer does not provide the second copy, the 
submission will be considered incomplete.
    (3) Incomplete notices. If EPA receives a submission which does not 
include all of the information required under this paragraph (e) of this 
section, the submission will be determined to be incomplete by EPA. When 
a submission for a new chemical substance has been determined to be 
incomplete, a manufacturer reapplying for an exemption for the new 
chemical substance must submit a new exemption notice containing all the 
information required under this paragraph (e) of this section including 
a certification page containing an original dated signature; partial 
submissions sent to EPA to supplement notices declared incomplete will 
not be accepted. Photocopied pages from previously submitted exemption 
forms will be accepted provided that the certifications page contains an 
original dated signature.
    (f) Multiple exemption holders. (1) A manufacturer who intends to 
manufacture a substance for which an exemption under this section was 
previously approved may apply for an exemption under paragraph (c)(1) or 
(c)(2) of this section; however, EPA will not approve any subsequent 
exemption application under paragraph (c)(1) of this section unless it 
can determine that the potential human exposure to, and environmental 
release of, the new chemical substance at the higher aggregate 
production volume will not present an unreasonable risk of injury to 
human health or the environment.
    (2)(i) If EPA proposes to deny an exemption application for a 
substance for which another manufacturer currently holds an exemption, 
and that proposed denial is based exclusively on the cumulative human 
exposure or environmental release of the substance which precludes the 
EPA from determining that the subsequent applicant's activities will not 
present an unreasonable risk of injury to human health or the 
environment, the EPA will notify the first exemption holder that it 
must, within 21 days of its receipt of EPA's notice, either:
    (A) Provide a new certification that it has commenced, or that it 
will commence, manufacture of the new chemical substance under this 
section within 1 year of the expiration of its exemption review period; 
or
    (B) Withdraw its exemption for the new chemical substance.
    (ii) If the first exemption holder does not respond to the EPA's 
notice under paragraph (f)(2)(i) of this section within the prescribed 
time period, EPA shall issue a notice of ineligibility to the first 
exemption holder under the provisions of paragraph (h)(2) of this 
section.
    (g) Review period. (1) EPA will review the notice submitted under 
paragraph (e) of this section to determine whether manufacture of the 
new chemical substance is eligible for the exemption. The review period 
will end 30 days after receipt of the notice by the TSCA Document 
Control Officer. To provide additional time to address any unresolved 
issues concerning an exemption application, the exemption applicant may, 
at any time during the review period, request a suspension of the review 
period pursuant to the provisions of Sec. 720.75(b) of this chapter.
    (2) Upon expiration of the 30-day review period, if EPA has taken no 
action, the manufacturer may consider its exemption approved and begin 
to manufacture the new chemical substance under the terms described in 
its notice and in this section.
    (h) Notice of ineligibility--(1) During the review period. If the 
EPA determines during the review period that manufacture of the new 
chemical substance does not meet the terms of this section or that there 
are issues concerning toxicity or exposure that require further review 
which cannot be accomplished within the 30-day review period, EPA will 
notify the manufacturer by telephone that the substance is not eligible. 
This telephone notification will subsequently be confirmed by certified 
letter that identifies the reasons for the ineligibility determination. 
The manufacturer may not begin manufacture of the new chemical substance 
without complying with section 5(a)(1) of the Act or submitting a new 
notice under paragraph (e) of this section that satisfies EPA's 
concerns.

[[Page 382]]

    (2) After the review period. (i)(A) If at any time after the review 
period specified in paragraph (g) of this section the Assistant 
Administrator for the Office of Prevention, Pesticides, and Toxic 
Substances (``the Assistant Administrator'') makes a preliminary 
determination that manufacture of the new chemical substance does not 
meet the terms of this section, the Assistant Administrator will notify 
the manufacturer by certified letter that EPA believes that the new 
chemical substance does not meet the terms of the section.
    (B) The manufacturer may continue to manufacture, process, 
distribute in commerce, and use the substance after receiving the notice 
under paragraph (h)(2)(i)(A) of this section if the manufacturer was 
manufacturing, processing, distributing in commerce, or using the 
substance at the time of the notification and if the manufacturer 
submits objections or an explanation under paragraph (h)(2)(ii) of this 
section. Manufacturers not manufacturing, processing, distributing in 
commerce, or using the substance at the time of the notification may not 
begin manufacture until EPA makes its final determination under 
paragraph (h)(2)(iii) of this section.
    (ii) A manufacturer who has received notice under paragraph 
(h)(2)(i)(A) of this section may submit, within 15 days of receipt of 
written notification, detailed objections to the determination or an 
explanation of its diligence and good faith efforts in attempting to 
comply with the terms of this section.
    (iii) The Assistant Administrator will consider any objections or 
explanation submitted under paragraph (h)(2)(ii) of this section and 
will make a final determination. The Assistant Administrator will notify 
the manufacturer of the final determination by telephone within 15 days 
of receipt of the objections or explanation, and subsequently by 
certified letter.
    (iv) If the Assistant Administrator determines that manufacture of 
the new chemical substance meets the terms of this section, the 
manufacturer may continue or resume manufacture, processing, 
distribution in commerce, and use in accordance with the terms of this 
section.
    (v) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer did not act with due diligence and in good faith 
to meet the terms of this section, the manufacturer must cease any 
continuing manufacture, processing, distribution in commerce, and use of 
the new chemical substance within 7 days of the written notification 
under paragraph (h)(2)(iii) of this section. The manufacturer may not 
resume manufacture, processing, distribution in commerce, and use of the 
new chemical substance until it submits a notice under section 5(a)(1) 
of the Act and part 720 of this chapter and the notice review period has 
ended.
    (vi) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer acted with due diligence and in good faith to meet 
the terms of this section, the manufacturer may continue manufacture, 
processing, distribution in commerce, and use of the new chemical 
substance if:
    (A) It was actually manufacturing, processing, distributing in 
commerce, or using the chemical substance at the time it received the 
notification specified in paragraph (h)(2)(i)(A) of this section.
    (B) It submits a notice on the new chemical substance under section 
5(a)(1) of the Act and part 720 of this chapter within 15 days of 
receipt of the written notification under paragraph (h)(2)(iii) of this 
section. Such manufacture, processing, distribution in commerce, and use 
may continue unless EPA takes action under section 5(e) or 5(f) of the 
Act.
    (3) Action under this paragraph does not preclude action under 
sections 7, 15, 16, or 17 of the Act.
    (i) Additional information. If the manufacturer of a new chemical 
substance under the terms of this exemption obtains test data or other 
information indicating that the new chemical substance may not qualify 
under terms of this section, the manufacturer must submit these data or 
information to EPA within 15 working days of receipt

[[Page 383]]

of the information. If, during the notice review period specified in 
paragraph (g) of this section, the submitter obtains possession, 
control, or knowledge of new information that materially adds to, 
changes, or otherwise makes significantly more complete the information 
included in the notice, the submitter must send that information to the 
address listed on the notice form within 10 days of receiving the new 
information, but no later than 5 days before the end of the notice 
review period. The new submission must clearly identify the submitter 
and the exemption notice to which the new information is related. If the 
new information becomes available during the last 5 days of the notice 
review period, the submitter must immediately inform its EPA contact for 
that notice by telephone.
    (j) Changes in manufacturing site, use, human exposure and 
environmental release controls, and certain manufacturing volumes. (1) 
Except as provided in paragraph (j)(6) of this section, chemical 
substances manufactured under this section must be manufactured at the 
site or sites described, for the uses described, and under the human 
exposure and environmental release controls described in the exemption 
notice under paragraph (e) of this section.
    (2) Where the manufacturer lists a specific physical form in which 
the new chemical substance will be manufactured, processed, and/or used, 
the manufacturer must continue manufacturing, processing, and/or using 
the new chemical substance in either the same physical form described in 
the notice under paragraph (e), or in a physical form which will not 
increase the human exposure to or environmental release of the new 
chemical substance over those exposures or releases resulting from the 
specified physical form (e.g., a manufacturer which specifies that the 
new chemical substance will be produced in a non-volatile liquid form 
generally may not change to a respirable powder form).
    (3) The annual production volume of chemical substances manufactured 
under paragraph (c)(1) of this section for which the manufacturer 
designated a binding annual production volume pursuant to paragraph 
(e)(2)(vi) of this section must not exceed that designated volume.
    (4) Any person who manufactures a new chemical substance under 
paragraph (c)(1) or (c)(2) of this section must comply with the 
provisions of this section, including submission of a new notice under 
paragraph (e) of this section, before:
    (i) Manufacturing the new chemical substance at a site that was not 
approved in a previous exemption notice for the substance, except as 
provided in paragraph (j)(6) of this section.
    (ii) Manufacturing the new chemical substance for a use that was not 
approved in a previous exemption notice for the substance.
    (iii) Manufacturing the new chemical substance without employing the 
human exposure and environmental release controls approved in a previous 
exemption notice for the substance.
    (iv) Manufacturing the new chemical substance in a physical form 
different than that physical form approved in a previous exemption 
notice for the substance and which form may increase the human exposure 
to, or environmental release of, the new chemical substance over those 
exposures or releases resulting from the physical form approved in the 
previous notice.
    (v) Manufacturing the chemical substance in annual production 
volumes above any volume designated by the manufacturer as binding under 
paragraph (e)(2)(vi) of this section in a previous exemption notice for 
the substance.
    (5) In an exemption notice informing EPA of a change in site, use, 
or worker protection, or environmental release controls, the 
manufacturer is not required to provide all of the same information 
submitted to EPA in a previous exemption notice for that chemical 
substance. The new exemption notice, however, must indicate the identity 
of the new chemical substance; the manufacturer's name; the name and 
telephone number of a technical contact; and location of the new site, 
new worker protection or environmental release controls, and new use 
information. The notice must also include the EPA-designated exemption 
number assigned to

[[Page 384]]

the previous notice and a new certification by the manufacturer, as 
described in paragraph (e)(2)(xi) of this section.
    (6)(i) A manufacturer may, without submitting a new notice, 
manufacture the new chemical substance at a site not listed in its 
exemption application under the following conditions:
    (A) the magnitude, frequency, and duration of exposure of individual 
workers to the new chemical substance at the new manufacturing site is 
equal to, or less than, the magnitude, frequency, and duration of 
exposure of the individual workers to the new chemical substance at the 
manufacturing site for which the EPA performed its original risk-
assessment pursuant to the original exemption notice; and
    (B) Either (1) at the new manufacturing site, the manufacturer does 
not release to surface waters any of the new chemical substance, or any 
waste streams containing the new chemical substance; or (2) at the new 
manufacturing site, the manufacturer maintains surface water 
concentrations of the chemical substance, resulting from direct or 
indirect discharges from the manufacturing site, at or below 1 part per 
billion, or at or below an alternative concentration level approved by 
the Agency in writing or under the procedures described in paragraph 
(c)(2)(iii) of this section, using the water concentration calculation 
method described at Secs. 721.90 and 721.91.
    (ii) The manufacturer shall notify EPA of any new manufacturing site 
no later than 30 days after the commencement of manufacture of the new 
chemical substance under the exemption at the new manufacturing site as 
follows:
    (A) The notification must contain the EPA-designated exemption 
number to which the notification applies, manufacturer identity, the 
street address of the new manufacturing site, the date on which 
manufacture commenced at the new site, the name and telephone number of 
a technical contact at the new site, any claim of confidentiality, and a 
statement that the notification is an amendment to the original 
exemption application under the terms of this section.
    (B) The notification may be submitted on EPA form 7710-56 ``Notice 
of Commencement of Manufacture;'' however, the manufacturer must add the 
statement required under paragraph (j)(6)(ii)(A) of this section that 
the notification is an amendment to the original exemption.
    (C) The notification must contain an original signature of an 
authorized official of the manufacturer.
    (k) Customer notification. (1) Manufacturers of new chemical 
substances described in paragraphs (c)(1) and (c)(2) of this section 
must notify processors and industrial users that the substance can be 
used only for the uses specified in the exemption notice at paragraph 
(e) of this section. The manufacturer must also inform processors and 
industrial users of any controls specified in the exemption notice. The 
manufacturer may notify processors and industrial users by means of a 
container labeling system, written notification, or any other method 
that adequately informs them of use restrictions or controls.
    (2) A manufacturer of a new chemical substance described in 
paragraph (c)(2) of this section may distribute the chemical substance 
only to other persons who agree in writing to not further distribute the 
substance until it has been reacted, incorporated into an article, or 
otherwise rendered into a physical form or state in which environmental 
releases and human exposures above the eligibility criteria in paragraph 
(c)(2) of this section are not likely to occur.
    (3) If the manufacturer learns that a direct or indirect customer is 
processing or using the new substance in violation of use restrictions 
or without imposing prescribed worker protection or environmental 
release controls, the manufacturer must cease distribution of the 
substance to the customer or the customer's supplier immediately unless 
the manufacturer is able to document each of the following:
    (i) That the manufacturer has, within 5 working days, notified the 
customer in writing that the customer has failed to comply with the 
conditions specified in this section and the exemption notice under 
paragraph (e) of this section.
    (ii) That, within 15 working days of notifying the customer of the 
noncompliance, the manufacturer received

[[Page 385]]

from the customer, in writing, a statement of assurance that the 
customer is aware of the terms of this section and the exemption notice 
and will comply with those terms.
    (4) If, after receiving a statement of assurance from a customer 
under paragraph (k)(3)(ii) of this section, the manufacturer obtains 
knowledge that the customer has again failed to comply with any of the 
conditions specified in this section or the exemption notice, the 
manufacturer shall cease supplying the new chemical substance to that 
customer and shall report the failure to comply to EPA within 15 days of 
obtaining this knowledge. Within 30 days of its receipt of the report, 
EPA will notify the manufacturer whether, and under what conditions, 
distribution of the chemical substance to the customer may resume.
    (l) Confidentiality. (1) If the manufacturer submits information to 
EPA under this section which the manufacturer claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to EPA by bracketing, circling, or 
underlining it and stamping it with ``CONFIDENTIAL'' or some other 
appropriate designation. Any information so identified will be treated 
in accordance with the procedures in part 2 of this chapter. Any 
information not claimed confidential at the time of submission may be 
made available to the public without further notice.
    (2)(i) Any person who asserts a claim of confidentiality for 
chemical identity under this paragraph (l) must provide a generic 
chemical name that is only as generic as necessary to protect the 
confidential chemical identity of the particular chemical substance. The 
name should reveal the specific chemical identity to the maximum extent 
possible.
    (ii) The generic name provided by the manufacturer will be subject 
to EPA review and approval in accordance with the procedures specified 
in Sec. 720.85(b)(6) of this chapter. The generic name provided by the 
submitter or an alternative selected by EPA under these procedures will 
be placed on a public list of substances exempt under this section.
    (3) If any information is claimed confidential, the manufacturer 
must submit a second copy of the notice with all information claimed as 
confidential deleted. EPA will place the second copy in the public file.
    (m) Exemptions granted under superseded regulations. Manufacturers 
holding exemptions granted under the superseded requirements of this 
section (as in effect on May 26, 1995) shall either continue to comply 
with those requirements (including the production volume limit) or apply 
for a new exemption pursuant to this section. EPA will not accept 
requests to amend exemptions granted under the superseded requirements; 
manufacturers wishing to amend such exemptions must submit a new 
exemption under paragraph (e) of this section. If a new exemption for a 
new chemical substance is granted under this exemption to the 
manufacturer holding an exemption under the superseded requirements, the 
exemption under the superseded requirements for such substance shall be 
void.
    (n) Recordkeeping. (1) A manufacturer of a new chemical substance 
under paragraph (c) of this section must maintain the records described 
in this paragraph at the manufacturing site or site of importation for a 
period of 5 years after their preparation.
    (2) The records must include the following to demonstrate compliance 
with this section:
    (i) Records of annual production volume and import volume.
    (ii) Records documenting compliance with the applicable requirements 
and restrictions of paragraphs (c), (e), (f), (h), (i), (j), and (k) of 
this section.
    (3) Any person who manufactures a new chemical substance under the 
terms of this section must, upon request of a duly designated 
representative of EPA, permit such person at all reasonable times to 
have access to and to copy records kept under paragraph (n)(2) of this 
section.
     (4) The manufacturer must submit the records listed in paragraph 
(n)(2) of this section to EPA upon request. Manufacturers must provide 
these records within 15 working days of receipt of such request.
    (o) Compliance. (1) Failure to comply with any provision of this 
section is a

[[Page 386]]

violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this section is a 
violation of this section and therefore a violation of section 15 of the 
Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture or processing of a 
chemical substance in violation of this section, or act to seize any 
chemical substance manufactured or processed in violation of this 
section, or take other action under the authority of section 7 of the 
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 1616).

[60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62 
FR 17932, April 11, 1997; 64 FR 31989, June 15, 1999]



Sec. 723.175  Chemical substances used in or for the manufacture or processing of instant photographic and peel-apart film articles.

    (a) Purpose and scope. (1) This section grants an exemption from the 
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic 
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture and 
processing of new chemical substances used in or for the manufacture or 
processing of instant photographic and peel-apart film articles. This 
section does not apply to microorganisms subject to part 725 of this 
chapter.
    (2) To manufacture a new chemical substance under the terms of this 
exemption, a manufacturer of instant photographic or peel-apart film 
articles must:
    (i) Submit an exemption notice when manufacture begins under 
paragraph (i) of this section.
    (ii) Comply with certain requirements to limit exposure to the new 
chemical substance under paragraphs (e), (f), (g), and (h) of this 
section.
    (iii) Comply with all recordkeeping requirements under paragraph (j) 
of this section.
    (b) Definitions. (1) Act means the Toxic Substances Control Act (15 
U.S.C. 2601 et seq.).
    (2) An article is a manufactured item (i) which is formed to a 
specific shape or design during manufacture, (ii) which has end use 
function(s) dependent in whole or in part upon its shape or design 
during end use, and (iii) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the article and 
that may occur as described in Sec. 710.2 of this chapter except that 
fluids and particles are not considered articles regardless of shape or 
design.
    (3) The term byproduct, EPA, impurities, person, and site have the 
same meanings as in Sec. 710.2 of this chapter.
    (4) The term category of chemical substances has the same meaning as 
in section 26(c)(2) of the Act (15 U.S.C. 2625).
    (5) The terms chemical substance, distribute in commerce, 
distribution in commerce, environment, manufacture, new chemical 
substance, and process have the same meanings as in section 3 of the Act 
(15 U.S.C. 2602).
    (6) Director of the Office of Pollution Prevention and Toxics means 
the Director of the EPA Office of Pollution Prevention and Toxics or any 
EPA employee designated by the Office Director to carry out the Office 
Director's functions under this section.
    (7) The term exemption category means a category of chemical 
substances for which a person(s) has applied for or been granted an 
exemption under section 5(h)(4) of the Act (15 U.S.C. 2604).
    (8) The term instant photographic film article means a self-
developing photographic film article designed so that all the chemical 
substances contained in the article, including the chemical substances 
required to process the film, remain sealed during distribution and use.
    (9) Intermediate means any chemical substance which is consumed in 
whole or in part in a chemical reaction(s) used for the intentional 
manufacture of another chemical substance.
    (10) Known to or reasonably ascertainable means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to

[[Page 387]]

possess, control, or know, our could obtain without unreasonable burden 
or cost.
    (11) The term peel-apart film article means a self-developing 
photographic film article consisting of a positive image receiving 
sheet, a light sensitive negative sheet, and a sealed reagent pod 
containing a developer reagent and designed so that all the chemical 
substances required to develop or process the film will not remain 
sealed within the article during and after the development of the film.
    (12) Photographic article means any article which will become a 
component of an instant photographic or peel-apart film article.
    (13) Special production area means a demarcated area within which 
all manufacturing, processing, and use of a new chemical substance takes 
place, except as provided in paragraph (f) of this section, in 
accordance with the requirements of paragraph (e) of this section.
    (14) Test data means:
    (i) Data from a formal or informal study, test, experiment, recorded 
observation, monitoring, or measurement.
    (ii) Information concerning the objectives, experimental methods and 
materials, protocols, results, data analyses (including risk 
assessments), and conclusions from a study, test, experiment, recorded 
observation, monitoring, or measurement.
    (15) Used in or for the manufacturing or processing of an instant 
photographic or peel-apart film article, when used to describe 
activities involving a new chemical substance, means the new chemical 
substance (i) is included in the article, or (ii) is an intermediate to 
a chemical substance included in the article or is one of a series of 
intermediates used to manufacture a chemical substance included in the 
article.
    (16) Wet mixture means a water or organic solvent-based suspension, 
solution, dispersion, or emulsion used in the manufacture of an instant 
photographic or peel-apart film article.
    (c) Exemption category. The exemption category includes new chemical 
substances used in or for the manufacture or processing of instant 
photographic or peel-apart film articles which are manufactured and 
processed under the terms of this section.
    (d) Applicability. This exemption applies only to manufacturers of 
instant photographic or peel-apart film articles who:
    (1) Manufacture the new chemical substances used in or for the 
manufacture or processing of the instant photographic or peel-apart film 
articles.
    (2) Limit manufacture and processing of a new chemical substance to 
the site(s) listed in the exemption notice for that new chemical 
substance submitted under paragraph (i) of this section.
    (3) Comply with the requirements of paragraphs (e), (f), (g), (h), 
and (j) of this section.
    (4) Do not distribute in commerce or use a peel-apart film article 
containing a new chemical substance until submission of a premanufacture 
notice under section 5(a)(1)(A) of the Act (15 U.S.C. 2604) and until 
the review period for the notice has ended without EPA action to prevent 
distribution or use.
    (e) Conditions of manufacture and processing in the special 
production area. All manufacturing, processing, and use operations 
involving the new chemical substance must be performed in a special 
production area under the conditions set forth in this paragraph until 
the new chemical substance has been incorporated into a wet mixture, 
photographic article, or instant photographic or peel-apart film 
article.
    (1) Exposure limits. In the special production area, the ambient air 
concentration of the new chemical substance during manufacture, 
processing, and use cannot exceed an 8-hour time weighted average (TWA) 
of 10 ppm for gases and vapors and 50 g/m3for 
particulates, with an allowable TWA excursion of 50 percent above those 
concentrations for a duration of 30 minutes or less.
    (2) Respiratory protection--(i) Respirator requirement. Except as 
specified in paragraph (e)(2)(ii) of this section, each person in the 
special production area must wear an appropriate respiratory protection 
device to protect against dusts, fumes, vapors, and other airborne 
contaminants, as described in

[[Page 388]]

29 CFR 1910.134. Selection of an appropriate respirator must be made 
according to the guidance of American National Standard Practices for 
Respiratory Protection Z88.2-1969 and the NIOSH Certified Equipment 
List, U.S. Department of Health and Human Services, NIOSH publication 
No. 80-144.
    (ii) Waiver of respirator requirement. Employees are not required to 
wear respirators if monitoring information collected and analyzed in 
accordance with paragraph (e)(3) of this section demonstrates that the 
ambient 8-hour TWA concentration of the new chemical substance in the 
area is less than 1 ppm for gases and vapors and 5 g/
m3for particulates with an allowable TWA excursion of 50 
percent above these concentrations for a duration of 30 minutes or less.
    (iii) Quantitative fit test. Each respirator must be issued to a 
specific individual for personal use. A quantitative fit test must be 
performed for each respirator before its first use by that person in a 
special production area.
    (3) Monitoring--(i) When to monitor. (A) When suitable sampling and 
analytic methods exist, periodic monitoring in accordance with this 
paragraph must be done to ensure compliance with the exposure limits of 
paragraphs (e)(1) and (2)(ii) of this section.
    (B) When suitable sampling and analytic methods do not exist, 
compliance with the exposure limits of paragraph (e)(1) and the 
requirements of paragraph (e)(10) of this section must be determined by 
an evaluation of monitoring data developed for a surrogate chemical 
substance possessing comparable physical-chemical properties under 
similar manufacturing and processing conditions.
    (ii) Monitoring methods. A suitable air sampling method must permit 
personal or fixed location sampling by conventional collection methods. 
A suitable analytic method must have adequate sensitivity for the volume 
of sample available and be specific for the new chemical substance being 
monitored. If chemical-specific monitoring methods are not available, 
nonspecific methods may be used if the concentration of the new chemical 
substance is assumed to be the total concentration of chemical 
substances monitored.
    (iii) Monitoring frequency. (A) When suitable air sampling and 
analytical procedures are available, monitoring must be done in each 
special production area during the first three 8-hour work shifts 
involving the manufacture or processing of each new chemical substance. 
Thereafter, monitoring must be done in each special production area for 
at least one 8-hour period per month, during a production run in which 
the new chemical substance is manufactured or processed. Samples must be 
of such frequency and pattern as to represent with reasonable accuracy 
the mean level and maximum 30-minute level of employee exposure during 
an 8-hour work shift. In monitoring for an 8-hour work shift or the 
equivalent, samples must be collected periodically or continuously for 
the duration of the 8-hour work shift. Samples must be taken during a 
period which is likely to represent the maximum employee exposure.
    (B) If the manufacturer demonstrates compliance with the exposure 
limits for 3 consecutive months, further monitoring of the identical 
process must be performed only every 6 months thereafter, unless there 
is a significant change in the process, process design, or equipment. If 
there is such a change, the manufacturer must begin monitoring again 
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
    (iv) Location of monitoring. Air samples must be taken so as to 
ensure that the samples adequately represent the ambient air 
concentration of a new chemical substance present in each worker's 
breathing zone.
    (4) Engineering controls and exposure safeguards. Engineering 
controls such as, but not limited to, isolation, enclosure, local 
exhaust ventilation, and dust collection must be used to ensure 
compliance with the exposure limits prescribed in paragraphs (e)(1) or 
(e)(2)(ii) of this section.
    (5) Training, hygiene, and work practices--(i) Training. No employee 
may enter a special production area before the completion of a training 
program. The training program must be adapted to the individual 
circumstances of the

[[Page 389]]

manufacturer and must address: The known physical-chemical and 
toxicological properties of the chemical substances handled in the area; 
procedures for using and maintaining respirators and other personal 
safeguards; applicable principles of hygiene; special handling 
procedures designed to limit personal exposure to, and inadvertent 
release of, chemical substances; and procedures for responding to 
emergencies or spills.
    (ii) Hygiene. Appropriate standards of hygiene must be observed by 
all employees handling a new chemical substance in manufacturing, 
processing, or transfer operations. The manufacturer must provide 
appropriate facilities for employee changing and wash-up. Food, 
beverages, tobacco products, and cosmetics must not be allowed in 
special production areas.
    (iii) Work practices. Operating procedures such as those related to 
chemical weighing and filtering, or the charging, discharging and clean-
up of process equipment, must be designed and conducted to ensure 
compliance with the exposure limits prescribed in paragraph (e)(1) or 
(e)(2)(ii) of this section. Written procedures and all materials 
necessary for responding to emergency situations must be immediately 
accessible to all employees in a special production area. Any spill or 
unanticipated emission must be controlled by specially trained personnel 
using the equipment and protective clothing described in paragraph 
(e)(6) of this section.
    (6) Personal protection devices. All workers engaged in the 
manufacture and processing of a new chemical substance in the special 
production area must wear suitable protective clothing or equipment, 
such as chemical-resistant coveralls, protective eyewear, and gloves.
    (7) Caution signs. Each special production area must be clearly 
posted with signs identifying the area as a special production area 
where new chemical substances are manufactured and processed under 
controlled conditions. Each sign must clearly restrict entry into the 
special production area to qualified personnel who are properly trained 
and equipped with appropriate personal exposure safeguards.
    (8) Removal for storage or transportation. A new chemical substance 
that is not incorporated into a wet mixture, photographic article, or 
instant photographic or peel-apart film article may be removed from the 
special production area for purposes of storage between operational 
steps or for purposes of transportation to another special production 
area. Such storage or transportation must be conducted in a manner that 
limits worker and environmental exposure through the use of engineering 
controls, training, hygiene, work practices, and personal protective 
devices appropriate to the chemical substance in question.
    (9) Labeling. (i) Any new chemical substance removed from a special 
production area or stored or transported between operational steps must 
be clearly labeled. The label must show the identity of the new chemical 
substance or an appropriate identification code, a statement of any 
known hazards associated with it, a list of special handling 
instructions, first aid information, spill control directions, and where 
applicable, the appropriate U.S. Department of Transportation notations.
    (ii) No label is required if the new chemical substance has been 
incorporated into a photographic article, or if it is contained in a 
sealed reaction vessel or pipeline, or if it has been incorporated into 
an instant photographic or peel-apart film article.
    (10) Areas immediately adjacent to the special production area. The 
ambient air concentration of the new chemical substance in areas 
immediately adjacent to the special production area must not exceed the 
exposure limit established in paragraph (e)(2)(ii) of this section for 
waiver of respirator protection within the special production area. 
Periodic monitoring in accordance with paragraph (e)(3) of this section 
must be performed in immediately adjacent areas where it is reasonable 
to expect a risk of inhalation exposure.
    (f) Conditions of processing outside the special production area. A 
wet mixture may be incorporated into a photographic article or an 
instant photographic or peel-apart film article outside the special 
production area under the conditions listed in this paragraph:

[[Page 390]]

    (1) Engineering controls and exposure safeguards. Engineering 
controls must limit the exposure to a new chemical substance contained 
in a wet mixture.
    (2) Training, hygiene and work practices--(i) Training. Training of 
employees involved in the handling of wet mixtures containing a new 
chemical substance must be adapted to the individual circumstances of 
the employees' activities and must address: Procedures for using 
personal exposure safeguards, applicable principles of hygiene, handling 
procedures designed to limit personal exposure, and procedures for 
responding to emergencies and spills.
    (ii) Hygiene. Appropriate standards of hygiene that limit exposure 
must be observed by all employees handling wet mixtures that contain new 
chemical substances.
    (iii) Work practices. Work practices and operating procedures must 
be designed to limit exposure to any new chemical substance contained in 
wet mixtures. Any spills or unanticipated releases of a wet mixture must 
be controlled by trained personnel wearing appropriate protective 
clothing or equipment such as gloves, eye protection, and, where 
necessary, respirators or chemically imprevious clothing.
    (3) Personal protection devices. All workers engaged in the 
processing of a wet mixture containing a new chemical substance must 
wear suitable protective clothing or equipment such as coveralls, 
protective eyewear, respirators, and gloves.
    (g) Incorporation of photographic articles into instant photographic 
and peel-apart film articles. A photographic article may be incorporated 
into the instant photographic or peel-apart film article outside the 
special production area. The manufacturer must take measures to limit 
worker and environmental exposure to new chemcial substances during 
these operations using engineering controls, training, hygiene, work 
practices, and personal protective devices.
    (h) Environmental release and waste treatment--(1) Release to land. 
Process waste from manufacturing and processing operations in the 
special production area that contain a new chemical substance are 
considered to be hazardous waste and must be handled in accordance with 
the requirements of parts 262 through 267 and parts 122 and 124 of this 
chapter.
    (2) Release to water. All wastewater or discharge which contain the 
new chemcial subtance must be appropriately pretreated before release to 
a Publicly Owned Treatment Works (POTW) or other receiving body of 
water. In the case of release to a POTW, the pretreatment must prevent 
structural damage to, obstruction of, or interference with the operation 
of the POTW. The treatment of direct release to a receiving body of 
water must be appropriate for the new chemical substance's physical-
chemical properties and potential toxicity.
    (3) Release to air. All process emissions released to the air which 
contain the new chemical substance must be vented through control 
devices appropriate for the new chemical substance's physical-chemical 
properties and potential toxicity.
    (i) Exemption notice. An exemption notices must be submitted to EPA 
when manufacture of the new chemical substance begins.
    (1) Contents of exemption notice. The exemption notice must include 
the following information:
    (i) Manufacturer and sites. The notice must identify the 
manufacturer and the sites and locations where the new chemical 
substance and the instant photographic or peel-apart film articles will 
be manufactured and processed.
    (ii) Chemical identification. The notice must identify the new 
chemical substance as follows:
    (A) Class 1 substances. For chemical substances whose composition 
can be represented by a definite structural disagram (Class 1 
substances), the notice must provide the chemical name (preferably CAS 
or IUPAC nomenclature), the molecular formula, CAS Registry Number (if 
available), known synonyms (including trade names), and a structural 
diagram.
    (B) Class 2 substances. For chemical substances that cannot be fully 
represented by a structural diagram, (Class 2 substances), the notice 
must

[[Page 391]]

provide the chemical name, the molecular formula, the CAS Registry 
Number (if available), and known synonyms (including trade names). The 
notice must identify the immediate precursors and reactants by name and 
CAS Registry Number (if available). The notice must include a partial or 
incomplete structural diagram, if available.
    (C) Polymers. For a polymer, the notice must indentify monomers and 
other reactants used in the manufacture of the polymer by chemical name 
and CAS Registry Number. The notice must indicate the amount of each 
monomer used (by weight percent of total monomer); the maximum residual 
of each monomer present in the polymer; and a partial or incomplete 
structural diagram, if available. The notice must indicate the number 
average molecular weight of the polymer and characterize the anticipated 
low molecular weight species. The notice must include this information 
for each typical average molecular weight composition of the polymer to 
be manufactured.
    (iii) Impurities. The notice must identify the impurities that can 
be reasonably anticipated to be present in the new chemcial substance 
when manufactured under the exemption by name and CAS Registry Number, 
by class of substances, or by process or source. The notice also must 
estimate the maximum percent (by weight) of each impurity in the new 
chemical substance and the percent of unknown impurities present.
    (iv) Physical-chemical properties. The notice must describe the 
physical-chemical properties of the new chemical substance. Where 
specific physical-chemical data are not available, reasonable estimates 
and the techniques used to develop these estimates must be provided.
    (v) Byproducts. The notice must identify the name, CAS Registry 
number (if available), and the volume of each byproduct that would be 
manufactured during manufacture of the new chemical substance.
    (vi) Production volume. The notice must include an estimate of the 
anticipated maximum annual production volume.
    (vii) Test data. The notice must include all information and test 
data on the new chemical substance's health and environmental effects 
that are known to or reasonably ascertainable by the manufacturer.
    (viii) Identity of the article. The notice must identify and 
describe the instant photographic film article(s) or peel-apart film 
article(s) that will contain the new chemical substance.
    (ix) Release to water. The notice must include a description of the 
methods used to control and treat wastewater or discharge released to a 
POTW or other receiving body of water. The notice must also identify the 
POTW or receiving body of water.
    (x) Certification. The manufacturer must certify in the notice that 
it is familiar with the terms of the exemption and that the manufacture, 
processing, distribution, use, and disposal of the new chemical 
substance will comply with those terms.
    (2) Duplication of information in premanufacture notice. If a 
manufacturer who submits an exemption notice under this paragraph has 
already submitted, or simultaneously submits, a premanufacture notice 
under section 5(a)(1)(A) of the Act for the new chemical substance, it 
may, in lieu of submitting the information required by this paragraph, 
reference the required information to the extent it is included in the 
premanufacture notice. At a minimum, the exemption notice must identify 
the manufacturer and the new chemical substance, and contain the 
certification required by paragraph (i)(1)(x) of this section.
    (3) Address. The exemption notice must be addressed to the Document 
Control Office (7407), Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, Room G-099, 401 M St., SW., Washington, 
DC., 20460.
    (j) Recordkeeping. (1) Manufacturers of a new chemical substance 
under this exemption must keep the following records for 30 years from 
the final date of manufacture.
    (i) Production records. Each manufacturer must maintain records of 
the annual production volume of each new chemical substance manufactured 
under the terms of the exemption. This

[[Page 392]]

record must indicate when manufacture of the new chemical substance 
began.
    (ii) Exposure monitoring records. Manufacturers must maintain an 
accurate record of all monitoring required by this section. Monitoring 
records may be adapted to the individual circumstances of the 
manufacturer but, at a minimum, must contain the following information: 
The chemical identity of the new chemical substance, date of the 
monitoring, the actual monitoring data for each monitoring location and 
sampling, and a reference to or description of the collection and 
analytic techniques. If the manufacturer does not monitor, the 
manufacturer must maintain a record of the reasons for not monitoring 
and the methods used to determine compliance with the exposure limits of 
paragraph (e)(1) of this section.
    (iii) Training and exposure records. For each employee engaged in 
the manufacture or processing of a new chemical substance, the company 
must develop and maintain a record of the worker's participation in 
required training. This record must also demonstrate the regular use of 
personal exposure safeguards, including the results of any personal 
exposure monitoring, the results of the quantitative fit test for the 
worker's personal respirator, and any additional information related to 
the worker's occupational exposure.
    (iv) Treatment records. Manufacturers who release treated wastewater 
or discharge containing a new chemical substance to a POTW or other 
receiving body of water must maintain records of the method of 
treatment.
    (2) The manufacturer must make the records listed in paragraph 
(j)(1) of this section available to EPA upon written request by the 
Director of the Office of Pollution Prevention and Toxics. The 
manufacturer must provide these records within 15 working days of 
receipt of this request.
    (k) Confidentiality. If the manufacturer submits information under 
paragraph (i) or (j) of this section which it claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to the Agency by bracketing, 
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or 
some other appropriate designation. Any information so identified will 
be treated in accordance with the procedures in part 2 of this chapter. 
Any information not claimed confidential at the time of submission will 
be made available to the public without further notice to the submitter.
    (l) Amendment and repeal. (1) EPA may amend or repeal any term of 
this exemption if it determines that the manufacture, processing, 
distribution, use, and disposal of new chemical substances under the 
terms of the exemption may present an unreasonable risk of injury to 
health or the environment. EPA also may amend this exemption to enlarge 
the exemption category or to reduce the restrictions or conditions of 
the exemption.
    (2) As required by section 5(h)(4) of the Act, EPA will amend or 
repeal the substantive terms of an exemption granted under this part 
only by the formal rulemaking procedures described in section 6(c)(2) 
and (3) of the Act (15 U.S.C. 2605(c)).
    (m) Prohibition of use of the exemption. The Director of the Office 
of Pollution Prevention and Toxics may prohibit the manufacture, 
processing, distribution, use, or disposal of any new chemical substance 
under the terms of this exemption if he or she determines that the 
manufacture, processing, distribution in commerce, use, or disposal of 
the new chemical substance may present an unreasonable risk of injury to 
health or the environment.
    (n) Enforcement. (1) A failure to comply with any provision of this 
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this part is a 
violation of this regulation and therefore a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture of a new chemical 
substance in violation of this exemption or act to seize any chemical 
substances manufactured in violation of the exemption

[[Page 393]]

under the authority of section 17 of the Act (15 U.S.C. 2616).

[47 FR 24317, June 4, 1982, as amended at 53 FR 12523, Apr. 15, 1988; 60 
FR 34465, July 3, 1995; 62 FR 17932, April 11, 1997]



Sec. 723.250  Polymers.

    (a) Purpose and scope. (1) This section grants an exemption from 
certain of the premanufacture notice requirements of section 5(a)(1)(A) 
of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the 
manufacture of certain polymers. This section does not apply to 
microorganisms subject to part 725 of this chapter.
    (2) To manufacture a new chemical substance under the terms of this 
section, a manufacturer must:
    (i) Determine that the substance meets the definition of polymer in 
paragraph (b) of this section.
    (ii) Determine that the substance is not specifically excluded by 
paragraph (d) of this section.
    (iii) Ensure that the substance meets the exemption criteria of 
paragraph (e) of this section.
    (iv) Submit a report as required under paragraph (f) of this 
section.
    (v) Comply with the recordkeeping requirements of paragraph (j) of 
this section.
    (b) Definitions. In addition to the definitions under section 3 of 
the Act, 15 U.S.C. 2602, the following definitions apply to this part.
    Act means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
    Biopolymer means a polymer directly produced by living or once-
living cells or cellular components.
    Category of chemical substances has the same meaning as in section 
26(c)(2) of the Act (15 U.S.C. 2625).
    Cationic polymer means a polymer that contains a net positively 
charged atom(s) or associated groups of atoms covalently linked to its 
polymer molecule.
    Chemical substance, Director, EPA, importer, impurity, Inventory, 
known to or reasonably ascertainable, manufacture, manufacturer, 
mixture, new chemical, person, possession or control, process and test 
data have the same meanings as in Sec. 720.3 of this chapter.
    Equivalent weight of a functional group means the ratio of the 
molecular weight to the number of occurrences of that functional group 
in the molecule. It is the weight of substance that contains one 
formula-weight of the functional group.
    Internal monomer unit means a monomer unit that is covalently bonded 
to at least two other molecules. Internal monomer units of polymer 
molecules are chemically derived from monomer molecules that have formed 
covalent bonds between two or more other monomer molecules or other 
reactants.
    Monomer means a chemical substance that is capable of forming 
covalent bonds with two or more like or unlike molecules under the 
conditions of the relevant polymer-forming reaction used for the 
particular process.
    Monomer Unit means the reacted form of the monomer in a polymer.
    Number-average molecular weight means the arithmetic average (mean) 
of the molecular weight of all molecules in a polymer.
    Oligomer means a polymer molecule consisting of only a few monomer 
units (dimer, trimer, tetramer)
    Other reactant means a molecule linked to one or more sequences of 
monomer units but which, under the relevant reaction conditions used for 
the particular process, cannot become a repeating unit in the polymer 
structure.
    Polyester means a chemical substance that meets the definition of 
polymer and whose polymer molecules contain at least two carboxylic acid 
ester linkages, at least one of which links internal monomer units 
together.
    Polymer means a chemical substance consisting of molecules 
characterized by the sequence of one or more types of monomer units and 
comprising a simple weight majority of molecules containing at least 3 
monomer units which are covalently bound to at least one other monomer 
unit or other reactant and which consists of less than a simple weight 
majority of molecules of the same molecular weight. Such molecules must 
be distributed over a range of molecular weights wherein differences in 
the molecular weight are primarily attributable to differences in the 
number of monomer units. In the context of this definition, sequence 
means that the monomer units under

[[Page 394]]

consideration are covalently bound to one another and form a continuous 
string within the molecule, uninterrupted by units other than monomer 
units.
    Polymer molecule means a molecule which contains a sequence of at 
least 3 monomer units which are covalently bound to at least one other 
monomer unit or other reactant.
    Reactant means a chemical substance that is used intentionally in 
the manufacture of a polymer to become chemically a part of the polymer 
composition.
    Reactive functional group means an atom or associated group of atoms 
in a chemical substance that is intended or can reasonably be 
anticipated to undergo further chemical reaction.
    Reasonably anticipated means that a knowledgeable person would 
expect a given physical or chemical composition or characteristic to 
occur based on such factors as the nature of the precursors used to 
manufacture the polymer, the type of reaction, the type of manufacturing 
process, the products produced in polymerization, the intended uses of 
the substance, or associated use conditions.
    (c) Applicability. This section applies to manufacturers of new 
chemical substances that otherwise must submit a premanufacture notice 
to EPA under Sec. 720.22 of this chapter. New substances are eligible 
for exemption under this section if they meet the definition of 
``polymer'' in paragraph (b) of this section, and the criteria in 
paragraph (e) of this section, and if they are not excluded from the 
exemption under paragraph (d) of this section.
    (d) Polymers that cannot be manufactured under this section--(1) 
Cationic polymers. A polymer cannot be manufactured under this section 
if the polymer is a cationic polymer as defined under paragraph (b) of 
this section or if the polymer is reasonably anticipated to become a 
cationic polymer in a natural aquatic environment (e.g., rivers, lakes) 
unless:
    (i) The polymer is a solid material that is not soluble or 
dispersible in water and will be used only in the solid phase (e.g., 
polymers that will be used as ion exchange beads), or
    (ii) The combined (total) functional group equivalent weight of 
cationic groups in the polymer is equal to or greater than 5,000.
    (2) Elemental limitations. (i) A polymer manufactured under this 
section must contain as an integral part of its composition at least two 
of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and 
sulfur.
    (ii) A polymer cannot be manufactured under this section if it 
contains as an integral part of its composition, except as impurities, 
any elements other than the following:
    (A) The elements listed in paragraph (d)(2)(i) of this section.
    (B) Sodium, magnesium, aluminum, potassium, calcium, chlorine, 
bromine, and iodine as the monatomic counterions Na=, 
Mg=2, Al=3, K=, Ca=2, 
Cl-, Br-, or I-.
    (C) Fluorine, chlorine, bromine, and iodine covalently bound to 
carbon.
    (D) Less than 0.20 weight percent of any combination of the atomic 
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, 
copper, zinc, tin, and zirconium.
    (3) Polymers which degrade, decompose, or depolymerize. A polymer 
cannot be manufactured under this section if the polymer is designed or 
is reasonably anticipated to substantially degrade, decompose, or 
depolymerize, including those polymers that could substantially 
decompose after manufacture and use, even though they are not actually 
intended to do so. For the purposes of this section, degradation, 
decomposition, or depolymerization mean those types of chemical change 
that convert a polymeric substance into simpler, smaller substances, 
through processes including but not limited to oxidation, hydrolysis, 
attack by solvents, heat, light, or microbial action.
    (4) Polymers manufactured or imported from monomers and reactants 
not on the TSCA Chemical Substance Inventory. A polymer cannot be 
manufactured under this section if the polymer being manufactured or 
imported is prepared from monomers and/or other reactants (that are 
either charged to the reaction vessel or incorporated in the polymer at 
levels of greater than 2 weight percent) that are not already included 
on the TSCA Chemical Substance Inventory

[[Page 395]]

or manufactured under an applicable TSCA section 5 exemption.
    (5) Water absorbing polymers with number average molecular weight 
(MW) 10,000 and greater. A polymer cannot be manufactured under this 
section if the polymer being manufactured or imported is a water 
absorbing polymer and has a number average MW greater than or equal to 
10,000 daltons. For purposes of this section, a water-absorbing polymer 
is a polymeric substance that is capable of absorbing its weight of 
water.
    (e) Exemption criteria. To be manufactured under this section, the 
polymer must meet one of the following criteria:
    (1) Polymers with number average MW greater than or equal to 1,000 
and less than 10,000 daltons (and oligomer content less than 10 percent 
below MW 500 and less than 25 percent below MW 1,000). (i) The polymer 
must have a number average MW greater than or equal to 1,000 and less 
than 10,000 daltons and contain less than 10 percent oligomeric material 
below MW 500 and less than 25 percent oligomeric material below MW 
1,000.
    (ii) The polymer cannot contain reactive functional groups unless it 
meets one of the following criteria:
    (A) The polymer contains only the following reactive functional 
groups: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated 
olefinic groups that are considered ``ordinary,''(i.e., not specially 
activated either by being part of a larger functional group, such as a 
vinyl ether, or by other activating influences, e.g., strongly electron-
withdrawing sulfone group with which the olefinic groups interact), 
butenedioic acid groups, those conjugated olefinic groups contained in 
naturally-occurring fats, oils, and carboxylic acids, blocked 
isocyanates (including ketoxime-blocked isocyanates), thiols, 
unconjugated nitrile groups, and halogens (except that reactive halogen-
containing groups such as benzylic or allylichalides cannot be 
included).
    (B) The polymer has a combined (total) reactive group equivalent 
weight greater than or equal to 1,000 for the following reactive 
functional groups: acidhalides; acid anhydrides; aldehydes, hemiacetals; 
methylolamides,- amines or,- ureas; alkoxysilanes with alkoxy greater 
than C2-alkoxysilanes; allyl ethers; conjugated 
olefins;cyanates; epoxides; imines; or unsubstituted positions ortho or 
para to phenolic hydroxyl; or
    (C) If any reactive functional groups not included in paragraph 
(e)(1)(ii)(A) and (B) of this section are present, the combined (total) 
reactive group equivalent weight, including any groups listed in 
paragraph (e)(1)(ii)(B), is greater than or equal to 5,000.
    (2) Polymers with number average MW greater than or equal to 10,000 
(and oligomer content less than 2 percent below MW 500 and less than 5 
percent below MW 1,000) . The polymer must have a number average MW 
greater than or equal to 10,000 daltons and contain less than 2 percent 
oligomeric material below MW 500 and less than 5 percent oligomeric 
material below MW 1000.
    (3) Polyester polymers. The polymer is a polyester as defined in 
paragraph (b) of this section and is manufactured solely from one or 
more of the reactants in the following table 1:

      Table 1.-- List of Reactants From Which Polyester May be Made
------------------------------------------------------------------------
                  Reactant                             CAS No.
------------------------------------------------------------------------
                    Monobasic Acids and Natural Oils
  Benzoic acid.............................  65-85-0
  Canola oil...............................  120962-03-0
  Coconut oil..............................  8001-31-8*
  Corn oil.................................  8001-30-7*
  Cottonseed oil...........................  8001-29-4*
  Dodecanoic acid..........................  143-07-7
  Fats and glyceridic oils, anchovy........  128952-11-4*
  Fats and glyceridic oils, babassu........  91078-92-1*
  Fats and glyceridic oils, herring........  68153-06-0*
  Fats and glyceridic oils, menhaden.......  8002-50-4*
  Fats and glyceridic oils, sardine........  93334-41-9*
  Fats and glyceridic oils, oiticica.......  8016-35-1*
  Fatty acids,C16-18 and C18-unsatd........  67701-08-0*

[[Page 396]]

 
  Fatty acids, castor-oil..................  61789-44-4*
  Fatty acids, coco........................  61788-47-4*
  Fatty acids, dehydrated castor-oil.......  61789-45-5*
  Fatty acids, linseed oil.................  68424-45-3*
  Fatty acids, safflower oil...............
  Fatty acids, soya........................  68308-53-2*
  Fatty acids, sunflower oil...............  84625-38-7*
  Fatty acids, sunflower-oil, conjugated...  68953-27-5*
  Fatty acids, tall-oil....................  61790-12-3*
  Fatty acids, tall-oil, conjugated*.......
  Fatty acids, vegetable oil...............  61788-66-7*
  Glycerides, C16-18 and C18-unsatd........  67701-30-8*
  Heptanoic acid...........................   111-14-8
  Hexanoic acid............................   142-62-1
  Hexanoic acid, 3,3,5-trimethyl-..........  3302-10-1
  Linseed oil..............................  8001-26-1*
  Linseed oil, oxidized....................  68649-95-6*
  Nonanoic acid............................  112-05-0
  Oils, Cannabis*..........................
  Oils, palm kernel........................  8023-79-8*
  Oils, perilla............................  68132-21-8*
  Oils, walnut.............................  8024-09-7
  Safflower oil............................  8001-23-8*
  Soybean oil..............................  8001-22-7*
  Sunflower oil............................  8001-21-6*
  Tung oil.................................  8001-20-5*
 
Di and Tri Basic Acids:....................
  1,2-Benzenedicarboxylic acid.............  88-99-3
  1,3-Benzenedicarboxylic acid.............  121-91-5
  1,3-Benzenedicarboxylic acid, dimethyl     1459-93-4
   ester.
  1,4-Benzenedicarboxylic acid.............  100-21-0
  1,4-Benzenedicarboxylic acid, diethyl      636-09-9
   ester.
  1,4-Benzenedicarboxylic acid, dimethyl     120-61-6
   ester.
  1,2,4-Benzenetricarboxylic acid..........   528-44-9
  Butanedioic acid.........................   110-15-6
  Butanedioic acid, diethyl ester..........  123-25-1
  Butanedioic acid, dimethyl ester.........  106-65-0
  2-Butenedioic acid (E)-..................  110-17-8
  Decanedioic acid.........................  111-20-6
  Decanedioic acid, diethyl ester..........  110-40-7
  Decanedioic acid, dimethyl ester.........  106-79-6
  Dodecanedioic acid.......................  693-23-2
  Fatty acids, C18-unsatd., dimers.........  61788-89-4*
  Heptanedioic acid........................  111-16-0
  Heptanedioic acid, dimethyl ester........  1732-08-7
  Hexanedioic acid.........................  124-04-9
  Hexanedioic acid, dimethyl ester.........  627-93-0
  Hexanedioic acid, diethyl ester..........  141-28-6
  Nonanedioic acid.........................  123-99-9
  Nonanedioic acid, dimethyl ester.........  1732-10-1
  Nonanedioic acid, diethyl ester..........  624-17-9
  Octanedioic acid.........................  (505-48-6)
  Octanedioic acid, dimethyl ester.........  1732-09-8
  Pentanedioic acid........................  (110-94-1)
  Pentanedioic acid, dimethyl ester........  1119-40-0
  Pentanedioic acid, diethyl ester.........  818-38-2
  Undecanedioic acid.......................  1852-04-6
 
                                 Polyols
  1,3-Butanediol...........................  107-88-0
  1,4-Butanediol...........................  110-63-4
  1,4-Cyclohexanedimethanol................   105-08-8
  1,2-Ethanediol...........................  107-21-1
  Ethanol, 2,2-oxybis-.....................  111-46-6
  1,6-Hexanediol...........................  629-11-8
  1,3-Pentanediol, 2,2,4-trimethyl-........  144-19-4
  1,2-Propanediol,.........................  57-55-6
  1,3-Propanediol, 2,2-bis(hydroxymethyl)-.  115-77-5
  1,3-Propanediol, 2,2-dimethyl-...........  126-30-7
  1,3-Propanediol, 2-ethyl-2-                77-99-6
   (hydroxymethyl)-.
  1,3-Propanediol, 2-(hydroxymethyl)-2-      77-85-0
   methyl-.

[[Page 397]]

 
  1,3-propanediol, 2-methyl................  2163-42-0
  1,2,3-Propanetriol.......................  56-81-5
  1,2,3-Propanetriol, homopolymer..........  25618-55-7
  2-Propen-1-ol, polymer with                25119-62-4
   ethenylbenzene.
 
                                Modifiers
  Acetic acid, 2,2-oxybis-.................  110-99-6
  1-Butanol................................  71-36-3**
  Cyclohexanol.............................  108-93-0
  Cyclohexanol, 4,4-(1-methylethylidene)bis- 80-04-6
   .
  Ethanol, 2-(2-butoxyethoxy)-.............  112-34-5
  1-Hexanol................................  111-27-3
  Methanol, hydrolysis products with          72318-84-4*
   trichlorohexylsilane and
   trichlorophenylsilane.
  1-Phenanthrenemethanol, tetradecahydro-    13393-93-6
   1,4a-dimethyl-7-(1-methylethyl)-.
  Phenol, 4,4-(1-methylethylidene)bis-,       25036-25-3
   polymer with 2,2- [(1-
   methylethylidene)bis(4,1-
   phenyleneoxymethylene)] bis[oxirane].
  Siloxanes and Silicones, di-Me, di-Ph,      68440-65-3*
   polymers with Ph silsesquioxanes,
   methoxy-terminated.
  Siloxanes and Silicones, di-Me, methoxy    68957-04-0*
   Ph, polymers with Ph silsesquioxanes,
   methoxy-terminated.
  Siloxanes and Silicones, Me Ph, methoxy    \1\68957-06-2*
   Ph, polymers with Ph silsesquioxanes,
   methoxy- and Ph-terminated.
  Silsesquioxanes, Ph Pr...................  \1\68037-90-1*
------------------------------------------------------------------------
* Chemical substance of unknown or variable composition,complex reaction
  products, and biological materials (UVCB). The CAS Registry Numbers
  for UVCB substances are not used in CHEMICAL ABSTRACTS and its
  indexes.
** These substances may not be used in a substance manufactured from
  fumaric or maleic acid because of potential risks associated with
  esters, which may be formed by reaction of these reactants.


    (f) Exemption report for polymers manufactured under the terms of 
this section. For substances exempt under paragraphs (e)(1), (e)(2), and 
(e)(3) of this section a report of manufacture or import must be 
submitted (postmarked) by January 31 of the year subsequent to initial 
manufacture. The notice must include:
    (1) Manufacturer's name. This includes the name and address of the 
manufacturer and the name and telephone number of a technical contact.
    (2) Number of substances manufactured. Number of substances 
manufactured. The manufacturer must identify the number of polymers 
manufactured under terms of the exemption for the first time in the year 
preceding the notice.
    (g) Chemical identity information. For substances exempt under 
paragraph (e) of this section the manufacturer must to the extent known 
to or reasonably ascertainable by the manufacturer identify the 
following and maintain the records in accordance with paragraph (j) of 
this section:
    (1) A specific chemical name and CAS Registry Number (or EPA 
assigned Accession Number) for each ``reactant,'' as that term is 
defined in paragraph (b) of this section, used at any weight in the 
manufacture of the polymer. For purposes of determining chemical 
identity, the manufacturer may determine whether a reactant is used at 
greater than two weight percent according to either the weight of the 
reactant charged to the reaction vessel or the weight of the chemically 
combined (incorporated) reactant in the polymer. Manufacturers who 
choose the ``incorporated'' method must have analytical data, or 
theoretical calculations (if it can be documented that an analytical 
determination cannot be made or is not necessary), to demonstrate 
compliance with this paragraph. Reactants that introduce into the 
polymer elements, properties, or functional groups that would render the 
polymer ineligible for the exemption are not allowed at any level.
    (2) A representative structural diagram, if possible.
    (h) Certification. To manufacture a substance under the terms of 
this section, a manufacturer must as of the date of first manufacture, 
make the following certification statements and maintain them in 
accordance with paragraph (j) of this section:
    (1) The substance is manufactured or imported for a commercial 
purpose other than for research and development.

[[Page 398]]

    (2) All information in the certification is truthful.
    (3) The new chemical substance meets the definition of a polymer, is 
not specifically excluded from the exemption in paragraph (d) of this 
section, and meets the conditions of the exemption in paragraph (e) of 
this section.
    (i) Exemptions granted under superseded regulations. Manufacturers 
granted exemptions under the superseded requirements of Sec. 723.250 (as 
in effect on May 26, 1995) shall either continue to comply with those 
requirements or follow all procedural and recordkeeping requirements 
pursuant to this section. If an exemption holder continues to follow the 
superseded regulations, the Notice of Commencement requirements apply 
and the exempt polymer will continue to be listed on the Inventory with 
exclusion criteria and exemption category restrictions on residual 
monomer/reactant and low molecular weight species content limitations.
    (j) Recordkeeping. (1) A manufacturer of a new polymer under 
paragraphs (e) of this section, must retain the records described in 
this paragraph at the manufacturing site for a period of 5 years from 
the date of commencement of manufacture or import.
    (2) The records must include the following to demonstrate compliance 
with the terms of this section:
    (i) Chemical identity information as required in paragraph (g) of 
this section.
    (ii) Information to demonstrate that the new polymer is not 
specifically excluded from the exemption.
    (iii) Records of production volume for the first 3 years of 
manufacture and the date of commencement of manufacture.
    (iv) Information to demonstrate that the new polymer meets the 
exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this 
section.
    (v) Analytical data, or theoretical calculations (if it can be 
documented that an analytical determination cannot be made or is not 
necessary), to demonstrate that the polymer meets the number-average MW 
exemption criteria in paragraphs (e)(1) or (e)(2) of this section.The 
analytical tests may include gel permeation chromatography (GPC).vapor 
pressure osmometry (VPO), or other such tests which will demonstrate 
that the polymer meets the number-average MW criterion.
    (vi) Analytical data, or theoretical calculations (if it can be 
documented that an analytical determination cannot be made or is not 
necessary), to demonstrate that the polymer meets the criteria in 
paragraphs (e)(1) or (e)(2) of this section, meets the low MW content 
criteria in paragraphs (e)(1) or (e)(2) of this section.
    (vii) If applicable, analytical data, or theoretical calculations 
(if it can be documented that an analytical determination cannot be made 
or is not necessary) required in paragraph (g) of this section for 
determining monomers or reactants charged to the reaction vessel at 
greater than 2 weight percent but incorporated at 2 weight percent or 
less in the manufactured polymer.
    (viii) The certification statements as required under paragraph (h) 
of this section.
    (3) The manufacturer must submit the records listed in paragraph 
(j)(2) of this section to EPA upon written request by EPA. The 
manufacturer must provide these records within 15 working days of 
receipt of this request. In addition, any person who manufactures a new 
chemical substance under the terms of this section, upon request of EPA, 
must permit such person at all reasonable times to have access to and to 
copy these records.
    (k) Submission of information. Information submitted to EPA under 
this section must be sent in writing to: TSCA Document Control Officer, 
(7407), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    (l) Compliance. (1) A person who manufactures or imports a new 
chemical substance and fails to comply with any provision of this 
section is in violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Using for commercial purposes a chemical substance or mixture 
which a person knew or had reason to know was manufactured, processed, 
or distributed in commerce in violation of section 5 of the Act is a 
violation of section 15 of the Act (15 U.S.C. 2614).

[[Page 399]]

    (3) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by this section and 
section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).
    (4) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 
2614).
    (5) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who 
submit materially misleading or false information in connection with the 
requirements of any provision of this section may be subject to 
penalties calculated as if they never filed their notices.
    (6) EPA may seek to enjoin the manufacture or processing of a 
chemical substance in violation of this section or act to seize any 
chemical substance manufactured or processed in violation of this 
section or take other actions under the authority of section 7 of the 
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
    (m) Inspections. EPA will conduct inspections under section 11 of 
the Act to assure compliance with section 5 and this section, to verify 
that information submitted to EPA under this section is true and 
correct, and to audit data submitted to EPA under this section.
    (n) Confidentiality. If a manufacturer submits information to EPA 
under this section which the manufacturer claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to EPA by bracketing, circling, or 
underlining it and stamping it with ``CONFIDENTIAL'' or some other 
appropriate designation. Any information so identified will be treated 
in accordance with the procedures in 40 CFR part 2. Any information not 
claimed confidential at the time of submission may be made available to 
the public without further notice.

[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, April 11, 1997]



PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS--Table of Contents




             Subpart A--General Provisions and Applicability

Sec.
725.1  Scope and purpose.
725.3  Definitions.
725.8  Coverage of this part.
725.12  Identification of microorganisms for Inventory and other listing 
          purposes.
725.15  Determining applicability when microorganism identity or use is 
          confidential or uncertain.
725.17  Consultation with EPA.

                  Subpart B--Administrative Procedures

725.20  Scope and purpose.
725.25  General administrative requirements.
725.27  Submissions.
725.28  Notice that submission is not required.
725.29  EPA acknowledgement of receipt of submission.
725.32  Errors in the submission.
725.33  Incomplete submissions.
725.36  New information.
725.40  Notice in the Federal Register.
725.50  EPA review.
725.54  Suspension of the review period.
725.56  Extension of the review period.
725.60  Withdrawal of submission by the submitter.
725.65  Recordkeeping.
725.67  Applications to exempt new microorganisms from this part.
725.70  Compliance.
725.75  Inspections.

       Subpart C--Confidentiality and Public Access to Information

725.80  General provisions for confidentiality claims.
725.85  Microorganism identity.
725.88  Uses of a microorganism.
725.92  Data from health and safety studies of microorganisms.
725.94  Substantiation requirements.
725.95  Public file.

  Subpart D--Microbial Commercial Activities Notification Requirements

725.100  Scope and purpose.
725.105  Persons who must report.
725.110  Persons not subject to this subpart.
725.150  Procedural requirements for this subpart.

[[Page 400]]

725.155  Information to be included in the MCAN.
725.160  Submission of health and environmental effects data.
725.170  EPA review of the MCAN.
725.190  Notice of commencement of manufacture or import.

      Subpart E--Exemptions for Research and Development Activities

725.200  Scope and purpose.
725.205  Persons who may report under this subpart.
725.232  Activities subject to the jurisdiction of other Federal 
          programs or agencies.
725.234  Activities conducted inside a structure.
725.235  Conditions of exemption for activities conducted inside a 
          structure.
725.238  Activities conducted outside a structure.
725.239  Use of specific microorganisms in activities conducted outside 
          a structure.
725.250  Procedural requirements for the TERA.
725.255  Information to be included in the TERA.
725.260  Submission of health and environmental effects data.
725.270  EPA review of the TERA.
725.288  Revocation or modification of TERA approval.

                Subpart F--Exemptions for Test Marketing

725.300  Scope and purpose.
725.305  Persons who may apply under this subpart.
725.350  Procedural requirements for this subpart.
725.355  Information to be included in the TME application.
725.370  EPA review of the TME application.

          Subpart G--General Exemptions for New Microorganisms

725.400  Scope and purpose.
725.420  Recipient microorganisms.
725.421  Introduced genetic material.
725.422  Physical containment and control technologies.
725.424  Requirements for the Tier I exemption.
725.426  Applicability of the Tier I exemption.
725.428  Requirements for the Tier II exemption.
725.450  Procedural requirements for the Tier II exemption.
725.455  Information to be included in the Tier II exemption request.
725.470  EPA review of the Tier II exemption request.

Subparts H-K  [Reserved]

 Subpart L--Additional Procedures for Reporting on Significant New Uses 
                            of Microorganisms

725.900  Scope and purpose.
725.910  Persons excluded from reporting significant new uses.
725.912  Exemptions.
725.920  Exports and imports.
725.950  Additional recordkeeping requirements.
725.975  EPA approval of alternative control measures.
725.980  Expedited procedures for issuing significant new use rules for 
          microorganisms subject to section 5(e) orders.
725.984  Modification or revocation of certain notification 
          requirements.

       Subpart M--Significant New Uses for Specific Microorganisms

725.1000  Scope.

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

    Source: 62 FR 17932, April 11, 1997, unless otherwise noted.



             Subpart A--General Provisions and Applicability



Sec. 725.1  Scope and purpose.

    (a) This part establishes all reporting requirements under section 5 
of TSCA for manufacturers, importers, and processors of microorganisms 
subject to TSCA jurisdiction for commercial purposes, including research 
and development for commercial purposes. New microorganisms for which 
manufacturers and importers are required to report under section 
5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under 
section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may 
be required to report for any microorganism that EPA determines by rule 
is being manufactured, imported, or processed for a significant new use.
    (b) Any manufacturer, importer, or processor required to report 
under section 5 of TSCA (see Sec. 725.100 for new microorganisms and 
Sec. 725.900 for significant new uses) must file a Microbial Commercial 
Activity Notice (MCAN)

[[Page 401]]

with EPA, unless the activity is eligible for a specific exemption as 
described in this part. The general procedures for filing MCANs are 
described in subpart D of this part. The exemptions from the requirement 
to file a MCAN are for certain kinds of contained activities (see 
Secs. 725.424 and 725.428), test marketing activities (see 
Sec. 725.300), and research and development activities described in 
paragraph (c) of this section.
    (c) Any manufacturer, importer, or processor required to file a MCAN 
for research and development (R&D) activities may instead file a TSCA 
Experimental Release Application (TERA) for a specific test (see 
Sec. 725.250). A TERA is not required for certain R&D activities; 
however a TERA exemption does not extend beyond the research and 
development stage, to general commercial use of the microorganism, for 
which compliance with MCAN requirements is required. The TERA exemptions 
are for R&D activities subject to other Federal agencies or programs 
(see Sec. 725.232), certain kinds of contained R&D activities (see 
Sec. 725.234), and R&D activities using certain listed microorganisms 
(see Sec. 725.238).
    (d) New microorganisms will be added to the Inventory established 
under section 8 of TSCA once a MCAN has been received, the MCAN review 
period has expired, and EPA receives a Notice of Commencement (NOC) 
indicating that manufacture or importation has actually begun. New 
microorganisms approved for use under a TERA will not be added to the 
Inventory until a MCAN has been received, the MCAN review period has 
expired, and EPA has received an NOC.



Sec. 725.3  Definitions.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as 
definitions contained in Secs. 704.3, 720.3, and 721.3 of this chapter, 
apply to this part unless otherwise specified in this section. In 
addition, the following definitions apply to this part:
    Consolidated microbial commercial activity notice or consolidated 
MCAN means any MCAN submitted to EPA that covers more than one 
microorganism (each being assigned a separate MCAN number by EPA) as a 
result of a prenotice agreement with EPA.
    Containment and/or inactivation controls means any combination of 
engineering, mechanical, procedural, or biological controls designed and 
operated to restrict environmental release of viable microorganisms from 
a structure.
    Director means the Director of the EPA Office of Pollution 
Prevention and Toxics.
    Exemption request means any application submitted to EPA under 
subparts E, F, or G of this part.
    General commercial use means use for commercial purposes other than 
research and development.
    Genome means the sum total of chromosomal and extrachromosomal 
genetic material of an isolate and any descendants derived under pure 
culture conditions from that isolate.
    Health and safety study of a microorganism or health and safety 
study means any study of any effect of a microorganism or microbial 
mixture on health or the environment or on both, including underlying 
data and epidemiological studies, studies of occupational exposure to a 
microorganism or microbial mixture, toxicological, clinical, and 
ecological, or other studies of a microorganism or microbial mixture, 
and any test performed under the Act. Microorganism identity is always 
part of a health and safety study of a microorganism.
    (1) It is intended that the term ``health and safety study of a 
microorganism'' be interpreted broadly. Not only is information which 
arises as a result of a formal, disciplined study included, but other 
information relating to the effects of a microorganism or microbial 
mixture on health or the environment is also included. Any data that 
bear on the effects of a microorganism on health or the environment 
would be included.
    (2) Examples include:
    (i) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including: Acute 
toxicity tests, chronic toxicity tests, critical life stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests,

[[Page 402]]

bioconcentration or bioaccumulation tests, and model ecosystem 
(microcosm) studies.
    (ii) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; dermatoxicity; cumulative, additive, and synergistic 
effects; and acute, subchronic, and chronic effects.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular microorganism or 
microbial mixture on the environment, including surveys, tests, and 
studies of: Survival and transport in air, water, and soil; ability to 
exchange genetic material with other microorganisms, ability to colonize 
human or animal guts, and ability to colonize plants.
    (iv) Monitoring data, when they have been aggregated and analyzed to 
measure the exposure of humans or the environment to a microorganism.
    (v) Any assessments of risk to health and the environment resulting 
from the manufacture, processing, distribution in commerce, use, or 
disposal of the microorganism.
    Inactivation means that living microorganisms are rendered 
nonviable.
    Institutional Biosafety Committee means the committees described in 
the NIH Guidelines in section IV.B.2.
    Intergeneric microorganism means a microorganism that is formed by 
the deliberate combination of genetic material originally isolated from 
organisms of different taxonomic genera.
    (1) The term ``intergeneric microorganism'' includes a microorganism 
which contains a mobile genetic element which was first identified in a 
microorganism in a genus different from the recipient microorganism.
    (2) The term ``intergeneric microorganism'' does not include a 
microorganism which contains introduced genetic material consisting of 
only well-characterized, non-coding regulatory regions from another 
genus.
    Introduced genetic material means genetic material that is added to, 
and remains as a component of, the genome of the recipient.
    Manufacture, import, or process for commercial purposes means:
    (1) To import, produce, manufacture, or process with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
manufacturer, importer, or processor, and includes, among other things, 
``manufacture'' or ``processing'' of any amount of a microorganism or 
microbial mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development or as an intermediate.
    (2) The term also applies to substances that are produced 
coincidentally during the manufacture, processing, use, or disposal of 
another microorganism or microbial mixture, including byproducts that 
are separated from that other microorganism or microbial mixture and 
impurities that remain in that microorganism or microbial mixture. 
Byproducts and impurities without separate commercial value are 
nonetheless produced for the purpose of obtaining a commercial 
advantage, since they are part of the manufacture or processing of a 
microorganism for commercial purposes.
    Microbial commercial activity notice or MCAN means a notice for 
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act 
in accordance with subpart D of this part.
    Microbial mixture means any combination of microorganisms or 
microorganisms and other chemical substances, if the combination does 
not occur in nature and is not an article.
    Microorganism means an organism classified, using the 5-kingdom 
classification system of Whittacker, in the kingdoms Monera (or 
Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of 
the Plantae, and a virus or virus-like particle.
    Mobile genetic element or MGE means an element of genetic material 
that has the ability to move genetic material within and between 
organisms. ``Mobile genetic elements'' include all plasmids, viruses, 
transposons, insertion sequences, and other classes of elements with 
these general properties.
    New microorganism means a microorganism not included on the 
Inventory.
    NIH Guidelines means the National Institutes of Health (NIH) 
``Guidelines for Research Involving Recombinant DNA Molecules'' (July 5, 
1994).

[[Page 403]]

    Non-coding regulatory region means a segment of introduced genetic 
material for which:
    (1) The regulatory region and any inserted flanking nucleotides do 
not code for protein, peptide, or functional ribonucleic acid molecules.
    (2) The regulatory region solely controls the activity of other 
regions that code for protein or peptide molecules or act as recognition 
sites for the initiation of nucleic acid or protein synthesis.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or analysis 
or research on, or analysis of, such substance or another substance, 
including such research or analysis for development of a product'') 
means quantities of a microorganism manufactured, imported, or processed 
or proposed to be manufactured, imported, or processed solely for 
research and development that meet the requirements of Sec. 725.234.
    Structure means a building or vessel which effectively surrounds and 
encloses the microorganism and includes features designed to restrict 
the microorganism from leaving.
    Submission means any MCAN or exemption request submitted to EPA 
under this part.
    Technically qualified individual means a person or persons:
    (1) Who, because of education, training, or experience, or a 
combination of these factors, is capable of understanding the health and 
environmental risks associated with the microorganism which is used 
under his or her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or microbiological 
research to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the 
microorganism as may be appropriate or required within the scope of 
conducting a research and development activity.
    TSCA Experimental Release Application or TERA means an exemption 
request for a research and development activity, which is not eligible 
for a full exemption from reporting under Sec. 725.232, 725.234, or 
725.238, submitted to EPA in accordance with subpart E of this part.
    Well-characterized for introduced genetic material means that the 
following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.



Sec. 725.8  Coverage of this part.

    (a) Microorganisms subject to this part. Only microorganisms which 
are manufactured, imported, or processed for commercial purposes, as 
defined in Sec. 725.3, are subject to the requirements of this part.
    (b) Microorganisms automatically included on the Inventory. 
Microorganisms that are not intergeneric are automatically included on 
the Inventory.
    (c) Microorganisms not subject to this part. The following 
microorganisms are not subject to this part, either because they are not 
subject to jurisdiction under the Act or are not subject to reporting 
under section 5 of the Act.
    (1) Any microorganism which would be excluded from the definition of 
``chemical substance'' in section 3 of the Act and Sec. 720.3(e) of this 
chapter.
    (2) Any microbial mixture as defined in Sec. 725.3. This exclusion 
applies only to a microbial mixture as a whole and not to any 
microorganisms and other chemical substances which are part of the 
microbial mixture.
    (3) Any microorganism that is manufactured and processed solely for 
export if the following conditions are met:
    (i) The microorganism is labeled in accordance with section 
12(a)(1)(B) of the Act, when the microorganism is distributed in 
commerce.
    (ii) The manufacturer and processor can document at the commencement 
of manufacturing or processing that the

[[Page 404]]

person to whom the microorganism will be distributed intends to export 
it or process it solely for export as defined in Sec. 721.3 of this 
chapter.



Sec. 725.12  Identification of microorganisms for Inventory and other listing purposes.

    To identify and list microorganisms on the Inventory, both taxonomic 
designations and supplemental information will be used. The supplemental 
information required in paragraph (b) of this section will be used to 
specifically describe an individual microorganism on the Inventory. 
Submitters must provide the supplemental information required by 
paragraph (b) of this section to the extent necessary to enable a 
microorganism to be accurately and unambiguously identified on the 
Inventory.
    (a) Taxonomic designation. The taxonomic designation of a 
microorganism must be provided for the donor organism and the recipient 
microorganism to the level of strain, as appropriate. These designations 
must be substantiated by a letter from a culture collection, literature 
references, or the results of tests conducted for the purpose of 
taxonomic classification. Upon EPA's request to the submitter, data 
supporting the taxonomic designation must be provided to EPA. The 
genetic history of the recipient microorganism should be documented back 
to the isolate from which it was derived.
    (b) Supplemental information. The supplemental information described 
in paragraphs (b)(1) and (b)(2) of this section is required to the 
extent that it enables a microorganism to be accurately and 
unambiguously identified.
    (1) Phenotypic information. Phenotypic information means pertinent 
traits that result from the interaction of a microorganism's genotype 
and the environment in which it is intended to be used and may include 
intentionally added biochemical and physiological traits.
    (2) Genotypic information. Genotypic information means the pertinent 
and distinguishing genotypic characteristics of a microorganism, such as 
the identity of the introduced genetic material and the methods used to 
construct the reported microorganism. This also may include information 
on the vector construct, the cellular location, and the number of copies 
of the introduced genetic material.



Sec. 725.15  Determining applicability when microorganism identity or use is confidential or uncertain.

    (a) Consulting EPA. Persons intending to conduct activities 
involving microorganisms may determine their obligations under this part 
by consulting the Inventory or the microorganisms and uses specified in 
Sec. 725.239 or in subpart M of this part. This section establishes 
procedures for EPA to assist persons in determining whether the 
microorganism or the use is listed on the Inventory, in Sec. 725.239 or 
in subpart M of this part.
    (1) Confidential identity or use. In some cases it may not be 
possible to directly determine if a specific microorganism is listed, 
because portions of that entry may contain generic information to 
protect confidential business information (CBI). If any portion of the 
microorganism's identity or use has been claimed as CBI, that portion 
does not appear on the public version of the Inventory, in Sec. 725.239 
or in subpart M of this part. Instead, it is contained in a confidential 
version held in EPA's Confidential Business Information Center (CBIC). 
The public versions contain generic information which masks the 
confidential business information. A person who intends to conduct an 
activity involving a microorganism or use whose entry is described with 
generic information will need to inquire of EPA whether the unreported 
microorganism or use is on the confidential version.
    (2) Uncertain microorganism identity. The current state of 
scientific knowledge leads to some imprecision in describing a 
microorganism. As the state of knowledge increases, EPA will be 
developing policies to determine whether one microorganism is equivalent 
to another. Persons intending to conduct activities involving 
microorganisms may inquire of EPA whether the microorganisms they intend 
to manufacture, import, or process are equivalent to specific 
microorganisms described on the Inventory, in Sec. 725.239, or in 
subpart M of this part.

[[Page 405]]

    (b) Requirement of bona fide intent. (1) EPA will answer the 
inquiries described in paragraph (a) of this section only if the Agency 
determines that the person has a bona fide intent to conduct the 
activity for which reporting is required or for which any exemption may 
apply.
    (2) To establish a bona fide intent to manufacture, import, or 
process a microorganism, the person who intends to manufacture, import, 
or process the microorganism must submit the following information in 
writing to the Office of Pollution Prevention and Toxics, Document 
Control Officer, 7407, 401 M St., SW., Washington, DC 20460, ATTN: 
BIOTECH bona fide submission.
    (i) Taxonomic designations and supplemental information required by 
Sec. 725.12.
    (ii) A signed statement certifying that the submitter intends to 
manufacture, import, or process the microorganism for commercial 
purposes.
    (iii) A description of research and development activities conducted 
with the microorganism to date, demonstration of the submitter's ability 
to produce or obtain the microorganism from a foreign manufacturer, and 
the purpose for which the person will manufacture, import, or process 
the microorganism.
    (iv) An indication of whether a related microorganism was previously 
reviewed by EPA to the extent known by the submitter.
    (v) A specific description of the major intended application or use 
of the microorganism.
    (c) If an importer or processor cannot provide all the information 
required by paragraph (b) of this section, because it is claimed as 
confidential business information by its foreign manufacturer or 
supplier, the foreign manufacturer or supplier may supply the 
information directly to EPA.
    (d) EPA will review the information submitted by the manufacturer, 
importer, or processor under this paragraph to determine whether that 
person has shown a bona fide intent to manufacture, import, or process 
the microorganism. If necessary, EPA will compare this information to 
the information requested for the confidential microorganism under 
Sec. 725.85(b)(3)(iii).
    (e) In order for EPA to make a conclusive determination of the 
microorganism's status, the proposed manufacturer, importer, or 
processor must show a bona fide intent to manufacture, import, or 
process the microorganism and must provide sufficient information to 
establish identity unambiguously. After sufficient information has been 
provided, EPA will inform the manufacturer, importer, or processor 
whether the microorganism is subject to this part and if so, which 
sections of this part apply.
    (f) If the microorganism is found on the confidential version of the 
Inventory, in Sec. 725.239 or in subpart M of this part, EPA will notify 
the person(s) who originally reported the microorganism that another 
person (whose identity will remain confidential, if so requested) has 
demonstrated a bona fide intent to manufacture, import, or process the 
microorganism and therefore was told that the microorganism is on the 
Inventory, in Sec. 725.239, or in subpart M of this part.
    (g) A disclosure to a person with a bona fide intent to manufacture, 
import, or process a particular microorganism that the microorganism is 
on the Inventory, in Sec. 725.239, or in subpart M of this part will not 
be considered a public disclosure of confidential business information 
under section 14 of the Act.
    (h) EPA will answer an inquiry on whether a particular microorganism 
is subject to this part within 30 days after receipt of a complete 
submission under paragraph (b) of this section.



Sec. 725.17  Consultation with EPA.

    Persons may consult with EPA, either in writing or by telephone, 
about their obligations under this part. Written consultation is 
preferred. Written inquiries should be sent to the following address: 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, U.S. Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, ATTN: Biotechnology Notice Consultation. Persons 
wishing to consult with EPA by telephone should call (202) 554-1404; 
hearing impaired TDD (202) 554-0551 or e-mail: TSCA-
[email protected].

[[Page 406]]



                  Subpart B--Administrative Procedures



Sec. 725.20  Scope and purpose.

    This subpart describes general administrative procedures applicable 
to all persons who submit MCANs and exemption requests to EPA under 
section 5 of the Act for microorganisms.



Sec. 725.25  General administrative requirements.

    (a) General. (1) Each person who is subject to the notification 
provisions of this part must complete, sign, and submit a MCAN or 
exemption request containing the information as required for the 
appropriate submission under this part. Except as otherwise provided, 
each submission must include all referenced attachments. All information 
in the submission (unless certain attachments appear in the open 
scientific literature) must be in English. All information submitted 
must be true and correct.
    (2) In addition to specific information required, the submitter 
should submit all information known to or reasonably ascertainable by 
the submitter that would permit EPA to make a reasoned evaluation of the 
human health and environmental effects of the microorganism and any 
microbial mixture or article that may contain the microorganism.
    (b) Certification. Persons submitting MCANs and exemption requests 
to EPA under this part, and material related to their reporting 
obligations under this part, must attach the following statement to any 
information submitted to EPA. This statement must be signed and dated by 
an authorized official of the submitter:

    I certify that to the best of my knowledge and belief: The company 
named in this submission intends to manufacture, import, or process for 
a commercial purpose, other than in small quantities solely for research 
and development, the microorganism identified in this submission. All 
information provided in this submission is complete and truthful as of 
the date of submission. I am including with this submission all test 
data in my possession or control and a description of all other data 
known to or reasonably ascertainable by me as required by 40 CFR 725.160 
or 725.260.

    (c) Where to submit information under this part. Persons submitting 
MCANs and exemption requests to EPA under this part, and material 
related to their reporting obligations under this part, must send them 
to: TSCA Document Processing Center (7407), Rm. L-100, Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460.
    (d) General requirements for submission of data. (1) Submissions 
under this part must include the information described in Sec. 725.155, 
725.255, 725.355, or 725.455, as appropriate, to the extent such 
information is known to or reasonably ascertainable by the submitter.
    (2) In accordance with Sec. 725.160 or 725.260, as appropriate, the 
submission must also include any test data in the submitter's possession 
or control and descriptions of other data which are known to or 
reasonably ascertainable by the submitter and which concern the health 
and environmental effects of the microorganism.
    (e) Agency or joint submissions. (1) A manufacturer or importer may 
designate an agent to submit the MCAN or exemption request. Both the 
manufacturer or importer and the agent must sign the certification 
required in paragraph (b) of this section.
    (2) A manufacturer or importer may authorize another person (e.g., a 
foreign manufacturer or supplier, or a toll manufacturer) to report some 
of the information required in the MCAN or exemption request to EPA on 
its behalf. If separate portions of a joint submission are not submitted 
together, the submitter must indicate which information will be supplied 
by another person and identify that person. The manufacturer or importer 
and any other person supplying the information must sign the 
certification required by paragraph (b) of this section.
    (3) If EPA receives a submission which does not include the 
information required, which the submitter indicates that it has 
authorized another person to provide, the review period will not begin 
until EPA receives all of the required information.
    (f) Microorganisms subject to a section 4 test rule. (1) Except as 
provided in paragraph (f)(3) of this section, if a person

[[Page 407]]

intends to manufacture or import a new microorganism which is subject to 
the notification requirements of this part, and the microorganism is 
subject to a test rule promulgated under section 4 of the Act before the 
notice is submitted, section 5(b)(1) of the Act requires the person to 
submit the test data required by the testing rule with the notice. The 
person must submit the data in the form and manner specified in the test 
rule and in accordance with Sec. 725.160. If the person does not submit 
the test data, the submission is incomplete and EPA will follow the 
procedures in Sec. 725.33.
    (2) If EPA has granted the submitter an exemption under section 4(c) 
of the Act from the requirement to conduct tests and submit data, the 
person may not file a MCAN or TERA until EPA receives the test data.
    (3) If EPA has granted the submitter an exemption under section 4(c) 
of the Act and if another person previously has submitted the test data 
to EPA, the exempted person may either submit the test data or provide 
the following information as part of the notice:
    (i) The name, title, and address of the person who submitted the 
test data to EPA.
    (ii) The date the test data were submitted to EPA.
    (iii) A citation for the test rule.
    (iv) A description of the exemption and a reference identifying it.
    (g) Microorganisms subject to a section 5(b)(4) rule. (1) If a 
person:
    (i) Intends to manufacture or import a microorganism which is 
subject to the notification requirements of this part and which is 
subject to a rule issued under section 5(b)(4) of the Act; and
    (ii) Is not required by a rule issued under section 4 of the Act to 
submit test data for the microorganism before the filing of a 
submission, the person must submit to EPA data described in paragraph 
(g)(2) of this section at the time the submission is filed.
    (2) Data submitted under paragraph (g)(1) of this section must be 
data which the person submitting the notice believes show that the 
manufacture, processing, distribution in commerce, use, and disposal of 
the microorganism, or any combination of such activities, will not 
present an unreasonable risk of injury to health or the environment.
    (h) Data that need not be submitted. Specific data requirements are 
listed in subparts D, E, F, G, and L of this part. The following is a 
list of data that need not be submitted under this part:
    (1) Data previously submitted to EPA. (i) A person need not submit 
any data previously submitted to EPA with no claims of confidentiality 
if the new submission includes: the office or person to whom the data 
were submitted; the date of submission; and, if appropriate, a standard 
literature citation as specified in Sec. 725.160(a)(3)(ii).
    (ii) For data previously submitted to EPA with a claim of 
confidentiality, the person must resubmit the data with the new 
submission and any claim of confidentiality, under Sec. 725.80.
    (2) Efficacy data. This part does not require submission of any data 
related solely to product efficacy. However, including efficacy data 
will improve EPA's ability to assess the benefits of the use of the 
microorganism. This does not exempt a person from submitting any of the 
data specified in Sec. 725.160 or 725.260.
    (3) Non-U.S. exposure data. This part does not require submission of 
any data which relates only to exposure of humans or the environment 
outside the United States. This does not exclude nonexposure data such 
as data on health effects (including epidemiological studies), 
ecological effects, physical and chemical properties, or environmental 
fate characteristics.



Sec. 725.27  Submissions.

    Each person who is required to submit information under this part 
must submit the information in the form and manner set forth in the 
appropriate subpart.
    (a) Requirements specific to MCANs are described in Secs. 725.150 
through 725.160.
    (b) Requirements specific to TERAs are described in Secs. 725.250 
through 725.260.
    (c) Requirements specific to test marketing exemptions (TMEs) are 
described in Secs. 725.350 and 725.355.

[[Page 408]]

    (d) Requirements specific to Tier I and Tier II exemptions for 
certain general commercial uses are described in Secs. 725.424 through 
725.470.
    (e) Additional requirements specific to significant new uses for 
microorganisms are described at Sec. 725.950.



Sec. 725.28  Notice that submission is not required.

    When EPA receives a MCAN or exemption request, EPA will review it to 
determine whether the microorganism is subject to the requirements of 
this part. If EPA determines that the microorganism is not subject to 
these requirements, EPA will notify the submitter that section 5 of the 
Act does not prevent the manufacture, import, or processing of the 
microorganism and that the submission is not needed.



Sec. 725.29  EPA acknowledgement of receipt of submission.

    (a) EPA will acknowledge receipt of each submission by sending the 
submitter a letter that identifies the number assigned to each MCAN or 
exemption request and the date on which the review period begins. The 
review period will begin on the date the MCAN or exemption request is 
received by the Office of Pollution Prevention and Toxics Document 
Control Officer.
    (b) The acknowledgement does not constitute a finding by EPA that 
the submission is in compliance with this part.



Sec. 725.32  Errors in the submission.

    (a) Within 30 days of receipt of the submission, EPA may request 
that the submitter remedy errors in the submission. The following are 
examples of such errors:
    (1) Failure to date the submission.
    (2) Typographical errors that cause data to be misleading or answers 
to any questions to be unclear.
    (3) Contradictory information.
    (4) Ambiguous statements or information.
    (b) In the request to correct the submission, EPA will explain the 
action which the submitter must take to correct the submission.
    (c) If the submitter fails to correct the submission within 15 days 
of receipt of the request, EPA may extend the review period.



Sec. 725.33  Incomplete submissions.

    (a) A submission under this part is not complete, and the review 
period does not begin, if:
    (1) The wrong person files the submission.
    (2) The submitter does not attach and sign the certification 
statement as required by Sec. 725.25(b).
    (3) Some or all of the information in the submission or any 
attachments are not in English, except for published scientific 
literature.
    (4) The submitter does not provide information that is required by 
sections 5(d)(1)(B) and (C) of the Act and Sec. 725.160 or 725.260, as 
appropriate.
    (5) The submitter does not provide information required by 
Sec. 725.25, 725.155, 725.255, 725.355, or 725.455, as appropriate, or 
indicate that it is not known to or reasonably ascertainable by the 
submitter.
    (6) The submitter has asserted confidentiality claims and has failed 
to:
    (i) Submit a second copy of the submission with all confidential 
information deleted for the public file, as required by 
Sec. 725.80(b)(2).
    (ii) Comply with the substantiation requirements as described in 
Sec. 725.94.
    (7) The submitter does not include any information required by 
section 5(b)(1) of the Act and pursuant to a rule promulgated under 
section 4 of the Act, as required by Sec. 725.25(f).
    (8) The submitter does not submit data which the submitter believes 
show that the microorganism will not present an unreasonable risk of 
injury to health or the environment, if EPA has listed the microorganism 
under section 5(b)(4) of the Act, as required in Sec. 725.25(g).
    (9) For MCANs, the submitter does not remit the fees required by 
Sec. 700.45(b)(1) or (b)(2)(vi) of this chapter.
    (b)(1) If EPA receives an incomplete submission under this part, the 
Director, or a designee, will notify the submitter within 30 days of 
receipt that the submission is incomplete and that the review period 
will not begin until EPA receives a complete submission.
    (2) If EPA obtains additional information during the review period 
for

[[Page 409]]

any submission that indicates the original submission was incomplete, 
the Director, or a designee, may declare the submission incomplete 
within 30 days after EPA obtains the additional information and so 
notify the submitter.
    (c) The notification that a submission is incomplete under paragraph 
(b) of this section will include:
    (1) A statement of the basis of EPA's determination that the 
submission is incomplete.
    (2) The requirements for correcting the incomplete submission.
    (3) Information on procedures under paragraph (d) of this section 
for filing objections to the determination or requesting modification of 
the requirements for completing the submission.
    (d) Within 10 days after receipt of notification by EPA that a 
submission is incomplete, the submitter may file written objections 
requesting that EPA accept the submission as complete or modify the 
requirements necessary to complete the submission.
    (e)(1) EPA will consider the objections filed by the submitter. The 
Director, or a designee, will determine whether the submission was 
complete or incomplete, or whether to modify the requirements for 
completing the submission. EPA will notify the submitter in writing of 
EPA's response within 10 days of receiving the objections.
    (2) If the Director, or a designee, determines, in response to the 
objection, that the submission was complete, the review period will be 
deemed suspended on the date EPA declared the submission incomplete, and 
will resume on the date that the submission is declared complete. The 
submitter need not correct the submission as EPA originally requested. 
If EPA can complete its review within the review period beginning on the 
date of the submission, the Director, or a designee, may inform the 
submitter that the running of the review period will resume on the date 
EPA originally declared it incomplete.
    (3) If the Director, or a designee, modifies the requirements for 
completing the submission or concurs with EPA's original determination, 
the review period will begin when EPA receives a complete submission.
    (f) If EPA discovers at any time that a person submitted materially 
false or misleading statements in information submitted under this part, 
EPA may find that the submission was incomplete from the date it was 
submitted, and take any other appropriate action.



Sec. 725.36  New information.

    (a) During the review period, if a submitter possesses, controls, or 
knows of new information that materially adds to, changes, or otherwise 
makes significantly more complete the information included in the MCAN 
or exemption request, the submitter must send that information to the 
address listed in Sec. 725.25(c) within 10 days of receiving the new 
information, but no later than 5 days before the end of the review 
period.
    (b) The new submission must clearly identify the submitter, the MCAN 
or exemption request to which the new information is related, and the 
number assigned to that submission by EPA, if known to the submitter.
    (c) If the new information becomes available during the last 5 days 
of the review period, the submitter must immediately inform the EPA 
contact for that submission by telephone of the new information.



Sec. 725.40  Notice in the Federal Register.

    (a) Filing of Federal Register notice. After EPA receives a MCAN or 
an exemption request under this part, EPA will issue a notice in the 
Federal Register including the information specified in paragraph (b) of 
this section.
    (b) Contents of notice. (1) In the public interest, the specific 
microorganism identity listed in the submission will be published in the 
Federal Register unless the submitter has claimed the microorganism 
identity confidential. If the submitter claims confidentiality, a 
generic name will be published in accordance with Sec. 725.85.
    (2) The categories of use of the microorganism will be published as 
reported

[[Page 410]]

in the submission unless this information is claimed confidential. If 
confidentiality is claimed, the generic information which is submitted 
under Sec. 725.88 will be published.
    (3) A list of information submitted in accordance with 
Sec. 725.160(a), 725.255, 725.260, 725.355, or 725.455, as appropriate, 
will be published.
    (4) The submitter's identity will be published, unless the submitter 
has claimed it confidential.
    (c) Publication of exemption decisions. Following the expiration of 
the appropriate review period for the exemption request, EPA will issue 
a notice in the Federal Register indicating whether the request has been 
approved or denied and the reasons for the decision.



Sec. 725.50  EPA review.

    (a) MCANs. The review period specified in section 5(a) of the Act 
for MCANs runs for 90 days from the date the Document Control Officer 
receives a complete submission, or the date EPA determines the 
submission is complete under Sec. 725.33, unless the Agency extends the 
review period under section 5(c) of the Act and Sec. 725.56.
    (b) Exemption requests. The review period starts on the date the 
Document Control Officer receives a complete exemption request, or the 
date EPA determines the request is complete under Sec. 725.33, unless 
the Agency extends the review period under Sec. 725.56. The review 
periods for exemption requests run as follows:
    (1) TERAs. The review period for TERAs is 60 days.
    (2) TMEs. The review period for TMEs is 45 days.
    (3) Tier II exemption requests. The review period for Tier II 
exemption requests is 45 days.



Sec. 725.54  Suspension of the review period.

    (a) A submitter may voluntarily suspend the running of the review 
period if the Director, or a designee, agrees. If the Director does not 
agree, the review period will continue to run, and EPA will notify the 
submitter. A submitter may request a suspension at any time during the 
review period. The suspension must be for a specified period of time.
    (b) A request for suspension may be made in writing to the address 
listed in Sec. 725.25(c). The suspension also may be made orally, 
including by telephone, to the submitter's EPA contact for that 
submission. EPA will send the submitter a written confirmation that the 
suspension has been granted.
    (1) An oral request may be granted for no longer than 15 days. To 
obtain a longer suspension, the Document Control Officer for the Office 
of Pollution Prevention and Toxics must receive written confirmation of 
the oral request. The review period is suspended as of the date of the 
oral request.
    (2) If the submitter has not made a previous oral request, the 
running of the review period is suspended as of the date of receipt of 
the written request by the Document Control Officer for the Office of 
Pollution Prevention and Toxics.



Sec. 725.56  Extension of the review period.

    (a) At any time during the review period, EPA may unilaterally 
determine that good cause exists to extend the review period specified 
for MCANs, or the exemption requests.
    (b) If EPA makes such a determination, EPA:
    (1) Will notify the submitter that EPA is extending the review 
period for a specified length of time and state the reasons for the 
extension.
    (2) For MCANs, EPA may issue a notice for publication in the Federal 
Register which states that EPA is extending the review period and gives 
the reasons for the extension.
    (c) The total period of the extension may be for a period of up to 
the same length of time as specified for each type of submission in 
Sec. 725.50. If the initial extension is for less than the total time 
allowed, EPA may make additional extensions. However, the sum of the 
extensions may not exceed the total allowed.
    (d) The following are examples of situations in which EPA may find 
that good cause exists for extending the review period:
    (1) EPA has reviewed the submission and is seeking additional 
information.

[[Page 411]]

    (2) EPA has received significant additional information during the 
review period.
    (3) The submitter has failed to correct a submission after receiving 
EPA's request under Sec. 725.32.
    (4) EPA has reviewed the submission and determined that there is a 
significant possibility that the microorganism will be regulated under 
section 5(e) or section 5(f) of the Act, but EPA is unable to initiate 
regulatory action within the initial review period.



Sec. 725.60  Withdrawal of submission by the submitter.

    (a) A submitter may withdraw a submission during the review period. 
A statement of withdrawal must be made in writing to the address listed 
in Sec. 725.25(c). The withdrawal is effective upon receipt of the 
statement by the Document Control Officer.
    (b) If a manufacturer, importer, or processor who withdrew a 
submission later resubmits a submission for the same microorganism, a 
new review period begins.



Sec. 725.65  Recordkeeping.

    (a) General provisions. (1) Any person who submits a notice under 
this part must retain documentation of information in the submission, 
including:
    (i) Any data in the submitter's possession or control; and
    (ii) Records of production volume for the first 3 years of 
manufacture, import, or processing.
    (2) Any person who submits a notice under this part must retain 
documentation of the date of commencement of testing, manufacture, 
import, or processing.
    (3) Any person who is exempt from some or all of the reporting 
requirements of this part must retain documentation that supports the 
exemption.
    (4) All information required by this section must be retained for 3 
years from the date of commencement of each activity for which records 
are required under this part.
    (b) Specific requirements. In addition to the requirements of 
paragraph (a) of this section, specific recordkeeping requirements 
included in certain subparts must also be followed.
    (1) Additional recordkeeping requirements for activities conducted 
inside a structure are set forth in Sec. 725.235(h).
    (2) Additional recordkeeping requirements for TERAs are set forth in 
Sec. 725.250(f).
    (3) Additional recordkeeping requirements for TMEs are set forth in 
Sec. 725.350(c).
    (4) Additional recordkeeping requirements for Tier I exemptions 
under subpart G of this part are set forth in Sec. 725.424(a)(5).
    (5) Additional recordkeeping requirements for Tier II exemptions 
under subpart G of this part are set forth in Sec. 725.450(d).
    (6) Additional recordkeeping requirements for significant new uses 
of microorganisms reported under subpart L of this part are set forth in 
Sec. 725.850. Recordkeeping requirements may also be included when a 
microorganism and significant new use are added to subpart M of this 
part.



Sec. 725.67  Applications to exempt new microorganisms from this part.

    (a) Submission. (1) Any manufacturer or importer of a new 
microorganism may request, under section 5(h)(4) of the Act, an 
exemption, in whole or in part, from this part by sending a Letter of 
Application to the Chief, New Chemicals Branch, Chemical Control 
Division, Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    (2) General provisions. The Letter of Application should provide 
information to show that any activities affected by the requested 
exemption will not present an unreasonable risk of injury to health or 
the environment. This information should include data described in the 
following paragraphs.
    (i) The effects of the new microorganism on health and the 
environment.
    (ii) The magnitude of exposure of human beings and the environment 
to the new microorganism.
    (iii) The benefits of the new microorganism for various uses and the 
availability of substitutes for such uses.
    (iv) The reasonably ascertainable economic consequences of granting 
or

[[Page 412]]

denying the exemption, including effects on the national economy, small 
business, and technological innovation.
    (3) Specific requirements. In addition to the requirements of 
paragraph (a)(2) of this section, the specific information requirements 
of the relevant subpart under which the exemption is sought should be 
met.
    (i) Exemption from MCAN reporting under subpart D. Information 
requirements are set forth in Secs. 725.155 and 725.160.
    (ii) Exemption from TERA reporting under subpart E. Information 
requirements are set forth in Secs. 725.255 and 725.260.
    (iii) Listing a recipient microorganism as eligible for exemption 
under subpart G. Information regarding the following criteria should be 
addressed in an application to list a recipient microorganism under 
Sec. 725.420:
    (A) Identification and classification of the microorganism using 
available genotypic and phenotypic information;
    (B) Information to evaluate the relationship of the microorganism to 
any other closely related microorganisms which have a potential for 
adverse effects on health or the environment;
    (C) A history of safe commercial use for the microorganism;
    (D) Commercial uses indicating that the microorganism products might 
be subject to TSCA;
    (E) Studies which indicate the potential for the microorganism to 
cause adverse effects to health or the environment; and
    (F) Studies which indicate the survival characteristics of the 
microorganism in the environment.
    (b) Processing of the Letter of Application by EPA--(1) Grant of the 
Application. If, after consideration of the Letter of Application and 
any other relevant information available to EPA, the Assistant 
Administrator for Prevention, Pesticides and Toxic Substances makes a 
preliminary determination that the new microorganism will not present an 
unreasonable risk of injury to health or the environment, the Assistant 
Administrator will propose a rule to grant the exemption using the 
applicable procedures in part 750 of this chapter.
    (2) Denial of the application. If the Assistant Administrator 
decides that the preliminary determination described in paragraph (b)(1) 
of this section cannot be made, the application will be denied by 
sending the applicant a written statement with the Assistant 
Administrator's reasons for denial.
    (c) Processing of the exemption--(1) Unreasonable risk standard. 
Granting a section 5(h)(4) exemption requires a determination that the 
activities will not present an unreasonable risk of injury to health or 
the environment.
    (i) An unreasonable risk determination under the Act is an 
administrative judgment that requires balancing of the harm to health or 
the environment that a chemical substance may cause and the magnitude 
and severity of that harm, against the social and economic effects on 
society of EPA action to reduce that harm.
    (ii) A determination of unreasonable risk under section 5(h)(4) of 
the Act will examine the reasonably ascertainable economic and social 
consequences of granting or denying the exemption after consideration of 
the effect on the national economy, small business, technological 
innovation, the environment, and public health.
    (2) Grant of the exemption. The exemption will be granted if the 
Assistant Administrator determines, after consideration of all relevant 
evidence presented in the rulemaking proceeding described in paragraph 
(b)(1) of this section, that the new microorganism will not present an 
unreasonable risk of injury to health or the environment.
    (3) Denial of the exemption. The exemption will be denied if the 
Assistant Administrator determines, after consideration of all relevant 
evidence presented in the rulemaking proceeding described in paragraph 
(b)(1) of this section, that the determination described in paragraph 
(c)(2) of this section cannot be made. A final decision terminating the 
rulemaking proceeding will be published in the Federal Register.



Sec. 725.70  Compliance.

    (a) Failure to comply with any provision of this part is a violation 
of section 15 of the Act (15 U.S.C. 2614).

[[Page 413]]

    (b) A person who manufactures or imports a microorganism before a 
MCAN is submitted and the MCAN review period expires is in violation of 
section 15 of the Act even if that person was not required to submit the 
MCAN under Sec. 725.105.
    (c) Using a microorganism which a person knew or had reason to know 
was manufactured, processed, or distributed in commerce in violation of 
section 5 of the Act or this part is a violation of section 15 of the 
Act (15 U.S.C. 2614).
    (d) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (e) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 
2614).
    (f) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who 
submit materially misleading or false information in connection with the 
requirements of any provision of this part may be subject to penalties 
calculated as if they never filed their submissions.
    (g) EPA may seek to enjoin the manufacture or processing of a 
microorganism in violation of this part or act to seize any 
microorganism manufactured or processed in violation of this part or 
take other actions under the authority of section 7 of the Act (15 
U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).



Sec. 725.75  Inspections.

    EPA will conduct inspections under section 11 of the Act to assure 
compliance with section 5 of the Act and this part, to verify that 
information required by EPA under this part is true and correct, and to 
audit data submitted to EPA under this part.



       Subpart C--Confidentiality and Public Access to Information



Sec. 725.80  General provisions for confidentiality claims.

    (a) A person may assert a claim of confidentiality for any 
information submitted to EPA under this part. However,
    (1) Any person who asserts a claim of confidentiality for portions 
of the specific microorganism identity must provide the information as 
described in Sec. 725.85.
    (2) Any person who asserts a claim of confidentiality for a use of a 
microorganism must provide the information as described in Sec. 725.88.
    (3) Any person who asserts a claim of confidentiality for 
information contained in a health and safety study of a microorganism 
must provide the information described in Sec. 725.92.
    (b) Any claim of confidentiality must accompany the information when 
it is submitted to EPA.
    (1) When a person submits any information under this part, including 
any attachments, for which claims of confidentiality are made, the 
claim(s) must be asserted by circling the specific information which is 
claimed and marking the page on which that information appears with an 
appropriate designation such as ``trade secret,'' ``TSCA CBI,'' or 
``confidential business information.''
    (2) If any information is claimed confidential, the person must 
submit two copies of the document including the claimed information.
    (i) One copy of the document must be complete. In that copy, the 
submitter must mark the information which is claimed as confidential in 
the manner prescribed in paragraph (b)(1) of this section.
    (ii) The second copy must be complete except that all information 
claimed as confidential in the first copy must be deleted. EPA will 
place the second copy in the public file.
    (iii) If the submitter does not provide the second copy, the 
submission is incomplete and the review period does not begin to run 
until EPA receives the second copy, in accordance with Sec. 725.33.
    (iv) Any information contained within the copy submitted under 
paragraph (b)(2)(ii) of this section which has been in the public file 
for more than 30 days will be presumed to be in the public domain, 
notwithstanding any assertion of confidentiality made under this 
section.
    (3) A person who submits information to EPA under this part must 
reassert a

[[Page 414]]

claim of confidentiality and substantiate the claim each time the 
information is submitted to EPA.
    (c) Any person asserting a claim of confidentiality under this part 
must substantiate each claim in accordance with the requirements in 
Sec. 725.94.
    (d) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent permitted 
by the Act, this subpart, and part 2 of this title.
    (e) If a submitter does not assert a claim of confidentiality for 
information at the time it is submitted to EPA, EPA may make the 
information public and place it in the public file without further 
notice to the submitter.



Sec. 725.85  Microorganism identity.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import for general commercial use--(1) When to make a 
claim. (i) A person who submits information to EPA under this part may 
assert a claim of confidentiality for portions of the specific 
microorganism identity at the time of submission of the information. 
This claim will apply only to the period prior to the commencement of 
manufacture or import for general commercial use.
    (ii) A person who submits information to EPA under this part must 
reassert a claim of confidentiality and substantiate the claim each time 
the information is submitted to EPA. For example, if a person claims 
certain information confidential in a TERA submission and wishes the 
same information to remain confidential in a subsequent TERA or MCAN 
submission, the person must reassert and resubstantiate the claim in the 
subsequent submission.
    (2) Assertion of claim. (i) A submitter may assert a claim of 
confidentiality only if the submitter believes that public disclosure 
prior to commencement of manufacture or import for general commercial 
use of the fact that anyone is initiating research and development 
activities pertaining to the specific microorganism or intends to 
manufacture or import the specific microorganism for general commercial 
use would reveal confidential business information. Claims must be 
substantiated in accordance with the requirements of Sec. 725.94(a).
    (ii) If the submission includes a health and safety study concerning 
the microorganism and if the claim for confidentiality with respect to 
the specific identity is denied in accordance with Sec. 725.92(c), EPA 
will deny a claim asserted under paragraph (a) of this section.
    (3) Development of generic name. Any person who asserts a claim of 
confidentiality for portions of the specific microorganism identity 
under this paragraph must provide one of the following items at the time 
the submission is filed:
    (i) The generic name which was accepted by EPA in the prenotice 
consultation conducted under paragraph (a)(4) of this section.
    (ii) One generic name that is only as generic as necessary to 
protect the confidential identity of the particular microorganism. The 
name should reveal the specific identity to the maximum extent possible. 
The generic name will be subject to EPA review and approval.
    (4) Determination by EPA. (i) Any person who intends to assert a 
claim of confidentiality for the specific identity of a new 
microorganism may seek a determination by EPA of an appropriate generic 
name for the microorganism before filing a submission. For this purpose, 
the person should submit to EPA:
    (A) The specific identity of the microorganism.
    (B) A proposed generic name(s) which is only as generic as necessary 
to protect the confidential identity of the new microorganism. The 
name(s) should reveal the specific identity of the microorganism to the 
maximum extent possible.
    (ii) Within 30 days, EPA will inform the submitter either that one 
of the proposed generic names is adequate or that none is adequate and 
further consultation is necessary.
    (5) Use of generic name. If a submitter claims microorganism 
identity as confidential under paragraph (a) of this section, and if the 
submitter complies with paragraph (a)(2) of this section, EPA will issue 
for publication in the

[[Page 415]]

Federal Register notice described in Sec. 725.40 the generic name 
proposed by the submitter or one agreed upon by EPA and the submitter.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use--(1) Maintaining claim. 
Any claim of confidentiality under paragraph (a) of this section is 
applicable only until the microorganism is manufactured or imported for 
general commercial use and becomes eligible for inclusion on the 
Inventory. To maintain the confidential status of the microorganism 
identity when the microorganism is added to the Inventory, a submitter 
must reassert the confidentiality claim and substantiate the claim in 
the notice of commencement of manufacture required under Sec. 725.190.
    (i) A submitter may not claim the microorganism identity 
confidential for the period after commencement of manufacture or import 
for general commercial use unless the submitter claimed the 
microorganism identity confidential under paragraph (a) of this section 
in the MCAN submitted for the microorganism.
    (ii) A submitter may claim the microorganism identity confidential 
for the period after commencement of manufacture or import for general 
commercial use if the submitter did not claim the microorganism identity 
confidential under paragraph (a) of this section in any TERA submitted 
for the microorganism, but subsequently did claim microorganism identity 
confidential in the MCAN submitted for the microorganism.
    (2) Assertion of claim. (i) A person who believes that public 
disclosure of the fact that anyone manufactures or imports the 
microorganism for general commercial use would reveal confidential 
business information may assert a claim of confidentiality under 
paragraph (b) of this section.
    (ii) If the notice includes a health and safety study concerning the 
new microorganism, and if the claim for confidentiality with respect to 
the microorganism identity is denied in accordance with Sec. 725.92(c), 
EPA will deny a claim asserted under paragraph (b) of this section.
    (3) Requirements for assertion. Any person who asserts a 
confidentiality claim for microorganism identity must:
    (i) Comply with the requirements of paragraph (a)(3) of this section 
regarding submission of a generic name.
    (ii) Agree that EPA may disclose to a person with a bona fide intent 
to manufacture or import the microorganism the fact that the particular 
microorganism is included on the confidential Inventory for purposes of 
notification under section 5(a)(1)(A) of the Act.
    (iii) Have available and agree to furnish to EPA upon request the 
taxonomic designations and supplemental information required by 
Sec. 725.12.
    (iv) Provide a detailed written substantiation of the claim, in 
accordance with the requirements of Sec. 725.94(b).
    (4) Denial of claim. If the submitter does not meet the requirements 
of paragraph (b) of this section, EPA will deny the claim of 
confidentiality.
    (5) Acceptance of claim. (i) EPA will publish a generic name on the 
public Inventory if:
    (A) The submitter asserts a claim of confidentiality in accordance 
with this paragraph.
    (B) No claim for confidentiality of the microorganism identity as 
part of a health and safety study has been denied in accordance with 
part 2 of this title or Sec. 725.92.
    (ii) Publication of a generic name on the public Inventory does not 
create a category for purposes of the Inventory. Any person who has a 
bona fide intent to manufacture or import a microorganism which is 
described by a generic name on the public Inventory may submit an 
inquiry to EPA under Sec. 725.15(b) to determine whether the particular 
microorganism is included on the confidential Inventory.
    (iii) Upon receipt of a request described in Sec. 725.15(b), EPA may 
require the submitter who originally asserted confidentiality for a 
microorganism to submit to EPA the information listed in paragraph 
(b)(3)(iii) of this section.
    (iv) Failure to submit any of the information required under 
paragraph (b)(3)(iii) of this section within 10 calendar days of receipt 
of a request by EPA under paragraph (b) of this section will constitute 
a waiver of the original submitter's confidentiality

[[Page 416]]

claim. In this event, EPA may place the specific microorganism identity 
on the public Inventory without further notice to the original 
submitter.
    (6) Use of generic name on the public Inventory. If a submitter 
asserts a claim of confidentiality under paragraph (b) of this section, 
EPA will examine the generic microorganism name proposed by the 
submitter.
    (i) If EPA determines that the generic name proposed by the 
submitter is only as generic as necessary to protect the confidential 
identity of the particular microorganism, EPA will place that generic 
name on the public Inventory.
    (ii) If EPA determines that the generic name proposed by the 
submitter is more generic than necessary to protect the confidential 
identity, EPA will propose in writing, for review by the submitter, an 
alternative generic name that will reveal the identity of the 
microorganism to the maximum extent possible.
    (iii) If the generic name proposed by EPA is acceptable to the 
submitter, EPA will place that generic name on the public Inventory.
    (iv) If the generic name proposed by EPA is not acceptable to the 
submitter, the submitter must explain in detail why disclosure of that 
generic name would reveal confidential business information and propose 
another generic name which is only as generic as necessary to protect 
the confidential identity of the microorganism. If EPA does not receive 
a response from the submitter within 30 days after the submitter 
receives the proposed name, EPA will place EPA's chosen generic name on 
the public Inventory. If the submitter does provide the information 
requested, EPA will review the response. If the submitter's proposed 
generic name is acceptable, EPA will publish that generic name on the 
public Inventory. If the submitter's proposed generic name is not 
acceptable, EPA will notify the submitter of EPA's choice of a generic 
name. Thirty days after this notification, EPA will place the chosen 
generic name on the public Inventory.



Sec. 725.88  Uses of a microorganism.

    (a) Assertion of claim. A person who submits information to EPA 
under this part on the categories or proposed categories of use of a 
microorganism may assert a claim of confidentiality for this 
information.
    (b) Requirements for claim. A submitter that asserts such a claim 
must:
    (1) Report the categories or proposed categories of use of the 
microorganism.
    (2) Provide, in nonconfidential form, a description of the uses that 
is only as generic as necessary to protect the confidential business 
information. The generic use description will be included in the Federal 
Register notice described in Sec. 725.40.
    (c) Generic use description. The person must submit the information 
required by paragraph (b) of this section by describing the uses as 
precisely as possible, without revealing the information which is 
claimed confidential, to disclose as much as possible how the use may 
result in human exposure to the microorganism or its release to the 
environment.



Sec. 725.92  Data from health and safety studies of microorganisms.

    (a) Information other than specific microorganism identity. Except 
as provided in paragraph (b) of this section, EPA will deny any claim of 
confidentiality with respect to information included in a health and 
safety study of a microorganism, unless the information would disclose 
confidential business information concerning:
    (1) Processes used in the manufacture or processing of a 
microorganism.
    (2) Information which is not in any way related to the effects of a 
microorganism on health or the environment, such as, the name of the 
submitting company, cost or other financial data, product development or 
marketing plans, and advertising plans, for which the person submits a 
claim of confidentiality in accordance with Sec. 725.80.
    (b) Microorganism identity--(1) Claims applicable to the period 
prior to commencement of manufacture or import for general commercial 
use. A claim of confidentiality for the period prior to commencement of 
manufacture or import

[[Page 417]]

for general commercial use for the specific identity of a microorganism 
for which a health and safety study was submitted must be asserted in 
conjunction with a claim asserted under Sec. 725.85(a). The submitter 
must substantiate each claim in accordance with the requirements of 
Sec. 725.94(a).
    (2) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. To maintain the 
confidential status of the specific identity of a microorganism for 
which a health and safety study was submitted after commencement of 
manufacture or import for general commercial use, the claim must be 
reasserted and substantiated in conjunction with a claim under 
Sec. 725.85(b). The submitter must substantiate each claim in accordance 
with the requirements of Sec. 725.94(b).
    (c) Denial of confidentiality claim. EPA will deny a claim of 
confidentiality for microorganism identity under paragraph (b) of this 
section, unless:
    (1) The information would disclose processes used in the manufacture 
or processing of a microorganism.
    (2) The microorganism identity is not necessary to interpret a 
health and safety study.
    (d) Use of generic names. When EPA discloses a health and safety 
study containing a microorganism identity, which the submitter has 
claimed confidential, and if the Agency has not denied the claim under 
paragraph (c) of this section, EPA will identify the microorganism by 
the generic name selected under Sec. 725.85.



Sec. 725.94  Substantiation requirements.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import for general commercial use--(1) MCAN, TME, Tier I 
certification, and Tier II exemption request requirements. Any person 
who submits a MCAN, TME, Tier I certification, or Tier II exemption 
request should strictly limit confidentiality claims to that information 
which is confidential and proprietary to the business.
    (i) If any information in the submission is claimed as confidential 
business information, the submitter must substantiate each claim by 
submitting written answers to the questions in paragraphs (c), (d), and 
(e) of this section at the time the person submits the information.
    (ii) If the submitter does not provide written substantiation as 
required in paragraph (a)(1)(i) of this section, the submission will be 
considered incomplete and the review period will not begin in accordance 
with Sec. 725.33.
    (2) TERA requirements. Any person who submits a TERA, should 
strictly limit confidentiality claims to that information which is 
confidential and proprietary to the business. If any information in such 
a submission is claimed as confidential business information, the 
submitter must have available for each of those claims, and agree to 
furnish to EPA upon request, written answers to the questions in 
paragraphs (d) and (e) of this section.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. (1) If a submitter 
claimed portions of the microorganism identity confidential in the MCAN 
and wants the identity to be listed on the confidential Inventory, the 
claim must be reasserted and substantiated at the time the Notice of 
Commencement (NOC) is submitted under Sec. 725.190. Otherwise, EPA will 
list the specific microorganism identity on the public Inventory.
    (2) The submitter must substantiate the claim for confidentiality of 
the microorganism identity by answering all of the questions in 
paragraphs (c), (d), and (e) in this section. In addition, the following 
questions must be answered:
    (i) What harmful effects to the company's or institution's 
competitive position, if any, would result if EPA publishes on the 
Inventory the identity of the microorganism? How could a competitor use 
such information given the fact that the identity of the microorganism 
otherwise would appear on the TSCA Inventory with no link between the 
microorganism and the company or institution? How substantial would the 
harmful effects of disclosure be? What is the causal relationship 
between the disclosure and the harmful effects?
    (ii) Has the identity of the microorganism been kept confidential to 
the extent that competitors do not know it

[[Page 418]]

is being manufactured or imported for general commercial use by anyone?
    (c) General questions. The following questions must be answered in 
detail for each confidentiality claim:
    (1) For what period of time is a claim of confidentiality being 
asserted? If the claim is to extend until a certain event or point in 
time, indicate that event or time period. Explain why the information 
should remain confidential until such point.
    (2) Briefly describe any physical or procedural restrictions within 
the company or institution relating to the use and storage of the 
information claimed as confidential. What other steps, if any, apply to 
use or further disclosure of the information?
    (3) Has the information claimed as confidential been disclosed to 
individuals outside of the company or institution? Will it be disclosed 
to such persons in the future? If so, what restrictions, if any, apply 
to use or further disclosure of the information?
    (4) Does the information claimed as confidential appear, or is it 
referred to, in any of the following questions? If the answer is yes to 
any of these questions, indicate where the information appears and 
explain why it should nonetheless be treated as confidential.
    (i) Advertising or promotional materials for the microorganism or 
the resulting end product?
    (ii) Material safety data sheets or other similar materials for the 
microorganism or the resulting end product?
    (iii) Professional or trade publications?
    (iv) Any other media available to the public or to competitors?
    (v) Patents?
    (vi) Local, State, or Federal agency public files?
    (5) Has EPA, another Federal agency, a Federal court, or a State 
made any confidentiality determination regarding the information claimed 
as confidential? If so, provide copies of such determinations.
    (6) For each type of information claimed confidential, describe the 
harm to the company's or institution's competitive position that would 
result if this information were disclosed. Why would this harm be 
substantial? How could a competitor use such information? What is the 
causal connection between the disclosure and harm?
    (7) If EPA disclosed to the public the information claimed as 
confidential, how difficult would it be for the competitor to enter the 
market for the resulting product? Consider such constraints as capital 
and marketing cost, specialized technical expertise, or unusual 
processes.
    (d) Microorganism identity and production method. If confidentiality 
claims are asserted for the identity of the microorganism or information 
on how the microorganism is produced, the following questions must be 
answered:
    (1) Has the microorganism or method of production been patented in 
the U.S. or elsewhere? If so, why is confidentiality necessary?
    (2) Does the microorganism leave the site of production or testing 
in a form which is accessible to the public or to competitors? What is 
the cost to a competitor, in time and money, to develop appropriate use 
conditions? What factors facilitate or impede product analysis?
    (3) For each additional type of information claimed as confidential, 
explain what harm would result from disclosure of each type of 
information if the identity of the microorganism were to remain 
confidential.
    (e) Health and safety studies of microorganisms. If confidentiality 
claims are asserted for information in a health or safety study of a 
microorganism, the following questions must be answered:
    (1) Would the disclosure of the information claimed confidential 
reveal: confidential process information, or information unrelated to 
the effects of the microorganism on health and the environment. Describe 
the causal connection between the disclosure and harm.
    (2) Does the company or institution assert that disclosure of the 
microorganism identity is not necessary to interpret any health and 
safety studies which have been submitted? If so, explain how a less 
specific identity would be sufficient to interpret the studies.

[[Page 419]]



Sec. 725.95  Public file.

    All information submitted, including any health and safety study of 
a microorganism and other supporting documentation, will become part of 
the public file for that submission, unless such materials are claimed 
confidential. In addition, EPA may add materials to the public file, 
unless such materials are claimed confidential. Any of the 
nonconfidential material described in this subpart will be available for 
public inspection in the TSCA Public Docket Office, Rm. NE-B607, 401 M 
St., SW., Washington, DC, between the hours of noon to 4 p.m., Monday 
through Friday, excluding legal holidays.



  Subpart D--Microbial Commercial Activities Notification Requirements



Sec. 725.100  Scope and purpose.

    (a) This subpart establishes procedures for submission of a notice 
to EPA under section 5(a) of the Act for persons who manufacture, 
import, or process microorganisms for commercial purposes. This notice 
is called a Microbial Commercial Activity Notice (MCAN). It is expected 
that MCANs will in general only be submitted for microorganisms intended 
for general commercial use. Persons who manufacture, import, or process 
a microorganism in small quantities solely for research and development 
as defined in Sec. 725.3 are not required to submit a notice to EPA. 
Persons who manufacture, import, or process a microorganism for research 
and development activities that do not fit the definition of small 
quantities solely for research and development may nonetheless qualify 
for more limited reporting requirements in Subpart E, including the TERA 
which can be used for review of research and development involving 
environmental release.
    (b) Persons subject to MCAN submission are described in 
Sec. 725.105.
    (c) Exclusions and exemptions specific to MCAN submissions are 
described in Sec. 725.110.
    (d) Submission requirements applicable specifically to MCANs are 
described at Sec. 725.150.
    (e) Data requirements for MCANs are set forth in Secs. 725.155 and 
725.160.
    (f) EPA review procedures specific to MCANs are set forth in 
Sec. 725.170.
    (g) Subparts A through C of this part apply to any MCAN submitted 
under this subpart.



Sec. 725.105  Persons who must report.

    (a) Manufacturers of new microorganisms. (1) MCAN submission is 
required for any person who intends to manufacture for commercial 
purposes in the United States a new microorganism. Exclusions are 
described in Sec. 725.110.
    (2) If a person contracts with a manufacturer to produce or process 
a new microorganism and the manufacturer produces or processes the 
microorganism exclusively for that person, and that person specifies the 
identity of the microorganism, and controls the total amount produced 
and the basic technology for the plant process, then that person must 
submit the MCAN. If it is unclear who must report, EPA should be 
contacted to determine who must submit the MCAN.
    (3) Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a MCAN.
    (b) Importers of new microorganisms. (1) MCAN submission is required 
for a person who intends to import into the United States for commercial 
purposes a new microorganism. Exclusions are described in Sec. 725.110.
    (2) When several persons are involved in an import transaction, the 
MCAN must be submitted by the principal importer. If no one person fits 
the principal importer definition in a particular transaction, the 
importer should contact EPA to determine who must submit the MCAN for 
that transaction.
    (3) Except as otherwise provided in paragraph (b)(4) of this 
section, the provisions of this subpart D apply to each person who 
submits a MCAN for a new microorganism which such person intends to 
import for a commercial purpose. In addition, each importer must comply 
with paragraph (b)(4) of this section.
    (4) EPA will hold the principal importer, or the importer that EPA 
determines must submit the MCAN when

[[Page 420]]

there is no principal importer under paragraph (b)(2) of this section, 
liable for complying with this part, for completing the MCAN, and for 
the completeness and truthfulness of all information which it submits.
    (c) Manufacturers, importers, or processors of microorganisms for a 
significant new use. MCAN submission is required for any person who 
intends to manufacture, import, or process for commercial purposes a 
microorganism identified as having one or more significant new uses in 
subpart M of this part, and who intends either to engage in a designated 
significant new use of the microorganism or intends to distribute it in 
commerce. Persons excluded from reporting on significant new uses of 
microorganisms and additional procedures for reporting are described in 
subpart L of this part.



Sec. 725.110  Persons not subject to this subpart.

    Persons are not subject to the requirements of this subpart for the 
following activities:
    (a) Manufacturing, importing, or processing solely for research and 
development microorganisms that meet the requirements for an exemption 
under subpart E of this part.
    (b) Manufacturing, importing, or processing microorganisms for test 
marketing activities which have been granted an exemption under subpart 
F of this part.
    (c) Manufacturing or importing new microorganisms under the 
conditions of a Tier I or Tier II exemption under subpart G of this 
part.



Sec. 725.150  Procedural requirements for this subpart.

    General requirements for all MCANs under this part are contained in 
subparts A through C of this part. In addition, the following 
requirements apply to MCANs submitted under this subpart:
    (a) When to submit a MCAN. A MCAN must be submitted at least 90 
calendar days prior to manufacturing or importing a new microorganism 
and at least 90 calendar days prior to manufacturing, importing, or 
processing a microorganism for a significant new use.
    (b) Section 5(b) of the Act. The submitter must comply with any 
applicable requirement of section 5(b) of the Act for the submission of 
test data.
    (c) Contents of a MCAN. Each person who submits a MCAN under this 
subpart must provide the information and test data described in 
Secs. 725.155 and 725.160.
    (d) Recordkeeping. Each person who submits a MCAN under this subpart 
must comply with the recordkeeping requirements of Sec. 725.65.



Sec. 725.155  Information to be included in the MCAN.

    (a) Each person who is required by this part to submit a MCAN must 
include the information specified in paragraphs (c) through (h) of this 
section, to the extent it is known to or reasonably ascertainable by 
that person. However, no person is required to include information which 
relates solely to exposure of humans or ecological populations outside 
of the United States.
    (b) Each person should also submit, in writing, all other 
information known to or reasonably ascertainable by that person that 
would permit EPA to make a reasoned evaluation of the health and 
environmental effects of the microorganism, or any microbial mixture or 
article, including information on its effects on humans, animals, 
plants, and other microorganisms, and in the environment. The 
information to be submitted under this subpart includes the information 
listed in paragraphs (c) through (h) of this section relating to the 
manufacture, processing, distribution in commerce, use, and disposal of 
the new microorganism.
    (c) Submitter identification. (1) The name and headquarters address 
of the submitter.
    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (d) Microorganism identity information. Persons must submit 
sufficient information to allow the microorganism to be accurately and 
unambiguously identified for listing purposes as required by 
Sec. 725.12.
    (1) Description of the recipient microorganism and the new 
microorganism. (i)

[[Page 421]]

Data substantiating the taxonomy of the recipient microorganism and the 
new microorganism to the level of strain, as appropriate. In lieu of 
data, EPA will accept a letter from a culture collection substantiating 
taxonomy, provided EPA, upon request to the submitter, may have access 
to the data supporting the taxonomic designation.
    (ii) Information on the morphological and physiological features of 
the new microorganism.
    (iii) Other specific data by which the new microorganism may be 
uniquely identified for Inventory purposes.
    (2) Genetic construction of the new microorganism. (i) Data 
substantiating the taxonomy of the donor organism(s). In lieu of data, 
EPA will accept a letter from a culture collection substantiating 
taxonomy, provided EPA, upon request to the submitter, may have access 
to the data supporting the taxonomic designation.
    (ii) Description of the traits for which the new microorganism has 
been selected or developed and other traits known to have been added or 
modified.
    (iii) A detailed description of the genetic construction of the new 
microorganism, including the technique used to modify the microorganism 
(e.g., fusion of cells, injection of DNA, electroporation or chemical 
poration, or methods used for induced mutation and selection). The 
description should include, for example, a description of the introduced 
genetic material, including any regulatory sequences and structural 
genes and the products of those genes; how the introduced genetic 
material is expected to affect behavior of the recipient; expression, 
alteration, and stability of the introduced genetic material; methods 
for vector construction and introduction; and a description of the 
regulatory and structural genes that are components of the introduced 
genetic material, including genetic maps of the introduced sequences.
    (3) Phenotypic and ecological characteristics. (i) Habitat, 
geographical distribution, and source of the recipient microorganism.
    (ii) Survival and dissemination under relevant environmental 
conditions including a description of methods for detecting the new or 
recipient microorganism(s) in the environment and the sensitivity limit 
of detection for these techniques.
    (iii) A description of anticipated biological interactions with and 
effects on target organisms and other organisms such as competitors, 
prey, hosts, symbionts, parasites, and pathogens; a description of host 
range; a description of pathogenicity, infectivity, toxicity, virulence, 
or action as a vector of pathogens; and capacity for genetic transfer 
under laboratory and relevant environmental conditions.
    (iv) A description of anticipated involvement in biogeochemical or 
biological cycling processes, involvement in rate limiting steps in 
mineral or nutrient cycling, or involvement in inorganic compounds 
cycling (such as possible sequestration or transformation of heavy 
metals).
    (e) Byproducts. A description of the byproducts resulting from the 
manufacture, processing, use, and disposal of the new microorganism.
    (f) Total production volume. The estimated maximum amount of the new 
microorganism intended to be manufactured or imported during the first 
year of production and the estimated maximum amount to be manufactured 
or imported during any consecutive 12-month period during the first 3 
years of production. This estimate may be by weight or volume and should 
include an estimation of viability (i.e., viable cells per unit volume 
or colony forming units per unit dry weight).
    (g) Use information. A description of intended categories of use by 
function and application, the estimated percent of production volume 
devoted to each category of use, and the percent of the new 
microorganism in the formulation for each commercial or consumer use.
    (h) Worker exposure and environmental release. (1) For sites 
controlled by the submitter:
    (i) The identity of sites where the new microorganism will be 
manufactured, processed, or used. For purposes of this section, the site 
for a person who imports a new microorganism is the site of the 
operating unit within the person's organization which is directly 
responsible for importing the new microorganism and which controls the 
import transaction. The import

[[Page 422]]

site may in some cases be the organization's headquarters office in the 
United States.
    (ii) A process description of each manufacture, processing, and use 
operation, which includes a diagram of the major unit operations and 
conversions, the identity and entry point of all feedstocks, and the 
identity of any possible points of release of the new microorganism from 
the process, including a description of all controls, including 
engineering controls, used to prevent such releases.
    (iii) Worker exposure information, including worker activities, 
physical form of process streams which contain the new microorganism to 
which workers may be exposed, the number of workers, and the duration of 
activities.
    (iv) Information on release of the new microorganism to the 
environment, including the quantity and media of release and type of 
control technology used.
    (v) A narrative description of the intended transport of the new 
microorganism, including the means of transport, containment methods to 
be used during transport, and emergency containment procedures to be 
followed in case of accidental release.
    (vi) Procedures for disposal of any articles, waste, clothing, or 
other equipment involved in the activity, including procedures for 
inactivation of the new microorganism, containment, disinfection, and 
disposal of contaminated items.
    (2) For sites not controlled by the submitter, a description of each 
type of processing and use operation involving the new microorganism, 
including identification of the estimated number of processing or use 
sites, situations in which worker exposure to and/or environmental 
release of the new microorganism will occur, the number of workers 
exposed and the duration of exposure; procedures for transport of the 
new microorganism and for disposal, including procedures for 
inactivation of the new microorganism; and control measures which limit 
worker exposure and environmental release.



Sec. 725.160  Submission of health and environmental effects data.

    (a) Test data on the new microorganism in the possession or control 
of the submitter. (1) Except as provided in Sec. 725.25(h), and in 
addition to the information required by Sec. 725.155(d)(3), each MCAN 
must contain all test data in the submitter's possession or control 
which are related to the effects on health or the environment of any 
manufacture, processing, distribution in commerce, use, or disposal of 
the new microorganism or any microbial mixture or article containing the 
new microorganism, or any combination of such activities. This includes 
test data concerning the new microorganism in a pure culture or 
formulated form as used or as intended to be used in one of the 
activities listed above.
    (2) A full report or standard literature citation must be submitted 
for the following types of test data:
    (i) Health effects data.
    (ii) Ecological effects data.
    (iii) Physical and chemical properties data.
    (iv) Environmental fate characteristics.
    (v) Monitoring data and other test data related to human exposure to 
or environmental release of the new microorganism.
    (3)(i) If the data do not appear in the open scientific literature, 
the submitter must provide a full report. A full report includes the 
experimental methods and materials, results, discussion and data 
analysis, conclusions, references, and the name and address of the 
laboratory that developed the data.
    (ii) If the data appear in the open scientific literature, the 
submitter need only provide a standard literature citation. A standard 
literature citation includes author, title, periodical name, date of 
publication, volume, and page numbers.
    (4)(i) If a study, report, or test is incomplete when a person 
submits a MCAN, the submitter must identify the nature and purpose of 
the study; name and address of the laboratory developing the data; 
progress to date; types of data collected, significant preliminary 
results; and anticipated completion date.

[[Page 423]]

    (ii) If a test or experiment is completed before the MCAN review 
period ends, the person must submit the study, report, or test, as 
specified in paragraph (a)(3)(i) of this section, to the address listed 
in Sec. 725.25(c) within 10 days of receiving it, but no later than 5 
days before the end of the review period. If the test or experiment is 
completed during the last 5 days of the review period, the submitter 
must immediately inform its EPA contact for that submission by 
telephone.
    (5) For test data in the submitter's possession or control which are 
not listed in paragraph (a)(2) of this section, a person is not required 
to submit a complete report. The person must submit a summary of the 
data. If EPA so requests, the person must submit a full report within 10 
days of the request, but no later than 5 days before the end of the 
review period.
    (6) All test data described under paragraph (a) of this section are 
subject to these requirements, regardless of their age, quality, or 
results.
    (b) Other data concerning the health and environmental effects of 
the new microorganism that are known to or reasonably ascertainable by 
the submitter. (1) Except as provided in Sec. 725.25(h), and in addition 
to the information required by Sec. 725.155(c)(3), any person who 
submits a MCAN must describe the following data, including any data from 
a health and safety study of a microorganism, if the data are related to 
effects on health or the environment of any manufacture, processing, 
distribution in commerce, use, or disposal of the microorganism, of any 
microbial mixture or article containing the new microorganism, or of any 
combination of such activities:
    (i) Any data, other than test data, in the submitter's possession or 
control.
    (ii) Any data, including test data, which are not in the submitter's 
possession or control, but which are known to or reasonably 
ascertainable by the submitter. For the purposes of this section, data 
are known to or reasonably ascertainable by the submitter if the data 
are known to any of its employees or other agents who are associated 
with the research and development, test marketing, or commercial 
marketing of the microorganism.
    (2) Data that must be described include data concerning the new 
microorganism in a pure culture or formulated form as used or as 
intended to be used in one of the activities listed in paragraph (b)(1) 
of this section.
    (3) The description of data reported under paragraph (b) of this 
section must include:
    (i) If the data appear in the open scientific literature, a standard 
literature citation, which includes the author, title, periodical name, 
date of publication, volume, and pages.
    (ii) If the data are not available in the open scientific 
literature, a description of the type of data and summary of the 
results, if available, and the names and addresses of persons the 
submitter believes may have possession or control of the data.
    (4) All data described in paragraph (b) of this section are subject 
to these requirements, regardless of their age, quality, or results; and 
regardless of whether they are complete at the time the MCAN is 
submitted.



Sec. 725.170  EPA review of the MCAN.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of MCANs submitted under this subpart:
    (a) Length of the review period. The MCAN review period specified in 
section 5(a) of the Act runs for 90 days from the date the Document 
Control Officer for the Office of Pollution Prevention and Toxics 
receives a complete MCAN, or the date EPA determines the MCAN is 
complete under Sec. 725.33, unless the Agency extends the period under 
section 5(c) of the Act and Sec. 725.56.
    (b) Notice of expiration of MCAN review period. (1) EPA will notify 
the submitter that the MCAN review period has expired or that EPA has 
completed its review of the MCAN. Expiration of the review period does 
not constitute EPA approval or certification of the new microorganism, 
and does not mean that EPA may not take regulatory action against the 
microorganism in the future.
    (2) After expiration of the MCAN review period, in the absence of 
regulatory action by EPA under section

[[Page 424]]

5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import 
the microorganism even if the submitter has not received notice of 
expiration.
    (3) Early notification that EPA has completed its review does not 
permit commencement of manufacture or import prior to the expiration of 
the 90-day MCAN review period.
    (c) No person submitting a MCAN in response to the requirements of 
this subpart may manufacture, import, or process a microorganism subject 
to this subpart until the review period, including all extensions and 
suspensions, has expired.



Sec. 725.190  Notice of commencement of manufacture or import.

    (a) Applicability. Any person who commences the manufacture or 
import of a new microorganism for nonexempt, commercial purposes for 
which that person previously submitted a section 5(a) notice under this 
part must submit a notice of commencement (NOC) of manufacture or 
import.
    (b) When to report. (1) If manufacture or import for nonexempt, 
commercial purposes begins on or after May 27, 1997, the submitter must 
submit the NOC to EPA no later than 30 calendar days after the first day 
of such manufacture or import.
    (2) If manufacture or import for nonexempt, commercial purposes 
began or will begin before May 27, 1997, the submitter must submit the 
NOC by May 27, 1997.
    (3) Submission of an NOC prior to the commencement of manufacture or 
import is a violation of section 15 of the Act.
    (c) Information to be reported. The NOC must contain the following 
information: Specific microorganism identity, MCAN number, and the date 
when manufacture or import commences. If the person claimed 
microorganism identity confidential in the MCAN, and wants the identity 
to be listed on the confidential Inventory, the claim must be reasserted 
and resubstantiated in accordance with Sec. 725.85(b). Otherwise, EPA 
will list the specific microorganism identity on the public Inventory.
    (d) Where to submit. NOCs should be submitted to the address listed 
in Sec. 725.25(c).



      Subpart E--Exemptions for Research and Development Activities



Sec. 725.200  Scope and purpose.

    (a) This subpart describes exemptions from the reporting 
requirements under subpart D of this part for research and development 
activities involving microorganisms.
    (b) In lieu of complying with subpart D of this part, persons 
described in Sec. 725.205 may submit a TSCA Experimental Release 
Application (TERA) for research and development activities involving 
microorganisms or otherwise comply with this subpart.
    (c) Exemptions from part 725 are provided at Secs. 725.232, 725.234, 
and 725.238.
    (d) Submission requirements specific for TERAs are described at 
Sec. 725.250.
    (e) Data requirements for TERAs are set forth in Secs. 725.255 and 
725.260.
    (f) EPA review procedures specific for TERAs are set forth in 
Secs. 725.270 and 725.288.
    (g) Subparts A through C of this part apply to any submission under 
this subpart.



Sec. 725.205  Persons who may report under this subpart.

    (a) Commercial research and development activities involving new 
microorganisms or significant new uses of microorganisms are subject to 
reporting under this part unless they qualify for an exemption under 
this part.
    (b) Commercial purposes for research and development means that the 
activities are conducted with the purpose of obtaining an immediate or 
eventual commercial advantage for the researcher and would include:
    (1) All research and development activities which are funded 
directly, in whole or in part, by a commercial entity regardless of who 
is actually conducting the research. Indications that the research and 
development activities are funded directly, in whole or in part, may 
include, but are not limited to:
    (i) Situations in which a commercial entity contracts directly with 
a university or researcher; or
    (ii) Situations in which a commercial entity gives a conditional 
grant where the commercial entity holds patent

[[Page 425]]

rights, or establishes a joint venture where the commercial entity holds 
patent or licensing rights; or
    (iii) Any other situation in which the commercial entity intends to 
obtain an immediate or eventual commercial advantage for the commercial 
entity and/or the researcher.
    (2) Research and development activities that are not funded directly 
by a commercial entity, if the researcher intends to obtain an immediate 
or eventual commercial advantage. Indications that the researcher 
intends to obtain an immediate or eventual commercial advantage may 
include, but are not limited to:
    (i) The research is directed toward developing a commercially viable 
improvement of a product already on the market; or
    (ii) The researcher has sought or is seeking commercial funding for 
the purpose of developing a commercial application; or
    (iii) The researcher or university has sought or is seeking a patent 
to protect a commercial application which the research is developing; or
    (iv) Other evidence that the researcher is aware of a commercial 
application for the research and has directed the research toward 
developing that application.
    (c) Certain research and development activities involving 
microorganisms subject to jurisdiction under the Act are exempt from 
reporting under this part. A person conducting research and development 
activities which meet the conditions for the exemptions described in 
Secs. 725.232, 725.234, or 725.238 is exempt from TERA reporting under 
this subpart.
    (d) A microorganism is not exempt from reporting under subpart D of 
this part if any amount of the microorganism, including as part of a 
mixture, is processed, distributed in commerce, or used, for any 
commercial purpose other than research and development.
    (e) Quantities of the inactivated microorganism, or mixtures or 
articles containing the inactivated microorganism, remaining after 
completion of research and development activities may be disposed of as 
a waste in accordance with applicable Federal, State, and local 
regulations.
    (f) A person who manufactures, imports, or processes a microorganism 
solely for research and development is not required to comply with the 
requirements of this section if:
    (1) The person is manufacturing a microbial pesticide identified in 
Sec. 172.45(c), or
    (2) The person is manufacturing a microbial pesticide for which an 
Experimental Use Permit is required, pursuant to Sec. 172.3; or
    (3) The person is manufacturing a microbial pesticide for which a 
notification or an Experimental Use Permit is not required to be 
submitted.



Sec. 725.232  Activities subject to the jurisdiction of other Federal programs or agencies.

    This part does not apply to any research and development activity 
that meets all of the following conditions.
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec. 725.3.
    (c)(1) The person receives research funds from another Federal 
agency, and the funds are awarded on the condition that the research 
will be conducted in accordance with the relevant portions of the NIH 
Guidelines, or
    (2) A Federal agency or program otherwise imposes the legally 
binding requirement that the research is to be conducted in accordance 
with relevant portions of the NIH Guidelines.



Sec. 725.234  Activities conducted inside a structure.

    A person who manufactures, imports, or processes a microorganism is 
not subject to the reporting requirements under subpart D of this part 
if all of the following conditions are met:
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) The microorganism is used by, or directly under the supervision 
of, a technically qualified individual, as defined in Sec. 725.3. The 
technically qualified individual must maintain documentation of the 
procedures selected to

[[Page 426]]

comply with paragraph (d) of this section and must ensure that the 
procedures are used.
    (c) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec. 725.3.
    (d) Containment and/or inactivation controls. (1) Selection and use 
of containment and/or inactivation controls inside a structure for a 
particular microorganism shall take into account the following:
    (i) Factors relevant to the organism's ability to survive in the 
environment.
    (ii) Potential routes of release in air, solids and liquids; in or 
on waste materials and equipment; in or on people, including maintenance 
and custodial personnel; and in or on other organisms, such as insects 
and rodents.
    (iii) Procedures for transfer of materials between facilities.
    (2) The technically qualified individual's selection of containment 
and/or inactivation controls shall be approved and certified by an 
authorized official (other than the TQI) of the institution that is 
conducting the test prior to the commencement of the test.
    (3) Records shall be developed and maintained describing the 
selection and use of containment and/or inactivation controls, as 
specified in Sec. 725.235(c). These records, which must be maintained at 
the location where the research and development activity is being 
conducted, shall be submitted to EPA upon written request and within the 
time frame specified in EPA's request.
    (4) Subsequent to EPA review of records in accordance with paragraph 
(d)(3) of this section, changes to the containment/inactivation controls 
selected under paragraph (d)(1) of this section must be made upon EPA 
order. Failure to comply with EPA's order shall result in automatic loss 
of eligibility for an exemption under this section.
    (e) The manufacturer, importer, or processor notifies all persons in 
its employ or to whom it directly distributes the microorganism, who are 
engaged in experimentation, research, or analysis on the microorganism, 
including the manufacture, processing, use, transport, storage, and 
disposal of the microorganism associated with research and development 
activities, of any risk to health, identified under Sec. 725.235(a), 
which may be associated with the microorganism. The notification must be 
made in accordance with Sec. 725.235(b).



Sec. 725.235  Conditions of exemption for activities conducted inside a structure.

    (a) Determination of risks. To determine whether notification under 
Sec. 725.234(e) is required, the manufacturer, importer, or processor 
must do one of the following:
    (1) For research conducted in accordance with the NIH Guidelines, 
the manufacturer, importer, or processor must meet the conditions laid 
out at IV-B-4-d of the NIH Guidelines; or
    (2) For all other research conducted in accordance with 
Sec. 725.234, the manufacturer, importer, or processor must review and 
evaluate the following information to determine whether there is reason 
to believe there is any risk to health which may be associated with the 
microorganism:
    (i) Information in its possession or control concerning any 
significant adverse reaction of persons exposed to the microorganism 
which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer, importer, or 
processor by a supplier or any other person concerning a health risk 
believed to be associated with the microorganism.
    (iii) Health and environmental effects data in its possession or 
control concerning the microorganism.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under TSCA section 4, 5, or 6 of the Act that applies to 
the microorganism and of which the manufacturer, importer, or processor 
has knowledge.
    (b) Notification to employees and others. (1) The manufacturer, 
importer, or processor must notify the persons identified in 
Sec. 725.234(e) by means of a container labeling system, conspicuous 
placement of notices in areas where exposure may occur, written 
notification to each person potentially exposed, or any other method of 
notification which adequately informs persons of health

[[Page 427]]

risks which the manufacturer, importer, or processor has reason to 
believe may be associated with the microorganism, as determined under 
paragraph (a) of this section.
    (2) If the manufacturer, importer, or processor distributes a 
microorganism manufactured, imported, or processed under this section to 
persons not in its employ, the manufacturer, importer, or processor must 
in written form:
    (i) Notify those persons that the microorganism is to be used only 
for research and development purposes and the requirements of 
Sec. 725.234 are to be met.
    (ii) Provide the notice of health risks specified in paragraph 
(b)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer, importer, or processor.
    (c) Recordkeeping. (1) For research conducted in accordance with the 
NIH Guidelines, a person who manufactures, imports, or processes a 
microorganism under this section must retain the following records:
    (i) Documentation that the NIH Guidelines have been adhered to. Such 
documentation shall include:
    (A) For experiments subject to Institutional Biosafety Committee 
review, or notification simultaneous with initiation of the experiment, 
the information submitted for review or notification, along with 
standard laboratory records, shall satisfy the recordkeeping 
requirements specified in Sec. 725.234(d)(3).
    (B) For experiments exempt from Institutional Biosafety Committee 
review or notification simultaneous with initiation of the experiment, 
documentation of the exemption, along with standard laboratory records, 
shall satisfy the recordkeeping requirement specified in 
Sec. 725.234(d)(3).
    (ii) Documentation of how the following requirements are satisfied 
under the NIH Guidelines:
    (A) Copies or citations to information reviewed and evaluated to 
determine the need to make any notification of risk.
    (B) Documentation of the nature and method of notification of risk, 
including copies of any labels or written notices used.
    (C) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the microorganism, the amount distributed, 
and copies of the notifications required.
    (2) For all other research conducted in accordance with 
Sec. 725.234, a person who manufacturers, imports, or processes a 
microorganism under this section, must maintain the following records:
    (i) Records describing selection and use of containment and/or 
inactivation controls required by Sec. 725.234(d)(3) and certification 
by an authorized official required by Sec. 725.234(d)(2) for each 
microorganism.
    (ii) Copies or citations to information reviewed and evaluated under 
paragraph (a) of this section to determine the need to make any 
notification of risk.
    (iii) Documentation of the nature and method of notification under 
paragraph (b)(1) of this section, including copies of any labels or 
written notices used.
    (iv) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the microorganism, the amount distributed, 
and copies of the notifications required under paragraph (b)(2) of this 
section.



Sec. 725.238  Activities conducted outside a structure.

    (a) Exemption. (1) Research and development activities involving 
intentional testing in the environment of certain microorganisms listed 
in Sec. 725.239 may be conducted without prior review by EPA if all of 
the conditions of this section and Sec. 725.239 are met.
    (2) The research and development activity involving a microorganism 
listed in Sec. 725.239 must be conducted by, or directly under the 
supervision of, a technically qualified individual, as defined in 
Sec. 725.3.
    (b) Certification. To be eligible for the exemption under this 
section, a manufacturer or importer must submit to EPA prior to 
initiation of the activity a document signed by an authorized official 
containing the following information:

[[Page 428]]

    (1) Name, address, and telephone number of the manufacturer or 
importer.
    (2) Location, estimated duration, and planned start date of the 
test.
    (3) Certification of the following:
    (i) Compliance with the conditions of the exemption specified for 
the microorganism in Sec. 725.239.
    (ii) If state and/or local authorities have been notified of the 
activity, evidence of notification.
    (c) Recordkeeping. Persons who conduct research and development 
activities under this section must comply with the recordkeeping 
requirements of Sec. 725.65 and retain documentation that supports their 
compliance with the requirements of this section and the specific 
requirements for the microorganism listed in Sec. 725.239.



Sec. 725.239  Use of specific microorganisms in activities conducted outside a structure.

    (a) Bradyrhizobium japonicum. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Bradyrhizobium japonicum:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Bradyrhizobium japonicum.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c).
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Bradyrhizobium japonicum.
    (b) Rhizobium meliloti. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Rhizobium meliloti:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Rhizobium meliloti.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c) of 
this part.
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Rhizobium meliloti.

[[Page 429]]



Sec. 725.250  Procedural requirements for the TERA.

    General requirements for all submissions under this part are 
contained in subparts A through C of this part. In addition, the 
following requirements apply to TERAs submitted under this subpart:
    (a) When to submit the TERA. Each person who is eligible to submit a 
TERA under this subpart must submit the TERA at least 60 calendar days 
before the person intends to initiate the proposed research and 
development activity.
    (b) Contents of the TERA. Each person who submits a TERA under this 
subpart must provide the information and test data described in 
Secs. 725.255 and 725.260. In addition, the submitter must supply 
sufficient information to enable EPA to evaluate the effects of all 
activities for which approval is requested.
    (c) A person may submit a TERA for one or more microorganisms and 
one or more research and development activities, including a research 
program.
    (d) EPA will either approve the TERA, with or without conditions, or 
disapprove it under procedures established in this subpart.
    (e) The manufacturer, importer, or processor who receives a TERA 
approval must comply with all terms of the approval, as well as 
conditions described in the TERA, and remains liable for compliance with 
all terms and conditions, regardless of who conducts the research and 
development activity. Any person conducting the research and development 
activity approved under the TERA must comply with all terms of the TERA 
approval, as well as the conditions described in the TERA.
    (f) Recordkeeping. Persons submitting a TERA must comply with the 
recordkeeping requirements of Sec. 725.65. In addition, the following 
requirements apply to TERAs:
    (1) Each person submitting a TERA under this part must retain 
documentation of information contained in the TERA for a period of 3 
years from the date that the results of the study are submitted to the 
Agency.
    (2) Summaries of all data, conclusions, and reports resulting from 
the conduct of the research and development activity under the TERA must 
be submitted to the EPA address identified in Sec. 725.25(c) within 1 
year of the termination of the activity.



Sec. 725.255  Information to be included in the TERA.

    (a) To review a TERA, EPA must have sufficient information to permit 
a reasoned evaluation of the health and environmental effects of the 
planned test in the environment. The person seeking EPA approval must 
submit all information known to or reasonably ascertainable by the 
submitter on the microorganism(s) and the research and development 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will be useful for EPA's 
risk assessment. The TERA must be in writing and must include at least 
the information described in the following paragraphs.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TERA, must include the submitter 
identification and microorganism identity information required for MCANs 
in Sec. 725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TERA must submit phenotypic and 
ecological characteristics information required in Sec. 725.155(d)(3) as 
it relates directly to the conditions of the proposed research and 
development activity.
    (e) Persons applying for a TERA must also submit the following 
information about the proposed research and development activity:
    (1) A detailed description of the proposed research and development 
activity. (i) The objectives and significance of the activity and a 
rationale for testing the microorganisms in the environment.
    (ii) Number of microorganisms released (including viability per 
volume if applicable) and the method(s) of application or release.
    (iii) Characteristics of the test site(s), including location, 
geographical, physical, chemical, and biological features, proximity to 
human habitation or activity, and description

[[Page 430]]

of site characteristics that would influence dispersal or confinement.
    (iv) Target organisms (if the microorganism(s) to be tested has an 
intended target), including identification of each target organism and 
anticipated mechanism and result of interaction.
    (v) Planned start date and duration of each activity.
    (vi) If State and/or local authorities have been notified of the 
activity, evidence of notification.
    (2) Information on monitoring, confinement, mitigation, and 
emergency termination procedures. (i) Confinement procedures for the 
activity, access and security measures, and procedures for routine 
termination of the activity.
    (ii) Mitigation and emergency procedures.
    (iii) Measures to detect and control potential adverse effects.
    (iv) Name of principal investigator and chief of site personnel 
responsible for emergency procedures.
    (v) Personal protective equipment, engineering controls, and 
procedures to be followed to minimize dispersion of the microorganism(s) 
by people, machinery, or equipment.
    (vi) Procedures for disposal of any articles, waste, clothing, 
machinery, or other equipment involved in the experimental release, 
including methods for inactivation of the microorganism(s), containment, 
disinfection, and disposal of contaminated items.



Sec. 725.260  Submission of health and environmental effects data.

    Each TERA must contain all available data concerning actual or 
potential effects on health or the environment of the new microorganism 
that are in the possession or control of the submitter and a description 
of other data known to or reasonably ascertainable by the submitter that 
will permit a reasoned evaluation of the planned test in the 
environment. The data must be reported in the manner described in 
Sec. 725.160(a)(3) and (b)(3).



Sec. 725.270  EPA review of the TERA.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of applications submitted under this 
subpart:
    (a) Length of the review period. (1) The review period for the TERA 
will be 60 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete TERA, or 
the date EPA determines the TERA is complete under Sec. 725.33, unless 
EPA finds good cause for an extension under Sec. 725.56.
    (2) A submitter shall not proceed with the research and development 
activity described in the TERA unless and until EPA provides written 
approval of the TERA. A submitter may receive early approval if a review 
is completed in less than 60 days.
    (b) EPA decision regarding proposed TERA activity. (1) A decision 
concerning a TERA under this subpart will be made by the Administrator, 
or a designee.
    (2) If EPA determines that the proposed research and development 
activity for the microorganism does not present an unreasonable risk of 
injury to health or the environment, EPA will notify the submitter that 
the TERA is approved and that the submitter can proceed with the 
proposed research and development activity described in the TERA.
    (3) EPA may include requirements and conditions in its approval of 
the TERA that would be stated in the TERA approval under paragraph (c) 
of this section.
    (4) If EPA concludes that it cannot determine that the proposed 
research and development activity described in the TERA will not present 
an unreasonable risk of injury to health or the environment, EPA will 
deny the TERA and will provide reasons for the denial in writing.
    (c) TERA approval. (1) A TERA approval issued by EPA under this 
section is legally binding on the TERA submitter.
    (2) When EPA approves a TERA, the submitter must conduct the 
research and development activity only as described in the TERA and in 
accordance with any requirements and conditions prescribed by EPA in its 
approval of the TERA.
    (3) Any person who fails to conduct the research and development 
activity

[[Page 431]]

as described in the TERA and in accordance with any requirements and 
conditions prescribed by EPA in its approval of the TERA under this 
section, shall be in violation of sections 5 and 15 of the Act and be 
subject to civil and criminal penalties under section 16 of the Act.



Sec. 725.288  Revocation or modification of TERA approval.

    (a) Significant questions about risk. (1) If, after approval of a 
TERA under this subpart, EPA receives information which raises 
significant questions about EPA's determination that the activity does 
not present an unreasonable risk of injury to health or the environment, 
EPA will notify the submitter in writing of those questions.
    (2) The submitter may, within 10 days of receipt of EPA's notice, 
provide in writing additional information or arguments concerning the 
significance of the questions and whether EPA should modify or revoke 
the approval of the TERA.
    (3) After considering any such information and arguments, EPA will 
decide whether to change its determination regarding approval of the 
TERA.
    (i) If EPA determines that the activity will not present an 
unreasonable risk of injury to health or the environment, it will notify 
the submitter in writing. To make this finding, EPA may prescribe 
additional conditions which must be followed by the submitter.
    (ii) If EPA determines that it can no longer conclude that the 
activity will not present an unreasonable risk of injury to health or 
the environment, it will notify the submitter in writing that EPA is 
revoking its approval and state its reasons. In that event, the 
submitter must terminate the research and development activity within 48 
hours of receipt of the notice in accordance with directions provided by 
EPA in the notice.
    (b) Evidence of unreasonable risk. (1) If, after approval of a TERA 
under this subpart, EPA determines that the proposed research and 
development activity will present an unreasonable risk of injury to 
health or the environment, EPA will notify the submitter in writing and 
state its reasons.
    (2) In the notice, EPA may prescribe additional safeguards to 
address or reduce the risk, or may instruct the submitter to suspend the 
research and development activities.
    (3) Within 48 hours, the submitter must implement the instructions 
contained in the notice. The submitter may then submit additional 
information or arguments concerning the matters raised by EPA and 
whether EPA should modify or revoke the approval of the TERA in 
accordance with paragraph (a)(2) of this section.
    (4) EPA will consider the information and arguments in accordance 
with paragraph (a)(3) of this section.
    (5) Following consideration of the information and arguments under 
paragraph (a)(3) of this section, if EPA notifies the submitter that the 
R&D activity must be suspended or terminted, the submitter may resume 
the activity only upon written notice from EPA that EPA has approved 
resumption of the activity. In approving resumption of an activity, EPA 
may prescribe additional conditions which must be followed by the 
submitter.
    (c) Modifications. If, after approval of a TERA under this subpart, 
the submitter concludes that it is necessary to alter the conduct of the 
research and development activity in a manner which would result in the 
activity being different from that described in the TERA agreement and 
any conditions EPA prescribed in its approval, the submitter must inform 
the EPA contact for the TERA and may not modify the activity without the 
approval of EPA.



                Subpart F--Exemptions for Test Marketing



Sec. 725.300  Scope and purpose.

    (a) This subpart describes exemptions from the reporting 
requirements under subpart D of this part for test marketing activities 
involving microorganisms.
    (b) In lieu of complying with subpart D of this part, persons 
described in Sec. 725.305 may submit an application for a test marketing 
exemption (TME).
    (c) Submission requirements specific for TME applications are 
described at Sec. 725.350.

[[Page 432]]

    (d) Data requirements for TME applications are set forth in 
Sec. 725.355.
    (e) EPA review procedures specific for TMEs are set forth in 
Sec. 725.370.
    (f) Subparts A through C of this part apply to any submission under 
this subpart.



Sec. 725.305  Persons who may apply under this subpart.

    A person identified in this section may apply for a test marketing 
exemption. EPA may grant the exemption if the person demonstrates that 
the microorganism will not present an unreasonable risk of injury to 
health or the environment as a result of the test marketing. A person 
may apply under this subpart for the following test marketing 
activities:
    (a) A person who intends to manufacture or import for commercial 
purposes a new microorganism.
    (b) A person who intends to manufacture, import, or process for 
commercial purposes a microorganism identified in subpart M of this part 
for a significant new use.



Sec. 725.350  Procedural requirements for this subpart.

    General requirements for all submissions under this part are 
contained in subparts A through C of this part. In addition, the 
following requirements apply to applications submitted under this 
subpart:
    (a) Prenotice consultation. EPA strongly suggests that for a TME, 
the applicant contact EPA for a prenotice consultation regarding 
eligibility for a TME.
    (b) When to submit a TME application. Each person who is eligible to 
apply for a TME under this subpart must submit the application at least 
45 calendar days before the person intends to commence the test 
marketing activity.
    (c) Recordkeeping. Each person who is granted a TME must comply with 
the recordkeeping requirements of Sec. 725.65. In addition, any person 
who obtains a TME must retain documentation of compliance with any 
restrictions imposed by EPA when it grants the TME. This information 
must be retained for 3 years from the final date of manufacture or 
import under the exemption.



Sec. 725.355  Information to be included in the TME application.

    (a) To review a TME application, EPA must have sufficient 
information to permit a reasoned evaluation of the health and 
environmental effects of the planned test marketing activity. The person 
seeking EPA approval must submit all information known to or reasonably 
ascertainable by the person on the microorganism and the test marketing 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will demonstrate that the 
microorganism will not present an unreasonable risk of injury to health 
or the environment as a result of the test marketing. The TME 
application must be in writing and must include at least the information 
described in paragraphs (b), (c), (d), and (e) of this section.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TME must submit the submitter 
identification and microorganism identity information required for MCANs 
in Sec. 725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TME must submit phenotypic and ecological 
characteristics information required in Sec. 725.155(d)(3) as it relates 
directly to the conditions of the proposed test marketing activity.
    (e) Persons applying for a TME must also submit the following 
information about the proposed test marketing activity:
    (1) Proposed test marketing activity. (i) The maximum quantity of 
the microorganism which the applicant will manufacture or import for 
test marketing.
    (ii) The maximum number of persons who may be provided the 
microorganism during test marketing.
    (iii) The maximum number of persons who may be exposed to the 
microorganism as a result of test marketing, including information 
regarding duration and route of such exposures.
    (iv) A description of the test marketing activity, including its 
duration and how it can be distinguished from full-scale commercial 
production and research and development activities.

[[Page 433]]

    (2) Health and environmental effects data. All existing data 
regarding health and environmental effects of the microorganism must be 
reported in accordance with Sec. 725.160.



Sec. 725.370  EPA review of the TME application.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of TME applications submitted under this 
subpart:
    (a) No later than 45 days after EPA receives a TME, the Agency will 
either approve or deny the application.
    (b) A submitter may only proceed with test marketing activities 
after receipt of EPA approval.
    (c) In approving a TME application, EPA may impose any restrictions 
necessary to ensure that the microorganism will not present an 
unreasonable risk of injury to health and the environment as a result of 
test marketing.



          Subpart G--General Exemptions for New Microorganisms



Sec. 725.400  Scope and purpose.

    (a) This subpart describes exemptions from reporting under subpart D 
of this part, and from review under this part altogether, for 
manufacturing and importing of certain new microorganisms for commercial 
purposes.
    (b) Recipient microorganisms eligible for the tiered exemption from 
review under this part are listed in Sec. 725.420.
    (c) Criteria for the introduced genetic material contained in the 
new microorganisms are described in Sec. 725.421.
    (d) Physical containment and control technologies are described in 
Sec. 725.422.
    (e) The conditions for the Tier I exemption are listed in 
Sec. 725.424.
    (f) In lieu of complying with subpart D of this part, persons using 
recipient microorganisms eligible for the tiered exemption may submit a 
Tier II exemption request. The limited reporting requirements for the 
Tier II exemption, including data requirements, are described in 
Secs. 725.450 and 725.455.
    (g) EPA review procedures for the Tier II exemption are set forth in 
Sec. 725.470.
    (h) Subparts A through C of this part apply to any submission under 
this subpart.



Sec. 725.420  Recipient microorganisms.

    The following recipient microorganisms are eligible for either 
exemption under this subpart:
    (a) Acetobacter aceti.
    (b) Aspergillus niger.
    (c) Aspergillus oryzae.
    (d) Bacillus licheniformis.
    (e) Bacillus subtilis.
    (f) Clostridium acetobutylicum.
    (g) Escherichia coli K-12.
    (h) Penicillium roqueforti.
    (i) Saccharomyces cerevisiae.
    (j) Saccharomyces uvarum.



Sec. 725.421  Introduced genetic material.

    For a new microorganism to qualify for either exemption under this 
subpart, introduced genetic material must meet all of the criteria 
listed in this section.
    (a) Limited in size. The introduced genetic material must consist 
only of the following:
    (1) The structural gene(s) of interest.
    (2) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (3) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (4) The nucleotide sequences needed for vector transfer.
    (5) The nucleotide sequences needed for vector maintenance.
    (b) Well-characterized. For introduced genetic material, well-
characterized means that the following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.

[[Page 434]]

    (c) Poorly mobilizable. The ability of the introduced genetic 
material to be transferred and mobilized is inactivated, with a 
resulting frequency of transfer of less than 10-8 transfer 
events per recipient.
    (d) Free of certain sequences. (1) The introduced genetic material 
must not contain a functional portion of any of the toxin-encoding 
sequences described in this paragraph (d).
    (i) For the purposes of this section, a functional portion of a 
toxin-encoding sequence means any sequence which codes for a polypeptide 
that has one of the following effects:
    (A) It directly or indirectly contributes to toxic effects in 
humans. Directly contributes to toxic effects in humans means those 
sequences encoding polypeptides that have direct toxicity to target 
cells. An example of a sequence which directly contributes to toxic 
effects in humans is one which encodes the portion of diphtheria toxin, 
listed in paragraph (d)(2) of this section, capable of interacting with 
elongation factor 2, leading to inhibition of protein synthesis in 
target respiratory, heart, kidney, and nerve tissues. Indirectly 
contributes to toxic effects in humans means a sequence whose encoded 
polypeptide is not directly toxic to target cells, yet still adversely 
affects humans. An example of a sequence which indirectly contributes to 
toxic effects is the sequence which encodes the portion of the botulinum 
toxin, listed in paragraph (d)(3) of this section, capable of blocking 
the release of acetylcholine from gangliosides. Botulinum toxin affects 
neuromuscular junctions by its blockage of acetylcholine release, 
leading to irreversible relaxation of muscles and respiratory arrest.
    (B) It binds a toxin or toxin precursor to target human cells.
    (C) It facilitates intracellular transport of a toxin in target 
human cells.
    (ii) While these toxins are listed (with synonyms in parentheses) in 
paragraphs (d)(2) through (d)(7) of this section according to the source 
organism, it is use of the nucleotide sequences that encode the toxins 
that is being restricted and not the use of the source organisms. The 
source organisms are listed to provide specificity in identification of 
sequences whose use is restricted. Although similar or identical 
sequences may be isolated from organisms other than those listed below 
in paragraphs (d)(2) through (d)(7) of this section, these comparable 
toxin sequences, regardless of the organism from which they are derived, 
must not be included in the introduced genetic material.
    (2) Sequences for protein synthesis inhibitor.

 
              Sequence Source                        Toxin Name
 
Corynebacterium diphtheriae & C. ulcerans   Diphtheria toxin
Pseudomonas aeruginosa                      Exotoxin A
Shigella dysenteriae                        Shigella toxin (Shiga toxin,
                                             Shigella dysenteriae type I
                                             toxin, Vero cell toxin)
Abrus precatorius, seeds                    Abrin
Ricinus communis, seeds                     Ricin
 

    (3) Sequences for neurotoxins.

 
              Sequence Source                        Toxin Name
 
Clostridium botulinum                       Neurotoxins A, B, C1, D, E,
                                             F, G (Botulinum toxins,
                                             botulinal toxins)
Clostridium tetani                          Tetanus toxin
                                             (tetanospasmin)
Proteus mirabilis                           Neurotoxin
Staphylococcus aureus                       Alpha toxin (alpha lysin)
Yersinia pestis                             Murine toxin
 
  Snake toxins                              ............................
Bungarus caeruleus                          Caeruleotoxin
Bungarus multicinctus                       Beta-bungarotoxin
                                             (phospholipase)
Crotalus spp.                               Crotoxin (phospholipase)
Dendroaspis viridis                         Neurotoxin
Naja naja varieties                         Neurotoxin
Notechia scutatus                           Notexin (phospholipase)
Oxyuranus scutellatus                       Taipoxin
 
  Invertebrate toxins
Chironex fleckeri                           Neurotoxin
Androctnus australis                        Neurotoxin
Centruroides sculpturatus                   Neurotoxin
 

    (4) Sequences for oxygen labile cytolysins.

 
              Sequence Source                        Toxin Name
 
Bacillus alve                               Alveolysin
Bacillus cereus                             Cereolysin
Bacillus laterosporus                       Laterosporolysin
Bacillus thuringiensis                      Thuringiolysin
Clostridium bifermentans                    Lysin
Clostridium botulinum                       Lysin
Clostridium caproicum                       Lysin
Clostridium chauvoei                        Delta-toxin
Clostridium histolyticum                    Epsilon-toxin
Clostridium novyi                           Gamma-toxin
Clostridium oedematiens                     Delta-toxin
Clostridium perfringens                     Theta-toxin (Perfringolysin)
Clostridium septicum                        Delta-toxin
Clostridium sordellii                       Lysin
Clostridium tetani                          Tetanolysin
Listeria monocytogenes                      Listeriolysin (A B)
Streptococcus pneumoniae                    Pneumolysin
Streptococcus pyogene                       Streptolysin O (SLO)
 


[[Page 435]]

    (5) Sequences for toxins affecting membrane function.

 
              Sequence Source                        Toxin Name
 
 Bacillus anthracis                         Edema factor (Factors I II);
                                             Lethal factor (Factors II
                                             III)
Bacillus cereus                             Enterotoxin (diarrheagenic
                                             toxin, mouse lethal factor)
Bordetella pertussis                        Adenylate cyclase (Heat-
                                             labile factor); Pertussigen
                                             (pertussis toxin, islet
                                             activating factor,
                                             histamine sensitizing
                                             factor, lymphocytosis
                                             promoting factor)
Clostridium botulinum                       C2 toxin
Clostridium difficile                       Enterotoxin (toxin A)
Clostridium perfringens                     Beta-toxin; Delta-toxin
Escherichia coli & other                    Heat-labile enterotoxins
 Enterobacteriaceae spp.                     (LT); Heat-stable
                                             enterotoxins (STa, ST1
                                             subtypes ST1a ST1b; also
                                             STb, STII)
Legionella pneumophila                      Cytolysin
Vibrio cholerae & Vibrio mimicus            Cholera toxin (choleragen)
 

    (6) Sequences that affect membrane integrity.

 
              Sequence Source                        Toxin Name
 
Clostridium bifermentans & other            Lecithinase
 Clostridium spp
Clostridium perfringens                     Alpha-toxin (phospholipase
                                             C, lecithinase);
                                             Enterotoxin
Corynebacterium pyogenes & other            Cytolysin (phospholipase C),
 Corynebacterium spp.                        Ovis toxin
                                             (sphingomyelinase D)
Staphylococcus aureus                       Beta-lysin (beta toxin)
 

    (7) Sequences that are general cytotoxins.

 
              Sequence Source                        Toxin Name
 
Adenia digitata                             Modeccin
Aeromonas hydrophila                        Aerolysin (beta-lysin,
                                             cytotoxic lysin)
Clostridium difficile                       Cytotoxin (toxin B)
Clostridium perfringens                     Beta-toxin; Epsilon-toxin;
                                             Kappa-toxin
Escherichia coli & other                    Cytotoxin (Shiga-like toxin,
 Enterobacteriaceae spp.                     Vero cell toxin)
Pseudomonas aeruginosa                      Proteases
Staphylococcus aureus                       Gamma lysin (Gamma toxin);
                                             Enterotoxins (SEA, SEB,
                                             SEC, SED SEE); Pyrogenic
                                             exotoxins A B; Toxic shock
                                             syndrome toxins (TSST-1)
Staphylococcus aureus & Pseudomonas         Leucocidin (leukocidin,
 aeruginosa                                  cytotoxin)
Streptococcus pyogenes                      Streptolysin S (SLS);
                                             Erythrogenic toxins
                                             (scarlet fever toxins,
                                             pyrogenic exotoxins)
Yersinia enterocolitica                     Heat-stable enterotoxins
                                             (ST)
 



Sec. 725.422  Physical containment and control technologies.

    The manufacturer must meet all of the following criteria for 
physical containment and control technologies for any facility in which 
the new microorganism will be used for a Tier I exemption; these 
criteria also serve as guidance for a Tier II exemption.
    (a) Use a structure that is designed and operated to contain the new 
microorganism.
    (b) Control access to the structure.
    (c) Provide written, published, and implemented procedures for the 
safety of personnel and control of hygiene.
    (d) Use inactivation procedures demonstrated and documented to be 
effective against the new microorganism contained in liquid and solid 
wastes prior to disposal of the wastes. The inactivation procedures must 
reduce viable microbial populations by at least 6 logs in liquid and 
solid wastes.
    (e) Use features known to be effective in minimizing viable 
microbial populations in aerosols and exhaust gases released from the 
structure, and document use of such features.
    (f) Use systems for controlling dissemination of the new 
microorganism through other routes, and document use of such features.
    (g) Have in place emergency clean-up procedures.



Sec. 725.424  Requirements for the Tier I exemption.

    (a) Conditions of exemption. The manufacture or import of a new 
microorganism for commercial purposes is not subject to review under 
this part if all of the following conditions are met for all activities 
involving the new microorganism:
    (1) The recipient microorganism is listed in and meets any 
requirements specified in Sec. 725.420.
    (2) The introduced genetic material meets the criteria under 
Sec. 725.421.
    (3) The physical containment and control technologies of any 
facility in which the microorganism will be manufactured, processed, or 
used meet the criteria under Sec. 725.422.
    (4) The manufacturer or importer submits a certification described 
in paragraph (b) of this section to EPA at least 10 days before 
commencing initial manufacture or import of a new microorganism derived 
from a recipient microorganism listed in Sec. 725.420.

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    (5) The manufacturer or importer complies with the recordkeeping 
requirements of Sec. 725.65 and maintains records for the initial and 
subsequent uses of the new microorganism that verify compliance with the 
following:
    (i) The certifications made in paragraph (b) of this section.
    (ii) All the eligibility criteria for the Tier I exemption including 
the criteria for the recipient microorganism, the introduced genetic 
material, the physical containment and control technologies.
    (b) Certification. To be eligible for the Tier I exemption under 
this subpart, the manufacturer or importer must submit to EPA a document 
signed by a responsible company official containing the information 
listed in this paragraph.
    (1) Name and address of manufacturer or importer.
    (2) Date when manufacture or import is expected to begin.
    (3) The identification (genus, species) of the recipient 
microorganism listed in Sec. 725.420 which is being used to create the 
new microorganism which will be used under the conditions of the Tier I 
exemption.
    (4) Certification of the following:
    (i) Compliance with the introduced genetic material criteria 
described in Sec. 725.421.
    (ii) Compliance with the containment requirements described in 
Sec. 725.422, including the provision in paragraph (a)(3) of this 
section.
    (5) The site of waste disposal and the type of permits for disposal, 
the permit numbers and the institutions issuing the permits.
    (6) The certification statement required in Sec. 725.25(b). 
Certification of submission of test data is not required for the Tier I 
exemption.



Sec. 725.426  Applicability of the Tier I exemption.

    The Tier I exemption under Sec. 725.424 applies only to a 
manufacturer or importer of a new microorganism that certifies that the 
microorganism will be used in all cases in compliance with 
Secs. 725.420, 725.421, and 725.422.



Sec. 725.428  Requirements for the Tier II exemption.

    The manufacturer or importer of a new microorganism for commercial 
purposes may submit to EPA a Tier II exemption request in lieu of a MCAN 
under subpart D of this part if all of the following conditions are met:
    (a) The recipient microorganism is listed in and meets any 
requirements specified in Sec. 725.420.
    (b) The introduced genetic material meets the criteria under 
Sec. 725.421.
    (c) Adequate physical containment and control technologies are used. 
The criteria listed under Sec. 725.422 for physical containment and 
control technologies of facilities should be used as guidance to satisfy 
the Tier II exemption request data requirements listed at 
Sec. 725.455(d). EPA will review proposed process and containment 
procedures as part of the submission for a Tier II exemption under this 
section.



Sec. 725.450  Procedural requirements for the Tier II exemption.

    General requirements for all submissions under this part are 
contained in Sec. 725.25. In addition, the following requirements apply 
to requests submitted under this subpart:
    (a) Prenotice consultation. EPA strongly suggests that for a Tier II 
exemption, the submitter contact the Agency for a prenotice consultation 
regarding eligibility for the exemption.
    (b) When to submit the Tier II exemption request. Each person who is 
eligible to submit a Tier II exemption request under this subpart must 
submit the request at least 45 calendar days before the person intends 
to commence manufacture or import.
    (c) Contents of the Tier II exemption request. Each person who 
submits a request under this subpart must provide the information 
described in Secs. 725.428 and 725.455, as well as information known to 
or reasonably ascertainable by the person that would permit EPA to 
determine that use of the microorganism, under the conditions specified 
in the request, will not present an unreasonable risk of injury to 
health or the environment.
    (d) Recordkeeping. Each person who submits a request under this 
subpart must comply with the recordkeeping

[[Page 437]]

requirements of Sec. 725.65. In addition, the submitter should maintain 
records which contain information that verifies compliance with the 
following:
    (1) The certifications made in the request.
    (2) All the eligibility criteria for the Tier II exemption request 
including the criteria for the recipient microorganism, the introduced 
genetic material, the physical containment and control technologies.



Sec. 725.455  Information to be included in the Tier II exemption request.

    The submitter must indicate clearly that the submission is a Tier II 
exemption request for a microorganism instead of the MCAN under subpart 
D of this part and must submit the following information:
    (a) Submitter identification. (1) The name and headquarters address 
of the submitter.
    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (b) Microorganism identity information. (1) Identification (genus, 
species, and strain) of the recipient microorganism. Genus, species 
designation should be substantiated by a letter from a culture 
collection or a brief summary of the results of tests conducted for 
taxonomic identification.
    (2) Type of genetic modification and the function of the introduced 
genetic material.
    (3) Site of insertion.
    (4) Certification of compliance with the introduced genetic material 
criteria described in Sec. 725.421.
    (c) Production volume. Production volume, including total liters per 
year, and the maximum cell concentration achieved during the production 
process.
    (d) Process and containment information. (1) A description of the 
process including the following:
    (i) Identity and location of the manufacturing site(s).
    (ii) Process flow diagram illustrating the production process, 
including downstream separations, and indicating the containment 
envelope around the appropriate equipment.
    (iii) Identities and quantities of feedstocks.
    (iv) Sources and quantities of potential releases to both the 
workplace and environment, and a description of engineering controls, 
inactivation procedures, and other measures which will reduce worker 
exposure and environmental releases.
    (v) A description of procedures which will be undertaken to prevent 
fugitive emissions, i.e. leak detection and repair program.
    (vi) A description of procedures/safeguards to prevent and mitigate 
accidental releases to the workplace and the environment.
    (2) Certification of those elements of the containment criteria 
described in Sec. 725.422 with which the manufacturer is in compliance, 
including stating by number the elements with which the manufacturer is 
in full compliance.
    (e) The site of waste disposal and the type of permits for disposal, 
the permit numbers and the institutions issuing the permits.
    (f) The certification statement required in Sec. 725.25(b). 
Certification of submission of test data is not required for the Tier II 
exemption.



Sec. 725.470  EPA review of the Tier II exemption request.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of Tier II exemption requests submitted 
under this subpart:
    (a) Length of the review period. The review period for the request 
will be 45 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete request, 
or the date EPA determines the request is complete under Sec. 725.33, 
unless the Agency extends the review period for good cause under 
Sec. 725.56.
    (b) Criteria for review. EPA will review the request to determine 
that the new microorganism complies with Sec. 725.428 and that its 
manufacture, processing, use, and disposal as described in the request 
will not present an unreasonable risk of injury to health or the 
environment.

[[Page 438]]

    (c) EPA decision regarding the Tier II exemption request. A decision 
concerning a request under this subpart will be made by the 
Administrator, or a designee.
    (d) Determination that the microorganism is ineligible for a Tier II 
review. (1) EPA may determine that the manufacturer or importer is not 
eligible for Tier II review, because the microorganism does not meet the 
criteria under Sec. 725.428 or the Administrator, or a designee, decides 
that there is insufficient information to determine that the conditions 
of manufacture, processing, use, or disposal of the microorganism as 
described in the request will not present an unreasonable risk to health 
or the environment.
    (2) If the Agency makes this determination, the Administrator, or a 
designee will notify the manufacturer or importer by telephone, followed 
by a letter, that the request has been denied. The letter will explain 
reasons for the denial.
    (3) If the request is denied, the manufacturer or importer may 
submit the information necessary to constitute a MCAN under subpart D of 
this part.
    (e) Approval or denial of the Tier II exemption request. (1) No 
later than 45 days after EPA receives a request, the Agency will either 
approve or deny the request.
    (2) In approving a request, EPA may impose any restrictions 
necessary to ensure that the microorganism will not present an 
unreasonable risk of injury to health and the environment as a result of 
general commercial use.
    (f) EPA may seek to enjoin the manufacture or import of a 
microorganism in violation of this subpart, or act to seize any 
microorganism manufactured or imported in violation of this section or 
take other actions under the authority of sections 7 or 17 of the Act.
    (g) A manufacturer or importer may only proceed after receipt of EPA 
approval.

Subparts H-K  [Reserved]



 Subpart L--Additional Procedures for Reporting on Significant New Uses 
                            of Microorganisms



Sec. 725.900  Scope and purpose.

    (a) This subpart describes additional provisions governing 
submission of MCANs for microorganisms subject to significant new use 
rules identified in subpart M of this part.
    (b) Manufacturers, importers, and processors described in 
Sec. 725.105(c) must submit a MCAN under subpart D of this part for 
significant new uses of microorganisms described in subpart M of this 
part, unless they are excluded under Secs. 725.910 or 725.912.
    (c) Section 725.920 discusses exports and imports.
    (d) Additional recordkeeping requirements specific to significant 
new uses of microorganisms are described in Sec. 725.950.
    (e) Section 725.975 describes how EPA will approve alternative means 
of complying with significant new use requirements designated in subpart 
M of this part.
    (f) Expedited procedures for promulgating significant new use 
requirements under subpart M of this part for microorganisms subject to 
section 5(e) orders are discussed in Secs. 725.980 and 725.984.
    (g) This subpart L contains provisions governing submission and 
review of notices for the microorganisms and significant new uses 
identified in subpart M of this part. The provisions of this subpart L 
apply to the microorganisms and significant new uses identified in 
subpart M of this part, except to the extent that they are specifically 
modified or supplanted by specific requirements in subpart M of this 
part. In the event of a conflict between the provisions of this subpart 
L and the provisions of subpart M of this part, the provisions of 
subpart M of this part shall govern.

[[Page 439]]

    (h) The provisions of subparts A through F of this part also apply 
to subparts L and M of this part. For purposes of subparts L and M of 
this part, wherever the words ``microorganism'' or ``new microorganism'' 
appear in subparts A through F of this part, it shall mean the 
microorganism subject to subparts L and M of this part. In the event of 
a conflict between the provisions of subparts A through F and the 
provisions of subparts L and M of this part, the provisions of subparts 
L and M of this part shall govern.



Sec. 725.910  Persons excluded from reporting significant new uses.

    (a) A person who intends to manufacture, import, or process a 
microorganism identified in subpart M of this part and who intends to 
distribute it in commerce is not required to submit a MCAN under subpart 
D of this part, if that person can document one or more of the following 
as to each recipient of the microorganism from that person:
    (1) That the person has notified the recipient, in writing, of the 
specific section in subpart M of this part which identifies the 
microorganism and its designated significant new uses, or
    (2) That the recipient has knowledge of the specific section in 
subpart M of this part which identifies the microorganism and its 
designated significant new uses, or
    (3) That the recipient cannot undertake any significant new use 
described in the specific section in subpart M of this part.
    (b) The manufacturer, importer, or processor described in paragraph 
(a) of this section must submit a MCAN under subpart D of this part, if 
such person has knowledge at the time of commercial distribution of the 
microorganism identified in the specific section in subpart M of this 
part that a recipient intends to engage in a designated significant new 
use of that microorganism without submitting a MCAN under this part.
    (c) A person who processes a microorganism identified in a specific 
section in subpart M of this part for a significant new use of that 
microorganism is not required to submit a MCAN if that person can 
document each of the following:
    (1) That the person does not know the specific microorganism 
identity of the microorganism being processed, and
    (2) That the person is processing the microorganism without 
knowledge that the microorganism is identified in subpart M of this 
part.
    (d)(1) If at any time after commencing distribution in commerce of a 
microorganism identified in a specific section in subpart M of this 
part, a person who manufactures, imports, or processes a microorganism 
described in subpart M of this part and distributes it in commerce has 
knowledge that a recipient of the microorganism is engaging in a 
significant new use of that microorganism designated in that section 
without submitting a MCAN under this part, the person is required to 
cease supplying the microorganism to that recipient and to submit a MCAN 
for that microorganism and significant new use, unless the person is 
able to document each of the following:
    (i) That the person has notified the recipient and EPA enforcement 
authorities (at the address in paragraph (d)(1)(iii) of this section), 
in writing within 15 working days of the time the person develops 
knowledge that the recipient is engaging in a significant new use, that 
the recipient is engaging in a significant new use without submitting a 
MCAN.
    (ii) That, within 15 working days of notifying the recipient as 
described in paragraph (d)(1)(i) of this section, the person received 
from the recipient, in writing, a statement of assurance that the 
recipient is aware of the terms of the applicable section in subpart M 
of this part and will not engage in the significant new use.
    (iii) That the person has promptly provided EPA enforcement 
authorities with a copy of the recipient's statement of assurance 
described in paragraph (d)(1)(ii) of this section. The copy must be sent 
to the Director, Office of Compliance (2221A), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    (2) If EPA notifies the manufacturer, importer, or processor that 
the recipient is engaging in a significant new use after providing the 
statement of assurance described in paragraph (d)(1)(ii) of this section 
and without submitting a

[[Page 440]]

MCAN under this part, the manufacturer, importer, or processor shall 
immediately cease distribution to that recipient until the manufacturer, 
importer, or processor or the recipient has submitted a MCAN under this 
part and the MCAN review period has ended.
    (3) If, after receiving a statement of assurance from a recipient 
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or 
processor has knowledge that the recipient is engaging in a significant 
new use without submitting a MCAN under this part, the manufacturer, 
importer, or processor must immediately cease distributing the 
microorganism to that recipient and notify EPA enforcement authorities 
at the address identified in paragraph (d)(1)(iii) of this section. The 
manufacturer, importer, or processor may not resume distribution to that 
recipient until any one of the following has occurred:
    (i) The manufacturer, importer, or processor has submitted a MCAN 
under this part and the MCAN review period has ended.
    (ii) The recipient has submitted a MCAN under this part and the MCAN 
review period has ended.
    (iii) The manufacturer, importer, or processor has received notice 
from EPA enforcement authorities that it may resume distribution to that 
recipient.



Sec. 725.912  Exemptions.

    Persons identified in Sec. 725.105(c) are not required to submit a 
MCAN under subpart D of this part for a microorganism identified in 
subpart M of this part, unless otherwise specified in a specific section 
in subpart M, if:
    (a) The person submits a MCAN for the microorganism prior to the 
promulgation date of the section in subpart M of this part which 
identifies the microorganism, and the person receives written 
notification of compliance from EPA prior to the effective date of such 
section. The MCAN submitter must comply with any applicable requirement 
of section 5(b) of the Act. The MCAN must include the information and 
test data specified in section 5(d)(1) of the Act. For purposes of this 
exemption, the specific section in subpart M of this part which 
identifies the microorganism and Secs. 725.3, 725.15, 725.65, 725.70, 
725.75, 725.100, and 725.900 apply; after the effective date of the 
section in subpart M of this part which identifies the microorganism, 
Secs. 725.105 and 725.910 apply and Sec. 725.920 continues to apply. EPA 
will provide the MCAN submitter with written notification of compliance 
only if one of the following occurs:
    (1) EPA is unable to make the finding that the activities described 
in the MCAN will or may present an unreasonable risk of injury to health 
or the environment under reasonably foreseeable circumstances, or
    (2) EPA and the person negotiate a consent order under section 5(e) 
of the Act, such order to take effect on the effective date of the 
section in subpart M of this part which identifies the microorganism.
    (b) The person is operating under the terms of a consent order 
issued under section 5(e) of the Act applicable to that person. If a 
provision of such section 5(e) order is inconsistent with a specific 
significant new use identified in subpart M of this part, abiding by the 
provision of the section 5(e) order exempts the person from submitting a 
MCAN for that specific significant new use.



Sec. 725.920  Exports and imports.

    (a) Exports. Persons who intend to export a microorganism identified 
in subpart M of this part, or in any proposed rule which would amend 
subpart M of this part, are subject to the export notification 
provisions of section 12(b) of the Act. The regulations that interpret 
section 12(b) appear at part 707 of this chapter.
    (b) Imports. Persons who import a substance identified in a specific 
section in subpart M of this part are subject to the import 
certification requirements under section 13 of the Act, which are 
codified at 19 CFR Secs. 12.118 through 12.127 and 127.28(i). The EPA 
policy in support of the import certification requirements appears at 
part 707 of this chapter.



Sec. 725.950  Additional recordkeeping requirements.

    Persons submitting a MCAN for a significant new use of a 
microorganism must comply with the recordkeeping

[[Page 441]]

requirements of Sec. 725.65. In addition, the following requirements 
apply:
    (a) At the time EPA adds a microorganism to subpart M of this part, 
EPA may specify appropriate recordkeeping requirements. Each 
manufacturer, importer, and processor of the microorganism shall 
maintain the records for 3 years from the date of their creation.
    (b) The records required to be maintained under this section may 
include the following:
    (1) Records documenting the information contained in the MCAN 
submitted to EPA.
    (2) Records documenting the manufacture and importation volume of 
the microorganism and the corresponding dates of manufacture and import.
    (3) Records documenting volumes of the microorganism purchased 
domestically by processors of the microorganism, names and addresses of 
suppliers and corresponding dates of purchase.
    (4) Records documenting the names and addresses (including shipment 
destination address, if different) of all persons outside the site of 
manufacture or import to whom the manufacturer, importer, or processor 
directly sells or transfers the microorganism, the date of each sale or 
transfer, and the quantity of the microorganism sold or transferred on 
such date.



Sec. 725.975  EPA approval of alternative control measures.

    (a) In certain sections of subpart M of this part, significant new 
uses for the identified microorganisms are described as the failure to 
establish and implement programs providing for the use of either: 
specific measures to control worker exposure to or release of 
microorganisms which are identified in such sections, or alternative 
measures to control worker exposure or environmental release which EPA 
has determined provide substantially the same degree of protection as 
the specified control measures. Persons who manufacture, import, or 
process a microorganism identified in such sections and who intend to 
employ alternative measures to control worker exposure or environmental 
release must submit a request to EPA for a determination of equivalency 
before commencing manufacture, import, or processing involving the 
alternative control measures.
    (b) A request for a determination of equivalency must be submitted 
in writing to the Office of Pollution Prevention and Toxics, Document 
Control Officer, 7407, 401 M St., SW., Washington, DC 20460: ATTN: SNUR 
Equivalency Determination, and must contain:
    (1) The name of the submitter.
    (2) The specific identity of the microorganism.
    (3) The citation for the specific section in subpart M of this part 
which pertains to the microorganism for which the request is being 
submitted.
    (4) A detailed description of the activities involved.
    (5) The specifications of the alternative worker exposure control 
measures or environmental release control measures.
    (6) A detailed analysis explaining why such alternative control 
measures provide substantially the same degree of protection as the 
specific control measures identified in the specific section in subpart 
M of this part which pertains to the microorganism for which the request 
is being submitted.
    (7) The data and information described in Secs. 725.155 and 725.160. 
If such data and information have already been submitted to EPA's Office 
of Pollution Prevention and Toxics, the submitter need only document 
that it was previously submitted, to whom, and the date it was 
submitted.
    (c) Requests for determinations of equivalency will be reviewed by 
EPA within 45 days. Determinations under this paragraph will be made by 
the Director, or a designee. Notice of the results of such 
determinations will be mailed to the submitter.
    (d) If EPA notifies the submitter under paragraph (c) of this 
section that EPA has determined that the alternative control measures 
provide substantially the same degree of protection as the specified 
control measures identified in the specific section of subpart M of this 
part which pertains to the microorganism for which the request is being 
submitted, the submitter may commence manufacture, import, or processing 
in accordance with the specifications for alternative worker

[[Page 442]]

exposure control measures or environmental release control measures 
identified in the submitter's request, and may alter any corresponding 
notification to workers to reflect such alternative controls. Deviations 
from the activities described in the EPA notification constitute a 
significant new use and are subject to the requirements of this part.



Sec. 725.980  Expedited procedures for issuing significant new use rules for microorganisms subject to section 5(e) orders.

    (a) Selection of microorganisms. (1) In accordance with the 
expedited process specified in this section, EPA will issue significant 
new use notification requirements for each new microorganism that, after 
MCAN review under subpart D of this part, becomes subject to a final 
order issued under section 5(e) of the Act, except for an order that 
prohibits manufacture and import of the microorganism, unless EPA 
determines that significant new use notification requirements are not 
needed for the microorganism.
    (2) If EPA determines that significant new use notifications 
requirements are not needed for a microorganism that is subject to a 
final order issued under section 5(e) of the Act, EPA will issue a 
notice in the Federal Register explaining why the significant new use 
requirements are not needed.
    (b) Designation of requirements. (1) The significant new use 
notification and other specific requirements will be based on and be 
consistent with the provisions included in the final order issued for 
the microorganism under section 5(e) of the Act. EPA may also designate 
additional activities as significant new uses which will be subject to 
notification.
    (2) Significant new use requirements and other specific requirements 
designated under this section will be listed in subpart M of this part. 
For each microorganism, subpart M of this part will identify:
    (i) The microorganism name.
    (ii) The activities designated as significant new uses.
    (iii) Other specific requirements applicable to the microorganism, 
including recordkeeping requirements or any other requirements included 
in the final section 5(e) order.
    (c) Procedures for issuing significant new use rules. (1) Possible 
processes. EPA will issue significant new use rules (SNURs) under this 
section by one of the following three processes: direct final 
rulemaking, interim final rulemaking, or notice and comment rulemaking. 
EPA will use the direct final rulemaking process to issue significant 
new use rules unless it determines that, in a particular case, one of 
the other processes is more appropriate.
    (2) Notice in the Federal Register. Federal Register documents 
issued to propose or establish significant new uses under this section 
will contain the following:
    (i) The microorganism identity or, if its specific identity is 
claimed confidential, an appropriate generic microorganism name and an 
accession number assigned by EPA.
    (ii) The MCAN number.
    (iii) A summary of EPA's findings under section 5(e)(1)(A) of the 
Act for the final order issued under section 5(e).
    (iv) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (v) Any modification of subpart L of this part applicable to the 
specific microorganism and significant new uses.
    (vi) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (3) Direct final rulemaking. (i) EPA will use direct final 
rulemaking to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. EPA will issue a final rule in the Federal Register 
following its decision to develop a significant new use rule under this 
section for a specific new microorganism.
    (ii) The Federal Register document will state that, unless written 
notice is

[[Page 443]]

received by EPA within 30 days of publication that someone wishes to 
submit adverse or critical comments, the rule will be effective 60 days 
from the date of publication. The written notice of intent to submit 
adverse or critical comments should state which SNUR(s) will be the 
subject of the adverse or critical comments, if several SNURs are 
established through the direct final rule. If notice is received within 
30 days that someone wishes to submit adverse or critical comments, the 
section(s) of the direct final rule containing the SNUR(s) for which a 
notice of intent to comment was received will be withdrawn by EPA 
issuing a document in the final rule section of the Federal Register, 
and a proposal will be published in the proposed rule section of the 
Federal Register. The proposal will establish a 30-day comment period.
    (iii) If EPA, having considered any timely comments submitted in 
response to the proposal, decides to establish notification requirements 
under this section, EPA will issue a final rule adding the microorganism 
to subpart M of this part and designating the significant new uses 
subject to notification.
    (4) Interim final rulemaking. (i) EPA will use the interim final 
rulemaking procedure to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. The Agency will issue an interim final rule in the 
Federal Register following its decision to develop a significant new use 
rule for a specific new microorganism. The document will state EPA's 
reasons for using the interim final rulemaking procedure.
    (A) The significant new use rule will take effect on the date of 
publication.
    (B) Persons will be given 30 days from the date of publication to 
submit comments.
    (ii) Interim final rules issued under this section shall cease to be 
in effect 180 days after publication unless, within the 180-day period, 
EPA issues a final rule in the Federal Register responding to any 
written comments received during the 30-day comment period specified in 
paragraph (c)(4)(i)(B) of this section and promulgating final 
significant new use notification requirements and other requirements for 
the microorganism.
    (5) Notice and comment rulemaking. (i) EPA will use a notice and 
comment procedure to issue a significant new use rule, when EPA is 
designating additional activities which are not provisions included in 
the final order issued for the microorganism under section 5(e) of the 
Act as significant new uses which will be subject to notification. EPA 
will issue a proposal in the Federal Register following its decision to 
develop a significant new use rule under this section for a specific new 
microorganism. Persons will be given 30 days to comment on whether EPA 
should establish notification requirements for the microorganism under 
this part.
    (ii) If EPA, having considered any timely comments, decides to 
establish notification requirements under this section, EPA will issue a 
final rule adding the microorganism to subpart M of this part and 
designating the significant new uses subject to notification.
    (d) Schedule for issuing significant new use rules. (1) Unless EPA 
determines that a significant new use rule should not be issued under 
this section, EPA will issue a proposed rule, a direct final rule, or an 
interim final rule within 180 days of receipt of a valid notice of 
commencement under Sec. 725.190.
    (2) If EPA receives adverse or critical significant comments 
following publication of a proposed or interim final rule, EPA will 
either withdraw the rule or issue a final rule addressing the comments 
received.



Sec. 725.984  Modification or revocation of certain notification requirements.

    (a) Criteria for modification or revocation. EPA may at any time 
modify or revoke significant new use notification requirements for a 
microorganism which has been added to subpart M of this part using the 
procedures of Sec. 725.980. Such action may be taken under this section 
if EPA makes one of the following determinations, unless other 
information shows that the requirements should be retained:

[[Page 444]]

    (1) Test data or other information obtained by EPA provide a 
reasonable basis for concluding that activities designated as 
significant new uses of the microorganism will not present an 
unreasonable risk of injury to health or the environment.
    (2) EPA has promulgated a rule under section 4 or 6 of the Act, or 
EPA or another agency has taken action under another law, for the 
microorganism that eliminates the need for significant new use 
notification under section 5(a)(2) of the Act.
    (3) EPA has received MCANs for some or all of the activities 
designated as significant new uses of the microorganism and, after 
reviewing such MCANs, concluded that there is no need to require 
additional notice from persons who propose to engage in identical or 
similar activities.
    (4) EPA has examined new information, or has reexamined the test 
data or other information supporting its finding under section 
5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no 
longer exists for the findings that activities involving the 
microorganism may present an unreasonable risk of injury to health or 
the environment required under section 5(e)(1)(A) of the Act.
    (5) Certain activities involving the microorganism have been 
designated as significant new uses pending the completion of testing, 
and adequate test data developed in accordance with applicable 
procedures and criteria have been submitted to EPA.
    (b) Procedures for limitation or revocation. Modification or 
revocation of significant new use notification requirements for a 
microorganism that has been added to subpart M of this part using the 
procedures described in Sec. 725.980 may occur either at EPA's 
initiative or in response to a written request.
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a microorganism that 
has been added to subpart M of this part using the procedures described 
in Sec. 725.980 by writing to the Director, or a designee, and stating 
the basis for such request. The request must be accompanied by 
information sufficient to support the request. All requests should be 
sent to the TSCA Document Processing Center (7407), Room L-100, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, 
ATTN: Request to amend SNUR.
    (2) The Director, or a designee, will consider the request, make a 
determination whether to initiate rulemaking to modify the requirements, 
and notify the requester of that determination by certified letter. If 
the request is denied, the letter will explain why EPA has concluded 
that the significant new use notification requirements for that 
microorganism should remain in effect.
    (3) If EPA concludes that significant new use notification 
requirements for a microorganism should be limited or revoked, EPA will 
propose the changes in a notice in the Federal Register, briefly 
describe the grounds for the action, and provide interested parties an 
opportunity to comment.



       Subpart M--Significant New Uses for Specific Microorganisms



Sec. 725.1000  Scope.

    This subpart identifies uses of microorganisms which EPA has 
determined to be significant new uses under the authority of section 
5(a)(2) of the Toxic Substances Control Act.



PART 745--LEAD-BASED PAINT POISIONING PREVENTION IN CERTAIN RESIDENTIAL STRUCTURES--Table of Contents




Subparts A-D [Reserved]

               Subpart E--Residential Property Renovation

Sec.
745.80  Purpose.
745.81  Effective date.
745.82  Applicability.
745.83  Definitions.
745.84  Confidential business information.
745.85  Information distribution requirements.
745.86  Recordkeeping requirements.
745.87  Enforcement and inspections.
745.88  Acknowledgment and certification statements.

[[Page 445]]

Subpart F--Disclosure of Known Lead-Based Paint and/or Lead-Based Paint 
           Hazards Upon Sale or Lease of Residential Property

745.100  Purpose.
745.101  Scope and applicability.
745.102  Effective dates.
745.103  Definitions.
745.107  Disclosure requirements for sellers and lessors.
745.110  Opportunity to conduct an evaluation.
745.113  Certification and acknowledgment of disclosure.
745.115  Agent responsibilities.
745.118  Enforcement.
745.119  Impact on State and local requirements.

Subparts G-K [Reserved]

                 Subpart L--Lead-Based Paint Activities

745.220  Scope and applicability.
745.223  Definitions.
745.225  Accreditation of training programs: target housing and child-
          occupied facilities.
745.226  Certification of individuals and firms engaged in lead-based 
          paint activities: target housing and child-occupied 
          facilities.
745.227  Work practice standards for conducting lead-based paint 
          activities: target housing and child-occupied facilities.
745.228  Accreditation of training programs: public and commercial 
          buildings, bridges and superstructures [Reserved].
745.229  Certification of individuals and firms engaged in lead-based 
          paint activities: public and commercial buildings, bridges and 
          superstructures [Reserved].
745.230  Work practice standards for conducting lead-based paint 
          activities: public and commercial buildings, bridges and 
          superstructures [Reserved].
745.233  Lead-based paint activities requirements.
745.235  Enforcement.
745.237  Inspections.
745.238   Fees for accreditation and certification of lead-based paint 
          activities.
745.239  Effective dates.

Subparts M-P [Reserved]

               Subpart Q--State and Indian Tribal Programs

745.320  Scope and purpose.
745.323  Definitions.
745.324  Authorization of State or Tribal programs.
745.325  Lead-based paint activities: State and Tribal program 
          requirements.
745.326  Pre-renovation notification: State and Tribal program 
          requirements.
745.327  State or Indian Tribal lead-based paint compliance and 
          enforcement programs.
745.330  Grants.
745.339  Effective dates.

    Authority: 15 U.S.C. 2605, 2607, 2681-2692 and 42 U.S.C. 4852d.

    Source: 61 FR 9085, Mar. 6, 1996, unless otherwise noted.

Subparts A-D  [Reserved]



               Subpart E--Residential Property Renovation

    Source: 63 FR 29919, June 1, 1998, unless otherwise noted.



Sec. 745.80   Purpose.

    This subpart contains regulations developed under Title IV (15 
U.S.C. 2681-2692) of the Toxic Substances Control Act and applies to all 
renovations of target housing performed for compensation. The purpose of 
this subpart is to require each person who performs a renovation of 
target housing for compensation to provide a lead hazard information 
pamphlet to the owner and occupant of such housing prior to commencing 
the renovation.



Sec. 745.81   Effective date.

    The requirements in this subpart shall take effect on June 1, 1999.



Sec. 745.82   Applicability.

    (a) Except as provided in paragraph (b) of this section, this 
subpart applies to all renovations of target housing performed for 
compensation.
    (b) This subpart does not apply to renovation activities that are 
limited to the following:
    (1) Minor repair and maintenance activities (including minor 
electrical work and plumbing) that disrupt 2 square feet or less of 
painted surface per component.
    (2) Emergency renovation operations.
    (3) Renovations in target housing in which a written determination 
has been made by an inspector (certified pursuant to either Federal 
regulations at Sec. 745.226 or a State or Tribal certification program 
authorized pursuant to Sec. 745.324) that the components affected

[[Page 446]]

by the renovation are free of paint or other surface coatings that 
contain lead equal to or in excess of 1.0 milligram per square 
centimeter or 0.5 percent by weight, where the renovator has obtained a 
copy of the determination.



Sec. 745.83   Definitions.

    For purposes of this part, the definitions in Sec. 745.103 as well 
as the following definitions apply:
    Administrator means the Administrator of the Environmental 
Protection Agency.
    Emergency renovation operations means renovation activities, such as 
operations necessitated by non-routine failures of equipment, that were 
not planned but result from a sudden, unexpected event that, if not 
immediately attended to, presents a safety or public health hazard, or 
threatens equipment and/or property with significant damage.
    Multi-family housing means a housing property consisting of more 
than four dwelling units.
    Pamphlet means the EPA pamphlet developed under section 406(a) of 
TSCA for use in complying with this and other rulemakings under Title IV 
of TSCA and the Residential Lead-Based Paint Hazard Reduction Act, or 
any State or Tribal pamphlet approved by EPA pursuant to 40 CFR 745.326 
that is developed for the same purpose. This includes reproductions of 
the pamphlet when copied in full and without revision or deletion of 
material from the pamphlet (except for the addition or revision of State 
or local sources of information).
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any Indian Tribe, 
State, or political subdivision thereof; any interstate body; and any 
department, agency, or instrumentality of the Federal Government.
    Renovation means the modification of any existing structure, or 
portion thereof, that results in the disturbance of painted surfaces, 
unless that activity is performed as part of an abatement as defined by 
this part (40 CFR 745.223). The term renovation includes (but is not 
limited to): the removal or modification of painted surfaces or painted 
components (e.g., modification of painted doors, surface preparation 
activity (such as sanding, scraping, or other such activities that may 
generate paint dust)); the removal of large structures (e.g., walls, 
ceiling, large surface replastering, major re-plumbing); and window 
replacement.
    Renovator means any person who performs for compensation a 
renovation.



Sec. 745.84   Confidential business information.

    (a) Those who assert a confidentiality claim for submitted 
information must provide EPA with two copies of their submission. The 
first copy must be complete and contain all information being claimed as 
confidential. The second copy must contain only information not claimed 
as confidential. EPA will place the second copy of the submission in the 
public file.
    (b) EPA will disclose information subject to a claim of 
confidentiality only to the extent permitted by section 14 of TSCA and 
40 CFR part 2, subpart B. If a person does not assert a claim of 
confidentiality for information at the time it is submitted to EPA, EPA 
may make the information public without further notice to that person.



Sec. 745.85   Information distribution requirements.

    (a) Renovations in dwelling units. No more than 60 days before 
beginning renovation activities in any residential dwelling unit of 
target housing, the renovator shall:
    (1) Provide the owner of the unit with the pamphlet, and comply with 
one of the following:
    (i) Obtain, from the owner, a written acknowledgment that the owner 
has received the pamphlet.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (2) In addition to the requirements in paragraph (a)(1) of this 
section, if the owner does not occupy the dwelling unit, provide an 
adult occupant of the unit with the pamphlet, and comply with one of the 
following:
    (i) Obtain, from the adult occupant, a written acknowledgment that 
the occupant has received the pamphlet; or certify in writing that a 
pamphlet has

[[Page 447]]

been delivered to the dwelling and that the renovator has been 
unsuccessful in obtaining a written acknowledgment from an adult 
occupant. Such certification must include the address of the unit 
undergoing renovation, the date and method of delivery of the pamphlet, 
names of the persons delivering the pamphlet, reason for lack of 
acknowledgment (e.g., occupant refuses to sign, no adult occupant 
available), the signature of the renovator, and the date of signature.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (b) Renovations in common areas. No more than 60 days before 
beginning renovation activities in common areas of multi-family housing, 
the renovator shall:
    (1) Provide the owner with the pamphlet, and comply with one of the 
following:
    (i) Obtain, from the owner, a written acknowledgment that the owner 
has received the pamphlet.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (2) Notify in writing, or ensure written notification of, each unit 
of the multi-family housing and make the pamphlet available upon request 
prior to the start of renovation. Such notification shall be 
accomplished by distributing written notice to each affected unit. The 
notice shall describe the general nature and locations of the planned 
renovation activities; the expected starting and ending dates; and a 
statement of how the occupant can obtain the pamphlet, at no charge, 
from the renovator.
    (3) Prepare, sign, and date a statement describing the steps 
performed to notify all occupants of the intended renovation activities 
and to provide the pamphlet.
    (4) If the scope, locations, or expected starting and ending dates 
of the planned renovation activities change after the initial 
notification, the renovator shall provide further written notification 
to the owners and occupants providing revised information on the ongoing 
or planned activities. This subsequent notification must be provided 
before the renovator initiates work beyond that which was described in 
the original notice.
    (c) Written acknowledgment. Sample language for such acknowledgments 
is provided in Sec. 745.88. The written acknowledgments required in 
paragraphs (a)(1)(i), (a)(2)(i), and (b)(1)(i) of this section shall:
    (1) Include a statement recording the owner or occupant's name and 
acknowledging receipt of the pamphlet prior to the start of renovation, 
the address of the unit undergoing renovation, the signature of the 
owner or occupant as applicable, and the date of signature.
    (2) Be either a separate sheet or part of any written contract or 
service agreement for the renovation.
    (3) Be written in the same language as the text of the contract or 
agreement for the renovation or, in the case of non-owner occupied 
target housing, in the same language as the lease or rental agreement or 
the pamphlet.



Sec. 745.86   Recordkeeping requirements.

    (a) Renovators shall retain and, if requested, make available to EPA 
all records necessary to demonstrate compliance with this subpart for a 
period of 3 years following completion of the renovation activities in 
target housing. This 3-year retention requirement does not supersede 
longer obligations required by other provisions for retaining the same 
documentation, including any applicable State or Tribal laws or 
regulations.
    (b) Records that must be retained pursuant to paragraph (a) of this 
section shall include (where applicable):
    (1) Reports certifying that a determination had been made by an 
inspector (certified pursuant to either Federal regulations at 
Sec. 745.226 or an EPA-authorized State or Tribal certification program) 
that lead-based paint is not present in the area affected by the 
renovation, as described in Sec. 745.82(b)(vi).
    (2) Signed and dated acknowledgments of receipt as described in 
Sec. 745.85(a)(1)(i), (a)(2)(i), and (b)(1)(i).
    (3) Certifications of attempted delivery as described in 
Sec. 745.85(a)(2)(i).
    (4) Certificates of mailing as described in Sec. 745.85(a)(1)(ii), 
(a)(2)(ii), and (b)(1)(ii).

[[Page 448]]

    (5) Records of notification activities performed regarding common 
area renovations, as described in Sec. 745.85(b) (3) and (4).



Sec. 745.87   Enforcement and inspections.

    (a) Failure or refusal to comply with any provision of this subpart 
is a violation of TSCA section 409 (15 U.S.C. 2689).
    (b) Failure or refusal to establish and maintain records or to make 
available or permit access to or copying of records, as required by this 
subpart, is a violation of TSCA sections 15 and 409 (15 U.S.C. 2614 and 
2689).
    (c) Failure or refusal to permit entry or inspection as required by 
40 CFR 745.87 and TSCA section 11 (15 U.S.C. 2610) is a violation of 
sections 15 and 409 (15 U.S.C. 2614 and 2689).
    (d) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.
    (e) EPA may conduct inspections and issue subpoenas pursuant to the 
provisions of TSCA section 11 (15 U.S.C. 2610) to ensure compliance with 
this subpart.



Sec. 745.88   Acknowledgment and certification statements.

    (a)(1) Acknowledgment statement. As required under 
Sec. 745.85(c)(1), acknowledgments shall include a statement of receipt 
of the pamphlet prior to the start of renovation, the address of the 
unit undergoing renovation, the signature of the owner or occupant as 
applicable, and the date of signature.
    (2) Sample acknowledgment language. The following is a sample of 
language that could be used for such acknowledgments:

I have received a copy of the pamphlet, Protect Your Family From Lead In 
Your Home, informing me of the potential risk of lead hazard exposure 
from renovation activity to be performed in my dwelling unit. I received 
this pamphlet before the work began.
__________________________________________
__________________________________________

Printed Name and Signature

__________________________________________
Date

__________________________________________
__________________________________________
Unit Address

    (b)(1) Certification of attempted delivery. When an occupant is 
unavailable for signature or refuses to sign the acknowledgment of 
receipt of the pamphlet, the renovator is permitted (per 
Sec. 745.85(a)(2)(i)) to certify delivery for each instance. The 
certification shall include the address of the unit undergoing 
renovation, the date and method of delivery of the pamphlet, names of 
the persons delivering the pamphlet, reason for lack of acknowledgment 
(e.g. occupant refuses to sign, no adult occupant available), the 
signature of the renovator, and the date of signature.
    (2) Sample certification language. The following is a sample of 
language that could be used under those circumstances:
    (i) Unavailable for signature.

    I certify that I have made a good faith effort to deliver the 
pamphlet, Protect Your Family From Lead In Your Home, to the unit listed 
below at the dates and times indicated, and that the occupant refused to 
sign the acknowledgment. I further certify that I have left a copy of 
the pamphlet at the unit with the occupant.
__________________________________________
__________________________________________

Printed Name and Signature
__________________________________________
Date
__________________________________________
__________________________________________
Unit Address

Attempted delivery dates and times:

    (ii) Refusal to sign.

    I certify that I have made a good faith effort to deliver the 
pamphlet, Protect Your Family From Lead In Your Home, to the unit listed 
below, and that the occupant was unavailable to sign the acknowledgment. 
I further certify that I have left a copy of the pamphlet at the unit by 
sliding it under the door.
__________________________________________
__________________________________________

Printed Name and Signature
__________________________________________
Date
__________________________________________
__________________________________________
Unit Address

Attempted delivery dates and times:

[[Page 449]]



Subpart F--Disclosure of Known Lead-Based Paint and/or Lead-Based Paint 
           Hazards Upon Sale or Lease of Residential Property



Sec. 745.100  Purpose.

    This subpart implements the provisions of 42 U.S.C. 4852d, which 
impose certain requirements on the sale or lease of target housing. 
Under this subpart, a seller or lessor of target housing shall disclose 
to the purchaser or lessee the presence of any known lead-based paint 
and/or lead-based paint hazards; provide available records and reports; 
provide the purchaser or lessee with a lead hazard information pamphlet; 
give purchasers a 10-day opportunity to conduct a risk assessment or 
inspection; and attach specific disclosure and warning language to the 
sales or leasing contract before the purchaser or lessee is obligated 
under a contract to purchase or lease target housing.



Sec. 745.101  Scope and applicability.

    This subpart applies to all transactions to sell or lease target 
housing, including subleases, with the exception of the following:
    (a) Sales of target housing at foreclosure.
    (b) Leases of target housing that have been found to be lead-based 
paint free by an inspector certified under the Federal certification 
program or under a federally accredited State or tribal certification 
program. Until a Federal certification program or federally accredited 
State certification program is in place within the State, inspectors 
shall be considered qualified to conduct an inspection for this purpose 
if they have received certification under any existing State or tribal 
inspector certification program. The lessor has the option of using the 
results of additional test(s) by a certified inspector to confirm or 
refute a prior finding.
    (c) Short-term leases of 100 days or less, where no lease renewal or 
extension can occur.
    (d) Renewals of existing leases in target housing in which the 
lessor has previously disclosed all information required under 
Sec. 745.107 and where no new information described in Sec. 745.107 has 
come into the possession of the lessor. For the purposes of this 
paragraph, renewal shall include both renegotiation of existing lease 
terms and/or ratification of a new lease.



Sec. 745.102  Effective dates.

    The requirements in this subpart take effect in the following 
manner:
    (a) For owners of more than four residential dwellings, the 
requirements shall take effect on September 6, 1996.
    (b) For owners of one to four residential dwellings, the 
requirements shall take effect on December 6, 1996.



Sec. 745.103  Definitions.

    The following definitions apply to this subpart.
    The Act means the Residential Lead-Based Paint Hazard Reduction Act 
of 1992, 42 U.S.C. 4852d.
    Agent means any party who enters into a contract with a seller or 
lessor, including any party who enters into a contract with a 
representative of the seller or lessor, for the purpose of selling or 
leasing target housing. This term does not apply to purchasers or any 
purchaser's representative who receives all compensation from the 
purchaser.
    Available means in the possession of or reasonably obtainable by the 
seller or lessor at the time of the disclosure.
    Common area means a portion of a building generally accessible to 
all residents/users including, but not limited to, hallways, stairways, 
laundry and recreational rooms, playgrounds, community centers, and 
boundary fences.
    Contract for the purchase and sale of residential real property 
means any contract or agreement in which one party agrees to purchase an 
interest in real property on which there is situated one or more 
residential dwellings used or occupied, or intended to be used or 
occupied, in whole or in part, as the home or residence of one or more 
persons.
    EPA means the Environmental Protection Agency.
    Evaluation means a risk assessment and/or inspection.

[[Page 450]]

    Foreclosure means any of the various methods, statutory or 
otherwise, known in different jurisdictions, of enforcing payment of a 
debt, by the taking and selling of real property.
    Housing for the elderly means retirement communities or similar 
types of housing reserved for households composed of one or more persons 
62 years of age or more at the time of initial occupancy.
    HUD means the U.S. Department of Housing and Urban Development.
    Inspection means:
    (1) A surface-by-surface investigation to determine the presence of 
lead-based paint as provided in section 302(c) of the Lead-Based Paint 
Poisoning and Prevention Act [42 U.S.C. 4822], and
    (2) The provision of a report explaining the results of the 
investigation.
    Lead-based paint means paint or other surface coatings that contain 
lead equal to or in excess of 1.0 milligram per square centimeter or 0.5 
percent by weight.
    Lead-based paint free housing means target housing that has been 
found to be free of paint or other surface coatings that contain lead 
equal to or in excess of 1.0 milligram per square centimeter or 0.5 
percent by weight.
    Lead-based paint hazard means any condition that causes exposure to 
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible 
surfaces, friction surfaces, or impact surfaces that would result in 
adverse human health effects as established by the appropriate Federal 
agency.
    Lessee means any entity that enters into an agreement to lease, 
rent, or sublease target housing, including but not limited to 
individuals, partnerships, corporations, trusts, government agencies, 
housing agencies, Indian tribes, and nonprofit organizations.
    Lessor means any entity that offers target housing for lease, rent, 
or sublease, including but not limited to individuals, partnerships, 
corporations, trusts, government agencies, housing agencies, Indian 
tribes, and nonprofit organizations.
    Owner means any entity that has legal title to target housing, 
including but not limited to individuals, partnerships, corporations, 
trusts, government agencies, housing agencies, Indian tribes, and 
nonprofit organizations, except where a mortgagee holds legal title to 
property serving as collateral for a mortgage loan, in which case the 
owner would be the mortgagor.
    Purchaser means an entity that enters into an agreement to purchase 
an interest in target housing, including but not limited to individuals, 
partnerships, corporations, trusts, government agencies, housing 
agencies, Indian tribes, and nonprofit organizations.
    Reduction means measures designed to reduce or eliminate human 
exposure to lead-based paint hazards through methods including interim 
controls and abatement.
    Residential dwelling means:
    (1) A single-family dwelling, including attached structures such as 
porches and stoops; or
    (2) A single-family dwelling unit in a structure that contains more 
than one separate residential dwelling unit, and in which each such unit 
is used or occupied, or intended to be used or occupied, in whole or in 
part, as the residence of one or more persons.
    Risk assessment means an on-site investigation to determine and 
report the existence, nature, severity, and location of lead-based paint 
hazards in residential dwellings, including:
    (1) Information gathering regarding the age and history of the 
housing and occupancy by children under age 6;
    (2) Visual inspection;
    (3) Limited wipe sampling or other environmental sampling 
techniques;
    (4) Other activity as may be appropriate; and
    (5) Provision of a report explaining the results of the 
investigation.
    Secretary means the Secretary of Housing and Urban Development.
    Seller means any entity that transfers legal title to target 
housing, in whole or in part, in return for consideration, including but 
not limited to individuals, partnerships, corporations, trusts, 
government agencies, housing agencies, Indian tribes, and nonprofit 
organizations. The term ``seller'' also includes:
    (1) An entity that transfers shares in a cooperatively owned 
project, in return for consideration; and

[[Page 451]]

    (2) An entity that transfers its interest in a leasehold, in 
jurisdictions or circumstances where it is legally permissible to 
separate the fee title from the title to the improvement, in return for 
consideration.
    Target housing means any housing constructed prior to 1978, except 
housing for the elderly or persons with disabilities (unless any child 
who is less than 6 years of age resides or is expected to reside in such 
housing) or any 0-bedroom dwelling.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601.
    0-bedroom dwelling means any residential dwelling in which the 
living area is not separated from the sleeping area. The term includes 
efficiencies, studio apartments, dormitory housing, military barracks, 
and rentals of individual rooms in residential dwellings.



Sec. 745.107  Disclosure requirements for sellers and lessors.

    (a) The following activities shall be completed before the purchaser 
or lessee is obligated under any contract to purchase or lease target 
housing that is not otherwise an exempt transaction pursuant to 
Sec. 745.101. Nothing in this section implies a positive obligation on 
the seller or lessor to conduct any evaluation or reduction activities.
    (1) The seller or lessor shall provide the purchaser or lessee with 
an EPA-approved lead hazard information pamphlet. Such pamphlets include 
the EPA document entitled Protect Your Family From Lead in Your Home 
(EPA 747-K-94-001) or an equivalent pamphlet that has been approved for 
use in that State by EPA.
    (2) The seller or lessor shall disclose to the purchaser or lessee 
the presence of any known lead-based paint and/or lead-based paint 
hazards in the target housing being sold or leased. The seller or lessor 
shall also disclose any additional information available concerning the 
known lead-based paint and/or lead-based paint hazards, such as the 
basis for the determination that lead-based paint and/or lead-based 
paint hazards exist, the location of the lead-based paint and/or lead-
based paint hazards, and the condition of the painted surfaces.
    (3) The seller or lessor shall disclose to each agent the presence 
of any known lead-based paint and/or lead-based paint hazards in the 
target housing being sold or leased and the existence of any available 
records or reports pertaining to lead-based paint and/or lead-based 
paint hazards. The seller or lessor shall also disclose any additional 
information available concerning the known lead-based paint and/or lead-
based paint hazards, such as the basis for the determination that lead-
based paint and/or lead-based paint hazards exist, the location of the 
lead-based paint and/or lead-based paint hazards, and the condition of 
the painted surfaces.
    (4) The seller or lessor shall provide the purchaser or lessee with 
any records or reports available to the seller or lessor pertaining to 
lead-based paint and/or lead-based paint hazards in the target housing 
being sold or leased. This requirement includes records or reports 
regarding common areas. This requirement also includes records or 
reports regarding other residential dwellings in multifamily target 
housing, provided that such information is part of an evaluation or 
reduction of lead-based paint and/or lead-based paint hazards in the 
target housing as a whole.
    (b) If any of the disclosure activities identified in paragraph (a) 
of this section occurs after the purchaser or lessee has provided an 
offer to purchase or lease the housing, the seller or lessor shall 
complete the required disclosure activities prior to accepting the 
purchaser's or lessee's offer and allow the purchaser or lessee an 
opportunity to review the information and possibly amend the offer.



Sec. 745.110  Opportunity to conduct an evaluation.

    (a) Before a purchaser is obligated under any contract to purchase 
target housing, the seller shall permit the purchaser a 10-day period 
(unless the parties mutually agree, in writing, upon a different period 
of time) to conduct a risk assessment or inspection for the presence of 
lead-based paint and/or lead-based paint hazards.
    (b) Not withstanding paragraph (a) of this section, a purchaser may 
waive

[[Page 452]]

the opportunity to conduct the risk assessment or inspection by so 
indicating in writing.



Sec. 745.113  Certification and acknowledgment of disclosure.

    (a) Seller requirements. Each contract to sell target housing shall 
include an attachment containing the following elements, in the language 
of the contract (e.g., English, Spanish):
    (1) A Lead Warning Statement consisting of the following language:

    Every purchaser of any interest in residential real property on 
which a residential dwelling was built prior to 1978 is notified that 
such property may present exposure to lead from lead-based paint that 
may place young children at risk of developing lead poisoning. Lead 
poisoning in young children may produce permanent neurological damage, 
including learning disabilities, reduced intelligence quotient, 
behavioral problems, and impaired memory. Lead poisoning also poses a 
particular risk to pregnant women. The seller of any interest in 
residential real property is required to provide the buyer with any 
information on lead-based paint hazards from risk assessments or 
inspections in the seller's possession and notify the buyer of any known 
lead-based paint hazards. A risk assessment or inspection for possible 
lead-based paint hazards is recommended prior to purchase.

    (2) A statement by the seller disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being 
sold or indicating no knowledge of the presence of lead-based paint and/
or lead-based paint hazards. The seller shall also provide any 
additional information available concerning the known lead-based paint 
and/or lead-based paint hazards, such as the basis for the determination 
that lead-based paint and/or lead-based paint hazards exist, the 
location of the lead-based paint and/or lead-based paint hazards, and 
the condition of the painted surfaces.
    (3) A list of any records or reports available to the seller 
pertaining to lead-based paint and/or lead-based paint hazards in the 
housing that have been provided to the purchaser. If no such records or 
reports are available, the seller shall so indicate.
    (4) A statement by the purchaser affirming receipt of the 
information set out in paragraphs (a)(2) and (a)(3) of this section and 
the lead hazard information pamphlet required under 15 U.S.C. 2696.
    (5) A statement by the purchaser that he/she has either:
    (i) Received the opportunity to conduct the risk assessment or 
inspection required by Sec. 745.110(a); or
    (ii) Waived the opportunity.
    (6) When one or more agents are involved in the transaction to sell 
target housing on behalf of the seller, a statement that:
    (i) The agent has informed the seller of the seller's obligations 
under 42 U.S.C. 4852d; and
    (ii) The agent is aware of his/her duty to ensure compliance with 
the requirements of this subpart.
    (7) The signatures of the sellers, agents, and purchasers certifying 
to the accuracy of their statements to the best of their knowledge, 
along with the dates of signature.
    (b) Lessor requirements. Each contract to lease target housing shall 
include, as an attachment or within the contract, the following 
elements, in the language of the contract (e.g., English, Spanish):
    (1) A Lead Warning Statement with the following language:

    Housing built before 1978 may contain lead-based paint. Lead from 
paint, paint chips, and dust can pose health hazards if not managed 
properly. Lead exposure is especially harmful to young children and 
pregnant women. Before renting pre-1978 housing, lessors must disclose 
the presence of lead-based paint and/or lead-based paint hazards in the 
dwelling. Lessees must also receive a federally approved pamphlet on 
lead poisoning prevention.

    (2) A statement by the lessor disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being 
leased or indicating no knowledge of the presence of lead-based paint 
and/or lead-based paint hazards. The lessor shall also disclose any 
additional information available concerning the known lead-based paint 
and/or lead-based paint hazards, such as the basis for the determination 
that lead-based paint and/or lead-based paint hazards exist, the 
location of the lead-based paint and/or lead-based paint hazards, and 
the condition of the painted surfaces.

[[Page 453]]

    (3) A list of any records or reports available to the lessor 
pertaining to lead-based paint and/or lead-based paint hazards in the 
housing that have been provided to the lessee. If no such records or 
reports are available, the lessor shall so indicate.
    (4) A statement by the lessee affirming receipt of the information 
set out in paragraphs (b)(2) and (b)(3) of this section and the lead 
hazard information pamphlet required under 15 U.S.C. 2696.
    (5) When one or more agents are involved in the transaction to lease 
target housing on behalf of the lessor, a statement that:
    (i) The agent has informed the lessor of the lessor as obligations 
under 42 U.S.C. 4852d; and
    (ii) The agent is aware of his/her duty to ensure compliance with 
the requirements of this subpart.
    (6) The signatures of the lessors, agents, and lessees, certifying 
to the accuracy of their statements, to the best of their knowledge, 
along with the dates of signature.
    (c) Retention of Certification and Acknowledgment Information.
    (1) The seller, and any agent, shall retain a copy of the completed 
attachment required under paragraph (a) of this section for no less than 
3 years from the completion date of the sale. The lessor, and any agent, 
shall retain a copy of the completed attachment or lease contract 
containing the information required under paragraph (b) of this section 
for no less than 3 years from the commencement of the leasing period.
    (2) This recordkeeping requirement is not intended to place any 
limitations on civil suits under the Act, or to otherwise affect a 
lessee's or purchaser's rights under the civil penalty provisions of 42 
U.S.C. 4852d(b)(3).
    (d) The seller, lessor, or agent shall not be responsible for the 
failure of a purchaser's or lessee's legal representative (where such 
representative receives all compensation from the purchaser or lessee) 
to transmit disclosure materials to the purchaser or lessee, provided 
that all required parties have completed and signed the necessary 
certification and acknowledgment language required under paragraphs (a) 
and (b) of this section.



Sec. 745.115  Agent responsibilities.

    (a) Each agent shall ensure compliance with all requirements of this 
subpart. To ensure compliance, the agent shall:
    (1) Inform the seller or lessor of his/her obligations under 
Secs. 745.107, 745.110, and 745.113.
    (2) Ensure that the seller or lessor has performed all activities 
required under Secs. 745.107, 745.110, and 745.113, or personally ensure 
compliance with the requirements of Secs. 745.107, 745.110, and 745.113.
    (b) If the agent has complied with paragraph (a)(1) of this section, 
the agent shall not be liable for the failure to disclose to a purchaser 
or lessee the presence of lead-based paint and/or lead-based paint 
hazards known by a seller or lessor but not disclosed to the agent.



Sec. 745.118  Enforcement.

    (a) Any person who knowingly fails to comply with any provision of 
this subpart shall be subject to civil monetary penalties in accordance 
with the provisions of 42 U.S.C. 3545 and 24 CFR part 30.
    (b) The Secretary is authorized to take such action as may be 
necessary to enjoin any violation of this subpart in the appropriate 
Federal district court.
    (c) Any person who knowingly violates the provisions of this subpart 
shall be jointly and severally liable to the purchaser or lessee in an 
amount equal to 3 times the amount of damages incurred by such 
individual.
    (d) In any civil action brought for damages pursuant to 42 U.S.C. 
4852d(b)(3), the appropriate court may award court costs to the party 
commencing such action, together with reasonable attorney fees and any 
expert witness fees, if that party prevails.
    (e) Failure or refusal to comply with Sec. 745.107 (disclosure 
requirements for sellers and lessors), Sec. 745.110 (opportunity to 
conduct an evaluation), Sec. 745.113 (certification and acknowledgment 
of disclosure), or Sec. 745.115 (agent responsibilities) is a violation 
of 42

[[Page 454]]

U.S.C. 4852d(b)(5) and of TSCA section 409 (15 U.S.C. 2689).
    (f) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation. For 
purposes of enforcing this subpart, the penalty for each violation 
applicable under 15 U.S.C. 2615 shall not be more than $11,000 for all 
violations occuring after July 28, 1997; all violations occuring on or 
prior to that date are subject to a penalty not more than $10,000.

[61 FR 9085, Mar. 6, 1996, as amended at 62 FR 35041, June 27, 1997]



Sec. 745.119  Impact on State and local requirements.

    Nothing in this subpart shall relieve a seller, lessor, or agent 
from any responsibility for compliance with State or local laws, 
ordinances, codes, or regulations governing notice or disclosure of 
known lead-based paint or lead-based paint hazards. Neither HUD nor EPA 
assumes any responsibility for ensuring compliance with such State or 
local requirements.

Subparts G-K [Reserved]



                 Subpart L--Lead-Based Paint Activities

    Source: 61 FR 45813, Aug. 29, 1996, unless otherwise noted.



Sec. 745.220  Scope and applicability.

    (a) This subpart contains procedures and requirements for the 
accreditation of lead-based paint activities training programs, 
procedures and requirements for the certification of individuals and 
firms engaged in lead-based paint activities, and work practice 
standards for performing such activities. This subpart also requires 
that, except as discussed below, all lead-based paint activities, as 
defined in this subpart, be performed by certified individuals and 
firms.
    (b) This subpart applies to all individuals and firms who are 
engaged in lead-based paint activities as defined in Sec. 745.223, 
except persons who perform these activities within residential dwellings 
that they own, unless the residential dwelling is occupied by a person 
or persons other than the owner or the owner's immediate family while 
these activities are being performed, or a child residing in the 
building has been identified as having an elevated blood lead level. 
This subpart applies only in those States or Indian Country that do not 
have an authorized State or Tribal program pursuant to Sec. 745.324 of 
subpart Q.
    (c) Each department, agency, and instrumentality of the executive, 
legislative, and judicial branches of the Federal Government having 
jurisdiction over any property or facility, or engaged in any activity 
resulting, or which may result, in a lead-based paint hazard, and each 
officer, agent, or employee thereof shall be subject to, and comply 
with, all Federal, State, interstate, and local requirements, both 
substantive and procedural, including the requirements of this subpart 
regarding lead-based paint, lead-based paint activities, and lead-based 
paint hazards.
    (d) While this subpart establishes specific requirements for 
performing lead-based paint activities should they be undertaken, 
nothing in this subpart requires that the owner or occupant undertake 
any particular lead-based paint activity.



Sec. 745.223  Definitions.

    The definitions in subpart A apply to this subpart. In addition, the 
following definitions apply.
    Abatement means any measure or set of measures designed to 
permanently eliminate lead-based paint hazards. Abatement includes, but 
is not limited to:
    (1) The removal of lead-based paint and lead-contaminated dust, the 
permanent enclosure or encapsulation of lead-based paint, the 
replacement of lead-painted surfaces or fixtures, and the removal or 
covering of lead-contaminated soil; and
    (2) All preparation, cleanup, disposal, and post-abatement clearance 
testing activities associated with such measures.
    (3) Specifically, abatement includes, but is not limited to:
    (i) Projects for which there is a written contract or other 
documentation, which provides that an individual or

[[Page 455]]

firm will be conducting activities in or to a residential dwelling or 
child-occupied facility that:
    (A) Shall result in the permanent elimination of lead-based paint 
hazards; or
    (B) Are designed to permanently eliminate lead-based paint hazards 
and are described in paragraphs (1) and (2) of this definition.
    (ii) Projects resulting in the permanent elimination of lead-based 
paint hazards, conducted by firms or individuals certified in accordance 
with Sec. 745.226, unless such projects are covered by paragraph (4) of 
this definition;
    (iii) Projects resulting in the permanent elimination of lead-based 
paint hazards, conducted by firms or individuals who, through their 
company name or promotional literature, represent, advertise, or hold 
themselves out to be in the business of performing lead-based paint 
activities as identified and defined by this section, unless such 
projects are covered by paragraph (4) of this definition; or
    (iv) Projects resulting in the permanent elimination of lead-based 
paint hazards, that are conducted in response to State or local 
abatement orders.
    (4) Abatement does not include renovation, remodeling, landscaping 
or other activities, when such activities are not designed to 
permanently eliminate lead-based paint hazards, but, instead, are 
designed to repair, restore, or remodel a given structure or dwelling, 
even though these activities may incidentally result in a reduction or 
elimination of lead-based paint hazards. Furthermore, abatement does not 
include interim controls, operations and maintenance activities, or 
other measures and activities designed to temporarily, but not 
permanently, reduce lead-based paint hazards.
    Accredited training program means a training program that has been 
accredited by EPA pursuant to Sec. 745.225 to provide training for 
individuals engaged in lead-based paint activities.
    Adequate quality control means a plan or design which ensures the 
authenticity, integrity, and accuracy of samples, including dust, soil, 
and paint chip or paint film samples. Adequate quality control also 
includes provisions for representative sampling.
    Certified firm means a company, partnership, corporation, sole 
proprietorship, association, or other business entity that performs 
lead-based paint activities to which EPA has issued a certificate of 
approval pursuant to Sec. 745.226(f).
    Certified inspector means an individual who has been trained by an 
accredited training program, as defined by this section, and certified 
by EPA pursuant to Sec. 745.226 to conduct inspections. A certified 
inspector also samples for the presence of lead in dust and soil for the 
purposes of abatement clearance testing.
    Certified abatement worker means an individual who has been trained 
by an accredited training program, as defined by this section, and 
certified by EPA pursuant to Sec. 745.226 to perform abatements.
    Certified project designer means an individual who has been trained 
by an accredited training program, as defined by this section, and 
certified by EPA pursuant to Sec. 745.226 to prepare abatement project 
designs, occupant protection plans, and abatement reports.
    Certified risk assessor means an individual who has been trained by 
an accredited training program, as defined by this section, and 
certified by EPA pursuant to Sec. 745.226 to conduct risk assessments. A 
risk assessor also samples for the presence of lead in dust and soil for 
the purposes of abatement clearance testing.
    Certified supervisor means an individual who has been trained by an 
accredited training program, as defined by this section, and certified 
by EPA pursuant to Sec. 745.226 to supervise and conduct abatements, and 
to prepare occupant protection plans and abatement reports.
    Child-occupied facility means a building, or portion of a building, 
constructed prior to 1978, visited regularly by the same child, 6 years 
of age or under, on at least two different days within any week (Sunday 
through Saturday period), provided that each day's visit lasts at least 
3 hours and the combined weekly visit lasts at least 6 hours, and the 
combined annual visits last at least 60 hours. Child-occupied

[[Page 456]]

facilities may include, but are not limited to, day-care centers, 
preschools and kindergarten classrooms.
    Clearance levels are values that indicate the maximum amount of lead 
permitted in dust on a surface following completion of an abatement 
activity.
    Common area means a portion of a building that is generally 
accessible to all occupants. Such an area may include, but is not 
limited to, hallways, stairways, laundry and recreational rooms, 
playgrounds, community centers, garages, and boundary fences.
    Component or building component means specific design or structural 
elements or fixtures of a building, residential dwelling, or child-
occupied facility that are distinguished from each other by form, 
function, and location. These include, but are not limited to, interior 
components such as: ceilings, crown molding, walls, chair rails, doors, 
door trim, floors, fireplaces, radiators and other heating units, 
shelves, shelf supports, stair treads, stair risers, stair stringers, 
newel posts, railing caps, balustrades, windows and trim (including 
sashes, window heads, jambs, sills or stools and troughs), built in 
cabinets, columns, beams, bathroom vanities, counter tops, and air 
conditioners; and exterior components such as: painted roofing, 
chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias, 
rake boards, cornerboards, bulkheads, doors and door trim, fences, 
floors, joists, lattice work, railings and railing caps, siding, 
handrails, stair risers and treads, stair stringers, columns, 
balustrades, window sills or stools and troughs, casings, sashes and 
wells, and air conditioners.
    Containment means a process to protect workers and the environment 
by controlling exposures to the lead-contaminated dust and debris 
created during an abatement.
    Course agenda means an outline of the key topics to be covered 
during a training course, including the time allotted to teach each 
topic.
    Course test means an evaluation of the overall effectiveness of the 
training which shall test the trainees' knowledge and retention of the 
topics covered during the course.
    Course test blue print means written documentation identifying the 
proportion of course test questions devoted to each major topic in the 
course curriculum.
    Deteriorated paint means paint that is cracking, flaking, chipping, 
peeling, or otherwise separating from the substrate of a building 
component.
    Discipline means one of the specific types or categories of lead-
based paint activities identified in this subpart for which individuals 
may receive training from accredited programs and become certified by 
EPA. For example, ``abatement worker'' is a discipline.
    Distinct painting history means the application history, as 
indicated by its visual appearance or a record of application, over 
time, of paint or other surface coatings to a component or room.
    Documented methodologies are methods or protocols used to sample for 
the presence of lead in paint, dust, and soil.
    Elevated blood lead level (EBL) means an excessive absorption of 
lead that is a confirmed concentration of lead in whole blood of 20 
 g/dl (micrograms of lead per deciliter of whole blood) for a 
single venous test or of 15-19  g/dl in two consecutive tests 
taken 3 to 4 months apart.
    Encapsulant means a substance that forms a barrier between lead-
based paint and the environment using a liquid-applied coating (with or 
without reinforcement materials) or an adhesively bonded covering 
material.
    Encapsulation means the application of an encapsulant.
    Enclosure means the use of rigid, durable construction materials 
that are mechanically fastened to the substrate in order to act as a 
barrier between lead-based paint and the environment.
    Guest instructor means an individual designated by the training 
program manager or principal instructor to provide instruction specific 
to the lecture, hands-on activities, or work practice components of a 
course.
    Hands-on skills assessment means an evaluation which tests the 
trainees' ability to satisfactorily perform the work practices and 
procedures identified in Sec. 745.225(d), as well as any other skill 
taught in a training course.
    Hazardous waste means any waste as defined in 40 CFR 261.3.

[[Page 457]]

    Inspection means a surface-by-surface investigation to determine the 
presence of lead-based paint and the provision of a report explaining 
the results of the investigation.
    Interim certification means the status of an individual who has 
successfully completed the appropriate training course in a discipline 
from an accredited training program, as defined by this section, but has 
not yet received formal certification in that discipline from EPA 
pursuant to Sec. 745.226. Interim certifications expire 6 months after 
the completion of the training course, and is equivalent to a 
certificate for the 6-month period.
    Interim controls means a set of measures designed to temporarily 
reduce human exposure or likely exposure to lead-based paint hazards, 
including specialized cleaning, repairs, maintenance, painting, 
temporary containment, ongoing monitoring of lead-based paint hazards or 
potential hazards, and the establishment and operation of management and 
resident education programs.
    Lead-based paint means paint or other surface coatings that contain 
lead equal to or in excess of 1.0 milligrams per square centimeter or 
more than 0.5 percent by weight.
    Lead-based paint activities means, in the case of target housing and 
child-occupied facilities, inspection, risk assessment, and abatement, 
as defined in this subpart.
    Lead-based paint hazard means any condition that causes exposure to 
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible 
surfaces, friction surfaces, or impact surfaces that would result in 
adverse human health effects as identified by the Administrator pursuant 
to TSCA section 403.
    Lead-contaminated dust means surface dust in residential dwellings, 
or child-occupied facilities that contains an area or mass concentration 
of lead at or in excess of levels identified by the Administrator 
pursuant to TSCA section 403.
    Lead-contaminated soil means bare soil on residential real property 
and on the property of a child-occupied facility that contains lead at 
or in excess of levels identified by the Administrator pursuant to TSCA 
section 403.
    Lead-hazard screen is a limited risk assessment activity that 
involves limited paint and dust sampling as described in 
Sec. 745.227(c).
    Living area means any area of a residential dwelling used by one or 
more children age 6 and under, including, but not limited to, living 
rooms, kitchen areas, dens, play rooms, and children's bedrooms.
    Local government means a county, city, town, borough, parish, 
district, association, or other public body (including an agency 
comprised of two or more of the foregoing entities) created under State 
law.
    Multi-family dwelling means a structure that contains more than one 
separate residential dwelling unit, which is used or occupied, or 
intended to be used or occupied, in whole or in part, as the home or 
residence of one or more persons.
    Nonprofit means an entity which has demonstrated to any branch of 
the Federal Government or to a State, municipal, tribal or territorial 
government, that no part of its net earnings inure to the benefit of any 
private shareholder or individual.
    Paint in poor condition means more than 10 square feet of 
deteriorated paint on exterior components with large surface areas; or 
more than 2 square feet of deteriorated paint on interior components 
with large surface areas (e.g., walls, ceilings, floors, doors); or more 
than 10 percent of the total surface area of the component is 
deteriorated on interior or exterior components with small surface areas 
(window sills, baseboards, soffits, trim).
    Permanently covered soil means soil which has been separated from 
human contact by the placement of a barrier consisting of solid, 
relatively impermeable materials, such as pavement or concrete. Grass, 
mulch, and other landscaping materials are not considered permanent 
covering.
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any Indian Tribe, 
State, or political subdivision thereof; any interstate body; and any 
department, agency, or

[[Page 458]]

instrumentality of the Federal government.
    Principal instructor means the individual who has the primary 
responsibility for organizing and teaching a particular course.
    Recognized laboratory means an environmental laboratory recognized 
by EPA pursuant to TSCA section 405(b) as being capable of performing an 
analysis for lead compounds in paint, soil, and dust.
    Reduction means measures designed to reduce or eliminate human 
exposure to lead-based paint hazards through methods including interim 
controls and abatement.
    Residential dwelling means (1) a detached single family dwelling 
unit, including attached structures such as porches and stoops; or (2) a 
single family dwelling unit in a structure that contains more than one 
separate residential dwelling unit, which is used or occupied, or 
intended to be used or occupied, in whole or in part, as the home or 
residence of one or more persons.
    Risk assessment means (1) an on-site investigation to determine the 
existence, nature, severity, and location of lead-based paint hazards, 
and (2) the provision of a report by the individual or the firm 
conducting the risk assessment, explaining the results of the 
investigation and options for reducing lead-based paint hazards.
    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, the Northern Mariana Islands, or any other 
territory or possession of the United States.
    Target housing means any housing constructed prior to 1978, except 
housing for the elderly or persons with disabilities (unless any one or 
more children age 6 years or under resides or is expected to reside in 
such housing for the elderly or persons with disabilities) or any 0-
bedroom dwelling.
    Training curriculum means an established set of course topics for 
instruction in an accredited training program for a particular 
discipline designed to provide specialized knowledge and skills.
    Training hour means at least 50 minutes of actual learning, 
including, but not limited to, time devoted to lecture, learning 
activities, small group activities, demonstrations, evaluations, and/or 
hands-on experience.
    Training manager means the individual responsible for administering 
a training program and monitoring the performance of principal 
instructors and guest instructors.
    Visual inspection for clearance testing means the visual examination 
of a residential dwelling or a child-occupied facility following an 
abatement to determine whether or not the abatement has been 
successfully completed.
    Visual inspection for risk assessment means the visual examination 
of a residential dwelling or a child-occupied facility to determine the 
existence of deteriorated lead-based paint or other potential sources of 
lead-based paint hazards.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31097, June 9, 1999]



Sec. 745.225  Accreditation of training programs: target housing and child-occupied facilities.

    (a) Scope. (1) A training program may seek accreditation to offer 
lead-based paint activities courses in any of the following disciplines: 
inspector, risk assessor, supervisor, project designer, and abatement 
worker. A training program may also seek accreditation to offer 
refresher courses for each of the above listed disciplines.
    (2) Training programs may first apply to EPA for accreditation of 
their lead-based paint activities courses or refresher courses pursuant 
to this section on or after August 31, 1998.
    (3) A training program shall not provide, offer, or claim to provide 
EPA-accredited lead-based paint activities courses without applying for 
and receiving accreditation from EPA as required under paragraph (b) of 
this section on or after March 1, 1999.
    (b) Application process. The following are procedures a training 
program shall follow to receive EPA accreditation to offer lead-based 
paint activities courses:
    (1) A training program seeking accreditation shall submit a written 
application to EPA containing the following information:

[[Page 459]]

    (i) The training program's name, address, and telephone number.
    (ii) A list of courses for which it is applying for accreditation.
    (iii) A statement signed by the training program manager certifying 
that the training program meets the requirements established in 
paragraph (c) of this section. If a training program uses EPA-
recommended model training materials, or training materials approved by 
a State or Indian Tribe that has been authorized by EPA under subpart Q 
of this part, the training program manager shall include a statement 
certifying that, as well.
    (iv) If a training program does not use EPA-recommended model 
training materials or training materials approved by an authorized State 
or Indian Tribe, its application for accreditation shall also include:
    (A) A copy of the student and instructor manuals, or other materials 
to be used for each course.
    (B) A copy of the course agenda for each course.
    (v) All training programs shall include in their application for 
accreditation the following:
    (A) A description of the facilities and equipment to be used for 
lecture and hands-on training.
    (B) A copy of the course test blueprint for each course.
    (C) A description of the activities and procedures that will be used 
for conducting the assessment of hands-on skills for each course.
    (D) A copy of the quality control plan as described in paragraph 
(c)(9) of this section.
    (2) If a training program meets the requirements in paragraph (c) of 
this section, then EPA shall approve the application for accreditation 
no more than 180 days after receiving a complete application from the 
training program. In the case of approval, a certificate of 
accreditation shall be sent to the applicant. In the case of 
disapproval, a letter describing the reasons for disapproval shall be 
sent to the applicant. Prior to disapproval, EPA may, at its discretion, 
work with the applicant to address inadequacies in the application for 
accreditation. EPA may also request additional materials retained by the 
training program under paragraph (i) of this section. If a training 
program's application is disapproved, the program may reapply for 
accreditation at any time.
    (3) A training program may apply for accreditation to offer courses 
or refresher courses in as many disciplines as it chooses. A training 
program may seek accreditation for additional courses at any time as 
long as the program can demonstrate that it meets the requirements of 
this section.
    (4) A training program applying for accreditation must submit the 
appropriate fees in accordance with Sec. 745.238.
    (c) Requirements for the accreditation of training programs. For a 
training program to obtain accreditation from EPA to offer lead-based 
paint activities courses, the program shall meet the following 
requirements:
    (1) The training program shall employ a training manager who has:
    (i) At least 2 years of experience, education, or training in 
teaching workers or adults; or
    (ii) A bachelor's or graduate degree in building construction 
technology, engineering, industrial hygiene, safety, public health, 
education, business administration or program management or a related 
field; or
    (iii) Two years of experience in managing a training program 
specializing in environmental hazards; and
    (iv) Demonstrated experience, education, or training in the 
construction industry including: lead or asbestos abatement, painting, 
carpentry, renovation, remodeling, occupational safety and health, or 
industrial hygiene.
    (2) The training manager shall designate a qualified principal 
instructor for each course who has:
    (i) Demonstrated experience, education, or training in teaching 
workers or adults; and
    (ii) Successfully completed at least 16 hours of any EPA-accredited 
or EPA-authorized State or Tribal-accredited lead-specific training; and
    (iii) Demonstrated experience, education, or training in lead or 
asbestos abatement, painting, carpentry, renovation, remodeling, 
occupational safety and health, or industrial hygiene.
    (3) The principal instructor shall be responsible for the 
organization of the course and oversight of the teaching of

[[Page 460]]

all course material. The training manager may designate guest 
instructors as needed to provide instruction specific to the lecture, 
hands-on activities, or work practice components of a course.
    (4) The following documents shall be recognized by EPA as evidence 
that training managers and principal instructors have the education, 
work experience, training requirements or demonstrated experience, 
specifically listed in paragraphs (c)(1) and (c)(2) of this section. 
This documentation need not be submitted with the accreditation 
application, but, if not submitted, shall be retained by the training 
program as required by the recordkeeping requirements contained in 
paragraph (i) of this section. Those documents include the following:
    (i) Official academic transcripts or diploma as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Certificates from train-the-trainer courses and lead-specific 
training courses, as evidence of meeting the training requirements.
    (5) The training program shall ensure the availability of, and 
provide adequate facilities for, the delivery of the lecture, course 
test, hands-on training, and assessment activities. This includes 
providing training equipment that reflects current work practices and 
maintaining or updating the equipment and facilities as needed.
    (6) To become accredited in the following disciplines, the training 
program shall provide training courses that meet the following training 
hour requirements:
    (i) The inspector course shall last a minimum of 24 training hours, 
with a minimum of 8 hours devoted to hands-on training activities. The 
minimum curriculum requirements for the inspector course are contained 
in paragraph (d)(1) of this section.
    (ii) The risk assessor course shall last a minimum of 16 training 
hours, with a minimum of 4 hours devoted to hands-on training 
activities. The minimum curriculum requirements for the risk assessor 
course are contained in paragraph (d)(2) of this section.
    (iii) The supervisor course shall last a minimum of 32 training 
hours, with a minimum of 8 hours devoted to hands-on activities. The 
minimum curriculum requirements for the supervisor course are contained 
in paragraph (d)(3) of this section.
    (iv) The project designer course shall last a minimum of 8 training 
hours. The minimum curriculum requirements for the project designer 
course are contained in paragraph (d)(4) of this section.
    (v) The abatement worker course shall last a minimum of 16 training 
hours, with a minimum of 8 hours devoted to hands-on training 
activities. The minimum curriculum requirements for the abatement worker 
course are contained in paragraph (d)(5) of this section.
    (7) For each course offered, the training program shall conduct 
either a course test at the completion of the course, and if applicable, 
a hands-on skills assessment, or in the alternative, a proficiency test 
for that discipline. Each individual must successfully complete the 
hands-on skills assessment and receive a passing score on the course 
test to pass any course, or successfully complete a proficiency test.
    (i) The training manager is responsible for maintaining the validity 
and integrity of the hands-on skills assessment or profiency test to 
ensure that it accurately evaluates the trainees' performance of the 
work practices and procedures associated with the course topics 
contained in paragraph (d) of this section.
    (ii) The training manager is responsible for maintaining the 
validity and integrity of the course test to ensure that it accurately 
evaluates the trainees' knowledge and retention of the course topics.
    (iii) The course test shall be developed in accordance with the test 
blueprint submitted with the training accreditation application.
    (8) The training program shall issue unique course completion 
certificates to each individual who passes the training course. The 
course completion certificate shall include:

[[Page 461]]

    (i) The name, a unique identification number, and address of the 
individual.
    (ii) The name of the particular course that the individual 
completed.
    (iii) Dates of course completion/test passage.
    (iv) Expiration date of interim certification, which shall be 6 
months from the date of course completion.
    (v) The name, address, and telephone number of the training program.
    (9) The training manager shall develop and implement a quality 
control plan. The plan shall be used to maintain and improve the quality 
of the training program over time. This plan shall contain at least the 
following elements:
    (i) Procedures for periodic revision of training materials and the 
course test to reflect innovations in the field.
    (ii) Procedures for the training manager's annual review of 
principal instructor competency.
    (10) The training program shall offer courses which teach the work 
practice standards for conducting lead-based paint activities contained 
in Sec. 745.227, and other standards developed by EPA pursuant to Title 
IV of TSCA. These standards shall be taught in the appropriate courses 
to provide trainees with the knowledge needed to perform the lead-based 
paint activities they are responsible for conducting.
    (11) The training manager shall be responsible for ensuring that the 
training program complies at all times with all of the requirements in 
this section.
    (12) The training manager shall allow EPA to audit the training 
program to verify the contents of the application for accreditation as 
described in paragraph (b) of this section.
    (d) Minimum training curriculum requirements. To become accredited 
to offer lead-based paint courses instruction in the specific 
disciplines listed below, training programs must ensure that their 
courses of study include, at a minimum, the following course topics. 
Requirements ending in an asterisk (*) indicate areas that require 
hands-on activities as an integral component of the course.
    (1) Inspector. (i) Role and responsibilities of an inspector.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State, and local 
regulations and guidance that pertains to lead-based paint and lead-
based paint activities.
    (iv) Lead-based paint inspection methods, including selection of 
rooms and components for sampling or testing.*
    (v) Paint, dust, and soil sampling methodologies.*
    (vi) Clearance standards and testing, including random sampling.*
    (vii) Preparation of the final inspection report.*
    (viii) Recordkeeping.
    (2) Risk assessor. (i) Role and responsibilities of a risk assessor.
    (ii) Collection of background information to perform a risk 
assessment.
    (iii) Sources of environmental lead contamination such as paint, 
surface dust and soil, water, air, packaging, and food.
    (iv) Visual inspection for the purposes of identifying potential 
sources of lead-based paint hazards.*
    (v) Lead hazard screen protocol.
    (vi) Sampling for other sources of lead exposure.*
    (vii) Interpretation of lead-based paint and other lead sampling 
results, including all applicable State or Federal guidance or 
regulations pertaining to lead-based paint hazards.*
    (viii) Development of hazard control options, the role of interim 
controls, and operations and maintenance activities to reduce lead-based 
paint hazards.
    (ix) Preparation of a final risk assessment report.
    (3) Supervisor. (i) Role and responsibilities of a supervisor.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State, and local 
regulations and guidance that pertain to lead-based paint abatement.
    (iv) Liability and insurance issues relating to lead-based paint 
abatement.
    (v) Risk assessment and inspection report interpretation.*
    (vi) Development and implementation of an occupant protection plan 
and abatement report.
    (vii) Lead-based paint hazard recognition and control.*
    (viii) Lead-based paint abatement and lead-based paint hazard 
reduction

[[Page 462]]

methods, including restricted practices.*
    (ix) Interior dust abatement/cleanup or lead-based paint hazard 
control and reduction methods.*
    (x) Soil and exterior dust abatement or lead-based paint hazard 
control and reduction methods.*
    (xi) Clearance standards and testing.
    (xii) Cleanup and waste disposal.
    (xiii) Recordkeeping.
    (4) Project designer. (i) Role and responsibilities of a project 
designer.
    (ii) Development and implementation of an occupant protection plan 
for large scale abatement projects.
    (iii) Lead-based paint abatement and lead-based paint hazard 
reduction methods, including restricted practices for large-scale 
abatement projects.
    (iv) Interior dust abatement/cleanup or lead hazard control and 
reduction methods for large-scale abatement projects.
    (v) Clearance standards and testing for large scale abatement 
projects.
    (vi) Integration of lead-based paint abatement methods with 
modernization and rehabilitation projects for large scale abatement 
projects.
    (5) Abatement worker. (i) Role and responsibilities of an abatement 
worker.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State and local regulations 
and guidance that pertain to lead-based paint abatement.
    (iv) Lead-based paint hazard recognition and control.*
    (v) Lead-based paint abatement and lead-based paint hazard reduction 
methods, including restricted practices.*
    (vi) Interior dust abatement methods/cleanup or lead-based paint 
hazard reduction.*
    (vii) Soil and exterior dust abatement methods or lead-based paint 
hazard reduction.*
    (e) Requirements for the accreditation of refresher training 
programs. A training program may seek accreditation to offer refresher 
training courses in any of the following disciplines: inspector, risk 
assessor, supervisor, project designer, and abatement worker. To obtain 
EPA accreditation to offer refresher training, a training program must 
meet the following minimum requirements:
    (1) Each refresher course shall review the curriculum topics of the 
full-length courses listed under paragraph (d) of this section, as 
appropriate. In addition, to become accredited to offer refresher 
training courses, training programs shall ensure that their courses of 
study include, at a minimum, the following:
    (i) An overview of current safety practices relating to lead-based 
paint activities in general, as well as specific information pertaining 
to the appropriate discipline.
    (ii) Current laws and regulations relating to lead-based paint 
activities in general, as well as specific information pertaining to the 
appropriate discipline.
    (iii) Current technologies relating to lead-based paint activities 
in general, as well as specific information pertaining to the 
appropriate discipline.
    (2) Each refresher course, except for the project designer course, 
shall last a minimum of 8 training hours. The project designer refresher 
course shall last a minimum of 4 training hours.
    (3) For each course offered, the training program shall conduct a 
hands-on assessment (if applicable), and at the completion of the 
course, a course test.
    (4) A training program may apply for accreditation of a refresher 
course concurrently with its application for accreditation of the 
corresponding training course as described in paragraph (b) of this 
section. If so, EPA shall use the approval procedure described in 
paragraph (b) of this section. In addition, the minimum requirements 
contained in paragraphs (c) (except for the requirements in paragraph 
(c)(6)), and (e)(1), (e)(2) and (e)(3) of this section shall also apply.
    (5) A training program seeking accreditation to offer refresher 
training courses only shall submit a written application to EPA 
containing the following information:
    (i) The refresher training program's name, address, and telephone 
number.
    (ii) A list of courses for which it is applying for accreditation.
    (iii) A statement signed by the training program manager certifying 
that the refresher training program meets

[[Page 463]]

the minimum requirements established in paragraph (c) of this section, 
except for the requirements in paragraph (c)(6) of this section. If a 
training program uses EPA-developed model training materials, or 
training materials approved by a State or Indian Tribe that has been 
authorized by EPA under Sec. 745.324 to develop its refresher training 
course materials, the training manager shall include a statement 
certifying that, as well.
    (iv) If the refresher training course materials are not based on 
EPA-developed model training materials or training materials approved by 
an authorized State or Indian Tribe, the training program's application 
for accreditation shall include:
    (A) A copy of the student and instructor manuals to be used for each 
course.
    (B) A copy of the course agenda for each course.
    (v) All refresher training programs shall include in their 
application for accreditation the following:
    (A) A description of the facilities and equipment to be used for 
lecture and hands-on training.
    (B) A copy of the course test blueprint for each course.
    (C) A description of the activities and procedures that will be used 
for conducting the assessment of hands-on skills for each course (if 
applicable).
    (D) A copy of the quality control plan as described in paragraph 
(c)(9) of this section.
    (vi) The requirements in paragraphs (c)(1) through (c)(5), and 
(c)(7) through (c)(12) of this section apply to refresher training 
providers.
    (vii) If a refresher training program meets the requirements listed 
in this paragraph, then EPA shall approve the application for 
accreditation no more than 180 days after receiving a complete 
application from the refresher training program. In the case of 
approval, a certificate of accreditation shall be sent to the applicant. 
In the case of disapproval, a letter describing the reasons for 
disapproval shall be sent to the applicant. Prior to disapproval, EPA 
may, at its discretion, work with the applicant to address inadequacies 
in the application for accreditation. EPA may also request additional 
materials retained by the refresher training program under paragraph (i) 
of this section. If a refresher training program's application is 
disapproved, the program may reapply for accreditation at any time.
    (f) Re-accreditation of training programs. (1) Unless re-accredited, 
a training program's accreditation (including refresher training 
accreditation) shall expire 4 years after the date of issuance. If a 
training program meets the requirements of this section, the training 
program shall be re-accredited.
    (2) A training program seeking re-accreditation shall submit an 
application to EPA no later than 180 days before its accreditation 
expires. If a training program does not submit its application for re-
accreditation by that date, EPA cannot guarantee that the program will 
be re-accredited before the end of the accreditation period.
    (3) The training program's application for re-accreditation shall 
contain:
    (i) The training program's name, address, and telephone number.
    (ii) A list of courses for which it is applying for re-
accreditation.
    (iii) A description of any changes to the training facility, 
equipment or course materials since its last application was approved 
that adversely affects the students ability to learn.
    (iv) A statement signed by the program manager stating:
    (A) That the training program complies at all times with all 
requirements in paragraphs (c) and (e) of this section, as applicable; 
and
    (B) The recordkeeping and reporting requirements of paragraph (i) of 
this section shall be followed.
    (v) A payment of appropriate fees in accordance with Sec.  745.238.
    (4) Upon request, the training program shall allow EPA to audit the 
training program to verify the contents of the application for re-
accreditation as described in paragraph (f)(3) of this section.
    (g) Suspension, revocation, and modification of accredited training 
programs. (1) EPA may, after notice and an opportunity for hearing, 
suspend, revoke, or modify training program accreditation (including 
refresher training accreditation) if a training program,

[[Page 464]]

training manager, or other person with supervisory authority over the 
training program has:
    (i) Misrepresented the contents of a training course to EPA and/or 
the student population.
    (ii) Failed to submit required information or notifications in a 
timely manner.
    (iii) Failed to maintain required records.
    (iv) Falsified accreditation records, instructor qualifications, or 
other accreditation-related information or documentation.
    (v) Failed to comply with the training standards and requirements in 
this section.
    (vi) Failed to comply with Federal, State, or local lead-based paint 
statutes or regulations.
    (vii) Made false or misleading statements to EPA in its application 
for accreditation or re-accreditation which EPA relied upon in approving 
the application.
    (2) In addition to an administrative or judicial finding of 
violation, execution of a consent agreement in settlement of an 
enforcement action constitutes, for purposes of this section, evidence 
of a failure to comply with relevant statutes or regulations.
    (h) Procedures for suspension, revocation or modification of 
training program accreditation. (1) Prior to taking action to suspend, 
revoke, or modify the accreditation of a training program, EPA shall 
notify the affected entity in writing of the following:
    (i) The legal and factual basis for the suspension, revocation, or 
modification.
    (ii) The anticipated commencement date and duration of the 
suspension, revocation, or modification.
    (iii) Actions, if any, which the affected entity may take to avoid 
suspension, revocation, or modification, or to receive accreditation in 
the future.
    (iv) The opportunity and method for requesting a hearing prior to 
final EPA action to suspend, revoke or modify accreditation.
    (v) Any additional information, as appropriate, which EPA may 
provide.
    (2) If a hearing is requested by the accredited training program, 
EPA shall:
    (i) Provide the affected entity an opportunity to offer written 
statements in response to EPA's assertions of the legal and factual 
basis for its proposed action, and any other explanations, comments, and 
arguments it deems relevant to the proposed action.
    (ii) Provide the affected entity such other procedural opportunities 
as EPA may deem appropriate to ensure a fair and impartial hearing.
    (iii) Appoint an official of EPA as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific matter.
    (3) The Presiding Officer appointed pursuant to paragraph (h)(2) of 
this section shall:
    (i) Conduct a fair, orderly, and impartial hearing within 90 days of 
the request for a hearing.
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted.
    (iii) Notify the affected entity in writing within 90 days of 
completion of the hearing of his or her decision and order. Such an 
order is a final agency action which may be subject to judicial review.
    (4) If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the accreditation of any training 
program prior to the opportunity for a hearing, it shall:
    (i) Notify the affected entity of its intent to immediately suspend 
training program accreditation for the reasons listed in paragraph 
(g)(1) of this section. If a suspension, revocation, or modification 
notice has not previously been issued pursuant to paragraph (g)(1) of 
this section, it shall be issued at the same time the emergency 
suspension notice is issued.
    (ii) Notify the affected entity in writing of the grounds for the 
immediate suspension and why it is necessary to suspend the entity's 
accreditation before an opportunity for a suspension, revocation or 
modification hearing.
    (iii) Notify the affected entity of the anticipated commencement 
date and duration of the immediate suspension.
    (iv) Notify the affected entity of its right to request a hearing on 
the immediate suspension within 15 days of

[[Page 465]]

the suspension taking place and the procedures for the conduct of such a 
hearing.
    (5) Any notice, decision, or order issued by EPA under this section, 
any transcripts or other verbatim record of oral testimony, and any 
documents filed by an accredited training program in a hearing under 
this section shall be available to the public, except as otherwise 
provided by section 14 of TSCA or by part 2 of this title. Any such 
hearing at which oral testimony is presented shall be open to the 
public, except that the Presiding Officer may exclude the public to the 
extent necessary to allow presentation of information which may be 
entitled to confidential treatment under section 14 of TSCA or part 2 of 
this title.
    (6) The public shall be notified of the suspension, revocation, 
modification or reinstatement of a training program's accreditation 
through appropriate mechanisms.
    (7) EPA shall maintain a list of parties whose accreditation has 
been suspended, revoked, modified or reinstated.
    (i) Training program recordkeeping requirements. (1) Accredited 
training programs shall maintain, and make available to EPA, upon 
request, the following records:
    (i) All documents specified in paragraph (c)(4) of this section that 
demonstrate the qualifications listed in paragraphs (c)(1) and (c)(2) of 
this section of the training manager and principal instructors.
    (ii) Current curriculum/course materials and documents reflecting 
any changes made to these materials.
    (iii) The course test blueprint.
    (iv) Information regarding how the hands-on assessment is conducted 
including, but not limited to:
    (A) Who conducts the assessment.
    (B) How the skills are graded.
    (C) What facilities are used.
    (D) The pass/fail rate.
    (v) The quality control plan as described in paragraph (c)(9) of 
this section.
    (vi) Results of the students' hands-on skills assessments and course 
tests, and a record of each student's course completion certificate.
    (vii) Any other material not listed above in paragraphs (i)(1)(i) 
through (i)(1)(vi) of this section that was submitted to EPA as part of 
the program's application for accreditation.
    (2) The training program shall retain these records at the address 
specified on the training program accreditation application (or as 
modified in accordance with paragraph (i)(3) of this section for a 
minimum of 3 years and 6 months.
    (3) The training program shall notify EPA in writing within 30 days 
of changing the address specified on its training program accreditation 
application or transferring the records from that address.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31098, June 9, 1999]



Sec. 745.226  Certification of individuals and firms engaged in lead-based paint activities: target housing and child-occupied facilities.

    (a) Certification of individuals. (1) Individuals seeking 
certification by EPA to engage in lead-based paint activities must 
either:
    (i) Submit to EPA an application demonstrating that they meet the 
requirements established in paragraphs (b) or (c) of this section for 
the particular discipline for which certification is sought; or
    (ii) Submit to EPA an application with a copy of a valid lead-based 
paint activities certification (or equivalent) from a State or Tribal 
program that has been authorized by EPA pursuant to subpart Q of this 
part.
    (2) Individuals may first apply to EPA for certification to engage 
in lead-based paint activities pursuant to this section on or after 
March 1, 1999.
    (3) Following the submission of an application demonstrating that 
all the requirements of this section have been meet, EPA shall certify 
an applicant as an inspector, risk assessor, supervisor, project 
designer, or abatement worker, as appropriate.
    (4) Upon receiving EPA certification, individuals conducting lead-
based paint activities shall comply with the work practice standards for 
performing the appropriate lead-based paint activities as established in 
Sec. 745.227.

[[Page 466]]

    (5) It shall be a violation of TSCA for an individual to conduct any 
of the lead-based paint activities described in Sec. 745.227 after 
August 30, 1999, if that individual has not been certified by EPA 
pursuant to this section to do so.
    (6) Individuals applying for certification must submit the 
appropriate fees in accordance with Sec. 745.238.
    (b) Inspector, risk assessor or supervisor. (1) To become certified 
by EPA as an inspector, risk assessor, or supervisor, pursuant to 
paragraph (a)(1)(i) of this section, an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Pass the certification exam in the appropriate discipline 
offered by EPA; and,
    (iii) Meet or exceed the following experience and/or education 
requirements:
    (A) Inspectors. (1) No additional experience and/or education 
requirements.
    (2) [Reserved]
    (B) Risk assessors. (1) Successful completion of an accredited 
training course for inspectors; and
    (2) Bachelor's degree and 1 year of experience in a related field 
(e.g., lead, asbestos, environmental remediation work, or construction), 
or an Associates degree and 2 years experience in a related field (e.g., 
lead, asbestos, environmental remediation work, or construction); or
    (3) Certification as an industrial hygienist, professional engineer, 
registered architect and/or certification in a related engineering/
health/environmental field (e.g., safety professional, environmental 
scientist); or
    (4) A high school diploma (or equivalent), and at least 3 years of 
experience in a related field (e.g., lead, asbestos, environmental 
remediation work or construction).
    (C) Supervisor: (1) One year of experience as a certified lead-based 
paint abatement worker; or
    (2) At least 2 years of experience in a related field (e.g., lead, 
asbestos, or environmental remediation work) or in the building trades.
    (2) The following documents shall be recognized by EPA as evidence 
of meeting the requirements listed in (b)(2)(iii) of this paragraph:
    (i) Official academic transcripts or diploma, as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) In order to take the certification examination for a particular 
discipline an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the education and/or experience requirements in 
paragraph (b)(1)(iii) of this section.
    (4) The course completion certificate shall serve as interim 
certification for an individual until the next available opportunity to 
take the certification exam. Such interim certification shall expire 6 
months after issuance.
    (5) After passing the appropriate certification exam and submitting 
an application demonstrating that he/she meets the appropriate training, 
education, and/or experience prerequisites described in paragraph (b)(1) 
of this section, an individual shall be issued a certificate by EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (6) An individual may take the certification exam no more than three 
times within 6 months of receiving a course completion certificate.
    (7) If an individual does not pass the certification exam and 
receive a certificate within 6 months of receiving his/her course 
completion certificate, the individual must retake the appropriate 
course from an accredited training program before reapplying for 
certification from EPA.
    (c) Abatement worker and project designer. (1) To become certified 
by EPA as an abatement worker or project designer, pursuant to paragraph 
(a)(1)(i) of this section, an individual must:

[[Page 467]]

    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the following additional experience and/or 
education requirements:
    (A) Abatement workers. (1) No additional experience and/or education 
requirements.
    (2) [Reserved]
    (B) Project designers. (1) Successful completion of an accredited 
training course for supervisors.
    (2) Bachelor's degree in engineering, architecture, or a related 
profession, and 1 year of experience in building construction and design 
or a related field; or
    (3) Four years of experience in building construction and design or 
a related field.
    (2) The following documents shall be recognized by EPA as evidence 
of meeting the requirements listed in this paragraph:
    (i) Official academic transcripts or diploma, as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) The course completion certificate shall serve as an interim 
certification until certification from EPA is received, but shall be 
valid for no more than 6 months from the date of completion.
    (4) After successfully completing the appropriate training courses 
and meeting any other qualifications described in paragraph (c)(1) of 
this section, an individual shall be issued a certificate from EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (d) Certification based on prior training. (1) Any individual who 
received training in a lead-based paint activity between October 1, 
1990, and March 1, 1999 shall be eligible for certification by EPA under 
the alternative procedures contained in this paragraph. Individuals who 
have received lead-based paint activities training at an EPA-authorized 
State or Tribal accredited training program shall also be eligible for 
certification by EPA under the following alternative procedures:
    (i) Applicants for certification as an inspector, risk assessor, or 
supervisor shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets or exceeds the education 
and/or experience requirements in paragraph (b)(1)(iii) of this section.
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (D) Pass a certification exam administered by EPA for the 
appropriate discipline.
    (ii) Applicants for certification as an abatement worker or project 
designer shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets the education and/or 
experience requirements in paragraphs (c)(1) of this section; and
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (2) Individuals shall have until August 30, 1999 to apply to EPA for 
certification under the above procedures. After that date, all 
individuals wishing to obtain certification must do so through the 
procedures described in paragraph (a), and paragraph (b) or (c) of this 
section, according to the discipline for which certification is sought.
    (e) Re-certification. (1) To maintain certification in a particular 
discipline, a certified individual shall apply to and be re-certified by 
EPA in that discipline by EPA either:
    (i) Every 3 years if the individual completed a training course with 
a course test and hands-on assessment; or

[[Page 468]]

    (ii) Every 5 years if the individual completed a training course 
with a proficiency test.
    (2) An individual shall be re-certified if the individual 
successfully completes the appropriate accredited refresher training 
course and submits a valid copy of the appropriate refresher course 
completion certificate.
    (3) Individuals applying for re-certification must submit the 
appropriate fees in accordance with Sec. 745.238.
    (f) Certification of firms. (1) All firms which perform or offer to 
perform any of the lead-based paint activities described in Sec. 745.227 
after August 30, 1999 shall be certified by EPA.
    (2) A firm seeking certification shall submit to EPA a letter 
attesting that the firm shall only employ appropriately certified 
employees to conduct lead-based paint activities, and that the firm and 
its employees shall follow the work practice standards in Sec. 745.227 
for conducting lead-based paint activities.
    (3) From the date of receiving the firm's letter requesting 
certification, EPA shall have 90 days to approve or disapprove the 
firm's request for certification. Within that time, EPA shall respond 
with either a certificate of approval or a letter describing the reasons 
for a disapproval.
    (4) The firm shall maintain all records pursuant to the requirements 
in Sec. 745.227.
    (5) Firms may first apply to EPA for certification to engage in 
lead-based paint activities pursuant to this section on or after March 
1, 1999.
    (6) Firms applying for certification must submit the appropriate 
fees in accordance with Sec. 745.238.
    (7) To maintain certification a firm shall submit appropriate fees 
in accordance with Sec. 745.238 every 3 years.
    (g) Suspension, revocation, and modification of certifications of 
individuals engaged in lead-based paint activities. (1) EPA may, after 
notice and opportunity for hearing, suspend, revoke, or modify an 
individual's certification if an individual has:
    (i) Obtained training documentation through fraudulent means.
    (ii) Gained admission to and completed an accredited training 
program through misrepresentation of admission requirements.
    (iii) Obtained certification through misrepresentation of 
certification requirements or related documents dealing with education, 
training, professional registration, or experience.
    (iv) Performed work requiring certification at a job site without 
having proof of certification.
    (v) Permitted the duplication or use of the individual's own 
certificate by another.
    (vi) Performed work for which certification is required, but for 
which appropriate certification has not been received.
    (vii) Failed to comply with the appropriate work practice standards 
for lead-based paint activities at Sec. 745.227.
    (viii) Failed to comply with Federal, State, or local lead-based 
paint statutes or regulations.
    (2) In addition to an administrative or judicial finding of 
violation, for purposes of this section only, execution of a consent 
agreement in settlement of an enforcement action constitutes evidence of 
a failure to comply with relevant statutes or regulations.
    (h) Suspension, revocation, and modification of certifications of 
firms engaged in lead-based paint activities. (1) EPA may, after notice 
and opportunity for hearing, suspend, revoke, or modify a firm's 
certification if a firm has:
    (i) Performed work requiring certification at a job site with 
individuals who are not certified.
    (ii) Failed to comply with the work practice standards established 
in Sec. 745.227.
    (iii) Misrepresented facts in its letter of application for 
certification to EPA.
    (iv) Failed to maintain required records.
    (v) Failed to comply with Federal, State, or local lead-based paint 
statutes or regulations.
    (2) In addition to an administrative or judicial finding of 
violation, for purposes of this section only, execution of a consent 
agreement in settlement of an enforcement action constitutes evidence of 
a failure to comply with relevant statutes or regulations.
    (i) Procedures for suspension, revocation, or modification of the 
certification of individuals or firms.

[[Page 469]]

    (1) If EPA decides to suspend, revoke, or modify the certification 
of any individual or firm, it shall notify the affected entity in 
writing of the following:
    (i) The legal and factual basis for the suspension, revocation, or 
modification.
    (ii) The commencement date and duration of the suspension, 
revocation, or modification.
    (iii) Actions, if any, which the affected entity may take to avoid 
suspension, revocation, or modification or to receive certification in 
the future.
    (iv) The opportunity and method for requesting a hearing prior to 
final EPA action to suspend, revoke, or modify certification.
    (v) Any additional information, as appropriate, which EPA may 
provide.
    (2) If a hearing is requested by the certified individual or firm, 
EPA shall:
    (i) Provide the affected entity an opportunity to offer written 
statements in response to EPA's assertion of the legal and factual basis 
and any other explanations, comments, and arguments it deems relevant to 
the proposed action.
    (ii) Provide the affected entity such other procedural opportunities 
as EPA may deem appropriate to ensure a fair and impartial hearing.
    (iii) Appoint an official of EPA as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific matter.
    (3) The Presiding Officer shall:
    (i) Conduct a fair, orderly, and impartial hearing within 90 days of 
the request for a hearing;
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted; and
    (iii) Notify the affected entity in writing within 90 days of 
completion of the hearing of his or her decision and order. Such an 
order is a final EPA action subject to judicial review.
    (4) If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the certification of any individual 
or firm prior to the opportunity for a hearing, it shall:
    (i) Notify the affected entity of its intent to immediately suspend 
certification for the reasons listed in paragraph (h)(1) of this 
section. If a suspension, revocation, or modification notice has not 
previously been issued, it shall be issued at the same time the 
immediate suspension notice is issued.
    (ii) Notify the affected entity in writing of the grounds upon which 
the immediate suspension is based and why it is necessary to suspend the 
entity's accreditation before an opportunity for a hearing to suspend, 
revoke, or modify the individual's or firm's certification.
    (iii) Notify the affected entity of the commencement date and 
duration of the immediate suspension.
    (iv) Notify the affected entity of its right to request a hearing on 
the immediate suspension within 15 days of the suspension taking place 
and the procedures for the conduct of such a hearing.
    (5) Any notice, decision, or order issued by EPA under this section, 
transcript or other verbatim record of oral testimony, and any documents 
filed by a certified individual or firm in a hearing under this section 
shall be available to the public, except as otherwise provided by 
section 14 of TSCA or by part 2 of this title. Any such hearing at which 
oral testimony is presented shall be open to the public, except that the 
Presiding Officer may exclude the public to the extent necessary to 
allow presentation of information which may be entitled to confidential 
treatment under section 14 of TSCA or part 2 of this title.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31098, June 9, 1999]



Sec. 745.227  Work practice standards for conducting lead-based paint activities: target housing and child-occupied facilities.

    (a) Effective date, applicability, and terms. (1) Beginning on March 
1, 1999, all lead-based paint activities shall be performed pursuant to 
the work practice standards contained in this section.
    (2) When performing any lead-based paint activity described by the 
certified individual as an inspection, lead-hazard screen, risk 
assessment or abatement, a certified individual must perform that 
activity in compliance

[[Page 470]]

with the appropriate requirements below.
    (3) Documented methodologies that are appropriate for this section 
are found in the following: The U.S. Department of Housing and Urban 
Development (HUD) Guidelines for the Evaluation and Control of Lead-
Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-
Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil; the EPA 
Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA 
report number 7474-R-95-001); Regulations, guidance, methods or 
protocols issued by States and Indian Tribes that have been authorized 
by EPA; and other equivalent methods and quidelines.
    (4) Clearance levels are appropriate for the purposes of this 
section may be found in the EPA Guidance on Residential Lead-Based 
Paint, Lead-Contaminated Dust, and Lead Contaminiated Soil or other 
equivalent guidelines.
    (b) Inspection. (1) An inspection shall be conducted only by a 
person certified by EPA as an inspector or risk assessor and, if 
conducted, must be conducted according to the procedures in this 
paragraph.
    (2) When conducting an inspection, the following locations shall be 
selected according to documented methodologies and tested for the 
presence of lead-based paint:
    (i) In a residential dwelling and child-occupied facility, each 
component with a distinct painting history and each exterior component 
with a distinct painting history shall be tested for lead-based paint, 
except those components that the inspector or risk assessor determines 
to have been replaced after 1978, or to not contain lead-based paint; 
and
    (ii) In a multi-family dwelling or child-occupied facility, each 
component with a distinct painting history in every common area, except 
those components that the inspector or risk assessor determines to have 
been replaced after 1978, or to not contain lead-based paint.
    (3) Paint shall be sampled in the following manner: (i) The analysis 
of paint to determine the presence of lead shall be conducted using 
documented methodologies which incorporate adequate quality control 
procedures; and/or
    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) The certified inspector or risk assessor shall prepare an 
inspection report which shall include the following information:
    (i) Date of each inspection.
    (ii) Address of building.
    (iii) Date of construction.
    (iv) Apartment numbers (if applicable).
    (v) Name, address, and telephone number of the owner or owners of 
each residential dwelling or child-occupied facility.
    (vi) Name, signature, and certification number of each certified 
inspector and/or risk assessor conducting testing.
    (vii) Name, address, and telephone number of the certified firm 
employing each inspector and/or risk assessor, if applicable.
    (viii) Each testing method and device and/or sampling procedure 
employed for paint analysis, including quality control data and, if 
used, the serial number of any x-ray fluorescence (XRF) device.
    (ix) Specific locations of each painted component tested for the 
presence of lead-based paint.
    (x) The results of the inspection expressed in terms appropriate to 
the sampling method used.
    (c) Lead hazard screen. (1) A lead hazard screen shall be conducted 
only by a person certified by EPA as a risk assessor.
    (2) If conducted, a lead hazard screen shall be conducted as 
follows:
    (i) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (ii) A visual inspection of the residential dwelling or child-
occupied facility shall be conducted to:
    (A) Determine if any deteriorated paint is present, and

[[Page 471]]

    (B) Locate at least two dust sampling locations.
    (iii) If deteriorated paint is present, each surface with 
deteriorated paint, which is determined, using documented methodologies, 
to be in poor condition and to have a distinct painting history, shall 
be tested for the presence of lead.
    (iv) In residential dwellings, two composite dust samples shall be 
collected, one from the floors and the other from the windows, in rooms, 
hallways or stairwells where one or more children, age 6 and under, are 
most likely to come in contact with dust.
    (v) In multi-family dwellings and child-occupied facilities, in 
addition to the floor and window samples required in paragraph 
(c)(1)(iii) of this section, the risk assessor shall also collect 
composite dust samples from common areas where one or more children, age 
6 and under, are most likely to come into contact with dust.
    (3) Dust samples shall be collected and analyzed in the following 
manner:
    (i) All dust samples shall be taken using documented methodologies 
that incorporate adequate quality control procedures.
    (ii) All collected dust samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) Paint shall be sampled in the following manner: (i) The analysis 
of paint to determine the presence of lead shall be conducted using 
documented methodologies which incorporate adequate quality control 
procedures; and/or
    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (5) The risk assessor shall prepare a lead hazard screen report, 
which shall include the following information:
    (i) The information required in a risk assessment report as 
specified in paragraph (d) of this section, including paragraphs 
(d)(11)(i) through (d)(11)(xiv), and excluding paragraphs (d)(11)(xv) 
through (d)(11)(xviii) of this section. Additionally, any background 
information collected pursuant to paragraph (c)(2)(i) of this section 
shall be included in the risk assessment report; and
    (ii) Recommendations, if warranted, for a follow-up risk assessment, 
and as appropriate, any further actions.
    (d) Risk assessment. (1) A risk assessment shall be conducted only 
by a person certified by EPA as a risk assessor and, if conducted, must 
be conducted according to the procedures in this paragraph.
    (2) A visual inspection for risk assessment of the residential 
dwelling or child-occupied facility shall be undertaken to locate the 
existence of deteriorated paint, assess the extent and causes of the 
deterioration, and other potential lead-based paint hazards.
    (3) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (4) Each surface with deteriorated paint, which is determined, using 
documented methodologies, to be in poor condition and to have a distinct 
painting history, shall be tested for the presence of lead. Each other 
surface determined, using documented methodologies, to be a potential 
lead-based paint hazard and having a distinct painting history, shall 
also be tested for the presence of lead.
    (5) In residential dwellings, dust samples (either composite or 
single-surface samples) from the window and floor shall be collected in 
all living areas where one or more children, age 6 and under, are most 
likely to come into contact with dust.
    (6) For multi-family dwellings and child-occupied facilities, the 
samples required in paragraph (d)(4) of this section shall be taken. In 
addition, window and floor dust samples (either composite or single-
surface samples) shall be collected in the following locations:
    (i) Common areas adjacent to the sampled residential dwelling or 
child-occupied facility; and
    (ii) Other common areas in the building where the risk assessor 
determines that one or more children, age 6 and under, are likely to 
come into contact with dust.

[[Page 472]]

    (7) For child-occupied facilities, window and floor dust samples 
(either composite or single-surface samples) shall be collected in each 
room, hallway or stairwell utilized by one or more children, age 6 and 
under, and in other common areas in the child-occupied facility where 
the risk assessor determines one or more children, age 6 and under, are 
likely to come into contact with dust.
    (8) Soil samples shall be collected and analyzed for lead 
concentrations in the following locations:
    (i) Exterior play areas where bare soil is present; and
    (ii) Dripline/foundation areas where bare soil is present.
    (9) Any paint, dust, or soil sampling or testing shall be conducted 
using documented methodologies that incorporate adequate quality control 
procedures.
    (10) Any collected paint chip, dust, or soil samples shall be 
analyzed according to paragraph (f) of this section to determine if they 
contain detectable levels of lead that can be quantified numerically.
    (11) The certified risk assessor shall prepare a risk assessment 
report which shall include the following information:
    (i) Date of assessment.
    (ii) Address of each building.
    (iii) Date of construction of buildings.
    (iv) Apartment number (if applicable).
    (v) Name, address, and telephone number of each owner of each 
building.
    (vi) Name, signature, and certification of the certified risk 
assessor conducting the assessment.
    (vii) Name, address, and telephone number of the certified firm 
employing each certified risk assessor if applicable.
    (viii) Name, address, and telephone number of each recognized 
laboratory conducting analysis of collected samples.
    (ix) Results of the visual inspection.
    (x) Testing method and sampling procedure for paint analysis 
employed.
    (xi) Specific locations of each painted component tested for the 
presence of lead.
    (xii) All data collected from on-site testing, including quality 
control data and, if used, the serial number of any XRF device.
    (xiii) All results of laboratory analysis on collected paint, soil, 
and dust samples.
    (xiv) Any other sampling results.
    (xv) Any background information collected pursuant to paragraph 
(d)(3) of this section.
    (xvi) To the extent that they are used as part of the lead-based 
paint hazard determination, the results of any previous inspections or 
analyses for the presence of lead-based paint, or other assessments of 
lead-based paint-related hazards.
    (xvii) A description of the location, type, and severity of 
identified lead-based paint hazards and any other potential lead 
hazards.
    (xviii) A description of interim controls and/or abatement options 
for each identified lead-based paint hazard and a suggested 
prioritization for addressing each hazard. If the use of an encapsulant 
or enclosure is recommended, the report shall recommend a maintenance 
and monitoring schedule for the encapsulant or enclosure.
    (e) Abatement. (1) An abatement shall be conducted only by an 
individual certified by EPA, and if conducted, shall be conducted 
according to the procedures in this paragraph.
    (2) A certified supervisor is required for each abatement project 
and shall be onsite during all work site preparation and during the 
post-abatement cleanup of work areas. At all other times when abatement 
activities are being conducted, the certified supervisor shall be onsite 
or available by telephone, pager or answering service, and able to be 
present at the work site in no more than 2 hours.
    (3) The certified supervisor and the certified firm employing that 
supervisor shall ensure that all abatement activities are conducted 
according to the requirements of this section and all other Federal, 
State and local requirements.
    (4) Notification of the commencement of lead-based paint abatement 
activities in a residential dwelling or child-occupied facility or as a 
result of

[[Page 473]]

a Federal, State, or local order shall be given to EPA prior to the 
commencement of abatement activities. The procedure for this 
notification will be developed by EPA prior to August 31, 1998.
    (5) A written occupant protection plan shall be developed for all 
abatement projects and shall be prepared according to the following 
procedures:
    (i) The occupant protection plan shall be unique to each residential 
dwelling or child-occupied facility and be developed prior to the 
abatement. The occupant protection plan shall describe the measures and 
management procedures that will be taken during the abatement to protect 
the building occupants from exposure to any lead-based paint hazards.
    (ii) A certified supervisor or project designer shall prepare the 
occupant protection plan.
    (6) The work practices listed below shall be restricted during an 
abatement as follows:
    (i) Open-flame burning or torching of lead-based paint is 
prohibited;
    (ii) Machine sanding or grinding or abrasive blasting or 
sandblasting of lead-based paint is prohibited unless used with High 
Efficiency Particulate Air (HEPA) exhaust control which removes 
particles of 0.3 microns or larger from the air at 99.97 percent or 
greater efficiency;
    (iii) Dry scraping of lead-based paint is permitted only in 
conjunction with heat guns or around electrical outlets or when treating 
defective paint spots totaling no more than 2 square feet in any one 
room, hallway or stairwell or totaling no more than 20 square feet on 
exterior surfaces; and
    (iv) Operating a heat gun on lead-based paint is permitted only at 
temperatures below 1100 degrees Fahrenheit.
    (7) If conducted, soil abatement shall be conducted in one of the 
following ways:
    (i) If soil is removed, the lead-contaminated soil shall be replaced 
with soil that is not lead-contaminated; or
    (ii) If soil is not removed, the lead-contaminated soil shall be 
permanently covered, as defined in Sec. 745.223.
    (8) The following post-abatement clearance procedures shall be 
performed only by a certified inspector or risk assessor:
    (i) Following an abatement, a visual inspection shall be performed 
to determine if deteriorated painted surfaces and/or visible amounts of 
dust, debris or residue are still present. If deteriorated painted 
surfaces or visible amounts of dust, debris or residue are present, 
these conditions must be eliminated prior to the continuation of the 
clearance procedures.
    (ii) Following the visual inspection and any post-abatement cleanup 
required by paragraph (e)(8)(i) of this section, clearance sampling for 
lead-contaminated dust shall be conducted. Clearance sampling may be 
conducted by employing single-surface sampling or composite sampling 
techniques.
    (iii) Dust samples for clearance purposes shall be taken using 
documented methodologies that incorporate adequate quality control 
procedures.
    (iv) Dust samples for clearance purposes shall be taken a minimum of 
1 hour after completion of final post-abatement cleanup activities.
    (v) The following post-abatement clearance activities shall be 
conducted as appropriate based upon the extent or manner of abatement 
activities conducted in or to the residential dwelling or child-occupied 
facility:
    (A) After conducting an abatement with containment between abated 
and unabated areas, one dust sample shall be taken from one window (if 
available) and one dust sample shall be taken from the floor of no less 
than four rooms, hallways or stairwells within the containment area. In 
addition, one dust sample shall be taken from the floor outside the 
containment area. If there are less than four rooms, hallways or 
stairwells within the containment area, then all rooms, hallways or 
stairwells shall be sampled.
    (B) After conducting an abatement with no containment, two dust 
samples shall be taken from no less than four rooms, hallways or 
stairwells in the residential dwelling or child-occupied facility. One 
dust sample shall be taken from one window (if available) and one dust 
sample shall be taken from the floor of each room, hallway or stairwell 
selected. If there are less than four rooms, hallways or stairwells

[[Page 474]]

within the residential dwelling or child-occupied facility then all 
rooms, hallways or stairwells shall be sampled.
    (C) Following an exterior paint abatement, a visible inspection 
shall be conducted. All horizontal surfaces in the outdoor living area 
closest to the abated surface shall be found to be cleaned of visible 
dust and debris. In addition, a visual inspection shall be conducted to 
determine the presence of paint chips on the dripline or next to the 
foundation below any exterior surface abated. If paint chips are 
present, they must be removed from the site and properly disposed of, 
according to all applicable Federal, State and local requirements.
    (vi) The rooms, hallways or stairwells selected for sampling shall 
be selected according to documented methodologies.
    (vii) The certified inspector or risk assessor shall compare the 
residual lead level (as determined by the laboratory analysis) from each 
dust sample with applicable clearance levels for lead in dust on floors 
and windows. If the residual lead levels in a dust sample exceed the 
clearance levels, all the components represented by the failed sample 
shall be recleaned and retested until clearance levels are met.
    (9) In a multi-family dwelling with similarly constructed and 
maintained residential dwellings, random sampling for the purposes of 
clearance may be conducted provided:
    (i) The certified individuals who abate or clean the residential 
dwellings do not know which residential dwelling will be selected for 
the random sample.
    (ii) A sufficient number of residential dwellings are selected for 
dust sampling to provide a 95 percent level of confidence that no more 
than 5 percent or 50 of the residential dwellings (whichever is smaller) 
in the randomly sampled population exceed the appropriate clearance 
levels.
    (iii) The randomly selected residential dwellings shall be sampled 
and evaluated for clearance according to the procedures found in 
paragraph (e)(8) of this section.
    (10) An abatement report shall be prepared by a certified supervisor 
or project designer. The abatement report shall include the following 
information:
    (i) Start and completion dates of abatement.
    (ii) The name and address of each certified firm conducting the 
abatement and the name of each supervisor assigned to the abatement 
project.
    (iii) The occupant protection plan prepared pursuant to paragraph 
(e)(5) of this section.
    (iv) The name, address, and signature of each certified risk 
assessor or inspector conducting clearance sampling and the date of 
clearance testing.
    (v) The results of clearance testing and all soil analyses (if 
applicable) and the name of each recognized laboratory that conducted 
the analyses.
    (vi) A detailed written description of the abatement, including 
abatement methods used, locations of rooms and/or components where 
abatement occurred, reason for selecting particular abatement methods 
for each component, and any suggested monitoring of encapsulants or 
enclosures.
    (f) Collection and laboratory analysis of samples. Any paint chip, 
dust, or soil samples collected pursuant to the work practice standards 
contained in this section shall be:
    (1) Collected by persons certified by EPA as an inspector or risk 
assessor; and
    (2) Analyzed by a laboratory recognized by EPA pursuant to section 
405(b) of TSCA as being capable of performing analyses for lead 
compounds in paint chip, dust, and soil samples.
    (g) Composite dust sampling. Composite dust sampling may only be 
conducted in the situations specified in paragraphs (c) through (e) of 
this section. If such sampling is conducted, the following conditions 
shall apply:
    (1) Composite dust samples shall consist of at least two subsamples;
    (2) Every component that is being tested shall be included in the 
sampling; and
    (3) Composite dust samples shall not consist of subsamples from more 
than one type of component.
    (h) Recordkeeping. All reports or plans required in this section 
shall be maintained by the certified firm or individual who prepared the 
report for no fewer than 3 years. The certified firm

[[Page 475]]

or individual also shall provide copies of these reports to the building 
owner who contracted for its services.



Sec. 745.228  Accreditation of training programs: public and commercial buildings, bridges and superstructures. [Reserved]



Sec. 745.229  Certification of individuals and firms engaged in lead-based paint activities: public and commercial buildings, bridges and superstructures. 
          [Reserved]



Sec. 745.230  Work practice standards for conducting lead-based paint activities: public and commercial buildings, bridges and superstructures. [Reserved]



Sec. 745.233  Lead-based paint activities requirements.

    Lead-based paint activities, as defined in this part, shall only be 
conducted according to the procedures and work practice standards 
contained in Sec. 745.227 of this subpart. No individual or firm may 
offer to perform or perform any lead-based paint activity as defined in 
this part, unless certified to perform that activity according to the 
procedures in Sec. 745.226.



Sec. 745.235  Enforcement.

    (a) Failure or refusal to comply with any requirement of 
Secs. 745.225, 745.226, 745.227, or 745.233 is a prohibited act under 
sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
    (b) Failure or refusal to establish, maintain, provide, copy, or 
permit access to records or reports as required by Secs. 745.225, 
745.226, or 745.227 is a prohibited act under sections 15 and 409 of 
TSCA (15 U.S.C. 2614, 2689).
    (c) Failure or refusal to permit entry or inspection as required by 
Sec. 745.237 and section 11 of TSCA (15 U.S.C. 2610) is a prohibited act 
under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
    (d) In addition to the above, any individual or firm that performs 
any of the following acts shall be deemed to have committed a prohibited 
act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689). These 
include the following:
    (i) Obtaining certification through fraudulent representation;
    (ii) Failing to obtain certification from EPA and performing work 
requiring certification at a job site; or
    (iii) Fraudulently obtaining certification and engaging in any lead-
based paint activities requiring certification.
    (e) Violators are subject to civil and criminal sanctions pursuant 
to section 16 of TSCA (15 U.S.C. 2615) for each violation.



Sec. 745.237  Inspections.

    EPA may conduct reasonable inspections pursuant to the provisions of 
section 11 of TSCA (15 U.S.C. 2610) to ensure compliance with this 
subpart.



Sec. 745.238   Fees for accreditation and certification of lead-based paint activities.

    (a) Purpose. To establish and impose fees for certified individuals 
and firms engaged in lead-based paint activities and persons operating 
accredited training programs under section 402(a) of the Toxic 
Substances Control Act (TSCA).
    (b) Persons who must pay fees. Fees in accordance with paragraph (c) 
of this section must be paid by:
    (1) Training programs. (i) All non-exempt training programs applying 
to EPA for the accreditation and re-accreditation of training programs 
in one or more of the following disciplines: inspector, risk assessor, 
supervisor, project designer, abatement worker.
    (ii) Exemptions. No fee shall be imposed on any training program 
operated by a State, federally recognized Indian Tribe, local 
government, or nonprofit organization. This exemption does not apply to 
the certification of firms or individuals.
    (2) Firms and individuals. All firms and individuals seeking 
certification and re-certification from EPA to engage in lead-based 
paint activities in one or more of the following disciplines: inspector, 
risk assessor, supervisor, project designer, abatement worker.
    (c) Fee amounts--(1) Certification and accreditation fees. Initial 
and renewal certification and accreditation fees are specified in the 
following table:

[[Page 476]]



               Certification and Accreditation Fee Levels
------------------------------------------------------------------------
                                                       Re-accreditation
                                                     \1\ [every 4 years,
                                                          see 40 CFR
       Training Program          Accreditation \1\    745.225(f)(1) for
                                                           details]
 
------------------------------------------------------------------------
Initial Course
  Inspector                     $2,500               $1,600
  Risk assessor                 $1,760               $1,150
  Supervisor                    $3,250               $2,050
  Worker                        $1,760               $1,150
  Project designer              $1,010               $710
------------------------------------------------------------------------
Refresher Course
  Inspector                     $1,010               $710
  Risk assessor                 $1,010               $710
  Supervisor                    $1,010               $710
  Worker                        $1,010               $710
  Project designer              $640                 $490
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                       Re-certification
                                                      \1\ [every 3 or 5
 Lead-based Paint Activities-                         years, see 40 CFR
          Individual             Certification \1\    745.226(e)(1) for
                                                           details]
 
------------------------------------------------------------------------
Inspector                       $400                 $350
Risk assessor                   $520                 $420
Supervisor                      $470                 $390
Worker                          $280                 $240
Project designer                $470                 $390
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                         Certification
                                                          Renewal \1\
  Lead-based Paint Activities-                          [every 3 years,
              Firm                 Certification \1\       see 40 CFR
                                                       745.226(f)(7) for
                                                            details]
------------------------------------------------------------------------
Firm                             $540                  $430
------------------------------------------------------------------------
\1\ Fees will be adjusted periodically based on adjustments accounting
  for changes in participation and operating costs.

    (2) Certification examination fee. Individuals required to take a 
certification exam in accordance with Sec. 745.226 will be assessed a 
fee of $70 for each exam attempt.
    (3) Multi-jurisdiction registration fee. An individual, firm, or 
training program certified or accredited by EPA may wish to provide 
training or perform lead-based paint activities in additional EPA-
administered jurisdictions. A fee of $35 per discipline will be assessed 
for each additional EPA-administered jurisdiction in which an 
individual, firm, or training program applies for certification/re-
certification or accreditation/re-accreditation. For purposes of this 
multi-jurisdiction registration fee, an EPA-administered jurisdiction is 
either an individual state without an authorized program or all Indian 
Tribes without authorized programs that are within a given EPA Region.
    (4) Lost identification card or certificate. A $15 fee shall be 
charged for replacement of an identification card or certificate. (See 
replacement procedure in paragraph (e) of this section.)
    (d) Application/payment procedure--(1) Certification and re-
certification in one or more EPA-administered jurisdiction--(i) 
Individuals. Submit a completed application (titled ``Application for 
Individuals to Conduct Lead-based Paint Activities''), the materials 
described at Sec. 745.226, and the application fee(s) described in 
paragraph (c) of this section.
    (ii) Firms. Submit a completed application (titled ``Application for 
Firms to Conduct Lead-based Paint Activities''), the materials described 
at Sec. 745.226, and the application fee(s) described in paragraph (c) 
of this section.
    (2) Accreditation and re-accreditation in one or more EPA-
administered jurisdiction. Submit a completed application (titled 
``Accreditation Application for Training Programs''), the materials 
described at Sec. 745.225, and the application fee described in 
paragraph (c) of this section.
    (3) Application forms. Application forms and instructions can be 
obtained

[[Page 477]]

from the National Lead Information Center at: 1-800-424-LEAD.
    (e) Identification card replacement and certificate replacement. (1) 
Parties seeking identification card or certificate replacement shall 
complete the applicable portions of the appropriate application in 
accordance with the instructions provided. The appropriate applications 
are:
    (i) Individuals. ``Application for Individuals to Conduct Lead-based 
Paint Activities.''
    (ii) Firms. ``Application for Firms to Conduct Lead-based Paint 
Activities.''
    (iii) Training programs. ``Accreditation Application for Training 
Programs.''
    (2) Submit application and payment in the amount specified in 
paragraph (c)(4) of this section in accordance with the instructions 
provided with the application package.
    (f) Adjustment of fees. (1) EPA will collect fees reflecting the 
costs associated with the administration and enforcement of subpart L of 
this part with the exception of costs associated with the accreditation 
of training programs operated by a State, federally recognized Indian 
Tribe, local government, and nonprofit organization. In order to do 
this, EPA will periodically adjust the fees to reflect changed economic 
conditions.
    (2) The fees will be evaluated based on the cost to administer and 
enforce the program, and the number of applicants. New fee schedules 
will be published in the Federal Register.
    (g) Failure to remit a fee. (1) EPA will not provide certification, 
re-certification, accreditation, or re-accreditation for any individual, 
firm, or training program which does not remit fees described in 
paragraph (c) of this section in accordance with the procedures 
specified in paragraph (d) of this section.
    (2) EPA will not replace identification cards or certificates for 
any individual, firm, or training program which does not remit fees 
described in paragraph (c) of this section in accordance with the 
procedures specified in paragraph (e) of this section.

[64 FR 31098, June 9, 1999]



Sec. 745.239  Effective dates.

    This subpart L shall apply in any State or Indian Country that does 
not have an authorized program under subpart Q, effective August 31, 
1998. In such States or Indian Country:
    (a) Training programs shall not provide, offer or claim to provide 
training or refresher training for certification without accreditation 
from EPA pursuant to Sec. 745.225 on or after March 1, 1999.
    (b) No individual or firm shall perform, offer, or claim to perform 
lead-based paint activities, as defined in this subpart, without 
certification from EPA to conduct such activities pursuant to 
Sec. 745.226 on or after August 30, 1999.
    (c) All lead-based paint activities shall be performed pursuant to 
the work practice standards contained in Sec. 745.227 on or after August 
30, 1999.

Subparts M-P [Reserved]



               Subpart Q--State and Indian Tribal Programs

    Source: 61 FR 45825, Aug. 29, 1996, unless otherwise noted.



Sec. 745.320  Scope and purpose.

    (a) This subpart establishes the requirements that State or Tribal 
programs must meet for authorization by the Administrator to administer 
and enforce the standards, regulations, or other requirements 
established under TSCA section 402 and/or section 406 and establishes 
the procedures EPA will follow in approving, revising, and withdrawing 
approval of State or Tribal programs.
    (b) For State or Tribal lead-based paint training and certification 
programs, a State or Indian Tribe may seek authorization to administer 
and enforce Secs. 745.225, 745.226, and 745.227. The provisions of 
Secs. 745.220, 745.223, 745.233, 745.235, 745.237, and 745.239 shall be 
applicable for the purposes of such program authorization.
    (c) For State or Tribal pre-renovation notification programs, a 
State or Indian Tribe may seek authorization to administer and enforce 
regulations developed pursuant to TSCA section 406.

[[Page 478]]

    (d) A State or Indian Tribe applying for program authorization may 
seek either interim approval or final approval of the compliance and 
enforcement portion of the State or Tribal lead-based paint program 
pursuant to the procedures at Sec. 745.327(a).
    (e) State or Tribal submissions for program authorization shall 
comply with the procedures set out in this subpart.
    (f) Any State or Tribal program approved by the Administrator under 
this subpart shall at all times comply with the requirements of this 
subpart.
    (g) In many cases States will lack authority to regulate activities 
in Indian Country. This lack of authority does not impair a State's 
ability to obtain full program authorization in accordance with this 
subpart. EPA will administer the program in Indian Country if neither 
the State nor Indian Tribe has been granted program authorization by 
EPA.



Sec. 745.323  Definitions.

    The definitions in subpart A apply to this subpart. In addition, the 
definitions in Sec. 745.223 and the following definitions apply:
    Indian Country means (1) all land within the limits of any American 
Indian reservation under the jurisdiction of the U.S. government, 
notwithstanding the issuance of any patent, and including rights-of-way 
running throughout the reservation; (2) all dependent Indian communities 
within the borders of the United States whether within the original or 
subsequently acquired territory thereof, and whether within or outside 
the limits of a State; and (3) all Indian allotments, the Indian titles 
which have not been extinguished, including rights-of-way running 
through the same.
    Indian Tribe means any Indian Tribe, band, nation, or community 
recognized by the Secretary of the Interior and exercising substantial 
governmental duties and powers.



Sec. 745.324  Authorization of State or Tribal programs.

    (a) Application content and procedures. (1) Any State or Indian 
Tribe that seeks authorization from EPA to administer and enforce any 
provisions of subpart L of this part under section 402(a) of TSCA or the 
provisions of regulations developed under section 406 of TSCA shall 
submit an application to the Administrator in accordance with the 
procedures of this paragraph (a).
    (2) Before developing an application for authorization, a State or 
Indian Tribe shall disseminate a public notice of intent to seek such 
authorization and provide an opportunity for a public hearing.
    (3) A State or Tribal application shall include:
    (i) A transmittal letter from the State Governor or Tribal 
Chairperson (or equivalent official) requesting program approval.
    (ii) A summary of the State or Tribal program. This summary will be 
used to provide notice to residents of the State or Tribe.
    (iii) A description of the State or Tribal program in accordance 
with paragraph (b) of this section.
    (iv) An Attorney General's or Tribal Counsel's (or equivalent) 
statement in accordance with paragraph (c) of this section.
    (v) Copies of all applicable State or Tribal statutes, regulations, 
standards, and other materials that provide the State or Indian Tribe 
with the authority to administer and enforce a lead-based paint program.
    (4) After submitting an application, the Agency will publish a 
Federal Register notice that contains an announcement of the receipt of 
the State or Tribal application, the summary of the program as provided 
by the State or Tribe, and a request for public comments to be mailed to 
the appropriate EPA Regional Office. This comment period shall last for 
no less than 45 days. EPA will consider these comments during its review 
of the State or Tribal application.
    (5) Within 60 days of submission of a State or Tribal application, 
EPA will, if requested, conduct a public hearing in each State or Indian 
Country seeking program authorization and will consider all comments 
submitted at that hearing during the review of the State or Tribal 
application.
    (b) Program description. A State or Indian Tribe seeking to 
administer and enforce a program under this subpart

[[Page 479]]

must submit a description of the program. The description of the State 
or Tribal program must include:
    (1)(i) The name of the State or Tribal agency that is or will be 
responsible for administering and enforcing the program, the name of the 
official in that agency designated as the point of contact with EPA, and 
addresses and phone numbers where this official can be contacted.
    (ii) Where more than one agency is or will be responsible for 
administering and enforcing the program, the State or Indian Tribe must 
designate a primary agency to oversee and coordinate administration and 
enforcement of the program and serve as the primary contact with EPA.
    (iii) In the event that more than one agency is or will be 
responsible for administering and enforcing the program, the application 
must also include a description of the functions to be performed by each 
agency. The desciption shall explain and how the program will be 
coordinated by the primary agency to ensure consistency and effective 
administration of the lead-based paint training accreditation and 
certification program within the State or Indian Tribe.
    (2) To demonstrate that the State or Tribal program is at least as 
protective as the Federal program, fulfilling the criteria in paragraph 
(e)(2)(i) of this section, the State or Tribal application must include:
    (i) A description of the program that demonstrates that the program 
contains all of the elements specified in Sec. 745.325, Sec. 745.326, or 
both; and
    (ii) An analysis of the State or Tribal program that compares the 
program to the Federal program in subpart L of this part, regulations 
developed pursuant to TSCA section 406, or both. This analysis shall 
demonstrate how the program is, in the State's or Indian Tribe's 
assessment, at least as protective as the elements in the Federal 
program at subpart L of this part, regulations developed pursuant to 
TSCA section 406, or both. EPA will use this analysis to evaluate the 
protectiveness of the State or Tribal program in making its 
determination pursuant to paragraph (e)(2)(i) of this section.
    (3) To demonstrate that the State or Tribal program provides 
adequate enforcement, fulfilling the criteria in paragraph (e)(2)(ii) of 
this section, the State or Tribal application must include a description 
of the State or Tribal lead-based paint compliance and enforcement 
program that demonstrates that the program contains all of the elements 
specified at Sec. 745.327. This description shall include copies of all 
policies, certifications, plans, reports, and other materials that 
demonstrate that the State or Tribal program contains all of the 
elements specified at Sec. 745.327.
    (4)(i) The program description for an Indian Tribe shall also 
include a map, legal description, or other information sufficient to 
identify the geographical extent of the territory over which the Indian 
Tribe exercises jurisdiction.
    (ii) The program description for an Indian Tribe shall also include 
a demonstration that the Indian Tribe:
    (A) Is recognized by the Secretary of the Interior.
    (B) has an existing government exercising substantial governmental 
duties and powers.
    (C) has adequate civil regulatory jurisdiction (as shown in the 
Tribal legal certification in paragraph (c)(2) of this section) over the 
subject matter and entities regulated.
    (D) is reasonably expected to be capable of administering the 
Federal program for which it is seeking authorization.
    (iii) If the Administrator has previously determined that an Indian 
Tribe has met the prerequisites in paragraphs (b)(4)(ii)(A) and (B) of 
this section for another EPA program, the Indian Tribe need provide only 
that information unique to the lead-based paint program required by 
paragraphs (b)(4)(ii)(C) and (D) of this section.
    (c) Attorney General's statement. (1) A State or Indian Tribe must 
submit a written statement signed by the Attorney General or Tribal 
Counsel (or equivalent) certifying that the laws and regulations of the 
State or Indian Tribe provide adequate legal authority to administer and 
enforce the State or Tribal program. This statement shall

[[Page 480]]

include citations to the specific statutes and regulations providing 
that legal authority.
    (2) The Tribal legal certification (the equivalent to the Attorney 
General's statement) may also be submitted and signed by an independent 
attorney retained by the Indian Tribe for representation in matters 
before EPA or the courts pertaining to the Indian Tribe's program. The 
certification shall include an assertion that the attorney has the 
authority to represent the Indian Tribe with respect to the Indian 
Tribe's authorization application.
    (3) If a State application seeks approval of its program to operate 
in Indian Country, the required legal certification shall include an 
analysis of the applicant's authority to implement its provisions in 
Indian Country. The applicant shall include a map delineating the area 
over which it seeks to operate the program.
    (d) Program certification. (1) At the time of submitting an 
application, a State may also certify to the Administrator that the 
State program meets the requirements contained in paragraphs (e)(2)(i) 
and (e)(2)(ii) of this section.
    (2) If this certification is contained in a State's application, the 
program shall be deemed to be authorized by EPA until such time as the 
Administrator disapproves the program application or withdraws the 
program authorization. A program shall not be deemed authorized pursuant 
to this subpart to the extent that jurisdiction is asserted over Indian 
Country, including non-member fee lands within an Indian reservation.
    (3) If the application does not contain such certification, the 
State program will be authorized only after the Administrator authorizes 
the program in accordance with paragraph (e) of this section.
    (4) This certification shall take the form of a letter from the 
Governor or the Attorney General to the Administrator. The certification 
shall reference the program analysis in paragraph (b)(3) of this section 
as the basis for concluding that the State program is at least as 
protective as the Federal program, and provides adequate enforcement.
    (e) EPA approval. (1) EPA will fully review and consider all 
portions of a State or Tribal application.
    (2) Within 180 days of receipt of a complete State or Tribal 
application, the Administrator shall either authorize the program or 
disapprove the application. The Administrator shall authorize the 
program, after notice and the opportunity for public comment and a 
public hearing, only if the Administrator finds that:
    (i)(A) In the case of an application to authorize the State or 
Indian Tribe to administer and enforce the provisions of subpart L of 
this part, the State or Tribal program is at least as protective of 
human health and the environment as the corresponding Federal program 
under subpart L of this part; and/or
    (B) In the case of an application to authorize the State or Indian 
Tribe to administer and enforce the regulations developed pursuant to 
TSCA section 406, the State or Tribal program is at least as protective 
of human health and the environment as the Federal regulations developed 
pursuant to TSCA section 406.
    (ii) The State or Tribal program provides adequate enforcement.
    (3) EPA shall notify in writing the State or Indian Tribe of the 
Administrator's decision to authorize the State or Tribal program or 
disapprove the State's or Indian Tribe's application.
    (4) If the State or Indian Tribe applies for authorization of State 
or Tribal programs under both subpart L and regulations developed 
pursuant to TSCA section 406, EPA may, as appropriate, authorize one 
program and disapprove the other.
    (f) EPA administration and enforcement. (1) If a State or Indian 
Tribe does not have an authorized program to administer and enforce 
subpart L of this part in effect by August 31, 1998, the Administrator 
shall, by such date, establish and enforce the provisions of subpart L 
of this part as the Federal program for that State or Indian Country.
    (2) If a State or Indian Tribe does not have an authorized program 
to administer and enforce regulations developed pursuant to TSCA section 
406 in effect by August 31, 1998, the Administrator

[[Page 481]]

shall, by such date, establish and enforce the provisions of regulations 
developed pursuant to TSCA section 406 as the Federal program for that 
State or Indian Country.
    (3) Upon authorization of a State or Tribal program, pursuant to 
paragraph (d) or (e) of this section, it shall be an unlawful act under 
sections 15 and 409 of TSCA for any person to fail or refuse to comply 
with any requirements of such program.
    (g) Oversight. EPA shall periodically evaluate the adequacy of a 
State's or Indian Tribe's implementation and enforcement of its 
authorized programs.
    (h) Reports. Beginning 12 months after the date of program 
authorization, the primary agency for each State or Indian Tribe that 
has an authorized program shall submit a written report to the EPA 
Regional Administrator for the Region in which the State or Indian Tribe 
is located. This report shall be submitted at least once every 12 months 
for the first 3 years after program authorization. If these reports 
demonstrate successful program implementation, the Agency will 
automatically extend the reporting interval to every 2 years. If the 
subsequent reports demonstrate problems with implementation, EPA will 
require a return to annual reporting until the reports demonstrate 
successful program implementation, at which time the Agency will extend 
the reporting interval to every 2 years.
    The report shall include the following information:
    (1) Any significant changes in the content or administration of the 
State or Tribal program implemented since the previous reporting period; 
and
    (2) All information regarding the lead-based paint enforcement and 
compliance activities listed at Sec. 745.327(d) ``Summary on Progress 
and Performance.''
    (i) Withdrawal of authorization. (1) If EPA concludes that a State 
or Indian Tribe is not administering and enforcing an authorized program 
in compliance with the standards, regulations, and other requirements of 
sections 401 through 412 of TSCA and this subpart, the Administrator 
shall notify the primary agency for the State or Indian Tribe in writing 
and indicate EPA's intent to withdraw authorization of the program.
    (2) The Notice of Intent to Withdraw shall:
    (i) Identify the program aspects that EPA believes are inadequate 
and provide a factual basis for such findings.
    (ii) Include copies of relevant documents.
    (iii) Provide an opportunity for the State or Indian Tribe to 
respond either in writing or at a meeting with appropriate EPA 
officials.
    (3) EPA may request that an informal conference be held between 
representatives of the State or Indian Tribe and EPA officials.
    (4) Prior to issuance of a withdrawal, a State or Indian Tribe may 
request that EPA hold a public hearing. At this hearing, EPA, the State 
or Indian Tribe, and the public may present facts bearing on whether the 
State's or Indian Tribe's authorization should be withdrawn.
    (5) If EPA finds that deficiencies warranting withdrawal did not 
exist or were corrected by the State or Indian Tribe, EPA may rescind 
its Notice of Intent to Withdraw authorization.
    (6) Where EPA finds that deficiencies in the State or Tribal program 
exist that warrant withdrawal, an agreement to correct the deficiencies 
shall be jointly prepared by the State or Indian Tribe and EPA. The 
agreement shall describe the deficiencies found in the program, specify 
the steps the State or Indian Tribe has taken or will take to remedy the 
deficiencies, and establish a schedule, no longer than 180 days, for 
each remedial action to be initiated.
    (7) If the State or Indian Tribe does not respond within 60 days of 
issuance of the Notice of Intent to Withdraw or an agreement is not 
reached within 180 days after EPA determines that a State or Indian 
Tribe is not in compliance with the Federal program, the Agency shall 
issue an order withdrawing the State's or Indian Tribe's authorization.
    (8) By the date of such order, the Administrator shall establish and 
enforce the provisions of subpart L of this part or regulations 
developed pursuant to

[[Page 482]]

TSCA section 406, or both, as the Federal program for that State or 
Indian Country.



Sec. 745.325  Lead-based paint activities: State and Tribal program requirements.

    (a) Program elements. To receive authorization from EPA, a State or 
Tribal program must contain at least the following program elements for 
lead-based paint activities:
    (1) Procedures and requirements for the accreditation of lead-based 
paint activities training programs.
    (2) Procedures and requirements for the certification of individuals 
engaged in lead-based paint activities.
    (3) Work practice standards for the conduct of lead-based paint 
activities.
    (4) Requirements that all lead-based paint activities be conducted 
by appropriately certified contractors.
    (5) Development of the appropriate infrastructure or government 
capacity to effectively carry out a State or Tribal program.
    (b) Accreditation of training programs. The State or Indian Tribe 
must have either:
    (1) Procedures and requirements for the accreditation of training 
programs that establish:
    (i) Requirements for the accreditation of training programs, 
including but not limited to:
    (A) Training curriculum requirements.
    (B) Training hour requirements.
    (C) Hands-on training requirements.
    (D) Trainee competency and proficiency requirements.
    (E) Requirements for training program quality control.
    (ii) Procedures for the re-accreditation of training programs.
    (iii) Procedures for the oversight of training programs.
    (iv) Procedures for the suspension, revocation, or modification of 
training program accreditations; or
    (2) Procedures or regulations, for the purposes of certification, 
for the acceptance of training offered by an accredited training 
provider in a State or Tribe authorized by EPA.
    (c) Certification of individuals. The State or Indian Tribe must 
have requirements for the certification of individuals that:
    (1) Ensure that certified individuals:
    (i) Are trained by an accredited training program; and
    (ii) Possess appropriate education or experience qualifications for 
certification.
    (2) Establish procedures for re-certification.
    (3) Require the conduct of lead-based paint activities in accordance 
with work practice standards established by the State or Indian Tribe.
    (4) Establish procedures for the suspension, revocation, or 
modification of certifications.
    (5) Establish requirements and procedures for the administration of 
a third-party certification exam.
    (d) Work practice standards for the conduct of lead-based paint 
activities. The State or Indian Tribe must have requirements or 
standards that ensure that lead-based paint activities are conducted 
reliably, effectively, and safely. At a minimum the State's or Indian 
Tribe's work practice standards for conducting inspections, risk 
assessments, and abatements must contain the requirements specified in 
paragraphs (d)(1), (d)(2), and (d)(3) of this section.
    (1) The work practice standards for the inspection for the presence 
of lead-based paint must require that:
    (i) Inspections are conducted only by individuals certified by the 
appropriate State or Tribal authority to conduct inspections.
    (ii) Inspections are conducted in a way that identifies the presence 
of lead-based paint on painted surfaces within the interior or on the 
exterior of a residential dwelling or child-occupied facility.
    (iii) Inspections are conducted in a way that uses documented 
methodologies that incorporate adequate quality control procedures.
    (iv) A report is developed that clearly documents the results of the 
inspection.
    (v) Records are retained by the certified inspector or the firm.
    (2) The work practice standards for risk assessment must require 
that:

[[Page 483]]

    (i) Risk assessments are conducted only by individuals certified by 
the appropriate State or Tribal authority to conduct risk assessments.
    (ii) Risk assessments are conducted in a way that identifies and 
reports the presence of lead-based paint hazards.
    (iii) Risk assessments consist of, at least:
    (A) An assessment, including a visual inspection, of the physical 
characteristics of the residential dwelling or child-occupied facility; 
and
    (B) Environmental sampling for lead in paint, dust, and soil.
    (iv) The risk assessor develops a report that clearly presents the 
results of the assessment and recommendations for the control or 
elimination of all identified hazards.
    (v) The certified risk assessor or the firm retains the appropriate 
records.
    (3) The work practice standards for abatement must require that:
    (i) Abatements are conducted only by individuals certified by the 
appropriate State or Tribal authority to conduct or supervise 
abatements.
    (ii) Abatements permanently eliminate lead-based paint hazards and 
are conducted in a way that does not increase the hazards of lead-based 
paint to the occupants of the dwelling or child-occupied facility.
    (iii) Abatements include post-abatement lead in dust clearance 
sampling and conformance with clearance levels established or adopted by 
the State or Indian Tribe.
    (iv) The abatement contractor develops a report that describes areas 
of the residential dwelling or child-occupied facility abated and the 
techniques employed.
    (v) The certified abatement contractor or the firm retains 
appropriate records.



Sec. 745.326  Pre-renovation notification: State and Tribal program requirements.

    (a) Program elements. To receive authorization from EPA, a State or 
Tribal program must contain the following program elements for 
renovation disclosure:
    (1) Procedures and requirements for the distribution of lead hazard 
information to owners and occupants of target housing before renovations 
for compensation; and
    (2) An approved lead hazard information pamphlet meeting the 
requirements of section 406 of TSCA, as determined by EPA. EPA will 
provide States or Tribes with guidance on what is necessary for a State 
or Tribal pamphlet approval application.
    (b) Program to distribute lead information. To be considered at 
least as protective as the Federal requirements for pre-renovation 
distribution of information, the State or Indian Tribe must have 
procedures and requirements that establish:
    (1) Clear standards for identifying home improvement activities that 
trigger the pamphlet distribution requirements; and
    (2) Procedures for distributing the lead hazard information to 
owners and occupants of the housing prior to renovation activities.
    (c) Distribution of acceptable lead hazard information. To be 
considered at least as protective as the Federal requirements for the 
distribution of a lead hazard information pamphlet, the State or Indian 
Tribe must either:
    (1) Distribute the lead hazard information pamphlet developed by EPA 
under section 406(a) of TSCA, titled Protect Your Family from Lead in 
Your Home; or
    (2) Distribute an alternate pamphlet or package of lead hazard 
information that has been submitted by the State or Tribe, reviewed by 
EPA, and approved by EPA for use in that State or Tribe. Such 
information must meet the content requirements prescribed by section 
406(a) of TSCA, and be in a format that is readable to the diverse 
audience of housing owners and occupants in that State or Tribe.



Sec. 745.327  State or Indian Tribal lead-based paint compliance and enforcement programs.

    (a) Approval of compliance and enforcement programs. A State or 
Indian Tribe seeking authorization of a lead-based paint program can 
apply for and receive either interim or final approval of the compliance 
and enforcement program portion of its lead-based paint

[[Page 484]]

program. Indian Tribes are not required to exercise criminal enforcement 
jurisdiction as a condition for program authorization.
    (1) Interim approval. Interim approval of the compliance and 
enforcement program portion of the State or Tribal lead-based paint 
program may be granted by EPA only once, and subject to a specific 
expiration date.
    (i) To be considered adequate for purposes of obtaining interim 
approval for the compliance and enforcement program portion of a State 
or Tribal lead-based paint program, a State or Indian Tribe must, in its 
application described at Sec. 745.324(a):
    (A) Demonstrate it has the legal authority and ability to 
immediately implement the elements in paragraph (b) of this section. 
This demonstration shall include a statement that the State or Indian 
Tribe, during the interim approval period, shall carry out a level of 
compliance monitoring and enforcement necessary to ensure that the State 
or Indian Tribe addresses any significant risks posed by noncompliance 
with lead-based paint activity requirements.
    (B) Present a plan with time frames identified for implementing in 
the field each element in paragraph (c) of this section. All elements of 
paragraph (c) of this section must be fully implemented no later than 3 
years from the date of EPA's interim approval of the compliance and 
enforcement program portion of a State or Tribal lead-based paint 
program. A statement of resources must be included in the State or 
Tribal plan which identifies what resources the State or Indian Tribe 
intends to devote to the administration of its lead-based paint 
compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (ii) Any interim approval granted by EPA for the compliance and 
enforcement program portion of a State or Tribal lead-based paint 
program will expire no later than 3 years from the date of EPA's interim 
approval. One hundred and eighty days prior to this expiration date, a 
State or Indian Tribe shall apply to EPA for final approval of the 
compliance and enforcement program portion of a State or Tribal lead-
based paint program. Final approval shall be given to any State or 
Indian Tribe which has in place all of the elements of paragraphs (b), 
(c), and (d) of this section. If a State or Indian Tribe does not 
receive final approval for the compliance and enforcement program 
portion of a State or Tribal lead-based paint program by the date 3 
years after the date of EPA's interim approval, the Administrator shall, 
by such date, initiate the process to withdraw the State or Indian 
Tribe's authorization pursuant to Sec. 745.324(i).
    (2) Final approval. Final approval of the compliance and enforcement 
program portion of a State or Tribal lead-based paint program can be 
granted by EPA either through the application process described at 
Sec. 745.324(a), or, for States or Indian Tribes which previously 
received interim approval as described in paragraph (a)(1) of this 
section, through a separate application addressing only the compliance 
and enforcement program portion of a State or Tribal lead-based paint 
program.
    (i) For the compliance and enforcement program to be considered 
adequate for final approval through the application described at 
Sec. 745.324(a), a State or Indian Tribe must, in its application:
    (A) Demonstrate it has the legal authority and ability to 
immediately implement the elements in paragraphs (b) and (c) of this 
section.
    (B) Submit a statement of resources which identifies what resources 
the State or Indian Tribe intends to devote to the administration of its 
lead-based paint compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (ii) For States or Indian Tribes which previously received interim 
approval as described in paragraph (a)(1) of this section, in order for 
the State or Tribal compliance and enforcement program to be considered 
adequate for final approval through a separate application

[[Page 485]]

addressing only the compliance and enforcement program portion of a 
State or Tribal lead-based paint program, a State or Indian Tribe must, 
in its application:
    (A) Demonstrate that it has the legal authority and ability to 
immediately implement the elements in paragraphs (b) and (c) of this 
section.
    (B) Submit a statement which identifies the resources the State or 
Indian Tribe intends to devote to the administration of its lead-based 
paint compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (D) To the extent not previously submitted through the application 
described at Sec. 745.324(a), submit copies of all applicable State or 
Tribal statutes, regulations, standards, and other material that provide 
the State or Indian Tribe with authority to administer and enforce the 
lead-based paint compliance and enforcement program, and copies of the 
policies, certifications, plans, reports, and any other documents that 
demonstrate that the program meets the requirements established in 
paragraphs (b) and (c) of this section.
    (b) Standards, regulations, and authority. The standards, 
regulations, and authority described in paragraphs (b)(1) through (b)(4) 
of this section are part of the required elements for the compliance and 
enforcement portion of a State or Tribal lead-based paint program.
    (1) Lead-based paint activities and requirements. State or Tribal 
lead-based paint compliance and enforcement programs will be considered 
adequate if the State or Indian Tribe demonstrates, in its application 
at Sec. 745.324(a), that it has established a lead-based paint program 
containing the following requirements:
    (i) Accreditation of training programs as described at 
Sec. 745.325(b).
    (ii) Certification of individuals engaged in lead-based paint 
activities as described at Sec. 745.325(c).
    (iii) Standards for the conduct of lead-based paint activities as 
described at Sec. 745.325(d); and, as appropriate,
    (iv) Requirements that regulate the conduct of pre-renovation 
notification activities as described at Sec. 745.326.
    (2) Authority to enter. State or Tribal officials must be able to 
enter, through consent, warrant, or other authority, premises or 
facilities where lead-based paint activities violations may occur for 
purposes of conducting inspections.
    (i) State or Tribal officials must be able to enter premises or 
facilities where those engaged in training for lead-based paint 
activities conduct business.
    (ii) For the purposes of enforcing a pre-renovation notification 
program, State or Tribal officials must be able to enter a renovator's 
place of business.
    (iii) State or Tribal officials must have authority to take samples 
and review records as part of the lead-based paint activities inspection 
process.
    (3) Flexible remedies. A State or Tribal lead-based paint compliance 
and enforcement program must provide for a diverse and flexible array of 
enforcement remedies. At a minimum, the remedies that must be reflected 
in an enforcement response policy must include the following:
    (i) Warning letters, Notices of Noncompliance, Notices of Violation, 
or the equivalent;
    (ii) Administrative or civil actions, including penalty authority 
(e.g., accreditation or certification suspension, revocation, or 
modification); and
    (iii) Authority to apply criminal sanctions or other criminal 
authority using existing State or Tribal laws, as applicable.
    (4) Adequate resources. An application must include a statement that 
identifies the resources that will be devoted by the State or Indian 
Tribe to the administration of the State or Tribal lead-based paint 
compliance and enforcement program. This statement must address fiscal 
and personnel resources that will be devoted to the program.
    (c) Performance elements. The performance elements described in 
paragraphs (c)(1) through (c)(7) of this section are part of the 
required elements for the compliance and enforcement program portion of 
a State or Tribal lead-based paint program.

[[Page 486]]

    (1) Training. A State or Tribal lead-based paint compliance and 
enforcement program must implement a process for training enforcement 
and inspection personnel and ensure that enforcement personnel and 
inspectors are well trained. Enforcement personnel must understand case 
development procedures and the maintenance of proper case files. 
Inspectors must successfully demonstrate knowledge of the requirements 
of the particular discipline (e.g., abatement supervisor, and/or 
abatement worker, and/or lead-based paint inspector, and/or risk 
assessor, and/or project designer) for which they have compliance 
monitoring and enforcement responsibilities. Inspectors must also be 
trained in violation discovery, methods of obtaining consent, evidence 
gathering, preservation of evidence and chain-of-custody, and sampling 
procedures. A State or Tribal lead-based paint compliance and 
enforcement program must also implement a process for the continuing 
education of enforcement and inspection personnel.
    (2) Compliance assistance. A State or Tribal lead-based paint 
compliance and enforcement program must provide compliance assistance to 
the public and the regulated community to facilitate awareness and 
understanding of and compliance with State or Tribal requirements 
governing the conduct of lead-based paint activities. The type and 
nature of this assistance can be defined by the State or Indian Tribe to 
achieve this goal.
    (3) Sampling techniques. A State or Tribal lead-based paint 
compliance and enforcement program must have the technological 
capability to ensure compliance with the lead-based paint program 
requirements. A State or Tribal application for approval of a lead-based 
paint program must show that the State or Indian Tribe is 
technologically capable of conducting a lead-based paint compliance and 
enforcement program. The State or Tribal program must have access to the 
facilities and equipment necessary to perform sampling and laboratory 
analysis as needed. This laboratory facility must be a recognized 
laboratory as defined at Sec. 745.223, or the State or Tribal program 
must implement a quality assurance program that ensures appropriate 
quality of laboratory personnel and protects the integrity of analytical 
data.
    (4) Tracking tips and complaints. A State or Tribal lead-based paint 
compliance and enforcement program must demonstrate the ability to 
process and react to tips and complaints or other information indicating 
a violation.
    (5) Targeting inspections. A State or Tribal lead-based paint 
compliance and enforcement program must demonstrate the ability to 
target inspections to ensure compliance with the lead-based paint 
program requirements. Such targeting must include a method for obtaining 
and using notifications of commencement of abatement activities.
    (6) Follow up to inspection reports. A State or Tribal lead-based 
paint compliance and enforcement program must demonstrate the ability to 
reasonably, and in a timely manner, process and follow-up on inspection 
reports and other information generated through enforcement-related 
activities associated with a lead-based paint program. The State or 
Tribal program must be in a position to ensure correction of violations 
and, as appropriate, effectively develop and issue enforcement remedies/
responses to follow up on the identification of violations.
    (7) Compliance monitoring and enforcement. A State or Tribal lead-
based paint compliance and enforcement program must demonstrate, in its 
application for approval, that it is in a position to implement a 
compliance monitoring and enforcement program. Such a compliance 
monitoring and enforcement program must ensure correction of violations, 
and encompass either planned and/or responsive lead-based paint 
compliance inspections and development/issuance of State or Tribal 
enforcement responses which are appropriate to the violations.
    (d) Summary on Progress and Performance. The Summary on Progress and 
Performance described below is part of the required elements for the 
compliance and enforcement program portion of a State or Tribal lead-
based paint program. A State or Tribal lead-based paint compliance and 
enforcement program must submit to the appropriate EPA Regional 
Administrator a report

[[Page 487]]

which summarizes the results of implementing the State or Tribal lead-
based paint compliance and enforcement program, including a summary of 
the scope of the regulated community within the State or Indian Tribe 
(which would include the number of individuals and firms certified in 
lead-based paint activities and the number of training programs 
accredited), the inspections conducted, enforcement actions taken, 
compliance assistance provided, and the level of resources committed by 
the State or Indian Tribe to these activities. The report shall be 
submitted according to the requirements at Sec. 745.324(h).
    (e) Memorandum of Agreement. An Indian Tribe that obtains program 
approval must establish a Memorandum of Agreement with the Regional 
Administrator. The Memorandum of Agreement shall be executed by the 
Indian Tribe's counterpart to the State Director (e.g., the Director of 
Tribal Environmental Office, Program or Agency). The Memorandum of 
Agreement must include provisions for the timely and appropriate 
referral to the Regional Administrator for those criminal enforcement 
matters where that Indian Tribe does not have the authority (e.g., those 
addressing criminal violations by non-Indians or violations meriting 
penalties over $5,000). The Agreement must also identify any enforcement 
agreements that may exist between the Indian Tribe and any State.



Sec. 745.330   Grants.

    (a) The Administrator may make grants to States and Indian Tribes, 
under section 404(g) of TSCA to develop and, if authorized, carry out 
lead-based paint activities programs to ensure that individuals employed 
in lead-based paint activities are properly trained; that training 
programs are accredited; and that contractors employed in such 
activities are certified, pursuant to this subpart. The Administrator 
may treat a tribe as eligible to apply for a TSCA section 404(g) grant 
if the tribe:
    (1) Is recognized by the Secretary of Interior.
    (2) Has an existing government exercising substantial governmental 
duties and powers.
    (3) Has adequate authority to carry out the grant activities.
    (4) Is reasonably expected to be capable, in the Administrator's 
judgment, of administering the grant program.
    (b) If the Administrator has previously determined that an Indian 
tribe has met the prerequisites in paragraphs (a)(1) and (a)(2) of this 
section for another EPA program, the tribe need provide only that 
information unique to the TSCA section 404(g) grant program required by 
paragraphs (a)(3) and (a)(4) of this section. Grants made under this 
section are subject to the requirements of part 31 of this chapter.

[63 FR 41432, Aug. 4, 1998]



Sec. 745.339  Effective dates.

    States and Indian Tribes may seek authorization to administer and 
enforce subpart L pursuant to this subpart effective October 28, 1996.



PART 747--METALWORKING FLUIDS--Table of Contents




Subpart A [Reserved]

  Subpart B--Specific Use Requirements for Certain Chemical Substances

Sec.
747.115  Mixed mono and diamides of an organic acid.
747.195  Triethanolamine salt of a substituted organic acid.
747.200  Triethanolamine salt of tricarboxylic acid.

    Authority: 15 U.S.C. 2604 and 2605.

Subpart A [Reserved]



  Subpart B--Specific Use Requirements for Certain Chemical Substances



Sec. 747.115  Mixed mono and diamides of an organic acid.

    This section identifies activities with respect to a chemical 
substance which are prohibited and requires that warnings and 
instructions accompany the substance when distributed in commerce.

[[Page 488]]

    (a) Chemical substance subject to this section. The following 
chemical substance, referred to by its premanufacture notice number and 
generic chemical name, is subject to this section: P-84-529, mixed mono 
and diamides of an organic acid.
    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development have the same meaning as 
in Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (-NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.
    (4) Process or distribute in commerce solely for export means to 
process or distribute in commerce solely for export from the United 
States under the following restrictions on domestic activity:
    (i) Processing must be performed at sites under the control of the 
processor.
    (ii) Distribution in commerce is limited to purposes of export.
    (iii) The processor or distributor may not use the substance except 
in small quantities solely for research and development.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-529, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) Any person using as a metalworking fluid a product containing P-
84-529 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-529 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-529 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as mixed mono and diamides of an 
organic acid, contained in the product (insert distributor's other 
identifier for product containing P-84-529) has been regulated by the 
Environmental Protection Agency, at 40 CFR 747.115, as published in the 
Federal Register of September 20, 1984. A copy of the regulation is 
enclosed. The regulation prohibits the addition of any nitrosating 
agent, including nitrites, to the mixed mono and diamides of an organic 
acid, when the substance is or could be used in metalworking fluids. The 
addition of nitrites or other nitrosating agents to this substance leads 
to formation of a substance known to cause cancer in laboratory animals. 
The mixed mono and diamides of an organic acid has been specifically 
designed to be used without nitrites. Consult the enclosed regulation 
for further information.

    (ii) A copy of this Sec. 747.115.
    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-529 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrites leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (iii) The first work of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area. The type size of the remainder of the warning statement 
shall be no smaller than six point type. All required label text shall 
be of sufficient prominence, and shall be placed with such 
conspicuousness relative to other label text and

[[Page 489]]

graphic material, to insure that the warning statement is read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by the generic chemical name in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-84-529, no 
processor, distributor, or user of P-84-529 will be in violation of this 
section unless that person has received a letter specified in paragraph 
(d)(1) of this section or a container with the label specified in 
paragraph (d)(2) of this section.
    (f) Exemptions. A person identified in paragraphs (c) and (d) of 
this section is not subject to the requirements of those paragraphs if:
    (1) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only in small quantities solely for 
research and development and in accordance with section 5(h)(3) of the 
Act.
    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export and, when distributing in commerce, lables the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act [15 U.S.C. 2614].
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act [15 U.S.C. 2614].
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act [15 
U.S.C. 2614].
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act [15 U.S.C. 2615] for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section; act to 
seize any chemical substance processed, distributed in commerce, or used 
in violation of this section; or take other actions under the authority 
of sections 7 and 17 of the Act [15 U.S.C. 2605 and 2616].

[49 FR 36855, Sept. 20, 1984]



Sec. 747.195  Triethanolamine salt of a substituted organic acid.

    This section identifies activities with respect to a chemical 
substance which are prohibited and requires that warnings and 
instructions accompany the substance when distributed in commerce.
    (a) Chemical substance subject to this section. The following 
chemical substance, referred to by its premanufacture notice number and 
generic chemical name, is subject to this section: P-84-310, 
triethanolamine salt of a substituted organic acid.
    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development, have the same meaning as 
in Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.

[[Page 490]]

    (4) Process or distribute in commerce solely for export means to 
process or distribute in commerce solely for export from the United 
States under the following restrictions on domestic activity:
    (i) Processing must be performed at sites under the control of the 
processor.
    (ii) Distribution in commerce is limited to purposes of export.
    (iii) The processor or distributor may not use the substance except 
in small quantities solely for research and development.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-310, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) A person using as a metalworking fluid a product containing P-
84-310 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-310 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-310 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements: A substance, 
identified generically as a triethanolamine salt of a substituted 
organic acid, contained in the product (insert distributor's trade name 
or other identifier for product containing P-84-310) has been regulated 
by the Environmental Protection Agency, at 40 CFR 747.195, as published 
in the Federal Register of June 14, 1984. A copy of the regulation is 
enclosed. The regulation prohibits the addition of any nitrosating 
agent, including nitrites, to the triethanolamine salt of a substituted 
organic acid, when the substance is or could be used in metalworking 
fluids. The addition of nitrites or other nitrosating agents to this 
substance leads to formation of a substance known to cause cancer in 
laboratory animals. The triethanolamine salt of a substituted organic 
acid has been specifically designed to be used without nitrites. Consult 
the enclosed regulation for further information.
    (ii) A copy of this Sec. 747.195.
    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-310 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrites leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (iii) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area. The type size of the remainder of the warning statement 
shall be no smaller than six point type. All required label text shall 
be of sufficient prominence, and shall be placed with such 
conspicuousness relative to other label text and graphic material, to 
insure that the warning statement is read and understood by the ordinary 
individual under customary conditions of purchase and use.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by the generic chemical name in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-84-310, no 
processor, distributor, or user of P-84-310 will be in violation of this 
section unless that

[[Page 491]]

person has received a letter specified in paragraph (d)(1) of this 
section or a container with the label specified in paragraph (d)(2) of 
this section.
    (f) Exemptions. A person identified in paragraphs (c) and (d) of 
this section is not subject to the requirements of those paragraphs if:
    (1) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only in small quantities solely for 
research and development and in accordance with section 5(h)(3) of the 
Act.
    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export, and when distributing in commerce, labels the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).

[49 FR 24668, June 14, 1984]



Sec. 747.200  Triethanolamine salt of tricarboxylic acid.

    This section identifies activities with respect to two chemical 
substances which are prohibited and requires that warnings and 
instructions accompany the substances when distributed in commerce.
    (a) Chemical substances subject to this section. The following 
chemical substances, referred to by their premanufacture notice numbers 
and generic chemical names, are subject to this section:

    P-83-1005, triethanolamine salt of tricarboxylic acid; and
    P-83-1062, tricarboxylic acid.

    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, byproducts, chemical substance, 
commerce, imported, impurity, Inventory, manufacture or import for 
commercial purposes, manufacture solely for export, manufacturer, new 
chemical substance, person, process, processor, and small quantities 
solely for research and development have the same meaning as in 
Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling or lubricating.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a secondary or tertiary amine to 
form the corresponding nitrosamine.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-83-1005 is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) Any person using as metalworking fluid a product containing P-
83-1005 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-83-1005 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must sent to each 
recipient of P-83-1005 and confirm receipt prior to the first shipment 
to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as triethanolamine salt, of 
tricarboxylic acid, contained in the product (insert distributor's trade 
name or other identifier for product containing P-83-1005) has been 
regulated by the Environmental Protection Agency, at 40 CFR 747.200, as 
published in the Federal Register of January 23, 1984. A copy of the 
regulation is enclosed. The regulation prohibits the addition of any 
nitrosating agent, including nitrites, to the triethanolamine salt of 
tricarboxylic acid, when the substance is or could be used in 
metalworking fluids. The addition of nitrites or other nitrosating 
agents to this substance leads to formation

[[Page 492]]

of a substance known to cause cancer in laboratory animals. The 
triethanolamine salt of the tricarboxylic acid, has been specifically 
designed to be used without nitrites. Consult the enclosed regulation 
for further information.

    (ii) A copy of this rule.
    (2) Any person who distributes in commerce a metalworking fluid 
containing P-83-1005 must affix to each container containing the fluid a 
label that includes, in letters no smaller than ten point type, the 
following statement:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrite leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (3) Any person who distributes in commerce P-83-1062 in any form in 
which it could be combined with water and triethanolamine to produce P-
83-1005 must send to each recipient of P-83-1062, and confirm receipt 
prior to the first shipment to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as tricarboxylic acid, contained 
in the product (insert distributor's trade name or other identifier for 
product containing P-83-1062) has been regulated by the Environmental 
Protection Agency (40 CFR 747.200 published in the Federal Register of 
January 23, 1984. A copy of the regulation is enclosed. Combining 
tricarboxylic acid with water and the triethanolamine produces a 
substance, identified generically as the triethanolamine salt of the 
tricarboxylic acid. The regulation prohibits the addition of nitrosating 
agents, including nitrites, to the triethanolamine salt of tricarboxylic 
acid, when that substance is or could be used in metalworking fluids. 
The addition of nitrites or other nitrosating agents to that substance 
leads to formation of a substance known to cause cancer in laboratory 
animals. Consult the enclosed regulation for further information.

    (ii) A copy of this rule.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by one of the generic names in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-83-1005 and P-83-
1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will 
be in violation of this section unless that person has received a letter 
specified in paragraph (d)(1) or (3) of this section or a container with 
the label specified in paragraph (d)(2) of this section.
    (f) Exemptions and exclusions. The chemical substances identified in 
paragraph (a) of this section are not subject to the requirements of 
paragraphs (c) and (d) of this section, if:
    (1) The substance is manufactured, imported, processed, distributed 
in commerce, and used only in small quantities solely for research and 
development, and if the substance is manufactured, imported, processed, 
distributed in commerce, and used in accordance with section 5(h)(3) of 
the Act.
    (2) The substance is manufactured, imported, processed, distributed 
in commerce, or used only as an impurity.
    (3) The substance is imported, processed, distributed in commerce, 
or used only as part of an article.
    (4) The substance is manufactured solely for export.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of a section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C 2615) for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section, act to 
seize any

[[Page 493]]

chemical substance, processed, distributed in commerce, or used in 
violation of this section or take other actions under the authority of 
section 7 or 17 of the Act (15 U.S.C. 2605 or 2616).

[49 FR 2772, Jan. 23, 1984]



PART 749--WATER TREATMENT CHEMICALS--Table of Contents




Subparts A-C [Reserved]

             Subpart D--Air Conditioning and Cooling Systems

Sec.
749.68  Hexavalent chromium-based water treatment chemicals in cooling 
          systems.

    Authority: 15 U.S.C. 2605 and 2607.

Subpart A-C [Reserved]



             Subpart D--Air Conditioning and Cooling Systems



Sec. 749.68  Hexavalent chromium-based water treatment chemicals in cooling systems.

    (a) Chemicals subject to this section. Hexavalent chromium-based 
water treatment chemicals that contain hexavalent chromium, usually in 
the form of sodium dichromate (CAS No. 10588-01-9), are subject to this 
section. Other examples of hexavalent chromium compounds that can be 
used to treat water are: Chromic acid (CAS No. 7738-94-5), chromium 
trioxide (CAS No. 1333-83-0), dichromic acid (CAS No.13530-68-2), 
potassium chromate (CAS No. 7789-00-6), potassium dichromate (CAS No. 
7778-50-9), sodium chromate (CAS No. 7775-11-3), zinc chromate (CAS No. 
13530-65-9), zinc chromate hydroxide (CAS No. 153936-94-6), zinc 
dichromate (CAS No. 14018-95-2), and zinc potassium chromate (CAS No. 
11103-86-9).
    (b) Purpose. The purpose of this section is to impose certain 
requirements on activities involving hexavalent chromium-based water 
treatment chemicals to prevent unreasonable risks associated with human 
exposure to air emissions of hexavalent chromium from comfort cooling 
towers.
    (c) Applicability. This section is applicable to use of hexavalent 
chromium-based water treatment chemicals in comfort cooling towers and 
to distribution in commerce of hexavalent chromium-based water treatment 
chemicals for use in cooling systems.
    (d) Definitions. Definitions in section 3 of the Toxic Substances 
Control Act, 15 U.S.C. 2602, apply to this section unless otherwise 
specified in this paragraph. In addition, the following definitions 
apply:
    (1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.
    (2) Chilled water loop means any closed cooling water system that 
transfers heat from air handling units or refrigeration equipment to a 
refrigeration machine, or chiller.
    (3) Closed cooling water system means any configuration of equipment 
in which heat is transferred by circulating water that is contained 
within the equipment and not discharged to the air; chilled water loops 
are included.
    (4) Comfort cooling towers means cooling towers that are dedicated 
exlusively to and are an integral part of heating, ventilation, and air 
conditioning or refrigeration systems.
    (5) Container means any bag, barrel, bottle, box, can, cylinder, 
drum, or the like that holds hexavalent chromium-based water treatment 
chemicals for use in cooling systems.
    (6) Cooling tower means an open water recirculating device that uses 
fans or natural draft to draw or force ambient air through the device to 
cool warm water by direct contact.
    (7) Cooling system means any cooling tower or closed cooling water 
system.
    (8) Distributor means any person who distributes in commerce water 
treatment chemicals for use in cooling systems.
    (9) EPA means the Environmental Protection Agency.
    (10) Hexavalent chromium means the oxidation state of chromium with 
an oxidation number of +6; a coordination number of 4 and tetrahedral 
geometry.
    (11) Hexavalent chromium-based water treatment chemicals means any 
chemical containing hexavalent chromium which can be used to treat 
water, either alone or in combination with other chemicals, where the 
mixture can be used to treat water.

[[Page 494]]

    (12) Industrial cooling tower means any cooling tower used to remove 
heat from industrial processes, chemical reactions, or plants producing 
electrical power.
    (13) Label means any written, printed, or graphic material displayed 
on or affixed to containers of hexavalent chromium-based water treatment 
chemicals that are to be used in cooling systems.
    (14) Person means any natural person, firm, company, corporation, 
joint venture, partnership, sole proprietorship, association, or any 
other business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    (15) Shipment means the act or process of shipping goods by any form 
of conveyance.
    (16) Water treatment chemicals means any combination of chemical 
substances used to treat water in cooling systems and can include 
corrosion inhibitors, antiscalants, dispersants, and any other chemical 
substances except biocides.
    (e) Prohibition of distribution in commerce and commercial use. (1) 
All persons are prohibited from distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers.
    (2) All persons are prohibited from commercial use of hexavalent 
chromium-based water treatment chemicals in comfort cooling towers.
    (3) Distribution in commerce of hexavalent chromium-based water 
treatment chemicals for use in, and commercial use of hexavalent 
chromium-based water treatment chemicals in, industrial cooling towers 
and closed cooling water systems are not prohibited.
    (f) Effective dates. (1) The prohibition described in paragraph 
(e)(1) of this section against distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers is effective February 20, 1990.
    (2) The prohibition described in paragraph (e)(2) of this section 
against using hexavalent chromium-based water treatment chemicals in 
comfort cooling towers is effective May 18, 1990.
    (g) Labeling. (1) Each person who distributes in commerce hexavalent 
chromium-based water treatment chemicals for use in cooling systems 
after February 20, 1990, shall affix a label or keep affixed an existing 
label in accordance with this paragraph, to each container of the 
chemicals. The label shall consist of the following language:

    WARNING: This product contains hexavalent chromium. Inhalation of 
hexavalent chromium air emissions increases the risk of lung cancer. 
Federal Law prohibits use of this substance in comfort cooling towers, 
which are towers that are open water recirculation devices and that are 
dedicated exclusively to, and are an integral part of, heating, 
ventilation, and air conditioning or refrigeration systems.

    (2) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than 10-point 
type for a label less than or equal to 10 square inches in area, 12-
point type for a label above 10 but less than or equal to 15 square 
inches in area, 14-point type for a label above 15 but less than or 
equal to 30 square inches in area, or 18-point type for a label above 30 
square inches in area. The type size of the remainder of the warning 
statement shall be no smaller than 6-point type. All required label text 
shall be in English and of sufficient prominence and shall be placed 
with such conspicuousness, relative to other label text and graphic 
material, to ensure that the warning statement is read and understood by 
the ordinary individual under customary conditions of purchase and use.
    (h) Recordkeeping. (1) Each person who distributes in commerce any 
hexavalent chromium-based water treatment chemicals for use in cooling 
systems after February 20, 1990, shall retain in one location at the 
headquarters of the distributor documentation showing:
    (i) The name, address, contact, and telephone number of the cooling 
system owners/operators to whom the chemicals were shipped.
    (ii) The chemicals included in the shipment, the amount of each 
chemical shipped, and the location(s) at which the chemicals will be 
used.

[[Page 495]]

    (2) The information described in paragraph (h)(1) of this section 
shall be retained for 2 years from the date of shipment.
    (i) Reporting. (1) Each person who distributes in commerce any 
hexavalent chromium-based water treatment chemicals for use in cooling 
systems shall report to the Regional Administrator of the EPA Region in 
which the distibutor headquarters is located. The report shall be 
postmarked not later than February 20, 1990, or 30 days after the person 
first begins the distribution in commerce of hexavalent chromium-based 
water treatment chemicals, whichever is later, and shall include:
    (i) For the headquarters, the distributor name, address, telephone 
number, and the name of a contact.
    (ii) For the shipment offices through which hexavalent chromium-
based water treatment chemicals are sold for use in cooling systems, the 
distributor name, address, telephone number, and the name of a contact.
    (2) The report identified in paragraph (i)(1) of this section shall 
be updated as changes occur in the distributor headquarters or shipment 
office information. The updated report shall be submitted to the 
Regional Administrator and postmarked no later than 10 calendar days 
after the change occurs.
    (3) A person may assert a claim of confidentiality for any 
information submitted to EPA in connection with this rule. Any claim of 
confidentiality must accompany the information when submitted to EPA. 
Persons claiming information as confidential should do so by circling, 
bracketing, or underlining it and marking it with ``CONFIDENTIAL.'' EPA 
will disclose information subject to a claim of confidentiality only to 
the extent permitted by section 14 of TSCA and 40 CFR part 2, subpart B. 
If a person does not assert a claim of confidentiality for information 
at the time it is submitted to EPA, EPA may make the information public 
without further notice to that person.
    (j) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (k) Inspections. EPA will conduct inspections under section 11 of 
the Act (15 U.S.C. 2610) to ensure compliance with this section.

[55 FR 240, Jan. 3, 1990, as amended at 59 FR 42773, Aug. 19, 1994]



PART 750--PROCEDURES FOR RULEMAKING UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT--Table of Contents




   Subpart A--Procedures for Rulemaking Under Section 6 of the Toxic 
                         Substances Control Act

Sec.
750.1  Applicability.
750.2  Notice of proposed rulemaking.
750.3  Record.
750.4  Public comments.
750.5  Subpoenas.
750.6  Participation in informal hearing.
750.7  Conduct of legislative hearing.
750.8  Cross-examination.
750.9  Final rule.

Appendix A to Subpart A

    Subpart B--Interim Procedural Rules for Manufacturing Exemptions

750.10  Applicability.
750.11  Filing of petitions for exemption.
750.12  Consolidation of rulemakings.
750.13  Notice of proposed rulemaking.
750.14  Record.
750.15  Public comments.
750.16  Confidentiality.
750.17  Subpoenas.
750.18  Participation in informal hearing.
750.19  Conduct of informal hearing.
750.20  Cross-examination.
750.21  Final rule.

 Subpart C--Interim Procedural Rules for Processing and Distribution in 
                           Commerce Exemptions

750.30  Applicability.
750.31  Filing of petitions for exemption.
750.32  Consolidation of rulemaking.
750.33  Notice of proposed rulemaking.

[[Page 496]]

750.34  Record.
750.35  Public comments.
750.36  Confidentiality.
750.37  Subpoenas.
750.38  Participation in informal hearing.
750.39  Conduct of informal hearing.
750.40  Cross-examination.
750.41  Final rule.

    Authority: 15 U.S.C. 2605.



   Subpart A--Procedures for Rulemaking Under Section 6 of the Toxic 
                         Substances Control Act

    Source: 42 FR 61259, Dec. 2, 1977, unless otherwise noted.



Sec. 750.1  Applicability.

    This part applies to all rulemakings under authority of section 6 of 
the Toxic Substances Control Act (TSCA), 15 U.S.C. 2605.



Sec. 750.2  Notice of proposed rulemaking.

    (a) Each rulemaking becomes subject to this part with the 
publication of a Notice of Proposed Rulemaking in the Federal Register. 
A proceeding under section 6 of the Toxic Substances Control Act may 
begin, as appropriate, with the publication in the Federal Register of a 
Notice of Proposed Rulemaking, an Advance Notice of Proposed Rulemaking, 
or notice of other action, such as a formal regulatory investigation 
designed to lead to issuance of rules within a reasonable time.
    (b) Each such notice shall contain:
    (1) A draft finding that there is a reasonable basis to conclude 
that the manufacture, processing, distribution in commerce, use or 
disposal of the chemical substance(s) or mixture(s) at issue, or any 
combination of such activities, presents or will present an unreasonable 
risk of injury to health or the environment.
    (2) A Notice of Proposed Rulemaking stating with particularity the 
reasons for the proposed rule together with a statement why the proposed 
rule protects adequately against the risk(s) involved using the least 
burdensome requirements authorized by TSCA.
    (3) Either the draft text of the proposed rule (which may include 
alternative approaches among which a final choice has not yet been made) 
or a description of the approaches and provisions being considered for 
inclusion in the rule, or some combination of the above.
    (4) Except for rules published under authority of section 6(e), a 
draft statement with respect to:
    (i) The effects of the substance(s) or mixture(s) at issue on health 
and the magnitude of the exposure of human beings to such substance(s) 
or mixture(s);
    (ii) The effects of the substace(s) or mixture(s) at issue on the 
environment and the magnitude of the exposure of the environment to such 
substance(s) or mixture(s).
    (iii) The benefits of the substance(s) or mixture(s) at issue for 
various uses and the availability of substitutes for such uses; and
    (iv) The reasonably ascertainable economic consequences of the rule, 
after consideration of the effect on the national economy, small 
business, technological innovation, the environment, and public health.
    (v) Major impacts of alternatives to the proposed rule shall also be 
analyzed.
    (5) In cases where the administrator, in his or her discretion, 
determines that a risk of injury to health or the environment could be 
eliminated or reduced to a sufficient extent by actions taken under a 
Federal law (or laws) other than TSCA administered in whole or in part 
by the Administrator, a finding that it is in the public interest to 
proceed against such risk under TSCA. Any such finding shall be 
accompanied by a brief statement discussing:
    (i) All relevant aspects of the risk;
    (ii) A comparison of the estimated costs of complying with actions 
taken under TSCA and under such other law (or laws); and
    (iii) The relative efficiency of actions under TSCA and under such 
other law (or laws) to protect against risk of injury.

Two or more or all of the statements required above may be combined in 
the same narrative for efficiency of exposition as long as each of the 
required points is discussed. Any statement required by this paragraph 
may reference

[[Page 497]]

other documents which are not published in the Federal Register. All 
such referenced documents shall be included in the rulemaking record. 
Either the statements required by this paragraph or the documents they 
reference shall contain a discussion of the factual, analytical, policy 
and legal considerations behind the agency decision to issue the 
proposed rule in the form chosen. A brief summary of these 
considerations shall be included in the preamble in any case. All 
factual materials and each analytical methodology seriously considered 
shall be fully disclosed. Significant areas of uncertainty known to the 
Agency under each heading shall be identified, and the manner in which 
the Agency intends to deal with them shall be specified.
    (c) In addition to the material required under paragraph (b) of this 
section, each notice of proposed rulemaking shall contain:
    (1) A statement of the time and place at which the informal hearing 
required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent 
these are not specified, a statement that they will be specified later 
in a separate Federal Register notice Provided, That Federal Register 
notice of the date and city at which any informal hearing shall begin 
shall be given at least 30 days in advance;
    (2) A statement identifying the place at which the official record 
of the rulemaking is located, the hours during which it will be open for 
public inspection, the documents contained in it as of the date the 
notice of proposed rulemaking was issued, and a statement of the 
approximate times at which additional materials such as public comments, 
hearing transcripts, and agency studies in progress will be added to the 
record. If any material other than public comments or material generated 
by a hearing is added to the record after publication of the notice 
required by this section, and notice of its future addition was not 
given at the time of that initial publication, a separate Federal 
Register notice announcing its addition to the record and inviting 
comment shall be published;
    (3) The due date for public comments, which shall be at least two 
weeks prior to the informal hearing for main comments and no more than 
two weeks after the informal hearing for reply comments;
    (4) The name, address and office telephone number of the Record and 
Hearing Clerk for the rulemaking in question; and
    (5) A nonbinding target date for issuing the final rule.

[42 FR 61259, Dec. 1977, as amended at 54 FR 21623, May 19, 1989]



Sec. 750.3  Record.

    (a) No later than the date of proposal of a rule subject to this 
part, a rulemaking record for that rule shall be established. It shall 
consist of a separate identified filing space containing:
    (1) All documents required by Sec. 750.2(b);
    (2) All documents cited in the documents required by Sec. 750.2(b);
    (3) All public comments timely received;
    (4) All public hearing transcripts;
    (5) All material received during an informal hearing and accepted 
for the record of that hearing; and
    (6) Any other information which the Administrator considers to be 
relevant to such rule and which the Administrator identified, on or 
before the date of the promulgation of the rule, in a notice published 
in the Federal Register.

All material in the record shall be appropriately indexed. Each record 
shall be available for public inspection during normal Agency business 
hours. Appropriate arrangements allowing members of the public to copy 
record materials that do not risk the permanent loss of such materials 
shall be made. All material required to be included in the record shall 
be added to the record as soon as feasible after its receipt by the 
Agency.
    (b) The Record and Hearing Clerk for each rulemaking shall be 
responsible for Agency compliance with the requirements of paragraph (a) 
of this section.



Sec. 750.4  Public comments.

    (a) Main comments shall be postmarked or received no later than the 
time specified in the Notice of Proposed Rulemaking and shall contain 
all comments on and criticisms of that

[[Page 498]]

Notice by the commenting person, based on information which is or 
reasonably could have been available to that person at the time.
    (b) Reply comments shall be postmarked or received no later than two 
weeks after the close of all informal hearings on the proposed rule and 
shall be restricted to comments on:
    (1) Other comments;
    (2) Material in the hearing record; and
    (3) Material which was not and could not reasonably have been 
available to the commenting party a sufficient time before main comments 
were due.
    (c) Extensions of the time for filing comments may be granted in 
writing by the Record and Hearing Clerk. Application for an extension 
shall be made in writing. Comments submitted after the comment period 
and all extensions of it have expired need not be added to the 
rulemaking record and need not be considered in decisions concerning the 
rule. Unless the Notice of Proposed Rulemaking states otherwise, four 
copies of all comments shall be submitted.



Sec. 750.5  Subpoenas.

    (a) Where necessary, subpoenas requiring the production of 
documentary material, the attendance of persons at the hearing, or 
responses to written questions may be issued. Subpoenas may be issued 
either upon request as provided in paragraph (b) of this section or by 
EPA on its own motion.
    (b) All subpoena requests shall be in writing. Hearing participants 
may request the issuance of subpoenas as follows:
    (1) Subpoenas for the attendance of persons, and for the production 
of documents or responses to questions at the legislative hearing may be 
requested at any time up to the deadline for filing main comments.
    (2) Subpoenas for production of documents or answers to questions 
after the legislative hearing may be requested at any time between the 
beginning of the legislative hearing and the deadline for submitting 
reply comments.
    (c) EPA will rule on all subpoena requests filed under paragraph 
(b)(1) of this section no later than the beginning of the legislative 
hearing. Such requests may be granted, denied, or deferred. EPA will 
rule on all subpoena requests filed under paragraph (b)(2) of this 
section and all deferred subpoena requests filed under paragraph (b)(1) 
of this section no later than the promulgation of the final rule. Such 
requests shall be either granted or denied.



Sec. 750.6  Participation in informal hearing.

    (a) Each person or organization desiring to participate in the 
informal hearing required by section 6(c)(2)(C) of TSCA shall file a 
written request to so participate with the Record and Hearing Clerk 
which shall be postmarked or received no later than three weeks prior to 
the scheduled start of such hearing. The request shall include:
    (1) A brief statement of the interest of the person or organization 
in the proceeding;
    (2) A brief outline of the points to be addressed;
    (3) An estimate of the time required; and
    (4) If the request comes from an organization, a nonbinding list of 
the persons to take part in the presentation. Organizations are 
requested to bring with them, to the extent possible, employees with 
individual expertise in and responsibility for each of the areas to be 
addressed. No organization not filing main comments in the rulemaking 
will be allowed to participate at the hearing, unless a waiver of this 
requirement is granted in writing by the Record and Hearing Clerk or the 
organization is appearing at the request of EPA or under subpoena.
    (b) No later than one week prior to the start of the hearing, the 
Record and Hearing Clerk shall make a hearing schedule publicly 
available and mail or deliver it to each of the persons who requested to 
appear at the hearing. This schedule shall be subject to change during 
the course of the hearing at the discretion of those presiding over it.
    (c) Opening statements should be brief, and restricted either to 
points that could not have been made in main comments, or to emphasizing 
points which are made in main comments, but which the participant 
believes can be

[[Page 499]]

more forcefully urged in the hearing context.



Sec. 750.7  Conduct of legislative hearing.

    (a) A panel of EPA employees shall preside at each hearing conducted 
under section 6(c)(2)(C) of TSCA. In appropriate cases other Executive 
Branch employees may also sit with and assist the panel. The membership 
of the panel may change as different topics arise during the hearing. In 
general, the panel membership will consist of agency employees with 
special responsibility for the final rule or special expertise in the 
topics under discussion. One member of the panel shall be named to chair 
the proceedings and shall attend throughout the hearing, unless 
unavoidably prevented by sickness or similar personal circumstances.
    (b) The panel may question any individual or group participating in 
the hearing on any subject relating to the rulemaking. Cross-examination 
by others will normally not be permitted at this stage. It may be 
granted in compelling circumstances at the sole discretion of the 
hearing panel. However, persons in the hearing audience may submit 
questions in writing for the hearing panel to ask the participants, and 
the hearing panel may, at their discretion, ask these questions.
    (c) Participants in the hearing may submit additional material for 
the hearing record and shall submit such additional material as the 
hearing panel may request. All such submissions shall become part of the 
record of the hearing. A verbatim transcript of the hearing shall be 
made.



Sec. 750.8  Cross-examination.

    (a) After the close of the legislative hearing conducted under 
Sec. 750.7, any participant in that hearing may submit a written request 
for cross-examination. The request shall be received by EPA within one 
week after a full transcript of the legislative hearing becomes 
available and shall specify:
    (1) The disputed issue(s) of material fact as to which cross-
examination is requested. This shall include an explanation of why the 
questions at issue are ``factual'', rather than of an analytical or 
policy nature, the extent to which they are in ``dispute'' in the light 
of the record made thus far, and the extent to which and why they can 
reasonably be considered ``material'' to the decision on the final rule; 
and
    (2) The person(s) the participant desires to cross-examine, and an 
estimate of the time necessary. This shall include a statement by the 
cross-examination requested can be expected to result in ``full and true 
disclosure'' resolving the issue of material fact involved.
    (b) Within one week after receipt of all requests for cross-
examination under paragraph (a) of this section the hearing panel shall 
rule on them. The ruling shall be served by the Record and Hearing Clerk 
on all participants who have requested cross-examination and shall be 
inserted in the record. Written notice of the ruling shall be given to 
all persons requesting cross-examination and all persons to be cross-
examined. The ruling shall specify:
    (1) The issues as to which cross-examination is granted,
    (2) The persons to be cross-examined on each issue,
    (3) The persons to be allowed to conduct cross-examination, and
    (4) Time limits for the examination of each witness by each cross-
examiner.

In issuing this ruling, the panel may determine that one or more 
participants who have requested cross-examination have the same or 
similar interests and should be required to choose a single 
representative for purposes of cross-examination. In such a case the 
order shall simply assign time for cross-examination by that single 
representative without identifying the representative further. Subpoenas 
for witnesses may be issued where necessary.
    (c) Within one week after the insertion into the record of the 
ruling under paragraph (b) of this section, the hearing at which the 
cross-examination will be conducted shall commence. One or more members 
of the original panel shall preside for the Agency. The panel shall have 
authority to conduct cross-examination on behalf of any participant, 
although as a general rule this right will not be exercised. The panel 
shall also have authority to modify the

[[Page 500]]

governing ruling in any respect and to make new rulings on group 
representation under section 6(c)(3)(C) of TSCA. A verbatim transcript 
of the hearing shall be made.
    (d)(1) No later than the time set for requesting cross-examination, 
a hearing participant may request that other alternative methods of 
clarifying the record (such as informal conferences or the submittal of 
additional information) be used. Such requests may be submitted either 
in lieu of cross-examination requests, or in conjunction with them.
    (2) The panel in passing on a cross-examination request may as a 
precondition to ruling on its merits require that alternative means of 
clarifying the record be used whether or not that has been requested 
under paragraph (d)(1) of this section. In such a case the results of 
the use of such alternative means shall be made available to the person 
requesting cross-examination of a one-week comment period, and the panel 
shall make a final ruling on cross-examination within one week 
thereafter.
    (e) Waivers or extensions of any deadline in this section applicable 
to persons other than EPA may be granted on the record of the hearing by 
the person chairing it or in writing by the Record and Hearing Clerk.



Sec. 750.9  Final rule.

    (a) As soon as feasible after the deadline for submittal of reply 
comments, the Agency shall issue a final rule. Final versions of the 
statements required by paragraph (b) of Sec. 750.2 shall be published in 
the Federal Register together with the final rule. The Agency shall also 
publish at that time:
    (1) A list of all material added to the record (other than public 
comments and material from the hearng record) which has not previously 
been listed in a Federal Register document, and
    (2) The effective date of the rule.
    (b) [Reserved]

                         Appendix A to Subpart A

    To assist in reading the regulations set forth above, this appendix 
sets forth the principal stages through which rules promulgated under 
section 6 of TSCA will pass.
    The second column gives the relationship that one date bears to 
another whenever that relationship is specified in the regulations, and 
cites the governing provision. The third column contains estimates of 
the time that a typical rulemaking is likely to require to reach and 
complete each stage of these proceedings. In drawing up this third 
column, we have assumed that 60 days will be allowed for the submission 
of main comments; that the legislative phase of the informal hearing 
will take two weeks, and that cross-examination will take four days. 
Since these are only estimates, in any given rulemaking shorter or 
longer times may actually be required for each of these stages.

------------------------------------------------------------------------
                                                               Estimated
                                                                 total
                Stage                  Timing in relation to      time
                                            other stages        elapsed
                                                                 (days)
------------------------------------------------------------------------
Proposed regulation.................  Sec. 750.2.............
Requests to participate in informal   3 weeks prior to               53
 hearing due.                          beginning of hearing
                                       (Sec.  750.2(a)).
Main comments due...................  2 weeks prior to               60
                                       beginning of hearing
                                       (Sec.  750.2(c)(3)).
Begin informal hearing..............  .......................        74
End legislative hearing.............  .......................        88
Requests for cross-examination due..  1 week after end of            95
                                       legislative hearing
                                       (Sec.  750.8(a)).
Ruling on cross-examination requests  1 week after requests         102
                                       are due (Sec.
                                       750.8(b)).
Cross-examination begins............  1 week afer ruling on         109
                                       cross-examination
                                       requests (Sec.
                                       750.8(c)).
Cross-examination ends; informal      .......................       113
 hearing ends.
Reply comments due..................  2 weeks after end of          127
                                       informal hearing (Sec.
                                        750.4(b)).
------------------------------------------------------------------------



    Subpart B--Interim Procedural Rules for Manufacturing Exemptions

    Source: 43 FR 50905, Nov. 1, 1978, unless otherwise noted.



Sec. 750.10  Applicability.

    Sections 750.10-750.21 apply to all rulemakings under authority of 
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 
2605(e)(3)(B) with respect to petitions filed pursuant to Sec. 750.11(a) 
of this part.



Sec. 750.11  Filing of petitions for exemption.

    (a) Who may file. Any person seeking an exemption from the PCB 
manufacturing ban imposed by section

[[Page 501]]

6(e)(3)(A) of TSCA may file a petition for exemption. Petitions must be 
submitted on an individual basis for each manufacturer or individual 
affected by the 1979 manufacturing ban.
    (b) Where to file. All petitions must be submitted to the following 
location: OPPT Document Control Officer (7407), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    (c) Content of petition. Each petition shall contain the following:
    (1) Name, address and telephone number of petitioner.
    (2) Description of PCB ban exemption requested, including items to 
be manufactured and nature of manufacturing process--such as smelting.
    (3) Location(s) of manufacturing sites requiring exemption.
    (4) Length of time requested for exemption (maximum length of 
exemption is 1 year).
    (5) Amount of PCB chemical substance or PCB mixture (by pounds and/
or volume) to be manufactured or used during requested exemption period 
and the manner of release of PCB's into the environment associated with 
such manufacture or use.
    (6) The basis for the petitioner's contention that under section 
6(e)(3)(B)(i) of TSCA ``an unreasonable risk of injury to health or 
environment would not result'' from the granting of his petition for 
exemption.
    (7) The basis for the petitioner's contention that he meets the 
criterion of section 6(e)(3)(B)(ii) of TSCA concerning substitutes for 
PCB's.
    (8) Quantification of the reasonably ascertainable economic 
consequences of denial of the petition for exemption from the 1979 
manufacturing ban and an explanation of the manner of computation.
    (d) Request for further information. The Agency reserves the right 
to request further information as to each petition prior to or after 
publication of the notice of proposed rulemaking required by 
Sec. 750.13.
    (e) Renewal requests. (1) Any petitioner who has been granted an 
exemption under section 6(e)(3)(B) of TSCA, on or after May 25, 1994, 
and who seeks to renew that exemption without changing its terms, must 
submit a letter by certified mail to EPA requesting that the exemption 
be granted for the following year.
    (i) This letter must contain a certification by the petitioner that 
the type of activities, the procedures for handling the PCBs, the amount 
of PCBs handled, and any other aspect of the exemption have not changed 
from the original exemption petition request.
    (ii) This letter must be received by EPA at least 6 months prior to 
the expiration of the existing exemption.
    (iii) If a petitioner fails to make a submission or the submission 
is not timely under this section, the exemption will expire 1 year from 
the effective date of granting that exemption.
    (iv) EPA will address a timely submission of a renewal request by 
rulemaking and either grant or deny the request.
    (2) Any petitioner who has been granted an exemption on or after May 
25, 1994, and who seeks to increase the amount of PCBs handled or to 
change the type of activities, the procedures for handling the PCBs, and 
any other aspect of their existing exemption must submit a new exemption 
petition to EPA. The existing exemption activity may continue until the 
new submission is addressed by rulemaking, provided the activity 
conforms to the terms of the current exemption approved by EPA, and the 
petitioner complies with the conditions of paragraph (e)(1) of this 
section.
    (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) 
exemption in a rule prior to May 25, 1994, and who seeks to increase the 
amount of PCBs handled or to change the type of activities, the 
procedures for handling the PCBs, and any other aspect of their existing 
exemption must submit a new exemption petition to EPA. The existing 
exemption activity may continue until the new submission is addressed by 
rulemaking, provided the activity conforms to the terms of the original 
exemption approved by EPA.

[43 FR 50905, Nov. 1, 1978, as amended at 53 FR 12524, Apr. 15, 1988; 59 
FR 16998, Apr. 11, 1994]



Sec. 750.12  Consolidation of rulemakings.

    All petitions received pursuant to Sec. 750.11(a) will be 
consolidated into one

[[Page 502]]

rulemaking with one informal hearing held on all petitions.



Sec. 750.13  Notice of proposed rulemaking.

    Rulemaking for PCB exemptions filed pursuant to Sec. 750.11(a) shall 
begin with the publication of a notice of proposed rulemaking in the 
Federal Register. The notice shall state in summary form the required 
information described in Sec. 750.11(c). Due to time constraints, the 
notice need not indicate what action EPA proposes to take on the 
exemption petitions. The notice shall also be subject to Sec. 750.2(c) 
with the exceptions (1) that the clause ``in addition to the material 
required under paragraph (b)'' is eliminated; and (2) that 
Sec. 750.2(c)(3) is changed to read:

    The due date for public comments, which shall be (1) thirty days 
after publication of the notice of proposed rulemaking for main comments 
and (2) one week after the close of the informal hearing for reply 
comments.

[43 FR 50905, Nov. 1, 1978, as amended at 59 FR 16998, Apr. 11, 1994]



Sec. 750.14  Record.

    Section 750.3 shall be applicable with the exception that the words 
``Sec. 750.11(c)'' are substituted for ``Sec. 750.2(b)'' in 
Sec. 750.3(a)(1) and (2).

[43 FR 50905, Nov. 1, 1978, as amended at 59 FR 16998, Apr. 11, 1994]



Sec. 750.15  Public comments.

    Section 750.4 shall be applicable with the exception that the time 
period in Sec. 750.4(b) is shortened to 1 week.



Sec. 750.16  Confidentiality.

    The Agency encourages the submission of nonconfidential information 
by petitioners and commenters. The Agency does not wish to have 
unnecessary restrictions on access to the rulemaking record. However, if 
a petitioner or commenter believes that he can only state his position 
through the use of information claimed to be confidential, he may submit 
it. Such information must be separately submitted for the rulemaking 
record and marked ``confidential'' by the submitter. For the information 
claimed to be confidential, the Agency will list only the date and the 
name and address of the petitioner or commenter in the public file, 
noting that the petitioner or commenter has requested confidential 
treatment. The information claimed to be confidential will be placed in 
a confidential file. A petitioner must also file a nonconfidential 
petition with a nonconfidential summary of the confidential information 
to be placed in the public file. Similarly, a commenter must supply a 
nonconfidential summary of the information claimed to be confidential to 
be placed in the public file. Any information not marked as confidential 
will be placed in the public file. Information marked confidential will 
be treated in accordance with the procedures in part 2, subpart B of 
this title.



Sec. 750.17  Subpoenas.

    Section 750.5 shall be applicable.



Sec. 750.18  Participation in informal    hearing.

    (a) Each person or organization desiring to participate in the 
informal hearing required by section 6(c)(2)(C) of TSCA shall file a 
written request to so participate with the record and hearing clerk 
which shall be received no later than 7 days prior to the scheduled 
start of the hearing. The hearing shall begin 7 days after the close of 
the 30-day comment period or as soon thereafter as practicable.
    (b) With the exception of the first sentence in Sec. 750.6(a), 
Sec. 750.6 shall be applicable with the further exception that the time 
period in Sec. 750.6(b) is shortened to no later than 3 days prior to 
the start of the hearing.



Sec. 750.19  Conduct of informal hearing.

    Section 750.7 shall be applicable with the addition of the following 
sentence at the end of Sec. 750.7(c):

    Participants shall be allowed to designate testimony from prior EPA 
informal rulemaking hearings concerning PCB's under TSCA. The hearing 
panel may reject repetative testimony previously presented at such 
hearings.



Sec. 750.20  Cross-examination.

    Section 750.8 shall be applicable.



Sec. 750.21  Final rule.

    (a) As soon as feasible after the deadline for submittal of reply 
comments,

[[Page 503]]

the Agency shall issue a final rule. The Agency shall also publish at 
that time:
    (1) A list of all material added to the record (other than public 
comments and material from the hearing record) which has not previously 
been listed in a Federal Register document, and
    (2) The effective date of the rule.
    (b) The Administrator hereby delegates final Agency authority to 
grant or deny petitions under section 6(e)(3)(B) of TSCA submitted 
pursuant to Sec. 750.11 of these rules to the Assistant Administrator 
for Prevention, Pesticides and Toxic Substances. The Assistant 
Administrator shall act on such petitions subsequent to opportunity for 
an informal hearing pursuant to these rules.
    (c) In determining whether to grant an exemption to the PCB ban, the 
Agency shall apply the two standards enunciated in section 6(e)(3)(B) of 
TSCA.



 Subpart C--Interim Procedural Rules for Processing and Distribution in 
                           Commerce Exemptions

    Source: 44 FR 31560, Mar. 31, 1979, unless otherwise noted.



Sec. 750.30  Applicability.

    Sections 750.30-750.41 apply to all rulemakings under authority of 
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 
2605(e)(3)(B) with respect to petitions for PCB processing and 
distribution in commerce exemptions filed pursuant to Sec. 750.31(a) of 
this part.



Sec. 750.31  Filing of petitions for exemption.

    (a) Who may file. Any person seeking an exemption from the PCB 
processing and distribution in commerce prohibitions imposed by section 
6(e)(3)(A)(ii) of TSCA may file a petition for exemption. Petitions must 
be submitted on an individual basis for each processor, distributor, 
seller or individual affected by the 1979 processing and distribution in 
commerce prohibitions, except as described in paragraphs (a) (1) through 
(9) of this section.
    (1) Processing and distribution in commerce of PCB-contaminated 
transformer dielectric fluid. Persons who process or distribute in 
commerce dielectric fluid containing 50 ppm or greater PCB (but less 
than 500 ppm PCB) for use in PCB-Contaminated Transformers may submit a 
single consolidated petition on behalf of any number of petitioners. The 
name and address of each petitioner must be stated in the petition.
    (2) Contaminated substances and mixtures--processing. Persons who 
process the same chemical substance or the same mixture containing 50 
ppm or greater PCB as an impurity or contaminant may submit a 
consolidated petition if the chemical substance or mixture is processed 
for the same use by each person represented by the petition. For 
example, persons who process a PCB-contaminated pigment into printing 
inks may combine their petitions into one petition. The name and address 
of each petitioner must be stated in the petition.
    (3) Contaminated substances and mixtures--distribution in commerce. 
Persons who distribute in commerce the same chemical substance or the 
same mixture containing 50 ppm or greater PCB as an impurity or 
contaminant may submit a consolidated petition if the chemical substance 
or mixture is distributed in commerce for a common use. Such a petition 
is not required to name each person who distributes in commerce the 
chemical substance or mixture.
    (4) PCB capacitor distribution for purposes of repair. Persons who 
distribute in commerce PCB capacitors for servicing (repair) of PCB 
Equipment may submit a single consolidated petition on behalf of any 
number of petitioners engaged in such distribution in commerce for 
purposes of repair. The name of each petitioner need not be stated in 
the petition.
    (5) Small quantities for research and development. Persons who 
process or distribute in commerce small quantities of PCBs for research 
and development may submit a single consolidated petition. The name and 
address of each petitioner must be stated in the petition.
    (6) Microscopy. Persons who process or distribute in commerce PCBs 
for use as a mounting medium in microscopy

[[Page 504]]

may submit a single consolidated petition on behalf of any number of 
petitioners. The name and address of each petitioner must be stated in 
the petition.
    (7) Processing of PCB Articles into PCB Equipment. A person who 
processes (incorporates) PCB Articles (such as small PCB Capacitors) 
into PCB Equipment may submit a petition on behalf of himself and all 
persons who further process or distribute in commerce PCB Equipment 
built by the petitioner. For example, a builder of motors who places 
small PCB Capacitors in the motors may submit a petition on behalf of 
all persons who process or incorporate motors built by the petitioner 
into other pieces of PCB Equipment and all those who sell the equipment. 
Such a petition is not required to identify the persons who distribute 
in commerce or further process the PCB Equipment. A separate petition 
must be filed, however, by each processor of PCB Articles into PCB 
Equipment.
    (8) Processing of PCB Equipment into other PCB Equipment. A person 
who processes (incorporates) PCB Equipment into other PCB Equipment may 
submit a petition on behalf of himself and all persons who further 
process or distribute in commerce PCB Equipment built by the petitioner. 
Such a petition is not required to identify the persons who distribute 
in commerce or further process the PCB Equipment. If a petition has been 
filed under paragraph (a)(7) of this section by the builder of the 
original PCB Equipment, no other petition is required.
    (9) Distribution of PCB Equipment. Distributors in commerce of PCB 
Equipment may submit a consolidated petition on behalf of persons who 
distribute in commerce PCB Equipment of one type (such as air 
conditioners). The petition is not required to name the persons who 
distribute in commerce the affected PCB Equipment.
    (b) Where to file. All petitions must be submitted to the following 
location: OPPT Document Control Officer (7407), East Tower, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    (c) Content of petition. Each petition must contain the following:
    (1) Name, address and telephone number of petitioner. See also 
paragraphs (a) (1) through (9) of this section for additional 
identification requirements applicable to certain consolidated 
petitions.
    (2) Description of PCB processing or distribution in commerce 
exemption requested, including a description of the chemical substances, 
mixtures or items to be processed or distributed in commerce and, if 
processing is involved, the nature of the processing.
    (3) For processing petitions, location(s) of sites requiring 
exemption.
    (4) Length of time requested for exemption (maximum length of 
exemption is one year).
    (5) Estimated amount of PCBs (by pound and/or volume) to be 
processed, distributed in commerce, or used during requested exemption 
period and the manner of release of PCBs into the environment associated 
with such processing, distribution in commerce, or use. Where the PCB 
concentration is less than 500 ppm, both the total liquid volume and the 
total PCB volume must be provided.
    (6) The basis for the petitioner's contention that under section 
6(e)(3)(B)(i) of TSCA ``an unreasonable risk of injury to health or 
environment would not result'' from the granting of the petition for 
exemption.
    (7) The basis for the petitioner's contention that under section 
6(e)(3)(B)(ii) ``good faith efforts have been made to develop a chemical 
substance which does not present an unreasonable risk of injury to 
health or the environment and which may be substituted for'' the PCB.
    (8) Quantification of the reasonably ascertainable economic 
consequences of denying the petition for exemption and an explanation of 
the manner of computation.
    (9) In addition to the information in paragraphs (c)(1) through 
(c)(8) of this section, certain petitions must contain additional 
information as follows:
    (i) Persons who process or distribute in commerce dielectric fluids 
containing 50 ppm or greater PCB for use in PCB Transformers, railroad 
transformers, or PCB electromagnets must also state the expected number 
of PCB Transformers, railroad transformers,

[[Page 505]]

or PCB electromagnets to be serviced under the exemption. In addition, a 
person must identify all the facilities which he owns or operates where 
he services PCB transformers, railroad transformers, or PCB 
electromagnets.
    (ii) Persons filing petitions under paragraph (a)(1) of this section 
(Processing and Distribution in Commerce of PCB-Contaminated Transformer 
Dielectric Fluid) must also provide the expected number of PCB-
Contaminated Transformers to be serviced under the requested exemption 
and the expected method of disposal of waste dielectric fluid. In 
addition, a person must identify all the facilities which he owns or 
operates where he services PCB-Contaminated Transformers. This 
information, as well as the information required by paragraphs (c)(1), 
(c)(3), and (c)(5) of this section, must be provided for each person 
represented by the petition. All other information may be provided on a 
group basis.
    (iii) Persons filing petitions under paragraphs (a)(2) (Contaminated 
Substances and Mixtures-Processing) and (a)(3) (Contaminated Substances 
and Mixtures-Distribution in Commerce) must also provide a justification 
for the class grouping selected and a description of the uses and the 
human and environmental exposure associated with each use of the PCB-
contaminated chemical substance or mixture for which an exemption is 
sought. Information may be provided on a group basis, except that the 
information required by paragraphs (c)(1), (c)(3) and (c)(5) of this 
section, must be provided for each person represented by a petition 
under paragraph (a)(2) of this section.
    (iv) Persons filing petitions under paragraph (a)(4) of this section 
(PCB Capacitor Distribution for Purposes of Repair) must also provide an 
estimate of the expected total number of PCB Capacitors to be 
distributed in commerce under the requested exemption. All information 
may be provided on a group basis.
    (v) Persons filing petitions under paragraphs (a) (7) and (8) of 
this section (Processing of PCB Articles into PCB Equipment and 
Processing of PCB Equipment into Other PCB Equipment) must provide a 
description of each type of PCB Equipment (including the amount of PCBs 
by poundage and/or volume in the PCB Equipment) to be processed and/or 
distributed in commerce under the exemption, the number of each type of 
equipment expected to be processed and/or distributed in commerce, and 
the approximate number of distributors or further processors covered by 
the petition. All information may be provided on a group basis. However, 
in the case of a petition under paragraph (a)(7) of this section, the 
processor of PCB Articles into PCB Equipment must be identified in the 
petition. In the case of a petition under paragraph (a)(8) of this 
section, the processor of PCB Equipment who files the petition must be 
identified.
    (vi) Persons filing petitions under paragraph (a)(9) of this section 
(Distribution of PCB Equipment) must provide a description of each type 
of PCB Equipment (including the amount of PCBs by poundage and/or volume 
in the PCB Equipment) to be distributed in commerce under the exemption, 
the number of each type of equipment to be distributed in commerce, and 
the approximate number of distributors covered by the petition. All 
information may be provided on a group basis.
    (vii) Persons filing petitions under paragraphs (a) (5) and (6) of 
this section must provide the information required by paragraphs (c) (1) 
through (8) of this section for each petitioner named in the petition.
    (d) EPA reserves the right to request further information as to each 
petition where necessary to determine whether the petition meets the 
statutory tests of section 6(e)(3)(B) of TSCA prior to or after 
publication of the notice of proposed rulemaking required by Sec. 750.33 
of these rules.
    (e) Renewal requests. (1) Any petitioner who has been granted an 
exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on 
or after May 25, 1994, and who seeks to renew that exemption without 
changing its terms, must submit a letter by certified mail to EPA 
requesting that the exemption be granted for the following year.
    (i) This letter must contain a certification by the petitioner that 
the type

[[Page 506]]

of activities, the procedures for handling the PCBs, the amount of PCBs 
handled, and any other aspect of the exemption have not changed from the 
original exemption petition request.
    (ii) This letter must be received by EPA at least 6 months prior to 
the expiration of the existing exemption.
    (iii) If a petitioner fails to make a submission or the submission 
is not timely under this section, the exemption will expire 1 year from 
the effective date of granting that exemption.
    (iv) EPA will address a timely submission of a renewal request by 
rulemaking and either grant or deny the request.
    (2) Any petitioner who has been granted an exemption on or after May 
25, 1994, and who seeks to increase the amount of PCBs handled or to 
change the type of activities, the procedures for handling the PCBs, and 
any other aspect of their existing exemption must submit a new exemption 
petition to EPA. The existing exemption activity may continue until the 
new submission is addressed by rulemaking, provided the activity 
conforms to the terms of the current exemption approved by EPA, and the 
petitioner complies with the conditions of paragraph (e)(1) of this 
section.
    (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) 
exemption in a rule prior to May 25, 1994, and who seeks to increase the 
amount of PCBs handled or to change the type of activities, the 
procedures for handling the PCBs, and any other aspect of their existing 
exemption must submit a new exemption petition to EPA. The existing 
exemption activity may continue until the new submission is addressed by 
rulemaking, provided the activity conforms to the terms of the original 
exemption approved by EPA.

[44 FR 31560, Mar. 31, 1979, as amended at 53 FR 12524, Apr. 15, 1988; 
59 FR 16998, Apr. 11, 1994; 63 FR 35436, June 29, 1998]



Sec. 750.32  Consolidation of rulemaking.

    All petitions received pursuant to Sec. 750.31(a) will be 
consolidated into one rulemaking with one informal hearing held on all 
petitions.



Sec. 750.33  Notice of proposed rulemaking.

    Rulemaking for PCB processing and distribution in commerce 
exemptions filed pursuant to Sec. 750.31(a) will begin with the 
publication of a Notice of Proposed Rulemaking in the Federal Register. 
Each notice will contain:
    (a) A summary of the information required in Sec. 750.31(d);
    (b) A statement of the time and place at which the informal hearing 
required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent 
these are not specified, a statement that they will be specified later 
in a separate Federal Register notice provided that Federal Register 
notice of the date and city at which any informal hearing shall begin 
will be given at least 30 days in advance;
    (c) A statement identifying the place at which the official record 
of the rulemaking is located, the hours during which it will be open for 
public inspection, the documents contained in it as of the date the 
Notice of Proposed Rulemaking was issued, and a statement of the 
approximate times at which additional materials such as public comments, 
hearing transcripts, and Agency studies in progress will be added to the 
record. If any material other than public comments or material generated 
by a hearing is added to the record after publication of the notice 
required by this action, and notice of its future addition was not given 
at the time of that initial publication, a separate Federal Register 
notice announcing its addition to the record and inviting comment will 
be published;
    (d) The due date for public comments, which will be (1) 30 days 
after publication of the notice of proposed rulemaking for main comments 
and (2) one week after the informal hearing for reply comments;
    (e) The name, address, and office telephone number of the Record 
Clerk and the Hearing Clerk for the rulemaking in question; and
    (f) A nonbinding target date for issuing the final rule.

[[Page 507]]



Sec. 750.34  Record.

    (a) No later than the date of proposal of a rule subject to this 
subpart, a rulemaking record for that rule will be established. It will 
consist of a separate identified filing space containing:
    (1) All documents required by Sec. 750.31(d);
    (2) All public comments timely received;
    (3) All public hearing transcripts;
    (4) All material received during an informal hearing and accepted 
for the record of that hearing; and
    (5) Any other information that the Assistant Administrator for 
Prevention, Pesticides and Toxic Substances considers to be relevant to 
such rule and that the Assistant Administrator identified, on or before 
the date of the promulgation of the rule, in a notice published in the 
Federal Register.
    (b) All material in the record will be appropriately indexed. Each 
record will be available for public inspection during normal EPA 
business hours. Appropriate arrangements allowing members of the public 
to copy record materials that do not risk the permanent loss of such 
materials will be made. All material required to be included in the 
record will be added to the record as soon as feasible after its receipt 
by EPA.
    (c) The Record Clerk for each rulemaking will be responsible for EPA 
compliance with the requirements of paragraph (a) of this section.



Sec. 750.35  Public comments.

    (a) Main comments must be postmarked or received no later than the 
time specified in the Notice of Proposed Rulemaking and must contain all 
comments on and criticisms of that Notice by the commenting person, 
based on information which is or reasonably could have been available to 
that person at the time.
    (b) Reply comments must be postmarked or received no later than one 
week after the close of all informal hearings on the proposed rule and 
must be restricted to comments on:
    (1) Other comments;
    (2) Material in the hearing record; and
    (3) Material which was not and could not reasonably have been 
available to the commenting party a sufficient time before main comments 
were due.
    (c) Extensions of the time for filing comments may be granted in 
writing by the Hearing Chairman. Application for an extension must be 
made in writing. Comments submitted after the comment period and all 
extensions of it have expired need not be added to the rulemaking record 
and need not be considered in decisions concerning the rule.
    (d) Unless the Notice of Proposed Rulemaking states otherwise, four 
copies of all comments must be submitted.



Sec. 750.36  Confidentiality.

    EPA encourages the submission of non-confidential information by 
petitioners and commentors. EPA does not wish to have unnecessary 
restrictions on access to the rulemaking record. However, if a 
petitioner or commentor believes that he can only state his position 
through the use of information claimed to be confidential, he may submit 
it. Such information must be separately submitted for the rulemaking 
record and marked ``confidential'' by the submitter. For the information 
claimed to be confidential, EPA will list only the date and the name and 
address of the petitioner or commentor in the public file, noting that 
the petitioner or commentor has requested confidential treatment. The 
information claimed to be confidential will be placed in a confidential 
file. A petitioner must also file a non-confidential petition with a 
non-confidential summary of the confidential information to be placed in 
the public file. Similarly, a commentor must supply a non-confidential 
summary of the information claimed to be confidential to be placed in 
the public file. Any information not marked as confidential will be 
placed in the public file. Information marked confidential will be 
treated in accordance with the procedures in part 2, subpart B of this 
title.



Sec. 750.37  Subpoenas.

    (a) Where necessary, subpoenas requiring the production of 
documentary material, the attendance of persons at the hearing, or 
responses to written questions may be issued. Subpoenas may be issued 
either upon request as

[[Page 508]]

provided in paragraph (b) of this section or by EPA on its own motion.
    (b) All subpoena requests must be in writing. Hearing participants 
may request the issuance of subpoenas as follows:
    (1) Subpoenas for the attendance of persons or for the production of 
documents or responses to questions at the legislative hearing may be 
requested at any time up to the deadline for filing main comments.
    (2) Subpoenas for production of documents or answers to questions 
after the legislative hearing may be requested at any time between the 
beginning of the legislative hearing and the deadline for submitting 
reply comments.
    (c) EPA will rule on all subpoena requests filed under paragraph 
(b)(1) of this section no later than the beginning of the informal 
hearing. Such requests may be granted, denied, or deferred. EPA will 
rule on all subpoena requests filed under paragraph (b)(2) of this 
section and all deferred subpoena requests filed under paragraph (b)(1) 
of this section no later than the promulgation of the final rule. Such 
requests will be either granted or denied.



Sec. 750.38  Participation in informal    hearing.

    (a) Each person or organization desiring to participate in the 
informal hearing required by section 6(c)(2)(C) of TSCA must file a 
written request to participate with the Hearing Clerk. This request must 
be received no later than seven days prior to the scheduled start of the 
hearing. The hearing will begin seven days after the close of the thirty 
day comment period or as soon thereafter as practicable. The request 
must include:
    (1) A brief statement of the interest of the person or organization 
in the proceeding;
    (2) A brief outline of the points to be addressed;
    (3) An estimate of the time required; and
    (4) If the request comes from an organization, a nonbinding list of 
the persons to take part in the presentation. Organizations are 
requested to bring with them, to the extent possible, employees with 
individual expertise in and responsibility for each of the areas to be 
addressed. No organization not filing main comments in the rulemaking 
will be allowed to participate at the hearing, unless a waiver of this 
requirement is granted in writing by the Hearing Chairman or the 
organization is appearing at the request of EPA or under subpoena.
    (b) No later than three days prior to the start of the hearing, the 
Hearing Clerk will make a hearing schedule publicly available and mail 
or deliver it to each of the persons who requested to appear at the 
hearing. This schedule will be subject to change during the course of 
the hearing at the discretion of those presiding over it.
    (c) Opening statements should be brief, and restricted either to 
points that could not have been made in main comments or to emphasizing 
points which are made in main comments, but which the participant 
believes can be more forcefully urged in the hearing context.



Sec. 750.39  Conduct of informal hearing.

    (a) A panel of EPA employees shall preside at each hearing conducted 
under section 6(c)(2)(C) of TSCA. In appropriate cases, other Executive 
Branch employees may also sit with and assist the panel. The membership 
of the panel may change as different topics arise during the hearing. In 
general, the panel membership will consist of EPA employees with special 
responsibility for the final rule or special expertise in the topics 
under discussion. One member of the panel will be named to chair the 
proceedings and will attend throughout the hearing, unless unavoidably 
prevented by sickness or similar personal circumstances.
    (b) The panel may question any individual or group participating in 
the hearing on any subject relating to the rulemaking. Cross-examination 
by others will normally not be permitted at this stage. It may be 
granted in compelling circumstances at the sole discretion of the 
hearing panel. However, persons in the hearing audience may submit 
questions in writing for the hearing panel to ask the participants, and 
the hearing panel may, at their discretion, ask these questions.
    (c) Participants in the hearing may submit additional material for 
the

[[Page 509]]

hearing record and shall submit such additional material as the hearing 
panel may request. All such submissions will become part of the record 
of the hearing. A verbatim transcript of the hearing shall be made. 
Participants will be allowed to designate testimony from prior EPA 
informal rulemaking hearings concerning PCBs under TSCA. The hearing 
panel may reject repetitive testimony previously presented at such 
hearings.



Sec. 750.40  Cross-examination.

    (a) After the close of the informal hearing conducted under 
Sec. 750.39, any participant in that hearing may submit a written 
request for cross-examination. The request must be received by EPA 
within one week after a full transcript of the informal hearing becomes 
available and must specify:
    (1) The disputed issue(s) of material fact as to which cross-
examination is requested. This must include an explanation of why the 
questions at issue are ``factual'', rather than of an analytical or 
policy nature, the extent to which they are in ``dispute'' in the light 
of the record made thus far, and the extent to which and why they can 
reasonably be considered ``material'' to the decision on the final rule; 
and
    (2) The person(s) the participant desires to cross-examine, and an 
estimate of the time necessary. This must include a statement as to how 
the cross-examination requested can be expected to result in ``full and 
true disclosure'' resolving the issue of material fact involved.
    (b) Within one week after receipt of all requests for cross-
examination under paragraph (a), the hearing panel will rule on them. 
The ruling will be served by the Hearing Clerk on all participants who 
have requested cross-examination and will be inserted in the record. 
Written notice of the ruling will be given to all persons requesting 
cross-examination and all persons to be cross-examined. The ruling will 
specify:
    (1) The issues as to which cross-examination is granted;
    (2) The persons to be cross-examined on each issue;
    (3) The persons to be allowed to conduct cross-examination; and
    (4) Time limits for the examination of each witness by each cross-
examiner.
    (c) In issuing this ruling, the panel may determine that one or more 
participants who have requested cross-examination have the same or 
similar interests and should be required to choose a single 
representative for purposes of cross-examination by that single 
representative without identifying the representative further. Subpoenas 
for witnesses may be issued where necessary.
    (d) Within one week after the insertion into the record of the 
ruling under paragraph (b) of this section, the hearing at which the 
cross-examination will be conducted will begin. One or more members of 
the original panel will preside for EPA. The panel will have authority 
to conduct cross-examination on behalf of any participant, although as a 
general rule this right will not be exercised. The panel will also have 
authority to modify the governing ruling in any respect and to make new 
rulings on group representation under section 6(c)(3)(C) of TSCA. A 
verbatim transcript of the hearing will be made.
    (e)(1) No later than the time set for requesting cross-examination, 
a hearing participant may request that other alternative methods of 
clarifying the record (such as informal conferences or the submittal of 
additional information) be used. Such requests may be submitted either 
in lieu of cross-examination requests, or in conjunction with them.
    (2) The panel in passing on a cross-examination request may, as a 
precondition to ruling on its merits, require that alternative means of 
clarifying the record be used whether or not that has been requested 
under paragraph (e)(1) of this section. In such a case, the results of 
the use of such alternative means will be made available to the person 
requesting cross-examination for a one-week comment period, and the 
panel will make a final ruling on cross-examination within one week 
thereafter.
    (f) Waivers or extensions of any deadline in this section applicable 
to persons other than EPA may be granted

[[Page 510]]

on the record of the hearing by the person chairing it or in writing by 
the Hearing Chairman.



Sec. 750.41  Final rule.

    (a) As soon as feasible after the deadline for submittal of reply 
comments, EPA will issue a final rule. EPA will also publish at that 
time:
    (1) A list of all material added to the record (other than public 
comments and material from the hearing record) which has not previously 
been listed in a Federal Register document, and
    (2) The effective date of the rule.
    (b) Pursuant to the delegation of authority made in the Preamble to 
the Final Regulation for the PCB Manufacturing, Processing, Distribution 
in Commerce and Use Prohibitions, the Assistant Administrator for 
Prevention, Pesticides and Toxic Substances will grant or deny petitions 
under section 6(e)(3)(B) of TSCA submitted pursuant to Sec. 750.31. The 
Assistant Administrator will act on such petitions subsequent to 
opportunity for an informal hearing pursuant to this rule.
    (c) In determining whether to grant an exemption to the PCB ban, EPA 
will apply the two standards enunciated in section 6(e)(3)(B) of TSCA.



PART 761--POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING, DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS--Table of Contents




                           Subpart A--General

Sec.
761.1  Applicability.
761.2  PCB concentration assumptions for use.
761.3  Definitions.
761.19  References.

Subpart B--Manufacturing, Processing, Distribution in Commerce, and Use 
                          of PCBs and PCB Items

761.20  Prohibitions and exceptions.
761.30  Authorizations.
761.35  Storage for reuse.

                Subpart C--Marking of PCBs and PCB Items

761.40  Marking requirements.
761.45  Marking formats.

                     Subpart D--Storage and Disposal

761.50  Applicability.
761.60  Disposal requirements.
761.61  PCB remediation waste.
761.62  Disposal of PCB bulk product waste.
761.63  PCB household waste storage and dsiposal.
761.64  Disposal of wastes generated as a result of research and 
          development activities authorized under Sec. 761.30(j) and 
          chemical analysis of PCBs.
761.65  Storage for disposal.
761.70  Incineration.
761.71  High efficiency boilers.
761.72  Scrap metal recovery ovens and smelters.
761.75  Chemical waste landfills.
761.77  Coordinated approval.
761.79  Decontamination standards and procedures.

                          Subpart E--Exemptions

761.80  Manufacturing, processing and distribution in commerce 
          exemptions.

         Subpart F--Transboundary Shipments of PCBs for Disposal

761.91  Applicability.
761.93  Import for disposal.
761.97  Export for disposal.
761.99  Other transboundary shipments.

                   Subpart G--PCB Spill Cleanup Policy

761.120  Scope.
761.123  Definitions.
761.125  Requirements for PCB spill cleanup.
761.130  Sampling requirements.
761.135  Effect of compliance with this policy and enforcement.

Subparts H-I  [Reserved]

                 Subpart J--General Records and Reports

761.180  Records and monitoring.
761.185  Certification program and retention of records by importers and 
          persons generating PCBs in excluded manufacturing processes.
761.187  Reporting importers and by persons generating PCBs in excluded 
          manufacturing processes.
761.193  Maintenance of monitoring records by persons who import, 
          manufacture, process, distribute in commerce, or use chemicals 
          containing inadvertently generated PCBs.

            Subpart K--PCB Waste Disposal Records and Reports

761.202  EPA identification numbers.
761.205  Notification of PCB waste activity (EPA Form 7710-53).

[[Page 511]]

761.207  The manifest--general requirements.
761.208  Use of the manifest.
761.209  Retention of manifest records.
761.210  Manifest discrepancies.
761.211  Unmanifested waste report.
761.215  Exception reporting.
761.218  Certificate of disposal.

Subpart L  [Reserved]

 Subpart M--Determining a PCB Concentration for Purposes of Abandonment 
or Disposal of Natural Gas Pipeline: Selecting Sample Sites, Collecting 
        Surface Samples, and Analyzing Standard PCB Wipe Samples

761.240  Scope and definitions.
761.243  Standard wipe sample method and size.
761.247  Sample site selection for pipe segment removal.
761.250   Sample site selection for pipeline section abandonment.
761.253  Chemical analysis.
761.257  Determining the regulatory status of sampled pipe.

 Subpart N--Cleanup Site Characterization Sampling for PCB Remediation 
               Waste in Accordance with Sec. 761.61(a)(2)

761.260  Applicability.
761.265  Sampling bulk PCB remediation waste and porous surfaces.
761.267  Sampling non-porous surfaces.
761.269  Sampling liquid PCB remediation waste.
761.272  Chemical extraction and analysis of samples.
761.274  Reporting PCB concentrations in samples.

 Subpart O--Sampling to Verify Completion of Self-Implementing Cleanup 
 and On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces 
                  in Accordance with Sec. 761.61(a)(6)

761.280  Application and scope.
761.283  Determination of the number of samples to collect and sample 
          collection locations.
761.286  Sample size and procedure for collecting a sample.
761.289  Compositing samples.
761.292  Chemical extraction and analysis of individual samples and 
          composite samples.
761.295  Reporting and recordkeeping of the PCB concentrations in 
          samples.
761.298  Decisions based on PCB concentration measurements resulting 
          from sampling.

   Subpart P--Sampling Non-Porous Surfaces for Measurement-Based Use, 
  Reuse, and On-Site or Off-Site Disposal Under Sec. 761.61(a)(6) and 
                  Determination Under Sec. 761.79(b)(3)

761.300  Applicability.
761.302  Proportion of the total surface area to sample.
761.304  Determining sample location.
761.306  Sampling 1 meter square surfaces by random selection of halves.
761.308  Sample selection by random number generation on any two-
          dimensional square grid.
761.310  Collecting the sample.
761.312  Compositing of samples.
761.314  Chemical analysis of standard wipe test samples.
761.316  Interpreting PCB concentration measurements resulting from this 
          sampling scheme.

    Subpart Q--Self-Implementing Alternative Extraction and Chemical 
    Analysis Procedures for Non-liquid PCB Remediation Waste Samples

761.320  Applicability.
761.323  Sample preparation.
761.326  Conducting the comparison study.

  Subpart R--Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for 
    Purposes of Characterization for PCB Disposal in Accordance With
 
 Sec. 761.62, and Sampling PCB Remediation Waste Destined for Off-Site 
                Disposal, in Accordance With Sec. 761.61

761.340  Applicability.
761.345  Form of the waste to be sampled.
761.346  Three levels of sampling.
761.347  First level sampling--waste from existing piles.
761.348  Contemporaneous sampling.
761.350  Subsampling from composite samples.
761.353  Second level of sample selection.
761.355  Third level of sample selection.
761.356  Conducting a leach test.
761.357  Reporting the results of the procedure used to simulate 
          leachate generation.
761.358  Determining the PCB concentration of samples of waste.
761.359  Reporting the PCB concentrations in samples.

   Subpart S--Double Wash/Rinse Method for Decontaminating Non-Porous 
                                Surfaces

761.360  Background.
761.363  Applicability.
761.366  Cleanup equipment.
761.369  Pre-cleaning the surface.

[[Page 512]]

761.372  Specific requirements for relatively clean surfaces.
761.375  Specific requirements for surfaces coated or covered with dust, 
          dirt, grime, grease, or another absorbent material.
761.378  Decontamination, reuse, and disposal of solvents, cleaners, and 
          equipment.

   Subpart T--Comparison Study for Validating a New Performance-Based 
             Decontamination Solvent Under Sec. 761.79(d)(4)

761.380  Background.
761.383  Applicability.
761.386  Required experimental conditions for the validation study and 
          subsequent use during decontamination.
761.389  Testing parameter requirements.
761.392  Preparing validation study samples.
761.395  A validation study.
761.398  Reporting and recordkeeping.

    Authority: 15 U.S.C. 2605, 2607, 2611, 2614, and 2616.



                           Subpart A--General



Sec. 761.1  Applicability.

    (a) This part establishes prohibitions of, and requirements for, the 
manufacture, processing, distribution in commerce, use, disposal, 
storage, and marking of PCBs and PCB Items.
    (b)(1) This part applies to all persons who manufacture, process, 
distribute in commerce, use, or dispose of PCBs or PCB Items. Substances 
that are regulated by this part include, but are not limited to: 
dielectric fluids; solvents; oils; waste oils; heat transfer fluids; 
hydraulic fluids; paints or coatings; sludges; slurries; sediments; 
dredge spoils; soils; materials containing PCBs as a result of spills; 
and other chemical substances or combinations of substances, including 
impurities and byproducts and any byproduct, intermediate, or impurity 
manufactured at any point in a process.
    (2) Unless otherwise noted, PCB concentrations shall be determined 
on a weight-per-weight basis (e.g., milligrams per kilogram), or for 
liquids, on a weight-per-volume basis (e.g., milligrams per liter) if 
the density of the liquid is also reported. Unless otherwise provided, 
PCBs are quantified based on the formulation of PCBs present in the 
material analyzed. For example, measure AroclorTM 1242 PCBs 
based on a comparison with AroclorTM 1242 standards. Measure 
individual congener PCBs based on a comparison with individual PCB 
congener standards.
    (3) Most provisions in this part apply only if PCBs are present in 
concentrations above a specified level. Provisions that apply to PCBs at 
concentrations of <50 ppm apply also to contaminated surfaces at PCB 
concentrations of 10 g/100 cm2. 
Provisions that apply to PCBs at concentrations of 50 to <500 
ppm apply also to contaminated surfaces at PCB concentrations of >10/100 
cm2 to <100 g/100 cm2. Provisions that 
apply to PCBs at concentrations of 500 ppm apply also to 
contaminated surfaces at PCB concentrations of 100 
g/100 cm2.
    (4) PCBs can be found in liquid, non-liquid and multi-phasic 
(combinations of liquid and non-liquid) forms. A person should use the 
following criteria to determine PCB concentrations to determine which 
provisions of this part apply to such PCBs.
    (i) Any person determining PCB concentrations for non-liquid PCBs 
must do so on a dry weight basis.
    (ii) Any person determining PCB concentrations for liquid PCBs must 
do so on a wet weight basis. Liquid PCBs containing more than 0.5 
percent by weight non-dissolved material shall be analyzed as multi-
phasic non-liquid/liquid mixtures.
    (iii) Any person determining the PCB concentration of samples 
containing PCBs and non-dissolved non-liquid materials 0.5 
percent, must separate the non-dissolved materials into non-liquid PCBs 
and liquid PCBs. For multi-phasic non-liquid/liquid or liquid/liquid 
mixtures, the phases shall be separated before chemical analysis. 
Following phase separation, the PCB concentration in each non-liquid 
phase shall be determined on a dry weight basis and the PCB 
concentration in each liquid phase shall be determined separately on a 
wet weight basis.
    (iv) Any person disposing of multi-phasic non-liquid/liquid or 
liquid/liquid mixtures must use the PCB disposal requirements that apply 
to the individual phase with the highest PCB concentration except where 
otherwise noted. Alternatively, phases may be separated and disposed of 
using the

[[Page 513]]

PCB disposal requirements that apply to each separated, single-phase 
material.
    (5) No person may avoid any provision specifying a PCB concentration 
by diluting the PCBs, unless otherwise specifically provided.
    (6) Unless otherwise specified, references to weights or volumes of 
PCBs in this part apply to the total weight or total volume of the 
material (oil, soil, debris, etc.) that contains regulated 
concentrations of PCBs, not the calculated weight or volume of only the 
PCB molecules contained in the material.
    (c) Definitions of the terms used in these regulations are in 
subpart A. The basic requirements applicable to disposal and marking of 
PCBs and PCB Items are set forth in subpart D--Disposal of PCBs and PCB 
Items and in subpart C--Marking of PCBs and PCB Items. Prohibitions 
applicable to PCB activities are set forth in subpart B--Manufacture, 
Processing, Distribution in Commerce, and Use of PCBs and PCB Items. 
Subpart B also includes authorizations from the prohibitions. Subparts C 
and D set forth the specific requirements for disposal and marking of 
PCBs and PCB Items.
    (d) Section 15 of the Toxic Substances Control Act (TSCA) states 
that failure to comply with these regulations is unlawful. Section 16 
imposes liability for civil penalties upon any person who violates these 
regulations, and the Administrator can establish appropriate remedies 
for any violations subject to any limitations included in section 16 of 
TSCA. Section 16 also subjects a person to criminal prosecution for a 
violation which is knowing or willful. In addition, section 17 
authorizes Federal district courts to enjoin activities prohibited by 
these regulations, compel the taking of actions required by these 
regulations, and issue orders to seize PCBs and PCB Items manufactured, 
processed or distributed in violation of these regulations.
    (e) These regulations do not preempt other more stringent Federal 
statutes and regulations.
    (f) Unless and until superseded by any new more stringent 
regulations issued under EPA authorities, or any permits or any 
pretreatment requirements issued by EPA, a state or local government 
that affect release of PCBs to any particular medium:
    (1) Persons who inadvertently manufacture or import PCBs generated 
as unintentional impurities in excluded manufacturing processes, as 
defined in Sec. 761.3, are exempt from the requirements of subpart B of 
this part, provided that such persons comply with subpart J of this 
part, as applicable.
    (2) Persons who process, distribute in commerce, or use products 
containing PCBs generated in excluded manufacturing processes defined in 
Sec. 761.3 are exempt from the requirements of subpart B provided that 
such persons comply with subpart J of this part, as applicable.
    (3) Persons who process, distribute in commerce, or use products 
containing recycled PCBs defined in Sec. 761.3, are exempt from the 
requirements of subpart B of this part, provided that such persons 
comply with subpart J of this part, as applicable.
    (4) Except as provided in Sec. 761.20 (d) and (e), persons who 
process, distribute in commerce, or use products containing excluded PCB 
products as defined in Sec. 761.3, are exempt from the requirements of 
subpart B of this part.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979, as amended at 49 FR 28189, July 10, 1984; 53 
FR 24220, June 27, 1988; 63 FR 35436, June 29, 1998; 64 FR 33759, June 
24, 1999]



Sec. 761.2   PCB concentration assumptions for use.

    (a)(1) Any person may assume that transformers with <3 pounds (1.36 
kilograms (kgs)) of fluid, circuit breakers, reclosers, oil-filled 
cable, and rectifiers whose PCB concentration is not established contain 
PCBs at <50 ppm.
    (2) Any person must assume that mineral oil-filled electrical 
equipment that was manufactured before July 2, 1979, and whose PCB 
concentration is not established is PCB-Contaminated Electrical 
Equipment (i.e., contains 50 ppm PCB, but <500 ppm PCB). All 
pole-top and pad-mounted distribution transformers manufactured before 
July 2, 1979, must be assumed to be mineral-oil filled. Any person may 
assume that electrical equipment manufactured

[[Page 514]]

after July 2, 1979, is non-PCB (i.e., <50 ppm PCBs). If the date of 
manufacture of mineral oil-filled electrical equipment is unknown, any 
person must assume it to be PCB-Contaminated.
    (3) Any person must assume that a transformer manufactured prior to 
July 2, 1979, that contains 1.36 kg (3 pounds) or more of fluid other 
than mineral oil and whose PCB concentration is not established, is a 
PCB Transformer (i.e., 500 ppm). If the date of manufacture 
and the type of dielectric fluid are unknown, any person must assume the 
transformer to be a PCB Transformer.
    (4) Any person must assume that a capacitor manufactured prior to 
July 2, 1979, whose PCB concentration is not established contains 
500 ppm PCBs. Any person may assume that a capacitor 
manufactured after July 2, 1979, is non-PCB (i.e., <50 ppm PCBs). If the 
date of manufacture is unknown, any person must assume the capacitor 
contains 500 ppm PCBs. Any person may assume that a capacitor 
marked at the time of manufacture with the statement ``No PCBs'' in 
accordance with Sec. 761.40(g) is non-PCB.
    (b) PCB concentration may be established by:
    (1) Testing the equipment; or
    (2)(i) A permanent label, mark, or other documentation from the 
manufacturer of the equipment indicating its PCB concentration at the 
time of manufacture; and
    (ii) Service records or other documentation indicating the PCB 
concentration of all fluids used in servicing the equipment since it was 
first manufactured.

[63 FR 35436, June 29, 1998, as amended at 64 FR 33759, June 24, 1999]



Sec. 761.3  Definitions.

    For the purpose of this part:
    Administrator means the Administrator of the Environmental 
Protection Agency, or any employee of the Agency to whom the 
Administrator may either herein or by order delegate his authority to 
carry out his functions, or any person who shall by operation of law be 
authorized to carry out such functions.
    Agency means the United States Environmental Protection Agency.
    Air compressor system means air compressors, piping, receiver tanks, 
volume tanks and bottles, dryers, airlines, and related appurtenances.
    Annual document log means the detailed information maintained at the 
facility on the PCB waste handling at the facility.
    Annual report means the written document submitted each year by each 
disposer and commercial storer of PCB waste to the appropriate EPA 
Regional Administrator. The annual report is a brief summary of the 
information included in the annual document log.
     ASTM means American Society for Testing and Materials, 100 Barr 
Harbor Drive, West Conshohocken, PA 19428-2959.
    Byproduct means a chemical substance produced without separate 
commercial intent during the manufacturing or processing of another 
chemical substance(s) or mixture(s).
    Capacitor means a device for accumulating and holding a charge of 
electricity and consisting of conducting surfaces separated by a 
dielectric. Types of capacitors are as follows:
    (1) Small capacitor means a capacitor which contains less than 1.36 
kg (3 lbs.) of dielectric fluid. The following assumptions may be used 
if the actual weight of the dielectric fluid is unknown. A capacitor 
whose total volume is less than 1,639 cubic centimeters (100 cubic 
inches) may be considered to contain less than 1.36 kgs (3 lbs.) of 
dielectric fluid and a capacitor whose total volume is more than 3,278 
cubic centimeters (200 cubic inches) must be considered to contain more 
than 1.36 kg (3 lbs.) of dielectric fluid. A capacitor whose volume is 
between 1,639 and 3,278 cubic centimeters may be considered to contain 
less then 1.36 kg (3 lbs.) of dielectric fluid if the total weight of 
the capacitor is less than 4.08 kg (9 lbs.).
    (2) Large high voltage capacitor means a capacitor which contains 
1.36 kg (3 lbs.) or more of dielectric fluid and which operates at 2,000 
volts (a.c. or d.c.) or above.
    (3) Large low voltage capacitor means a capacitor which contains 
1.36 kg (3 lbs.) or more of dielectric fluid and which operates below 
2,000 volts (a.c. or d.c.).

[[Page 515]]

    CERCLA means the Comprehensive Environmental Response, Compensation, 
and Liability Act (42 U.S.C. 9601-9657).
    Certification means a written statement regarding a specific fact or 
representation that contains the following language:

    Under civil and criminal penalties of law for the making or 
submission of false or fraudulent statements or representations (18 
U.S.C. 1001 and 15 U.S.C. 2615), I certify that the information 
contained in or accompanying this document is true, accurate, and 
complete. As to the identified section(s) of this document for which I 
cannot personally verify truth and accuracy, I certify as the company 
official having supervisory responsibility for the persons who, acting 
under my direct instructions, made the verification that this 
information is true, accurate, and complete.

    Chemical substance, (1) except as provided in paragraph (2) of this 
definition, means any organic or inorganic substance of a particular 
molecular identity, including: Any combination of such substances 
occurring in whole or part as a result of a chemical reaction or 
occurring in nature, and any element or uncombined radical.
    (2) Such term does not include: Any mixture; any pesticide (as 
defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when 
manufactured, processed, or distributed in commerce for use as a 
pesticide; tobacco or any tobacco product; any source material, special 
nuclear material, or byproduct material (as such terms are defined in 
the Atomic Energy Act of 1954 and regulations issued under such Act); 
any article the sale of which is subject to the tax imposed by section 
4181 of the Internal Revenue Code of 1954 (determined without regard to 
any exemptions from such tax provided by section 4182 or section 4221 or 
any provisions of such Code); and any food, food additive, drug, 
cosmetic, or device (as such terms are defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or 
distributed in commerce for use as a food, food additive, drug, 
cosmetic, or device.
    Chemical waste landfill means a landfill at which protection against 
risk of injury to health or the environment from migration of PCBs to 
land, water, or the atmosphere is provided from PCBs and PCB Items 
deposited therein by locating, engineering, and operating the landfill 
as specified in Sec. 761.75.
    Cleanup site means the areal extent of contamination and all 
suitable areas in very close proximity to the contamination necessary 
for implementation of a cleanup of PCB remediation waste, regardless of 
whether the site was intended for management of waste.
    Commerce means trade, traffic, transportation, or other commerce:
    (1) Between a place in a State and any place outside of such State, 
or
    (2) Which affects trade, traffic, transportation, or commerce 
described in paragraph (1) of this definition.
    Commercial storer of PCB waste means the owner or operator of each 
facility that is subject to the PCB storage unit standards of 
Sec. 761.65(b)(1) or (c)(7) or meets the alternate storage criteria of 
Sec. 761.65(b)(2), and who engages in storage activities involving 
either PCB waste generated by others or that was removed while servicing 
the equipment owned by others and brokered for disposal. The receipt of 
a fee or any other form of compensation for storage services is not 
necessary to qualify as a commercial storer of PCB waste. A generator 
who only stores its own waste is subject to the storage requirements of 
Sec. 761.65, but is not required to obtain approval as a commercial 
storer. If a facility's storage of PCB waste generated by others at no 
time exceeds a total of 500 gallons of liquid and/or non-liquid material 
containing PCBs at regulated levels, the owner or operator is a 
commercial storer but is not required to seek EPA approval as a 
commercial storer of PCB waste. Storage of one company's PCB waste by a 
related company is not considered commercial storage. A ``related 
company'' includes, but is not limited to: a parent company and its 
subsidiaries; sibling companies owned by the same parent company; 
companies owned by a common holding company; members of electric 
cooperatives; entities within the same Executive agency as defined at 5 
U.S.C. 105; and a company having a joint ownership interest in a 
facility from which PCB waste is generated (such as a jointly owned 
electric power generating station) where the PCB waste is

[[Page 516]]

stored by one of the co-owners of the facility. A ``related company'' 
does not include another voluntary member of the same trade association. 
Change in ownership or title of a generator's facility, where the 
generator is storing PCB waste, does not make the new owner of the 
facility a commercial storer of PCB waste.
    Designated facility means the off-site disposer or commercial storer 
of PCB waste designated on the manifest as the facility that will 
receive a manifested shipment of PCB waste.
    Disposal means intentionally or accidentally to discard, throw away, 
or otherwise complete or terminate the useful life of PCBs and PCB 
Items. Disposal includes spills, leaks, and other uncontrolled 
discharges of PCBs as well as actions related to containing, 
transporting, destroying, degrading, decontaminating, or confining PCBs 
and PCB Items.
    Disposer of PCB waste, as the term is used in subparts J and K of 
this part, means any person who owns or operates a facility approved by 
EPA for the disposal of PCB waste which is regulated for disposal under 
the requirements of subpart D of this part.
    Distribute in commerce and Distribution in Commerce when used to 
describe an action taken with respect to a chemical substance, mixture, 
or article containing a substance or mixture means to sell, or the sale 
of, the substance, mixture, or article in commerce; to introduce or 
deliver for introduction into commerce, or the introduction or delivery 
for introduction into commerce of the substance, mixture, or article; or 
to hold or the holding of, the substance, mixture, or article after its 
introduction into commerce.
    DOT means the United States Department of Transportation.
    Dry weight means the weight of the sample, excluding the weight of 
the water in the sample. Prior to chemical analysis the water may be 
removed by any reproducible method that is applicable to measuring PCBs 
in the sample matrix at the concentration of concern, such as air drying 
at ambient temperature, filtration, decantation, heating at low 
temperature followed by cooling in the presence of a desiccant, or other 
processes or combinations of processes which would remove water but not 
remove PCBs from the sample. Analytical procedures which calculate the 
dry weight concentration by adjusting for moisture content may also be 
used.
    EPA identification number means the 12-digit number assigned to a 
facility by EPA upon notification of PCB waste activity under 
Sec. 761.205.
    Excluded manufacturing process means a manufacturing process in 
which quantities of PCBs, as determined in accordance with the 
definition of inadvertently generated PCBs, calculated as defined, and 
from which releases to products, air, and water meet the requirements of 
paragraphs (1) through (5) of this definition, or the importation of 
products containing PCBs as unintentional impurities, which products 
meet the requirements of paragraphs (1) and (2) of this definition.
    (1) The concentration of inadvertently generated PCBs in products 
leaving any manufacturing site or imported into the United States must 
have an annual average of less than 25 ppm, with a 50 ppm maximum.
    (2) The concentration of inadvertently generated PCBs in the 
components of detergent bars leaving the manufacturing site or imported 
into the United States must be less than 5 ppm.
    (3) The release of inadvertently generated PCBs at the point at 
which emissions are vented to ambient air must be less than 10 ppm.
    (4) The amount of inadvertently generated PCBs added to water 
discharged from a manufacturing site must be less than 100 micrograms 
per resolvable gas chromatographic peak per liter of water discharged.
    (5) Disposal of any other process wastes above concentrations of 50 
ppm PCB must be in accordance with subpart D of this part.
    Excluded PCB products means PCB materials which appear at 
concentrations less than 50 ppm, including but not limited to:
    (1) Non-Aroclor inadvertently generated PCBs as a byproduct or 
impurity resulting from a chemical manufacturing process.
    (2) Products contaminated with Aroclor or other PCB materials from

[[Page 517]]

historic PCB uses (investment casting waxes are one example).
    (3) Recycled fluids and/or equipment contaminated during use 
involving the products described in paragraphs (1) and (2) of this 
definition (heat transfer and hydraulic fluids and equipment and other 
electrical equipment components and fluids are examples).
    (4) Used oils, provided that in the cases of paragraphs (1) through 
(4) of this definition:
    (i) The products or source of the products containing < 50 ppm 
concentration PCBs were legally manufactured, processed, distributed in 
commerce, or used before October 1, 1984.
    (ii) The products or source of the products containing < 50 ppm 
concentrations PCBs were legally manufactured, processed, distributed in 
commerce, or used, i.e., pursuant to authority granted by EPA 
regulation, by exemption petition, by settlement agreement, or pursuant 
to other Agency-approved programs;
    (iii) The resulting PCB concentration (i.e. below 50 ppm) is not a 
result of dilution, or leaks and spills of PCBs in concentrations over 
50 ppm.
    Facility means all contiguous land, and structures, other 
appurtenances, and improvements on the land, used for the treatment, 
storage, or disposal of PCB waste. A facility may consist of one or more 
treatment, storage, or disposal units.
    Fluorescent light ballast means a device that electrically controls 
fluorescent light fixtures and that includes a capacitor containing 0.1 
kg or less of dielectric.
    Generator of PCB waste means any person whose act or process 
produces PCBs that are regulated for disposal under subpart D of this 
part, or whose act first causes PCBs or PCB Items to become subject to 
the disposal requirements of subpart D of this part, or who has physical 
control over the PCBs when a decision is made that the use of the PCBs 
has been terminated and therefore is subject to the disposal 
requirements of subpart D of this part. Unless another provision of this 
part specifically requires a site-specific meaning, ``generator of PCB 
waste'' includes all of the sites of PCB waste generation owned or 
operated by the person who generates PCB waste.
    High occupancy area means any area where PCB remediation waste has 
been disposed of on-site and where occupancy for any individual not 
wearing dermal and respiratory protection for a calendar year is: 840 
hours or more (an average of 16.8 hours or more per week) for non-porous 
surfaces and 335 hours or more (an average of 6.7 hours or more per 
week) for bulk PCB remediation waste. Examples could include a 
residence, school, day care center, sleeping quarters, a single or 
multiple occupancy 40 hours per week work station, a school class room, 
a cafeteria in an industrial facility, a control room, and a work 
station at an assembly line.
    Importer means any person defined as an ``importer'' at 
Sec. 720.3(l) of this chapter who imports PCBs or PCB Items and is under 
the jurisdiction of the United States.
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    In or Near Commercial Buildings means within the interior of, on the 
roof of, attached to the exterior wall of, in the parking area serving, 
or within 30 meters of a non-industrial non-substation building. 
Commercial buildings are typically accessible to both members of the 
general public and employees, and include: (1) Public assembly 
properties, (2) educational properties, (3) institutional properties, 
(4) residential properties, (5) stores, (6) office buildings, and (7) 
transportation centers (e.g., airport terminal buildings, subway 
stations, bus stations, or train stations).
    Incinerator means an engineered device using controlled flame 
combustion to thermally degrade PCBs and PCB Items. Examples of devices 
used for incineration include rotary kilns, liquid injection 
incinerators, cement kilns, and high temperature boilers.
    Industrial building means a building directly used in manufacturing 
or technically productive enterprises. Industrial buildings are not 
generally or typically accessible to other than workers. Industrial 
buildings include buildings used directly in the production of power, 
the manufacture of products, the mining of raw materials, and

[[Page 518]]

the storage of textiles, petroleum products, wood and paper products, 
chemicals, plastics, and metals.
    Laboratory means a facility that analyzes samples for PCBs and is 
unaffiliated with any entity whose activities involve PCBs.
    Leak or leaking means any instance in which a PCB Article, PCB 
Container, or PCB Equipment has any PCBs on any portion of its external 
surface.
    Liquid PCBs means a homogenous flowable material containing PCBs and 
no more than 0.5 percent by weight non-dissolved material.
    Low occupancy area means any area where PCB remediation waste has 
been disposed of on-site and where occupancy for any individual not 
wearing dermal and respiratory protection for a calendar year is: less 
than 840 hours (an average of 16.8 hours per week) for non-porous 
surfaces and less than 335 hours (an average of 6.7 hours per week) for 
bulk PCB remediation waste. Examples could include an electrical 
substation or a location in an industrial facility where a worker spends 
small amounts of time per week (such as an unoccupied area outside a 
building, an electrical equipment vault, or in the non-office space in a 
warehouse where occupancy is transitory).
    Manifest means the shipping document EPA form 8700-22 and any 
continuation sheet attached to EPA form 8700-22, originated and signed 
by the generator of PCB waste in accordance with the instructions 
included with the form and subpart K of this part.
    Manned Control Center means an electrical power distribution control 
room where the operating conditions of a PCB Transformer are 
continuously monitored during the normal hours of operation (of the 
facility), and, where the duty engineers, electricians, or other trained 
personnel have the capability to deenergize a PCB Transformer completely 
within 1 minute of the receipt of a signal indicating abnormal operating 
conditions such as an overtemperature condition or overpressure 
condition in a PCB Transformer.
    Manufacture means to produce, manufacture, or import into the 
customs territory of the United States.
    Manufacturing process means all of a series of unit operations 
operating at a site, resulting in the production of a product.
    Mark means the descriptive name, instructions, cautions, or other 
information applied to PCBs and PCB Items, or other objects subject to 
these regulations.
    Marked means the marking of PCB Items and PCB storage areas and 
transport vehicles by means of applying a legible mark by painting, 
fixation of an adhesive label, or by any other method that meets the 
requirements of these regulations.
    Market/Marketers means the processing or distributing in commerce, 
or the person who processes or distributes in commerce, used oil fuels 
to burners or other marketers, and may include the generator of the fuel 
if it markets the fuel directly to the burner.
    Mineral Oil PCB Transformer means any transformer originally 
designed to contain mineral oil as the dielectric fluid and which has 
been tested and found to contain 500 ppm or greater PCBs.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that such term does 
include any combination which occurs, in whole or in part, as a result 
of a chemical reaction if none of the chemical substances comprising the 
combination is a new chemical substance and if the combination could 
have been manufactured for commercial purposes without a chemical 
reaction at the time the chemical substances comprising the combination 
were combined.
    Municipal solid wastes means garbage, refuse, sludges, wastes, and 
other discarded materials resulting from residential and non-industrial 
operations and activities, such as household activities, office 
functions, and commercial housekeeping wastes.
    Natural gas pipeline system means natural gas gathering facilities, 
natural gas pipe, natural gas compressors, natural gas storage 
facilities, and natural gas pipeline appurtenances (including 
instrumentation and vessels directly in contact with transported natural 
gas

[[Page 519]]

such as valves, regulators, drips, filter separators, etc., but not 
including air compressors).
    Non-liquid PCBs means materials containing PCBs that by visual 
inspection do not flow at room temperature (25  deg.C or 77  deg.F) or 
from which no liquid passes when a 100 g or 100 ml representative sample 
is placed in a mesh number 60  5 percent paint filter and 
allowed to drain at room temperature for 5 minutes.
    Non-PCB Transformer means any transformer that contains less than 50 
ppm PCB; except that any transformer that has been converted from a PCB 
Transformer or a PCB-Contaminated Transformer cannot be classified as a 
non-PCB Transformer until reclassification has occurred, in accordance 
with the requirements of Sec. 761.30(a)(2)(v).
    Non-porous surface means a smooth, unpainted solid surface that 
limits penetration of liquid containing PCBs beyond the immediate 
surface. Examples are: smooth uncorroded metal; natural gas pipe with a 
thin porous coating originally applied to inhibit corrosion; smooth 
glass; smooth glazed ceramics; impermeable polished building stone such 
as marble or granite; and high density plastics, such as polycarbonates 
and melamines, that do not absorb organic solvents.
    NTIS means the National Technical Information Service, U.S. 
Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161.
    On site means within the boundaries of a contiguous property unit.
    Open burning means the combustion of any PCB regulated for disposal, 
in a manner not approved or otherwise allowed under subpart D of this 
part, and without any of the following:
    (1) Control of combustion air to maintain adequate temperature for 
efficient combustion.
    (2) Containment of the combustion reaction in an enclosed device to 
provide sufficient residence time and mixing for complete combustion.
    (3) Control of emission of the gaseous combustion products.
    PCB and PCBs means any chemical substance that is limited to the 
biphenyl molecule that has been chlorinated to varying degrees or any 
combination of substances which contains such substance. Refer to 
Sec. 761.1(b) for applicable concentrations of PCBs. PCB and PCBs as 
contained in PCB items are defined in Sec. 761.3. For any purposes under 
this part, inadvertently generated non-Aroclor PCBs are defined as the 
total PCBs calculated following division of the quantity of 
monochlorinated biphenyls by 50 and dichlorinated biphenyls by 5.
    PCB Article means any manufactured article, other than a PCB 
Container, that contains PCBs and whose surface(s) has been in direct 
contact with PCBs. ``PCB Article'' includes capacitors, transformers, 
electric motors, pumps, pipes and any other manufactured item (1) which 
is formed to a specific shape or design during manufacture, (2) which 
has end use function(s) dependent in whole or in part upon its shape or 
design during end use, and (3) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the PCB Article.
    PCB Article Container means any package, can, bottle, bag, barrel, 
drum, tank, or other device used to contain PCB Articles or PCB 
Equipment, and whose surface(s) has not been in direct contact with 
PCBs.
    PCB bulk product waste means waste derived from manufactured 
products containing PCBs in a non-liquid state, at any concentration 
where the concentration at the time of designation for disposal was 
50 ppm PCBs. PCB bulk product waste does not include PCBs or 
PCB Items regulated for disposal under Sec. 761.60(a) through (c), 
Sec. 761.61, Sec. 761.63, or Sec. 761.64. PCB bulk product waste 
includes, but is not limited to:
    (1) Non-liquid bulk wastes or debris from the demolition of 
buildings and other man-made structures manufactured, coated, or 
serviced with PCBs. PCB bulk product waste does not include debris from 
the demolition of buildings or other man-made structures that is 
contaminated by spills from regulated PCBs which have not been disposed 
of, decontaminated, or otherwise cleaned up in accordance with subpart D 
of this part.

[[Page 520]]

    (2) PCB-containing wastes from the shredding of automobiles, 
household appliances, or industrial appliances.
    (3) Plastics (such as plastic insulation from wire or cable; radio, 
television and computer casings; vehicle parts; or furniture laminates); 
preformed or molded rubber parts and components; applied dried paints, 
varnishes, waxes or other similar coatings or sealants; caulking; 
adhesives; paper; Galbestos; sound deadening or other types of 
insulation; and felt or fabric products such as gaskets.
    (4) Fluorescent light ballasts containing PCBs in the potting 
material.
    PCB Capacitor means any capacitor that contains 500 ppm 
PCB. Concentration assumptions applicable to capacitors appear under 
Sec. 761.2.
    PCB Container means any package, can, bottle, bag, barrel, drum, 
tank, or other device that contains PCBs or PCB Articles and whose 
surface(s) has been in direct contact with PCBs.
    PCB-Contaminated means a non-liquid material containing PCBs at 
concentrations 50 ppm but <500 ppm; a liquid material 
containing PCBs at concentrations 50 ppm but <500 ppm or 
where insufficient liquid material is available for analysis, a non-
porous surface having a surface concentration >10 g/100 
cm2 but <100 g/100 cm2, measured by a 
standard wipe test as defined in Sec. 761.123.
    PCB-Contaminated Electrical Equipment means any electrical equipment 
including, but not limited to, transformers (including those used in 
railway locomotives and self-propelled cars), capacitors, circuit 
breakers, reclosers, voltage regulators, switches (including 
sectionalizers and motor starters), electromagnets, and cable, that 
contains PCBs at concentrations of 50 ppm and <500 ppm in the 
contaminating fluid. In the absence of liquids, electrical equipment is 
PCB-Contaminated if it has PCBs at >10 g/100 cm2 and 
<100 g/100 cm2 as measured by a standard wipe test 
(as defined in Sec. 761.123) of a non-porous surface.
    PCB Equipment means any manufactured item, other than a PCB 
Container or a PCB Article Container, which contains a PCB Article or 
other PCB Equipment, and includes microwave ovens, electronic equipment, 
and fluorescent light ballasts and fixtures.
    PCB field screening test means a portable analytical device or kit 
which measures PCBs. PCB field screening tests usually report less than 
or greater than a specific numerical PCB concentration. These tests 
normally build in a safety factor which increases the probability of a 
false positive report and decreases the probability of a false negative 
report. PCB field screening tests do not usually provide: an identity 
record generated by an instrument; a quantitative comparison record from 
calibration standards; any identification of PCBs; and/or any indication 
or identification of interferences with the measurement of the PCBs. PCB 
field screening test technologies include, but are not limited to, total 
chlorine colorimetric tests, total chlorine x-ray fluorescence tests, 
total chlorine microcoulometric tests, and rapid immunoassay tests.
    PCB household waste means PCB waste that is generated by residents 
on the premises of a temporary or permanent residence for individuals 
(including individually owned or rented units of a multi-unit 
construction), and that is composed primarily of materials found in 
wastes generated by consumers in their homes. PCB household waste 
includes unwanted or discarded non-commercial vehicles (prior to 
shredding), household items, and appliances or appliance parts and 
wastes generated on the premises of a residence for individuals as a 
result of routine household maintenance by or on behalf of the resident. 
Bulk or commingled liquid PCB wastes at concentrations of 50 
ppm, demolition and renovation wastes, and industrial or heavy duty 
equipment with PCBs are not household wastes.
    PCB Item means any PCB Article, PCB Article Container, PCB 
Container, PCB Equipment, or anything that deliberately or 
unintentionally contains or has as a part of it any PCB or PCBs.
    PCB/radioactive waste means PCBs regulated for disposal under 
subpart D of this part that also contain source, special nuclear, or 
byproduct material subject to regulation under the Atomic

[[Page 521]]

Energy Act of 1954, as amended, or naturally-occurring or accelerator-
produced radioactive material.
     PCB remediation waste means waste containing PCBs as a result of a 
spill, release, or other unauthorized disposal, at the following 
concentrations: Materials disposed of prior to April 18, 1978, that are 
currently at concentrations  50 ppm PCBs, regardless of the 
concentration of the original spill; materials which are currently at 
any volume or concentration where the original source was  
500 ppm PCBs beginning on April 18, 1978, or  50 ppm PCBs 
beginning on July 2, 1979; and materials which are currently at any 
concentration if the PCBs are spilled or released from a source not 
authorized for use under this part. PCB remediation waste means soil, 
rags, and other debris generated as a result of any PCB spill cleanup, 
including, but not limited to:
    (1) Environmental media containing PCBs, such as soil and gravel; 
dredged materials, such as sediments, settled sediment fines, and 
aqueous decantate from sediment.
    (2) Sewage sludge containing <50 ppm PCBs and not in use according 
to Sec. 761.20(a)(4); PCB sewage sludge; commercial or industrial sludge 
contaminated as the result of a spill of PCBs including sludges located 
in or removed from any pollution control device; aqueous decantate from 
an industrial sludge.
    (3) Buildings and other man-made structures (such as concrete 
floors, wood floors, or walls contaminated from a leaking PCB or PCB-
Contaminated Transformer), porous surfaces, and non-porous surfaces.
    PCB sewage sludge means sewage sludge as defined in 40 CFR 503.9(w) 
which contains 50 ppm PCBs, as measured on a dry weight 
basis.
    PCB Transformer means any transformer that contains 500 
ppm PCBs. For PCB concentration assumptions applicable to transformers 
containing 1.36 kilograms (3 lbs.) or more of fluid other than mineral 
oil, see Sec. 761.2. For provisions permitting reclassification of 
electrical equipment, including PCB Transformers, containing 
500 ppm PCBs to PCB-Contaminated Electrical Equipment, see 
Sec. 761.30(a) and (h).
    PCB waste(s) means those PCBs and PCB Items that are subject to the 
disposal requirements of subpart D of this part.
    Performance-based organic decontamination fluid (PODF) means 
kerosene, diesel fuel, terpene hydrocarbons, and terpene hydrocarbon/
alcohol mixtures.
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any State or 
political subdivision thereof; any interstate body; and any department, 
agency, or instrumentality of the Federal Government.
    Porous surface means any surface that allows PCBs to penetrate or 
pass into itself including, but not limited to, paint or coating on 
metal; corroded metal; fibrous glass or glass wool; unglazed ceramics; 
ceramics with a porous glaze; porous building stone such as sandstone, 
travertine, limestone, or coral rock; low-density plastics such as 
styrofoam and low-density polyethylene; coated (varnished or painted) or 
uncoated wood; concrete or cement; plaster; plasterboard; wallboard; 
rubber; fiberboard; chipboard; asphalt; or tar paper. For purposes of 
cleaning and disposing of PCB remediation waste, porous surfaces have 
different requirements than non-porous surfaces.
    Posing an exposure risk to food or feed means being in any location 
where human food or animal feed products could be exposed to PCBs 
released from a PCB Item. A PCB Item poses an exposure risk to food or 
feed if PCBs released in any way from the PCB Item have a potential 
pathway to human food or animal feed. EPA considers human food or animal 
feed to include items regulated by the U.S. Department of Agriculture or 
the Food and Drug Administration as human food or animal feed; this 
includes direct additives. Food or feed is excluded from this definition 
if it is used or stored in private homes.
    Process means the preparation of a chemical substance or mixture, 
after its manufacture, for distribution in commerce:
    (1) In the same form or physical state as, or in a different form or 
physical

[[Page 522]]

state from, that in which it was received by the person so preparing 
such substance or mixture, or
    (2) As part of an article containing the chemical substance or 
mixture.
    Qualified incinerator means one of the following:
    (1) An incinerator approved under the provisions of Sec. 761.70. Any 
level of PCB concentration can be destroyed in an incinerator approved 
under Sec. 761.70.
    (2) A high efficiency boiler which complies with the criteria of 
Sec. 761.71(a)(1), and for which the operator has given written notice 
to the appropriate EPA Regional Administrator in accordance with the 
notification requirements for the burning of mineral oil dielectric 
fluid under Sec. 761.71(a)(2).
    (3) An incinerator approved under section 3005(c) of the Resource 
Conservation and Recovery Act (42 U.S.C. 6925(c)) (RCRA).
    (4) Industrial furnaces and boilers which are identified in 40 CFR 
260.10 and 40 CFR 279.61 (a)(1) and (2) when operating at their normal 
operating temperatures (this prohibits feeding fluids, above the level 
of detection, during either startup or shutdown operations).
    Quantifiable Level/Level of Detection means 2 micrograms per gram 
from any resolvable gas chromatographic peak, i.e. 2 ppm.
    RCRA means the Resource Conservation and Recovery Act (40 U.S.C. 
6901 et seq.).
    Recycled PCBs means those PCBs which appear in the processing of 
paper products or asphalt roofing materials from PCB-contaminated raw 
materials. Processes which recycle PCBs must meet the following 
requirements:
    (1) There are no detectable concentrations of PCBs in asphalt 
roofing material products leaving the processing site.
    (2) The concentration of PCBs in paper products leaving any 
manufacturing site processing paper products, or in paper products 
imported into the United States, must have an annual average of less 
than 25 ppm with a 50 ppm maximum.
    (3) The release of PCBs at the point at which emissions are vented 
to ambient air must be less than 10 ppm.
    (4) The amount of Aroclor PCBs added to water discharged from an 
asphalt roofing processing site must at all times be less than 3 
micrograms per liter (g/L) for total Aroclors (roughly 3 parts 
per billion (3 ppb)). Water discharges from the processing of paper 
products must at all times be less than 3 micrograms per liter 
(g/L) for total Aroclors (roughly 3 ppb), or comply with the 
equivalent mass-based limitation.
    (5) Disposal of any other process wastes at concentrations of 50 ppm 
or greater must be in accordance with subpart D of this part.
    Research and development (R&D) for PCB disposal means demonstrations 
for commercial PCB disposal approvals, pre-demonstration tests, tests of 
major modifications to previously approved PCB disposal technologies, 
treatability studies for PCB disposal technologies which have not been 
approved, development of new disposal technologies, and research on 
chemical transformation processes including, but not limited to, 
biodegradation.
    Retrofill means to remove PCB or PCB-contaminated dielectric fluid 
and to replace it with either PCB, PCB-contaminated, or non-PCB 
dielectric fluid.
    Rupture of a PCB Transformer means a violent or non-violent break in 
the integrity of a PCB Transformer caused by an overtemperature and/or 
overpressure condition that results in the release of PCBs.
    Sale for purposes other than resale means sale of PCBs for purposes 
of disposal and for purposes of use, except where use involves sale for 
distribution in commerce. PCB Equipment which is first leased for 
purposes of use any time before July 1, 1979, will be considered sold 
for purposes other than resale.
    Sewage sludge means sewage sludge as defined in Sec. 503.9(w) of 
this chapter that contains <50 ppm (on a dry weight basis) PCBs.
    Small quantities for research and development means any quantity of 
PCBs (1) that is originally packaged in one or more hermetically sealed 
containers of a volume of no more than five (5.0) milliliters, and (2) 
that is used only for purposes of scientific experimentation or 
analysis, or chemical research on, or analysis of, PCBs, but not for 
research

[[Page 523]]

or analysis for the development of a PCB product.
    Soil washing means the extraction of PCBs from soil using a solvent, 
recovering the solvent from the soil, separating the PCBs from the 
recovered solvent for disposal, and then disposal or reuse of the 
solvent.
    Standard wipe sample means a sample collected for chemical 
extraction and analysis using the standard wipe test as defined in 
Sec. 761.123. Except as designated elsewhere in part 761, the minimum 
surface area to be sampled shall be 100 cm2.
    Storage for disposal means temporary storage of PCBs that have been 
designated for disposal.
    SW-846 means the document having the title ``SW-846, Test Methods 
for Evaluating Solid Waste,'' which is available from either the 
National Technical Information Service (NTIS, U.S. Department of 
Commerce, 5285 Port Royal Rd., Springfield, VA 22161, telephone: (703) 
487-4650 or the U.S. Government Printing Office (U.S. GPO, 710 North 
Capitol St., NW., Washington, DC 20401, telephone: (202) 783-3238.
    Totally enclosed manner means any manner that will ensure no 
exposure of human beings or the environment to any concentration of 
PCBs.
    Transfer facility means any transportation-related facility 
including loading docks, parking areas, and other similar areas where 
shipments of PCB waste are held during the normal course of 
transportation. Transport vehicles are not transfer facilities under 
this definition, unless they are used for the storage of PCB waste, 
rather than for actual transport activities. Storage areas for PCB waste 
at transfer facilities are subject to the storage facility standards of 
Sec. 761.65, but such storage areas are exempt from the approval 
requirements of Sec. 761.65(d) and the recordkeeping requirements of 
Sec. 761.180, unless the same PCB waste is stored there for a period of 
more than 10 consecutive days between destinations.
    Transporter of PCB waste means, for the purposes of subpart K of 
this part, any person engaged in the transportation of regulated PCB 
waste by air, rail, highway, or water for purposes other than 
consolidation by a generator.
    Transport vehicle means a motor vehicle or rail car used for the 
transportation of cargo by any mode. Each cargo-carrying body (e.g., 
trailer, railroad freight car) is a separate transport vehicle.
    Treatability Study means a study in which PCB waste is subjected to 
a treatment process to determine:
    (1) Whether the waste is amenable to the treatment process;
    (2) What pretreatment (if any) is required;
    (3) The optimal process conditions needed to achieve the desired 
treatment;
    (4) The efficiency of a treatment process for the specific type of 
waste (i.e., soil, sludge, liquid, etc.); or,
    (5) The characteristics and volumes of residuals from a particular 
treatment process. A ``treatability study'' is not a mechanism to 
commercially treat or dispose of PCB waste. Treatment is a form of 
disposal under this part.
    TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et 
seq.).
    TSCA PCB Coordinated Approval means the process used to recognize 
other Federal or State waste management documents governing the storage, 
cleanup, treatment, and disposal of PCB wastes. It is the mechanism 
under TSCA for accomplishing review, coordination, and approval of PCB 
waste management activities which are conducted outside of the TSCA PCB 
approval process, but require approval under the TSCA PCB regulations at 
40 CFR part 761.
    Unit means a particular building, structure, or cell used to manage 
PCB waste (including, but not limited to, a building used for PCB waste 
storage, a landfill, an industrial boiler, or an incinerator).
    U.S. GPO means the U.S. Government Printing Office, 710 North 
Capitol St., NW., Washington, DC 20401.
    Waste Oil means used products primarily derived from petroleum, 
which include, but are not limited to, fuel oils, motor oils, gear oils, 
cutting oils, transmission fluids, hydraulic fluids, and dielectric 
fluids.

[[Page 524]]

    Wet weight means reporting chemical analysis results by including 
either the weight, or the volume and density, of all liquids.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[49 FR 25239, June 20, 1984, as amended at 49 FR 28189, July 10, 1984; 
49 FR 29066, July 18, 1984; 49 FR 44638, Nov. 8, 1984; 50 FR 29199, July 
17, 1985; 50 FR 32176, Aug. 9, 1985; 53 FR 24220, June 27, 1988; 53 FR 
27327, July 19, 1988; 54 FR 52745, Dec. 21, 1989; 55 FR 26205, June 27, 
1990; 58 FR 32061, June 8, 1993; 61 FR 11106, Mar. 18, 1996; 63 FR 
35437, June 29, 1998; 64 FR 33759, June 24, 1999]



Sec. 761.19  References.

    (a) [Reserved]
    (b) Incorporation by reference. The following material is 
incorporated by reference, and is available for inspection at the Office 
of the Federal Register, 800 North Capitol St., NW., Suite 700, 
Washington, DC. These incorporations by reference were approved by the 
Director of the Office of the Federal Register. These materials are 
incorporated as they exist on the date of approval and a notice of any 
change in these materials will be published in the Federal Register. 
Copies of the incorporated material are available for inspection at the 
TSCA Nonconfidential Information Center (7407), Rm. B607, Northeast 
Mall, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Copies of the 
incorporated material may be obtained from the American Society for 
Testing and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, 
PA 19428-2959.

------------------------------------------------------------------------
             References                          CFR Citation
------------------------------------------------------------------------
ASTM D 93 - 90 Standard Test         Sec.  761.71(b)(2)(vi); Sec.
 Methods for Flash Point by Pensky-   761.75(b)(8)(iii)
 Martens Closed Tester.
 
ASTM D 129-64 (Reapproved 1978)      Sec.  761.71(b)(2)(vi)
 Standard Test Method for Sulfur in
 Petroleum Products (General Bomb
 Method).
ASTM D 240-87 Standard Test Method   Sec.  761.71(b)(2)(vi)
 for Heat of Combustion of Liquid
 Hydrocarbon Fuel by Bomb
 Calorimeter.
ASTM D 482-87 Standard Test Method   Sec.  761.71(b)(2)(vi)
 for Ash from Petroleum Products.
ASTM D 524-88 Standard Test Method   Sec.  761.71(b)(2)(vi)
 for Ramsbottom Carbon Residue of
 Petroleum Products.
ASTM D 808-87 Standard Test Method   Sec.  761.71(b)(2)(vi)
 for Chlorine in New and Used
 Petroleum Products (Bomb Method).
ASTM D 923-86 Standard Test Method   Sec.  761.60(g)(1)(ii); (g)(2)(ii)
 for Sampling Electrical Insulating
 Liquids.
ASTM D 923-89 Standard Methods of    Sec.  761.60(g)(1)(ii); (g)(2)(ii)
 Sampling Electrical Insulating
 Liquids.
ASTM D 1266-87 Standard Test Method  Sec.  761.71(b)(2)(vi)
 for Sulfur in Petroleum Products
 (Lamp Method).
ASTM D 1796-83 (Reapproved 1990)     Sec.  761.71(b)(2)(vi)
 Standard Test Method for Water and
 Sediment in Fuel Oils by the
 Centrifuge Method (Laboratory
 Procedure).
ASTM D 2158-89 Standard Test Method  Sec.  761.71(b)(2)(vi)
 for Residues in Liquified
 Petroleum (LP) Gases.
ASTM D 2709-88 Standard Test Method  Sec.  761.71(b)(2)(vi)
 for Water and Sediment in
 Distillate Fuels by Centrifuge.
ASTM D 2784-89 Standard Test Method  Sec.  761.71(b)(2)(vi)
 for Sulfur in Liquified Petroleum
 Gases (Oxy-hydrogen Burner or
 Lamp).
ASTM D 3178-84 Standard Test         Sec.  761.71(b)(2)(vi)
 Methods for Carbon and Hydrogen in
 the Analysis Sample of Coke and
 Coal.
ASTM D 3278-89 Standard Test         Sec.  761.75(b)(8)(iii)
 Methods for Flash Point of Liquids
 by Setaflash Closed-Cup Apparatus.
ASTM E 258-67 (Reapproved 1987)      Sec.  761.71(b)(2)(vi)
 Standard Test Method for Total
 Nitrogen Inorganic Material by
 Modified KJELDAHL Method.
------------------------------------------------------------------------


[47 FR 22098, May 21, 1982, as amended at 49 FR 29067, July 18, 1984; 49 
FR 36648, Sept. 19, 1984; 53 FR 10391, Mar. 31, 1988; 53 FR 12524, Apr. 
15, 1988; 53 FR 21641, June 9, 1988; 57 FR 13323, Apr. 16, 1992; 59 FR 
33697, June 30, 1994; 60 FR 34465, July 3, 1995; 63 FR 35439, June 29, 
1998; 64 FR 33759, June 24, 1999]

[[Page 525]]



Subpart B--Manufacturing, Processing, Distribution in Commerce, and Use 
                          of PCBs and PCB Items



Sec. 761.20  Prohibitions and exceptions.

    Except as authorized in Sec. 761.30, the activities listed in 
paragraphs (a) and (d) of this section are prohibited pursuant to 
section 6(e)(2) of TSCA. The requirements set forth in paragraph (c) of 
this section and subpart F of this part concerning export and import of 
PCBs and PCB Items for disposal are established pursuant to section 
6(e)(1) of TSCA. Subject to any exemptions granted pursuant to section 
6(e)(3)(B) of TSCA, the activities listed in paragraphs (b) and (c) of 
this section are prohibited pursuant to section (6)(e)(3)(A) of TSCA. In 
addition, the Administrator hereby finds, under the authority of section 
12(a)(2) of TSCA, that the manufacture, processing, and distribution in 
commerce of PCBs at concentrations of 50 ppm or greater and PCB Items 
with PCB concentrations of 50 ppm or greater present an unreasonable 
risk of injury to health within the United States. This finding is based 
upon the well-documented human health and environmental hazard of PCB 
exposure, the high probability of human and environmental exposure to 
PCBs and PCB Items from manufacturing, processing, or distribution 
activities; the potential hazard of PCB exposure posed by the 
transportation of PCBs or PCB Items within the United States; and the 
evidence that contamination of the environment by PCBs is spread far 
beyond the areas where they are used. In addition, the Administrator 
hereby finds, for purposes of section 6(e)(2)(C) of TSCA, that any 
exposure of human beings or the environment to PCBs, as measured or 
detected by any scientifically acceptable analytical method, may be 
significant, depending on such factors as the quantity of PCBs involved 
in the exposure, the likelihood of exposure to humans and the 
environment, and the effect of exposure. For purposes of determining 
which PCB Items are totally enclosed, pursuant to section 6(e)(2)(C) of 
TSCA, since exposure to such Items may be significant, the Administrator 
further finds that a totally enclosed manner is a manner which results 
in no exposure to humans or the environment to PCBs. The following 
activities are considered totally enclosed: distribution in commerce of 
intact, nonleaking electrical equipment such as transformers (including 
transformers used in railway locomotives and self-propelled cars), 
capacitors, electromagnets, voltage regulators, switches (including 
sectionalizers and motor starters), circuit breakers, reclosers, and 
cable that contain PCBs at any concentration and processing and 
distribution in commerce of PCB Equipment containing an intact, 
nonleaking PCB Capacitor. See paragraph (c)(1) of this section for 
provisions allowing the distribution in commerce of PCBs and PCB Items.
    (a) No persons may use any PCB, or any PCB Item regardless of 
concentration, in any manner other than in a totally enclosed manner 
within the United States unless authorized under Sec. 761.30, except 
that:
    (1) An authorization is not required to use those PCBs or PCB Items 
which consist of excluded PCB products as defined in Sec. 761.3.
    (2) An authorization is not required to use those PCBs or PCB Items 
resulting from an excluded manufacturing process or recycled PCBs as 
defined in Sec. 761.3, provided all applicable conditions of 
Sec. 761.1(f) are met.
    (3) An authorization is not required to use those PCB Items which 
contain or whose surfaces have been in contact with excluded PCB 
products as defined in Sec. 761.3.
    (4) An authorization is not required to use sewage sludge where the 
uses are regulated at parts 257, 258, and 503 of this chapter. No person 
may blend or otherwise dilute PCBs regulated for disposal, including PCB 
sewage sludge and sewage sludge not used pursuant to parts 257, 258, and 
503 of this chapter, for purposes of use or to avoid disposal 
requirements under this part. Except as explicitly provided in subpart D 
of this part, no person may dispose of regulated PCB wastes including, 
but not limited to, PCB remediation waste, PCB bulk product waste, PCBs, 
and PCB industrial sludges, into treatment

[[Page 526]]

works, as defined in Sec. 503.9(aa) of this chapter.
    (b) No person may manufacture PCBs for use within the United States 
or manufacture PCBs for export from the United States without an 
exemption, except that: an exemption is not required for PCBs 
manufactured in an excluded manufacturing process as defined in 
Sec. 761.3, provided all applicable conditions of Sec. 761.1(f) are met.
    (c) No persons may process or distribute in commerce any PCB, or any 
PCB Item regardless of concentration, for use within the United States 
or for export from the United States without an exemption, except that 
an exemption is not required to process or distribute in commerce PCBs 
or PCB Items resulting from an excluded manufacturing process as defined 
in Sec. 761.3, or to process or distribute in commerce recycled PCBs as 
defined in Sec. 761.3, or to process or distribute in commerce excluded 
PCB products as defined in Sec. 761.3, provided that all applicable 
conditions of Sec. 761.1(f) are met. In addition, the activities 
described in paragraphs (c) (1) through (5) of this section may also be 
conducted without an exemption, under the conditions specified therein.
    (1) PCBs at concentrations of 50 ppm or greater, or PCB Items with 
PCB concentrations of 50 ppm or greater, sold before July 1, 1979 for 
purposes other than resale may be distributed in commerce only in a 
totally enclosed manner after that date.
    (2) Any person may process and distribute in commerce for disposal 
PCBs at concentrations of 50 ppm, or PCB Items with PCB 
concentrations of 50 ppm, if they comply with the applicable 
provisions of this part.
    (i) Processing activities which are primarily associated with and 
facilitate storage or transportation for disposal do not require a TSCA 
PCB storage or disposal approval.
    (ii) Processing activities which are primarily associated with and 
facilitate treatment, as defined in Sec. 260.10 of this chapter, or 
disposal require a TSCA PCB disposal approval unless they are part of an 
existing approval, are part of a self-implementing activity under 
Sec. 761.61(a) or Sec. 761.79 (b) or (c), or are otherwise specifically 
allowed under subpart D of this part.
    (iii) With the exception of provisions in Sec. 761.60 (a)(2) and 
(a)(3), in order to meet the intent of Sec. 761.1(b), processing, 
diluting, or otherwise blending of waste prior to being introduced into 
a disposal unit for purposes of meeting a PCB concentration limit shall 
be done in accordance with a TSCA PCB disposal approval or comply with 
the requirements of Sec. 761.79.
    (iv) Where the rate of delivering liquids or non-liquids into a PCB 
disposal unit is an operating parameter, this rate shall be a condition 
of the TSCA PCB disposal approval for the unit when an approval is 
required.
    (3) PCBs and PCB Items may be exported for disposal in accordance 
with the requirements of subpart F of this part.
    (4) PCBs, at concentrations of less than 50 ppm, or PCB Items, with 
concentrations of less than 50 ppm, may be processed and distributed in 
commerce for purposes of disposal.
    (5) Decontaminated materials. Any person may distribute in commerce 
equipment, structures, or other liquid or non-liquid materials that were 
contaminated with PCBs 50 ppm, including those not otherwise 
authorized for distribution in commerce under this part, provided that 
one of the following applies:
    (i) The materials were decontaminated in accordance with a TSCA PCB 
disposal approval issued under subpart D of this part, with Sec. 761.79, 
or with applicable EPA PCB spill cleanup policies in effect at the time 
of the decontamination.
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec. 761.79(b).
    (d) The use of waste oil that contains any detectable concentration 
of PCB as a sealant, coating, or dust control agent is prohibited. 
Prohibited uses include, but are not limited to, road oiling, general 
dust control, use as a pesticide or herbicide carrier, and use as a rust 
preventative on pipes.
    (e) In addition to any applicable requirements under 40 CFR part 
279, subparts G and H, marketers and burners

[[Page 527]]

of used oil who market (process or distribute in commerce) for energy 
recovery, used oil containing any quantifiable level of PCBs are subject 
to the following requirements:
    (1) Restrictions on marketing. Used oil containing any quantifiable 
level of PCBs (2 ppm) may be marketed only to:
    (i) Qualified incinerators as defined in 40 CFR 761.3.
    (ii) Marketers who market off-specification used oil for energy 
recovery only to other marketers who have notified EPA of their used oil 
management activities, and who have an EPA identification number where 
an identification number is required by 40 CFR 279.73. This would 
include persons who market off-specification used oil who are subject to 
the requirements at 40 CFR part 279 and the notification requirements of 
40 CFR 279.73.
    (iii) Burners identified in 40 CFR 279.61(a)(1) and (2). Only 
burners in the automotive industry may burn used oil generated from 
automotive sources in used oil-fired space heaters provided the 
provisions of 40 CFR 279.23 are met. The Regional Administrator may 
grant a variance for a boiler that does not meet the 40 CFR 279.61(a)(1) 
and (2) criteria after considering the criteria listed in 40 CFR 260.32 
(a) through (f). The applicant must address the relevant criteria 
contained in 40 CFR 260.32 (a) through (f) in an application to the 
Regional Administrator.
    (2) Testing of used oil fuel. Used oil to be burned for energy 
recovery is presumed to contain quantifiable levels (2 ppm) of PCB 
unless the marketer obtains analyses (testing) or other information that 
the used oil fuel does not contain quantifiable levels of PCBs.
    (i) The person who first claims that a used oil fuel does not 
contain quantifiable level (2 ppm) PCB must obtain analyses or other 
information to support that claim.
    (ii) Testing to determine the PCB concentration in used oil may be 
conducted on individual samples, or in accordance with the testing 
procedures described in Sec. 761.60(g)(2). However, for purposes of this 
part, if any PCBs at a concentration of 50 ppm or greater have been 
added to the container or equipment, then the total container contents 
must be considered as having a PCB concentration of 50 ppm or greater 
for purposes of complying with the disposal requirements of this part.
    (iii) Other information documenting that the used oil fuel does not 
contain quantifiable levels (2 ppm) of PCBs may consist of either 
personal, special knowledge of the source and composition of the used 
oil, or a certification from the person generating the used oil claiming 
that the oil contains no detectable PCBs.
    (3) Restrictions on burning. (i) Used oil containing any 
quantifiable levels of PCB may be burned for energy recovery only in the 
combustion facilities identified in paragraph (e)(1) of this section 
when such facilities are operating at normal operating temperatures 
(this prohibits feeding these fuels during either startup or shutdown 
operations). Owners and operators of such facilities are ``burners'' of 
used oil fuels.
    (ii) Before a burner accepts from a marketer the first shipment of 
used oil fuel containing detectable PCBs (2 ppm), the burner must 
provide the marketer a one-time written and signed notice certifying 
that:
    (A) The burner has complied with any notification requirements 
applicable to ``qualified incinerators'' (Sec. 761.3) or to ``burners'' 
regulated under 40 CFR part 279, subpart G.
    (B) The burner will burn the used oil only in a combustion facility 
identified in paragraph (e)(1) of this section and identify the class of 
burner he qualifies.
    (4) Recordkeeping requirements. The following recordkeeping 
requirements are in addition to the recordkeeping requirements for 
marketers found in 40 CFR 279.72(b), 279.74(a), (b) and (c), and 279.75, 
and for burners found in 40 CFR 279.65 and 279.66.
    (i) Marketers. Marketers who first claim that the used oil fuel 
contains no detectable PCBs must include among the records required by 
40 CFR 279.72(b) and 279.74(b) and (c), copies of the analysis or other 
information documenting his claim, and he must include among the records 
required by 40 CFR 279.74(a) and (c) and 279.75, a copy of each 
certification notice received or prepared relating to transactions 
involving PCB-containing used oil.

[[Page 528]]

    (ii) Burners. Burners must include among the records required by 40 
CFR 279.65 and 279.66, a copy of each certification notice required by 
paragraph (e)(3)(ii) of this section that he sends to a marketer.


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020, (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 49 FR 25241, June 20, 1984; 49 FR 28190, July 10, 1984; 
49 FR 44638, Nov. 8, 1984; 53 FR 12524, Apr. 15, 1988; 53 FR 24220, June 
27, 1988; 58 FR 15435, Mar. 23, 1993; 58 FR 34205, June 23, 1993; 60 FR 
34465, July 3, 1995; 61 FR 11106, Mar. 18, 1996; 63 FR 35439, June 29, 
1998; 64 FR 33760, June 24, 1999]



Sec. 761.30  Authorizations.

    The following non-totally enclosed PCB activities are authorized 
pursuant to section 6(e)(2)(B) of TSCA:
    (a) Use in and servicing of transformers (other than railroad 
transformers). PCBs at any concentration may be used in transformers 
(other than in railroad locomotives and self-propelled railroad cars) 
and may be used for purposes of servicing including rebuilding these 
transformers for the remainder of their useful lives, subject to the 
following conditions:
    (1) Use conditions. (i) As of October 1, 1985, the use and storage 
for reuse of PCB Transformers that pose an exposure risk to food or feed 
is prohibited.
    (ii) As of October 1, 1990, the use of network PCB Transformers with 
higher secondary voltages (secondary voltages equal to or greater than 
480 volts, including 480/277 volt systems) in or near commercial 
buildings is prohibited. Network PCB Transformers with higher secondary 
voltages which are removed from service in accordance with this 
requirement must either be reclassified to PCB Contaminated or non PCB 
status, placed into storage for disposal, or disposed.
    (iii) Except as otherwise provided, as of October 1, 1985, the 
installation of PCB Transformers, which have been placed into storage 
for reuse or which have been removed from another location, in or near 
commercial buildings is prohibited.
    (A) Retrofilled mineral oil PCB Transformers may be installed for 
reclassification purposes indefinitely after October 1, 1990.
    (B) Once a retrofilled transformer has been installed for 
reclassification purposes, it must be tested 3 months after installation 
to ascertain the concentration of PCBs. If the PCB concentration is 
below 50 ppm, the transformer can be reclassified as a non-PCB 
Transformer. If the PCB concentration is between 50 and 500 ppm, the 
transformer can be reclassified as a PCB-Contaminated transformer. If 
the PCB concentration remains at 500 ppm or greater, the entire process 
must either be repeated until the transformer has been reclassified to a 
non-PCB or PCB-Contaminated transformer in accordance with paragraph 
(a)(2)(v) of this section or the transformer must be removed from 
service.
    (iv) As of October 1, 1990, all higher secondary voltage radial PCB 
Transformers, in use in or near commercial buildings, and lower 
secondary voltage network PCB Transformers not located in sidewalk 
vaults in or near commercial buildings (network transformers with 
secondary voltages below 480 volts) that have not been removed from 
service as provided in paragraph (a)(1)(iv)(B) of this section, must be 
equipped with electrical protection to avoid transformer ruptures caused 
by high current faults. As of February 25, 1991, all lower secondary 
voltage radial PCB Transformers, in use in or near commercial buildings, 
must be equipped with electrical protection to avoid transformer 
ruptures caused by high current faults.
    (A) Current-limiting fuses or other equivalent technology must be 
used to detect sustained high current faults and provide for the 
complete deenergization of the transformer (within several hundredths of 
a second in the case of higher secondary voltage radial PCB Transformers 
and within tenths of a second in the case of lower secondary voltage 
network PCB Transformers), before transformer rupture occurs. Lower 
secondary voltage radial PCB Transformers must be equipped with 
electrical protection as provided in paragraph (a)(1)(iv)(E) of this 
section. The installation, setting, and maintenance of current-limiting 
fuses or other equivalent technology to

[[Page 529]]

avoid PCB Transformer ruptures from sustained high current faults must 
be completed in accordance with good engineering practices.
    (B) All lower secondary voltage network PCB Transformers not located 
in sidewalk vaults (network transformers with secondary voltages below 
480 volts), in use in or near commercial buildings, which have not been 
protected as specified in paragraph (a)(1)(iv)(A) of this section by 
October 1, 1990, must be removed from service by October 1, 1993.
    (C) As of October 1, 1990, owners of lower secondary voltage network 
PCB Transformers, in use in or near commercial buildings which have not 
been protected as specified in paragraph (a)(1)(iv)(A) of this section 
and which are not located in sidewalk vaults, must register in writing 
those transformers with the EPA Regional Administrator in the 
appropriate region. The information required to be provided in writing 
to the Regional Administrator includes:
    (1) The specific location of the PCB Transformer(s).
    (2) The address(es) of the building(s) and the physical location of 
the PCB Transformer(s) on the building site(s).
    (3) The identification number(s) of the PCB Transformer(s).
    (D) As of October 1, 1993, all lower secondary voltage network PCB 
Transformers located in sidewalk vaults (network transformers with 
secondary voltages below 480 volts) in use near commercial buildings 
must be removed from service.
    (E) As of February 25, 1991, all lower secondary voltage radial PCB 
Transformers must be equipped with electrical protection, such as 
current-limiting fuses or other equivalent technology, to detect 
sustained high current faults and provide for the complete 
deenergization of the transformer or complete deenergization of the 
faulted phase of the transformer within several hundredths of a second. 
The installation, setting, and maintenance of current-limiting fuses or 
other equivalent technology to avoid PCB Transformer ruptures from 
sustained high current faults must be completed in accordance with good 
engineering practices.
    (v) As of October 1, 1990, all radial PCB Transformers with higher 
secondary voltages (480 volts and above, including 480/277 volt systems) 
in use in or near commercial buildings must, in addition to the 
requirements of paragraph (a)(1)(iv)(A) of this section, be equipped 
with protection to avoid transformer ruptures caused by sustained low 
current faults.
    (A) Pressure and temperature sensors (or other equivalent technology 
which has been demonstrated to be effective in early detection of 
sustained low current faults) must be used in these transformers to 
detect sustained low current faults.
    (B) Disconnect equipment must be provided to insure complete 
deenergization of the transformer in the event of a sensed abnormal 
condition (e.g., an overpressure or overtemperature condition in the 
transformer), caused by a sustained low current fault. The disconnect 
equipment must be configured to operate automatically within 30 seconds 
to 1 minute of the receipt of a signal indicating an abnormal condition 
from a sustained low current fault, or can be configured to allow for 
manual deenergization from a manned on-site control center upon the 
receipt of an audio or visual signal indicating an abnormal condition 
caused by a sustained low current fault. Manual deenergization from a 
manned on-site control center must occur within 1 minute of the receipt 
of the audio or visual signal indicating an abnormal condition caused by 
a sustained low current fault. If automatic operation is selected and a 
circuit breaker is utilized for disconnection, it must also have the 
capability to be manually opened if necessary.
    (C) The enhanced electrical protective system required for the 
detection of sustained low current faults and the complete and rapid 
deenergization of transformers must be properly installed, maintained, 
and set sensitive enough (in accordance with good engineering practices) 
to detect sustained low current faults and allow for rapid and total 
deenergization prior to PCB Transformer rupture (either violent or non 
violent rupture) and release of PCBs.

[[Page 530]]

    (vi)(A) No later than December 28, 1998 all owners of PCB 
Transformers, including those in storage for reuse, must register their 
transformers with the Environmental Protection Agency, National Program 
Chemicals Division, Office of Pollution Prevention and Toxics (7404), 
401 M St., SW., Washington, DC 20460. This registration requirement is 
subject to the limitations in paragraph (a)(1) of this section.
    (1) A transformer owner who assumes a transformer is a PCB-
Contaminated transformer, and discovers after December 28, 1998 that it 
is a PCB-Transformer, must register the newly-identified PCB 
Transformer, in writing, with the Environmental Protection Agency no 
later than 30 days after it is identified as such. This requirement does 
not apply to transformer owners who have previously registered with the 
EPA PCB Transformers located at the same address as the transformer that 
they assumed to be PCB-Contaminated and later determined to be a PCB 
Transformer.
    (2) A person who takes possession of a PCB Transformer after 
December 28, 1998 is not required to register or re-register the 
transformer with the EPA.
    (B) Any person submitting a registration under this section must 
include:
    (1) Company name and address.
    (2) Contact name and telephone number.
    (3) Address where these transformers are located. For mobile sources 
such as ships, provide the name of the ship.
    (4) Number of PCB Transformers and the total weight in kilograms of 
PCBs contained in the transformers.
    (5) Whether any transformers at this location contain flammable 
dielectric fluid (optional).
    (6) Signature of the owner, operator, or other authorized 
representative certifying the accuracy of the information submitted.
    (C) A transformer owner must retain a record of each PCB 
Transformer's registration (e.g., a copy of the registration and the 
return receipt signed by EPA) with the inspection and maintenance 
records required for each PCB Transformer under paragraph (a)(1)(xii)(I) 
of this section.
    (D) A transformer owner must comply with all requirements of 
paragraph (a)(1)(vi)(A) of this section to continue the PCB-
Transformer's authorization for use, or storage for reuse, pursuant to 
this section and TSCA section 6(e)(2)(B).
    (vii) As of December 1, 1985, PCB Transformers in use in or near 
commercial buildings must be registered with building owners. For PCB 
Transformers located in commercial buildings, PCB Transformer owners 
must register the transformers with the building owner of record. For 
PCB Transformers located near commercial buildings, PCB Transformer 
owners must register the transformers with all owners of buildings 
located within 30 meters of the PCB Transformer(s). Information required 
to be provided to building owners by PCB Transformer owners includes but 
is not limited to:
    (A) The specific location of the PCB Transformer(s).
    (B) The principal constituent of the dielectric fluid in the 
transformer(s) (e.g., PCBs, mineral oil, or silicone oil).
    (C) The type of transformer installation (e.g., 208/120 volt 
network, 208/120 volt radial, 208 volt radial, 480 volt network, 480/277 
volt network, 480 volt radial, 480/277 volt radial).
    (viii) As of December 1, 1985, combustible materials, including, but 
not limited to paints, solvents, plastics, paper, and sawn wood must not 
be stored within a PCB Transformer enclosure (i.e., in a transformer 
vault or in a partitioned area housing a transformer); within 5 meters 
of a transformer enclosure, or, if unenclosed (unpartitioned), within 5 
meters of a PCB Transformer.
    (ix) A visual inspection of each PCB Transformer (as defined in the 
definition of ``PCB Transformer'' under Sec. 761.3) in use or stored for 
reuse shall be performed at least once every 3 months. These inspections 
may take place any time during the 3-month periods: January-March, 
April-June, July-September, and October-December as long as there is a 
minimum of 30 days between inspections. The visual inspection must 
include investigation for any leak of dielectric fluid on or around the 
transformer. The extent of the visual inspections will depend on

[[Page 531]]

the physical constraints of each transformer installation and should not 
require an electrical shutdown of the transformer being inspected.
    (x) If a PCB Transformer is found to have a leak which results in 
any quantity of PCBs running off or about to run off the external 
surface of the transformer, then the transformer must be repaired or 
replaced to eliminate the source of the leak. In all cases any leaking 
material must be cleaned up and properly disposed of according to 
disposal requirements of subpart D of this part. Cleanup of the released 
PCBs must be initiated as soon as possible, but in no case later than 48 
hours of its discovery. Until appropriate action is completed, any 
active leak of PCBs must be contained to prevent exposure of humans or 
the environment and inspected daily to verify containment of the leak. 
Trenches, dikes, buckets, and pans are examples of proper containment 
measures.
    (xi) If a PCB Transformer is involved in a fire-related incident, 
the owner of the transformer must immediately report the incident to the 
National Response Center (toll-free 1-800-424-8802; in Washington, DC 
202-426-2675). A fire-related incident is defined as any incident 
involving a PCB Transformer which involves the generation of sufficient 
heat and/or pressure (by any source) to result in the violent or non-
violent rupture of a PCB Transformer and the release of PCBs. 
Information must be provided regarding the type of PCB Transformer 
installation involved in the fire-related incident (e.g., high or low 
secondary voltage network transformer, high or low secondary voltage 
simple radial system, expanded radial system, primary selective system, 
primary loop system, or secondary selective system or other systems) and 
the readily ascertainable cause of the fire-related incident (e.g., high 
current fault in the primary or secondary or low current fault in 
secondary). The owner of the PCB Transformer must also take measures as 
soon as practically and safely possible to contain and control any 
potential releases of PCBs and incomplete combustion products into 
water. These measures include, but are not limited to:
    (A) The blocking of all floor drains in the vicinity of the 
transformer.
    (B) The containment of water runoff.
    (C) The control and treatment (prior to release) of any water used 
in subsequent cleanup operations.
    (xii) Records of inspection and maintenance history shall be 
maintained at least 3 years after disposing of the transformer and shall 
be made available for inspection, upon request by EPA. Such records 
shall contain the following information for each PCB Transformer:
    (A) Its location.
    (B) The date of each visual inspection and the date that leak was 
discovered, if different from the inspection date.
    (C) The person performing the inspection.
    (D) The location of any leak(s).
    (E) An estimate of the amount of dielectric fluid released from any 
leak.
    (F) The date of any cleanup, containment, repair, or replacement.
    (G) A description of any cleanup, containment, or repair performed.
    (H) The results of any containment and daily inspection required for 
uncorrected active leaks.
    (I) Record of the registration of PCB Transformer(s).
    (J) Records of transfer of ownership in compliance with 
Sec. 761.180(a)(2)(ix).
    (xiii) A reduced visual inspection frequency of at least once every 
12 months applies to PCB Transformers that utilize either of the 
following risk reduction measures. These inspections may take place any 
time during the calendar year as long as there is a minimum of 180 days 
between inspections.
    (A) A PCB Transformer which has impervious, undrained, secondary 
containment capacity of at least 100 percent of the total dielectric 
fluid volume of all transformers so contained or
    (B) A PCB Transformer which has been tested and found to contain 
less than 60,000 ppm PCBs (after 3 months of in service use if the 
transformer has been serviced for purposes of reducing the PCB 
concentration).
    (xiv) An increased visual inspection frequency of at least once 
every week applies to any PCB Transformer in use or stored for reuse 
which poses an exposure risk to food or feed. The user of a PCB 
Transformer posing an exposure

[[Page 532]]

risk to food is responsible for the inspection, recordkeeping, and 
maintenance requirements under this section until the user notifies the 
owner that the transformer may pose an exposure risk to food or feed. 
Following such notification, it is the owner's ultimate responsibility 
to determine whether the PCB Transformer poses an exposure risk to food 
or feed.
    (xv) In the event a mineral oil transformer, assumed to contain less 
than 500 ppm of PCBs as provided in Sec. 761.2, is tested and found to 
be contaminated at 500 ppm or greater PCBs, it will be subject to all 
the requirements of this Part 761. In addition, efforts must be 
initiated immediately to bring the transformer into compliance in 
accordance with the following schedule:
    (A) Report fire-related incidents, effective immediately after 
discovery.
    (B) Mark the PCB transformer within 7 days after discovery.
    (C) Mark the vault door, machinery room door, fence, hallway or 
other means of access to the PCB Transformer within 7 days after 
discovery.
    (D) Register the PCB Transformer in writing with the building owner 
within 30 days of discovery.
    (E) Install electrical protective equipment on a radial PCB 
Transformer and a non-sidewalk vault, lower secondary voltage network 
PCB Transformer in or near a commercial building within 18 months of 
discovery or by October 1, 1990, whichever is later.
    (F) Remove a non-sidewalk vault, lower secondary voltage network PCB 
Transformer in or near a commercial building, if electrical protective 
equipment is not installed, within 18 months of discovery or by October 
1, 1993, whichever is later.
    (G) Remove a lower secondary voltage network PCB Transformer located 
in a sidewalk vault in or near a commercial building, within 18 months 
of discovery or by October 1, 1993, whichever is later.
    (H) Retrofill and reclassify a radial PCB Transformer or a lower or 
higher secondary voltage network PCB Transformer, located in other than 
a sidewalk vault in or near a commercial building, within 18 months or 
by October 1, 1990, whichever is later. This is an option in lieu of 
installing electrical protective equipment on a radial or lower 
secondary voltage network PCB Transformer located in other than a 
sidewalk vault or of removing a higher secondary voltage network PCB 
Transformer or a lower secondary voltage network PCB Transformer, 
located in a sidewalk vault, from service.
    (I) Retrofill and reclassify a lower secondary voltage network PCB 
Transformer, located in a sidewalk vault, in or near a commercial 
building within 18 months or by October 1, 1993, whichever is later. 
This is an option in lieu of installing electrical protective equipment 
or removing the transformer from service.
    (J) Retrofill and reclassify a higher secondary voltage network PCB 
Transformer, located in a sidewalk vault, in or near a commercial 
building within 18 months or by October 1, 1990, whichever is later. 
This is an option in lieu of other requirements.
    (2) Servicing conditions. (i) Transformers classified as PCB-
Contaminated Electrical Equipment (as defined in the definition of 
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be 
serviced (including rebuilding) only with dielectric fluid containing 
less than 500 ppm PCB.
    (ii) Any servicing (including rebuilding) of PCB Transformers (as 
defined in the definition of ``PCB Transformer'' under Sec. 761.3) that 
requires the removal of the transformer coil from the transformer casing 
is prohibited. PCB Transformers may be serviced (including topping off) 
with dielectric fluid at any PCB concentration.
    (iii) PCBs removed during any servicing activity must be captured 
and either reused as dielectric fluid or disposed of in accordance with 
the requirements of Sec. 761.60. PCBs from PCB Transformers must not be 
mixed with or added to dielectric fluid from PCB-Contaminated Electrical 
Equipment.
    (iv) Regardless of its PCB concentration, dielectric fluids 
containing less than 500 ppm PCB that are mixed with fluids that contain 
500 ppm or greater PCB must not be used as dielectric fluid in any 
electrical equipment. The entire mixture of dielectric fluid must be 
considered to be greater than 500 ppm PCB and must be disposed of in an

[[Page 533]]

incinerator that meets the requirements in Sec. 761.70.
    (v) A PCB Transformer may be converted to PCB-Contaminated 
Electrical Equipment or to a non-PCB Transformer and a transformer that 
is classified as PCB-Contaminated Electrical Equipment may be 
reclassified to a non-PCB Transformer by draining, refilling and/or 
otherwise servicing the transformer. In order to reclassify, the 
transformer's dielectric fluid must contain less than 500 ppm PCB (for 
conversion to PCB-Contaminated Electrical Equipment) or less than 50 ppm 
PCB (for conversion to a non-PCB Transformer) after a minimum of three 
months of in-service use subsequent to the last servicing conducted for 
the purpose of reducing the PCB concentration in the transformer. In-
service means that the transformer is used electrically under loaded 
conditions that raise the temperature of the dielectric fluid to at 
least 50  deg.Centigrade. The Director, National Programs Chemical 
Division may grant, without further rulemaking, approval for the use of 
alternative methods that simulate the loaded conditions of in-service 
use. All PCBs removed from transformers for purposes of reducing PCB 
concentrations are subject to the disposal requirements of Sec. 761.60.
    (vi) Any dielectric fluid containing 50 ppm or greater PCB used for 
servicing transformers must be stored in accordance with the storage for 
disposal requirements of Sec. 761.65.
    (vii) Processing and distribution in commerce of PCBs for purposes 
of servicing transformers is permitted only for persons who are granted 
an exemption under TSCA 6(e)(3)(B).
    (b) Use in and servicing of railroad transformers. PCBs may be used 
in transformers in railroad locomotives or railroad self-propelled cars 
(``railroad transformers'') and may be processed and distributed in 
commerce for purposes of servicing these transformers in a manner other 
than a totally enclosed manner subject to the following conditions:
    (1) Use restrictions. After July 1, 1986, use of railroad 
transformers that contain dielectric fluids with a PCB concentration 
>1,000 ppm is prohibited.
    (2) Servicing restrictions. (i) If the coil is removed from the 
casing of a railroad transformer (e.g., the transformer is rebuilt), 
after January 1, 1982, the railroad transformer may not be refilled with 
dielectric fluid containing a PCB concentration greater than 50 ppm;
    (ii) After January 1, 1984, railroad transformers may only be 
serviced with dielectric fluid containing less than 1000 ppm PCB, except 
as provided in paragraph (b)(2)(i) of this section;
    (iii) Dielectric fluid may be filtered through activated carbon or 
otherwise industrially processed for the purpose of reducing the PCB 
concentration in the fluid;
    (iv) Any PCB dielectric fluid that is used to service PCB railroad 
transformers must be stored in accordance with the storage for disposal 
requirements of Sec. 761.65;
    (v) After July 1, 1979, processing and distribution in commerce of 
PCBs for purposes of servicing railroad transformers is permitted only 
for persons who are granted an exemption under TSCA section 6(e)(3)(B).
    (vi) A PCB Transformer may be converted to a PCB-Contaminated 
Transformer or to a non-PCB Transformer by draining, refilling, and/or 
otherwise servicing the railroad transformer. In order to reclassify, 
the railroad transformer's dielectric fluid must contain less than 500 
ppm (for conversion to PCB-Contaminated Transformer) or less than 50 ppm 
PCB (for conversion to a non-PCB Transformer) after a minimum of three 
months of inservice use subsequent to the last servicing conducted for 
the purpose of reducing the PCB concentration in the transformer.
    (c) Use in mining equipment. After January 1, 1982, PCBs may be used 
in mining equipment only at a concentration level of <50 ppm.
    (d) Use in heat transfer systems. After July 1, 1984, PCBs may be 
used in heat transfer systems only at a concentration level of < 50 ppm. 
Heat transfer systems that were in operation after July 1, 1984, with a 
concentration level of <50 ppm PCBs may be serviced to maintain a 
concentration level of <50 ppm PCBs. Heat transfer systems may only be 
serviced with fluids containing <50 ppm PCBs.

[[Page 534]]

    (e) Use in hydraulic systems. After July 1, 1984, PCBs may be used 
in hydraulic systems only at a concentration level of <50 ppm. Hydraulic 
systems that were in operation after July 1, 1984, with a concentration 
level of <50 ppm PCBs may be serviced to maintain a concentration level 
of <50 ppm PCBs. Hydraulic systems may only be serviced with fluids 
containing <50 ppm PCBs.
    (f) Use in carbonless copy paper. Carbonless copy paper containing 
PCBs may be used in a manner other than a totally enclosed manner 
indefinitely.
    (g) [Reserved]
    (h) Use in and servicing of electromagnets, switches and voltage 
regulators. PCBs at any concentration may be used in electromagnets, 
switches (including sectionalizers and motor starters), and voltage 
regulators and may be used for purposes of servicing this equipment 
(including rebuilding) for the remainder of their useful lives, subject 
to the following conditions:
    (1) Use conditions. (i) After October 1, 1985, the use and storage 
for reuse of any electromagnet which poses an exposure risk to food or 
feed is prohibited if the electromagnet contains greater than 500 ppm 
PCBs.
    (ii) Use and storage for reuse of voltage regulators which contain 
1.36 kilograms (3 lbs) or more of dielectric fluid with a PCB 
concentration of 500 ppm are subject to the following 
provisions:
    (A) The owner of the voltage regulator must mark its location in 
accordance with Sec. 761.40.
    (B) If a voltage regulator is involved in a fire-related incident, 
the owner must immediately report the incident to the National Response 
Center (Toll-free: 1-800-424-8802; in Washington, DC: 202-426-2675). A 
fire-related incident is defined as any incident that involves the 
generation of sufficient heat and/or pressure, by any source, to result 
in the violent or non-violent rupture of the voltage regulator and the 
release of PCBs.
    (C) The owner of the voltage regulator must inspect it in accordance 
with the requirements of paragraphs (a)(1)(ix), (a)(1)(xiii), and 
(a)(1)(xiv) of this section that apply to PCB Transformers.
    (D) The owner of the voltage regulator must comply with the 
recordkeeping and reporting requirements at Sec. 761.180.
    (iii) The owner of a voltage regulator that assumes it contains <500 
ppm PCBs as provided in Sec. 761.2, and discovers by testing that it is 
contaminated at 500 ppm PCBs, must comply with paragraph 
(h)(1)(ii)(A) of this section 7 days after the discovery, and paragraphs 
(h)(1)(ii)(B), (h)(1)(ii)(C), and (h)(1)(ii)(D) of this section 
immediately upon discovery.
    (2) Servicing conditions. (i) Servicing (including rebuilding) any 
electromagnet, switch, or voltage regulator with a PCB concentration of 
500 ppm or greater which requires the removal and rework of the internal 
components is prohibited.
    (ii) Electromagnets, switches, and voltage regulators classified as 
PCB-Contaminated Electrical Equipment (as defined in the definition of 
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be 
serviced (including rebuilding) only with dielectric fluid containing 
less than 500 ppm PCB.
    (iii) PCBs removed during any servicing activity must be captured 
and either reused as dielectric fluid or disposed of in accordance with 
the requirements of Sec. 761.60. PCBs from electromagnets switches, and 
voltage regulators with a PCB concentration of at least 500 ppm must not 
be mixed with or added to dielectric fluid from PCB-Contaminated 
Electrical Equipment.
    (iv) Regardless of its PCB concentration, dielectric fluids 
containing less than 500 ppm PCB that are mixed with fluids that contain 
500 ppm or greater PCB must not be used as dielectric fluid in any 
electrical equipment. The entire mixture of dielectric fluid must be 
considered to be greater than 500 ppm PCB and must be disposed of in an 
incinerator that meets the requirements of Sec. 761.70.
    (v) An electromagnet, switch or voltage regulator with a PCB 
concentration of at least 500 ppm may be converted to PCB-Contaminated 
Electrical Equipment or to a non-PCB classification and PCB-Contaminated 
Electrical Equipment may be reclassified to a

[[Page 535]]

non-PCB classification by draining, refilling and/or otherwise servicing 
the equipment. In order to be reclassified, the equipment's dielectric 
fluid must contain less than 500 ppm PCB (for conversion to PCB-
Contaminated Electrical Equipment) or less than 50 ppm PCB (for 
conversion to a non-PCB classification) after a minimum of three months 
of in-service use subsequent to the last servicing conducted for the 
purpose of reducing the PCB concentration in the equipment. In-service 
use means the equipment is used electrically under loaded conditions. 
The Assistant Administrator may grant, without further rulemaking, 
approval for the use of alternative methods that simulate the loaded 
conditions of in-service use. All PCBs removed from this equipment for 
purposes of reducing PCB concentrations are subject to the disposal 
requirements of Sec. 761.60.
    (vi) Any dielectric fluid containing 50 ppm or greater PCB used for 
servicing electromagnets, switches, or voltage regulators must be stored 
in accordance with the storage for disposal requirements of Sec. 761.65.
    (vii) Processing and distribution in commerce of PCBs for purposes 
of servicing electromagnets, switches or voltage regulators is permitted 
only for persons who are granted an exemption under TSCA 6(e)(3)(B).
    (i) Use and reuse of PCBs in natural gas pipeline systems; use and 
reuse of PCB-Contaminated natural gas pipe and appurtenances. (1)(i) 
PCBs are authorized for use in natural gas pipeline systems at 
concentrations <50 ppm.
    (ii) PCBs are authorized for use, at concentrations 50 
ppm, in natural gas pipeline systems not owned or operated by a seller 
or distributor of natural gas.
    (iii)(A) PCBs are authorized for use, at concentrations 
50 ppm, in natural gas pipeline systems owned or operated by 
a seller or distributor of natural gas, if the owner or operator:
    (1) Submits to EPA, upon request, a written description of the 
general nature and location of PCBs 50 ppm in their natural 
gas pipeline system. Each written description shall be submitted to the 
EPA Regional Administrator having jurisdiction over the segment or 
component of the system (or the Director, National Program Chemicals 
Division, Office of Prevention, Pesticides, and Toxic Substances, if the 
system is contaminated in more than one region).
    (2) Within 120 days after discovery of PCBs 50 ppm in 
natural gas pipeline systems, or by December 28, 1998, whichever is 
later, characterizes the extent of PCB contamination by collecting and 
analyzing samples to identify the upstream and downstream end points of 
the segment or component where PCBs 50 ppm were discovered.
    (3) Within 120 days of characterization of the extent of PCB 
contamination, or by December 28, 1998, whichever is later, samples and 
analyzes all potential sources of introduction of PCBs into the natural 
gas pipeline system for PCBs 50 ppm. Potential sources 
include natural gas compressors, natural gas scrubbers, natural gas 
filters, and interconnects where natural gas is received upstream from 
the most downstream sampling point where PCBs 50 ppm were 
detected; potential sources exclude valves, drips, or other small liquid 
condensate collection points.
    (4) Within 1 year of characterization of the extent of PCB 
contamination, reduces all demonstrated sources of PCBs 50 
ppm to 50 ppm, or removes such sources from the natural gas pipeline 
system; or implements other engineering measures or methods to reduce 
PCB levels to 50 ppm and to prevent further introduction of PCBs 
50 ppm into the natural gas pipeline system (e.g., pigging, 
decontamination, in-line filtration).
    (5) Repeats sampling and analysis at least annually where PCBs are 
50 ppm, until sampling results indicate the natural gas 
pipeline segment or component is 50 ppm PCB in two successive samples 
with a minimum interval between samples of 180 days.
    (6) Marks aboveground sources of PCB liquids in natural gas pipeline 
systems with the ML Mark in accordance with Sec. 761.45(a), 
where such sources have been demonstrated through historical data or 
recent sampling to contain PCBs 50 ppm.

[[Page 536]]

    (B) Owners or operators of natural gas pipeline systems which do not 
include potential sources of PCB contamination as described in paragraph 
(i)(1)(iii)(A)(3) of this section containing 50 ppm PCB are 
not subject to paragraphs (i)(1)(iii)(A)(2), (i)(1)(iii)(A)(3), 
(i)(1)(iii)(A)(4), or (i)(1)(iii)(A)(6) of this section. Owners or 
operators of these systems, however, must comply with the other 
provisions of this section (e.g., sampling of any collected PCB liquids 
and recordkeeping).
    (C) The owner or operator of a natural gas pipeline system must 
document in writing all data collected and actions taken, or not taken, 
pursuant to the authorization in paragraph (i)(1)(iii)(A) of this 
section. They must maintain the information for 3 years after the PCB 
concentration in the component or segment is reduced to 50 ppm, and make 
it available to EPA upon request.
    (D) The Director, National Program Chemicals Division, after 
consulting with the appropriate EPA Region(s) may, based on a finding of 
no unreasonable risk, modify in writing the requirements of paragraph 
(i)(1)(iii)(A) of this section, including extending any compliance date, 
approving alternative formats for documentation, waiving one or more 
requirements for a segment or component, requiring sampling and 
analysis, and requiring implementation of engineering measures to reduce 
PCB concentrations. EPA will make such modifications based on the 
natural gas pipeline system size, configuration, and current operating 
conditions; nature, extent or source of contamination; proximity of 
contamination to end-users; or previous sampling, monitoring, remedial 
actions or documentation of activities taken regarding compliance with 
this authorization or other applicable Federal, State, or local laws and 
regulations. The Director, National Program Chemicals Division, may 
defer the authority described in this paragraph, upon request, to the 
appropriate EPA Region.
    (E) The owner or operator of a natural gas pipeline system may use 
historical data to fulfill the requirements of paragraphs 
(i)(1)(iii)(A)(1), (i)(1)(iii)(A)(2) and (i)(1)(iii)(A)(3) of this 
section. They may use documented historical actions taken to reduce PCB 
concentrations in known sources; decontaminate components or segments of 
natural gas pipeline systems; or otherwise to reduce PCB levels to 
fulfill the requirements of paragraph (i)(1)(iii)(A)(4) of this section.
    (2) Any person may reuse PCB-Contaminated natural gas pipe and 
appurtenances in a natural gas pipeline system, provided all free-
flowing liquids have been removed.
    (3) Any person may use PCB-Contaminated natural gas pipe, drained of 
all free-flowing liquids, in the transport of liquids (e.g., bulk 
hydrocarbons, chemicals, petroleum products, or coal slurry), as casing 
to provide secondary containment or protection (e.g., protection for 
electrical cable), as industrial structural material (e.g., fence posts, 
sign posts, or bridge supports), as temporary flume at construction 
sites, as equipment skids, as culverts under transportation systems in 
intermittent flow situations, for sewage service with written consent of 
the Publicly Owned Treatment Works (POTW), for steam service, as 
irrigation systems (<20 inch diameter) of less than 200 miles in length, 
and in a totally enclosed compressed air system.
    (4) Any person characterizing PCB contamination in natural gas pipe 
or natural gas pipeline systems must do so by analyzing organic liquids 
collected at existing condensate collection points in the pipe or 
pipeline system. The level of PCB contamination found at a collection 
point is assumed to extend to the next collection point downstream. Any 
person characterizing multi-phasic liquids must do so in accordance with 
Sec. 761.1(b)(4); if no liquids are present, they must use standard wipe 
samples in accordance with subpart M of this part.
    (5)(i) Any person disposing of liquids containing PCBs 50 
ppm removed, spilled, or otherwise released from a natural gas pipeline 
system must do so in accordance with Sec. 761.61(a)(5)(iv) based on the 
PCB concentration at the time of removal from the system. Any person 
disposing of materials contaminated by spills or other releases of

[[Page 537]]

PCBs 50 ppm from a natural gas pipeline systems, must do so 
in accordance with Secs. 761.61 or 761.79, as applicable.
    (ii) Any person who markets or burns for energy recovery liquids 
containing PCBs at concentrations <50 ppm PCBs at the time of removal 
from a natural gas pipeline system must do so in accordance with the 
provisions pertaining to used oil at Sec. 761.20(e). No other use of 
liquid containing PCBs at concentrations above the quantifiable level/
level of detection removed from a natural gas pipeline system is 
authorized.
    (j) Research and development. For purposes of this section, 
authorized research and development (R&D) activities include, but are 
not limited to: the chemical analysis of PCBs, including analyses to 
determine PCB concentration; determinations of the physical properties 
of PCBs; studies of environmental transport processes; studies of 
biochemical transport processes; studies of effects of PCBs on the 
environment; and studies of the health effects of PCBs, including direct 
toxicity and toxicity of metabolic products of PCBs. Authorized R&D 
activities do not include research, development, or analysis for the 
development of any PCB product. Any person conducting R&D activities 
under this section is also responsible for determining and complying 
with all other applicable Federal, State, and local laws and 
regulations. Although the use of PCBs and PCBs in analytical reference 
samples derived from waste material is authorized in conjunction with 
PCB-disposal related activities, R&D for PCB disposal (as defined under 
Sec. 761.3) is addressed in Sec. 761.60(j). PCBs and PCBs in analytical 
reference samples derived from waste materials are authorized for use, 
in a manner other than a totally enclosed manner, provided that:
    (1) They obtain the PCBs and PCBs in analytical reference samples 
derived from waste materials from sources authorized under Sec. 761.80 
to manufacture, process, and distribute PCBs in commerce and the PCBs 
are packaged in compliance with the Hazardous Materials Regulations at 
49 CFR parts 171 through 180.
    (2) They store all PCB wastes resulting from R&D activities (e.g., 
spent laboratory samples, residuals, contaminated media such as 
clothing, etc.) in compliance with Sec. 761.65(b) and dispose of all PCB 
wastes in compliance with Sec. 761.64.
    (3) [Reserved]
    (k) Use in scientific instruments. PCBs may be used indefinitely in 
scientific instruments, for example, in oscillatory flow birefringence 
and viscoelasticity instruments for the study of the physical properties 
of polymers, as microscopy mounting fluids, as microscopy immersion oil, 
and as optical liquids in a manner other than a totally enclosed manner. 
No person may manufacture, process, or distribute in commerce PCBs for 
use in scientific instruments unless they have been granted an exemption 
to do so under TSCA section 6(e)(3)(B).
    (l) Use in capacitors. PCBs at any concentration may be used in 
capacitors, subject to the following conditions:
    (1) Use conditions. (i) After October 1, 1988, the use and storage 
for reuse of PCB Large High Voltage Capacitors and PCB Large Low Voltage 
Capacitors which pose an exposure risk to food or feed is prohibited.
    (ii) After October 1, 1988, the use of PCB Large High Voltage 
Capacitors and PCB Large Low Voltage Capacitors is prohibited unless the 
capacitor is used within a restricted-access electrical substation or in 
a contained and restricted-access indoor installation. A restricted-
access electrical substation is an outdoor, fenced or walled-in facility 
that restricts public access and is used in the transmission or 
distribution of electric power. A contained and restricted-access indoor 
installation does not have public access and has an adequate roof, 
walls, and floor to contain any release of PCBs within the indoor 
location.
    (2) [Reserved]
    (m) Use in and servicing of circuit breakers, reclosers and cable. 
PCBs at any concentration may be used in circuit breakers, reclosers, 
and cable and may be used for purposes of servicing this electrical 
equipment (including rebuilding) for the remainder of their useful 
lives, subject to the following conditions:
    (1) Servicing conditions. (i) Circuit breakers, reclosers, and cable 
may be

[[Page 538]]

serviced (including rebuilding) only with dielectric fluid containing 
less than 50 ppm PCB.
    (ii) Any circuit breaker, recloser or cable found to contain at 
least 50 ppm PCBs may be serviced only in accordance with the conditions 
contained in 40 CFR 761.30(h)(2).
    (2) [Reserved]
    (n)-(o) [Reserved]
    (p) Continued use of porous surfaces contaminated with PCBs 
regulated for disposal by spills of liquid PCBs. (1) Any person may use 
porous surfaces contaminated by spills of liquid PCBs at concentrations 
 50 ppm for the remainder of the useful life of the surfaces 
and subsurface material if the following conditions are met:
    (i) The source of PCB contamination is removed or contained to 
prevent further release to porous surfaces.
    (ii) If the porous surface is accessible to superficial surface 
cleaning:
    (A) The double wash rinse procedure in subpart S of this part is 
conducted on the surface to remove surface PCBs.
    (B) The treated surface is allowed to dry for 24 hours.
    (iii) After accessible surfaces have been cleaned according to 
paragraph (p)(1)(ii) of this section and for all surfaces inaccessible 
to cleanup:
    (A) The surface is completely covered to prevent release of PCBs 
with:
    (1) Two solvent resistant and water repellent coatings of 
contrasting colors to allow for a visual indication of wear through or 
loss of outer coating integrity; or
    (2) A solid barrier fastened to the surface and covering the 
contaminated area or all accessible parts of the contaminated area. 
Examples of inaccessible areas are underneath a floor-mounted electrical 
transformer and in an impassible space between an electrical transformer 
and a vault wall.
    (B) The surface is marked with the ML Mark in a location 
easily visible to individuals present in the area; the ML 
Mark shall be placed over the encapsulated area or the barrier to the 
encapsulated area.
    (C) ML Marks shall be replaced when worn or illegible.
    (2) Removal of a porous surface contaminated with PCBs from its 
location or current use is prohibited except for removal for disposal in 
accordance with Secs. 761.61 or 761.79 for surfaces contaminated by 
spills, or Sec. 761.62 for manufactured porous surfaces.
    (q) [Reserved]
    (r) Use in and servicing of rectifiers. Any person may use PCBs at 
any concentration in rectifiers for the remainder of the PCBs' useful 
life, and may use PCBs <50 ppm in servicing (including rebuilding) 
rectifiers.
    (s) Use of PCBs in air compressor systems. (1) Any person may use 
PCBs in air compressor systems at concentrations <50 ppm.
    (2) Any person may use PCBs in air compressor systems (or components 
thereof) at concentrations 50 ppm provided that:
    (i) All free-flowing liquids containing PCBs 50 ppm are 
removed from the air compressor crankcase and the crankcase is refilled 
with non-PCB liquid.
    (ii) Other air compressor system components contaminated with PCBs 
50 ppm, are decontaminated in accordance with Sec. 761.79 or 
disposed of in accordance with subpart D of this part.
    (iii) Air compressor piping with a nominal inside diameter of <2 
inches is decontaminated by continuous flushing for 4 hours, at no <300 
gallons per hour (Sec. 761.79 contains solvent requirements).
    (3) The requirements in paragraph (s)(2) of this section must be 
completed by August 30, 1999 or within 1 year of the date of discovery 
of PCBs at 50 ppm in the air compressor system, whichever is 
later. The EPA Regional Administrator for the EPA Region in which an air 
compressor system is located may, at his/her discretion and in writing, 
extend this timeframe.
    (t) Use of PCBs in other gas or liquid transmission systems. (1) 
PCBs are authorized for use in intact and non-leaking gas or liquid 
transmission systems at concentrations <50 ppm PCBs.
    (2) PCBs are authorized for use at concentrations 50 ppm 
in intact and non-leaking gas or liquid transmission systems not owned 
or operated by a seller or distributor of the gas or liquid transmitted 
in the system.
    (3) Any person may use PCBs at concentrations 50 ppm in 
intact and non-leaking gas or liquid transmission systems, with the 
written approval of the Director, National Program Chemicals

[[Page 539]]

Division, subject to the requirements applicable to natural gas pipeline 
systems at paragraphs (i)(1)(iii)(A), (i)(1)(iii)(C) through 
(i)(1)(iii)(E), and (i)(2) through (i)(5) of this section.
    (u) Use of decontaminated materials. (1) Any person may use 
equipment, structures, other non-liquid or liquid materials that were 
contaminated with PCBs during manufacture, use, servicing, or because of 
spills from, or proximity to, PCBs 50 ppm, including those 
not otherwise authorized for use under this part, provided:
    (i) The materials were decontaminated in accordance with:
    (A) A TSCA PCB disposal approval issued under subpart D of this 
part;
    (B) Section 761.79; or
    (C) Applicable EPA PCB spill cleanup policies (e.g., TSCA, RCRA, 
CERCLA, EPA regional) in effect at the time of the decontamination; or
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec. 761.79(b).
    (2) No person shall use or reuse materials decontaminated in 
accordance with paragraph (u)(1)(i) of this section or meeting an 
applicable decontamination standard in paragraph (u)(1)(ii) of this 
section, in direct contact with food, feed, or drinking water unless 
otherwise allowed under this section or this part.
    (3) Any person may use water containing PCBs at concentrations 
0.5g/L PCBs without restriction.
    (4) Any person may use water containing PCBs at concentrations <200 
g/L (i.e.,  200 ppb PCBs) for non-contact use in a closed 
system where there are no releases (e.g., as a non-contact cooling 
water).


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020, 2025 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982]

    Editorial Note: For Federal Register citations affection Sec. 761.30 
see the List of CFR Sections Affected in the Finding Aids section of 
this volume.



Sec. 761.35   Storage for reuse.

    (a) The owner or operator of a PCB Article may store it for reuse in 
an area which is not designed, constructed, and operated in compliance 
with Sec. 761.65(b), for no more than 5 years after the date the Article 
was originally removed from use (e.g., disconnected electrical 
equipment) or 5 years after August 28, 1998, whichever is later, if the 
owner or operator complies with the following conditions:
    (1) Follows all use requirements at Sec. 761.30 and marking 
requirements at subpart C of this part that are applicable to the PCB 
Article.
    (2) Maintains records starting at the time the PCB Article is 
removed from use or August 28, 1998. The records must indicate:
    (i) The date the PCB Article was removed from use or August 28, 
1998, if the removal date is not known.
    (ii) The projected location and the future use of the PCB Article.
    (iii) If applicable, the date the PCB Article is scheduled for 
repair or servicing.
    (b) The owner or operator of a PCB Article may store it for reuse in 
an area that does not comply with Sec. 761.65(b) for a period longer 
than 5 years, provided that the owner or operator has received written 
approval from the EPA Regional Administrator for the Region in which the 
PCB Article is stored. An owner or operator of a PCB Article seeking 
approval to extend the 5-year period must submit a request for extension 
to the EPA Regional Administrator at least 6 months before the 5-year 
storage for reuse period expires and must include an item-by-item 
justification for the desired extension. The EPA Regional Administrator 
may include any conditions to such approval deemed necessary to protect 
health or the environment. The owner or operator of the PCB Article 
being stored for reuse must comply with the other applicable provisions 
of this part, including the record retention requirements at 
Sec. 761.180(a).
    (c) Any person may store a PCB Article for reuse indefinitely in:
    (1) A unit in compliance with Sec. 761.65(b).
    (2) A unit permitted under section 3004 of RCRA to manage hazardous 
wastes in containers.
    (3) A unit permitted by a State authorized under section 3006 of 
RCRA to manage hazardous waste.

[63 FR 35443, June 29, 1998]

[[Page 540]]



                Subpart C--Marking of PCBs and PCB Items



Sec. 761.40  Marking requirements.

    (a) Each of the following items in existence on or after July 1, 
1978 shall be marked as illustrated in Figure 1 in Sec. 761.45(a): The 
mark illustrated in Figure 1 is referred to as ML throughout 
this subpart.
    (1) PCB Containers;
    (2) PCB Transformers at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal from use if not already marked. [Marking of PCB-Contaminated 
Electrical Equipment is not required];
    (3) PCB Large High Voltage Capacitors at the time of manufacture, at 
the time of distribution in commerce if not already marked, and at the 
time of removal from use if not already marked;
    (4) Equipment containing a PCB Transformer or a PCB Large High 
Voltage Capacitor at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal of the equipment from use if not already marked;
    (5) PCB Large Low Voltage Capacitors at the time of removal from use 
(see also paragraph (k) of this section).
    (6) Electric motors using PCB coolants (See also paragraph (e) of 
this section).
    (7) Hydraulic systems using PCB hydraulic fluid (See also paragraph 
(e) of this section);
    (8) Heat transfer systems (other than PCB Transformers) using PCBs 
(See also paragraph (e) of this section);
    (9) PCB Article Containers containing articles or equipment that 
must be marked under paragraphs (a) (1) through (8) of this section;
    (10) Each storage area used to store PCBs and PCB Items for 
disposal.
    (b) As of October 1, 1978, each transport vehicle loaded with PCB 
Containers that contain more than 45 kg (99.4 lbs.) of liquid PCBs at 
concentrations of 50 ppm or with one or more PCB Transformers 
shall be marked on each end and each side with the ML mark as 
described in Sec. 761.45(a).
    (c) As of January 1, 1979, the following PCB Articles shall be 
marked with mark ML as described in Sec. 761.45(a):
    (1) All PCB Transformers not marked under paragraph (a) of this 
section [marking of PCB-Contaminated Electrical Equipment is not 
required];
    (2) All PCB Large High Voltage Capacitors not marked under paragraph 
(a) of this section
    (i) Will be marked individually with mark ML, or
    (ii) If one or more PCB Large High Voltage Capacitors are installed 
in a protected location such as on a power pole, or structure, or behind 
a fence; the pole, structure, or fence shall be marked with mark 
ML, and a record or procedure identifying the PCB Capacitors 
shall be maintained by the owner or operator at the protected location.
    (d) As of January 1, 1979, all PCB Equipment containing a PCB Small 
Capacitor shall be marked at the time of manufacture with the statement, 
``This equipment contains PCB Capacitor(s)''. The mark shall be of the 
same size as the mark ML.
    (e) As of October 1, 1979, applicable PCB Items in paragraphs 
(a)(1), (a)(6), (a)(7), and (a)(8) of this section containing PCBs in 
concentrations of 50 to 500 ppm shall be marked with the ML 
mark as described in Sec. 761.45(a).
    (f) Where mark ML is specified but the PCB Article or PCB 
Equipment is too small to accomodate the smallest permissible size of 
mark ML, mark MS as described in Sec. 761.45(b), 
may be used instead of mark ML.
    (g) Each large low voltage capacitor, each small capacitor normally 
used in alternating current circuits, and each fluorescent light ballast 
manufactured (``manufactured'', for purposes of this sentence, means 
built) between July 1, 1978 and July 1, 1998 that do not contain PCBs 
shall be marked by the manufacturer at the time of manufacture with the 
statement, ``No PCBs''. The mark shall be of similar durability and 
readability as other marking that indicate electrical information, part 
numbers, or the manufacturer's name. For purposes of this paragraph 
marking requirement only is applicable to items built domestically or 
abroad after June 30, 1978.
    (h) All marks required by this subpart must be placed in a position 
on

[[Page 541]]

the exterior of the PCB Items, storage units, or transport vehicles so 
that the marks can be easily read by any persons inspecting or servicing 
the marked PCB Items, storage units, or transport vehicles.
    (i) Any chemical substance or mixture that is manufactured after the 
effective date of this rule and that contains less than 500 ppm PCB 
(0.05% on a dry weight basis), including PCB that is a byproduct or 
impurity, must be marked in accordance with any requirements contained 
in the exemption granted by EPA to permit such manufacture and is not 
subject to any other requirement in this subpart unless so specified in 
the exemption. This paragraph applies only to containers of chemical 
substances or mixtures. PCB articles and equipment into which the 
chemical substances or mixtures are processed, are subject to the 
marking requirements contained elsewhere in this subpart.
    (j) PCB Transformer locations shall be marked as follows:
    (1) Except as provided in paragraph (j)(2) of this section, as of 
December 1, 1985, the vault door, machinery room door, fence, hallway, 
or means of access, other than grates and manhole covers, to a PCB 
Transformer must be marked with the mark ML as required by 
paragraph (a) of this section.
    (2) A mark other than the ML mark may be used provided 
all of the following conditions are met:
    (i) The program using such an alternative mark was initiated prior 
to August 15, 1985, and can be substantiated with documentation.
    (ii) Prior to August 15, 1985, coordination between the transformer 
owner and the primary fire department occurred, and the primary fire 
department knows, accepts, and recognizes what the alternative mark 
means, and that this can be substantiated with documentation.
    (iii) The EPA Regional Administrator in the appropriate region is 
informed in writing of the use of the alternative mark by October 3, 
1988 and is provided with documentation that the program began before 
August 15, 1985, and documentation that demonstrates that prior to that 
date the primary fire department knew, accepted and recognized the 
meaning of the mark, and included this information in firefighting 
training.
    (iv) The Regional Administrator will either approve or disapprove in 
writing the use of an alternative mark within 30 days of receipt of the 
documentation of a program.
    (3) Any mark placed in accordance with the requirements of this 
section must be placed in the locations described in paragraph (j)(1) of 
this section and in a manner that can be easily read by emergency 
response personnel fighting a fire involving this equipment.
    (k) As of April 26, 1999 the following PCB Items shall be marked 
with the ML mark as described in Sec. 761.45(a):
    (1) All PCB Large Low Voltage Capacitors not marked under paragraph 
(a) of this section shall be marked individually, or if one or more PCB 
Large Low Voltage Capacitors are installed in a protected location such 
as on a power pole, or structure, or behind a fence, then the owner or 
operator shall mark the pole, structure, or fence with the ML 
mark, and maintain a record or procedure identifying the PCB Capacitors 
at the protected location. PCB Large Low Voltage Capacitors in 
inaccessible locations inside equipment need not be marked individually, 
provided the owner or operator marks the equipment in accordance with 
paragraph (k)(2) of this section, and marks the individual capacitors at 
the time of removal from use in accordance with paragraph (a) of this 
section.
    (2) All equipment not marked under paragraph (a) of this section 
containing a PCB Transformer or a PCB Large High or Low Voltage 
Capacitor.
    (l)(1) All voltage regulators which contain 1.36 kilograms (3 lbs.) 
or more of dielectric fluid with a PCB concentration of  500 
ppm must be marked individually with the ML mark as described 
in Sec. 761.45(a).
    (2) Locations of voltage regulators which contain 1.36 kilograms (3 
lbs.) or more of dielectric fluid with a PCB concentration of 
 500 ppm shall be marked as follows: The vault door, 
machinery room door, fence, hallway, or means of access, other than 
grates or

[[Page 542]]

manhole covers, must be marked with the ML mark as described 
in Sec. 761.45(a).

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 47 FR 37359, Aug. 25, 1982; 50 FR 29201, July 17, 1985; 
50 FR 32176, Aug. 9, 1985; 53 FR 12524, Apr. 15, 1988; 53 FR 27329, July 
19, 1988; 63 FR 35443, June 29, 1998; 64 FR 33760, June 24, 1999]



Sec. 761.45  Marking formats.

    The following formats shall be used for marking:
    (a) Large PCB Mark--ML. Mark ML shall be as 
shown in Figure 1, letters and striping on a white or yellow background 
and shall be sufficiently durable to equal or exceed the life (including 
storage for disposal) of the PCB Article, PCB Equipment, or PCB 
Container. The size of the mark shall be at least 15.25 cm (6 inches) on 
each side. If the PCB Article or PCB Equipment is too small to 
accommodate this size, the mark may be reduced in size proportionately 
down to a minimum of 5 cm (2 inches) on each side.
    (b) Small PCB Mark--Ms. Mark Ms shall be as 
shown in Figure 2, letters and striping on a white or yellow background, 
and shall be sufficiently durable to equal or exceed the life (including 
storage for disposal) of the PCB Article, PCB Equipment, or PCB 
Container. The mark shall be a rectangle 2.5 by 5 cm (1 inch by 2 
inches). If the PCB Article or PCB Equipment is too small to accommodate 
this size, the mark may be reduced in size proportionately down to a 
minimum of 1 by 2 cm (.4 by .8 inches).
[GRAPHIC] [TIFF OMITTED] TC01AP92.000


[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982]



                     Subpart D--Storage and Disposal



Sec. 761.50   Applicability.

    (a) General PCB disposal requirements. Any person storing or 
disposing of PCB waste must do so in accordance with subpart D of this 
part. The following prohibitions and conditions apply to all PCB waste 
storage and disposal:
    (1) No person may open burn PCBs. Combustion of PCBs approved under 
Sec. 761.60 (a) or (e), or otherwise allowed under part 761, is not open 
burning.
    (2) No person may process liquid PCBs into non-liquid forms to 
circumvent the high temperature incineration requirements of 
Sec. 761.60(a).
    (3) No person may discharge water containing PCBs to a treatment 
works

[[Page 543]]

(as defined Sec. 503.9(aa) of this chapter) or to navigable waters 
unless the PCB concentration is <3 g/L (approximately 3 ppb), 
or unless the discharge is in accordance with a PCB discharge limit 
included in a permit issued under section 307(b) or 402 of the Clean 
Water Act.
    (4) Spills and other uncontrolled discharges of PCBs at 
concentrations of 50 ppm constitute the disposal of PCBs.
    (5) Any person land disposing of non-liquid PCBs may avoid 
otherwise-applicable sampling requirements by presuming that the PCBs 
disposed of are 500 ppm (or 100 g/100 
cm2 if no free-flowing liquids are present).
    (6) Any person storing or disposing of PCBs is also responsible for 
determining and complying with all other applicable Federal, State, and 
local laws and regulations.
    (b) PCB waste. (1) PCB liquids. Any person removing PCB liquids from 
use (i.e., not PCB remediation waste) must dispose of them in accordance 
with Sec. 761.60(a), or decontaminate them in accordance with 
Sec. 761.79.
    (2) PCB Items. Any person removing from use a PCB Item containing an 
intact and non-leaking PCB Article must dispose of it in accordance with 
Sec. 761.60(b), or decontaminate it in accordance with Sec. 761.79. PCB 
Items where the PCB Articles are no longer intact and non-leaking are 
regulated for disposal as PCB bulk product waste under Sec. 761.62(a) or 
(c).
    (i) Fluorescent light ballasts containing PCBs only in an intact and 
non-leaking PCB Small Capacitor are regulated for disposal under 
Sec. 761.60(b)(2)(ii).
    (ii) Fluorescent light ballasts containing PCBs in the potting 
material are regulated for disposal as PCB bulk product waste under 
Sec. 761.62.
    (3) PCB remediation waste. PCB remediation waste, including PCB 
sewage sludge, is regulated for cleanup and disposal in accordance with 
Sec. 761.61.
    (i) Any person responsible for PCB waste at as-found concentrations 
 50 ppm that was either placed in a land disposal facility, 
spilled, or otherwise released into the environment prior to April 18, 
1978, regardless of the concentration of the spill or release; or placed 
in a land disposal facility, spilled, or otherwise released into the 
environment on or after April 18, 1978, but prior to July 2, 1979, where 
the concentration of the spill or release was  50 ppm but < 
500 ppm, must dispose of the waste as follows:
    (A) Sites containing these wastes are presumed not to present an 
unreasonable risk of injury to health or the environment from exposure 
to PCBs at the site. However, the EPA Regional Administrator may inform 
the owner or operator of the site that there is reason to believe that 
spills, leaks, or other uncontrolled releases or discharges, such as 
leaching, from the site constitute ongoing disposal that may present an 
unreasonable risk of injury to health or the environment from exposure 
to PCBs at the site, and may require the owner or operator to generate 
data necessary to characterize the risk. If after reviewing any such 
data, the EPA Regional Administrator makes a finding, that an 
unreasonable risk exists, then he or she may direct the owner or 
operator of the site to dispose of the PCB remediation waste in 
accordance with Sec. 761.61 such that an unreasonable risk of injury no 
longer exists.
    (B) Unless directed by the EPA Regional Administrator to dispose of 
PCB waste in accordance with paragraph (b)(3)(i)(A) of this section, any 
person responsible for PCB waste at as-found concentrations  
50 ppm that was either placed in a land disposal facility, spilled, or 
otherwise released into the environment prior to April 18, 1978, 
regardless of the concentration of the spill or release; or placed in a 
land disposal facility, spilled, or otherwise released into the 
environment on or after April 18, 1978, but prior to July 2, 1979, where 
the concentration of the spill or release was  50 ppm but < 
500 ppm, who unilaterally decides to dispose of that waste (for example, 
to obtain insurance or to sell the property), is not required to clean 
up in accordance with Sec. 761.61. Disposal of the PCB remediation waste 
must comply with Sec. 761.61. However, cleanup of those wastes that is 
not in complete compliance with Sec. 761.61 will not afford the 
responsible party with relief from the applicable PCB regulations for 
that waste.

[[Page 544]]

    (ii) Any person responsible for PCB waste at as-found concentrations 
 50 ppm that was either placed in a land disposal facility, 
spilled, or otherwise released into the environment on or after April 
18, 1978, but prior to July 2, 1979, where the concentration of the 
spill or release was  500 ppm; or placed in a land disposal 
facility, spilled, or otherwise released into the environment on or 
after July 2, 1979, where the concentration of the spill or release was 
 50 ppm, must dispose of it in accordance with either of the 
following:
    (A) In accordance with the PCB Spill Cleanup Policy (Policy) at 
subpart G of this part, for those PCB remediation wastes that meet the 
criteria of the Policy. Consult the Policy for a description of the 
spills it covers and its notification and timing requirements.
    (B) In accordance with Sec. 761.61. Complete compliance with 
Sec. 761.61 does not create a presumption against enforcement action for 
penalties for any unauthorized PCB disposal.
    (iii) The owner or operator of a site containing PCB remediation 
waste has the burden of proving the date that the waste was placed in a 
land disposal facility, spilled, or otherwise released into the 
environment, and the concentration of the original spill.
    (4) PCB bulk product waste--(i) General. Any person disposing of PCB 
bulk product waste must do so in accordance with Sec. 761.62. PCB bulk 
product waste, as that term is defined in Sec. 761.3, is waste that was 
50 ppm when originally removed from service, even if its 
current PCB concentration is <50 ppm. PCB bulk product waste is 
regulated for disposal based on the risk from the waste once disposed 
of. For waste which is land disposed, the waste is regulated based on 
how readily the waste is released from disposal to the environment, in 
particular by leaching out from the land disposal unit.
    (ii) Metal surfaces in contact with PCBs. Any person disposing of 
metal surfaces in contact with PCBs (e.g., painted metal) may use 
thermal decontamination procedures in accordance with Sec. 761.79(c)(6) 
(see Sec. 761.62(a)(6)).
    (5) PCB household waste. Any person storing or disposing of PCB 
household waste, as that term is defined in Sec. 761.3, must do so in 
accordance with Sec. 761.63.
    (6) PCB research and development waste. Any person disposing of PCB 
wastes generated during and as a result of research and development for 
use under Sec. 761.30(j), or for disposal under Sec. 761.60(j), must do 
so in accordance with Sec. 761.64.
    (7) PCB/Radioactive waste. (i) Any person storing PCB/radioactive 
waste 50 ppm PCBs must do so taking into account both its PCB 
concentration and its radioactive properties, except as provided in 
Sec. 761.65(a)(1), (b)(1)(ii), and (c)(6)(i).
    (ii) Any person disposing of PCB/radioactive waste must do so taking 
into account both its PCB concentration and its radioactive properties. 
If, taking into account only the properties of the PCBs in the waste 
(and not the radioactive properties of the waste), the waste meets the 
requirements for disposal in a facility permitted, licensed, or 
registered by a State as a municipal or non-municipal non-hazardous 
waste landfill (e.g., PCB bulk product waste under Sec. 761.62(b)(1)), 
then the person may dispose of the PCB/radioactive waste, without regard 
to the PCB component of the waste, on the basis of its radioactive 
properties in accordance with all applicable requirements for the 
radioactive component of the waste.
    (8) Porous surfaces. In most cases a person must dispose of porous 
surfaces as materials where PCBs have penetrated far beneath the 
surface, rather than a simple surface contamination. Any person 
disposing of porous surfaces on which PCBs have been spilled and meeting 
the definition of PCB remediation waste at Sec. 761.3 must do so in 
accordance with Sec. 761.61. Any person disposing of porous surfaces 
which are part of manufactured non-liquid products containing PCBs and 
meeting the definition of PCB bulk product waste at Sec. 761.3 must do 
so in accordance with Sec. 761.62. Any person may decontaminate concrete 
surfaces upon which PCBs have been spilled in accordance with 
Sec. 761.79(b)(4), if the decontamination procedure is commenced within 
72 hours of the initial spill of PCBs to the concrete or portion thereof 
being decontaminated. Any person may decontaminate porous non-liquid 
PCBs in contact with non-porous surfaces, such

[[Page 545]]

as underground metal fuel tanks coated with fire retardant resin or 
pitch, for purposes of unrestricted use or disposal in a smelter in 
accordance with Sec. 761.79(b)(3).
    (c) Storage for disposal. Any person who holds PCB waste must store 
it in accordance with Sec. 761.65.
    (d) Performance specifications for disposal technologies--(1) 
Incinerators. Any person using an incinerator to dispose of PCBs must 
use an incinerator that meets the criteria set forth in Sec. 761.70.
    (2) High efficiency boilers. Any person using a high efficiency 
boiler to dispose of PCBs must use a boiler that meets the criteria set 
forth in Sec. 761.71.
    (3) Scrap metal recovery ovens and smelters. Any person using scrap 
metal recovery ovens and smelters to dispose of PCBs must use a device 
that meets the criteria set forth in Sec. 761.72.
    (4) Chemical waste landfills. Any person using a chemical waste 
landfill to dispose of PCBs must use a chemical waste landfill that 
meets the criteria set forth in Sec. 761.75.
    (e) TSCA PCB Coordinated Approval. Any person seeking a TSCA PCB 
Coordinated Approval must follow the procedures set forth in 
Sec. 761.77.

[63 FR 35444, June 29, 1998, as amended at 64 FR 33760, June 24, 1999]



Sec. 761.60   Disposal requirements.

    (a) PCB liquids. PCB liquids at concentrations 50 ppm 
must be disposed of in an incinerator which complies with Sec. 761.70, 
except that PCB liquids at concentrations 50 ppm and 500 ppm 
may be disposed of as follows:
    (1) For mineral oil dielectric fluid, in a high efficiency boiler 
according to Sec. 761.71(a).
    (2) For liquids other than mineral oil dielectric fluid, in a high 
efficiency boiler according to Sec. 761.71(b).
    (3) For liquids from incidental sources, such as precipitation, 
condensation, leachate or load separation and are associated with PCB 
Articles or non-liquid PCB wastes, in a chemical waste landfill which 
complies with Sec. 761.75 if:
    (i) [Reserved]
    (ii) Information is provided to or obtained by the owner or operator 
of the chemical waste landfill that shows that the liquids do not exceed 
500 ppm PCB and are not an ignitable waste as described in 
Sec. 761.75(b)(8)(iii).
    (b) PCB Articles. This paragraph does not authorize disposal that is 
otherwise prohibited in Sec. 761.20 or elsewhere in this part.
    (1) Transformers. (i) PCB Transformers shall be disposed of in 
accordance with either of the following:
    (A) In an incinerator that complies with Sec. 761.70; or
    (B) In a chemical waste landfill approved under Sec. 761.75; 
provided that all free-flowing liquid is removed from the transformer, 
the transformer is filled with a solvent, the transformer is allowed to 
stand for at least 18 continuous hours, and then the solvent is 
thoroughly removed. Any person disposing of PCB liquids that are removed 
from the transformer (including the dielectric fluid and all solvents 
used as a flush), shall do so in an incinerator that complies with 
Sec. 761.70 of this part, or shall decontaminate them in accordance with 
Sec. 761.79. Solvents may include kerosene, xylene, toluene, and other 
solvents in which PCBs are readily soluble. Any person disposing of 
these PCB liquids must ensure that the solvent flushing procedure is 
conducted in accordance with applicable safety and health standards as 
required by Federal or State regulations.
    (ii) [Reserved]
    (2) PCB Capacitors. (i) The disposal of any capacitor shall comply 
with all requirements of this subpart unless it is known from label or 
nameplate information, manufacturer's literature (including documented 
communications with the manufacturer), or chemical analysis that the 
capacitor does not contain PCBs.
    (ii) Any person may dispose of PCB Small Capacitors as municipal 
solid waste, unless that person is subject to the requirements of 
paragraph (b)(2)(iv) of this section.
    (iii) Any PCB Large High or Low Voltage Capacitor which contains 500 
ppm or greater PCBs, owned by any person, shall be disposed of in 
accordance with either of the following:
    (A) Disposal in an incinerator that complies with Sec. 761.70; or
    (B) Until March 1, 1981, disposal in a chemical waste landfill that 
complies with Sec. 761.75.

[[Page 546]]

    (iv) Any person who manufactures or at any time manufactured PCB 
Capacitors or PCB Equipment, and acquired the PCB Capacitor in the 
course of such manufacturing, shall place the PCB Small Capacitors in a 
container meeting the DOT packaging requirements at 49 CFR parts 171 
through 180 and dispose of them in accordance with either of the 
following:
    (A) Disposal in an incinerator which complies with Sec. 761.70; or
    (B) Until March 1, 1981, disposal in a chemical waste landfill which 
complies with Sec. 761.75.
    (v) Notwithstanding the restrictions imposed by paragraph 
(b)(2)(iii)(B) or (b)(2)(iv)(B) of this section, PCB capacitors may be 
disposed of in PCB chemical waste landfills that comply with Sec. 761.75 
subsequent to March 1, 1981, if the Assistant Administrator for 
Prevention, Pesticides and Toxic Substances publishes a notice in the 
Federal Register declaring that those landfills are available for such 
disposal and explaining the reasons for the extension or reopening. An 
extension or reopening for disposal of PCB capacitors that is granted 
under this subsection shall be subject to such terms and conditions as 
the Assistant Administrator may prescribe and shall be in effect for 
such period as the Assistant Administrator may prescribe. The Assistant 
Administrator may permit disposal of PCB capacitors in EPA approved 
chemical waste landfills after March 1, 1981, if in his opinion,
    (A) Adequate incineration capability for PCB capacitors is not 
available, or
    (B) The incineration of PCB capacitors will significantly interfere 
with the incineration of liquid PCBs, or
    (C) There is other good cause shown.

As part of this evaluation, the Assistant Administrator will consider 
the impact of his action on the incentives to construct or expand PCB 
incinerators.
    (vi) Any person disposing of large PCB capacitors or small PCB 
capacitors described in paragraph (b)(2)(iv) of this section in a 
chemical waste landfill approved under Sec. 761.75, shall first place 
them in a container meeting the DOT packaging requirements at 49 CFR 
parts 171 through 180. In all cases, the person must fill the 
interstitial space in the container with sufficient absorbent material 
(such as soil) to absorb any liquid PCBs remaining in the capacitors.
    (3) PCB hydraulic machines. (i) Any person disposing of PCB 
hydraulic machines containing PCBs at concentrations of 50 
ppm, such as die casting machines, shall do so by one of the following 
methods:
    (A) In accordance with Sec. 761.79.
    (B) In a facility which is permitted, licensed, or registered by a 
State to manage municipal solid waste subject to part 258 of this 
chapter or non-municipal non-hazardous waste subject to Secs. 257.5 
through 257.30 of this chapter, as applicable (excluding thermal 
treatment units).
    (C) In a scrap metal recovery oven or smelter operating in 
compliance with Sec. 761.72.
    (D) In a disposal facility approved under this part.
    (ii) All free-flowing liquid must be removed from each machine and 
the liquid must be disposed of in accordance with the provisions of 
paragraph (a) of this section. If the PCB liquid contains 
1,000 ppm PCB, then the hydraulic machine must be 
decontaminated in accordance with Sec. 761.79 or flushed prior to 
disposal with a solvent listed at paragraph (b)(1)(i)(B) of this section 
which contains <50 ppm PCB. The solvent must be disposed of in 
accordance with paragraph (a) of this section or Sec. 761.79.
    (4) PCB-Contaminated Electrical Equipment. Any person disposing of 
PCB-Contaminated Electrical Equipment, except capacitors, shall do so in 
accordance with paragraph (b)(6)(ii)(A) of this section. Any person 
disposing of Large Capacitors that contain  50 ppm but < 500 
ppm PCBs shall do so in a disposal facility approved under this part.
    (5) Natural gas pipeline systems containing PCBs. The owner or 
operator of natural gas pipeline systems containing 50 ppm 
PCBs, when no longer in use, shall dispose of the system either by 
abandonment in place of the pipe under paragraph (b)(5)(i) of this 
section or removal with subsequent action under paragraph (b)(5)(ii) of 
this section. Any person determining the PCB concentrations in natural 
gas

[[Page 547]]

pipeline systems shall do so in accordance with paragraph (b)(5)(iii) of 
this section.
    (i) Abandonment. Natural gas pipe containing 50 ppm PCBs 
may be abandoned in place under one or more of the following provisions:
    (A) Natural gas pipe having a nominal inside diameter of 
4 inches, and containing PCBs at any concentration but no 
free-flowing liquids, may be abandoned in the place it was used to 
transport natural gas if each end is sealed closed and the pipe is 
either:
    (1) Included in a public service notification program, such as a 
``one-call'' system under 49 CFR 192.614(a) and (b).
    (2) Filled to 50 percent or more of the volume of the pipe with 
grout (such as a hardening slurry consisting of cement, bentonite, or 
clay) or high density polyurethane foam.
    (B) PCB-Contaminated natural gas pipe of any diameter, where the PCB 
concentration was determined after the last transmission of gas through 
the pipe or at the time of abandonment, that contains no free-flowing 
liquids may be abandoned in the place it was used to transport natural 
gas if each end is sealed closed.
    (C) Natural gas pipe of any diameter which contains PCBs at any 
concentration but no free-flowing liquids, may be abandoned in the place 
it was used to transport natural gas, if each end is sealed closed, and 
either:
    (1) The interior surface is decontaminated with one or more washes 
of a solvent in accordance with the use and disposal requirements of 
Sec. 761.79(d). This decontamination process must result in a recovery 
of 95 percent of the solvent volume introduced into the system, and the 
PCB concentration of the recovered wash must be <50 ppm (see 
Sec. 761.79(a)(1) for requirements on use and disposal of 
decontaminating fluids).
    (2) The pipe is filled to 50 percent or more of the volume of the 
pipe with grout (such as a hardening slurry-like cement, bentonite, or 
clay) or high density polyurethane foam (except that only cement shall 
be used as grout under rivers or streams) and each end is sealed closed.
    (D) Natural gas pipe of any diameter which contains PCBs at any 
concentration may be abandoned in place after decontamination in 
accordance with Sec. 761.79(c)(3), (c)(4) or (h) or a PCB disposal 
approval issued under Sec. 761.60(e) or Sec. 761.61(c).
    (ii) Removal with subsequent action. Natural gas pipeline systems 
may be disposed of under one of the following provisions:
    (A) The following classifications of natural gas pipe containing no 
free-flowing liquids may be disposed of in a facility permitted, 
licensed, or registered by a State to manage municipal solid waste 
subject to part 258 of this chapter or non-municipal non-hazardous waste 
subject to Secs. 257.5 through 257.30 of this chapter, as applicable 
(excluding thermal treatment units); a scrap metal recovery oven or 
smelter operating in compliance with the requirements of Sec. 761.72; or 
a disposal facility approved under this part:
    (1) PCB-Contaminated natural gas pipe of any diameter where the PCB 
concentration was determined after the last transmission of gas through 
the pipe or during removal from the location it was used to transport 
natural gas.
    (2) Natural gas pipe containing PCBs at any concentration and having 
a nominal inside diameter 4 inches.
    (B) Any component of a natural gas pipeline system may be disposed 
of under one of the following provisions:
    (1) In an incinerator operating in compliance with Sec. 761.70.
    (2) In a chemical waste landfill operating in compliance with 
Sec. 761.75, provided that all free-flowing liquid PCBs have been 
thoroughly drained.
    (3) As a PCB remediation waste in compliance with Sec. 761.61.
    (4) In accordance with Sec. 761.79.
    (iii) Characterization of natural gas pipeline systems by PCB 
concentration in condensate. (A) Any person disposing of a natural gas 
pipeline system under paragraphs (b)(5)(i)(B) or (b)(5)(ii)(A)(1) of 
this section must characterize it for PCB contamination by analyzing 
organic liquids collected at existing condensate collection points in 
the natural gas pipeline system. The level of PCB contamination found at 
a collection point is assumed to extend to the next collection point 
downstream. If no organic liquids are present, drain free-

[[Page 548]]

flowing liquids and collect standard wipe samples according to subpart M 
of this part. Collect condensate within 72 hours of the final 
transmission of natural gas through the part of the system to be 
abandoned or removed. Collect wipe samples after the last transmission 
of gas through the pipe or during removal from the location it was used 
to transport natural gas.
    (B) PCB concentration of the organic phase of multi-phasic liquids 
shall be determined in accordance with Sec. 761.1(b)(4).
    (iv) Disposal of pipeline liquids. (A) Any person disposing of 
liquids containing PCBs 50 ppm removed, spilled, or otherwise 
released from a natural gas pipeline system must do so in accordance 
with Sec. 761.61(a)(5)(iv) based on the PCB concentration at the time of 
removal from the system. Any person disposing of material contaminated 
by spills or other releases of PCBs 50 ppm from a natural gas 
pipeline system, must do so in accordance with Sec. 761.61 or 
Sec. 761.79, as applicable.
    (B) Any person who markets or burns for energy recovery liquid 
containing PCBs at concentrations <50 ppm PCBs at the time of removal 
from a natural gas pipeline system must do so in accordance with the 
provisions pertaining to used oil at Sec. 761.20(e). No other use of 
liquid containing PCBs at concentrations above the quantifiable level/
level of detection removed from a natural gas pipeline system is 
authorized.
    (6) Other PCB Articles. (i) PCB articles with concentrations at 500 
ppm or greater must be disposed of:
    (A) In an incinerator that complies with Sec. 761.70; or
    (B) In a chemical waste landfill that complies with Sec. 761.75, 
provided that all free-flowing liquid PCBs have been thoroughly drained 
from any articles before the articles are placed in the chemical waste 
landfill and that the drained liquids are disposed of in an incinerator 
that complies with Sec. 761.70.
    (ii)(A) Except as specifically provided in paragraphs (b)(1) through 
(b)(5) of this section, any person disposing of a PCB-Contaminated 
Article must do so by removing all free-flowing liquid from the article, 
disposing of the liquid in accordance with paragraph (a) of this 
section, and disposing of the PCB-Contaminated Article with no free-
flowing liquid by one of the following methods:
    (1) In accordance with Sec. 761.79.
    (2) In a facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Secs. 257.5 through 257.30 of 
this chapter, as applicable (excluding thermal treatment units).
    (3) In a scrap metal recovery oven or smelter operating in 
compliance with Sec. 761.72.
    (4) In a disposal facility approved under this part.
    (B) Storage for disposal of PCB-Contaminated Articles from which all 
free-flowing liquids have been removed is not regulated under subpart D 
of this part.
    (C) Requirements in subparts J and K of this part do not apply to 
PCB-Contaminated Articles from which all free-flowing liquids have been 
removed.
    (iii) Fluorescent light ballasts containing PCBs in their potting 
material must be disposed of in a TSCA-approved disposal facility, as 
bulk product waste under Sec. 761.62, as household waste under 
Sec. 761.63 (where applicable), or in accordance with the 
decontamination provisions of Sec. 761.79.
    (7) Storage of PCB Articles. Except for a PCB Article described in 
paragraph (b)(2)(ii) of this section and hydraulic machines that comply 
with the municipal solid waste disposal provisions described in 
paragraph (b)(3) of this section, any PCB Article, with PCB 
concentrations at 50 ppm or greater, shall be stored in accordance with 
Sec. 761.65 prior to disposal.
    (8) Persons disposing of PCB Articles must wear or use protective 
clothing or equipment to protect against dermal contact with or 
inhalation of PCBs or materials containing PCBs.
    (c) PCB Containers. (1) Unless decontaminated in compliance with 
Sec. 761.79 or as provided in paragraph (c)(2) of this section, a PCB 
container with PCB concentrations at 500 ppm or greater shall be 
disposed of:
    (i) In an incinerator which complies with Sec. 761.70, or

[[Page 549]]

    (ii) In a chemical waste landfill that complies with Sec. 761.75; 
provided that if there are PCBs in a liquid state, the PCB Container 
shall first be drained and the PCB liquid disposed of in accordance with 
paragraph (a) of this section.
    (2) Any PCB Container used to contain only PCBs at a concentration 
less than 500 ppm shall be disposed of as municipal solid wastes; 
provided that if the PCBs are in a liquid state, the PCB Container shall 
first be drained and the PCB liquid shall be disposed of in accordance 
with paragraph (a) of this section.
    (3) Prior to disposal, a PCB container with PCB concentrations at 50 
ppm or greater shall be stored in a unit which complies with 
Sec. 761.65.
    (d) [Reserved]
    (e) Any person who is required to incinerate any PCBs and PCB Items 
under this subpart and who can demonstrate that an alternative method of 
destroying PCBs and PCB Items exists and that this alternative method 
can achieve a level of performance equivalent to an incinerator approved 
under Sec. 761.70 or a high efficiency boiler operating in compliance 
with Sec. 761.71, must submit a written request to either the EPA 
Regional Administrator or the Director, National Program Chemicals 
Division, for a waiver from the incineration requirements of Sec. 761.70 
or Sec. 761.71. Requests for approval of alternate methods that will be 
operated in more than one Region must be submitted to the Director, 
National Program Chemicals Division except for research and development 
activities involving less than 500 pounds of PCB material (see paragraph 
(i)(2) of this section). Requests for approval of alternate methods that 
will be operated in only one Region must be submitted to the appropriate 
EPA Regional Administrator. The applicant must show that his or her 
method of destroying PCBs will not present an unreasonable risk of 
injury to health or the environment. On the basis of such information 
and any available information, the EPA Regional Administrator or the 
Director, National Program Chemicals Division may, in his or her 
discretion, approve the use of the alternate method if he or she finds 
that the alternate disposal method provides PCB destruction equivalent 
to disposal in a Sec. 761.70 incinerator or a Sec. 761.71 high 
efficiency boiler and will not present an unreasonable risk of injury to 
health or the environment. Any approval must be stated in writing and 
may include such conditions and provisions as the EPA Regional 
Administrator or Director, National Program Chemicals Division deems 
appropriate. The person to whom such waiver is issued must comply with 
all limitations contained in such determination. No person may use the 
alternate method of destroying PCBs or PCB Items prior to obtaining 
permission from the appropriate EPA official.
    (f)(1) Each operator of a chemical waste landfill, incinerator, or 
alternative to incineration approved under paragraph (e) of this section 
shall give the following written notices to the state and local 
governments within whose jurisdiction the disposal facility is located:
    (i) Notice at least thirty (30) days before a facility is first used 
for disposal of PCBs required by these regulations; and
    (ii) At the request of any state or local government, annual notice 
of the quantities and general description of PCBs disposed of during the 
year. This annual notice shall be given no more than thirty (30) days 
after the end of the year covered.
    (iii) The Regional Administrator may reduce the notice period 
required by paragraph (f)(1)(i) of this section from thirty days to a 
period of no less than five days in order to expedite interim approval 
of the chemical waste landfill located in Sedgwick County, Kansas.
    (2) [Reserved]
    (g) Testing procedures. (1) Owners or users of mineral oil 
dielectric fluid electrical equipment may use the following procedures 
to determine the concentration of PCBs in the dielectric fluid:
    (i) Dielectric fluid removed from mineral oil dielectric fluid 
electrical equipment may be collected in a common container, provided 
that no other chemical substances or mixtures are added to the 
container. This common container option does not permit dilution of the 
collected oil. Mineral oil

[[Page 550]]

that is assumed or known to contain at least 50 ppm PCBs must not be 
mixed with mineral oil that is known or assumed to contain less than 50 
ppm PCBs to reduce the concentration of PCBs in the common container. If 
dielectric fluid from untested, oil-filled circuit breakers, reclosers, 
or cable is collected in a common container with dielectric fluid from 
other oil-filled electrical equipment, the entire contents of the 
container must be treated as PCBs at a concentration of at least 50 ppm, 
unless all of the fluid from the other oil-filled electrical equipment 
has been tested and shown to contain less than 50 ppm PCBs.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration, except that if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this subparagraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including EPA Method 608, ``Organochlorine 
Pesticides and PCBs'' at 40 CFR part 136, Appendix A;'' EPA Method 8082, 
``Polychlorinated Biphenyls (PCBs) by Capillary Column Gas 
Chromatography'' of SW-846, ``OSW Test Methods for Evaluating Solid 
Waste,'' which is available from NTIS; and ASTM Standard D-4059, 
``Standard Test Method for Analysis of Polychlorinated Biphenyls in 
Insulating Liquids by Gas Chromatography,'' which is available from 
ASTM.
    (2) Owners or users of waste oil may use the following procedures to 
determine the PCB concentration of waste oil:
    (i) Waste oil from more than one source may be collected in a common 
container, provided that no other chemical substances or mixtures, such 
as non-waste oils, are added to the container.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration. Except, That if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this paragraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including those indicated in paragraph (g)(1)(iii) 
of this section.
    (h) Requirements for export and import of PCBs and PCB Items for 
disposal are found in Subpart F of this part.
    (i) Approval authority for disposal methods. (1) The officials (the 
Director, National Programs Chemical Division and the Regional 
Administrators) designated in Secs. 761.60(e) and 761.70 (a) and (b) to 
receive requests for approval of PCB disposal activities are the primary 
approval authorities for these activities. Notwithstanding, the 
Director, National Programs Chemical Division may, at his/her 
discretion, assign the

[[Page 551]]

authority to review and approve any aspect of a disposal system to the 
Office of Prevention, Pesticides and Toxic Substances or to a Regional 
Administrator.
    (2) Except for activity authorized under paragraph (j) of this 
section, research and development (R&D) for PCB disposal using a total 
of <500 pounds of PCB material (regardless of PCB concentration) will be 
reviewed and approved by the EPA Regional Administrator for the Region 
where the R&D will be conducted, and R&D for PCB disposal using 500 
pounds or more of PCB material (regardless of PCB concentration) will be 
reviewed and approved by the Director, National Program Chemicals 
Division.
    (j) Self-implementing requirements for research and development 
(R&D) for PCB disposal.
    (1) Any person may conduct R&D for PCB disposal without prior 
written approval from EPA if they meet the following conditions:
    (i) File a notification and obtain an EPA identification number 
pursuant to subpart K of this part.
    (ii) Notify in writing the EPA Regional Administrator, the State 
environmental protection agency, and local environmental protection 
agency, having jurisdiction where the R&D for PCB disposal activity will 
occur at least 30 days prior to the commencement of any R&D for PCB 
disposal activity conducted under this section. Each written 
notification shall include the EPA identification number of the site 
where the R&D for PCB disposal activities will be conducted, the 
quantity of PCBs to be treated, the type of R&D technology to be used, 
the general physical and chemical properties of material being treated, 
and an estimate of the duration of the PCB activity. The EPA Regional 
Administrator, the State environmental protection agency, and the local 
environmental protection agency may waive notification in writing prior 
to commencement of the research.
    (iii) The amount of material containing PCBs treated annually by the 
facility during R&D for PCB disposal activities does not exceed 500 
gallons or 70 cubic feet of liquid or non-liquid PCBs and does not 
exceed a maximum concentration of 10,000 ppm PCBs.
    (iv) No more than 1 kilogram total of pure PCBs per year is disposed 
of in all R&D for PCB disposal activities at a facility.
    (v) Each R&D for PCB disposal activity under this section lasts no 
more than 1 calendar year.
    (vi) Store all PCB wastes (treated and untreated PCB materials, 
testing samples, spent laboratory samples, residuals, untreated samples, 
contaminated media or instrumentation, clothing, etc.) in compliance 
with Sec. 761.65(b) and dispose of them according to the undiluted PCB 
concentration prior to treatment. However, PCB materials not treated in 
the R&D for PCB disposal activity may be returned either to the physical 
location where the samples were collected or a location where other 
regulated PCBs from the physical location where the samples were 
collected are being stored for disposal.
    (vii) Use manifests pursuant to subpart K of this part for all R&D 
PCB wastes being transported from the R&D facility to an approved PCB 
storage or disposal facility. However, Secs. 761.207 through 761.218 do 
not apply if the residuals or treated samples are returned either to the 
physical location where the samples were collected or a location where 
other regulated PCBs from the physical location where the samples were 
collected are being stored for disposal.
    (viii) Package and ship all PCB wastes pursuant to DOT requirements 
under 49 CFR parts 171 through 180.
    (ix) Comply with the recordkeeping requirements of Sec. 761.180.
    (2) Do not exceed material limitations set out in paragraphs (j)(1) 
(iii) and (iv) of this section and the time limitation set out in 
paragraph (j)(1)(v) of this section without prior written approval from 
EPA. Requests for approval to exceed the material limitations for PCBs 
in R&D for PCB disposal activities as specified in this section must be 
submitted in writing to the EPA Regional Administrator for the Region in 
which the facility conducting R&D for PCB disposal activities is 
located. Each request shall specify the quantity or concentration 
requested or additional time needed for

[[Page 552]]

disposal and include a justification for each increase. For extensions 
to the duration of the R&D for PCB disposal activity, the request shall 
also include a report on the accomplishments and progress of the 
previously authorized R&D for PCB disposal activity for which the 
extension is sought. The EPA Regional Administrator may grant a waiver 
in writing for an increase in the volume of PCB material, the maximum 
concentration of PCBs, the total amount of pure PCBs, or the duration of 
the R&D activity. Approvals will state all requirements applicable to 
the R&D for PCB disposal activity.
    (3) The EPA Regional Administrator for the Region in which an R&D 
for PCB disposal activity is conducted may determine, at any time, that 
an R&D PCB disposal approval is required under paragraphs (e) and (i)(2) 
of this section or Sec. 761.70(d) to ensure that any R&D for PCB 
disposal activity does not present an unreasonable risk of injury to 
health or the environment.


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979]

    Editorial Note: For Fedearl Register citations affecting 
Sec. 761.60, see the List of CFR Sections Affected in the Finding Aids 
section of this volume.



Sec. 761.61   PCB remediation waste.

    This section provides cleanup and disposal options for PCB 
remediation waste. Any person cleaning up and disposing of PCBs managed 
under this section shall do so based on the concentration at which the 
PCBs are found. This section does not prohibit any person from 
implementing temporary emergency measures to prevent, treat, or contain 
further releases or mitigate migration to the environment of PCBs or PCB 
remediation waste.
    (a) Self-implementing on-site cleanup and disposal of PCB 
remediation waste. EPA designed the self-implementing procedure for a 
general, moderately-sized site where there should be low residual 
environmental impact from remedial activities. The procedure may be less 
practical for larger or environmentally diverse sites. For these other 
sites, the self-implementing procedure still applies, but an EPA 
Regional Administrator may authorize more practical procedures through 
paragraph (c) of this section. Any person may conduct self-implementing 
cleanup and disposal of PCB remediation waste in accordance with the 
following requirements without prior written approval from EPA.
    (1) Applicability. (i) The self-implementing procedures may not be 
used to clean up:
    (A) Surface or ground waters.
    (B) Sediments in marine and freshwater ecosystems.
    (C) Sewers or sewage treatment systems.
    (D) Any private or public drinking water sources or distribution 
systems.
    (E) Grazing lands.
    (F) Vegetable gardens.
    (ii) The self-implementing cleanup provisions shall not be binding 
upon cleanups conducted under other authorities, including but not 
limited to, actions conducted under section 104 or section 106 of 
CERCLA, or section 3004(u) and (v) or section 3008(h) of RCRA.
    (2) Site characterization. Any person conducting self-implementing 
cleanup of PCB remediation waste must characterize the site adequately 
to be able to provide the information required by paragraph (a)(3) of 
this section. Subpart N of this part provides a method for collecting 
new site characterization data or for assessing the sufficiency of 
existing site characterization data.
    (3) Notification and certification. (i) At least 30 days prior to 
the date that the cleanup of a site begins, the person in charge of the 
cleanup or the owner of the property where the PCB remediation waste is 
located shall notify, in writing, the EPA Regional Administrator, the 
Director of the State or Tribal environmental protection agency, and the 
Director of the county or local environmental protection agency where 
the cleanup will be conducted. The notice shall include:
    (A) The nature of the contamination, including kinds of materials 
contaminated.
    (B) A summary of the procedures used to sample contaminated and 
adjacent areas and a table or cleanup site map showing PCB 
concentrations

[[Page 553]]

measured in all pre-cleanup characterization samples. The summary must 
include sample collection and analysis dates. The EPA Regional 
Administrator may require more detailed information including, but not 
limited to, additional characterization sampling or all sample 
identification numbers from all previous characterization activities at 
the cleanup site.
    (C) The location and extent of the identified contaminated area, 
including topographic maps with sample collection sites cross referenced 
to the sample identification numbers in the data summary from paragraph 
(a)(3)(i)(B) of this section.
    (D) A cleanup plan for the site, including schedule, disposal 
technology, and approach. This plan should contain options and 
contingencies to be used if unanticipated higher concentrations or wider 
distributions of PCB remediation waste are found or other obstacles 
force changes in the cleanup approach.
    (E) A written certification, signed by the owner of the property 
where the cleanup site is located and the party conducting the cleanup, 
that all sampling plans, sample collection procedures, sample 
preparation procedures, extraction procedures, and instrumental/chemical 
analysis procedures used to assess or characterize the PCB contamination 
at the cleanup site, are on file at the location designated in the 
certificate, and are available for EPA inspection. Persons using 
alternate methods for chemical extraction and chemical analysis for site 
characterization must include in the certificate a statement that such a 
method will be used and that a comparison study which meets or exceeds 
the requirements of subpart Q of this part, and for which records are on 
file, has been completed prior to verification sampling.
    (ii) Within 30 calendar days of receiving the notification, the EPA 
Regional Administrator will respond in writing approving of the self-
implementing cleanup, disapproving of the self-implementing cleanup, or 
requiring additional information. If the EPA Regional Administrator does 
not respond within 30 calendar days of receiving the notice, the person 
submitting the notification may assume that it is complete and 
acceptable and proceed with the cleanup according to the information the 
person provided to the EPA Regional Administrator. Once cleanup is 
underway, the person conducting the cleanup must provide any proposed 
changes from the notification to the EPA Regional Administrator in 
writing no less than 14 calendar days prior to the proposed 
implementation of the change. The EPA Regional Administrator will 
determine in his or her discretion whether to accept the change, and 
will respond to the change notification verbally within 7 calendar days 
and in writing within 14 calendar days of receiving it. If the EPA 
Regional Administrator does not respond verbally within 7 calendar days 
and in writing within 14 calendar days of receiving the change notice, 
the person who submitted it may deem it complete and acceptable and 
proceed with the cleanup according to the information in the change 
notice provided to the EPA Regional Administrator.
    (iii) Any person conducting a cleanup activity may obtain a waiver 
of the 30-day notification requirement, if they receive a separate 
waiver, in writing, from each of the agencies they are required to 
notify under this section. The person must retain the original written 
waiver as required in paragraph (a)(9) of this section.
    (4) Cleanup levels. For purposes of cleaning, decontaminating, or 
removing PCB remediation waste under this section, there are four 
general waste categories: bulk PCB remediation waste, non-porous 
surfaces, porous surfaces, and liquids. Cleanup levels are based on the 
kind of material and the potential exposure to PCBs left after cleanup 
is completed.
    (i) Bulk PCB remediation waste. Bulk PCB remediation waste includes, 
but is not limited to, the following non-liquid PCB remediation waste: 
soil, sediments, dredged materials, muds, PCB sewage sludge, and 
industrial sludge.
    (A) High occupancy areas. The cleanup level for bulk PCB remediation 
waste in high occupancy areas is 1 ppm without further 
conditions. High occupancy areas where bulk PCB remediation waste 
remains at concentrations >1 ppm and 10 ppm shall be covered 
with a cap meeting the requirements of

[[Page 554]]

paragraphs (a)(7) and (a)(8) of this section.
    (B) Low occupancy areas. (1) The cleanup level for bulk PCB 
remediation waste in low occupancy areas is 25 ppm unless 
otherwise specified in this paragraph.
    (2) Bulk PCB remediation wastes may remain at a cleanup site at 
concentrations >25 ppm and 50 ppm if the site is secured by a 
fence and marked with a sign including the ML mark.
    (3) Bulk PCB remediation wastes may remain at a cleanup site at 
concentrations >25 ppm and 100 ppm if the site is covered 
with a cap meeting the requirements of paragraphs (a)(7) and (a)(8) of 
this section.
    (ii) Non-porous surfaces. In high occupancy areas, the surface PCB 
cleanup standard is  10 g/100 cm2 of 
surface area. In low occupancy areas, the surface cleanup standard is 
100 g/100 cm2 of surface area. Select sampling 
locations in accordance with subpart P of this part or a sampling plan 
approved under paragraph (c) of this section.
    (iii) Porous surfaces. In both high and low occupancy areas, any 
person disposing of porous surfaces must do so based on the levels in 
paragraph (a)(4)(i) of this section. Porous surfaces may be cleaned up 
for use in accordance with Sec. 761.79(b)(4) or Sec. 761.30(p).
    (iv) Liquids. In both high and low occupancy areas, cleanup levels 
are the concentrations specified in Sec. 761.79(b)(1) and (b)(2).
    (v) Change in the land use for a cleanup site. Where there is an 
actual or proposed change in use of an area cleaned up to the levels of 
a low occupancy area, and the exposure of people or animal life in or at 
that area could reasonably be expected to increase, resulting in a 
change in status from a low occupancy area to a high occupancy area, the 
owner of the area shall clean up the area in accordance with the high 
occupancy area cleanup levels in paragraphs (a)(4)(i) through (a)(4)(iv) 
of this section.
    (vi) The EPA Regional Administrator, as part of his or her response 
to a notification submitted in accordance with Sec. 761.61(a)(3) of this 
part, may require cleanup of the site, or portions of it, to more 
stringent cleanup levels than are otherwise required in this section, 
based on the proximity to areas such as residential dwellings, 
hospitals, schools, nursing homes, playgrounds, parks, day care centers, 
endangered species habitats, estuaries, wetlands, national parks, 
national wildlife refuges, commercial fisheries, and sport fisheries.
    (5) Site cleanup. In addition to the options set out in this 
paragraph, PCB disposal technologies approved under Secs. 761.60 and 
761.70 are acceptable for on-site self-implementing PCB remediation 
waste disposal within the confines of the operating conditions of the 
respective approvals.
    (i) Bulk PCB remediation waste. Any person cleaning up bulk PCB 
remediation waste shall do so to the levels in paragraph (a)(4)(i) of 
this section.
    (A) Any person cleaning up bulk PCB remediation waste on-site using 
a soil washing process may do so without EPA approval, subject to all of 
the following:
    (1) A non-chlorinated solvent is used.
    (2) The process occurs at ambient temperature.
    (3) The process is not exothermic.
    (4) The process uses no external heat.
    (5) The process has secondary containment to prevent any solvent 
from being released to the underlying or surrounding soils or surface 
waters.
    (6) Solvent disposal, recovery, and/or reuse is in accordance with 
relevant provisions of approvals issued according to paragraphs (b)(1) 
or (c) of this section or applicable paragraphs of Sec. 761.79.
    (B) Bulk PCB remediation waste may be sent off-site for 
decontamination or disposal in accordance with this paragraph, provided 
the waste is either dewatered on-site or transported off-site in 
containers meeting the requirements of the DOT Hazardous Materials 
Regulations (HMR) at 49 CFR parts 171 through 180.
    (1) Removed water shall be disposed of according to paragraph (b)(1) 
of this section.
    (2) Any person disposing off-site of dewatered bulk PCB remediation 
waste shall do so as follows:
    (i) Unless sampled and analyzed for disposal according to the 
procedures set out in Sec. Sec. 761.283, 761.286, and 761.292,

[[Page 555]]

the bulk PCB remediation waste shall be assumed to contain  
50 ppm PCBs.
    (ii) Bulk PCB remediation wastes with a PCB concentration of <50 ppm 
shall be disposed of in accordance with paragraph (a)(5)(v)(A) of this 
section.
    (iii) Bulk PCB remediation wastes with a PCB concentration 
50 ppm shall be disposed of in a hazardous waste landfill 
permitted by EPA under section 3004 of RCRA, or by a State authorized 
under section 3006 of RCRA, or a PCB disposal facility approved under 
this part.
    (iv) The generator must provide written notice, including the 
quantity to be shipped and highest concentration of PCBs (using 
extraction EPA Method 3500B/3540C or Method 3500B/3550B followed by 
chemical analysis using EPA Method 8082 in SW-846 or methods validated 
under subpart Q of this part) at least 15 days before the first shipment 
of bulk PCB remediation waste from each cleanup site by the generator, 
to each off-site facility where the waste is destined for an area not 
subject to a TSCA PCB Disposal Approval.
    (3) Any person may decontaminate bulk PCB remediation waste in 
accordance with Sec. 761.79 and return the waste to the cleanup site for 
disposal as long as the cleanup standards of paragraph (a)(4) of this 
section are met.
    (ii) Non-porous surfaces. PCB remediation waste non-porous surfaces 
shall be cleaned on-site or off-site for disposal on-site, disposal off-
site, or use, as follows:
    (A) For on-site disposal, non-porous surfaces shall be cleaned on-
site or off-site to the levels in paragraph (a)(4)(ii) of this section 
using:
    (1) Procedures approved under Sec. 761.79.
    (2) Technologies approved under Sec. 761.60(e).
    (3) Procedures or technologies approved under paragraph (c) of this 
section.
    (B) For off-site disposal, non-porous surfaces:
    (1) Having surface concentrations <100 g/100 cm2 
shall be disposed of in accordance with paragraph (a)(5)(i)(B)(2)(ii) of 
this section. Metal surfaces may be thermally decontaminated in 
accordance with Sec. 761.79(c)(6)(i).
    (2) Having surface concentrations 100 g/100 
cm2 shall be disposed of in accordance with paragraph 
(a)(5)(i)(B)(2)(iii) of this section. Metal surfaces may be thermally 
decontaminated in accordance with Sec. 761.79(c)(6)(ii).
    (C) For use, non-porous surfaces shall be decontaminated on-site or 
off-site to the standards specified in Sec. 761.79(b)(3) or in 
accordance with Sec. 761.79(c).
    (iii) Porous surfaces. Porous surfaces shall be disposed on-site or 
off-site as bulk PCB remediation waste according to paragraph (a)(5)(i) 
of this section or decontaminated for use according to 
Sec. 761.79(b)(4), as applicable.
    (iv) Liquids. Any person disposing of liquid PCB remediation waste 
shall either:
    (A) Decontaminate the waste to the levels specified in 
Sec. 761.79(b)(1) or (b)(2).
    (B) Dispose of the waste in accordance with paragraph (b) of this 
section or an approval issued under paragraph (c) of this section.
    (v) Cleanup wastes. Any person generating the following wastes 
during and from the cleanup of PCB remediation waste shall dispose of or 
reuse them using one of the following methods:
    (A) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
cleanup activities shall be either decontaminated in accordance with 
Sec. 761.79(b) or (c), or disposed of in one of the following 
facilities, without regard to the requirements of subparts J and K of 
this part:
    (1) A facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter.
    (2) A facility permitted, licensed, or registered by a State to 
manage non-municipal non-hazardous waste subject to Sec. Sec. 257.5 
through 257.30 of this chapter, as applicable.
    (3) A hazardous waste landfill permitted by EPA under section 3004 
of RCRA, or by a State authorized under section 3006 of RCRA.
    (4) A PCB disposal facility approved under this part.

[[Page 556]]

    (B) Cleaning solvents, abrasives, and equipment may be reused after 
decontamination in accordance with Sec. 761.79.
    (6) Cleanup verification--(i) Sampling and analysis. Any person 
collecting and analyzing samples to verify the cleanup and on-site 
disposal of bulk PCB remediation wastes and porous surfaces must do so 
in accordance with subpart O of this part. Any person collecting and 
analyzing samples from non-porous surfaces must do so in accordance with 
subpart P of this part. Any person collecting and analyzing samples from 
liquids must do so in accordance with Sec. 761.269. Any person 
conducting interim sampling during PCB remediation waste cleanup to 
determine when to sample to verify that cleanup is complete, may use PCB 
field screening tests.
    (ii) Verification. (A) Where sample analysis results in a 
measurement of PCBs less than or equal to the levels specified in 
paragraph (a)(4) of this section, self-implementing cleanup is complete.
    (B) Where sample analysis results in a measurement of PCBs greater 
than the levels specified in paragraph (a)(4) of this section, self-
implementing cleanup of the sampled PCB remediation waste is not 
complete. The owner or operator of the site must either dispose of the 
sampled PCB remediation waste, or reclean the waste represented by the 
sample and reinitiate sampling and analysis in accordance with paragraph 
(a)(6)(i) of this section.
    (7) Cap requirements. A cap means, when referring to on-site cleanup 
and disposal of PCB remediation waste, a uniform placement of concrete, 
asphalt, or similar material of minimum thickness spread over the area 
where remediation waste was removed or left in place in order to prevent 
or minimize human exposure, infiltration of water, and erosion. Any 
person designing and constructing a cap must do so in accordance with 
Sec. 264.310(a) of this chapter, and ensure that it complies with the 
permeability, sieve, liquid limit, and plasticity index parameters in 
Sec. 761.75(b)(1)(ii) through (b)(1)(v). A cap of compacted soil shall 
have a minimum thickness of 25 cm (10 inches). A concrete or asphalt cap 
shall have a minimum thickness of 15 cm (6 inches). A cap must be of 
sufficient strength to maintain its effectiveness and integrity during 
the use of the cap surface which is exposed to the environment. A cap 
shall not be contaminated at a level 1 ppm PCB per 
AroclorTM (or equivalent) or per congener. Repairs shall 
begin within 72 hours of discovery for any breaches which would impair 
the integrity of the cap.
    (8) Deed restrictions for caps, fences and low occupancy areas. When 
a cleanup activity conducted under this section includes the use of a 
fence or a cap, the owner of the site must maintain the fence or cap, in 
perpetuity. In addition, whenever a cap, or the procedures and 
requirements for a low occupancy area, is used, the owner of the site 
must meet the following conditions:
    (i) Within 60 days of completion of a cleanup activity under this 
section, the owner of the property shall:
    (A) Record, in accordance with State law, a notation on the deed to 
the property, or on some other instrument which is normally examined 
during a title search, that will in perpetuity notify any potential 
purchaser of the property:
    (1) That the land has been used for PCB remediation waste disposal 
and is restricted to use as a low occupancy area as defined in 
Sec. 761.3.
    (2) Of the existence of the fence or cap and the requirement to 
maintain the fence or cap.
    (3) The applicable cleanup levels left at the site, inside the 
fence, and/or under the cap.
    (B) Submit a certification, signed by the owner, that he/she has 
recorded the notation specified in paragraph (a)(8)(i)(A) of this 
section to the EPA Regional Administrator.
    (ii) The owner of a site being cleaned up under this section may 
remove a fence or cap after conducting additional cleanup activities and 
achieving cleanup levels, specified in paragraph (a)(4) of this section, 
which do not require a cap or fence. The owner may remove the notice on 
the deed no earlier than 30 days after achieving the cleanup levels 
specified in this section which do not require a fence or cap.
    (9) Recordkeeping. For paragraphs (a)(3), (a)(4), and (a)(5) of this 
section,

[[Page 557]]

recordkeeping is required in accordance with Sec. 761.125(c)(5).
    (b) Performance-based disposal. (1) Any person disposing of liquid 
PCB remediation waste shall do so according to Sec. 761.60(a) or (e), or 
decontaminate it in accordance with Sec. 761.79.
    (2) Any person disposing of non-liquid PCB remediation waste shall 
do so by one of the following methods:
    (i) Dispose of it in a high temperature incinerator approved under 
Sec. 761.70(b), an alternate disposal method approved under 
Sec. 761.60(e), a chemical waste landfill approved under Sec. 761.75, or 
in a facility with a coordinated approval issued under Sec. 761.77.
    (ii) Decontaminate it in accordance with Sec. 761.79.
    (3) Any person may manage or dispose of material containing <50 ppm 
PCBs that has been dredged or excavated from waters of the United 
States:
    (i) In accordance with a permit that has been issued under section 
404 of the Clean Water Act, or the equivalent of such a permit as 
provided for in regulations of the U.S. Army Corps of Engineers at 33 
CFR part 320.
    (ii) In accordance with a permit issued by the U.S. Army Corps of 
Engineers under section 103 of the Marine Protection, Research, and 
Sanctuaries Act, or the equivalent of such a permit as provided for in 
regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.
    (c) Risk-based disposal approval. (1) Any person wishing to sample, 
cleanup, or dispose of PCB remediation waste in a manner other than 
prescribed in paragraphs (a) or (b) of this section, or store PCB 
remediation waste in a manner other than prescribed in Sec. 761.65, must 
apply in writing to the EPA Regional Administrator in the Region where 
the sampling, cleanup, disposal or storage site is located, for 
sampling, cleanup, disposal or storage occurring in a single EPA Region; 
or to the Director of the National Program Chemicals Division, for 
sampling, cleanup, disposal or storage occurring in more than one EPA 
Region. Each application must contain information described in the 
notification required by Sec. 761.61(a)(3). EPA may request other 
information that it believes necessary to evaluate the application. No 
person may conduct cleanup activities under this paragraph prior to 
obtaining written approval by EPA.
    (2) EPA will issue a written decision on each application for a 
risk-based method for PCB remediation wastes. EPA will approve such an 
application if it finds that the method will not pose an unreasonable 
risk of injury to health or the environment.

[63 FR 35448, June 29, 1998, as amended at 64 FR 33761, June 24, 1999]



Sec. 761.62   Disposal of PCB bulk product waste.

    PCB bulk product waste shall be disposed of in accordance with 
paragraph (a), (b), or (c) of this section. Under some of these 
provisions, it may not be necessary to determine the PCB concentration 
or leaching characteristics of the PCB bulk product waste. When it is 
necessary to analyze the waste to make either of these determinations, 
use the applicable procedures in subpart R of this part to sample the 
waste for analysis, unless EPA approves another sampling plan under 
paragraph (c) of this section.
    (a) Performance-based disposal. Any person disposing of PCB bulk 
product waste may do so as follows:
    (1) In an incinerator approved under Sec. 761.70.
    (2) In a chemical waste landfill approved under Sec. 761.75.
    (3) In a hazardous waste landfill permitted by EPA under section 
3004 of RCRA, or by a State authorized under section 3006 of RCRA.
    (4) Under an alternate disposal approval under Sec. 761.60(e).
    (5) In accordance with the decontamination provisions of 
Sec. 761.79.
    (6) For metal surfaces in contact with PCBs, in accordance with the 
thermal decontamination provisions of Sec. 761.79(c)(6).
    (7) In accordance with a TSCA PCB Coordinated Approval issued under 
Sec. 761.77.
    (b) Disposal in solid waste landfills. (1) Any person may dispose of 
the following PCB bulk product waste in a facility permitted, licensed, 
or registered by a State as a municipal or non-municipal non-hazardous 
waste landfill:
    (i) Plastics (such as plastic insulation from wire or cable; radio, 
television

[[Page 558]]

and computer casings; vehicle parts; or furniture laminates); preformed 
or molded rubber parts and components; applied dried paints, varnishes, 
waxes or other similar coatings or sealants; caulking; Galbestos; non-
liquid building demolition debris; or non-liquid PCB bulk product waste 
from the shredding of automobiles or household appliances from which PCB 
small capacitors have been removed (shredder fluff).
    (ii) Other PCB bulk product waste, sampled in accordance with the 
protocols set out in subpart R of this part, that leaches PCBs at <10 
g/L of water measured using a procedure used to simulate 
leachate generation.
    (2) Any person may dispose of PCB bulk product waste other than 
those materials meeting the conditions of paragraph (b)(1) of this 
section, (e.g., paper or felt gaskets contaminated by liquid PCBs in a 
facility that is permitted, licensed, or registered by a State to manage 
municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Secs. 257.5 through 257.30 of 
this chapter, as applicable, if:
    (i) The PCB bulk product waste is segregated from organic liquids 
disposed of in the landfill unit.
    (ii) Leachate is collected from the landfill unit and monitored for 
PCBs.
    (3) Any release of PCBs (including but not limited to leachate) from 
the landfill unit shall be cleaned up in accordance with Sec. 761.61.
    (4)(i) Any person disposing off-site of PCB bulk product waste 
regulated under paragraph (b)(1) of this section at a waste management 
facility not having a commercial PCB storage or disposal approval must 
provide written notice to the facility a minimum of 15 days in advance 
of the first shipment from the same disposal waste stream. The notice 
shall state that the PCB bulk product waste may include components 
containing PCBs at  50 ppm based on analysis of the waste in 
the shipment or application of a general knowledge of the waste stream 
(or similar material) which is known to contain PCBs at those levels, 
and that the PCB bulk product waste is known or presumed to leach <10 
g/L PCBs.
    (ii) Any person disposing off-site of PCB bulk product waste 
regulated under paragraph (b)(2) of this section at a waste management 
facility not having a commercial PCB storage or disposal approval must 
provide written notice to the facility a minimum of 15 days in advance 
of the first shipment from the same disposal waste stream and with each 
shipment thereafter. The notice shall state that the PCB bulk product 
waste may include components containing PCBs at 50 ppm based 
on analysis of the waste in the shipment or application of a general 
knowledge of the waste stream (or similar material) which is known to 
contain PCBs at those levels, and that the PCB bulk product waste is 
known or presumed to leach 10 g/L PCBs.
    (5) Any person disposing of PCB bulk product waste must maintain a 
written record of all sampling and analysis of PCBs or notifications 
made under this paragraph for 3 years from the date of the waste's 
generation. The records must be made available to EPA upon request.
    (6) Requirements in subparts C, J, and K of this part do not apply 
to waste disposed of under paragraph (b) of this section.
    (c) Risk-based disposal approval. (1) Any person wishing to sample 
or dispose of PCB bulk product waste in a manner other than prescribed 
in paragraphs (a) or (b) of this section, or store PCB bulk product 
waste in a manner other than prescribed in Sec. 761.65, must apply in 
writing to: the EPA Regional Administrator in the Region where the 
sampling, disposal, or storage site is located, for sampling, disposal, 
or storage occurring in a single EPA Region; or the Director of the 
National Program Chemicals Division, for sampling, disposal, or storage 
occurring in more than one EPA Region. Each application must contain 
information indicating that, based on technical, environmental, or 
waste-specific characteristics or considerations, the proposed sampling, 
disposal, or storage methods or locations will not pose an unreasonable 
risk of injury to health or the environment. EPA may request other 
information that it believes necessary to evaluate the application. No 
person may conduct sampling, disposal,

[[Page 559]]

or storage activities under this paragraph prior to obtaining written 
approval by EPA.
    (2) EPA will issue a written decision on each application for a 
risk-based sampling, disposal, or storage method for PCB bulk product 
wastes. EPA will approve such an application if it finds that the method 
will not pose an unreasonable risk of injury to health or the 
environment.
    (d) Disposal as daily landfill cover or roadbed. Bulk product waste 
described in paragraph (b)(1) of this section may be disposed of:
    (1) As daily landfill cover as long as the daily cover remains in 
the landfill and is not released or dispersed by wind or other action; 
or
    (2) Under asphalt as part of a road bed.

[63 FR 35451, June 29, 1998, as amended at 64 FR 33761, June 24, 1999]



Sec. 761.63   PCB household waste storage and disposal.

    PCB household waste, as defined at Sec. 761.3, managed in a facility 
permitted, licensed, or registered by a State to manage municipal or 
industrial solid waste, or in a facility with an approval to dispose of 
PCB bulk product waste under Sec. 761.62(c), is not subject to any other 
requirements of part 761 of this chapter. PCB household waste stored in 
a unit regulated for storage of PCB waste must not be commingled with 
PCB waste.

[63 FR 35452, June 29, 1998]



Sec. 761.64   Disposal of wastes generated as a result of research and development activities authorized under Sec. 761.30(j) and chemical analysis of PCBs.

    This section provides disposal requirements for wastes generated 
during and as a result of research and development authorized under 
Sec. 761.30(j). This section also provides disposal requirements for 
wastes generated during the chemical analysis of samples containing PCBs 
under part 761, including Secs.  761.30, 761.60, 761.61, 761.62, and 
761.79. For determining the presence of PCBs in samples, chemical 
analysis includes: sample preparation, sample extraction, extract 
cleanup, extract concentration, addition of PCB standards, and 
instrumental analysis.
    (a) Portions of samples of a size designated in a chemical 
extraction and analysis method for PCBs and extracted for purposes of 
determining the presence of PCBs or concentration of PCBs are 
unregulated for PCB disposal under this part.
    (b) All other wastes generated during these activities are regulated 
for disposal based on their concentration at the time of disposal as 
follows:
    (1) Liquid wastes, including rinse solvents, must be disposed of 
according to Sec. 761.61(a)(5)(iv).
    (2) Non-liquid wastes must be disposed of in the same manner as non-
liquid cleaning materials and personal protective equipment waste 
according to Sec. 761.61(a)(5)(v)(A).

[63 FR 35452, June 29, 1998]



Sec. 761.65  Storage for disposal.

    This section applies to the storage for disposal of PCBs at 
concentrations of 50 ppm or greater and PCB Items with PCB 
concentrations of 50 ppm or greater.
    (a)(1) Storage limitations. Any PCB waste shall be disposed of as 
required by subpart D of this part within 1-year from the date it was 
determined to be PCB waste and the decision was made to dispose of it. 
This date is the date of removal from service for disposal and the point 
at which the 1-year time frame for disposal begins. PCB/radioactive 
waste removed from service for disposal is exempt from the 1-year time 
limit provided that the provisions at paragraphs (a)(2)(ii) and 
(a)(2)(iii) of this section are followed and the waste is managed in 
accordance with all other applicable Federal, State, and local laws and 
regulations for the management of radioactive material.
    (2) One-year extension. Any person storing PCB waste that is subject 
to the 1-year time limit for storage and disposal in paragraph (a)(1) of 
this section may provide written notification to the EPA Regional 
Administrator for the Region in which the PCB waste is stored that their 
continuing attempts to dispose of or secure disposal for their waste 
within the 1-year time

[[Page 560]]

limit have been unsuccessful. Upon receipt of the notice by the EPA 
Regional Administrator, the time for disposal is automatically extended 
for 1 additional year (2 years total) if the following conditions are 
met:
    (i) The notification is received by the EPA Regional Administrator 
at least 30 days before the initial 1-year time limit expires and the 
notice identifies the storer, the types, volumes, and locations of the 
waste and the reasons for failure to meet the initial 1-year time limit.
    (ii) A written record documenting all continuing attempts to secure 
disposal is maintained until the waste is disposed of.
    (iii) The written record required by paragraph (a)(2)(ii) of this 
section is available for inspection or submission if requested by EPA.
    (iv) Continuing attempts to secure disposal were initiated within 
270 days after the time the waste was first subject to the 1-year time 
limit requirement, as specified in paragraph (a)(1) of this section. 
Failure to initiate and continue attempts to secure disposal throughout 
the total time the waste is in storage shall automatically disqualify 
the notifier from receiving an automatic extension under this section.
    (3) Additional extensions. Upon written request, the EPA Regional 
Administrator for the Region in which the wastes are stored or the 
Director, National Program Chemicals Division, may grant additional 
extensions beyond the 1-year extension authorized in paragraph (a)(2) of 
this section. At the time of the request, the requestor must supply 
specific justification for the additional extension and indicate what 
measures the requestor is taking to secure disposal of the waste or 
indicate why disposal could not be conducted during the period of the 
prior extension. The EPA Regional Administrator or the Director, 
National Program Chemicals Division may require, as a condition to 
granting any extension under this section, specific actions including, 
but not limited to, marking, inspection, recordkeeping, or financial 
assurance to ensure that the waste does not pose an unreasonable risk of 
injury to health or the environment.
    (4) Storage at an approved facility. Increased time for storage may 
be granted as a condition of any TSCA PCB storage or disposal approval, 
by the EPA Regional Administrator for the Region in which the PCBs or 
PCB Items are to be stored or disposed of, or by the Director, National 
Program Chemicals Division, if EPA determines that there is a 
demonstrated need or justification for additional time, that the owner 
or operator of the facility is pursuing relevant treatment or disposal 
options, and that no unreasonable risk of injury to health or the 
environment will result from the increased storage time. In making this 
determination, EPA will consider such factors as absence of any approved 
treatment technology and insufficient time to complete the treatment or 
destruction process. EPA may require as a condition of the approval that 
the owner or operator submit periodic progress reports.
    (b) Except as provided in paragraphs (b)(2), (c)(1), (c)(7), (c)(9), 
and (c)(10) of this section, after July 1, 1978, owners or operators of 
any facilities used for the storage of PCBs and PCB Items designated for 
disposal shall comply with the following storage unit requirements:
    (1) The facilities shall meet the following criteria:
    (i) Adequate roof and walls to prevent rain water from reaching the 
stored PCBs and PCB Items;
    (ii) An adequate floor that has continuous curbing with a minimum 6 
inch high curb. The floor and curbing must provide a containment volume 
equal to at least two times the internal volume of the largest PCB 
Article or PCB Container or 25 percent of the total internal volume of 
all PCB Articles or PCB Containers stored there, whichever is greater. 
PCB/radioactive wastes are not required to be stored in an area with a 
minimum 6 inch high curbing. However, the floor and curbing must still 
provide a containment volume equal to at least two times the internal 
volume of the largest PCB Container or 25 percent of the total internal 
volume of all PCB Containers stored there, whichever is greater.
    (iii) No drain valves, floor drains, expansion joints, sewer lines, 
or other

[[Page 561]]

openings that would permit liquids to flow from the curbed area;
    (iv) Floors and curbing constructed of Portland cement, concrete, or 
a continuous, smooth, non-porous surface as defined at Sec. 761.3, which 
prevents or minimizes penetration of PCBs.
    (v) Not located at a site that is below the 100-year flood water 
elevation.
    (2) No person may store PCBs and PCB Items designated for disposal 
in a storage unit other than one approved pursuant to paragraph (d) of 
this section or meeting the design requirements of paragraph (b) of this 
section, unless the unit meets one of the following conditions:
    (i) Is permitted by EPA under section 3004 of RCRA to manage 
hazardous waste in containers, and spills of PCBs are cleaned up in 
accordance with subpart G of this part.
    (ii) Qualifies for interim status under section 3005 of RCRA to 
manage hazardous waste in containers, meets the requirements for 
containment at Sec. 264.175 of this chapter, and spills of PCBs are 
cleaned up in accordance with subpart G of this part.
    (iii) Is permitted by a State authorized under section 3006 of RCRA 
to manage hazardous waste in containers, and spills of PCBs are cleaned 
up in accordance with subpart G of this part.
    (iv) Is approved or otherwise regulated pursuant to a State PCB 
waste management program no less stringent in protection of health or 
the environment than the applicable TSCA requirements found in this 
part.
    (v) Is subject to a TSCA Coordinated Approval, which includes 
provisions for storage of PCBs, issued pursuant to Sec. 761.77.
    (vi) Has a TSCA PCB waste management approval, which includes 
provisions for storage, issued pursuant to Sec. 761.61(c) or 
Sec. 761.62(c).
    (c)(1) The following PCB Items may be stored temporarily in an area 
that does not comply with the requirements of paragraph (b) of this 
section for up to thirty days from the date of their removal from 
service, provided that a notation is attached to the PCB Item or a PCB 
Container (containing the item) indicating the date the item was removed 
from service:
    (i) Non-leaking PCB Articles and PCB Equipment;
    (ii) Leaking PCB Articles and PCB Equipment if the PCB Items are 
placed in a non-leaking PCB Container that contains sufficient sorbent 
materials to absorb any liquid PCBs remaining in the PCB Items;
    (iii) PCB Containers containing non-liquid PCBs such as contaminated 
soil, rags, and debris; and
    (iv) PCB containers containing liquid PCBs at concentrations of 
50 ppm, provided a Spill Prevention, Control and 
Countermeasure Plan has been prepared for the temporary storage area in 
accordance with part 112 of this chapter and the liquid PCB waste is in 
packaging authorized in the DOT Hazardous Materials Regulations at 49 
CFR parts 171 through 180 or stationary bulk storage tanks (including 
rolling stock such as, but not limited to, tanker trucks, as specified 
by DOT).
    (2) Non-leaking and structurally undamaged PCB Large High Voltage 
Capacitors and PCB-Contaminated Electrical Equipment that have not been 
drained of free flowing dielectric fluid may be stored on pallets next 
to a storage facility that meets the requirements of paragraph (b) of 
this section. PCB-Contaminated Electrical Equipment that has been 
drained of free flowing dielectric fluid is not subject to the storage 
provisions of Sec. 761.65. Storage under this subparagraph will be 
permitted only when the storage facility has immediately available 
unfilled storage space equal to 10 percent of the volume of capacitors 
and equipment stored outside the facility. The capacitors and equipment 
temporarily stored outside the facility shall be checked for leaks 
weekly.
    (3) Any storage area subject to the requirements of paragraph (b) or 
paragraph (c)(1) of this section shall be marked as required in subpart 
C Sec. 761.40(a)(10).
    (4) No item of movable equipment that is used for handling PCBs and 
PCB Items in the storage units and that comes in direct contact with 
PCBs shall be removed from the storage unit area unless it has been 
decontaminated as specified in Sec. 761.79.
    (5) All PCB Items in storage shall be checked for leaks at least 
once every 30

[[Page 562]]

days. Any leaking PCB Items and their contents shall be transferred 
immediately to properly marked non-leaking containers. Any spilled or 
leaked materials shall be immediately cleaned up and the materials and 
residues containing PCBs shall be disposed of in accordance with 
Sec. 761.61. Records of inspections, maintenance, cleanup and disposal 
must be maintained in accordance with Sec. 761.180(a) and (b).
    (6) Except as provided in paragraphs (c)(6)(i) and (c)(6)(ii) of 
this section, any container used for the storage of liquid or non-liquid 
PCB waste shall be in accordance with the requirements set forth in the 
DOT Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 
180. PCB waste not subject to the HMR (i.e., PCB wastes at 
concentrations of <20 ppm or <1 pound of PCBs regardless of 
concentration) must be packaged in accordance with Packaging Group III, 
unless other hazards associated with the PCB waste cause it to require 
packaging in accordance with Packaging Groups I or II. For purposes of 
describing PCB waste not subject to DOT's HMR on a manifest, one may use 
the term ``Non-DOT Regulated PCBs.''
    (i) Containers other than those meeting HMR performance standards 
may be used for storage of PCB/radioactive waste provided the following 
requirements are met:
    (A) Containers used for storage of liquid PCB/radioactive wastes 
must be non-leaking.
    (B) Containers used for storage of non-liquid PCB/ radioactive 
wastes must be designed to prevent the buildup of liquids if such 
containers are stored in an area meeting the containment requirements of 
paragraph (b)(1)(ii) of this section, as well as all other applicable 
State or Federal regulations or requirements for control of radioactive 
materials.
    (C) Containers used to store both liquid and non-liquid PCB/
radioactive wastes must meet all regulations and requirements pertaining 
to nuclear criticality safety. Acceptable container materials currently 
include polyethylene and stainless steel provided that the container 
material is chemically compatible with the wastes being stored. Other 
containers may be used to store both liquid and non-liquid PCB/
radioactive wastes if the users are able to demonstrate, to the 
appropriate Regional Administrator and other appropriate regulatory 
authorities (i.e., Nuclear Regulatory Commission, Department of Energy 
or the Department of Transportation), that the use of such containers is 
protective of health and the environment as well as public health and 
safety.
    (ii) The following DOT specification containers that conform to the 
requirements of 49 CFR, chapter I, subchapter C in effect on September 
30, 1991, may be used for storage and transportation activities that are 
not subject to DOT regulation, and may be used on a transitional basis 
as permitted at 49 CFR 171.14. For liquid PCBs: Specification 5 
container without removable head, Specification 5B container without 
removable head, Specification 6D overpack with Specification 2S or 2SL 
polyethylene containers, or Specification 17E container. For non-liquid 
PCBs: Specification 5 container, Specification 5B container, or 
Specification 17C container.
    (7) Stationary storage containers for liquid PCBs can be larger than 
the containers specified in paragraph (c)(6) of this section provided 
that:
    (i) The containers are designed, constructed, and operated in 
compliance with Occupational Safety and Health Standards, 29 CFR 
1910.106, Flammable and combustible liquids. Before using these 
containers for storing PCBs, the design of the containers must be 
reviewed to determine the effect on the structural safety of the 
containers that will result from placing liquids with the specific 
gravity of PCBs into the containers (see 29 CFR 1910.106(b)(1)(i)(f)).
    (ii) The owners or operators of any facility using containers 
described in paragraph (c)(7)(i) of this section, shall prepare and 
implement a Spill Prevention Control and Countermeasure (SPCC) Plan as 
described in part 112 of this title. In complying with 40 CFR part 112, 
the owner or operator shall read ``oil(s)'' as ``PCB(s)'' whenever it 
appears. The exemptions for storage capacity, 40 CFR 112.1(d)(2), and 
the amendment of SPCC plans by the Regional Administrator, 40 CFR 112.4,

[[Page 563]]

shall not apply unless some fraction of the liquids stored in the 
container are oils as defined by section 311 of the Clean Water Act.
    (8) PCB Items shall be dated on the item when they are removed from 
service for disposal. The storage shall be managed so that the PCB Items 
can be located by this date. Storage containers provided in paragraph 
(c)(7) of this section, shall have a record that includes for each batch 
of PCBs the quantity of the batch and date the batch was added to the 
container. The record shall also include the date, quantity, and 
disposition of any batch of PCBs removed from the container.
    (9) Bulk PCB remediation waste or PCB bulk product waste may be 
stored at the clean-up site or site of generation for 180 days subject 
to the following conditions:
    (i) The waste is placed in a pile designed and operated to control 
dispersal of the waste by wind, where necessary, by means other than 
wetting.
    (ii) The waste must not generate leachate through decomposition or 
other reactions.
    (iii) The storage site must have:
    (A) A liner that is designed, constructed, and installed to prevent 
any migration of wastes off or through the liner into the adjacent 
subsurface soil, ground water or surface water at any time during the 
active life (including the closure period) of the storage site. The 
liner may be constructed of materials that may allow waste to migrate 
into the liner. The liner must be:
    (1) Constructed of materials that have appropriate chemical 
properties and sufficient strength and thickness to prevent failure due 
to pressure gradients (including static head and external hydrogeologic 
forces), physical contact with the waste or leachate to which they are 
exposed, climatic conditions, the stress of installation, and the stress 
of daily operation.
    (2) Placed upon a foundation or base capable of providing support to 
the liner and resistance to pressure gradients above and below the liner 
to prevent failure of the liner due to settlement, compression, or 
uplift.
    (3) Installed to cover all surrounding earth likely to be in contact 
with the waste.
    (B) A cover that meets the requirements of paragraph (c)(9)(iii)(A) 
of this section, is installed to cover all of the stored waste likely to 
be contacted with precipitation, and is secured so as not to be 
functionally disabled by winds expected under normal seasonal 
meteorological conditions at the storage site.
    (C) A run-on control system designed, constructed, operated, and 
maintained such that:
    (1) It prevents flow onto the stored waste during peak discharge 
from at least a 25-year storm.
    (2) It collects and controls at least the water volume resulting 
from a 24-hour, 25-year storm. Collection and holding facilities (e.g., 
tanks or basins) must be emptied or otherwise managed expeditiously 
after storms to maintain design capacity of the system.
    (iv) The provisions of this paragraph may be modified under 
Sec. 761.61(c).
    (10) Owners or operators of storage facilities shall establish and 
maintain records as provided in Sec. 761.180.
    (d) Approval of commercial storers of PCB waste. (1) All commercial 
storers of PCB waste shall have interim approval to operate commercial 
facilities for the storage of PCB waste until August 2, 1990. Commercial 
storers of PCB waste are prohibited from storing any PCB waste at their 
facilities after August 2, 1990 unless they have submitted by August 2, 
1990 a complete application for a final storage approval under paragraph 
(d)(2) of this section. The period of interim approval shall continue 
until the Regional Administrator (or the Director of the Chemical 
Management Division (Director, National Programs Chemical Division) in 
cases involving commercial storage ancillary to a facility approved for 
disposal by the Director, National Programs Chemical Division) makes a 
final decision on the storage application at which time such interim 
approval shall terminate.
    (2) The Regional Administrator for the region in which the storage 
facility is located (or the Director, National Programs Chemical 
Division, if the commercial storage area is ancillary to a facility 
approved for disposal by the Director, National Programs Chemical 
Division) shall grant written, final approval to engage in the 
commercial

[[Page 564]]

storage of PCB waste upon a determination by the Regional Administrator 
or the Director, National Programs Chemical Division, that the criteria 
in paragraph (d)(2)(i) through (d)(2)(vii) of this section have been met 
by the applicant:
    (i) The applicant, its principals, and its key employees responsible 
for the establishment or operation of the commercial storage facility 
are qualified to engage in the business of commercial storage of PCB 
waste.
    (ii) The facility possesses the capacity to handle the quantity of 
PCB waste which the owner or operator of the facility has estimated will 
be the maximum quantity of PCB waste that will be handled at any one 
time at the facility.
    (iii) The owner or operator of the unit has certified compliance 
with the storage facility standards in paragraphs (b) and (c)(7) of this 
section.
    (iv) The owner or operator has developed a written closure plan for 
the facility that is deemed acceptable by the Regional Administrator (or 
the Director, National Programs Chemical Division, if the commercial 
storage is ancillary to a disposal facility permitted by the Director, 
National Programs Chemical Division) under the closure plan standards of 
paragraph (e) of this section.
    (v) The owner or operator has included in the application for final 
approval a demonstration of financial responsibility for closure that 
meets the financial responsibility standards of paragraph (g) of this 
section.
    (vi) The operation of the storage facility will not pose an 
unreasonable risk of injury to health or the environment.
    (vii) The environmental compliance history of the applicant, its 
principals, and its key employees may be deemed to constitute a 
sufficient basis for denial of approval whenever in the judgment of the 
Regional Administrator (or Director, National Programs Chemical 
Division) that history of environmental civil violations or criminal 
convictions evidences a pattern or practice of noncompliance that 
demonstrates the applicant's unwillingness or inability to achieve and 
maintain compliance with the regulations.
    (3) Applicants for storage approvals shall submit a written 
application that includes any relevant information bearing upon the 
qualifications of the facility's principals and key employees to engage 
in the business of commercial storage of PCB wastes. This information 
shall include, but is not limited to:
    (i) The identification of the owner and the operator of the 
facility, including all general partners of a partnership, any limited 
partner of a partnership, any stockholder of a corporation or any 
participant in any other type of business organization or entity who 
owns or controls, directly or indirectly, more than 5 percent of each 
partnership, corporation, or other business organization and all 
officials of the facility who have direct management responsibility for 
the facility.
    (ii) The identification of the person responsible for the overall 
operations of the facility (i.e., a plant manager, superintendent, or a 
person of similar responsibility) and the supervisory employees who are 
or will be responsible for the operation of the facility.
    (iii) Information concerning the technical qualifications and 
experience of the persons responsible for the overall operation of the 
facility and the employees responsible for handling PCB waste or other 
wastes.
    (iv) Information concerning any past State or Federal environmental 
violations involving the same business or another business with which 
the principals or supervisory employees were affiliated directly that 
occurred within 5 years preceding the date of submission and which 
relate directly to violations that resulted in either a civil penalty 
(irrespective of whether the matter was disposed of by an adjudication 
or by a without prejudice settlement) or judgment of conviction whether 
entered after trial or a plea, either of guilt or nolo contendere or 
civil injunctive relief and involved storage, disposal, transport, or 
other waste handling activities.
    (v) A list of all companies currently owned or operated in the past 
by the principals or key employees identified in paragraphs (d)(3)(i) 
and (d)(3)(ii) of this section that are or were directly

[[Page 565]]

or indirectly involved with waste handling activities.
    (vi) The owner's or operator's estimate of maximum PCB waste 
quantity to be handled at the facility.
    (vii) A written statement certifying compliance with paragraph (b) 
or (c) of this section and containing a certification as defined in 
Sec. 761.3.
    (viii) A written closure plan for the facility, as described in 
paragraph (e) of this section.
    (ix) The current closure cost estimate for the facility, as 
described in paragraph (f) of this section.
    (x) A demonstration of financial responsibility to close the 
facility, as described in paragraph (g) of this section.
    (4) The written approval issued by the Regional Administrator (or 
the Director, National Programs Chemical Division, if the commercial 
storage area is ancillary to a disposal facility approved by the 
Director, National Programs Chemical Division) shall include, but not be 
limited to, the following:
    (i) The determination that the applicant has satisfied the 
requirements set forth in paragraph (d)(2) of this section, and a brief 
statement setting forth the basis for the determination.
    (ii) Incorporation of the closure plan submitted by the facility 
owner or operator and approved by the Regional Administrator (or the 
Director, National Programs Chemical Division, if the commercial storage 
area is ancillary to a disposal facility approved by the Director, 
National Programs Chemical Division).
    (iii) A condition imposing a maximum PCB storage capacity which the 
facility shall not exceed during its PCB waste storage operations. The 
maximum storage capacity imposed under this condition shall not be 
greater than the estimated maximum inventory of PCB waste included in 
the owner's or operator's application for final approval.
    (iv) Such other conditions as deemed necessary by the Regional 
Administrator (or the Director, National Programs Chemical Division, if 
the commercial storage area is ancillary to a disposal facility approved 
by the Director, National Programs Chemical Division) to ensure that the 
operations of the PCB storage facility will not pose an unreasonable 
risk of injury to health or the environment.
    (5) Storage areas at transfer facilities are exempt from the 
requirement to obtain approval as a commercial storer of PCB waste under 
this paragraph, unless the same PCB waste is stored at these facilities 
for a period of time greater than 10 consecutive days between 
destinations.
    (6) Storage areas at RCRA-permitted facilities may be exempt from 
the separate TSCA storage approval requirements in this paragraph (d) 
upon a showing to the Regional Administrator's satisfaction that the 
facility's existing RCRA closure plan is substantially equivalent to 
this rule's closure plan standards, and that such facility's closure 
cost estimate and financial assurance demonstration account for maximum 
PCB waste inventories, and the requirements of paragraph (d)(3)(i) 
through (d)(3)(v) and (d)(3)(vii) of this section are met. A pay-in 
period of longer than 3 years after approval of the storage facility 
pursuant to this rule, will be acceptable to EPA if that pay-in period 
has already been established for a valid RCRA facility or previously 
approved TSCA facility.
    (7) Storage areas ancillary to TSCA-approved disposal facilities may 
be exempt from a separate facility approval provided all of the 
following conditions are met:
    (i) The current disposal approval contains an expiration date.
    (ii) The current disposal approval's closure and financial 
responsibility conditions specifically extend to storage areas ancillary 
to disposal.
    (iii) The current disposal approval's closure and financial 
responsibility conditions provide for annual adjustments for inflation, 
and for modification when changes in operation would affect closure 
costs.
    (iv) The current disposal approval contains conditions on closure 
and financial responsibility that are at least as stringent as those in 
paragraphs (e) and (g) of this section. However, the provision for a 3-
year closure trust pay-in period, as specified in paragraph (g)(1)(i) of 
this section, would be waived in a case in which an approved TSCA 
facility or RCRA facility that

[[Page 566]]

covers PCB storage has a longer pay-in period for the trust.
    (v) The current disposal approval satisfies the requirements of 
paragraph (d)(3)(i) through (d)(3)(v) of this section.
    (8) The approval of any existing TSCA-approved disposal facility 
ancillary to a commercial storage facility that is deficient in any of 
the conditions of paragraph (d)(7)(i) through (d)(7)(v) of this section 
shall be called in by the Regional Administrator or the Director, 
National Programs Chemical Division, if it was the Director, National 
Programs Chemical Division who issued it. The approval shall be modified 
to meet the requirements of paragraph (d)(7) of this section within 180 
days of the effective date of this final rule, or a separate application 
for approval of the storage facility may be submitted to the Regional 
Administrator or the Director, National Programs Chemical Division, in 
the cases where the Director, National Programs Chemical Division issued 
the approval.
    (e) Closure. (1) A commercial storer of PCB waste shall have a 
written closure plan that identifies the steps that the owner or 
operator of the facility shall take to close the PCB waste storage 
facility in a manner that eliminates the potential for post-closure 
releases of PCBs which may present an unreasonable risk to human health 
or the environment. An acceptable closure plan must include, at a 
minimum, all of the following:
    (i) A description of how the PCB storage areas of the facility will 
be closed in a manner that eliminates the potential for post-closure 
releases of PCBs into the environment.
    (ii) An identification of the maximum extent of storage operations 
that will be open during the active life of the facility, including an 
identification of the extent of PCB storage operations at the facility 
relative to other wastes that will be handled at the facility.
    (iii) An estimate of the maximum inventory of PCB wastes that could 
be handled at one time at the facility over its active life, and a 
detailed description of the methods or arrangements to be used during 
closure for removing, transporting, storing, or disposing of the 
facility's inventory of PCB waste, including an identification of any 
off-site facilities that will be used.
    (iv) A detailed description of the steps needed to remove or 
decontaminate PCB waste residues and contaminated containment system 
components, equipment, structures, and soils during closure in 
accordance with the levels specified in the PCB Spills Cleanup Policy in 
subpart G of this part, including a description of the methods for 
sampling and testing of surrounding soils, and the criteria for 
determining the extent of removal or decontamination.
    (v) A detailed description of other activities necessary during the 
closure period to ensure that any post-closure releases of PCBs will not 
present unreasonable risks to human health or the environment. This 
includes activities such as ground-water monitoring, run-on and run-off 
control, and facility security.
    (vi) A schedule for closure of each area of the facility where PCB 
waste is stored or handled, including the total time required to close 
each area of PCB waste storage or handling, and the time required for 
any intervening closure activities.
    (vii) An estimate of the expected year of closure of the PCB waste 
storage areas, if a trust fund is opted for as the financial mechanism.
    (2) A written closure plan determined to be acceptable by the 
Regional Administrator (or the Director, National Programs Chemical 
Division, if the commercial storage area is ancillary to a disposal 
facility approved by the Director, National Programs Chemical Division) 
under this section shall become a condition of any approval granted 
under paragraph (d) of this section.
    (3) A separate and new closure plan need not be submitted in cases 
where a facility is currently covered by a TSCA approval or a RCRA 
permit, upon a showing to the satisfaction of the Regional Administrator 
(or the Director, National Programs Chemical Division, if the commercial 
storage area is ancillary to a disposal facility approved by the 
Director, National Programs Chemical Division) that the existing closure 
plan is substantially equivalent to closure plans required under 
paragraphs

[[Page 567]]

(d) through (g) of this section, and that the plan adequately accounts 
for PCB waste inventories.
    (4) The commercial storer of PCB waste shall submit a written 
request to the Regional Administrator (or the Director, National 
Programs Chemical Division, if he approved the closure plan) for a 
modification to its storage approval to amend its closure plan, 
whenever:
    (i) Changes in ownership, operating plans, or facility design affect 
the existing closure plan.
    (ii) There is a change in the expected date of closure, if 
applicable.
    (iii) In conducting closure activities, unexpected events require a 
modification of the approved closure plan.
    (5) The Regional Administrator or the Director, National Programs 
Chemical Division, if he approved the closure plan, may modify the 
existing closure plan under the conditions described in paragraph (e)(4) 
of this section.
    (6) Commercial storers of PCB waste shall comply with the following 
closure schedule:
    (i) The commercial storer shall notify in writing the Regional 
Administrator or the Director, National Programs Chemical Division if he 
approved the closure plan, at least 60 days prior to the date on which 
final closure of its PCB storage facility is expected to begin.
    (ii) The date when a commercial storer of PCB waste ``expects to 
begin closure'' shall be no later than 30 days after the date on which 
the storage facility received its final quantities of PCB waste. For 
good cause shown, the Regional Administrator or the Director, National 
Programs Chemical Division if he approved the closure plan, may extend 
the date for commencement of closure for an additional 30-day period.
    (iii) Within 90 days after receiving the final quantity of PCB waste 
for storage, a commercial storer of PCB waste shall remove all PCB waste 
in storage at the facility from the facility in accordance with the 
approved closure plan. For good cause shown, the Regional Administrator 
or the Director, National Programs Chemical Division if he approved the 
closure plan, may approve a reasonable extension to the period for 
removal of the PCB waste.
    (iv) A commercial storer of PCB waste shall complete closure 
activities in accordance with the approved closure plan and within 180 
days after receiving the final quantity of PCB waste for storage at the 
facility. For good cause shown, the Regional Administrator or Director, 
National Programs Chemical Division if he approved the closure plan, may 
approve a reasonable extension to the closure period.
    (7) During the closure period, all contaminated system component 
equipment, structures, and soils shall be disposed of in accordance with 
the disposal requirements of subpart D of this part, or, if applicable, 
decontaminated in accordance with the levels specified in the PCB Spills 
Cleanup Policy at subpart G of this part. When PCB waste is removed from 
the storage facility during closure, the owner or operator becomes a 
generator of PCB waste subject to the generator requirements of subpart 
J of this part.
    (8) Within 60 days of completion of closure of each facility for the 
storage of PCB waste, the commercial storer of PCB waste shall submit to 
the Regional Administrator (or Director, National Programs Chemical 
Division if he approved the closure plan), by registered mail, a 
certification that the PCB storage facility has been closed in 
accordance with the approved closure plan. The certification shall be 
signed by the owner or operator and by an independent registered 
professional engineer.
    (f) Closure cost estimate. (1) A commercial storer of PCB wastes 
shall have a detailed estimate, in current dollars, of the cost of 
closing the facility in accordance with its approved closure plan. The 
closure cost estimate shall be in writing, be certified by the person 
preparing it (using the certification defined in Sec. 761.3) and comply 
with all of the following criteria:
    (i) The closure cost estimate shall equal the cost of final closure 
at the point in the PCB storage facility's active life when the extent 
and manner of PCB storage operations would make closure the most 
expensive, as indicated by the facility's closure plan.

[[Page 568]]

    (ii) The closure cost estimate shall be based on the costs to the 
owner or operator of hiring a third party to close the facility, and the 
third party shall not be either a corporate parent or subsidiary of the 
owner or operator, or member in joint ownership of the facility.
    (iii) The owner or operator shall include in the estimate the 
current market costs for off-site commercial disposal of the facility's 
maximum estimated inventory of PCB wastes, except that on-site disposal 
costs may be used if on-site disposal capacity will exist at the 
facility at all times over the life of the PCB storage facility.
    (iv) The closure cost estimate may not incorporate any salvage value 
that may be realized with the sale of wastes, facility structures or 
equipment, land, or other assets associated with the facility at the 
time of closure.
    (2) During the active life of the PCB storage facility, the 
commercial storer of PCB waste shall adjust annually for inflation the 
closure cost estimate within 60 days prior to the anniversary date of 
the establishment of the financial instruments used to demonstrate 
financial responsibility for closure, except that owners or operators 
who use the financial test or corporate guarantee shall adjust their 
closure cost estimates for inflation within 30 days after the close of 
the storer's fiscal year. The adjustment may be made by recalculating 
the maximum costs of closure in current dollars, or by using an 
inflation factor derived from the most recent Implicit Price Deflator 
for Gross National Product published by the U.S. Department of Commerce 
in its Survey of Current Business. The Implicit Price Deflator for Gross 
National Product is included in a monthly publication titled Economic 
Indicators, which is available from the Superintendent of Documents, 
Government Printing Office, Washington, DC 20402. The inflation factor 
used in the latter method is the result of dividing the latest published 
annual Deflator by the Deflator for the previous year. The adjustment to 
the closure cost estimate is then made by multiplying the most recent 
closure cost estimate by the latest inflation factor.
    (3) Where the Regional Administrator (or the Director, National 
Programs Chemical Division, if he approved the closure plan) approves a 
modification to the facility's closure plan, and that modification 
increases the cost of closure, the owner or operator shall revise the 
closure cost estimate no later than 30 days after the modification is 
approved. Any such revision shall also be adjusted for inflation in 
accordance with paragraph (f)(2) of this section.
    (4) The owner or operator of the facility shall keep at the facility 
during its operating life the most recent closure cost estimate, 
including any adjustments resulting from inflation or from modifications 
to the closure plan.
    (g) Financial assurance for closure. A commercial storer of PCB 
waste shall establish financial assurance for closure of each PCB 
storage facility that he owns or operates. In establishing financial 
assurance for closure, the commercial storer of PCB waste may choose 
from the following financial assurance mechanisms or any combination of 
mechanisms:
    (1) The ``closure trust fund,'' as specified in Sec. 264.143(a) of 
this chapter, except for paragraph (a)(3) of Sec. 264.143. For purposes 
of this paragraph, the following provisions also apply:
    (i) Payments into the trust fund shall be made annually by the owner 
or operator over the remaining operating life of the facility as 
estimated in the closure plan, or over 3 years, whichever period is 
shorter. This period of time is hereafter referred to as the ``pay-in 
period.'' For an existing facility, the first payment must be made 
within 30 calendar days after EPA has notified the facility of its 
conditional approval. Interim approval to operate is canceled and the 
application is denied if EPA does not receive verification that the 
payment was made in that 30-day period.
    (ii) For a new facility, the first payment into the closure trust 
fund shall be made before EPA grants final approval of the application 
and before the facility may accept the initial shipment of PCB waste for 
commercial storage. A receipt from the trustee shall be submitted by the 
owner or operator to the Regional Administrator (or the Director, 
National Programs

[[Page 569]]

Chemical Division, if the commercial storage area is ancillary to a 
disposal facility approved by the Director CMD) before this initial 
delivery of PCB waste. The first payment shall be at least equal to the 
current closure cost estimate, divided by the number of years in the 
pay-in period, except as provided in paragraph (g)(7) of this section 
for multiple mechanisms. Subsequent payments shall be made no later than 
30 days after each anniversary date of the first payment. The amount of 
each subsequent payment shall be determined by subtracting the current 
value of the trust fund from the current closure cost estimate, and 
dividing this difference by the number of years remaining in the pay-in 
period.
    (iii) If an owner or operator of a facility existing on the 
effective date of this paragraph establishes a trust fund to meet the 
financial assurance requirements of this paragraph, and the value of the 
trust fund is less than the current closure cost estimate when a final 
approval is granted for the facility, the amount of the current closure 
cost estimate still to be paid into the trust fund shall be paid in over 
the pay-in period as defined in paragraph (g)(1)(i) of this section. 
Payments shall continue to be made no later than 30 days after each 
anniversary date of the first payment made into the trust fund. The 
amount of each payment shall be determined by subtracting the current 
value of the trust fund from the current closure cost estimate, and 
dividing this difference by the number of years remaining in the pay-in 
period.
    (iv) The submission of a trust agreement with the wording specified 
in Sec. 264.151(a)(1) of this chapter, including any reference to 
hazardous waste management facilities, shall be deemed to be in 
compliance with the requirement to submit a trust agreement under this 
subpart.
    (2) The ``surety bond guaranteeing payment into a closure trust 
fund,'' as specified in Sec. 264.143(b) of this chapter, including the 
use of the surety bond instrument specified at Sec. 264.151(b) of this 
chapter and the standby trust specified at Sec. 264.143(b)(3) of this 
chapter. The use of the surety bonds, surety bond instruments, and 
standby trust agreements specified in Sec. Sec. 264.143(b) and 
264.151(b) of this chapter shall be deemed to be in compliance with this 
subpart.
    (3)(i) The ``surety bond guaranteeing performance of closure,'' as 
specified at Sec. 264.143(c) of this chapter, except for paragraph 
(c)(5) of Sec. 264.143 of this chapter. The submission and use of the 
surety bond instrument specified at Sec. 264.151(c) of this chapter and 
the standby trust specified at Sec. 264.143(c)(3) of this chapter shall 
be deemed to be in compliance with the requirements under this subpart 
relating to the use of surety bonds and standby trust funds.
    (ii) For the purposes of this paragraph, and under the terms of the 
bond, the surety shall become liable on the bond obligation when the 
owner or operator fails to perform as guaranteed by the bond. Liability 
is established by a final administrative determination pursuant to 
section 16 of TSCA that the owner or operator has failed to perform 
final closure in accordance with the closure plan and other approval or 
regulatory requirements when required to do so.
    (4)(i) The ``closure letter of credit'' specified in Sec. 264.143(d) 
of this chapter, except for paragraph (d)(8). The submission and use of 
the irrevocable letter of credit instrument specified in Sec. 264.151(d) 
of this chapter and the standby trust specified in Sec. 264.143(d)(3) of 
this chapter shall be deemed to be in compliance with the requirements 
of this subpart relating to the use of letters of credit and standby 
trust funds.
    (ii) For the purposes of this paragraph, the Regional Administrator 
(or the Director, National Programs Chemical Division, if the commercial 
storage area is ancillary to a disposal facility approved by the 
Director, National Programs Chemical Division) may draw on the letter of 
credit following a final administrative determination pursuant to 
section 16 of TSCA that the owner or operator has failed to perform 
final closure in accordance with the closure plan and other approval or 
regulatory requirements when required to do so.
    (5) ``Closure insurance,'' as specified in Sec. 264.143(e) of this 
chapter, utilizing the certificate of insurance for closure specified at 
Sec. 264.151(e) of this chapter.

[[Page 570]]

The use of closure insurance as specified in Sec. 264.143(e) of this 
chapter and the submission and use of the certificate of insurance 
specified in Sec. 264.151(e) of this chapter shall be deemed to be in 
compliance with the requirements of this subpart relating to the use of 
closure insurance.
    (6) The ``financial test and corporate guarantee for closure,'' as 
described in Sec. 264.143(f) of this chapter, including a letter signed 
by the owner's or operator's chief financial officer as specified at 
Sec. 264.151(f) of this chapter and, if applicable, the written 
corporate guarantee specified at Sec. 264.151(h) of this chapter. The 
use of the financial test and corporate guarantee specified in 
Sec. 264.143(f) of this chapter, the submission and use of the letter 
specified in Sec. 264.151(f) of this chapter, and the submission and use 
of the written corporate guarantee specified at Sec. 264.151(h) of this 
chapter shall be deemed to be in compliance with the requirements of 
this subpart relating to the use of financial tests and corporate 
guarantees.
    (7) The corporate guarantee as specified in Sec. 264.143(f)(10) of 
this chapter.
    (8) The use of multiple financial mechanisms, as specified in 
Sec. 264.143(g) of this chapter is permitted.
    (9) A modification to a facility storing PCB waste that increases 
the maximum storage capacity indicated in the permit requires that a new 
financial assurance mechanism be established or an existing one be 
amended. When such a modification occurs, the Director of the Federal or 
State issuing authority must be notified in writing no later than 30 
days from the completion of the modification. The new or revised 
financial assurance mechanism must be established and activated no later 
than 30 days after the Director of the Federal or State issuing 
authority is notified of the completion of the modification, but prior 
to the use of the modified portion of the facility.
    (h) Release of owner or operator. Within 60 days after receiving 
certifications from the owner or operator and an independent registered 
professional engineer that final closure has been completed in 
accordance with the approved closure plan, the Regional Administrator or 
the Director, National Programs Chemical Division, if he approved the 
closure plan, will notify the owner or operator in writing that the 
owner or operator is no longer required by this section to maintain 
financial assurance for final closure of the facility, unless the 
Regional Administrator or the Director, National Programs Chemical 
Division, if he approved the closure plan, has reason to believe that 
final closure has not been completed in accordance with the approved 
closure plan. The Regional Administrator or the Director, National 
Programs Chemical Division, if he approved the closure plan, shall 
provide the owner or operator with a detailed written statement stating 
the reasons why he believed closure was not conducted in accordance with 
the approved closure plan.
    (i) Laboratories and samples. (1) A laboratory is conditionally 
exempt from the notification and approval requirements for a commercial 
storer under Sec. 761.65 (d) through (h) when it stores samples held for 
disposal in a facility that complies with the standards in Sec. 761.65 
(b)(1)(i) through (b)(1)(iv).
    (2) A laboratory sample is exempt from the manifesting requirements 
in Sec. 761.208 when:
    (i) The sample is being transported to a laboratory for the purpose 
of testing.
    (ii) The sample is being transported back to the sample collector 
after testing.
    (iii) The sample is being stored by the sample collector before 
transport to a laboratory for testing.
    (iv) The sample is being stored in a laboratory before testing.
    (v) The sample is being stored in a laboratory after testing but 
before it is returned to the sample collector.
    (vi) The sample is being stored temporarily in the laboratory after 
testing for a specific purpose (for example, until conclusion of a court 
case or enforcement action where further testing of the sample may be 
necessary).
    (3) In order to qualify for the exemption in paragraph (i)(2)(i) and 
(i)(2)(ii) of this section, a sample collector shipping samples to a 
laboratory and a laboratory returning samples to a sample collector 
must:
    (i) Comply with applicable U.S. Department of Transportation (DOT) 
or

[[Page 571]]

U.S. Postal Service (USPS) shipping requirements, found respectively in 
49 CFR 173.345 and U.S. Postal Regulations 652.2 and 652.3.
    (ii) Assure that the following information accompanies the sample:
    (A) The sample collector's name, mailing address, and telephone 
number.
    (B) The laboratory's name, mailing address, and telephone number.
    (C) The quantity of the sample.
    (D) The date of shipment.
    (E) A description of the sample.
    (iii) Package the sample so that it does not leak, spill, or 
vaporize from its packaging.
    (4) When the concentration of the PCB sample has been determined, 
and its use is terminated, the sample must be properly disposed. A 
laboratory must either manifest the PCB waste to a disposer or 
commercial storer, as required under Sec. 761.208, retain a copy of each 
manifest, as required under Sec. 761.209, and follow up on exception 
reporting, as required under Sec. 761.215 (a) and (b), or return the 
sample to the sample collector who must then properly dispose of the 
sample. If the laboratory returns the sample to the sample collector, 
the laboratory must comply with the shipping requirements set forth in 
paragraph (i)(3)(i) through (i)(3)(iii) of this section.
    (j) Changes in ownership or operational control of a commercial 
storage facility. The date of transfer of interim status or final 
approval shall be the date the EPA Regional Administrator (or Director, 
National Program Chemicals Division) provides written approval of the 
transfer. EPA will provide a final written decision within 90 days of 
receipt of the complete new or amended application. The Agency will 
approve the transfer if the following conditions are met:
    (1) The transferee has established financial assurance for closure 
pursuant to paragraph (g) of this section using a mechanism effective as 
of the date of final approval so that there will be no lapse in 
financial assurance for the transferred facility.
    (2) The transferor or transferee has resolved any deficiencies 
(e.g., technical operations, closure plans, cost estimates, etc.) the 
Agency has identified in the transferor's application.
    (k) States and the Federal Government. States and the Federal 
Government are exempt from the requirements of paragraphs (f) and (g) of 
this section.


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 47 FR 37359, Aug. 8, 1982; 49 FR 28191, July 10, 1984; 53 
FR 12524, Apr. 15, 1988; 54 FR 52746, Dec. 21, 1989; 55 FR 695, Jan. 8, 
1990; 55 FR 26205, June 27, 1990; 58 FR 15809, Mar. 24, 1993; 58 FR 
34205, June 23, 1993; 58 FR 59374, Nov. 9, 1993; 63 FR 35439, 35452, 
June 29, 1998]



Sec. 761.70  Incineration.

    This section applies to facilities used to incinerate PCBs required 
to be incinerated by this part.
    (a) Liquid PCBs. An incinerator used for incinerating PCBs shall be 
approved by an EPA Regional Administrator or the Director, National 
Programs Chemical Division pursuant to paragraph (d) of this section. 
Requests for approval of incinerators to be used in more than one region 
must be submitted to the Director, National Programs Chemical Division, 
except for research and development involving less than 500 pounds of 
PCB material (see Sec. 761.60(i)(2)). Requests for approval of 
incinerators to be used in only one region must be submitted to the 
appropriate Regional Administrator. The incinerator shall meet all of 
the requirements specified in paragraphs (a) (1) through (9) of this 
section, unless a waiver from these requirements is obtained pursuant to 
paragraph (d)(5) of this section. In addition, the incinerator shall 
meet any other requirements which may be prescribed pursuant to 
paragraph (d)(4) of this section.
    (1) Combustion criteria shall be either of the following:
    (i) Maintenance of the introduced liquids for a 2-second dwell time 
at 1200  deg.C(plus-minus100  deg.C) and 3 percent excess 
oxygen in the stack gas; or
    (ii) Maintenance of the introduced liquids for a 1\1/2\ second dwell 
time at 1600  deg.C(plus-minus100  deg.C) and 2 percent 
excess oxygen in the stack gas.
    (2) Combustion efficiency shall be at least 99.9 percent computed as 
follows:


[[Page 572]]


Combustion efficiency=
[Cco2/(Cco2+Cco)]100


where

Cco2=Concentration of carbon dioxide.
Cco=Concentration of carbon monoxide.

    (3) The rate and quantity of PCBs which are fed to the combustion 
system shall be measured and recorded at regular intervals of no longer 
than 15 minutes.
    (4) The temperatures of the incineration process shall be 
continuously measured and recorded. The combustion temperature of the 
incineration process shall be based on either direct (pyrometer) or 
indirect (wall thermocouple-pyrometer correlation) temperature readings.
    (5) The flow of PCBs to the incinerator shall stop automatically 
whenever the combustion temperature drops below the temperatures 
specified in paragraph (a)(1) of this section.
    (6) Monitoring of stack emission products shall be conducted:
    (i) When an incinerator is first used for the disposal of PCBs under 
the provisions of this regulation;
    (ii) When an incinerator is first used for the disposal of PCBs 
after the incinerator has been modified in a manner which may affect the 
characteristics of the stack emission products; and
    (iii) At a minimum such monitoring shall be conducted for the 
following parameters:
    (a) O2; (b) CO; (c) CO2; (d) Oxides of 
Nitrogen (NOx); (e) Hydrochloric Acid (HCl); (f) Total 
Chlorinated Organic Content (RCl); (g) PCBs; and (h) Total Particulate 
Matter.
    (7) At a minimum monitoring and recording of combustion products and 
incineration operations shall be conducted for the following parameters 
whenever the incinerator is incinerating PCBs:
    (i) O2; (ii) CO; and (iii) CO2. The monitoring 
for O2 and CO shall be continuous. The monitoring for 
CO2 shall be periodic, at a frequency specified by the 
Regional Administrator or Director, National Programs Chemical Division.
    (8) The flow of PCBs to the incinerator shall stop automatically 
when any one or more of the following conditions occur, unless a 
contingency plan is submitted by the incinerator owner or operator and 
approved by the Regional Administrator or Director, National Programs 
Chemical Division. The contingency plan indicates what alternative 
measures the incinerator owner or operator would take if any of the 
following conditions occur:
    (i) Failure of monitoring operations specified in paragraph (a)(7) 
of this section;
    (ii) Failure of the PCB rate and quantity measuring and recording 
equipment specified in paragraph (a)(3) of this section; or
    (iii) Excess oxygen falls below the percentage specified in 
paragraph (a)(1) of this section.
    (9) Water scrubbers shall be used for HCl control during PCB 
incineration and shall meet any performance requirements specified by 
the appropriate EPA Regional Administrator or the Director, National 
Programs Chemical Division. Scrubber effluent shall be monitored and 
shall comply with applicable effluent or pretreatment standards, and any 
other State and Federal laws and regulations. An alternate method of HCl 
control may be used if the alternate method has been approved by the 
Regional Administrator or the Director, National Programs Chemical 
Division. (The HCl neutralizing capability of cement kilns is considered 
to be an alternate method.)
    (b) Nonliquid PCBs. An incinerator used for incinerating nonliquid 
PCBs, PCB Articles, PCB Equipment, or PCB Containers shall be approved 
by the appropriate EPA Regional Administrator or the Director, National 
Programs Chemical Division pursuant to paragraph (d) of this section. 
Requests for approval of incinerators to be used in more than one region 
must be submitted to the Director, National Programs Chemical Division 
except for research and development involving less than 500 pounds of 
PCB material (see Sec. 761.60(i)(2)). Requests for approval of 
incinerators to be used in only one region must be submitted to the 
appropriate Regional Administrator. The incinerator shall meet all of 
the requirements specified in paragraphs (b)(1) and (2) of this section 
unless a waiver from these requirements is obtained

[[Page 573]]

pursuant to paragraph (d)(5) of this section. In addition, the 
incinerator shall meet any other requirements that may be prescribed 
pursuant to paragraph (d)(4) of this section.
    (1) The mass air emissions from the incinerator shall be no greater 
than 0.001g PCB/kg of the PCB introduced into the incinerator.
    (2) The incinerator shall comply with the provisions of paragraphs 
(a)(2), (3), (4), (6), (7), (8)(i) and (ii), and (9) of this section.
    (c) Maintenance of data and records. All data and records required 
by this section shall be maintained in accordance with Sec. 761.180, 
Records and monitoring.
    (d) Approval of incinerators. Prior to the incineration of PCBs and 
PCB Items the owner or operator of an incinerator shall receive the 
written approval of the Agency Regional Administrator for the region in 
which the incinerator is located, or the Director, National Programs 
Chemical Division. Approval from the Director, National Programs 
Chemical Division may be effective in all ten EPA regions. Such approval 
shall be obtained in the following manner:
    (1) Application. The owner or operator shall submit to the Regional 
Administrator or the Director, National Programs Chemical Division an 
application which contains:
    (i) The location of the incinerator;
    (ii) A detailed description of the incinerator including general 
site plans and design drawings of the incinerator;
    (iii) Engineering reports or other information on the anticipated 
performance of the incinerator;
    (iv) Sampling and monitoring equipment and facilities available;
    (v) Waste volumes expected to be incinerated;
    (vi) Any local, State, or Federal permits or approvals; and
    (vii) Schedules and plans for complying with the approval 
requirements of this regulation.
    (2) Trial burn. (i) Following receipt of the application described 
in paragraph (d)(1) of this section, the Regional Administrator or the 
Director, National Programs Chemical Division shall determine if a trial 
burn is required and notify the person who submitted the report whether 
a trial burn of PCBs and PCB Items must be conducted. The Regional 
Administrator or the Director, National Programs Chemical Division may 
require the submission of any other information that the Regional 
Administrator or the Director, National Programs Chemical Division finds 
to be reasonably necessary to determine the need for a trial burn. Such 
other information shall be restricted to the types of information 
required in paragraphs (d)(1)(i) through (vii) of this section.
    (ii) If the Regional Administrator or the Director, National 
Programs Chemical Division determines that a trial burn must be held, 
the person who submitted the report described in paragraph (d)(1) of 
this section shall submit to the Regional Administrator or the Director, 
National Programs Chemical Division a detailed plan for conducting and 
monitoring the trial burn. At a minimum, the plan must include:
    (A) Date trial burn is to be conducted;
    (B) Quantity and type of PCBs and PCB Items to be incinerated;
    (C) Parameters to be monitored and location of sampling points;
    (D) Sampling frequency and methods and schedules for sample 
analyses; and
    (E) Name, address, and qualifications of persons who will review 
analytical results and other pertinent data, and who will perform a 
technical evaluation of the effectiveness of the trial burn.
    (iii) Following receipt of the plan described in paragraph 
(d)(2)(ii) of this section, the Regional Administrator or the Director, 
National Programs Chemical Division will approve the plan, require 
additions or modifications to the plan, or disapprove the plan. If the 
plan is disapproved, the Regional Administrator or the Director, 
National Programs Chemical Division will notify the person who submitted 
the plan of such disapproval, together with the reasons why it is 
disapproved. That person may thereafter submit a new plan in accordance 
with paragraph (d)(2)(ii) of this section. If the plan is

[[Page 574]]

approved (with any additions or modifications which the Regional 
Administrator or the Director, National Programs Chemical Division may 
prescribe), the Regional Administrator or the Director, National 
Programs Chemical Division will notify the person who submitted the plan 
of the approval. Thereafter, the trial burn shall take place at a date 
and time to be agreed upon between the Regional Administrator or the 
Director, National Programs Chemical Division and the person who 
submitted the plan.
    (3) Other information. In addition to the information contained in 
the report and plan described in paragraphs (d)(1) and (2) of this 
section, the Regional Administrator or the Assistant Administrator for 
Prevention, Pesticides and Toxic Substances may require the owner or 
operator to submit any other information that the Regional Administrator 
or the Assistant Administrator for Prevention, Pesticides and Toxic 
Substances finds to be reasonably necessary to determine whether an 
incinerator shall be approved.
    Note: The Regional Administrator will have available for review and 
inspection an Agency manual containing information on sampling methods 
and analytical procedures for the parameters required in Sec. 761.70(a) 
(3), (4), (6), and (7) plus any other parameters he/she may determine to 
be appropriate. Owners or operators are encouraged to review this manual 
prior to submitting any report required in Sec. 761.70.
    (4) Contents of approval. (i) Except as provided in paragraph (d)(5) 
of this section, the Regional Administrator or the Director, National 
Programs Chemical Division may not approve an incinerator for the 
disposal of PCBs and PCB Items unless he finds that the incinerator 
meets all of the requirements of paragraphs (a) and/or (b) of this 
section.
    (ii) In addition to the requirements of paragraphs (a) and/or (b) of 
this section, the Regional Administrator or the Director, National 
Programs Chemical Division may include in an approval any other 
requirements that the Regional Administrator or the Director, National 
Programs Chemical Division finds are necessary to ensure that operation 
of the incinerator does not present an unreasonable risk of injury to 
health or the environment from PCBs. Such requirements may include a 
fixed period of time for which the approval is valid.
    (5) Waivers. An owner or operator of the incinerator may submit 
evidence to the Regional Administrator or the Director, National 
Programs Chemical Division that operation of the incinerator will not 
present an unreasonable risk of injury to health or the enviroment from 
PCBs, when one or more of the requirements of paragraphs (a) and/or (b) 
of this section are not met. On the basis of such evidence and any other 
available information, the Regional Administrator or the Director, 
National Programs Chemical Division may in his/her discretion find that 
any requirement of paragraphs (a) and (b) of this section is not 
necessary to protect against such a risk, and may waive the requirements 
in any approval for that incinerator. Any finding and waiver under this 
paragraph must be stated in writing and included as part of the 
approval.
    (6) Persons approved. An approval will designate the persons who own 
and who are authorized to operate the incinerator, and will apply only 
to such persons, except as provided in paragraph (d)(8) of this section.
    (7) Final approval. Approval of an incinerator will be in writing 
and signed by the Regional Administrator or the Director, National 
Programs Chemical Division. The approval will state all requirements 
applicable to the approved incinerator.
    (8) Transfer of property. Any person who owns or operates an 
approved incinerator must notify EPA at least 30 days before 
transferring ownership in the incinerator or the property it stands 
upon, or transferring the right to operate the incinerator. The 
transferor must also submit to EPA, at least 30 days before such 
transfer, a notarized affidavit signed by the transferee which states 
that the transferee will abide by the transferor's EPA incinerator 
approval. Within 30 days of receiving such notification and affidavit, 
EPA will issue an amended approval substituting the transferee's name 
for the transferor's name, or EPA may require the transferee to apply 
for a new incinerator approval. In the latter

[[Page 575]]

case, the transferee must abide by the transferor's EPA approval until 
EPA issues the new approval to the transferee.


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 48 FR 13185, Mar. 30, 1983; 49 FR 28191, July 10, 1984; 
53 FR 12524, Apr. 15, 1988; 58 FR 15809, Mar. 24, 1993; 63 FR 35439, 
June 29, 1998]



Sec. 761.71   High efficiency boilers.

    (a) To burn mineral oil dielectric fluid containing a PCB 
concentration of 50 ppm, but <500 ppm:
    (1) The boiler shall comply with the following criteria:
    (i) The boiler is rated at a minimum of 50 million BTU hours.
    (ii) If the boiler uses natural gas or oil as the primary fuel, the 
carbon monoxide concentration in the stack is 50 ppm and the 
excess oxygen is at least 3 percent when PCBs are being burned.
    (iii) If the boiler uses coal as the primary fuel, the carbon 
monoxide concentration in the stack is 100 ppm and the excess 
oxygen is at least 3 percent when PCBs are being burned.
    (iv) The mineral oil dielectric fluid does not comprise more than 10 
percent (on a volume basis) of the total fuel feed rate.
    (v) The mineral oil dielectric fluid is not fed into the boiler 
unless the boiler is operating at its normal operating temperature (this 
prohibits feeding these fluids during either start up or shut down 
operations).
    (vi) The owner or operator of the boiler:
    (A) Continuously monitors and records the carbon monoxide 
concentration and excess oxygen percentage in the stack gas while 
burning mineral oil dielectric fluid; or
    (B) If the boiler will burn <30,000 gallons of mineral oil 
dielectric fluid per year, measures and records the carbon monoxide 
concentration and excess oxygen percentage in the stack gas at regular 
intervals of no longer than 60 minutes while burning mineral oil 
dielectric fluid.
    (vii) The primary fuel feed rates, mineral oil dielectric fluid feed 
rates, and total quantities of both primary fuel and mineral oil 
dielectric fluid fed to the boiler are measured and recorded at regular 
intervals of no longer than 15 minutes while burning mineral oil 
dielectric fluid.
    (viii) The carbon monoxide concentration and the excess oxygen 
percentage are checked at least once every hour that mineral oil 
dielectric fluid is burned. If either measurement falls below the levels 
specified in this section, the flow of mineral oil dielectric fluid to 
the boiler shall be stopped immediately.
    (2) Thirty days before any person burns mineral oil dielectric fluid 
in the boiler, the person gives written notice to the EPA Regional 
Administrator for the EPA Region in which the boiler is located and that 
the notice contains the following information:
    (i) The name and address of the owner or operator of the boiler and 
the address of the boiler.
    (ii) The boiler rating in units of BTU/hour.
    (iii) The carbon monoxide concentration and the excess oxygen 
percentage in the stack of the boiler when it is operated in a manner 
similar to the manner in which it will be operated when mineral oil 
dielectric fluid is burned.
    (iv) The type of equipment, apparatus, and procedures to be used to 
control the feed of mineral oil dielectric fluid to the boiler and to 
monitor and record the carbon monoxide concentration and excess oxygen 
percentage in the stack.
    (3) When burning mineral oil dielectric fluid, the boiler must 
operate at a level of output no less than the output at which the 
measurements required under paragraph (a)(2)(iii) of this section were 
taken.
    (4) Any person burning mineral oil dielectric fluid in a boiler 
obtains the following information and retains the information for 5 
years at the boiler location:
    (i) The data required to be collected under paragraphs (a)(1)(vi) 
and (vii) of this section.
    (ii) The quantity of mineral oil dielectric fluid burned in the 
boiler each month.
    (b) To burn liquids, other than mineral oil dielectric fluid, 
containing a

[[Page 576]]

PCB concentration of 50 ppm, but <500 ppm:
    (1) The boiler shall comply with the following criteria:
    (i) The boiler is rated at a minimum of 50 million BTU/hour.
    (ii) If the boiler uses natural gas or oil as the primary fuel, the 
carbon monoxide concentration in the stack is 50 ppm and the 
excess oxygen is at least 3 percent when PCBs are being burned.
    (iii) If the boiler uses coal as the primary fuel, the carbon 
monoxide concentration in the stack is 100 ppm and the excess 
oxygen is at least 3 percent when PCBs are being burned.
    (iv) The waste does not comprise more than 10 percent (on a volume 
basis) of the total fuel feed rate.
    (v) The waste is not fed into the boiler unless the boiler is 
operating at its normal operating temperature (this prohibits feeding 
these fluids during either start up or shut down operations).
    (vi) The owner or operator of the boiler must:
    (A) Continuously monitor and record the carbon monoxide 
concentration and excess oxygen percentage in the stack gas while 
burning waste fluid; or
    (B) If the boiler will burn <30,000 gallons of waste fluid per year, 
measure and record the carbon monoxide concentration and excess oxygen 
percentage in the stack gas at regular intervals of no longer than 60 
minutes while burning waste fluid.
    (vii) The primary fuel feed rate, waste fluid feed rate, and total 
quantities of both primary fuel and waste fluid fed to the boiler must 
be measured and recorded at regular intervals of no longer than 15 
minutes while burning waste fluid.
    (viii) The carbon monoxide concentration and the excess oxygen 
percentage must be checked at least once every hour that the waste is 
burned. If either measurement falls below the levels specified in either 
(a)(1)(ii) or (a)(1)(iii) of this section, the flow of waste to the 
boiler shall be stopped immediately.
    (2) Prior to any person burning these liquids in the boiler, 
approval must be obtained from the EPA Regional Administrator for the 
EPA Region in which the boiler is located and any persons seeking such 
approval must submit to the EPA Regional Administrator a request 
containing at least the following information:
    (i) The name and address of the owner or operator of the boiler and 
the address of the boiler.
    (ii) The boiler rating in units of BTU/hour.
    (iii) The carbon monoxide concentration and the excess oxygen 
percentage in the stack of the boiler when it is operated in a manner 
similar to the manner in which it will be operated when low 
concentration PCB liquid is burned.
    (iv) The type of equipment, apparatus, and procedures to be used to 
control the feed of mineral oil dielectric fluid to the boiler and to 
monitor and record the carbon monoxide concentration and excess oxygen 
percentage in the stack.
    (v) The type of waste to be burned (e.g., hydraulic fluid, 
contaminated fuel oil, heat transfer fluid, etc.).
    (vi) The concentration of PCBs and of any other chlorinated 
hydrocarbon in the waste and the results of analyses using the American 
Society of Testing and Materials (ASTM) methods as follows: Carbon and 
hydrogen content using ASTM D-3178-84, nitrogen content using ASTM E-
258-67 (Reapproved 1987), sulfur content using ASTM D-2784-89, ASTM D-
1266-87, or ASTM D-129-64, chlorine content using ASTM D-808-87, water 
and sediment content using either ASTM D-2709-88 or ASTM D-1796-83 
(Reapproved 1990), ash content using ASTM D-482-87, calorific value 
using ASTM D-240-87, carbon residue using either ASTM D-2158-89 or ASTM 
D-524-88, and flash point using ASTM D-93-90.
    (vii) The quantity of wastes estimated to be burned in a 30-day 
period.
    (viii) An explanation of the procedures to be followed to ensure 
that burning the waste will not adversely affect the operation of the 
boiler such that combustion efficiency will decrease.
    (3) On the basis of the information in paragraph (b)(2) of this 
section and any other available information, the Regional Administrator 
may, at his/her

[[Page 577]]

discretion, find that the alternate disposal method will not present an 
unreasonable risk of injury to health or the environment and approve the 
use of the boiler.
    (4) When burning PCB wastes, the boiler must operate at a level of 
output no less than the output at which the measurements required under 
paragraph (b)(2)(iii) of this section were taken.
    (5) Any person burning liquids in boilers approved as provided in 
paragraph (b)(3) of this section, must obtain the following information 
and retain the information for 5 years at the boiler location:
    (i) The data required to be collected in paragraphs (b)(1)(vi) and 
(b)(1)(vii) of this section.
    (ii) The quantity of low concentration PCB liquid burned in the 
boiler each month.
    (iii) The analysis of the waste required by paragraph (b)(2)(vi) of 
this section taken once a month for each month during which low 
concentration PCB liquid is burned in the boiler.

[63 FR 35454, June 29, 1998]



Sec. 761.72   Scrap metal recovery ovens and smelters.

    Any person may dispose of residual PCBs associated with PCB-
Contaminated articles regulated for disposal under Sec. 761.60(b), metal 
surfaces in PCB remediation waste regulated under Sec. 761.61, or metal 
surfaces in PCB bulk product waste regulated under Secs. 761.62(a)(6) 
and 761.79(c)(6), from which all free-flowing liquids have been removed:
    (a) In a scrap metal recovery oven:
    (1) The oven shall have at least two enclosed (i.e., negative draft, 
no fugitive emissions) interconnected chambers.
    (2) The equipment with all free-flowing liquid removed shall first 
be placed in the primary chamber at room temperature.
    (3) The primary chamber shall operate at a temperature between 537 
deg.C and 650  deg.C for a minimum of 2\1/2\ hours and reach a minimum 
temperature of 650  deg.C (1,202  deg.F) once during each heating cycle 
or batch treatment of unheated, liquid-free equipment.
    (4) Heated gases from the primary chamber must feed directly into 
the secondary chamber (i.e., afterburner) which must operate at a 
minimum temperature of 1,200  deg.C (2,192  deg.F) with at least a 3 
percent excess oxygen and a retention time of 2.0 seconds with a minimum 
combustion efficiency of 99.9 percent according to the definition in 
Sec. 761.70(a)(2).
    (5) Heating of the primary chamber shall not commence until the 
secondary chamber has reached a temperature of 1,200  100 
deg.C (2,192  deg.  180  deg.F).
    (6) Continuous emissions monitors and recorders for carbon dioxide, 
carbon monoxide, and excess oxygen in the secondary chamber and 
continuous temperature recorders in the primary and secondary chambers 
shall be installed and operated while the primary and secondary chambers 
are in operation to assure that the two chambers are within the 
operating parameters in paragraphs (a)(3) through (a)(5) of this 
section.
    (7) Emissions from the secondary chamber must be vented through an 
exhaust gas stack in accordance with either:
    (i) State or local air regulations or permits, or
    (ii) The standards in paragraph (a)(8) of this section.
    (8) Exhaust gas stack emissions shall be for: particulates 0.015 
grains/dry standard cubic foot, sulfur dioxide 35 parts per million by 
volume (ppmv), nitrogen oxide 150 ppmv, carbon monoxide 35 ppmv, and 
hydrogen chloride 35 ppmv.
    (9) A measurement of the temperature in the secondary chamber at the 
time the primary chamber starts heating must be taken, recorded and 
retained at the facility for 3 years from the date each charge is 
introduced into the primary chamber.
    (b) By smelting:
    (1) The operating temperature of the hearth must be at least 1,000 
deg.C at the time it is charged with any PCB-Contaminated non-porous 
surface.
    (2) Each charge containing a PCB-Contaminated item must be added 
into molten metal or a hearth at 1,000  deg.C.

[[Page 578]]

    (3) Successive charges may not be introduced into the hearth in less 
than 15-minute intervals.
    (4) The smelter must operate in compliance with any applicable 
emissions standards in part 60 of this chapter.
    (5) The smelter must have an operational device which accurately 
measures directly or indirectly, the temperature in the hearth.
    (6) Take, record and retain at the disposal facility for 3 years 
from the date each charge is introduced, a reading of the temperature in 
the hearth at the time it is charged with a non-porous surface item.
    (c)(1) Scrap metal recovery ovens and smelters must either have a 
final permit under RCRA (part 266, subpart H of this chapter and 
Sec. 270.66 of this chapter) or be operating under a valid State air 
emissions permit which includes a standard for PCBs.
    (2) Scrap metal recovery ovens and smelters disposing of PCBs must 
provide notification as disposers of PCBs, are not required to submit 
annual reports, and shall otherwise comply with all applicable 
provisions of subparts J and K of this part, as well as other applicable 
Federal, State, and local laws and regulations.
    (3) In lieu of the requirements in paragraph (c)(1) of this section, 
upon written request by the owner or operator of a scrap metal recovery 
oven or smelter, the EPA Regional Administrator, for the Region where 
the oven or smelter is located, may make a finding in writing, based on 
a site-specific risk assessment, that the oven or smelter does not pose 
an unreasonable risk of injury to health or the environment because it 
is operating in compliance with the parameters and conditions listed in 
paragraph (a) or (b) of this section even though the oven or smelter 
does not have a RCRA or State air permit as required by paragraph (c)(1) 
of this section. The written request shall include a site-specific risk 
assessment.
    (d) PCB liquids, other liquid waste qualifying as waste oils which 
may be used as provided for at Sec. 761.20(e), or PCB remediation waste, 
other than PCB-Contaminated articles, may not be disposed of in a scrap 
metal recovery oven or smelter unless approved or otherwise allowed 
under subpart D of this part.

[63 FR 35455, June 29, 1998, as amended at 64 FR 33761, June 24, 1999]



Sec. 761.75  Chemical waste landfills.

    This section applies to facilities used to dispose of PCBs in 
accordance with the part.
    (a) General. A chemical waste landfill used for the disposal of PCBs 
and PCB Items shall be approved by the Agency Regional Administrator 
pursuant to paragraph (c) of this section. The landfill shall meet all 
of the requirements specified in paragraph (b) of this section, unless a 
waiver from these requirements is obtained pursuant to paragraph (c)(4) 
of this section. In addition, the landfill shall meet any other 
requirements that may be prescribed pursuant to paragraph (c)(3) of this 
section.
    (b) Technical requirements. Requirements for chemical waste 
landfills used for the disposal of PCBs and PCB Items are as follows:
    (1) Soils. The landfill site shall be located in thick, relatively 
impermeable formations such as large-area clay pans. Where this is not 
possible, the soil shall have a high clay and silt content with the 
following parameters:
    (i) In-place soil thickness, 4 feet or compacted soil liner 
thickness, 3 feet;
    (ii) Permeability (cm/sec), equal to or less than 
1 x 10-7;
    (iii) Percent soil passing No. 200 Sieve, >30;
    (iv) Liquid Limit, >30; and
    (v) Plasticity Index >15.
    (2) Synthetic membrane liners. Synthetic membrane liners shall be 
used when, in the judgment of the Regional Administrator, the hydrologic 
or geologic conditions at the landfill require such a liner in order to 
provide at least a permeability equivalent to the soils in paragraph 
(b)(1) of this section. Whenever a synthetic liner is used at a landfill 
site, special precautions shall be taken to insure that its integrity is 
maintained and that it is chemically compatible with PCBs. Adequate soil 
underlining and soil cover shall be provided to prevent excessive stress 
on the liner and to prevent rupture of the liner. The liner must have a 
minimum thickness of 30 mils.

[[Page 579]]

    (3) Hydrologic conditions. The bottom of the landfill shall be above 
the historical high groundwater table as provided below. Floodplains, 
shorelands, and groundwater recharge areas shall be avoided. There shall 
be no hydraulic connection between the site and standing or flowing 
surface water. The site shall have monitoring wells and leachate 
collection. The bottom of the landfill liner system or natural in-place 
soil barrier shall be at least fifty feet from the historical high water 
table.
    (4) Flood protection. (i) If the landfill site is below the 100-year 
floodwater elevation, the operator shall provide surface water diversion 
dikes around the perimeter of the landfill site with a minimum height 
equal to two feet above the 100-year floodwater elevation.
    (ii) If the landfill site is above the 100-year floodwater 
elevation, the operators shall provide diversion structures capable of 
diverting all of the surface water runoff from a 24-hour, 25-year storm.
    (5) Topography. The landfill site shall be located in an area of low 
to moderate relief to minimize erosion and to help prevent landslides or 
slumping.
    (6) Monitoring systems--(i) Water sampling. (A) For all sites 
receiving PCBs, the ground and surface water from the disposal site area 
shall be sampled prior to commencing operations under an approval 
provided in paragraph (c) of this section for use as baseline data.
    (B) Any surface watercourse designated by the Regional Administrator 
using the authority provided in paragraph (c)(3)(ii) of this section 
shall be sampled at least monthly when the landfill is being used for 
disposal operations.
    (C) Any surface watercourse designated by the Regional Administrator 
using the authority provided in paragraph (c)(3)(ii) of this section 
shall be sampled for a time period specified by the Regional 
Administrator on a frequency of no less than once every six months after 
final closure of the disposal area.
    (ii) Groundwater monitor wells. (A) If underlying earth materials 
are homogenous, impermeable, and uniformly sloping in one direction, 
only three sampling points shall be necessary. These three points shall 
be equally spaced on a line through the center of the disposal area and 
extending from the area of highest water table elevation to the area of 
the lowest water table elevation on the property.
    (B) All monitor wells shall be cased and the annular space between 
the monitor zone (zone of saturation) and the surface shall be 
completely backfilled with Portland cement or an equivalent material and 
plugged with Portland cement to effectively prevent percolation of 
surface water into the well bore. The well opening at the surface shall 
have a removable cap to provide access and to prevent entrance of 
rainfall or stormwater runoff. The well shall be pumped to remove the 
volume of liquid initially contained in the well before obtaining a 
sample for analysis. The discharge shall be treated to meet applicable 
State or Federal discharge standards or recycled to the chemical waste 
landfill.
    (iii) Water analysis. As a minimum, all samples shall be analyzed 
for the following parameters, and all data and records of the sampling 
and analysis shall be maintained as required in Sec. 761.180(d)(1). 
Sampling methods and analytical procedures for these parameters shall 
comply with those specified in 40 CFR part 136 as amended in 41 FR 52779 
on December 1, 1976.
    (A) PCBs.
    (B) pH.
    (C) Specific conductance.
    (D) Chlorinated organics.
    (7) Leachate collection. A leachate collection monitoring system 
shall be installed above the chemical waste landfill. Leachate 
collection systems shall be monitored monthly for quantity and 
physicochemical characteristics of leachate produced. The leachate 
should be either treated to acceptable limits for discharge in 
accordance with a State or Federal permit or disposed of by another 
State or Federally approved method. Water analysis shall be conducted as 
provided in paragraph (b)(6)(iii) of this section. Acceptable leachate 
monitoring/collection systems shall be any of the following designs, 
unless a waiver is obtained pursuant to paragraph (c)(4) of this 
section.
    (i) Simple leachate collection. This system consists of a gravity 
flow

[[Page 580]]

drainfield installed above the waste disposal unit liner. This design is 
recommended for use when semi-solid or leachable solid wastes are placed 
in a lined pit excavated into a relatively thick, unsaturated, 
homogenous layer of low permeability soil.
    (ii) Compound leachate collection. This system consists of a gravity 
flow drainfield installed above the waste disposal unit liner and above 
a secondary installed liner. This design is recommended for use when 
semi-liquid or leachable solid wastes are placed in a lined pit 
excavated into relatively permeable soil.
    (iii) Suction lysimeters. This system consists of a network of 
porous ceramic cups connected by hoses/tubing to a vacuum pump. The 
porous ceramic cups or suction lysimeters are installed along the sides 
and under the bottom of the waste disposal unit liner. This type of 
system works best when installed in a relatively permeable unsaturated 
soil immediately adjacent to the bottom and/or sides of the disposal 
facility.
    (8) Chemical waste landfill operations. (i) PCBs and PCB Items shall 
be placed in a landfill in a manner that will prevent damage to 
containers or articles. Other wastes placed in the landfill that are not 
chemically compatible with PCBs and PCB Items including organic solvents 
shall be segregated from the PCBs throughout the waste handling and 
disposal process.
    (ii) An operation plan shall be developed and submitted to the 
Regional Administrator for approval as required in paragraph (c) of this 
section. This plan shall include detailed explanations of the procedures 
to be used for recordkeeping, surface water handling procedures, 
excavation and backfilling, waste segregation burial coordinates, 
vehicle and equipment movement, use of roadways, leachate collection 
systems, sampling and monitoring procedures, monitoring wells, 
environmental emergency contingency plans, and security measures to 
protect against vandalism and unauthorized waste placements. EPA 
guidelines entitled ``Thermal Processing and Land Disposal of Solid 
Waste'' (39 FR 29337, Aug. 14, 1974) are a useful reference in 
preparation of this plan. If the facility is to be used to dispose of 
liquid wastes containing between 50 ppm and 500 ppm PCB, the operations 
plan must include procedures to determine that liquid PCBs to be 
disposed of at the landfill do not exceed 500 ppm PCB and measures to 
prevent the migration of PCBs from the landfill. Bulk liquids not 
exceeding 500 ppm PCBs may be disposed of provided such waste is 
pretreated and/or stabilized (e.g., chemically fixed, evaporated, mixed 
with dry inert absorbant) to reduce its liquid content or increase its 
solid content so that a non-flowing consistency is achieved to eliminate 
the presence of free liquids prior to final disposal in a landfill. PCB 
Container of liquid PCBs with a concentration between 50 and 500 ppm PCB 
may be disposed of if each container is surrounded by an amount of inert 
sorbant material capable of absorbing all of the liquid contents of the 
container.
    (iii) Ignitable wastes shall not be disposed of in chemical waste 
landfills. Liquid ignitable wastes are wastes that have a flash point 
less than 60 degrees C (140 degrees F) as determined by the following 
method or an equivalent method: Flash point of liquids shall be 
determined by a Pensky-Martens Closed Cup Tester, using the protocol 
specified in ASTM D 93-90, or the Setaflash Closed Tester using the 
protocol specified in ASTM Standard D-3278-89.
    (iv) Records shall be maintained for all PCB disposal operations and 
shall include information on the PCB concentration in liquid wastes and 
the three dimensional burial coordinates for PCBs and PCB Items. 
Additional records shall be developed and maintained as required in 
Sec. 761.180.
    (9) Supporting facilities. (i) A six foot woven mesh fence, wall, or 
similar device shall be placed around the site to prevent unauthorized 
persons and animals from entering.
    (ii) Roads shall be maintained to and within the site which are 
adequate to support the operation and maintenance of the site without 
causing safety or nuisance problems or hazardous conditions.
    (iii) The site shall be operated and maintained in a manner to 
prevent

[[Page 581]]

safety problems or hazardous conditions resulting from spilled liquids 
and windblown materials.
    (c) Approval of chemical waste landfills. Prior to the disposal of 
any PCBs and PCB Items in a chemical waste landfill, the owner or 
operator of the landfill shall receive written approval of the Agency 
Regional Administrator for the Region in which the landfill is located. 
The approval shall be obtained in the following manner:
    (1) Initial report. The owner or operator shall submit to the 
Regional Administrator an initial report which contains:
    (i) The location of the landfill;
    (ii) A detailed description of the landfill including general site 
plans and design drawings;
    (iii) An engineering report describing the manner is which the 
landfill complies with the requirements for chemical waste landfills 
specified in paragraph (b) of this section;
    (iv) Sampling and monitoring equipment and facilities available;
    (v) Expected waste volumes of PCBs;
    (vi) General description of waste materials other than PCBs that are 
expected to be disposed of in the landfill;
    (vii) Landfill operations plan as required in paragraph (b) of this 
section;
    (viii) Any local, State, or Federal permits or approvals; and
    (ix) Any schedules or plans for complying with the approval 
requirements of these regulations.
    (2) Other information. In addition to the information contained in 
the report described in paragraph (c)(1) of this section, the Regional 
Administrator may require the owner or operator to submit any other 
information that the Regional Administrator finds to be reasonably 
necessary to determine whether a chemical waste landfill should be 
approved. Such other information shall be restricted to the types of 
information required in paragraphs (c)(1) (i) through (ix) of this 
section.
    (3) Contents of approval. (i) Except as provided in paragraph (c)(4) 
of this section the Regional Administrator may not approve a chemical 
waste landfill for the disposal of PCBs and PCB Items, unless he finds 
that the landfill meets all of the requirements of paragraph (b) of this 
section.
    (ii) In addition to the requirements of paragraph (b) of this 
section, the Regional Administrator may include in an approval any other 
requirements or provisions that the Regional Administrator finds are 
necessary to ensure that operation of the chemical waste landfill does 
not present an unreasonable risk of injury to health or the environment 
from PCBs. Such provisions may include a fixed period of time for which 
the approval is valid.

The approval may also include a stipulation that the operator of the 
chemical waste landfill report to the Regional Administrator any 
instance when PCBs are detectable during monitoring activities conducted 
pursuant to paragraph (b)(6) of this section.
    (4) Waivers. An owner or operator of a chemical waste landfill may 
submit evidence to the Regional Administrator that operation of the 
landfill will not present an unreasonable risk of injury to health or 
the environment from PCBs when one or more of the requirements of 
paragraph (b) of this section are not met. On the basis of such evidence 
and any other available information, the Regional Administrator may in 
his discretion find that one or more of the requirements of paragraph 
(b) of this section is not necessary to protect against such a risk and 
may waive the requirements in any approval for that landfill. Any 
finding and waiver under this paragraph will be stated in writing and 
included as part of the approval.
    (5) Persons approved. Any approval will designate the persons who 
own and who are authorized to operate the chemical waste landfill, and 
will apply only to such persons, except as provided by paragraph (c)(7) 
of this section.
    (6) Final approval. Approval of a chemical waste landfill will be in 
writing and will be signed by the Regional Administrator. The approval 
will state all requirements applicable to the approved landfill.
    (7) Transfer of property. Any person who owns or operates an 
approved chemical waste landfill must notify EPA at least 30 days before 
transferring ownership in the property or transferring the right to 
conduct the chemical waste landfill operation. The

[[Page 582]]

transferor must also submit to EPA, at least 30 days before such 
transfer, a notarized affidavit signed by the transferee which states 
that the transferee will abide by the transferor's EPA chemical waste 
landfill approval. Within 30 days of receiving such notification and 
affidavit, EPA will issue an amended approval substituting the 
transferee's name for the transferor's name, or EPA may require the 
transferee to apply for a new chemical waste landfill approval. In the 
latter case, the transferee must abide by the transferor's EPA approval 
until EPA issues the new approval to the transferee.


(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 48 FR 5730, Feb. 8, 1983; 49 FR 28191, July 10, 1984; 53 
FR 12524, Apr. 15, 1988; 53 FR 21641, June 9, 1988; 57 FR 13323, Apr. 
16, 1992; 63 FR 35456, June 29, 1998]



Sec. 761.77   Coordinated approval.

    (a) General requirements. Notwithstanding any other provision of 
this part, the EPA Regional Administrator for the Region in which a PCB 
disposal or PCB commercial storage facility described in paragraphs (b) 
and (c) of this section is located may issue a TSCA PCB Coordinated 
Approval to the persons described in those paragraphs if the conditions 
listed in this section are met. A TSCA PCB Coordinated Approval will 
designate the persons who own and who are authorized to operate the 
facilities described in paragraphs (b) and (c) of this section and will 
apply only to such persons. All requirements, conditions, and 
limitations of any other permit or waste management document cited or 
described in paragraphs (b) and (c) of this section, as the technical or 
legal basis on which the TSCA PCB Coordinated Approval is issued, are 
conditions of the TSCA PCB Coordinated Approval.
    (1) Persons seeking a TSCA PCB Coordinated Approval shall submit a 
request for approval by certified mail, to the EPA Regional 
Administrator for the Region in which the activity will take place. 
Persons seeking a TSCA PCB Coordinated Approval for a new PCB activity 
shall submit the request for approval at the same time they seek a 
permit, approval, or other action for a PCB waste management activity 
under any other Federal or State authority.
    (i) The request for a TSCA PCB Coordinated Approval shall include a 
copy of the letter from EPA announcing or confirming the EPA 
identification number issued to the facility for conducting PCB 
activities; the name, organization, and telephone number of the person 
who is the contact point for the non-TSCA Federal or State waste 
management authority; a copy of the relevant permit or waste management 
document specified in paragraphs (b) and (c) of this section, including 
all requirements, conditions, and limitations, if the EPA Regional 
Administrator does not have a copy of the document, or a description of 
the waste management activities to be conducted if a permit or other 
relevant waste management document has not been issued; and a 
certification that the person who owns or operates the facility is aware 
of and will adhere to the TSCA PCB reporting and recordkeeping 
requirements at subparts J and K of this part.
    (ii) The EPA Regional Administrator shall review the request for 
completeness, for compliance with the requirements of paragraphs (b) and 
(c) of this section, and to ensure that the PCB activity for which 
approval is requested will not present an unreasonable risk of injury to 
health or the environment. The EPA Regional Administrator shall either:
    (A) Issue a written notice of deficiency explaining why the request 
for approval is deficient. If appropriate, the EPA Regional 
Administrator may either:
    (1) Request additional information to cure the deficiency.
    (2) Deny the request for a TSCA PCB Coordinated Approval.
    (B) Issue a letter granting or denying the TSCA PCB Coordinated 
Approval. If the EPA Regional Administrator grants the TSCA PCB 
Coordinated Approval, he or she may acknowledge the non-TSCA approval 
meets the regulatory requirements under TSCA as written, or require 
additional conditions the EPA Regional Administrator

[[Page 583]]

has determined are necessary to prevent unreasonable risk of injury to 
health or the environment.
    (C) If the EPA Regional Administrator denies a request for a 
Coordinated Approval under paragraphs (a)(1)(ii)(A) or (a)(1)(ii)(B) of 
this section, the person who requested the TSCA PCB Coordinated Approval 
may submit an application for a TSCA Disposal Approval.
    (2) The EPA Regional Administrator may issue a notice of deficiency, 
revoke the TSCA PCB Coordinated Approval, require the person to whom the 
TSCA PCB Coordinated Approval was issued to submit an application for a 
TSCA PCB approval, or bring an enforcement action under TSCA if he or 
she determines that:
    (i) Conditions of the approval relating to PCB waste management 
activities are not met.
    (ii) The PCB waste management process is being operated in a manner 
which may result in an unreasonable risk of injury to health or the 
environment.
    (iii) The non-TSCA approval expires, is revoked, is suspended, or 
otherwise ceases to be in full effect.
    (3) Any person with a TSCA PCB Coordinated Approval must notify the 
EPA Regional Administrator in writing within 5 calendar days of changes 
relating to PCB waste requirements in the non-TSCA waste management 
document which serves as the basis for a TSCA PCB Coordinated Approval. 
Changes in the ownership of a commercial storage facility which holds a 
TSCA PCB Coordinated Approval shall be handled pursuant to 
Sec. 761.65(j).
    (b) Any person who owns or operates a facility that he or she 
intends to use to landfill PCB wastes; incinerate PCB wastes; dispose of 
PCB wastes using an alternative disposal method that is equivalent to 
disposal in an incinerator approved under Sec. 761.70 or a high 
efficiency boiler operating in compliance with Sec. 761.71; or stores 
PCB wastes may apply for a TSCA PCB Coordinated Approval. The EPA 
Regional Administrator may approve the request if the EPA Regional 
Administrator determines that the activity will not pose an unreasonable 
risk of injury to health or the environment and the person:
    (1)(i) Has a waste management permit or other decision or 
enforcement document which exercises control over PCB wastes, issued by 
EPA or an authorized State Director for a State program that has been 
approved by EPA and is no less stringent in protection of health or the 
environment than the applicable TSCA requirements found in this part; or
    (ii) Has a PCB waste management permit or other decision or 
enforcement document issued by a State Director pursuant to a State PCB 
waste management program no less stringent in protection of health or 
the environment than the applicable TSCA requirements found in this 
part; or
    (iii) Is subject to a waste management permit or other decision or 
enforcement document which is applicable to the disposal of PCBs and 
which was issued through the promulgation of a regulation published in 
Title 40 of the Code of Federal Regulations.
    (2) Complies with the terms and conditions of the permit or other 
decision or enforcement document described in paragraph (b)(1) of this 
section.
    (3) Unless otherwise waived or modified in writing by the EPA 
Regional Administrator, complies with Sec. 761.75(b); Sec. 761.70(a)(1) 
through (a)(9), (b)(1) and (b)(2), and (c); or the PCB storage 
requirements at Secs. 761.65(a), (c), and (d)(2), as appropriate.
    (4) Complies with the reporting and recordkeeping requirements in 
subparts J and K of this part.
    (c) A person conducting research and development (R&D) into PCB 
disposal methods (regardless of PCB concentration), or conducting PCB 
remediation activities may apply for a TSCA PCB Coordinated Approval. 
The EPA Regional Administrator may approve the request if the EPA 
Regional Administrator determines that the activity will not pose an 
unreasonable risk of injury to health or the environment and the person:
    (1)(i) Has a permit or other decision and enforcement document 
issued or otherwise agreed to by EPA, or permit or other decision and 
enforcement document issued by an authorized State Director for a State 
program that has

[[Page 584]]

been approved by EPA, which exercises control over the management of PCB 
wastes, and that person is in compliance with all terms and conditions 
of that document; or
    (ii) Has a permit, which exercises control over the management of 
PCB wastes, issued by a State Director pursuant to a State PCB disposal 
program no less stringent than the requirements in this part.
    (2) Complies with the terms and conditions of that permit or other 
decision and enforcement document.
    (3) Complies with the reporting and recordkeeping requirements in 
subparts J and K of this part.

[63 FR 35456, June 29, 1998]



Sec. 761.79   Decontamination standards and procedures.

    (a) Applicability. This section establishes decontamination 
standards and procedures for removing PCBs, which are regulated for 
disposal, from water, organic liquids, non-porous surfaces (including 
scrap metal from disassembled electrical equipment), concrete, and non-
porous surfaces covered with a porous surface, such as paint or coating 
on metal.
    (1) Decontamination in accordance with this section does not require 
a disposal approval under subpart D of this part.
    (2) Materials from which PCBs have been removed by decontamination 
in accordance with this section may be distributed in commerce in 
accordance with Sec. 761.20(c)(5).
    (3) Materials from which PCBs have been removed by decontamination 
in accordance with this section may be used or reused in accordance with 
Sec. 761.30(u).
    (4) Materials from which PCBs have been removed by decontamination 
in accordance with this section, not including decontamination waste and 
residuals under paragraph (g) of this section, are unregulated for 
disposal under subpart D of this part.
    (5) Any person decontaminating porous surfaces other than concrete 
under paragraph (b)(4) of this section and non-porous surfaces covered 
with a porous surface, such as paint or coating on metal, under 
paragraph (b)(3) or (c)(6) of this section must obtain an alternative 
decontamination approval in accordance with paragraph (h) of this 
section.
    (6) Any person engaging in decontamination under this section is 
responsible for determining and complying with all other applicable 
Federal, State, and local laws and regulations.
    (b) Decontamination standards. Chopping (including wire chopping), 
distilling, filtering, oil/water separation, spraying, soaking, wiping, 
stripping of insulation, scraping, scarification or the use of abrasives 
or solvents may be used to remove or separate PCBs, to the following 
standards, from liquids, concrete, or non-porous surfaces.
    (1) The decontamination standard for water containing PCBs is:
    (i) Less than 200 g/L (i.e., 200 ppb PCBs) for non-contact 
use in a closed system where there are no releases;
    (ii) For water discharged to a treatment works (as defined in 
Sec. 503.9(aa) of this chapter) or to navigable waters, <3 g/L 
(approximately <3 ppb) or a PCB discharge limit included in a permit 
issued under section 307(b) or 402 of the Clean Water Act; or
    (iii) Less than or equal to 0.5 g/L (i.e., approximately 
0.5 ppb PCBs) for unrestricted use.
    (2) The decontamination standard for organic liquids and non-aqueous 
inorganic liquids containing PCBs is <2 milligrams per kilogram (i.e., 2 
ppm PCBs).
    (3) The decontamination standard for non-porous surfaces in contact 
with liquid and non-liquid PCBs is:
    (i) For unrestricted use:
    (A) For non-porous surfaces previously in contact with liquid PCBs 
at any concentration, where no free-flowing liquids are currently 
present, 10 micrograms PCBs per 100 square centimeters 
(10 g/100 cm2) as measured by a standard 
wipe test (Sec. 761.123) at locations selected in accordance with 
subpart P of this part.
    (B) For non-porous surfaces in contact with non-liquid PCBs 
(including non-porous surfaces covered with a porous surface, such as 
paint or coating on metal), cleaning to Visual Standard No. 2, Near-
White Blast Cleaned Surface Finish, of the National Association of 
Corrosion Engineers (NACE). A

[[Page 585]]

person shall verify compliance with standard No. 2 by visually 
inspecting all cleaned areas.
    (ii) For disposal in a smelter operating in accordance with 
Sec. 761.72(b):
    (A) For non-porous surfaces previously in contact with liquid PCBs 
at any concentration, where no free-flowing liquids are currently 
present, <100 g/100 cm2 as measured by a standard 
wipe test (Sec. 761.123) at locations selected in accordance with 
subpart P of this part.
    (B) For non-porous surfaces in contact with non-liquid PCBs 
(including non-porous surfaces covered with a porous surface, such as 
paint or coating on metal), cleaning to Visual Standard No. 3, 
Commercial Blast Cleaned Surface Finish, of the National Association of 
Corrosion Engineers (NACE). A person shall verify compliance with 
standard No. 3 by visually inspecting all cleaned areas.
    (4) The decontamination standard for concrete is 10 
g/100 cm2 as measured by a standard wipe test 
(Sec. 761.123) if the decontamination procedure is commenced within 72 
hours of the initial spill of PCBs to the concrete or portion thereof 
being decontaminated.
    (c) Self-implementing decontamination procedures. The following 
self-implementing decontamination procedures are available as an 
alternative to the measurement-based decontamination methods specified 
in paragraph (b) of this section. Any person performing self-
implementing decontamination must comply with one of the following 
procedures.
    (1) Any person decontaminating a PCB Container must do so by 
flushing the internal surfaces of the container three times with a 
solvent containing <50 ppm PCBs. Each rinse shall use a volume of the 
flushing solvent equal to approximately 10 percent of the PCB Container 
capacity.
    (2) Any person decontaminating movable equipment contaminated by 
PCBs, tools, and sampling equipment may do so by:
    (i) Swabbing surfaces that have contacted PCBs with a solvent;
    (ii) A double wash/rinse as defined in subpart S of this part; or
    (iii) Another applicable decontamination procedure in this section.
    (3) Any person decontaminating a non-porous surface in contact with 
free-flowing mineral oil dielectric fluid (MODEF) at levels 
10,000 ppm PCBs must do so as follows:
    (i) Drain the free-flowing MODEF and allow the residual surfaces to 
drain for an additional 15 hours.
    (ii) Dispose of drained MODEF according to paragraph (g) of this 
section.
    (iii) Soak the surfaces to be decontaminated in a sufficient amount 
of clean (containing 2 ppm PCBs) performance-based organic 
decontamination fluid (PODF) such that there is a minimum of 800 ml of 
PODF for each 100 cm2 of contaminated or potentially 
contaminated surface for at least 15 hours at 20  deg.C.
    (iv) Approved PODFs include:
    (A) Kerosene.
    (B) Diesel fuel.
    (C) Terpene hydrocarbons.
    (D) Mixtures of terpene hydrocarbons and terpene alcohols.
    (v) Drain the PODF from the surfaces.
    (vi) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (4) Any person decontaminating a non-porous surface in contact with 
free-flowing MODEF containing >10,000 ppm PCB in MODEF or askarel PCB 
(up to 70 percent PCB in a mixture of trichlorobenzenes and 
tetrachlorobenzenes) must do so as follows:
    (i) Drain the free-flowing MODEF or askarel and allow the residual 
surfaces to drain for an additional 15 hours.
    (ii) Dispose of drained MODEF or askarel according to paragraph (g) 
of this section.
    (iii) Soak the surfaces to be decontaminated in a sufficient amount 
of clean PODF (containing 2 ppm PCBs) such that there is a minimum of 
800 ml of PODF for each 100 cm2 of contaminated or 
potentially contaminated surface for at least 15 hours at 20 
deg.C.
    (iv) Approved PODFs include:
    (A) Kerosene.
    (B) Diesel fuel.
    (C) Terpene hydrocarbons.
    (D) Mixtures of terpene hydrocarbons and terpene alcohols.

[[Page 586]]

    (v) Drain the PODF from the surfaces.
    (vi) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (vii) Resoak the surfaces to be decontaminated, pursuant to 
paragraph (c)(3)(iii) of this section, in a sufficient amount of clean 
PODF (containing 2 ppm PCBs) such that there is a minimum of 800 ml of 
PODF for each 100 cm2 of surface for at least 15 hours at 
20  deg.C.
    (viii) Drain the PODF from the surfaces.
    (ix) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (5) Any person decontaminating piping and air lines in an air 
compressor system must do so as follows:
    (i) Before decontamination proceeds, disconnect or bypass the air 
compressors and air dryers from the piping and air lines and 
decontaminate the air compressors and air dryers separately in 
accordance with paragraphs (b), (c)(1) through (c)(4), or (c)(6) of this 
section. Dispose of filter media and desiccant in the air dyers based on 
their existing PCB concentration.
    (ii) Test the connecting line and appurtenances of the system to 
assure that there is no leakage. Test by introducing air into the closed 
system at from 90 to 100 pounds per square inch (psi). Only if there is 
a pressure drop of <5 psi in 30 minutes may decontamination take place.
    (iii) When there is no leakage, fill the piping and air lines with 
clean (containing <2 ppm PCBs) solvent. Solvents include PODF, aqueous 
potassium hydroxide at a pH between 9 and 12, or water containing 5 
percent sodium hydroxide by weight.
    (iv) Circulate the solvent to achieve turbulent flow through the 
piping and air lines in the air compressor system until the total volume 
of solvent circulated equals 10 times the total volume of the particular 
article being decontaminated, then drain the solvent. Calculate the 
total volume of solvent circulated by multiplying the pump rate by the 
time of pumping. Turbulent flow means a Reynolds number range from 
20,000 to 43,000. Refill the system with clean solvent and repeat the 
circulation and drain process.
    (6) Any person using thermal processes to decontaminate metal 
surfaces in contact with PCBs, as required by Sec. 761.62(a)(6), must 
use one of the following options:
    (i) Surfaces in contact with liquid and non-liquid PCBs at 
concentrations 500 ppm may be decontaminated in a scrap metal recovery 
oven or smelter for purposes of disposal in accordance with Sec. 761.72.
    (ii) Surfaces in contact with liquid or non-liquid PCBs at 
concentrations 500 ppm may be smelted in a smelter operating 
in accordance with Sec. 761.72(b), but must first be decontaminated in 
accordance with Sec. 761.72(a) or to a surface concentration of 100 
g/100 cm2.
    (d) Decontamination solvents. (1) Unless otherwise provided in 
paragraphs (c)(3) through (c)(5) of this section, the solubility of PCBs 
in any solvent used for purposes of decontamination under this section 
must be 5 percent or more by weight.
    (2) The solvent may be reused for decontamination so long as its PCB 
concentration is <50 ppm.
    (3) Solvent shall be disposed of under paragraph (g) of this 
section.
    (4) Other than as allowed in paragraphs (c)(3) and (c)(4) of this 
section, solvents may be tested and validated for performance-based 
decontamination of non-porous surfaces contaminated with MODEF or other 
PCB liquids, in accordance with the self-implementing procedures found 
in subpart T of this part. Specific conditions for the performance-based 
testing from this validation are determined in the validation study.
    (e) Limitation of exposure and control of releases. (1) Any person 
conducting decontamination activities under this section shall take 
necessary measures to protect against direct release of PCBs to the 
environment from the decontamination area.
    (2) Persons participating in decontamination activities shall wear 
or use protective clothing or equipment to protect against dermal 
contact or inhalation of PCBs or materials containing PCBs.
    (f) Sampling and recordkeeping. (1) Confirmatory sampling is 
required

[[Page 587]]

under paragraph (b) of this section. For liquids described in paragraphs 
(b)(1) and (b)(2) of this section, sample in accordance with Secs.  
761.269 and 761.272. For non-porous surfaces and concrete described in 
paragraphs (b)(3) and (b)(4) of this section, sample in accordance with 
subpart P of this part. A written record of such sampling must be 
established and maintained for 3 years from the date of any 
decontamination under this section. The record must show sampling 
locations and analytical results and must be retained at the site of the 
decontamination or a copy of the record must be made available to EPA in 
a timely manner, if requested. In addition, recordkeeping is required in 
accordance with Sec. 761.180(a) for all wastes generated by a 
decontamination process and regulated for disposal under this subpart.
    (2) Confirmatory sampling is not required for self-implementing 
decontamination procedures under paragraph (c) of this section. Any 
person using these procedures must retain a written record documenting 
compliance with the procedures for 3 years after completion of the 
decontamination procedures (e.g., video recordings, photographs).
    (g) Decontamination waste and residues. Decontamination waste and 
residues shall be disposed of at their existing PCB concentration unless 
otherwise specified.
    (1) Distillation bottoms or residues and filter media are regulated 
for disposal as PCB remediation waste.
    (2) PCBs physically separated from regulated waste during 
decontamination (such as by chopping, shredding, scraping, abrading or 
oil/water separation, as opposed to solvent rinsing and soaking), other 
than wastes described in paragraph (g)(1) of this section, are regulated 
for disposal at their original concentration.
    (3) Hydrocarbon solvent used or reused for decontamination under 
this section that contains 50 ppm PCB must be burned and marketed in 
accordance with the requirements for used oil in Sec. 761.20(e), 
disposed of in accordance with Sec. 761.60(a) or (e), or decontaminated 
pursuant to this section.
    (4) Chlorinated solvent at any PCB concentration used for 
decontamination under this section shall be disposed of in an 
incinerator operating in compliance with Sec. 761.70, or decontaminated 
pursuant to this section.
    (5) Solvents 50 ppm other than those described in 
paragraphs (g)(3) and (g)(4) of this section shall be disposed of in 
accordance with Sec. 761.60(a) or decontaminated pursuant to this 
section.
    (6) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
decontamination shall be disposed of in accordance with 
Sec. 761.61(a)(5)(v).
    (h) Alternative decontamination or sampling approval. (1) Any person 
wishing to decontaminate material described in paragraph (a) of this 
section in a manner other than prescribed in paragraph (b) of this 
section must apply in writing to the EPA Regional Administrator in the 
Region where the activity would take place, for decontamination activity 
occurring in a single EPA Region; or the Director of the National 
Program Chemicals Division, for decontamination activity occurring in 
more than one EPA Region. Each application must describe the material to 
be decontaminated and the proposed decontamination method, and must 
demonstrate that the proposed method is capable of decontaminating the 
material to the applicable level set out in paragraphs (b)(1) through 
(b)(4) of this section.
    (2) Any person wishing to decontaminate material described in 
paragraph (a) of this section using a self-implementing procedure other 
than prescribed in paragraph (c) of this section must apply in writing 
to the EPA Regional Administrator in the Region where the activity would 
take place, for decontamination activity occurring in a single EPA 
Region; or the Director of the National Program Chemicals Division, for 
decontamination activity occurring in more than one EPA Region. Each 
application must describe the material to be decontaminated and the 
proposed self-implementing decontamination method and must include a

[[Page 588]]

proposed validation study to confirm performance of the method.
    (3) Any person wishing to sample decontaminated material in a manner 
other than prescribed in paragraph (f) of this section must apply in 
writing to the EPA Regional Administrator in the Region where the 
activity would take place, for decontamination activity occurring in a 
single EPA Region; or the Director of the National Program Chemicals 
Division, for decontamination activity occurring in more than one EPA 
Region. Each application must contain a description of the material to 
be decontaminated, the nature and PCB concentration of the contaminating 
material (if known), the decontamination method, the proposed sampling 
procedure, and a justification for how the proposed sampling is 
equivalent to or more comprehensive than the sampling procedure required 
under paragraph (f) of this section.
    (4) EPA may request additional information that it believes 
necessary to evaluate the application.
    (5) EPA will issue a written decision on each application for risk-
based decontamination or sampling. No person may conduct decontamination 
or sampling under this paragraph prior to obtaining written approval 
from EPA. EPA will approve an application if it finds that the proposed 
decontamination or sampling method will not pose an unreasonable risk of 
injury to health or the environment.

[63 FR 35457, June 29, 1998, as amended at 64 FR 33761, June 24, 1999]



                          Subpart E--Exemptions



Sec. 761.80  Manufacturing, processing and distribution in commerce exemptions.

    (a) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and distribute in commerce PCBs for use 
as a mounting medium in microscopy:
    (1) McCrone Accessories Components, Division of Walter C. McCrone 
Associates, Inc., 2820 South Michigan Avenue, Chicago, IL. 60616.
    (2) [Reserved]
    (b) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and distribute in commerce PCBs for use 
as a mounting medium in microscopy, an immersion oil in low fluorescence 
microscopy and an optical liquid:
    (1) R.P. Cargille Laboratories, Inc., 55 Commerce Road, Cedar Grove, 
N.J. 07009.
    (2) [Reserved]
    (c) The Administrator grants the following petitioner(s) an 
exemption for 1 year to export PCBs for use in small quantities for 
research and development:
    (1) Accu-Standard, New Haven, CT. 06503.
    (2) ManTech, Research Triangle Park, NC 27709.
    (d) The Administrator grants the following petitioner(s) an 
exemption for 1 year to import (manufacture) into the United States, 
small quantities of existing PCB fluids from electrical equipment for 
analysis:
    (1) Unison Transformer Services, Inc., Tarrytown, N.Y. 10591, 
provided each of the following conditions are met:
    (i) The samples must be shipped in 5.0 ml or less, hermetically 
sealed vials.
    (ii) The exemption is limited to no more than 250 total samples per 
year.
    (iii) Unison makes quarterly inspections of its laboratories to 
ensure that proper safety procedures are being followed.
    (iv) Unison annually notifies and describes to EPA its attempts to 
have samples analyzed abroad.
    (2) [Reserved]
    (e) The Administrator grants a class exemption to all research and 
development (R&D) facilities for a period of 1 year to manufacture or 
import PCBs for use solely in the manufacturer or importer's own 
research for the development of PCB disposal technologies. Each person 
that wishes to be part of the exemption must meet the following 
conditions:
    (1) A petition for an exemption from the PCB prohibition on 
manufacturing PCBs must be received by EPA 60 days prior to engaging in 
these activities.
    (2) Requests for renewal must be filed pursuant to Sec. 750.11 of 
this chapter. EPA will deem any properly filed request for the renewal 
of the exemption

[[Page 589]]

by any member of the class as a renewal request for the entire class.
    (3) The quantity of the PCBs manufactured annually must not exceed 
500 grams by total weight of pure PCBs. Any person who wishes to 
manufacture or import more than 500 grams of PCBs in 1 year must receive 
written approval from the Director, National Program Chemicals Division 
to exceed the limitations established by this provision. The Director, 
National Program Chemicals Division may grant approval without further 
rulemaking. Any increase granted will be in writing and will extend only 
for a maximum of the time remaining in a specific exemption year.
    (4) The owner or operator of the facility must notify the EPA 
Regional Administrator in writing 30 days prior to the commencement of 
R&D activities that include the manufacture or import of PCBs under the 
exemption, unless the facility has obtained a PCB R&D approval from EPA 
pursuant to Sec. 761.60(e), Sec. 761.60(i)(2), Sec. 761.70(a), or 
Sec. 761.70(b) and the approval contains a provision allowing the 
manufacture of PCBs.
    (5) Records are maintained of their PCB activities for a period of 3 
years after ceasing operations. The records must include the sources and 
the annual amounts of PCBs received if imported and the type and annual 
amount of PCBs that were manufactured.
    (6) All PCBs and materials containing PCBs, regardless of 
concentration, remaining from the disposal-related studies must be 
disposed of according to Sec. 761.60(j)(1)(vi), or decontaminated 
pursuant to Sec. 761.79, based on the original PCB concentration.
    (f) The Administrator grants the following petitioner(s) an 
exemption for 1 year to manufacture PCBs for use in small quantities for 
research and development:
    (1) California Bionuclear Corp., Sun Valley, CA 91352 (ME-13).
    (2) Foxboro Co., North Haven, CT 06473 (ME-6).
    (3) ULTRA-Scientific, Inc.,Hope, RI 02831 (ME-99.1).
    (4) Midwest Research Institute, Kansas City, MO 64110 (ME-70.1).
    (5) Pathfinder Laboratories, St. Louis, MO 63146 (A division of 
Sigma Aldridge Corporation, St. Louis, MO, 63178 (ME-76).
    (6) Radian Corp., Austin, TX 78766 (ME-81.2).
    (7) Wellington Sciences USA, College Station, TX 77840 (ME-104.1).
    (8) Accu-Standard, 25 Science Park, New Haven, CT. 06503.
    (g) The Administrator grants a class exemption to all processors and 
distributors of PCBs in small quantities for research and development 
provided that the following conditions are met:
    (1) All processors and distributors must maintain records of their 
PCB activities for a period of 5 years.
    (2) Any person or company which expects to process or distribute in 
commerce 100 grams (.22 lb) or more PCBs in 1 year must report to EPA 
identifying the sites of PCB activities and the quantity of PCBs to be 
processed or distributed in commerce.
    (h) The Administrator grants the following petitioners an exemption 
for 1 year to process and distribute in commerce PCBs for analytical 
reference samples derived from actual waste materials:
    (1) R.T. Corporation, Laramie, WY 82070.
    (2) [Reserved]
    (i) The Administrator grants a class exemption to all persons who 
manufacture, import, process, distribute in commerce, or export PCBs, or 
analytical reference samples derived from PCB waste material, provided 
the PCBs are manufactured, imported, processed, distributed in commerce, 
or exported solely for the purpose of R&D and the following conditions 
are met:
    (1) Notification in the form of a petition for an exemption from the 
PCB prohibitions on manufacture, import, processing, distribution in 
commerce, or export is received by EPA 60 days prior to engaging in 
these activities.
    (2) Requests for renewal are filed pursuant to Secs. 750.11 and 
750.31 of this chapter. EPA will deem any properly filed request for the 
renewal of the exemption by any member of the class as a renewal request 
for the entire class.
    (3) The PCBs are packaged in one or more hermetically sealed 
containers of a volume of no more than 5.0 ml each. Analytical reference 
samples derived

[[Page 590]]

from PCB waste material may be packaged in a container larger than 5.0 
ml when packaged pursuant to applicable DOT performance standards.
    (4) The quantity of PCBs manufactured, imported, processed, 
distributed in commerce, or exported annually must not exceed 500 grams 
by total weight of pure PCBs. Any person who expects to manufacture, 
import, process, distribute in commerce, or export more than 500 grams 
of PCBs in 1 year or to exceed the 5.0 ml packaging requirement must 
obtain a written approval from the Director, National Program Chemicals 
Division and must identify the sites of PCB activities and the quantity 
of PCBs to be manufactured, imported, processed, distributed in 
commerce, or exported. Each request must include a justification. The 
Director, National Program Chemicals Division, may grant approval 
without further rulemaking. Any increase granted will be in writing and 
will extend only for a maximum of the time remaining in a specific 
exemption year.
    (5) All treated and untreated PCB regulated material and material 
coming into contact with regulated material must be stored and disposed 
of according to subpart D of this part, or decontaminated pursuant to 
Sec. 761.79.
    (6) All PCB materials must be distributed in DOT-authorized 
packaging.
    (7) Records are maintained of their PCB activities for a period of 3 
years after ceasing operations. The records must include the sources and 
the annual amounts of PCBs received if imported, the annual amount of 
PCBs that were manufactured, the annual amount of PCBs that were 
processed and/or distributed in commerce (to include export), and the 
persons to whom the PCBs were shipped.
    (j)-(l) [Reserved]
    (m) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and export small quantities of PCBs for 
research and development:
    (1) Chem Service, Inc., West Chester, PA 19380 (PDE-41).
    (2) Foxboro Co., North Haven, CT 06473 (ME-6).
    (3) PolyScience Corp., Niles, IL 60648 (PDE-178).
    (4) ULTRA-Scientific, Inc., Hope, RI 02831 (PDE-282.1).
    (5) Supelco, Inc., Bellefonte, PA 16823-0048 (PDE-41.2).
    (6) Radian Corp., Austin, TX 78766 (PDE-182.1).
    (7) Restek Corporation, Bellefonte, PA
    (n) The 1-year exemption granted to petitioners in paragraphs (a) 
through (c)(1), (d), (f), and (m)(1) through (m)(6) of this section 
shall be renewed automatically as long as there is no increase in the 
amount of PCBs to be processed and distributed, imported (manufactured), 
or exported, nor any change in the manner of processing and 
distributing, importing (manufacturing), or exporting of PCBs. If there 
is such a change, a new exemption petition must be submitted to EPA and 
it will be addressed through an exemption rulemaking. In such a case, 
the activities granted under the existing exemption may continue until 
the new petition is addressed by rulemaking, but must conform to the 
terms of the existing exemption approved by EPA. The 1-year exemption 
granted to petitioners in paragraphs (c)(2), (h) and (m)(7) of this 
section may be extended pursuant to 40 CFR 750.11(e) or 750.31(e).
    (o) The 1-year class exemption granted to all processors and 
distributors of PCBs in small quantities for research and development in 
paragraph (g) of this section shall be renewed automatically unless 
information is submitted affecting EPA's conclusion that the class 
exemption, or the activities of any individual or company included in 
the exemption, will not pose an unreasonable risk of injury to health or 
the environment. EPA will evaluate the information, issue a proposed 
rule for public comment, and issue a final rule affecting the class 
exemption or individuals or companies included in the class exemption. 
Until EPA issues a final rule, individuals and companies included in the 
class exemption will be allowed to continue processing and distributing 
PCBs in small quantities for research and development.

[55 FR 38999, Sept. 24, 1990, as amended at 59 FR 16998, Apr. 11, 1994; 
63 FR 35460, June 29, 1998]

[[Page 591]]



         Subpart F--Transboundary Shipments of PCBs for Disposal

    Source: 61 FR 11107, Mar. 18, 1996, unless otherwise noted.



Sec.  761.91  Applicability.

    This subpart establishes requirements under section 6 of TSCA 
applicable to the transboundary shipments of PCBs and PCB Items into and 
out of the United States for disposal. Nothing in this subpart is 
intended to obviate or otherwise alter obligations applicable to 
imported or exported PCBs and PCB Items under foreign laws, 
international agreements or arrangements, other United States statutes 
and regulations, other sections of TSCA (e.g., sections 13 and 14), or 
laws of the various States of the United States. No provision of this 
section shall be construed to affect or limit the applicability of any 
requirement applicable to transporters of PCB waste under regulations 
issued by the U.S. Department of Transportation (DOT) and set forth at 
49 CFR parts 171-180.



Sec. 761.93   Import for disposal.

    (a) General provisions. No person may import PCBs or PCB Items for 
disposal without an exemption issued under the authority of TSCA section 
6(e)(3).
    (b) [Reserved]

[63 FR 35460, June 29, 1998]



Sec.  761.97  Export for disposal.

    (a) General provisions. No person may export PCBs or PCB Items for 
disposal without an exemption, except that:
    (1) PCBs and PCB Items at concentrations <50 ppm (or <10 g 
PCB/100 cm2 if no free-flowing liquids are present) may be 
exported for disposal.
    (2) For the purposes of this section, PCBs and PCB Items of unknown 
concentrations shall be treated as if they contain 50 ppm.
    (b) [Reserved]

[61 FR 11107, Mar. 18, 1996, as amended at 63 FR 35460, June 29, 1998]



Sec. 761.99   Other transboundary shipments.

    For purposes of this subpart, the following transboundary shipments 
are not considered exports or imports:
    (a) PCB waste generated in the United States, transported outside 
the Customs Territory of the United States (including any residuals 
resulting from cleanup of spills of such wastes in transit) through 
another country or its territorial waters, or through international 
waters, and returned to the United States for disposal.
    (b) PCB waste in transit, including any residuals resulting from 
cleanup of spills during transit, through the United States (e.g., from 
Mexico to Canada, from Canada to Mexico).

[63 FR 35461, June 29, 1998]



                   Subpart G--PCB Spill Cleanup Policy

    Source: 52 FR 10705, Apr. 2, 1987, unless otherwise noted.



Sec. 761.120  Scope.

    (a) General. This policy establishes criteria EPA will use to 
determine the adequacy of the cleanup of spills resulting from the 
release of materials containing PCBs at concentrations of 50 ppm or 
greater. The policy applies to spills which occur after May 4, 1987.
    (1) Existing spills (spills which occurred prior to May 4, 1987, are 
excluded from the scope of this policy for two reasons:
    (i) For old spills which have already been discovered, this policy 
is not intended to require additional cleanup where a party has already 
cleaned a spill in accordance with requirements imposed by EPA through 
its regional offices, nor is this policy intended to interfere with 
ongoing litigation of enforcement actions which bring into issue PCB 
spills cleanup.
    (ii) EPA recognizes that old spills which are discovered after the 
effective date of this policy will require site-by-site evaluation 
because of the likelihood that the site involves more pervasive PCB 
contamination than fresh

[[Page 592]]

spills and because old spills are generally more difficult to clean up 
than fresh spills (particularly on porous surfaces such as concrete). 
Therefore, spills which occurred before the effective date of this 
policy are to be decontaminated to requirements established at the 
discretion of EPA, usually through its regional offices.
    (2) EPA expects most PCB spills subject to the TSCA PCB regulations 
to conform to the typical spill situations considered in developing this 
policy. This policy does, however, exclude from application of the final 
numerical cleanup standards certain spill situations from its scope: 
Spills directly into surface waters, drinking water, sewers, grazing 
lands, and vegetable gardens. These types of spills are subject to final 
cleanup standards to be established at the discretion of the regional 
office. These spills are, however, subject to the immediate notification 
requirements and measures to minimize further environmental 
contamination.
    (3) For all other spills, EPA generally expects the decontamination 
standards of this policy to apply. Occasionally, some small percentage 
of spills covered by this policy may warrant more stringent cleanup 
requirements because of additional routes of exposure or significantly 
greater exposures than those assumed in developing the final cleanup 
standards of this policy. While the EPA regional offices have the 
authority to require additional cleanup in these circumstances, the 
Regional Administrator must first make a finding based on the specific 
facts of a spill that additional cleanup must occur to prevent 
unreasonable risk. In addition, before a final decision is made to 
require additional cleanup, the Regional Administrator must notify the 
Director, Office of Pollution Prevention and Toxics at Headquarters of 
his/her finding and the basis for the finding.
    (4) There may also be exceptional spill situations that requires 
less stringent cleanup or a different approach to cleanup because of 
factors associated with the particular spill. These factors may mitigate 
expected exposures and risks or make cleanup to these requirements 
impracticable.
    (b) Spills that may require more stringent cleanup levels. For 
spills within the scope of this policy, EPA generally retains, under 
Sec. 761.135, the authority to require additional cleanup upon finding 
that, despite good faith efforts by the responsible party, the numerical 
decontamination levels in the policy have not been met. In addition, EPA 
foresees the possibility of exceptional spill situations in which site-
specific risk factors may warrant additional cleanup to more stringent 
numerical decontamination levels than are required by the policy. In 
these situations, the Regional Administrator has the authority to 
require cleanup to levels lower than those included in this policy upon 
finding that further cleanup must occur to prevent unreasonable risk. 
The Regional Administrator will consult with the Director, Office of 
Pollution Prevention and Toxics, prior to making such a finding.
    (1) For example, site-specific characteristics, such as short depth 
to ground water, type of soil, or the presence of a shallow well, may 
pose exceptionally high potential for ground water contamination by PCBs 
remaining after cleanup to the standards specified in this policy. 
Spills that pose such a high degree of potential for ground water 
contamination have not been excluded from the policy under paragraph (d) 
of this section because the presence of such potential may not be 
readily apparent. EPA feels that automatically excluding such spills 
from the scope of the policy could result in the delay of cleanup--a 
particularly undesirable outcome if potential ground water contamination 
is, in fact, a significant concern.
    (2) In those situations, the Regional Administrator may require 
cleanup in addition to that required under Sec. 761.125 (b) and (c). 
However, the Regional Administrator must first make a finding, based on 
the specific facts of a spill, that additional cleanup is necessary to 
prevent unreasonable risk. In addition, before making a final decision 
on additional cleanup, the Regional Administrator must notify the 
Director of the Office of Pollution Prevention and Toxics of his finding 
and the basis for the finding.

[[Page 593]]

    (c) Flexibility to allow less stringent or alternative requirements. 
EPA retains the flexibility to allow less stringent or alternative 
decontamination measures based upon site-specific considerations. EPA 
will exercise this flexibility if the responsible party demonstrates 
that cleanup to the numerical decontamination levels is clearly 
unwarranted because of risk-mitigating factors, that compliance with the 
procedural requirements or numerical standards in the policy is 
impracticable at a particular site, or that site-specific 
characteristics make the costs of cleanup prohibitive. The Regional 
Administrator will notify the Director of OPPT of any decision and the 
basis for the decision to allow less stringent cleanup. The purpose of 
this notification is to enable the Director of OPPT to ensure 
consistency of spill cleanup standards under special circumstances 
across the regions.
    (d) Excluded spills. (1) Although the spill situations in paragraphs 
(d)(2) (i) through (vi) of this section are excluded from the automatic 
application of final decontamination standards under Sec. 761.125 (b) 
and (c), the general requirements under Sec. 761.125(a) do apply to 
these spills. In addition, all of these excluded situations require 
practicable, immediate actions to contain the area of contamination. 
While these situations may not always require more stringent cleanup 
measures, the Agency is excluding these scenarios because they will 
always involve significant factors that may not be adequately addressed 
by cleanup standards based upon typical spill characteristics.
    (2) For the spill situations in paragraphs (d)(2)(i) through (vi) of 
this section, the responsible party shall decontaminate the spill in 
accordance with site-specific requirements established by the EPA 
regional offices.
    (i) Spills that result in the direct contamination of surface waters 
(surface waters include, but are not limited to, ``waters of the United 
States'' as defined in part 122 of this chapter, ponds, lagoons, 
wetlands, and storage reservoirs).
    (ii) Spills that result in the direct contamination of sewers or 
sewage treatment systems.
    (iii) Spills that result in the direct contamination of any private 
or public drinking water sources or distribution systems.
    (iv) Spills which migrate to and contaminate surface waters, sewers, 
or drinking water supplies before cleanup has been completed in 
accordance with this policy.
    (v) Spills that contaminate animal grazing lands.
    (vi) Spills that contaminate vegetable gradens.
    (e) Relationship of policy to other statutes. (1) This policy does 
not affect cleanup standards or requirements for the reporting of spills 
imposed, or to be imposed, under other Federal statutory authorities, 
including but not limited to, the Clean Water Act (CWA), the Resource 
Conservation and Recovery Act (RCRA), and the Comprehensive 
Environmental Response Compensation and Liability Act of 1980 (CERCLA) 
as amended by the Superfund Amendments and Reauthorization Act (SARA). 
Where more than one requirement applies, the stricter standard must be 
met.
    (2) The Agency recognizes that the existence of this policy will 
inevitably result in attempts to apply the standards to situations 
within the scope of other statutory authorities. However, other statutes 
require the Agency to consider different or alternative factors in 
determining appropriate corrective actions. In addition, the types and 
magnitudes of exposures associated with sites requiring corrective 
action under other statutes often involve important differences from 
those expected of the typical, electrical equipment-type spills 
considered in developing this policy. Thus, cleanups under other 
statutes, such as RCRA corrective actions or remedial and response 
actions under SARA may result in different outcomes.



Sec. 761.123  Definitions.

    For purposes of this policy, certain words and phrases are used to 
denote specific materials, procedures, or circumstances. The following 
definitions are provided for purposes of clarity and are not to be taken 
as exhaustive lists of situations and materials covered by the policy.

[[Page 594]]

    Double wash/rinse means a minimum requirement to cleanse solid 
surfaces (both impervious and nonimpervious) two times with an 
appropriate solvent or other material in which PCBs are at least 5 
percent soluble (by weight). A volume of PCB-free fluid sufficient to 
cover the contaminated surface completely must be used in each wash/
rinse. The wash/rinse requirement does not mean the mere spreading of 
solvent or other fluid over the surface, nor does the requirement mean a 
once-over wipe with a soaked cloth. Precautions must be taken to contain 
any runoff resulting from the cleansing and to dispose properly of 
wastes generated during the cleansing.
    High-concentration PCBs means PCBs that contain 500 ppm or greater 
PCBs, or those materials which EPA requires to be assumed to contain 500 
ppm or greater PCBs in the absence of testing.
    High-contact industrial surface means a surface in an industrial 
setting which is repeatedly touched, often for relatively long periods 
of time. Manned machinery and control panels are examples of high-
contact industrial surfaces. High-contact industrial surfaces are 
generally of impervious solid material. Examples of low-contact 
industrial surfaces include ceilings, walls, floors, roofs, roadways and 
sidewalks in the industrial area, utility poles, unmanned machinery, 
concrete pads beneath electrical equipment, curbing, exterior structural 
building components, indoor vaults, and pipes.
    High-contact residential/commercial surface means a surface in a 
residential/commercial area which is repeatedly touched, often for 
relatively long periods of time. Doors, wall areas below 6 feet in 
height, uncovered flooring, windowsills, fencing, bannisters, stairs, 
automobiles, and children's play areas such as outdoor patios and 
sidewalks are examples of high-contact residential/commercial surfaces. 
Examples of low-contact residential/commercial surfaces include interior 
ceilings, interior wall areas above 6 feet in height, roofs, asphalt 
roadways, concrete roadways, wooden utility poles, unmanned machinery, 
concrete pads beneath electrical equipment, curbing, exterior structural 
building components (e.g., aluminum/vinyl siding, cinder block, asphalt 
tiles), and pipes.
    Impervious solid surfaces means solid surfaces which are nonporous 
and thus unlikely to absorb spilled PCBs within the short period of time 
required for cleanup of spills under this policy. Impervious solid 
surfaces include, but are not limited to, metals, glass, aluminum 
siding, and enameled or laminated surfaces.
    Low-concentration PCBs means PCBs that are tested and found to 
contain less than 500 ppm PCBs, or those PCB-containing materials which 
EPA requires to be assumed to be at concentrations below 500 ppm (i.e., 
untested mineral oil dielectric fluid).
    Nonimpervious solid surfaces means solid surfaces which are porous 
and are more likely to absorb spilled PCBs prior to completion of the 
cleanup requirements prescribed in this policy. Nonimpervious solid 
surfaces include, but are not limited to, wood, concrete, asphalt, and 
plasterboard.
    Nonrestricted access areas means any area other than restricted 
access, outdoor electrical substations, and other restricted access 
locations, as defined in this section. In addition to residential/
commercial areas, these areas include unrestricted access rural areas 
(areas of low density development and population where access is 
uncontrolled by either man-made barriers or naturally occurring 
barriers, such as rough terrain, mountains, or cliffs).
    Other restricted access (nonsubstation) locations means areas other 
than electrical substations that are at least 0.1 kilometer (km) from a 
residential/commercial area and limited by man-made barriers (e.g., 
fences and walls) to substantially limited by naturally occurring 
barriers such as mountains, cliffs, or rough terrain. These areas 
generally include industrial facilities and extremely remote rural 
locations. (Areas where access is restricted but are less than 0.1 km 
from a residential/commercial area are considered to be residential/
commercial areas.)
    Outdoor electrical substations means outdoor, fenced-off, and 
restricted access areas used in the transmission and/or distribution of 
electrical power Outdoor electrical substations restrict public access 
by being fenced or walled

[[Page 595]]

off as defined under Sec. 761.30(l)(1)(ii). For purposes of this TSCA 
policy, outdoor electrical substations are defined as being located at 
least 0.1 km from a residential/commercial area. Outdoor fenced-off and 
restricted access areas used in the transmission and/or distribution of 
electrical power which are located less than 0.1. km from a residential/
commercial area are considered to be residential/commercial areas.
    PCBs means polychlorinated biphenyls as defined under Sec. 761.3. As 
specified under Sec. 761.1(b), no requirements may be avoided through 
dilution of the PCB concentration.
    Requirements and standards means:
    (1) ``Requirements'' as used in this policy refers to both the 
procedural responses and numerical decontamination levels set forth in 
this policy as constituting adequate cleanup of PCBs.
    (2) ``Standards'' refers to the numerical decontamination levels set 
forth in this policy.
    Residential/commercial areas means those areas where people live or 
reside, or where people work in other than manufacturing or farming 
industries. Residential areas include housing and the property on which 
housing is located, as well as playgrounds, roadways, sidewalks, parks, 
and other similar areas within a residential community. Commercial areas 
are typically accessible to both members of the general public and 
employees and include public assembly properties, institutional 
properties, stores, office buildings, and transportation centers.
    Responsible party means the owner of the PCB equipment, facility, or 
other source of PCBs or his/her designated agent (e.g., a facility 
manager or foreman).
    Soil means all vegetation, soils and other ground media, including 
but not limited to, sand, grass, gravel, and oyster shells. It does not 
include concrete and asphalt.
    Spill means both intentional and unintentional spills, leaks, and 
other uncontrolled discharges where the release results in any quantity 
of PCBs running off or about to run off the external surface of the 
equipment or other PCB source, as well as the contamination resulting 
from those releases. This policy applies to spills of 50 ppm or greater 
PCBs. The concentration of PCBs spilled is determined by the PCB 
concentration in the material spilled as opposed to the concentration of 
PCBs in the material onto which the PCBs were spilled. Where a spill of 
untested mineral oil occurs, the oil is presumed to contain greater than 
50 ppm, but less than 500 ppm PCBs and is subject to the relevant 
requirements of this policy.
    Spill area means the area of soil on which visible traces of the 
spill can be observed plus a buffer zone of 1 foot beyond the visible 
traces. Any surface or object (e.g., concrete sidewalk or automobile) 
within the visible traces area or on which visible traces of the spilled 
material are observed is included in the spill area. This area 
represents the minimum area assumed to be contaminated by PCBs in the 
absence of precleanup sampling data and is thus the minimum area which 
must be cleaned.
    Spill boundaries means the actual area of contamination as 
determined by postcleanup verification sampling or by precleanup 
sampling to determine actual spill boundaries. EPA can require 
additional cleanup when necessary to decontaminate all areas within the 
spill boundaries to the levels required in this policy (e.g., additional 
cleanup will be required if postcleanup sampling indicates that the area 
decontaminated by the responsible party, such as the spill area as 
defined in this section, did not encompass the actual boundaries of PCB 
contamination).
    Standard wipe test means, for spills of high-concentration PCBs on 
solid surfaces, a cleanup to numerical surface standards and sampling by 
a standard wipe test to verify that the numerical standards have been 
met. This definition constitutes the minimum requirements for an 
appropriate wipe testing protocol. A standard-size template (10 
centimeters (cm) x 10 cm) will be used to delineate the area of cleanup; 
the wiping medium will be a gauze pad or glass wool of known size which 
has been saturated with hexane. It is important that the wipe be 
performed very quickly after the hexane is exposed to air. EPA strongly 
recommends that the gauze (or glass wool) be prepared with hexane in the 
laboratory

[[Page 596]]

and that the wiping medium be stored in sealed glass vials until it is 
used for the wipe test. Further, EPA requires the collection and testing 
of field blanks and replicates.

[52 FR 10705, Apr. 2, 1987; 52 FR 23397, June 19, 1987]



Sec. 761.125  Requirements for PCB spill cleanup.

    (a) General. Unless expressly limited, the reporting, disposal, and 
precleanup sampling requirements in paragraphs (a) (1) through (3) of 
this section apply to all spills of PCBs at concentrations of 50 ppm or 
greater which are subject to decontamination requirements under TSCA, 
including those spills listed under Sec. 761.120(b) which are excluded 
from the cleanup standards at paragraphs (b) and (c) of this section.
    (1) Reporting requirements. The reporting in paragraphs (a)(1) (i) 
through (iv) of this section is required in addition to applicable 
reporting requirements under the Clean Water Act (CWA) or the 
Comprehensive Environmental Response Compensation and Liability Act of 
1980 (CERCLA). For example, under the National Contingency Plan all 
spills involving 1 pound or more by weight of PCBs must currently be 
reported to the National Response Center (1-800-424-8802). The 
requirements in paragraphs (a)(1) (i) through (iv) of this section are 
designed to be consistent with existing reporting requirements to the 
extent possible so as to minimize reporting burdens on governments as 
well as the regulated community.
    (i) Where a spill directly contaminates surface water, sewers, or 
drinking water supplies, as discussed under Sec. 761.120(d), the 
responsible party shall notify the appropriate EPA regional office (the 
Office of Prevention, Pesticides and Toxic Substances Branch) and obtain 
guidance for appropriate cleanup measures in the shortest possible time 
after discovery, but in no case later than 24 hours after discovery.
    (ii) Where a spill directly contaminates grazing lands or vegetable 
gardens, as discussed under Sec. 761.120(d), the responsible party shall 
notify the appropriate EPA regional office (the Office of Prevention, 
Pesticides and Toxic Substances Branch) and proceed with the immediate 
requirements specified under paragraph (b) or (c) of this section, 
depending on the source of the spill, in the shortest possible time 
after discovery, but in no case later than 24 hours after discovery.
    (iii) Where a spill exceeds 10 pounds of PCBs by weight and is not 
addressed in paragraph (a)(1) (i) or (ii) of this section, the 
responsible party will notify the appropriate EPA regional office 
(Pesticides and Toxic Substances Branch) and proceed to decontaminate 
the spill area in accordance with this TSCA policy in the shortest 
possible time after discovery, but in no case later than 24 hours after 
discovery.
    (iv) Spills of 10 pounds or less, which are not addressed in 
paragraph (a)(1) (i) or (ii) of this section, must be cleaned up in 
accordance with this policy (in order to avoid EPA enforcement 
liability), but notification of EPA is not required.
    (2) Disposal of cleanup debris and materials. All concentrated 
soils, solvents, rags, and other materials resulting from the cleanup of 
PCBs under this policy shall be properly stored, labeled, and disposed 
of in accordance with the provisions of subpart D of this part.
    (3) Determination of spill boundaries in the absence of visible 
traces. For spills where there are insufficient visible traces yet there 
is evidence of a leak or spill, the boundaries of the spill are to be 
determined by using a statistically based sampling scheme.
    (b) Requirements for cleanup of low-concentration spills which 
involve less than 1 pound of PCBs by weight (less than 270 gallons of 
untested mineral oil)--(1) Decontamination requirements. Spills of less 
than 270 gallons of untested mineral oil, low-concentration PCBs, as 
defined under Sec. 761.123, which involve less than 1 pound of PCBs by 
weight (e.g., less than 270 gallons of untested mineral oil containing 
less than 500 ppm PCBs) shall be cleaned in the following manner:
    (i) Solid surfaces must be double washed/rinsed (as defined under 
Sec. 761.123); except that all indoor, residential surfaces other than 
vault areas must be cleaned to 10 micrograms per 100 square centimeters 
(10  g/100 cm2) by standard commercial wipe tests.

[[Page 597]]

    (ii) All soil within the spill area (i.e., visible traces of soil 
and a buffer of 1 lateral foot around the visible traces) must be 
excavated, and the ground be restored to its original configuration by 
back-filling with clean soil (i.e., containing less than 1 ppm PCBs).
    (iii) Requirements of paragraphs (b)(1) (i) and (ii) of this section 
must be completed within 48 hours after the responsible party was 
notified or became aware of the spill.
    (2) Effect of emergency or adverse weather. Completion of cleanup 
may be delayed beyond 48 hours in case of circumstances including but 
not limited to, civil emergency, adverse weather conditions, lack of 
access to the site, and emergency operating conditions. The occurrence 
of a spill on a weekend or overtime costs are not acceptable reasons to 
delay response. Completion of cleanup may be delayed only for the 
duration of the adverse conditions. If the adverse weather conditions, 
or time lapse due to other emergency, has left insufficient visible 
traces, the responsible party must use a statistically based sampling 
scheme to determine the spill boundaries as required under paragraph 
(a)(3) of this section.
    (3) Records and certification. At the completion of cleanup, the 
responsible party shall document the cleanup with records and 
certification of decontamination. The records and certification must be 
maintained for a period of 5 years. The records and certification shall 
consist of the following:
    (i) Identification of the source of the spill (e.g., type of 
equipment).
    (ii) Estimated or actual date and time of the spill occurrence.
    (iii) The date and time cleanup was completed or terminated (if 
cleanup was delayed by emergency or adverse weather: the nature and 
duration of the delay).
    (iv) A brief description of the spill location.
    (v) Precleanup sampling data used to establish the spill boundaries 
if required because of insufficient visible traces, and a brief 
description of the sampling methodology used to establish the spill 
boundaries.
    (vi) A brief description of the solid surfaces cleaned and of the 
double wash/rinse method used.
    (vii) Approximate depth of soil excavation and the amount of soil 
removed.
    (viii) A certification statement signed by the responsible party 
stating that the cleanup requirements have been met and that the 
information contained in the record is true to the best of his/her 
knowledge.
    (ix) While not required for compliance with this policy, the 
following information would be useful if maintained in the records:
    (A) Additional pre- or post-cleanup sampling.
    (B) The estimated cost of the cleanup by man-hours, dollars, or 
both.
    (c) Requirements for cleanup of high-concentration spills and low-
concentration spills involving 1 pound or more PCBs by weight (270 
gallons or more of untested mineral oil). Cleanup of low-concentration 
spills involving 1 lb or more PCBs by weight and of all spills of 
materials other than low-concentration materials shall be considered 
complete if all of the immediate requirements, cleanup standards, 
sampling, and recordkeeping requirements of paragraphs (c) (1) through 
(5) of this section are met.
    (1) Immediate requirements. The four actions in paragraphs (c)(1) 
(i) through (iv) of this section must be taken as quickly as possible 
and within no more than 24 hours (or within 48 hours for PCB 
Transformers) after the responsible party was notified or became aware 
of the spill, except that actions described in paragraphs (c)(1) (ii) 
through (iv) of this section can be delayed beyond 24 hours if 
circumstances (e.g., civil emergency, hurricane, tornado, or other 
similar adverse weather conditions, lack of access due to physical 
impossibility, or emergency operating conditions) so require for the 
duration of the adverse conditions. The occurrence of a spill on a 
weekend or overtime costs are not acceptable reasons to delay response. 
Owners of spilled PCBs who have delayed cleanup because of these types 
of circumstances must keep records documenting the fact that 
circumstances precluded rapid response.
    (i) The responsible party shall notify the EPA regional office and 
the NRC as required by Sec. 761.125(a)(1) or by other applicable 
statutes.

[[Page 598]]

    (ii) The responsible party shall effectively cordon off or otherwise 
delineate and restrict an area encompassing any visible traces plus a 3-
foot buffer and place clearly visible signs advising persons to avoid 
the area to minimize the spread of contamination as well as the 
potential for human exposure.
    (iii) The responsible party shall record and document the area of 
visible contamination, noting the extent of the visible trace areas and 
the center of the visible trace area. If there are no visible traces, 
the responsible party shall record this fact and contact the regional 
office of the EPA for guidance in completing statistical sampling of the 
spill area to establish spill boundaries.
    (iv) The responsible party shall initiate cleanup of all visible 
traces of the fluid on hard surfaces and initiate removal of all visible 
traces of the spill on soil and other media, such as gravel, sand, 
oyster shells, etc.
    (v) If there has been a delay in reaching the site and there are 
insufficient visible traces of PCBs remaining at the spill site, the 
responsible party must estimate (based on the amount of material missing 
from the equipment or container) the area of the spill and immediately 
cordon off the area of suspect contamination. The responsible party must 
then utilize a statistically based sampling scheme to identify the 
boundaries of the spill area as soon as practicable.
    (vi) Although this policy requires certain immediate actions, as 
described in paragraphs (c)(1)(i) through (iv) of this section, EPA is 
not placing a time limit on completion of the cleanup effort since the 
time required for completion will vary from case to case. However, EPA 
expects that decontamination will be achieved promptly in all cases and 
will consider promptness of completion in determining whether the 
responsible party made good faith efforts to clean up in accordance with 
this policy.
    (2) Requirements for decontaminating spills in outdoor electrical 
substations. Spills which occur in outdoor electrical substations, as 
defined under Sec. 761.123, shall be decontaminated in accordance with 
paragraphs (c)(2) (i) and (ii) of this section. Conformance to the 
cleanup standards under paragraphs (c)(2) (i) and (ii) of this section 
shall be verified by post-cleanup sampling as specified under 
Sec. 761.130. At such times as outdoor electrical substations are 
converted to another use, the spill site shall be cleaned up to the 
nonrestricted access requirements under paragraph (c)(4) of this 
section.
    (i) Contaminated solid surfaces (both impervious and non-impervious) 
shall be cleaned to a PCB concentration of 100 micrograms ( g)/
100 square centimeters (cm\2\) (as measured by standard wipe tests).
    (ii) At the option of the responsible party, soil contaminated by 
the spill will be cleaned either to 25 ppm PCBs by weight, or to 50 ppm 
PCBs by weight provided that a label or notice is visibly placed in the 
area. Upon demonstration by the responsible party that cleanup to 25 ppm 
or 50 ppm will jeopardize the integrity of the electrical equipment at 
the substation, the EPA regional office may establish an alternative 
cleanup method or level and place the responsible party on a reasonably 
timely schedule for completion of cleanup.
    (3) Requirements for decontaminating spills in other restricted 
access areas. Spills which occur in restricted access locations other 
than outdoor electrical substations, as defined under Sec. 761.123, 
shall be decontaminated in accordance with paragraphs (c)(3) (i) through 
(v) of this section. Conformance to the cleanup standards in paragraphs 
(c)(3) (i) through (v) of this section shall be verified by postcleanup 
sampling as specified under Sec. 761.130. At such times as restricted 
access areas other than outdoor electrical substations are converted to 
another use, the spill site shall be cleaned up to the nonrestricted 
access area requirements of paragraph (c)(4) of this section.
    (i) High-contact solid surfaces, as defined under Sec. 761.163 shall 
be cleaned to 10  g/100 cm\2\ (as measured by standard wipe 
tests).
    (ii) Low-contact, indoor, impervious solid surfaces will be 
decontaminated to 10  g/100 cm\2\.
    (iii) At the option of the responsible party, low-contact, indoor, 
nonimpervious surfaces will be cleaned either to 10

[[Page 599]]

 g/100 cm\2\ or to 100  g/100 cm\2\ and encapsulated. 
The Regional Administrator, however, retains the authority to disallow 
the encapsulation option for a particular spill situation upon finding 
that the uncertainties associated with that option pose special concerns 
at that site. That is, the Regional Administrator would not permit 
encapsulation if he/she determined that if the encapsulation failed the 
failure would create an imminent hazard at the site.
    (iv) Low-contact, outdoor surfaces (both impervious and 
nonimpervious) shall be cleaned to 100 g/100 cm\2\.
    (v) Soil contaminated by the spill will be cleaned to 25 ppm PCBs by 
weight.
    (4) Requirements for decontaminating spills in nonrestricted access 
areas. Spills which occur in nonrestricted access locations, as defined 
under Sec. 761.123, shall be decontaminated in accordance with 
paragraphs (c)(4) (i) through (v) of this section. Conformance to the 
cleanup standards at paragraphs (c)(4) (i) through (v) of this section 
shall be verified by postcleanup sampling as specified under 
Sec. 761.130.
    (i) Furnishings, toys, and other easily replaceable household items 
shall be disposed of in accordance with the provisions of subpart D of 
this part and replaced by the responsible party.
    (ii) Indoor solid surfaces and high-contact outdoor solid surfaces, 
defined as high contact residential/commercial surfaces under 
Sec. 761.123, shall be cleaned to 10  g/100 cm\2\ (as measured 
by standard wipe tests).
    (iii) Indoor vault areas and low-contact, outdoor, impervious solid 
surfaces shall be decontaminated to 10  g/100 cm\2\.
    (iv) At the option of the responsible party, low-contact, outdoor, 
nonimpervious solid surfaces shall be either cleaned to 10  g/
100 cm\2\ or cleaned to 100  g/100 cm\2\ and encapsulated. The 
Regional Administrator, however, retains the authority to disallow the 
encapsulation option for a particular spill situation upon finding that 
the uncertainties associated with that option pose special concerns at 
that site. That is, the Regional Administrator would not permit 
encapsulation if he/she determined that if the encapsulation failed the 
failure would create an imminent hazard at the site.
    (v) Soil contaminated by the spill will be decontaminated to 10 ppm 
PCBs by weight provided that soil is excavated to a minimum depth of 10 
inches. The excavated soil will be replaced with clean soil, i.e., 
containing less than 1 ppm PCBs, and the spill site will be restored 
(e.g., replacement of turf).
    (5) Records. The responsible party shall document the cleanup with 
records of decontamination. The records must be maintained for a period 
of 5 years. The records and certification shall consist of the 
following:
    (i) Identification of the source of the spill, e.g., type of 
equipment.
    (ii) Estimated or actual date and time of the spill occurrence.
    (iii) The date and time cleanup was completed or terminated (if 
cleanup was delayed by emergency or adverse weather: the nature and 
duration of the delay).
    (iv) A brief description of the spill location and the nature of the 
materials contaminated. This information should include whether the 
spill occurred in an outdoor electrical substation, other restricted 
access location, or in a nonrestricted access area.
    (v) Precleanup sampling data used to establish the spill boundaries 
if required because of insufficient visible traces and a brief 
description of the sampling methodology used to establish the spill 
boundaries.
    (vi) A brief description of the solid surfaces cleaned.
    (vii) Approximate depth of soil excavation and the amount of soil 
removed.
    (viii) Postcleanup verification sampling data and, if not otherwise 
apparent from the documentation, a brief description of the sampling 
methodology and analytical technique used.
    (ix) While not required for compliance with this policy, information 
on the estimated cost of cleanup (by man-hours, dollars, or both) would 
be useful if maintained in the records.

[52 FR 10705, Apr. 2, 1987, as amended at 53 FR 40884, Oct. 19, 1988; 63 
FR 35461, June 29, 1998]



Sec. 761.130  Sampling requirements.

    Postcleanup sampling is required to verify the level of cleanup 
under

[[Page 600]]

Sec. 761.125(c) (2) through (4). The responsible party may use any 
statistically valid, reproducible, sampling scheme (either random 
samples or grid samples) provided that the requirements of paragraphs 
(a) and (b) of this section are satisfied.
    (a) The sampling area is the greater of (1) an area equal to the 
area cleaned plus an additional 1-foot boundary, or (2) an area 20 
percent larger than the original area of contamination.
    (b) The sampling scheme must ensure 95 percent confidence against 
false positives.
    (c) The number of samples must be sufficient to ensure that areas of 
contamination of a radius of 2 feet or more within the sampling area 
will be detected, except that the minimum number of samples is 3 and the 
maximum number of samples is 40.
    (d) The sampling scheme must include calculation for expected 
variability due to analytical error.
    (e) EPA recommends the use of a sampling scheme developed by the 
Midwest Research Institute (MRI) for use in EPA enforcement inspections: 
``Verification of PCB Spill Cleanup by Sampling and Analysis.'' Guidance 
for the use of this sampling scheme is available in the MRI report 
``Field Manual for Grid Sampling of PCB Spill Sites to Verify Cleanup.'' 
Both the MRI sampling scheme and the guidance document are available 
from the Director, Environmental Assistance Division (7408), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room E-543B, 401 M St., SW., Washington, DC, 20460, Telephone: (202) 
554-1404, TDD: (202) 544-0551. The major advantage of this sampling 
scheme is that it is designed to characterize the degree of 
contamination within the entire sampling area with a high degree of 
confidence while using fewer samples than any other grid or random 
sampling scheme. This sampling scheme also allows some sites to be 
characterized on the basis of composite samples.
    (f) EPA may, at its discretion, take samples from any spill site. If 
EPA's sampling indicates that the remaining concentration level exceeds 
the required level, EPA will require further cleanup. For this purpose, 
the numerical level of cleanup required for spills cleaned in accordance 
with Sec. 761.125(b) is deemed to be the equivalent of numerical cleanup 
requirements required for cleanups under Sec. 761.125(c) (2) through 
(4). Using its best engineering judgment, EPA may sample a statistically 
valid random or grid sampling technique, or both. When using engineering 
judgment or random ``grab'' samples, EPA will take into account that 
there are limits on the power of a grab sample to dispute statistically 
based sampling of the type required of the responsible party. EPA 
headquarters will provide guidance to the EPA regions on the degree of 
certainty associated with various grab sample results.

[52 FR 10705, Apr. 2, 1987, as amended at 60 FR 34465, July 3, 1995]



Sec. 761.135  Effect of compliance with this policy and enforcement.

    (a) Although a spill of material containing 50 ppm or greater PCBs 
is considered improper PCB disposal, this policy establishes 
requirements that EPA considers to be adequate cleanup of the spilled 
PCBs. Cleanup in accordance with this policy means compliance with the 
procedural as well as the numerical requirements of this policy. 
Compliance with this policy creates a presumption against both 
enforcement action for penalties and the need for further cleanup under 
TSCA. The Agency reserves the right, however, to initiate appropriate 
action to compel cleanup where, upon review of the records of cleanup or 
EPA sampling following cleanup, EPA finds that the decontamination 
levels in the policy have not been achieved. The Agency also reserves 
the right to seek penalties where the Agency believes that the 
responsible party has not made a good faith effort to comply with all 
provisions of this policy, such as prompt notification of EPA of a 
spill, recordkeeping, etc.
    (b) EPA's exercise of enforcement discretion does not preclude 
enforcement action under other provisions of TSCA or any other Federal 
statute. This includes, even in cases where the numerical 
decontamination levels set forth in this policy have been met, civil or 
criminal action for penalties where

[[Page 601]]

EPA believes the spill to have been the result of gross negligence or 
knowing violation.

Subparts H-I [Reserved]



                 Subpart J--General Records and Reports



Sec. 761.180  Records and monitoring.

    This section contains recordkeeping and reporting requirements that 
apply to PCBs, PCB Items, and PCB storage and disposal facilities that 
are subject to the requirements of the part.
    (a) PCBs and PCB Items in service or projected for disposal. 
Beginning February 5, 1990, each owner or operator of a facility, other 
than a commercial storer or a disposer of PCB waste, using or storing at 
any one time at least 45 kilograms (99.4 pounds) of PCBs contained in 
PCB Container(s), or one or more PCB Transformers, or 50 or more PCB 
Large High or Low Voltage Capacitors shall develop and maintain at the 
facility, or a central facility provided they are maintained at that 
facility, all annual records and the written annual document log of the 
disposition of PCBs and PCB Items. The written annual document log must 
be prepared for each facility by July 1 covering the previous calendar 
year (January through December). The annual document log shall be 
maintained for at least 3 years after the facility ceases using or 
storing PCBs and PCB Items in the quantities prescribed in this 
paragraph. Annual records (manifests and certificates of disposal) shall 
be maintained for the same period. The annual records and the annual 
document log shall be available for inspection at the facility where 
they are maintained by authorized representatives of EPA during normal 
business hours, and each owner or operator of a facility subject to 
these requirements shall know the location of these records. All records 
and annual documents required to be prepared and maintained by this 
section prior to February 5, 1990 shall continue to be maintained at the 
facility for the same time as the annual records and the annual document 
log. The annual document required for 1989 shall cover the period from 
January 1, 1989 to February 5, 1990.
    (1) The annual records shall include the following:
    (i) All signed manifests generated by the facility during the 
calendar year.
    (ii) All Certificates of Disposal that have been received by the 
facility during the calendar year.
    (iii) Records of inspections and cleanups performed in accordance 
with Sec. 761.65(c)(5).
    (2) The written annual document log shall include the following:
    (i) The name, address, and EPA identification number of the facility 
covered by the annual document log and the calendar year covered by the 
annual document log.
    (ii) The unique manifest number of every manifest generated by the 
facility during the calendar year, and from each manifest and for 
unmanifested waste that may be stored at the facility, the following 
information:
    (A) For bulk PCB waste (e.g., in a tanker or truck), its weight in 
kilograms, the first date it was removed from service for disposal, the 
date it was placed into transport for off-site storage or disposal, and 
the date of disposal, if known.
    (B) The serial number (if available) or other means of identifying 
each PCB Article (e.g., transformer or capacitor), the weight in 
kilograms of the PCB waste in each transformer or capacitor, the date it 
was removed from service for disposal, the date it was placed in 
transport for off-site storage or disposal, and the date of disposal, if 
known.
    (C) A unique number identifying each PCB Container, a description of 
the contents of each PCB Container, such as liquid, soil, cleanup 
debris, etc., including the total weight of the material in kilograms in 
each PCB Container, the first date material placed in each PCB Container 
was removed from service for disposal, and the date each PCB Container 
was placed in transport for off-site storage or disposal, and the date 
of disposal (if known).
    (D) A unique number identifying each PCB Article Container, a 
description of the contents of each PCB Article Container, such as 
pipes, capacitors, electric motors, pumps, etc., including the

[[Page 602]]

total weight in kilograms of the content of each PCB Article Container, 
the first date a PCB Article placed in each PCB Article Container was 
removed from service for disposal, and the date the PCB Article 
Container was placed in transport for off-site storage or disposal, and 
the date of disposal (if known.)
    (iii) The total number by specific type of PCB Articles and the 
total weight in kilograms of PCBs in PCB Articles, the total number of 
PCB Article Containers and total weight in kilograms of the contents of 
PCB Article Containers, the total number of PCB Containers and the total 
weight in kilograms of the contents of PCB Containers, and the total 
weight in kilograms of bulk PCB waste that was placed into storage for 
disposal or disposed during the calendar year.
    (iv) The total number of PCB Transformers and total weight in 
kilograms of PCBs contained in the transformers remaining in service at 
the end of the calendar year.
    (v) The total number of Large High or Low Voltage PCB Capacitors 
remaining in service at the end of the calendar year.
    (vi) The total weight in kilograms of any PCBs and PCB Items in PCB 
Containers, including the identification of container contents, 
remaining in service at the facility at the end of the calendar year.
    (vii) For any PCBs or PCB item received from or shipped to another 
facility owned or operated by the same generator, the information 
required under paragraph (a)(2)(ii)(A) through (a)(2)(ii)(D) of this 
section.
    (viii) A record of each telephone call, or other means of 
verification agreed upon by both parties, made to each designated 
commercial storer or designated disposer to confirm receipt of PCB waste 
transported by an independent transporter, as required by Sec. 761.208.
    (ix) Whenever a PCB Item, excluding small capacitors, with a 
concentration of 50 ppm is distributed in commerce for reuse 
pursuant to Sec. 761.20(c)(1), the name, address, and telephone number 
of the person to whom the item was transferred, date of transfer, and 
the serial number of the item or the internal identification number, if 
a serial number is not available, must be recorded in the annual 
document log. The serial number or internal identification number shall 
be permanently marked on the equipment.
    (3) [Reserved]
    (4) For purposes of this paragraph, PCB Voltage Regulators shall be 
recorded as PCB Transformers.
    (b) Disposers and commercial storers of PCB waste. Beginning 
February 5, 1990, each owner or operator of a facility (including high 
efficiency boiler operations) used for the commercial storage or 
disposal of PCBs and PCB Items shall maintain annual records on the 
disposition of all PCBs and PCB items at the facility and prepare and 
maintain a written annual document log that includes the information 
required by paragraphs (b)(2) of this section for PCBs and PCB Items 
that were handled as PCB waste at the facility. The written annual 
document log shall be prepared by July 1 for the previous calendar year 
(January through December). The written annual document log shall be 
maintained at each facility for at least 3 years after the facility is 
no longer used for the storage or disposal of PCBs and PCB Items except 
that, in the case of chemical waste landfills, the annual document log 
shall be maintained at least 20 years after the chemical waste landfill 
is no longer used for the disposal of PCBs and PCB Items. The annual 
records shall be maintained for the same period. The annual records and 
written annual document log shall be available at the facility for 
inspection by authorized representatives of the EPA. All records and 
annual documents required to be prepared and maintained by this section 
prior to February 5, 1990 shall continue to be maintained at the 
facility for the same time as the annual records and the annual document 
log. The annual document for 1989 shall cover the period from January 1, 
1989 to February 5, 1990. From the written annual document log the owner 
or operator of a facility must prepare the annual report containing the 
information required by paragraphs (b)(3)(i) through (b)(3)(vi) of this 
section for PCBs and PCB Items that were handled as PCB waste at the 
facility during the previous calendar

[[Page 603]]

year (January through December). The annual report must be submitted by 
July 15 of each year for the preceding calendar year. If the facility 
ceases commercial PCB storage or disposal operations, the owner or 
operator of the facility shall provide at least 60 days advance written 
notice to the Regional Administrator for the region in which the 
facility is located of the date the facility intends to begin closure. d
    (1) The annual records shall include the following:
    (i) All signed manifests generated or received at the facility 
during the calendar year.
    (ii) All Certificates of Disposal that have been generated or 
received by the facility during the calendar year.
    (iii) Records of inspections and cleanups performed in accordance 
with Sec. 761.65(c)(5).
    (2) The written annual document log shall include the following:
    (i) The name, address, and EPA identification number of the storage 
or disposal facility covered by the annual document log and the calendar 
year covered by the annual document log.
    (ii) For each manifest generated or received by the facility during 
the calendar year, the unique manifest number and the name and address 
of the facility that generated the manifest and the following 
information:
    (A) For bulk PCB waste (e.g., in a tanker or truck), its weight in 
kilograms, the first date PCB waste placed in the tanker or truck was 
removed from service for disposal, the date it was received at the 
facility, the date it was placed in transport for off-site disposal (if 
applicable), and the date of disposal, (if known ).
    (B) The serial number or other means of identifying each PCB 
Article, not in a PCB Container or PCB Article Container, the weight in 
kilograms of the PCB waste in the PCB Article, the date it was removed 
from service for disposal, the date it was received at the facility, the 
date it was placed in transport for off-site disposal (if applicable), 
and the date of disposal (if known).
    (C) The unique number assigned by the generator identifying each PCB 
Container, a description of the contents of each PCB Container, such as 
liquid, soil, cleanup debris, etc., including the total weight of the 
PCB waste in kilograms in each PCB Container, the first date PCB waste 
placed in each PCB Container was removed from service for disposal, the 
date it was received at the facility, the date each PCB Container was 
placed in transport for off-site storage or disposal (as applicable), 
and the date the PCB Container was disposed of (if known).
    (D) The unique number assigned by the generator identifying each PCB 
Article Container, a description of the contents of each PCB Article 
Container, such as pipes, capacitors, electric motors, pumps, etc., 
including the total weight in kilograms of the PCB waste in each PCB 
Article Container, the first date a PCB Article placed in each PCB 
Article Container was removed from service for disposal, the date it was 
received at the facility, the date each PCB Article Container was placed 
in transport for off-site storage or disposal (as applicable), and the 
date the PCB Article Container was disposed of (if known).
    (E) Disposers of PCB waste shall include the confirmed date of 
disposal for items in paragraphs (b)(2)(ii)(A) through (b)(2)(ii)(D) of 
this section.
    (iii) For any PCB waste disposed at a facility that generated the 
PCB waste or any PCB waste that was not manifested to the facility, the 
information required under paragraph (b)(2)(ii)(A) through (b)(2)(ii)(E) 
of this section.
    (3) The owner or operator of a PCB disposal facility (including an 
owner or operator who disposes of his/her own waste and does not receive 
or generate manifests) or a commercial storage facility shall submit an 
annual report, which briefly summarizes the records and annual document 
log required to be maintained and prepared under paragraphs (b)(1) and 
(b)(2) of this section to the EPA Regional Administrator of the Region 
in which the facility is located by July 15 of each year, beginning with 
July 15, 1991. The first annual report submitted on July 15, 1991, shall 
be for the period starting February 5, 1990, and ending December 31, 
1990. The annual report shall contain no confidential business 
information. The annual report shall consist of the information listed 
in paragraphs

[[Page 604]]

(b)(3)(i) through (b)(3)(vi) of this section.
    (i) The name, address, and EPA identification number of the facility 
covered by the annual report for the calendar year.
    (ii) A list of the numbers of all signed manifests of PCB waste 
initiated or received by the facility during that year.
    (iii) The total weight in kilograms of bulk PCB waste, PCB waste in 
PCB Transformers, PCB waste in PCB Large High or Low Voltage Capacitors, 
PCB waste in PCB Article Containers, and PCB waste in PCB Containers in 
storage at the facility at the beginning of the calendar year, received 
or generated at the facility, transferred to another facility, or 
disposed of at the facility during the calendar year. The information 
must be provided for each of these categories, as appropriate.
    (iv) The total number of PCB Transformers, the total number of PCB 
Large High or Low Voltage Capacitors, the total number of PCB Article 
Containers, and the total number of PCB Containers in storage at the 
facility at the beginning of the calendar year, received or generated at 
the facility, transferred to another facility, or disposed of at the 
facility during the calendar year. The information must be provided for 
each of these categories, as appropriate.
    (v) The total weight in kilograms of each of the following PCB 
categories: bulk PCB waste, PCB waste in PCB Transformers, PCB waste in 
PCB Large High or Low Voltage Capacitors, PCB waste in PCB Article 
Containers, and PCB waste in PCB Containers remaining in storage for 
disposal at the facility at the end of the calendar year.
    (vi) The total number of PCB Transformers, the total number of PCB 
Large High or Low Voltage Capacitors, the total number of PCB Article 
Containers, and the total number of PCB Containers remaining in storage 
for disposal at the facility at the end of the calendar year.
    (vii) The requirement to submit annual reports to the Regional 
Administrator continues until the submission of the annual report for 
the calendar year during which the facility ceases PCB storage or 
disposal operations. Storage operations have not ceased until all PCB 
waste, including any PCB waste generated during closure, has been 
removed from the facility.
    (4) Whenever a commercial storer of PCB waste accepts PCBs or PCB 
Items at his storage facility and transfers the PCB waste off-site to 
another facility for storage or disposal, the commercial storer of PCB 
waste shall initiate a manifest under subpart K of this part for the 
transfer of PCBs or PCB Items to the next storage or disposal facility.
    Note: Any requirements for weights in kilograms of PCBs may be 
calculated values if the internal volume of PCBs in containers and 
transformers is known and included in the reports, together with any 
assumptions on the density of the PCBs contained in the containers or 
tranformers. If the internal volume of PCBs is not known, a best 
estimate may be used.
    (5) For purposes of this paragraph, PCB Voltage Regulators shall be 
recorded and reported as PCB Transformers.
    (c) Incineration facilities. Each owner or operator of a PCB 
incinerator facility shall collect and maintain for a period of 5 years 
from the date of collection the following information, in addition to 
the information required in paragraph (b) of this section:
    (1) When PCBs are being incinerated, the following continuous and 
short-interval data:
    (i) Rate and quantity of PCBs fed to the combustion system as 
required in Sec. 761.70(a)(3);
    (ii) Temperature of the combustion process as required in 
Sec. 761.70(a)(4); and
    (iii) Stack emission product to include O2, CO, and 
CO2 as required in Sec. 761.70(a)(7).
    (2) When PCBs are being incinerated, data and records on the 
monitoring of stack emissions as required in Sec. 761.70(a)(6).
    (3) Total weight in kilograms of any solid residues generated by the 
incineration of PCBs and PCB Items during the calendar year, the total 
weight in kilograms of any solid residues disposed of by the facility in 
chemical waste landfills, and the total weight in kilograms of any solid 
residues remaining on the facility site.
    (4) When PCBs and PCB Items are being incinerated, additional 
periodic data shall be collected and maintained

[[Page 605]]

as specified by the Regional Administrator pursuant to 
Sec. 761.70(d)(4).
    (5) Upon any suspension of the operation of any incinerator pursuant 
to Sec. 761.70(a)(8), the owner or operator of such an incinerator shall 
prepare a document. The document shall, at a minimum, include the date 
and time of the suspension and an explanation of the circumstances 
causing the suspension of operation. The document shall be sent to the 
appropriate Regional Administrator within 30 days of any such 
suspension.
    (d) Chemical waste landfill facilities. Each owner or operator of a 
PCB chemical waste landfill facility shall collect and maintain until at 
least 20 years after the chemical waste landfill is no longer used for 
the disposal of PCBs the following information in addition to the 
information required in paragraph (b) of this section:
    (1) Any water analysis obtained in compliance with 
Sec. 761.75(b)(6)(iii); and
    (2) Any operations records including burial coordinates of wastes 
obtained in compliance with Sec. 761.75(b)(8)(ii).
    (e) High efficiency boiler facilities. Each owner or operator of a 
high efficiency boiler used for the disposal of liquids between 50 and 
500 ppm PCB shall collect and maintain for a period of 5 years the 
following information, in addition to the information required in 
paragraph (b) of this section:
    (1) For each month PCBs are burned in the boiler the carbon monoxide 
and excess oxygen data required in Sec. 761.71(a)(1)(viii) and 
Sec. 761.71(b)(1)(viii);
    (2) The quantity of PCBs burned each month as required in 
Sec. 761.71(a)(1)(vii) and Sec. 761.71(b)(1)(vii); and
    (3) For each month PCBs (other than mineral oil dielectric fluid) 
are burned, chemical analysis data of the waste as required in 
Sec. 761.71(b)(2)(vi).
    (f) Retention of special records by storage and disposal facilities. 
In addition to the information required to be maintained under 
paragraphs (b), (c), (d) and (e) of this section, each owner or operator 
of a PCB storage or disposal facility (including high efficiency boiler 
operations) shall collect and maintain for the time period specified in 
paragraph (b) of this section the following data:
    (1) All documents, correspondence, and data that have been provided 
to the owner or operator of the facility by any State or local 
government agency and that pertain to the storage or disposal of PCBs 
and PCB Items at the facility.
    (2) All documents, correspondence, and data that have been provided 
by the owner or operator of the facility to any State or local 
government agency and that pertain to the storage or disposal of PCBs 
and PCB Items at the facility.
    (3) Any applications and related correspondence sent by the owner or 
operator of the facility to any local, State, or Federal authorities in 
regard to waste water discharge permits, solid waste permits, building 
permits, or other permits or authorizations such as those required by 
Secs. 761.70(d) and 761.75(c).

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and further redesignated at 47 FR 37360, Aug. 25, 1982; 49 FR 28191, 
July 10, 1984; 53 FR 12524, Apr. 15, 1988; 54 FR 52750, Dec. 21, 1989; 
55 FR 26205, June 27, 1990; 58 FR 34205, June 23, 1993; 63 FR 35461, 
June 29, 1998]



Sec. 761.185  Certification program and retention of records by importers and persons generating PCBs in excluded manufacturing processes.

    (a) In addition to meeting the basic requirements of Sec. 761.1(f) 
and the definition of excluded manufacturing processes at Sec. 761.3, 
manufacturers with processes inadvertently generating PCBs and importers 
of products containing inadvertently generated PCBs must report to EPA 
any excluded manufacturing process or imports for which the 
concentration of PCBs in products leaving the manufacturing site or 
imported is greater than 2 micrograms per gram (2 g/g, roughly 
2 ppm) for any resolvable gas chromatographic peak. Such reports must be 
filed by October 1, 1984 or, if no processes or imports require reports 
at the time, within 90 days of having processes or imports for which 
such reports are required.
    (b) Manufacturers required to report by paragraph (a) of this 
section must transmit a letter notifying EPA of the number, the type, 
and the location of

[[Page 606]]

excluded manufacturing processes in which PCBs are generated when the 
PCB level in products leaving any manufacturing site is greater than 2 
g/g for any resolvable gas chromatographic peak. Importers 
required to report by paragraph (a) of this section must transmit a 
letter notifying EPA of the concentration of PCBs in imported products 
when the PCB concentration of products being imported is greater than 2 
g/g for any resolvable gas chromatographic peak. Persons must 
also certify the following:
    (1) Their compliance with all applicable requirements of 
Sec. 761.1(f), including any applicable requirements for air and water 
releases and process waste disposal.
    (2) Whether determinations of compliance are based on actual 
monitoring of PCB levels or on theoretical assessments.
    (3) That such determinations of compliance are being maintained.
    (4) If the determination of compliance is based on a theoretical 
assessment, the letter must also notify EPA of the estimated PCB 
concentration levels generated and released.
    (c) Any person who reports pursuant to paragraph (a) of this 
section:
    (1) Must have performed either a theoretical analysis or actual 
monitoring of PCB concentrations.
    (2) Must maintain for a period of three years after ceasing process 
operations or importation, or for seven years, whichever is shorter, 
records containing the following information:
    (i) Theoretical analysis. Manufacturers records must include: the 
reaction or reactions believed to be generating PCBs; the levels of PCBs 
generated; and the levels of PCBs released. Importers records must 
include: the reaction or reactions believed to be generating PCBs and 
the levels of PCBs generated; the basis for all estimations of PCB 
concentrations; and the name and qualifications of the person or persons 
performing the theoretical analysis; or
    (ii) Actual monitoring. (A) The method of analysis.
    (B) The results of the analysis, including data from the Quality 
Assurance Plan.
    (C) Description of the sample matrix.
    (D) The name of the analyst or analysts.
    (E) The date and time of the analysis.
    (F) Numbers for the lots from which the samples are taken.
    (d) The certification required by paragraph (b) of this section must 
be signed by a responsible corporate officer. This certification must be 
maintained by each facility or importer for a period of three years 
after ceasing process operation or importation, or for seven years, 
whichever is shorter, and must be made available to EPA upon request. 
For the purpose of this section, a responsible corporate officer means:
    (1) A president, secretary, treasurer, or vice-president of the 
corporation in charge of a principal business function, or any other 
person who performs similar policy or decision-making functions for the 
corporation.
    (2) The manager of one or more manufacturing, production, or 
operating facilities employing more than 250 persons or having gross 
annual sales or expenditures exceeding $25,000,000 (in second quarter 
1980 dollars), if authority to sign documents has been assigned or 
delegated to the manager in accordance with corporate procedures.
    (e) Any person signing a document under paragraph (d) of this 
section shall also make the following certification:

    I certify under penalty of law that this document and all 
attachments were prepared under my direction or supervision in 
accordance with a system designed to assure that qualified personnel 
properly gather and evaluate information. Based on my inquiry of the 
person or persons directly responsible for gathering information, the 
information is, to the best of my knowledge and belief, true, accurate, 
and complete. I am aware that there are significant penalties for 
falsifying information, including the possibility of fines and 
imprisonment for knowing violations.

Dated:__________________________________________________________________
Signature:______________________________________________________________

    (f) This report must be submitted to the Document Control Office 
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, 
ATTN: PCB Notification. This report must be submitted by October 1, 1984 
or within 90

[[Page 607]]

days of starting up processes or commencing importation of PCBs.
    (g) This certification process must be repeated whenever process 
conditions are significantly modified to make the previous certification 
no longer valid.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[49 FR 28191, July 10, 1984; 49 FR 33019, Aug. 20, 1984, as amended at 
53 FR 12524, Apr. 15, 1988; 58 FR 34205, June 23, 1993; 59 FR 33697, 
June 30, 1994; 60 FR 34465, July 3, 1995]



Sec. 761.187  Reporting importers and by persons generating PCBs in excluded manufacturing processes.

    In addition to meeting the basic requirements of Sec. 761.1(f) and 
the definition of excluded manufacturing process at Sec. 761.3, PCB-
generating manufacturing processes or importers of PCB-containing 
products shall be considered ``excluded manufacturing processes'' only 
when the following conditions are met:
    (a) Data are reported to the EPA by the owner/operator or importer 
concerning the total quantity of PCBs in product from excluded 
manufacturing processes leaving any manufacturing site in any calendar 
year when such quantity exceeds 0.0025 percent of that site's rated 
capacity for such manufacturing processes as of October 1, 1984; or the 
total quantity of PCBs imported in any calendar year when such quantity 
exceeds 0.0025 percent of the average total quantity of such product 
containing PCBs imported by such importer during the years 1978, 1979, 
1980, 1981 and 1982.
    (b) Data are reported to the EPA by the owner/operator concerning 
the total quantity of inadvertently generated PCBs released to the air 
from excluded manufacturing processes at any manufacturing site in any 
calendar year when such quantity exceeds 10 pounds.
    (c) Data are reported to the EPA by the owner/operator concerning 
the total quantity of inadvertently generated PCBs released to water 
from excluded manufacturing processes from any manufacturing site in any 
calendar year when such quantity exceeds 10 pounds.
    (d) These reports must be submitted to the Document Control Office 
(7407), Office of Pollution Prevention and Toxics, U.S. Environmental 
Protection Agency, Room G-099, 401 M St., SW., Washington, DC., 20460, 
ATTN: PCB Notification.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[49 FR 28192, July 10, 1984, as amended at 53 FR 12524, Apr. 15, 1988; 
58 FR 34205, June 23, 1993; 59 FR 33697, June 30, 1994; 60 FR 34465, 
July 3, 1995]



Sec. 761.193  Maintenance of monitoring records by persons who import, manufacture, process, distribute in commerce, or use chemicals containing inadvertently 
          generated PCBs.

    (a) Persons who import, manufacture, process, distribute in 
commerce, or use chemicals containing PCBs present as a result of 
inadvertent generation or recycling who perform any actual monitoring of 
PCB concentrations must maintain records of any such monitoring for a 
period of three years after a process ceases operation or importing 
ceases, or for seven years, whichever is shorter.
    (b) Monitoring records maintained pursuant to paragraph (a) of this 
section must contain:
    (1) The method of analysis.
    (2) The results of the analysis, including data from the Quality 
Assurance Plan.
    (3) Description of the sample matrix.
    (4) The name of the analyst or analysts.
    (5) The date and time of the analysis.
    (6) Numbers for the lots from which the samples are taken.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[49 FR 28193, July 10, 1984, as amended at 58 FR 34205, June 23, 1993]



            Subpart K--PCB Waste Disposal Records and Reports

    Source: 54 FR 52752, Dec. 21, 1989, unless otherwise noted.



Sec. 761.202  EPA identification numbers.

    (a) General. Any generator, commercial storer, transporter, or 
disposer of PCB waste who is required to have an EPA identification 
number under this

[[Page 608]]

subpart must notify EPA of his/her PCB waste handling activities, using 
the notification procedures and form described in Sec. 761.205. EPA will 
confirm the EPA identification number of facilities already assigned 
one, and will assign an EPA identification number to facilities that do 
not have one.
    (b) Prohibitions. After June 4, 1990:
    (1) A generator of PCB waste shall not:
    (i) Process, store, dispose of, transport, or offer for 
transportation PCB waste without having received an EPA identification 
number from the Agency. A generator of PCB waste who is exempted from 
notification under Sec. 761.205(c)(1) or who notifies EPA in a timely 
manner under Sec. 761.205(c)(2)(i), but has not yet received a unique 
identification number, shall be regarded as having received from EPA the 
identification number ``40 CFR PART 761.''
    (ii) Offer the PCB waste to transporters, disposers, or commercial 
storers of PCB waste who have not received an EPA identification number.
    (2) A transporter of PCB waste shall not:
    (i) Transport PCB waste without having received an EPA 
identification number from EPA.
    (ii) Deliver PCB waste to transporters, disposers, or commercial 
storers of PCB waste that have not received an EPA identification 
number.
    (3) A commercial storer of PCB waste shall not accept any PCB waste 
for storage without having received an EPA identification number from 
EPA.
    (4) A disposer of PCB waste shall not accept any PCB waste for 
disposal without having received an EPA identification number from EPA. 
A disposer of PCB waste who owns more than one disposal facility or 
mobile treatment unit shall not accept waste unless the disposer has 
received an EPA identification number for each facility or mobile unit.
    (c) PCB waste handled prior to effective date of this subpart. 
Generators (other than generators exempt from notification under 
Sec. 761.205(c)(1)), commercial storers, transporters, and disposers of 
PCB waste who are required to have EPA identification numbers under this 
subpart, and who were engaged in PCB waste handling activities on or 
prior to February 5, 1990, are not subject to the prohibitions of 
paragraph (b) of this section if they have applied for an EPA 
identification number in accordance with the applicable notification 
procedures of Sec. 761.205. Such persons shall use the EPA 
identification number ``40 CFR PART 761,'' or a number assigned to the 
persons by EPA or a State under RCRA, until EPA issues to such persons a 
specific identification number under Sec. 761.205(a), (b), or (c).
    (d) PCB waste first handled after effective date of this subpart. 
Generators (other than generators exempt from notification under 
Sec. 761.205(c)(1)), commercial storers, transporters, and disposers of 
PCB waste who are required to have EPA identification numbers under this 
subpart, and who first engage in PCB waste activities after February 5, 
1990, are subject to the prohibitions in paragraph (b) of this section.



Sec. 761.205  Notification of PCB waste activity (EPA Form 7710-53).

    (a)(1) All commercial storers, transporters, and disposers of PCB 
waste who were engaged in PCB waste handling activities on or prior to 
February 5, 1990 shall notify EPA of their PCB waste activities by 
filing EPA Form 7710-53 with EPA by no later than April 4, 1990. Upon 
receiving the notification form, EPA will assign an EPA identification 
number to each entity that notifies.
    (2) All generators (other than generators exempt from notification 
under paragraph (c)(1) of this section), commercial storers, 
transporters, and disposers of PCB waste who first engage in PCB waste 
handling activities after February 5, 1990, shall notify EPA of their 
PCB waste activities by filing EPA Form 7710-53 with EPA prior to 
engaging in PCB waste handling activities.
    (3) Any person required to notify EPA under this section shall file 
with EPA Form 7710-53. Copies of EPA Form 7710-53 are available from the 
Operation Branch (7404), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St. SW, Washington, DC 20460. 
Descriptive information and instructions for filling in the form are 
included in paragraphs (a)(4) (i) through (vii) of this section.

[[Page 609]]

    (4) All of the following information shall be provided to EPA on 
Form 7710-53:
    (i) The name of the facility, and the name of the owner or operator 
of the facility.
    (ii) EPA identification number, if any, previously issued to the 
facility.
    (iii) The facility's mailing address.
    (iv) The location of the facility.
    (v) The facility's installation contact and telephone number.
    (vi) The type of PCB waste activity engaged in at the facility.
    (vii) Signature of the signer of the certification statement, typed 
or printed name and official title of signer, and date signed.
    (viii) EPA has determined that the information in paragraphs 
(a)(4)(i) through (a)(4)(vii) of this section shall not be treated as 
confidential business information. This information will be disclosed to 
the public without further notice to the submitter unless the submitter 
provides a written justification (submitted with the notification form) 
which demonstrates extraordinary reasons why the information should be 
entitled to confidential treatment.
    (b) Generators (other than those generators exempt from notification 
under paragraph (c)(1) of this section), commercial storers, 
transporters, and disposers of PCB waste who have previously notified 
EPA or a State of hazardous waste activities under RCRA shall notify EPA 
of their PCB waste activities under this part by filing EPA Form 7710-53 
with EPA by no later than April 4, 1990. The notification shall include 
the EPA identification number previously issued by EPA or the State and 
upon receipt of the notification, EPA shall verify and authorize the use 
of the previously issued identification number for PCB waste activities.
    (c)(1) Generators of PCB waste need not notify EPA and receive 
unique EPA identification numbers under this section, unless their PCB 
waste activities are described in paragraph (c)(2) of this section. 
Generators exempted from notifying EPA under this paragraph shall use 
the generic identification number ``40 CFR PART 761'' on the manifests, 
records, and reports which they shall prepare under this subpart, unless 
such generators elect to use a unique EPA identification number 
previously assigned to them under RCRA by EPA or a State.
    (2) Generators of PCB waste who use, own, service, or process PCBs 
or PCB Items shall notify EPA of their PCB waste activities only if they 
own or operate PCB storage facilities subject to the storage 
requirements of Sec. 761.65 (b) or (c)(7). Such generators shall notify 
EPA in the following manner:
    (i) Generators storing PCB waste subject to the storage requirements 
of Sec. 761.65 (b) or (c)(7) shall notify EPA by filing EPA Form 7710-53 
with EPA by no later than April 4, 1990.
    (ii) Generators who desire to commence storage of PCB waste after 
February 5, 1990 shall notify EPA and receive an EPA identification 
number before they may commence storage of PCBs at their facilities 
established under Sec. 761.65 (b) or (c)(7).
    (iii) A separate notification shall be submitted to EPA for each PCB 
storage facility owned or operated by generators of PCB waste. Upon 
receiving these notifications, EPA will assign generators unique EPA 
identification numbers for each storage facility notifying EPA under 
this section.
    (d) Persons required to notify under this section shall file EPA 
Form 7710-53 with EPA by mailing the form to the following address: 
Chief, Operation Branch (7404), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 401 M St., SW, Washington, DC 
20460.
    (e) The requirements under this section to notify EPA and obtain EPA 
identification numbers shall in no case excuse compliance by any person 
subject to the 1-year limit on storage prior to disposal under 
Sec. 761.65(a).
    (f) When a facility has previously notified EPA of its PCB waste 
handling activities using EPA Form 7710-53 and those activities change, 
the facility must resubmit EPA Form 7710-53 to reflect those changes no 
later than 30 days from when a change is made. Examples of when a PCB 
waste handler must renotify the Agency include, but are not limited to 
the following: the company changes location of the facility; or the 
company had notified solely as engaging in a certain type of PCB

[[Page 610]]

waste handling activity and now wishes to engage in another PCB waste 
activity (e.g., previously only commercially stored PCB waste and now 
wishes to transport PCB waste).

[54 FR 52752, Dec. 21, 1989, as amended at 58 FR 15809, Mar. 24, 1993; 
58 FR 34205, June 23, 1993; 59 FR 33697, June 30, 1994; 63 FR 35461, 
June 29, 1998]



Sec. 761.207  The manifest--general requirements.

    (a) A generator who relinquishes control over PCB wastes by 
transporting, or offering for transport by his own vehicle or by a 
vehicle owned by another person, PCB waste for commercial off-site 
storage or off-site disposal shall prepare a manifest on EPA Form 8700-
22, and if necessary, a continuation sheet. The generator shall specify:
    (1) For each bulk load of PCBs, the identity of the PCB waste, the 
earliest date of removal from service for disposal, and the weight in 
kilograms of the PCB waste.
    (2) For each PCB Article Container or PCB Container, the unique 
identifying number, type of PCB waste (e.g., soil, debris, small 
capacitors), earliest date of removal from service for disposal, and 
weight in kilograms of the PCB waste contained.
    (3) For each PCB Article not in a PCB Container or PCB Article 
Container, the serial number if available, or other identification if 
there is no serial number, the date of removal from service for 
disposal, and weight in kilograms of the PCB waste in each PCB Article.
    (b) EPA does not maintain supplies of printed copies of Form 8700-22 
for public use, although printed copies of the manifest may be available 
from State offices. Camera-ready copies of the form are available for 
printing purposes from State offices, EPA Regional Offices, and EPA 
Headquarters.
    (c) If the State to which the shipment is manifested (i.e., 
consignment State) supplies the manifest and requires its use, then the 
generator must use that manifest.
    (d) If the consignment State does not supply the manifest, but the 
State in which the generator is located (i.e., generator State) supplies 
the manifest and requires its use, then the generator must use that 
State's manifest.
    (e) If both the consignment State and the generator State supply 
manifests and require their use, the generator must use the consignment 
State's manifest.
    (f) If neither the generator State nor the consignment State 
supplies the manifest, the generator may obtain the manifest from any 
source.
    (g) A generator shall designate on the manifest one off-site 
commercial storage or disposal facility approved under this part for the 
commercial storage or disposal of the PCBs and PCB Items described on 
the manifest.
    (h) If the transporter is unable to deliver the PCB waste to the 
designated disposer or commercial storer, the transporter must contact 
the generator of the PCB waste for instructions. The generator shall 
either designate another approved disposer or commercial storer, or 
instruct the transporter to return the PCB waste back to the generator.
    (i) The manifest which accompanies the PCB waste shall consist of at 
a minimum the number of copies required to provide the generator, the 
initial transporter, each subsequent transporter, and the owner or 
operator of the designated commercial storage or disposal facility with 
one legible copy each for their records, and one additional copy to be 
returned to the generator by the owner or operator of the first 
designated commercial storage or disposal facility.
    (j) The requirements of this section apply only to PCB wastes as 
defined in Sec. 761.3. This includes PCB wastes with PCB concentrations 
below 50 ppm where the PCB concentration below 50 ppm was the result of 
dilution; these PCB wastes are required under Sec. 761.1(b) to be 
managed as if they contained PCB concentrations of 50 ppm and above. An 
example of such a PCB waste is spill cleanup material containing <50 ppm 
PCBs when the spill involved material containing PCBs at a concentration 
of 50 ppm. However, there is no manifest requirement for 
material currently below 50 ppm which derives from pre-April 18, 1978, 
spills of any concentration, pre-July 2, 1979, spills of <

[[Page 611]]

500 ppm PCBs, or materials decontaminated in accordance with 
Sec. 761.79.

[54 FR 52752, Dec. 21, 1989, as amended at 63 FR 35461, June 29, 1998]



Sec. 761.208  Use of the manifest.

    (a)(1) The generator of PCB waste shall:
    (i) Sign the manifest certification by hand.
    (ii) Obtain the handwritten signature of the initial transporter and 
date of acceptance on the manifest.
    (iii) Retain one copy among its records in accordance with 
Sec. 761.209(a).
    (iv) Give to the transporter the remaining copies of the manifest 
that will accompany the shipment of PCB waste.
    (2) For bulk shipments of PCB waste within the United States 
transported solely by water, the generator shall send three copies of 
the manifest dated and signed in accordance with this section directly 
to the owner or operator of the designated commercial storage or 
disposal facility. Copies of the manifest are not required for each 
transporter.
    (3) For rail shipments of PCB waste within the United States which 
originate at the site of generation, the generator shall send at least 
three copies of the manifest dated and signed in accordance with this 
section to:
    (i) The next non-rail transporter, if any.
    (ii) The designated commercial storage or disposal facility if 
transported solely by rail.
    (4) When a generator has employed an independent transporter to 
transport the PCB waste to a commercial storer or disposer, the 
generator shall confirm by telephone, or by other means of confirmation 
agreed to by both parties, that the commercial storer or disposer 
actually received the manifested waste. The generator shall confirm 
receipt of the waste by close of business the day after he receives the 
manifest hand-signed by the commercial storer or disposer, in accordance 
with paragraph (c)(1)(iv) of this section. If the generator has not 
received the hand-signed manifest within 35 days after the independent 
transporter accepted the PCB waste, the generator shall telephone, or 
communicate with by some other agreed-upon means, the disposer or 
commercial storer to determine whether the PCB waste has actually been 
received. If the PCB waste has not been received, the generator shall 
contact the independent transporter to determine the disposition of the 
PCB waste. If the generator has not received a hand-signed manifest from 
an EPA-approved facility within 10 days from the date of the telephone 
call or other agreed upon means of communication, to the independent 
transporter, the generator shall submit an exception report to the EPA 
Regional Administrator for the Region in which the generator is located, 
as specified in Sec. 761.215. The generator shall retain a written 
record of all telephone or other confirmations to be included in the 
annual document log, in accordance with Sec. 761.180.
    (b)(1) A transporter shall not accept PCB waste from a generator 
unless it is accompanied by a manifest signed by the generator in 
accordance with paragraph (a)(1) of this section, except that a manifest 
is not required if any one of the following conditions exists:
    (i) The shipment of PCB waste consists solely of PCB wastes with PCB 
concentrations below 50 ppm, unless the PCB concentration below 50 ppm 
was the result of dilution, in which case Sec. 761.1(b) requires that 
the waste be managed as if it contained PCBs at the concentration prior 
to dilution.
    (ii) The PCB waste is accepted by the transporter for transport only 
to a storage or disposal facility owned or operated by the generator of 
the PCB waste.
    (2) Before transporting the PCB waste, the transporter shall sign 
and date the manifest acknowledging acceptance of the PCB waste from the 
generator. The transporter shall return a signed copy to the generator 
before leaving the generator's facility.
    (3) The transporter shall ensure that the manifest accompanies the 
PCB waste.
    (4) A transporter who delivers PCB waste to another transporter, or 
to the designated commercial storer or disposer of PCB waste, shall:
    (i) Obtain the date of delivery and the handwritten signature of the 
subsequent transporter of PCB waste, or of

[[Page 612]]

the owner or operator of the designated commercial storage or disposal 
facility on the manifest.
    (ii) Retain one copy of the manifest in accordance with 
Sec. 761.209(b).
    (iii) Give the remaining copies of the manifest to the accepting 
transporter of PCB waste, or to the designated commercial storage or 
disposal facility.
    (5) The requirements of paragraphs (b) (3) and (4) of this section 
shall not apply to transporters of bulk shipments by water if all of the 
following conditions are met:
    (i) The PCB waste is delivered by water (bulk shipment) to the 
designated commercial storage or disposal facility.
    (ii) A shipping paper containing all the information required on the 
manifest (excluding EPA identification number, generator certification, 
and signatures) accompanies the PCB waste.
    (iii) The transporter delivering the PCB waste obtains the date of 
delivery and handwritten signature of the owner or operator of the 
designated commercial storage or disposal facility on either the 
manifest or the shipping paper.
    (iv) The person delivering the PCB waste to the initial water (bulk 
shipment) transporter obtains the date of delivery and signature of the 
water (bulk shipment) transporter on the manifest and forwards it to the 
designated facility.
    (v) A copy of the shipping paper or manifest is retained by each 
water (bulk shipment) transporter in accordance with Sec. 761.209(b).
    (6) For shipments involving rail transportation, the requirements of 
paragraphs (b)(3) and (b)(4) of this section shall not apply. Instead, 
the requirements described at Sec. 263.20(f) of this chapter for the 
rail transportation of hazardous waste apply to such shipments. The rail 
transporter shall retain one copy of the manifest or rail shipping paper 
in accordance with Sec. 761.209(b).
    (7) The transporter shall deliver the entire quantity of PCB waste 
accepted from a generator or transporter to either of the following 
destinations:
    (i) The designated commercial storage or disposal facility listed on 
the manifest.
    (ii) The next designated transporter of PCB waste.
    (8) If the PCB waste cannot be delivered in accordance with 
paragraph (b)(7) of this section, the transporter shall contact the 
generator for further directions and shall revise the manifest and/or 
return the PCB waste according to the generator's instructions.
    (9) No provision of this section shall be construed to affect or 
limit the applicability of any requirement applicable to transporters of 
PCB waste under regulations issued by the Department of Transportation 
(DOT) and set forth at 49 CFR part 171.
    (c)(1) If a commercial storage or disposal facility receives an off-
site shipment of PCB waste accompanied by a manifest, the owner or 
operator, or his agent, shall:
    (i) Sign and date each copy of the manifest to certify that the PCB 
waste covered by the manifest was received.
    (ii) Note any significant discrepancies in the manifest (as defined 
in Sec. 761.210(a)(1)) on each copy of the manifest.
    (iii) Immediately give the transporter at least one copy of the 
signed manifest.
    (iv) Within 30 days after the delivery, send a copy of the manifest 
to the generator.
    (v) Retain a copy of each manifest among the facility's records in 
accordance with Sec. 761.209(d).
    (2) If a commercial storage or disposal facility receives PCB waste 
from a rail or water (bulk shipment) transporter accompanied by a 
shipping paper containing all the information required on the manifest 
except the EPA identification numbers, generator's certification, and 
signatures, the owner or operator, or his agent, shall:
    (i) Sign and date each copy of the manifest or shipping paper to 
certify that the PCB waste covered by the manifest or shipping paper was 
received.
    (ii) Note any significant discrepancies in the manifest or shipping 
paper on each copy of the manifest or shipping paper.

[[Page 613]]

    (iii) Immediately give the rail or water transporter at least one 
copy of the manifest or shipping paper, if applicable.
    (iv) Within 30 days after the delivery, send a copy of the signed 
and dated manifest to the generator; however, if the manifest has not 
been received within 30 days after delivery, the owner or operator shall 
send a copy of the shipping paper signed and dated to the generator.
    (v) Retain at the commercial storage or disposal facility a copy of 
the manifest and shipping paper, if signed in lieu of the manifest, in 
accordance with Sec. 761.209(d).
    (3) Whenever an off-site shipment of PCB waste is initiated from a 
commercial storage or disposal facility, the owner or operator of the 
commercial storage or disposal facility shall comply with the manifest 
requirements that apply to generators of PCB waste.



Sec. 761.209  Retention of manifest    records.

    (a) A generator of PCB waste shall keep a copy of each manifest 
signed in accordance with Sec. 761.208(a)(1) until the generator 
receives a signed copy from the designated commercial storage or 
disposal facility which received the PCB waste. The copy signed by the 
commercial storer or disposer shall be retained for at least 3 years 
from the date the PCB waste was accepted by the initial transporter. A 
generator subject to annual document requirements under Sec. 761.180 
shall retain copies of each manifest for the period required by 
Sec. 761.180(a).
    (b)(1) A transporter of PCB waste shall keep a copy of the manifest 
signed by the generator, transporter, and the next designated 
transporter, if applicable, or the owner or operator of the designated 
commercial storage or disposal facility. This copy shall be retained for 
a period of at least 3 years from the date the PCB waste was accepted by 
the initial transporter.
    (2) For shipments of PCB waste delivered to the designated 
commercial storage or disposal facility by water (bulk shipment), each 
water (bulk shipment) transporter shall retain a copy of the shipping 
paper described in Sec. 761.208(b)(5)(ii) for a period of at least 3 
years from the date the PCB waste was accepted by the initial 
transporter.
    (3) For shipments of PCB waste by rail within the United States:
    (i) The initial rail transporter shall keep a copy of the manifest 
and the shipping paper required to accompany the PCB waste for a period 
of at least 3 years from the date the PCB waste was accepted by the 
initial transporter.
    (ii) The final rail transporter shall keep a copy of the signed 
manifest, or the required shipping paper if signed by the designated 
facility in lieu of the manifest, for a period of at least 3 years from 
the date the PCB waste was accepted by the initial transporter.
    (c) The owner or operator of a PCB commercial storage or disposal 
facility that receives off-site shipments of PCB waste shall retain at 
the facility for at least 3 years a copy of each manifest or shipping 
paper that the owner or operator signs in accordance with Sec. 761.208 
(c)(1) or (c)(3).
    (d) The periods of record retention required by this section shall 
be extended automatically during the course of any outstanding 
enforcement action regarding the regulated activity.

[54 FR 52752, Dec. 21, 1989, as amended at 58 FR 34205, June 23, 1993]



Sec. 761.210  Manifest discrepancies.

    (a) Manifest discrepancies are differences between the quantity or 
type of PCB waste designated on the manifest or shipping paper and the 
quantity or type of PCB waste actually delivered to and received by a 
designated facility.
    (1) Significant discrepancies in quantity are:
    (i) Variations greater than 10 percent in weight of PCB waste in 
containers.
    (ii) Any variation in piece count, such as a discrepancy of one PCB 
Transformer or PCB Container or PCB Article Container in a truckload.
    (2) Significant discrepancies in type of PCB waste are obvious 
differences which may be discovered by inspection or waste analysis, 
such as the substitution of solids for liquids or the substitution of 
high concentration PCBs (above 500 ppm) with lower concentration 
materials.
    (b) Upon discovering a significant discrepancy, the owner or 
operator of

[[Page 614]]

the designated commercial storage or disposal facility shall attempt to 
reconcile the discrepancy with the waste generator or transporter. If 
the discrepancy is not resolved within 15 days after receiving the PCB 
waste, such owner or operator shall immediately submit to the Regional 
Administrator for the Region in which the designated facility is located 
a letter describing the discrepancy and attempts to reconcile it, and a 
copy of the manifest or shipping paper at issue.

[54 FR 52752, Dec. 21, 1989, as amended at 58 FR 34205, June 23, 1993]



Sec. 761.211  Unmanifested waste report.

    (a) After April 4, 1990, if a PCB commercial storage or disposal 
facility receives any shipment of PCB waste from an off-site source 
without an accompanying manifest or shipping paper (where required in 
place of a manifest), and any part of the shipment consists of any PCB 
waste regulated for disposal, then the owner or operator of the 
commercial storage or disposal facility shall attempt to contact the 
generator, using information supplied by the transporter, to obtain a 
manifest or to return the PCB waste.
    (b) If the owner or operator of the commercial storage or disposal 
facility cannot contact the generator of the PCB waste, he shall notify 
the Regional Administrator of the EPA region in which his facility is 
located of the unmanifested PCB waste so that the Regional Administrator 
can determine whether further actions are required before the owner or 
operator may store or dispose of the unmanifested PCB waste.
    (c) Within 15 days after receiving the unmanifested PCB waste, the 
owner or operator shall prepare and submit a report to the Regional 
Administrator for the Region in which the commercial storage or disposal 
facility is located and to the Regional Administrator for the Region in 
which the PCB waste originated, if known. The report may be submitted on 
EPA Form 8700-13B, or by a written letter designated ``Unmanifested 
Waste Report.'' The report shall include the following information:
    (1) The EPA identification number, name, and address of the PCB 
commercial storage or disposal facility.
    (2) The date the commercial storage or disposal facility received 
the unmanifested PCB waste.
    (3) The EPA identification number, name, and address of the 
generator and transporter, if available.
    (4) A description of the type and quantity of the unmanifested PCB 
waste received at the facility.
    (5) A brief explanation of why the waste was unmanifested, if known.
    (6) The disposition made of the unmanifested waste by the commercial 
storage or disposal facility, including:
    (i) If the waste was stored or disposed by that facility, was the 
generator identified and was a manifest subsequently supplied.
    (ii) If the waste was sent back to the generator, why and when.

[54 FR 52752, Dec. 21, 1989, as amended at 58 FR 34205, June 23, 1993]



Sec. 761.215  Exception reporting.

    (a) A generator of PCB waste, who does not receive a copy of the 
manifest with the handwritten signature of the owner or operator of the 
designated PCB commercial storage or disposal facility within 35 days of 
the date the waste was accepted by the initial transporter, shall 
immediately contact the transporter and/or the owner or operator of the 
designated facility to determine the status of the PCB waste.
    (b) A generator of PCB waste subject to the manifesting requirements 
shall submit an Exception Report to the EPA Regional Administrator for 
the Region in which the generator is located if the generator has not 
received a copy of the manifest with the hand written signature of the 
owner or operator of the designated facility within 45 days of the date 
the waste was accepted by the initial transporter. The exception report 
shall be submitted to EPA no later than 45 days from the date on which 
the generator should have received the manifest. The Exception Report 
shall include the following:
    (1) A legible copy of the manifest for which the generator does not 
have confirmation of delivery.
    (2) A cover letter signed by the generator or his authorized 
representative

[[Page 615]]

explaining the efforts taken to locate the PCB waste and the results of 
those efforts.
    (c) A disposer of PCB waste shall submit a One-year Exception Report 
to the EPA Regional Administrator for the Region in which the disposal 
facility is located no later than 45 days from the end of the 1-year 
storage for disposal date when the following occurs:
    (1) The disposal facility receives PCBs or PCB Items on a date more 
than 9 months from the date the PCBs or PCB Items were removed from 
service for disposal, as indicated on the manifest or continuation 
sheet; and
    (2) Because of contractual commitments or other factors affecting 
the facility's disposal capacity, the disposer of PCB waste could not 
dispose of the affected PCBs or PCB Items within 1 year of the date of 
removal from service for disposal.
    (d) A generator or commercial storer of PCB waste who manifests PCBs 
or PCB Items to a disposer of PCB waste shall submit a One-year 
Exception Report to the EPA Regional Administrator for the Region in 
which the generator or commercial storer is located no later than 45 
days from the date the following occurs:
    (1) The generator or commercial storer transferred the PCBs or PCB 
Items to the disposer of PCB waste on a date within 9 months from the 
date of removal from service for disposal of the affected PCBs or PCB 
Items, as indicated on the manifest or continuation sheet; and
    (2) The generator or commercial storer either has not received 
within 13 months from the date of removal from service for disposal a 
Certificate of Disposal confirming the disposal of the affected PCBs or 
PCB Items, or the generator or commercial storer receives a Certificate 
of Disposal confirming disposal of the affected PCBs or PCB Items on a 
date more than 1 year after the date of removal from service.
    (e) The One-year Exception Report shall include:
    (1) A legible copy of any manifest or other written communication 
relevant to the transfer and disposal of the affected PCBs or PCB Items.
    (2) A cover letter signed by the submitter or an authorized 
representative explaining:
    (i) The date(s) when the PCBs or PCB Items were removed from service 
for disposal.
    (ii) The date(s) when the PCBs or PCB Items were received by the 
submitter of the report, if applicable.
    (iii) The date(s) when the affected PCBs or PCB Items were 
transferred to a designated disposal facility.
    (iv) The identity of the transporters, commercial storers, or 
disposers known to be involved with the transaction.
    (v) The reason, if known, for the delay in bringing about the 
disposal of the affected PCBs or PCB Items within 1 year from the date 
of removal from service for disposal.
    (f) PCB/radioactive waste that is exempt from the 1-year storage for 
disposal time limit pursuant to Sec. 761.65(a)(1) is also exempt from 
the exception reporting requirements of paragraphs (c), (d), and (e) of 
this section.

[54 FR 52752, Dec. 21, 1989, as amended at 55 FR 26205, June 27, 1990; 
58 FR 34205, June 23, 1993; 63 FR 35461, June 29, 1998]



Sec. 761.218  Certificate of disposal.

    (a) For each shipment of manifested PCB waste that the owner or 
operator of a disposal facility accepts by signing the manifest, the 
owner or operator of the disposal facility shall prepare a Certificate 
of Disposal for the PCBs and PCB Items disposed of at the facility, 
which shall include:
    (1) The identity of the disposal facility, by name, address, and EPA 
identification number.
    (2) The identity of the PCB waste affected by the Certificate of 
Disposal including reference to the manifest number for the shipment.
    (3) A statement certifying the fact of disposal of the identified 
PCB waste, including the date(s) of disposal, and identifying the 
disposal process used.
    (4) A certification as defined in Sec. 761.3.
    (b) The owner or operator of the disposal facility shall send the 
Certificate of Disposal to the generator identified on the manifest 
which accompanied the shipment of PCB waste within 30 days of the date 
that disposal of each item

[[Page 616]]

of PCB waste identified on the manifest was completed unless the 
generator and the disposer contractually agree to another time frame.
    (c) The disposal facility shall keep a copy of each Certificate of 
Disposal among the records that it retains under Sec. 761.180(b).
    (d)(1) Generators of PCB waste shall keep a copy of each Certificate 
of Disposal that they receive from disposers of PCB waste among the 
records they retain under Sec. 761.180(a).
    (2) Commercial storers of PCB waste shall keep a copy of each 
Certificate of Disposal that they receive from disposers of PCB waste 
among the records they retain under Sec. 761.180(b).

[54 FR 52752, Dec. 21, 1984, as amended at 63 FR 35462, June 29, 1998]

Subpart L  [Reserved]



 Subpart M--Determining a PCB Concentration for Purposes of Abandonment 
or Disposal of Natural Gas Pipeline: Selecting Sample Sites, Collecting 
        Surface Samples, and Analyzing Standard PCB Wipe Samples

    Source: 63 FR 35462, June 29, 1998, unless otherwise noted.



Sec. 761.240   Scope and definitions.

    (a) Use these procedures to select surface sampling sites for 
natural gas pipe to determine its PCB surface concentration for 
abandonment-in-place or removal and disposal off-site in accordance with 
Sec. 761.60(b)(5).
    (b) ``Pipe segment'' means a length of natural gas pipe that has 
been removed from the pipeline system to be disposed of or reused, and 
that is usually approximately 12.2 meters (40 feet) or shorter in 
length. Pipe segments are usually linear.
    (c) ``Pipeline section'' means a length of natural gas pipe that has 
been cut or otherwise separated from the active pipeline, usually for 
purposes of abandonment, and that is usually longer than 12.2 meters in 
length. Pipeline sections may be branched.



Sec. 761.243   Standard wipe sample method and size.

    (a) Collect a surface sample from a natural gas pipe segment or 
pipeline section using a standard wipe test as defined in Sec. 761.123. 
Detailed guidance for the entire wipe sampling process appears in the 
document entitled ``Wipe Sampling and Double Wash/Rinse Cleanup as 
Recommended by the Environmental Protection Agency PCB Spill Cleanup 
Policy,'' dated June 23, 1987 and revised on April 18, 1991. This 
document is available from the TSCA Assistance Information Service, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    (b) Collect a surface sample from a minimum surface area of 100 
cm2 at each sampling site selected. The EPA Regional 
Administrator may approve, in writing, requests to collect a sample from 
smaller surface areas, when <100 cm2 of surface eligible for 
sampling is present; e.g., when sampling a small diameter pipe, a small 
valve, or a small regulator. When smaller surfaces are sampled, convert 
the measurement to the equivalent measurement for 100 cm2 for 
purposes of comparison to standards based on 100 cm2.



Sec. 761.247   Sample site selection for pipe segment removal.

    (a) General. (1) Select the pipe segments to be sampled by following 
the directions in paragraph (b) of this section.
    (2) Locate the proper position along the length of the pipe segment 
that you have selected for sampling, by following the directions in 
paragraph (c) of this section.
    (3) Select the proper sampling position around the circumference of 
the pipe segment that you have selected for sampling, by following the 
directions in paragraph (d) of this section.
    (4) Prior to removing pipe from the ground or lifting the pipe from 
its location during former operations, mark the top side of the pipe.
    (5) Do not sample if there are free-flowing liquids in the pipe 
segment. Free-flowing liquids must be removed prior to sampling.
    (b) Selecting pipe segments to sample. Select the pipe segment(s) 
that you

[[Page 617]]

will sample from a length of pipe or group of pipe segments, as follows:
    (1) Do not sample a pipe segment that is longer than 12.2 meters (40 
feet). If a segment is longer than 12.2 meters in length, cut the 
segment so that all resulting segments are 12.2 meters or less in 
length.
    (2) Determine which pipe segments to sample as follows:
    (i) When a length of pipe having seven or fewer segments is removed 
for purposes of disposal, sample each pipe segment.
    (ii) When removing a length of pipe having multiple contiguous 
segments less than 3 miles in total length, take samples from a total of 
seven segments.
    (A) Sample the first and last segments removed.
    (B) Select the five additional segments according to one of the two 
following procedures:
    (1) Assign all segments a unique sequential number. Then select five 
numbers using a random number table or random number generator. If the 
random number generator or random number table produces either the first 
pipe segment, the last pipe segment, or any previously selected segment, 
select another random number until there are seven different numbers, 
each corresponding to a different pipe segment.
    (2) Divide the total number of segments by six. Round the resulting 
quotient off to the nearest whole number. The resulting number is the 
interval between the segments you will sample. For example, cut a 2.9 
mile length of pipeline into 383 segments of approximately 40 feet each. 
Sample the first (number 1) and last (number 383) segments. To determine 
which additional five segments to sample, divide the total number of 
segments, 383, by 6. Round up the resulting number in this example, 
63.8, to the next whole number, 64. Add 64 to the number of each 
preceding pipe segment five separate times to select five additional 
pipe segments for sampling. In this example, the first pipe segment has 
the number 1, add 64 to 1 to select segment 65. Next, add 64 to 65 to 
select segment 129. Continue in this fashion to select all seven 
segments: 1, 65, 129, 193, 257, 321, and 383.
    (iii) When removing a length of pipe having multiple contiguous 
segments more than 3 miles in total length for purposes of disposal, 
take samples of each segment that is \1/2\ mile distant from the segment 
previously sampled. Sample a minimum of seven segments.
    (c) Selecting the sampling position--length. Select the sampling 
position along the length of the pipe segment, as follows:
    (1) Take samples at the end upstream of the former gas flow of each 
segment removed.
    (2) If the pipe segment is cut with a torch or other high 
temperature heat source, take the sample at least 15 cm (6 inches) 
inside the cut end of the pipe segment.
    (3) If the pipe segment is cut with a saw or other mechanical 
device, take the sample at least 2 cm (1 inch) inside the end of the 
pipe segment.
    (4) If the sample site location selected in the procedure at 
paragraph (c)(2) or (c)(3) of this section is a porous surface (for 
example, there is significant corrosion so that the wipe material will 
be shredded), then move the sample site further inside the pipe segment 
(away from the end of the pipe or pipe segment) until there is no such 
porous surface. For purposes of this subpart, natural gas pipe with a 
thin porous corrosion preventive coating is a non-porous surface.
    (5) If there is not a non-porous surface accessible by paragraphs 
(c)(2) and (c)(3) of this section, use one of the following three 
options:
    (i) Sample the downstream end of the pipe segment using the same 
sample site location procedure as for the upstream end.
    (ii) Select another pipe segment using the random selection 
procedure described in paragraph (b) of this section.
    (iii) If there is no other pipe segment in the population to be 
sampled and both ends of a pipe segment have porous surfaces at all 
possible sample collection sites, then assume that the pipe segment 
contains 50 ppm PCB but <500 ppm PCB.
    (d) Selecting the sample position--circumference. Based on the mark 
on the top of the pipe segment made prior to

[[Page 618]]

removing pipe from the ground or lifting the pipe from its location 
during former operations, sample the inside center of the bottom of the 
pipe being sampled. Make sure the sample is centered on the bottom of 
the pipe segment; that is, sample an equal area on both sides of the 
middle of the bottom of the pipe segment for the entire length of the 
sample.

[63 FR 35462, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec. 761.250   Sample site selection for pipeline section abandonment.

    This procedure is for the sample site selection for a pipeline 
section to be abandoned, in accordance with Sec. 761.60(b)(5)(i)(B).
    (a) General. (1) Select sample collection sites in the pipeline 
section(s) by following the directions in paragraph (b) of this section.
    (2) Select the proper sampling position along the pipe by following 
the directions in Sec. 761.247 (c) and (d).
    (3) Assure, by visual inspection, the absence of free-flowing 
liquids in the pipe by affirming no liquids at all liquid collection 
points and all ends of the pipeline section to be abandoned.
    (b) Selection sample collection sites. At a minimum, sample all ends 
of all pipeline sections to be abandoned in place.
    (1) If the pipeline section to be abandoned is between the pressure 
side of one compressor station and the suction side of the next 
compressor station downstream of the former gas flow, at a minimum, 
sample all ends of the abandoned pipe.
    (2) If the pipeline section to be abandoned is longer than the 
distance between the pressure side of one compressor station and the 
suction side of the next compressor station downstream of the former gas 
flow, divide the pipeline section, for purposes of sampling, into 
smaller pipeline sections no longer than the distance from the pressure 
side of one compressor station to the suction side of the next 
compressor station downstream of the former gas flow. Consider each of 
the smaller sections to be a separate abandonment and sample each one, 
at a minimum, at all ends.
    (3) Use the following procedure to locate representative sample 
collection sites in pipeline sections at points other than the suction 
and pressure side of compressor stations, or the ends of the pipeline 
section to be abandoned.
    (i) First, assign a unique identifying sequential number to each 
kilometer or fraction of a kilometer length of pipe within the entire 
pipeline section.
    (ii) Use a random number table or a random number generator to 
select each representative sample collection site from a complete list 
of the sequential identification numbers.
    (iii) Samples may be collected by removing any covering soil, 
cutting the pipe to gain access to the sampling location, and collecting 
the surface sample with the pipe in place, rather than completely 
removing the pipeline sections to collect the surface sample.

[63 FR 35462, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec. 761.253   Chemical analysis.

    (a) Extract PCBs from the standard wipe sample collection medium and 
clean-up the extracted PCBs in accordance with either Method 3500B/3540C 
or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating 
Solid Waste, or a method validated under subpart Q of this part. Use 
Method 8082 from SW-846, or a method validated under subpart Q of this 
part, to analyze these extracts for PCBs.
    (b) Report all PCB sample concentrations in g/100 
cm2 (16 square inches) of surface sampled. If sampling an 
area smaller than 100 cm2, report converted sample 
concentrations in accordance with Sec. 761.243(b).



Sec. 761.257   Determining the regulatory status of sampled pipe.

    (a) For purposes of removal for disposal of a pipe segment that has 
been sampled, the sample results for that segment determines its PCB 
surface concentration. Determine the PCB surface concentration of a 
segment which was not sampled as follows:
    (1) If the unsampled pipe segment is between two pipe segments which 
have been sampled, assume that the unsampled segment has the same PCB 
surface concentration as the nearest sampled pipe segment.
    (2) If an unsampled pipe segment is equidistant between two pipe 
segments

[[Page 619]]

which have been sampled, assume the PCB surface concentration of the 
unsampled segment to be the arithmetic mean of the PCB surface 
concentrations measured in the two equidistant, sampled, pipe segments.
    (b) For purposes of abandonment of a pipeline section, assume that 
the PCB surface concentration for an entire pipeline section is the 
arithmetic mean of the PCB surface concentrations measured at the ends 
of the pipeline section. If additional representative samples were taken 
in a pipeline section, assume that the PCB surface concentration for the 
entire pipeline section is the arithmetic mean of the concentrations 
measured in all representative samples taken.
    (c) For purposes of removal for disposal under 
Sec. 761.60(b)(5)(ii)(A)(1) or abandonment under 
Sec. 761.60(b)(5)(i)(B), if the surface PCB concentration of a pipe 
segment, determined by direct measurement or in accordance with 
paragraph (a) of this section, or of a pipeline section as determined in 
accordance with paragraph (b) of this section, is >10 g/100 
cm2, but <100 g/100 cm2, then that 
segment or section is PCB-Contaminated.



 Subpart N--Cleanup Site Characterization Sampling for PCB Remediation 
               Waste in Accordance with Sec. 761.61(a)(2)

    Source: 63 FR 35464, June 29, 1998, unless otherwise noted.



Sec. 761.260   Applicability.

    This subpart provides a method for collecting new data for 
characterizing a PCB remediation waste cleanup site or for assessing the 
sufficiency of existing site characterization data, as required by 
Sec. 761.61(a)(2).



Sec. 761.265   Sampling bulk PCB remediation waste and porous surfaces.

    (a) Use a grid interval of 3 meters and the procedures in 
Secs. 761.283 and 761.286 to sample bulk PCB remediation waste that is 
not in a container and porous surfaces.
    (b) Use the following procedures to sample bulk PCB remediation 
waste that is in a single container.
    (1) Use a core sampler to collect a minimum of one core sample for 
the entire depth of the waste at the center of the container. Collect a 
minimum of 50 cm3 of waste for analysis.
    (2) If more than one core sample is taken, thoroughly mix all 
samples into a composite sample. Take a subsample of a minimum of 50 
cm3 from the mixed composite for analysis.
    (c) Use the following procedures to sample bulk PCB remediation 
waste that is in more than one container.
    (1) Segregate the containers by type (for example, a 55-gallon drum 
and a roll-off container are types of containers).
    (2) For fewer than three containers of the same type, sample all 
containers.
    (3) For more than three containers of the same type, list the 
containers and assign each container an unique sequential number. Use a 
random number generator or table to select a minimum of 10 percent of 
the containers from the list, or select three containers, whichever is 
the larger.
    (4) Sample the selected container(s) according to paragraph (b) of 
this section.



Sec. 761.267   Sampling non-porous surfaces.

    (a) Sample large, nearly flat, non-porous surfaces by dividing the 
surface into roughly square portions approximately 2 meters on each 
side. Follow the procedures in Sec. 761.302(a).
    (b) It is not necessary to sample small or irregularly shaped 
surfaces.



Sec. 761.269   Sampling liquid PCB remediation waste.

    (a) If the liquid is single phase, collect and analyze one sample. 
There are no required procedures for collecting a sample.
    (b) If the liquid is multi-phasic, separate the phases, and collect 
and analyze a sample from each liquid phase. There are no required 
procedures for collecting a sample from each single phase liquid.
    (c) If the liquid has a non-liquid phase which is >0.5 percent by 
total weight of the waste, separate the non-liquid phase from the liquid 
phase and sample it separately as a non-liquid in accordance with 
Sec. 761.265.

[[Page 620]]



Sec. 761.272   Chemical extraction and analysis of samples.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB remediation waste. Use Method 
8082 from SW-846, or a method validated under subpart Q of this part, to 
analyze these extracts for PCBs.



Sec. 761.274   Reporting PCB concentrations in samples.

    (a) Report all sample concentrations for non-liquid PCBs on a dry 
weight basis as micrograms of PCBs per gram of sample (ppm by weight). 
Report surface sampling results as g/100 cm2. Divide 
100 cm2 by the surface area and multiply this quotient by the 
total number of micrograms of PCBs on the surface to obtain the 
equivalent measurement of micrograms per 100 cm2.
    (b) Report all sample concentrations for liquid PCBs on a wet weight 
basis as micrograms of PCBs per gram of sample (ppm by weight).



 Subpart O--Sampling to Verify Completion of Self-Implementing Cleanup 
 and On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces 
                  in Accordance with Sec. 761.61(a)(6)

    Source: 63 FR 35465, June 29, 1998, unless otherwise noted.



Sec. 761.280   Application and scope.

    Follow the procedures in this subpart when sampling to verify 
completion of the cleanup for self-implementing, on-site disposal of 
bulk PCB remediation waste and porous surfaces consistent with the 
levels of Sec. 761.61(a)(4)(i) and (iii). The objective of this subpart 
is not to search for new contamination. Confirmation of compliance with 
the cleanup levels in Sec. 761.61(a)(4) is only verifiable for the area 
sampled in accordance with this subpart. Do not make conclusions or 
extrapolations about PCB concentrations outside of the area which has 
been cleaned up and verified based on the results of this verification 
sampling.



Sec. 761.283   Determination of the number of samples to collect and sample collection locations.

    This section addresses how to determine the number of samples to 
collect and sample collection locations for bulk PCB remediation waste 
and porous surfaces destined to remain at a cleanup site after cleanup.
    (a) Minimum number of samples. (1) At each separate cleanup site at 
a PCB remediation waste location, take a minimum of three samples for 
each type of bulk PCB remediation waste or porous surface at the cleanup 
site, regardless of the amount of each type of waste that is present. 
There is no upper limit to the number of samples required or allowed.
    (2) This is an example of how to calculate the minimum number of 
required samples at a PCB remediation waste location. There are three 
distinct cleanup sites at this example location: a loading dock, a 
transformer storage lot, and a disposal pit. The minimum number of 
samples to take appears in parentheses after each type of waste for each 
cleanup site. The PCB remediation wastes present at the loading dock are 
concrete (three samples) and clay soil (three samples). The non-liquid 
PCB remediation wastes present at the transformer storage lot are oily 
soil (three samples), clay soil (three samples) and gravel (three 
samples). The PCB remediation wastes present at the disposal pit are 
sandy soil (three samples), clay soil (three samples), oily soil (three 
samples), industrial sludge (three samples), and gravel (three samples).
    (b) Selection of sample locations--general. (1)(i) Use a square-
based grid system to overlay the entire area to be sampled. Orient the 
grid axes on a magnetic north-south line centered in the area and an 
east-west axis perpendicular to the magnetic north-south axis also 
centered in the area.
    (ii) If the site is recleaned based on the results of cleanup 
verification conducted in accordance with Sec. 761.61(a)(6), follow the 
procedures in paragraph (b) of this section for locating sampling

[[Page 621]]

points after the recleaning, but reorient the grid axes established in 
paragraph (b)(1)(i) of this section by moving the origin one meter in 
the direction of magnetic north and one meter in the direction east of 
magnetic north.
    (2) Mark out a series of sampling points 1.5 meters apart oriented 
to the grid axes. The sampling points shall proceed in every direction 
to the extent sufficient to result in a two-dimensional grid completely 
overlaying the sampling area.
    (3) Collect a sample at each point if the grid falls in the cleanup 
area. Analyze all samples either individually or according to the 
compositing schemes provided in the procedures at Sec. 761.289. So long 
as every sample collected at a grid point is analyzed as either an 
individual sample or as part of a composite sample, there are no other 
restrictions on how many samples are analyzed.
    (c) Selection of sample locations--small cleanup sites. When a 
cleanup site is sufficiently small or irregularly shaped that a square 
grid with a grid interval of 1.5 meters will not result in a minimum of 
three sampling points for each type of bulk PCB remediation waste or 
porous surface at the cleanup site, there are two options.
    (1) Use a smaller square grid interval and the procedures in 
paragraph (b) of this section.
    (2) Use the following coordinate-based random sampling scheme. If 
the site is recleaned based on the results of cleanup verification 
conducted in accordance with Sec. 761.61(a)(6), follow the procedures in 
this section for locating sampling points after the recleaning, but 
select three new pairs of sampling coordinates.
    (i) Beginning in the southwest corner (lower left when facing 
magnetic north) of the area to be sampled, measure in centimeters (or 
inches) the maximum magnetic north-south dimension of the area to be 
sampled. Next, beginning in the southwest corner, measure in centimeters 
(or inches) the maximum magnetic east-west dimension of the area to be 
sampled. Designate the north-south and east-west dimensions (describing 
the west and south boundaries, respectively, of the area to be sampled), 
as the reference axes of a square-based grid system.
    (ii) Use a random number table or random number generator to select 
a pair of coordinates that will locate the sample within the area to be 
sampled. The first coordinate in the pair is the measurement on the 
north-south axis. The second coordinate in the pair is the measurement 
on the east-west axis. Collect the sample at the intersection of an 
east-west line drawn through the measured spot on the north-south axis, 
and a north-south line drawn through the measured spot on the east-west 
axis. If the cleanup site is irregularly shaped and this intersection 
falls outside the cleanup site, select a new pair of sampling 
coordinates. Continue to select pairs of sampling coordinates until 
three are selected for each type of bulk PCB remediation waste or porous 
surface at the cleanup site.
    (d) Area of inference. Analytical results for an individual sample 
point apply to the sample point and to an area of inference extending to 
four imaginary lines parallel to the grid axes and one half grid 
interval distant from the sample point in four different directions. The 
area of inference forms a square around the sample point. The sides of 
the square are parallel to the grid axes and one grid interval in 
length. The sample point is in the center of the square area of 
inference. The area of inference from a composite sample is the total of 
the areas of the individual samples included in the composite.



Sec. 761.286   Sample size and procedure for collecting a sample.

    At each selected sampling location for bulk PCB remediation waste or 
porous surfaces, collect at least 20 milliliters of waste, or a portion 
of sufficient weight for the chemical analyst to measure the 
concentration of PCBs and still have sufficient analytical detection 
sensitivity to reproducibly measure PCBs at the levels designated in 
Sec. 761.61(a)(4). Use a core sampler having a diameter 2 cm 
and 3 cm. Collect waste to a maximum depth of 7.5 cms.



Sec. 761.289   Compositing samples.

    Compositing is a method of combining several samples of a specific 
type of bulk PCB remediation waste or porous surface from nearby 
locations

[[Page 622]]

for a single chemical analysis. There are two procedures for compositing 
bulk PCB remediation waste samples. These procedures are based on the 
method for selecting sampling site locations in Sec. 761.283(b) and (c). 
The single chemical analysis of a composite sample results in an 
averaging of the concentrations of its component samples. The area of 
inference of a composite is determined by the area of inference of each 
of its component samples as described in Sec. 761.283(d). Compositing is 
not mandatory. However, if compositing is used, it must be performed in 
accordance with the following procedures.
    (a) Compositing in the field or in a laboratory. Compositing may 
occur either in the field or in a laboratory. Prepare composite samples 
using equal volumes of each constituent or component sample. Composited 
samples must be from the same type of bulk PCB remediation waste or 
porous surface (see the example at Sec. 761.283(a)(2)). Mix composite 
samples thoroughly. From each well-mixed composite sample, take a 
portion of sufficient weight for the chemical analyst to measure the 
concentration of PCBs and still have sufficient analytical detection 
sensitivity to reproducibly measure PCBs at the levels designated in 
Sec. 761.61(a)(4).
    (b)(1) Compositing from samples collected at grid points in 
accordance with Sec. 761.283(b). There are two kinds of composite 
sampling procedures depending on the original source of contamination of 
the site.
    (i) The first procedure is for sites with multiple point sources of 
contamination (such as an old electrical equipment storage area, a scrap 
yard, or repair shop) or for unknown sources of contamination. Under 
this compositing scheme, composite a maximum of nine samples for each 
type of bulk PCB remediation waste or porous surface at the cleanup 
site. The maximum dimensions of the area enclosing a nine grid point 
composite is two grid intervals bounded by three collinear grid points 
(3.0 meters or approximately 10 feet long). Take all samples in the 
composite at the same depth. Assure that composite sample areas and 
individually analyzed samples completely overlay the cleanup site.
    (ii) The second procedure is for a single point source of 
contamination, such as discharge into a large containment area (e.g., 
pit, waste lagoon, or evaporation pond), or a leak onto soil from a 
single drum or tank. Single point source contamination may be from a 
one-time or continuous contamination. Composites come from two stages: 
an initial compositing area centered in the area to be sampled, and 
subsequent compositing areas forming concentric square zones around the 
initial compositing area. The center of the initial compositing area and 
each of the subsequent compositing areas is the origin of the grid axes.
    (A) Definition of the initial compositing area. The initial 
compositing area is based on a square that contains nine grid points, is 
centered on the grid origin, and has sides two grid intervals long. The 
initial compositing area has the same center as this square and sides 
one half a grid interval more distant from the center than the square. 
The initial compositing area has sides three grid intervals long.
    (B) Definition of subsequent compositing areas. Subsequent composite 
sampling areas are in concentric square zones one grid interval wide 
around the initial compositing area and around each successive 
subsequent compositing area. The inner boundary of the first subsequent 
compositing area is the outer boundary of the initial compositing area. 
The outer boundary of the first subsequent compositing area is centered 
on the grid origin, has sides one grid interval more distant from the 
grid origin than the inner boundary, and is two grid intervals longer on 
a side than the inner boundary. The inner boundary of each further 
subsequent compositing area is the outer boundary of the previous 
subsequent compositing area. The outer boundary of each further 
subsequent compositing area is centered on the grid origin, has sides 
one grid interval more distant from the grid origin than the inner 
boundary, and is two grid intervals longer on a side than the inner 
boundary.
    (C) Taking composite samples from the initial and subsequent 
compositing areas. (1) Select composite sampling areas from the initial 
compositing area and

[[Page 623]]

subsequent compositing areas such that all grid points in the initial 
compositing area and subsequent compositing areas are part of a 
composite or individual sample.
    (2) A person may include in a single composite sample a maximum of 
all nine grid points in the initial compositing area. The maximum number 
of grid points in a composite sample taken from a subsequent compositing 
area is eight. These eight grid points must be adjacent to one another 
in the subsequent compositing area, but need not be collinear.
    (2) Compositing from samples taken at grid points or pairs of 
coordinates in accordance with Sec. 761.283(c). Samples collected at 
small sites are based on selecting pairs of coordinates or using the 
sample site selection procedure for grid sampling with a smaller grid 
interval.
    (i) Samples collected from a grid having a smaller grid interval. 
Use the procedure in paragraph (b)(1)(i) of this section to composite 
samples and determine the area of inference for composite samples.
    (ii) Samples collected from pairs of coordinates. All three samples 
must be composited. The area of inference for the composite is the 
entire area sampled.



Sec. 761.292   Chemical extraction and analysis of individual samples and composite samples.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB remediation waste. Use Method 
8082 from SW-846, or a method validated under subpart Q of this part, to 
analyze these extracts for PCBs.



Sec. 761.295   Reporting and recordkeeping of the PCB concentrations in samples.

    (a) Report all sample concentrations for bulk PCB remediation waste 
and porous surfaces on a dry weight basis and as micrograms of PCBs per 
gram of sample (ppm by weight).
    (b) Record and keep on file for 3 years the PCB concentration for 
each sample or composite sample.



Sec. 761.298   Decisions based on PCB concentration measurements resulting from sampling.

    (a) For grid samples which are chemically analyzed individually, the 
PCB concentration applies to the area of inference as described in 
Sec. 761.283(d).
    (b) For grid samples analyzed as part of a composite sample, the PCB 
concentration applies to the area of inference of the composite sample 
as described in Sec. 761.283(d) (i.e., the area of inference is the 
total of the areas of the individual samples included in the composite).
    (c) For coordinate pair samples analyzed as part of a composite 
sample, in accordance with Secs. 761.283(c)(2) and 761.289(b)(2)(ii), 
the PCB concentration applies to the entire cleanup site.



   Subpart P--Sampling Non-Porous Surfaces for Measurement-Based Use, 
  Reuse, and On-Site or Off-Site Disposal Under Sec. 761.61(a)(6) and 
                 Decontamination Under Sec. 761.79(b)(3)

    Source: 63 FR 35467, June 29, 1998, unless otherwise noted.



Sec. 761.300   Applicability.

    This subpart provides sample site selection procedures for large, 
nearly flat non-porous surfaces, and for small or irregularly shaped 
non-porous surfaces. This subpart also provides procedures for analyzing 
the samples and interpreting the results of the sampling. Any person 
verifying completion of self-implementing cleanup and on-site disposal 
of non-porous surfaces under Sec. 761.61(a)(6), or verifying that 
decontamination standards under Sec. 761.79(b)(3) are met, must use 
these procedures.



Sec. 761.302   Proportion of the total surface area to sample.

    (a) Large nearly flat surfaces. Divide the entire surface into 
approximately 1 meter square portions and mark the

[[Page 624]]

portions so that they are clearly identified. Determine the sample 
location in each portion as directed in Sec. 761.304.
    (1) For large nearly flat surfaces contaminated by a single source 
of PCBs with a uniform concentration, assign each 1 meter square surface 
a unique sequential number.
    (i) For three or fewer 1 meter square areas, sample all of the 
areas.
    (ii) For four or more 1 meter square areas, use a random number 
generator or table to select a minimum of 10 percent of the areas from 
the list, or to select three areas, whichever is more.
    (2) For other large nearly flat surfaces, sample all of the one 
meter square areas.
    (b) Small or irregularly shaped surfaces. For small surfaces having 
irregular contours, such as hand tools, natural gas pipeline valves, and 
most exterior surfaces of machine tools, sample the entire surface. Any 
person may select sampling locations for small, nearly flat surfaces in 
accordance with Sec. 761.308 with the exception that the maximum area in 
Sec. 761.308(a) is <1 meter square.
    (c) Preparation of surfaces. Drain all free-flowing liquids from 
surfaces and brush off dust or loose grit.



Sec. 761.304   Determining sample location.

    (a) For 1 square meter non-porous surface areas having the same size 
and shape, it is permissible to sample the same 10 cm by 10 cm location 
or position in each identical 1 square meter area. This location or 
position is determined in accordance with Sec. 761.306 or Sec. 761.308.
    (b) If some 1 square meter surfaces for a larger non-porous surface 
area have different sizes and shapes, separately select the 10 cm by 10 
cm sampling position for each different 1 square meter surface in 
accordance with Sec. 761.308.
    (c) If non-porous surfaces have been cleaned and the cleaned 
surfaces do not meet the applicable standards or levels, surfaces may be 
recleaned and resampled. When resampling surfaces previously sampled to 
verify cleanup levels, use the sampling procedures in Secs. 761.306 
through 761.316 to resample the surfaces. If any sample site selected 
coincides with a previous sampling site, restart the sample selection 
process until all resampling sites are different from any previous 
sampling sites.



Sec. 761.306   Sampling 1 meter square surfaces by random selection of halves.

    (a) Divide each 1 meter square portion where it is necessary to 
collect a surface wipe test sample into two equal (or as nearly equal as 
possible) halves. For example, divide the area into top and bottom 
halves or left and right halves. Choose the top/bottom or left/right 
division that produces halves having as close to the shape of a circle 
as possible. For example, a square is closer to the shape of a circle 
than is a rectangle and a rectangle having a length to width ratio of 
2:1 is closer to the shape of a circle than a rectangle having a length 
to width ratio of 3:1.
    (b) Assign a unique identifier to each half and then select one of 
the halves for further sampling with a random number generator or other 
device (i.e., by flipping a coin).
    (c) Continue selecting progressively smaller halves by dividing the 
previously selected half, in accordance with paragraphs (a) and (b) of 
this section, until the final selected half is larger than or equal to 
100 cm2 and smaller than 200 cm2.
    (d) Perform a standard PCB wipe test on the final selected halves 
from each 1 meter square portion.
    (e) The following is an example of applying sampling by halves. 
Assume that the area to sample is a 1 meter square surface area (a 
square that has sides 1 meter long). Assign each half to one face of a 
coin. After flipping the coin, the half assigned to the face of the coin 
that is showing is the half selected.
    (1) Selecting the first half:
    (i) For a square shape the top/bottom halves have the same shape as 
the left/right halves when compared to a circle, i.e., regardless of 
which way the surface is divided, each half is 1 half meter wide by 1 
meter long. Therefore, divide the area either top/bottom or left/right. 
For selecting the first half, this example will select from left/right 
halves.
    (ii) A coin flip selects the left half. The dimensions of this 
selected surface

[[Page 625]]

area are 1 meter high and \1/2\ meter wide.
    (2) Selecting the second half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/4\ meter wide and 
1 meter high). Halves selected from top/bottom would be square (\1/2\ 
meter on a side). Therefore, select the next halves top/bottom, because 
the shape of the top/bottom halves (square) is closer to the shape of a 
circle than the shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the top half. The dimensions of this 
selected surface area are \1/2\ meter high and \1/2\ meter wide.
    (3) Selecting the third half:
    (i) Just as for the selection of the first half, which divided the 
original square area, both the left/right and the top/bottom halves have 
the same shape when compared to a circle (both are rectangles having the 
same dimensions). Therefore, choose either left/right or top/bottom 
halves. This example will select from left/right halves.
    (ii) A coin flip selects the right half. The dimensions of this 
selected surface are \1/4\ meter by \1/2\ meter.
    (4) Selecting the fourth half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/8\ meter wide and 
\1/2\ meter high. Halves selected from top/bottom would be square (\1/4\ 
meter on a side). Therefore, select the next halves top/bottom, because 
the shape of the top/bottom halves (square) are closer to the shape of a 
circle than the shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the bottom half. The dimensions of this 
selected surface area are \1/4\ meter high and \1/4\ meter wide.
    (5) Selecting the fifth half:
    (i) Just as for the selection of the first and third halves, both 
the left/right and the top/bottom halves have the same shape when 
compared to a circle (both are rectangles having the same dimensions). 
Therefore, choose either left/right or top/bottom halves. This example 
will select from left/right halves.
    (ii) A coin flip selects the right half. The dimensions of the 
selected surface are \1/8\ meter by \1/4\ meter.
    (6) Selecting the sixth half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/16\ meter wide and 
\1/4\ meter high. Halves selected from top/bottom would be square (\1/8\ 
meter on a side). Therefore, select the next halves top/bottom, because 
the shape of the top/bottom halves (square) are closer to the shape of a 
circle than the shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the top half. The dimensions of this 
selected surface are \1/8\ meter high and \1/8\ meter wide or 12.5 cm by 
12.5 cm.
    (7) Collect a standard wipe test sample in the sixth half. Since the 
dimensions of half of the sixth half would be 12.5 cm by 6.25 cm, the 
area (approximately 78 cm2) would be less than the required 
100 cm2 minimum area for the standard wipe test. Therefore, 
no further sampling by halves is necessary. Take the standard wipe test 
samples of the entire selected sixth half.



Sec. 761.308   Sample selection by random number generation on any two-dimensional square grid.

    (a) Divide the surface area of the non-porous surface into 
rectangular or square areas having a maximum area of 1 square meter and 
a minimum dimension of 10 centimeters.
    (b) Measure the length and width, in centimeters, of each area 
created in paragraph (a) of this section. Round off the number of 
centimeters in the length and the width measurements to the nearest 
centimeter.
    (c) For each 1 square meter area created in accordance with 
paragraph (a) of this section, select two random numbers: one each for 
the length and width borders measured in paragraph (b) of this section. 
An eligible random number can be from zero up to the total width, minus 
10 centimeters.
    (d) Locate the 10 centimeter by 10 centimeter sample.
    (1) Orient the 1 square meter surface area so that, when you are 
facing the area, the length is left to right and the width is top to 
bottom. The origin, or reference point for measuring selected

[[Page 626]]

random numbers of centimeters to the sampling area, is on the lower left 
corner when facing the surface.
    (2) Mark the random number selected for the length distance, in 
centimeters, from the origin to the right (at the bottom of the area 
away from the origin).
    (3) From the marked length distance on the bottom of the area, move 
perpendicularly up from the bottom of the area into the area for the 
distance randomly selected for the width.
    (4) Use the point determined in paragraph (d)(3) of this section as 
the lower left corner of the 10 centimeter by 10 centimeter sample.



Sec. 761.310   Collecting the sample.

    Use the standard wipe test as defined in Sec. 761.123 to sample one 
10 centimeter by 10 centimeter square (100 cm2) area to 
represent surface area PCB concentrations of each square meter or 
fraction of a square meter of a nearly flat, non-porous surface. For 
small surfaces, use the same procedure as for the standard wipe test, 
only sample the entire area, rather than 10 centimeter by 10 centimeter 
squares.



Sec. 761.312   Compositing of samples.

    For a surface originally contaminated by a single source of PCBs 
with a uniform concentration, it is permissible to composite surface 
wipe test samples and to use the composite measurement to represent the 
PCB concentration of the entire surface. Composite samples consist of 
more than one sample gauze extracted and chemically analyzed together 
resulting in a single measurement. The composite measurement represents 
an arithmetic mean of the composited samples.
    (a) Compositing samples from surfaces to be used or reused. For 
small or irregularly shaped surfaces or large nearly flat surfaces, if 
the surfaces are contaminated by a single source of PCBs with a uniform 
concentration, composite a maximum of three adjacent samples.
    (b) Compositing samples from surfaces to be disposed of off-site or 
on-site. (1) For small or irregularly shaped surfaces, composite a 
maximum of three adjacent samples.
    (2) For large nearly flat surfaces, composite a maximum of 10 
adjacent samples.



Sec. 761.314   Chemical analysis of standard wipe test samples.

    Perform the chemical analysis of standard wipe test samples in 
accordance with Sec. 761.272. Report sample results in micrograms per 
100 cm2.



Sec. 761.316   Interpreting PCB concentration measurements resulting from this sampling scheme.

    (a) For an individual sample taken from an approximately 1 meter 
square portion of the entire surface area and not composited with other 
samples, the status of the portion is based on the surface concentration 
measured in that sample. If the sample surface concentration is not 
equal to or lower than the cleanup level, by inference the entire 1 
meter area, and not just the immediate area where the sample was taken, 
is not equal to or lower than the cleanup level.
    (b) For areas represented by the measurement results from 
compositing more than one 10 centimeter by 10 centimeter sample, the 
measurement for the composite is the measurement for the entire area. 
For example, when there is a composite of 10 standard wipe test samples 
representing 9.5 square meters of surface area and the result of the 
analysis of the composite is 20 g/100 cm2, then the 
entire 9.5 square meters has a PCB surface concentration of 20 
g/100 cm2, not just the area in the 10 cm by 10 cm 
sampled areas.
    (c) For small surfaces having irregular contours, where the entire 
surface was sampled, measure the surface area. Divide 100 cm2 
by the surface area and multiply this quotient by the total number of 
micrograms of PCBs on the surface to obtain the equivalent measurement 
of micrograms per 100 cm2.



    Subpart Q--Self-Implementing Alternative Extraction and Chemical 
    Analysis Procedures for Non-liquid PCB Remediation Waste Samples

    Source: 63 FR 35468, June 29, 1998, unless otherwise noted.

[[Page 627]]



Sec. 761.320   Applicability.

    This subpart describes self-implementing comparison testing 
requirements for chemical extraction and chemical analysis methods used 
as an alternative to the methods required in Secs. 761.272 or 761.292. 
Any person conducting comparison testing under this subpart must comply 
with the requirements of Sec. 761.80(i), including notification. Use 
alternative methods only after successful completion of these comparison 
testing requirements and after documentation of the results of the 
testing.



Sec. 761.323   Sample preparation.

    (a) The comparison study requires analysis of a minimum of 10 
samples weighing at least 300 grams each. Samples of PCB remediation 
waste used in the comparison study must meet the following three 
requirements.
    (1) The samples must either be taken from the PCB remediation waste 
at the cleanup site, or must be the same kind of material as that waste. 
For example, if the waste at the cleanup site is sandy soil, you must 
use the same kind of sandy soil in the comparison study. Do not use 
unrelated materials such as clay soil or dredged sediments in place of 
sandy soil.
    (2) PCB remediation waste may contain interferences which confound 
or hamper sample extraction and chemical analysis. These interferences 
may be from chemicals or other attributes preexisting in the waste 
material, resulting from the PCB contamination source, or resulting from 
treatment to remove or destroy PCBs. Comparison study samples must also 
contain these interfering materials to demonstrate successful analysis 
in their presence. For example, a PCB remediation waste may have been 
co-disposed with chlorobenzene solvents or chlorinated pesticides. These 
chlorinated compounds would have to be present in the comparison study 
compounds at the same levels found, or at the highest levels expected to 
be found, in the PCB remediation waste. As another example, for PCB 
remediation waste which had been solvent washed with liquid amines to 
remove PCBs, comparison study samples would have to contain 
concentrations of these amines at the same levels found, or at the 
highest levels expected to be found, in the PCB remediation waste.
    (b) Prior to initiating the comparison study, confirm the following 
PCB concentrations in the comparison study samples using the methods 
specified in Sec. 761.292. All samples of non-liquid PCB remediation 
waste must have PCB concentrations between 0.1 and 150 ppm.
    (1) A minimum of three comparison study samples must have PCB 
concentrations above the cleanup level specified for the site in 
Sec. 761.61(a)(4) and a minimum of three comparison study samples must 
have PCB concentrations below the specified cleanup level.
    (2) At least one comparison study sample must have a PCB 
concentration 90 percent and 100 percent of the 
cleanup level.
    (3) At least one comparison study sample must have a PCB 
concentration 100 percent and 110 percent of the 
cleanup level.
    (c) If the comparison study samples do not have the concentrations 
or concentration ranges required by paragraph (b) of this section, for 
purposes of use in this chemical extraction and chemical analysis 
comparison study, a person may adjust PCB concentrations by dilution. 
Any excess material resulting from the preparation of these samples, 
which is not used as an analytical sample, is regulated as the PCB 
concentration in the component having the highest PCB concentration of 
the component materials in the sample.



Sec. 761.326   Conducting the comparison study.

    Extract or analyze the comparison study samples using the 
alternative method. For an alternative extraction method or alternative 
analytical method to be comparable to the methods required in 
Sec. 761.292, all of the following conditions must be met.
    (a) All samples having PCB concentrations greater than or equal to 
the level of concern, as measured by the methods required in 
Sec. 761.292, are found to be greater than or equal to the level of 
concern as measured by the alternative method (no false negatives).
    (b) Only one sample which contains PCBs at a level less than the 
level of

[[Page 628]]

concern, as measured by the methods required in Sec. 761.292, is found 
to have a PCB concentration greater than the level of concern as 
measured by the alternative method (false positive); and all other 
samples which contain PCBs at levels less than the level of concern, as 
measured by the methods required in Sec. 761.292, are found by the 
alternative method to have PCBs less than the level of concern (there 
are no additional false positives).



  Subpart R--Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for 
    Purposes of Characterization for PCB Disposal in Accordance With
 
 Sec. 761.62, and Sampling PCB Remediation Waste Destined for Off-Site 
                Disposal, in Accordance With Sec. 761.61

    Source: 63 FR 35469, June 29, 1998, unless otherwise noted.



Sec. 761.340   Applicability.

    Use the procedures specified in this subpart to sample the following 
types of waste when it is necessary to analyze the waste to determine 
PCB concentration or leaching characteristics for storage or disposal.
    (a) Existing accumulations of non-liquid, non-metal PCB bulk product 
waste.
    (b) Non-liquid, non-metal PCB bulk product waste from processes that 
continuously generate new waste.
    (c) Non-liquid PCB remediation waste from processes that 
continuously generate new waste, that will be sent off-site for 
disposal.



Sec. 761.345   Form of the waste to be sampled.

    PCB bulk product waste and PCB remediation waste destined for off-
site disposal must be in the form of either flattened or roughly conical 
piles. This subpart also contains a procedure for contemporaneous 
sampling of waste as it is being generated.



Sec. 761.346   Three levels of sampling.

    To select a sample of the waste and prepare it for chemical 
extraction and analysis, there are three required levels of random 
sampling.
    (a) First, select a single 19-liter (5 gallon) portion from a 
composite accumulated either contemporaneously with the generation of 
the waste or by sampling an existing pile of waste. Collection 
procedures for the first level of sampling from existing piles of waste 
are in Sec. 761.347. Collection procedures for the first level of 
sampling from a contemporaneous generation of waste are in Sec. 761.348. 
Compositing requirements and requirements for the subsampling of 
composite samples to result in a single 19-liter sample are in 
Sec. 761.350. Send the 19-liter sample to the laboratory for the second 
and third levels of sampling, including particle size reduction for 
leach testing and drying as required by Sec. 761.1(b)(4).
    (b) Second, at the laboratory, select one quarter of the 19-liter 
sample. Procedures the laboratory must use for this second level of 
sample selection appear in Sec. 761.353.
    (c) Third, select a 100 gram subsample from the second level 
subsample. Procedures the laboratory must use for this third level of 
sample selection appear in Sec. 761.355.



Sec. 761.347   First level sampling--waste from existing piles.

    (a) General. Sample piles that are either specifically configured 
for sampling (see paragraph (b) of this section) or that are of conical 
shape (see paragraph (c) of this section). If sampling from either of 
these shapes is not possible, conduct contemporaneous sampling, in 
accordance with the procedures in Sec. 761.348, or obtain the approval 
of the Regional Administrator for an alternate sampling plan in 
accordance with Sec. 761.62(c).
    (b) Specifically configured piles. A specifically configured pile is 
a single flattened pile in the shape of a square or rectangle having no 
restrictions on length or width but restricted to 30 cm (1 foot) in 
depth. A square shaped pile facilitates sampling site selection for the 
first level sample. Select eight 19-liter samples from the pile and 
composite them into one 19-liter sample as follows:
    (1) Divide the pile into quarters.

[[Page 629]]

    (2) Divide each of the quarter sections into quarters (i.e., into 
sixteenths of the original pile).
    (3) Select two sixteenths from each of the four quarters, according 
to one of the two following options:
    (i) Randomly select the two sixteenths from one quarter and sample 
the sixteenths occupying the same positions in each of the other three 
quarters.
    (ii) Randomly select two sixteenths from each of the four quarters 
(i.e., perform a random selection four different times).
    (4) At this point the eight selected sixteenths undergo further 
division and sample selection. Divide each of the eight selected 
sixteenths into four equal parts. Using a random number generator or 
random number table, select one of the four equal parts from each of the 
eight equal areas. If each of the four equal parts has a volume >76 
liters when projected downwards 30 cm, continue to divide each selected 
area into four equal parts, and select one of the parts, until each 
selected area has a volume of <76 liters but 19 liters. When 
projected to a depth of 30 cm, a square having a 25 cm side or a circle 
having a diameter of approximately 28.5 cm equals a volume of 
approximately 19 liters. The volume of 76 liters is equal to the volume 
enclosed by a square having a side of 50 cm (or other shape having an 
area of 250 cm2) projected to a depth of 30 cm.
    (5) Take one sample of approximately 19 unsorted liters of waste 
from each of the eight selected areas. Place each sample into a separate 
19-liter container, allowing only sufficient space at the top of the 
container to secure the lid.
    (6) Composite the eight 19-liter samples in accordance with 
Sec. 761.350.
    (c) Conical-shaped piles. If it is necessary to sample a pile which 
is too large to be spread on the site to a uniform thickness of 1 foot 
or 30 cm, or if there are too many piles to spread out in the space 
available, use the following procedure to sample the piles. This 
procedure assumes that the shape of the piles is analogous to a cone; 
that is, having a circular base with PCB bulk product waste or PCB 
remediation waste destined for off-site disposal stacked up uniformly to 
a peak that is a point centered above the center of the circular base. 
Collect eight 19-liter samples as follows:
    (1) Collecting samples from more than one pile. If the PCB bulk 
product waste or PCB remediation waste consists of more than one pile or 
container, assign each pile or container an integer number and then 
generate seven random integer numbers to select the piles from which you 
will collect samples. It is possible that this random selection 
procedure will result in selecting the same pile number more than once, 
even if seven or more piles are present. If so, sample the pile once and 
restart the sampling collection process to collect additional samples. 
Do not collect multiple samples from the same location in the pile.
    (2) Collecting samples from a single pile. If only one pile or 
container is present, collect all eight samples from the same pile.
    (3) Setting up the sample site selection system from a pile. Locate 
a sample in a pile by the use of three parameters: a particular radial 
direction, ``r,'' from the peak at the center of the pile to the outer 
edge at the base of the pile; a point, ``s,'' along that radial 
direction between the peak of the pile and the outer edge of the base of 
the pile; and a depth, ``t'', beneath point ``s.'' The top of the sample 
material will be below depth t, at point s, on radius r. Use a rod, 
dowel, stake, or broom handle as a marker. Nail or otherwise fasten to 
the top of the marker two pieces of string or cord of sufficient length 
and strength to reach from the top of the marker at the top of the pile 
to the farthest peripheral edge at the bottom of the pile, when the 
marker is positioned at the top or apex of the pile. Pound or push the 
marker into the top center (apex) of the pile, downward toward the 
center of the base. Insert the marker for at least 30 cm or one foot 
until the marker is rigidly standing on its own, even when the cord is 
pulled tight to the bottom peripheral edge of the pile. Ensure that the 
marker protrudes from the top of the pile sufficiently to allow the 
strings to move easily around the pile when they are

[[Page 630]]

pulled tight. Select the three parameters and the sampling location as 
follows:
    (i) Determine the radial component (r) of the location for each 
sample.
    (A) Tie to a stake or otherwise fasten one of the strings at ``b,'' 
the bottom of the pile, as a reference point for finding r.
    (B) Measure the circumference ``c,'' the distance around the bottom 
of the pile. Determine r from b in one of two ways:
    (1) Multiply c by a randomly generated fraction or percentage of 
one.
    (2) Select a random number between one and the total number of 
centimeters in c.
    (C) Locate r by starting at b, the place where the fixed string 
meets the base of the pile, and travel clockwise around the edge of the 
pile at the base for the distance you selected in paragraph (c)(3)(i)(B) 
of this section.
    (D) Fasten the second string at the selected distance. The second 
string marks the first parameter r.
    (ii) Determine the second parameter s of the location for each 
sample.
    (A) Measure the distance, l, along the string, positioned in 
paragraph (c)(3)(i)(D) of this section, from the top to the bottom of 
the pile at the selected radial distance r. Determine the distance s 
from l in one of two ways:
    (1) Multiply l by a randomly generated fraction or percentage of 
one.
    (2) Select a random number between one and the total number of 
centimeters in l.
    (B) Mark, for example by placing a piece of tape on the string 
positioned according to paragraph (c)(3)(i)(D) of this section, the 
distance s, up from the bottom of the pile on the string at r.
    (iii) Determine the third and final parameter t of the location for 
each sample.
    (A) Mark and number 1 cm intervals from one end of a rigid device, 
for example a rod, dowel, stake, or broom handle, for measuring the 
distance from the top of the pile to the bottom at the point s selected 
in paragraph (c)(3)(ii)(B) of this section. The marked and numbered 
device shall be of sufficient strength to be forced down through the 
maximum depth of the pile and sufficient length to measure the depth of 
the waste in the pile at any point.
    (B) Take the measuring device, constructed according to paragraph 
(c)(3)(iii)(A) of this section, and at position s, push the end of the 
device marked with zero straight down into the pile until it reaches the 
bottom of the pile or ground level. The vertical distance ``v'' is the 
number of centimeters from the surface of the pile at point s on the 
string to the bottom of the pile or ground level. Read the distance v on 
the measuring device at the surface of the pile. From the distance v, 
determine t, in one of two ways:
    (1) Randomly generate a fraction of one and multiply the fraction 
times v.
    (2) Select a random number between zero and the total number of 
centimeters of the vertical distance v.
    (iv) Dig a hole straight down into the pile for t centimeters 
(inches) from the surface of the pile at s.
    (v) At depth t, directly under the s mark on the string, outline the 
top of the sample container and collect (shovel) all waste under the 
outline in the following order of preference in paragraphs (c)(3)(v)(A) 
through (c)(3)(v)(C) of this section. It is possible that some of the 
eight sampling locations will not provide 19 liters of sample.
    (A) For a depth of 30 cm.
    (B) Until the container is full.
    (C) Until the ground level is reached.
    (d) Compositing the samples. Composite the eight 19-liter samples 
and subsample in accordance with Sec. 761.350. Send the subsample to a 
laboratory for further sampling as described in Secs. 761.353 and 
761.355 and for chemical extraction and analysis. If there is 
insufficient sample for a 19-liter sample from the composite sample 
composed of the eight iterations of sample site selection, according to 
the procedures in paragraphs (c)(3)(i) through (c)(3)(v) of this 
section, select additional sample sites, collect additional samples and 
composite the additional waste in the samples until a minimum of 19 
liters is in the composite.

[63 FR 35469, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec. 761.348   Contemporaneous sampling.

    Contemporaneous sampling is possible when there is active generation 
of

[[Page 631]]

waste and it is possible to sample the waste stream as it is generated. 
Collect eight 19-liter samples as follows.
    (a) Collect each sample by filling a 19-liter (5 gallon) container 
at a location where the PCB bulk product waste is released from the 
waste generator onto a pile or into a receptacle container before the 
waste reaches the pile or receptacle container.
    (b) Determine a sample collection start time using a random number 
generator or a random number table to select a number between 1 and 60. 
Collect the first sample at the randomly selected time in minutes after 
start up of the waste output, or if the waste is currently being 
generated, after the random time is selected. For example, if the 
randomly selected time is 35, begin collection 35 minutes after the 
start up of waste generation. Similarly, if waste output is ongoing and 
the random start determination occurred at 8:35 a.m., collect the first 
sample at 9:10 a.m. (35 minutes after the random start determination).
    (c) Collect seven more samples, one every 60 minutes after the 
initial sample is collected. If the waste output process stops, stop the 
60-minute interval time clock. When the process restarts, restart the 
60-minute interval time clock and complete the incomplete 60-minute 
interval.
    (d) Composite the eight 19-liter samples and subsample in accordance 
with Sec. 761.350.



Sec. 761.350   Subsampling from composite samples.

    (a) Preparing the composite. Composite the samples (eight from a 
flattened pile; eight or more from a conical pile; eight from waste that 
is continuously generated) and select a 19-liter subsample for shipment 
to the chemical extraction and analysis laboratory for further 
subsampling. There are two options for the preparation of the composite:
    (1) Option one. Place all of the contents of all 19-liter samples 
that you collected into a 209 liter (55 gallon) drum or similar sized, 
cylinder-shaped container. Completely close the container, and roll it 
10 or more complete revolutions to mix the contents.
    (2) Option two. Add the 19-liter samples one at a time to a 209 
liter (55 gallon) drum. Between the addition of each 19-liter sample, 
stir the composite using a broom handle or similar long, narrow, sturdy 
rod that reaches the bottom of the container. Stir the mixture for a 
minimum of 10 complete revolutions of the stirring instrument around the 
container at a distance approximately half way between the outside and 
center of the container.
    (b) Selecting a 19-liter subsample from the composite. Once the 
composite is mixed, pour the mixture of waste out on a plastic sheet and 
either divide it into 19-liter size piles or make one large pile.
    (1) From 19-liter sized piles, use a random number generator or 
random number table to select one of the piles.
    (2) From one large pile, flatten the pile to a depth of 30 cm and 
divide it into 4 quarters of equal size. Use a random number generator 
or random number table to select one quarter of the pile. Further divide 
the selected quarter pile into 19-liter portions and use a random number 
generator or random number table to select one 19-liter portion. A 
square having a 25 cm side or a circle having a diameter of 
approximately 28.5 cm when projected downwards 30 cm equals 
approximately 19 liters.
    (c) Transferring the sample to the analytical laboratory. Place the 
selected 19-liter subsample in a container, approved for shipment of the 
sample, to the chemical extraction and analysis laboratory, for the next 
step in sample selection in accordance with Sec. 761.353.



Sec. 761.353   Second level of sample selection.

    The second level of sample selection reduces the size of the 19-
liter subsample that was collected according to either Sec. 761.347 or 
Sec. 761.348 and subsampled according to Sec. 761.350. The purpose of 
the sample size reduction is to limit the amount of time required to 
manually cut up larger particles of the waste to pass through a 9.5 
millimeter (mm) screen.
    (a) Selecting a portion of the subsample for particle size 
reduction. At the chemical extraction and analysis laboratory, pour the 
19-liter subsample onto a

[[Page 632]]

plastic sheet or into a pan and divide the subsample into quarters. Use 
a random number generator or random number table to select one of these 
quarters.
    (b) Reduction of the particle size by the use of a 9.5 mm screen. 
Collect the contents of the selected quarter of waste resulting from 
conducting the procedures in paragraph (a) of this section and shake the 
waste in a 9.5 mm screen. Separate the waste material which passes 
through the screen from the waste material which does not pass through 
the screen. Manually cut or otherwise reduce the size of all parts of 
the waste portion which did not pass through the 9.5 mm screen, such 
that each part of the waste shall pass through the 9.5 mm screen by 
shaking.
    (c) Drying the reduced particle size waste. Dry all of the waste 
portion resulting from conducting the procedures in paragraph (b) of 
this section, from 10 to 15 hours in a drying oven at 100  deg.C. Allow 
the dried waste to cool to room temperature.
    (d) Mixing the dried waste. Place all of the waste resulting from 
conducting the procedures in paragraph (c) of this section in a 19-liter 
pail or similarly sized, cylinder-shaped container. Mix the dried 
material according to one of the two following options:
    (1) First mixing option. Completely close the container and roll the 
container a minimum of 10 complete revolutions to mix the contents.
    (2) Second mixing option. Use a sturdy stirring rod, such as a broom 
handle or other device that reaches the bottom of the container, to stir 
the waste for a minimum of 10 complete revolutions around the container 
at a distance approximately half way between the outside and the center 
of the container.



Sec. 761.355   Third level of sample selection.

    The third level of sample selection further reduces the size of the 
subsample to 100 grams which is suitable for the chemical extraction and 
analysis procedure.
    (a) Divide the subsample resulting from conducting the procedures in 
Sec. 761.353 of this part into 100 gram portions.
    (b) Use a random number generator or random number table to select 
one 100 gram size portion as a sample for a procedure used to simulate 
leachate generation.
    (c) Dry the 100 gram sample, selected after conducting the procedure 
in paragraph (b) of this section, for 10 to 15 hours in a drying oven at 
100  deg.C and cool it to the analytical laboratory room temperature 
before analysis using a procedure used to simulate leachate generation. 
This sample was dried previously in the larger quantity sample at the 
second level of sampling (Sec. 761.353(c)) and is dried a second time 
here (in the third level of sample selection). This dried and cooled 
sample must weigh at least 50 grams.
    (d) If the dried and cooled sample weighs <50 grams, select 
additional 100 gram portions of sample one at a time by repeating the 
directions in paragraph (b) and (c) of this section, and add each 
additional 100 gram portion of sample to the first 100 gram portion 
until at least 50 grams of dried material is in the sample to be 
analyzed using a procedure used to simulate leachate generation.



Sec. 761.356   Conducting a leach test.

    No method is specified as a procedure used to simulate leachate 
generation.



Sec. 761.357   Reporting the results of the procedure used to simulate leachate generation.

    Report the results of the procedure used to simulate leachate 
generation as micrograms PCBs per liter of extract from a 100 gram 
sample of dry bulk product waste. Divide 100 grams by the grams in the 
sample and multiply this quotient by the number of micrograms PCBs per 
liter of extract to obtain the equivalent measurement from a 100 gram 
sample.



Sec. 761.358   Determining the PCB concentration of samples of waste.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB bulk product waste. Use Method 
8082 from SW-

[[Page 633]]

846, or a method validated under subpart Q of this part, to analyze 
these extracts for PCBs.



Sec. 761.359  Reporting the PCB concentrations in samples.

    Report all sample concentrations as ppm by weight on a dry weight 
basis.



   Subpart S--Double Wash/Rinse Method for Decontaminating Non-Porous 
                                Surfaces

    Source: 63 FR 35472, June 29, 1998, unless otherwise noted.



Sec. 761.360   Background.

    The double wash/rinse procedure is used to quickly and effectively 
remove PCBs on surfaces. It is important to select and use the proper 
cleanup equipment, to conduct the procedure correctly so as not to 
redistribute PCBs, and to comply with disposal requirements for all 
cleanup materials.



Sec. 761.363   Applicability.

    The double wash/rinse procedure includes two washing steps and two 
rinsing steps. The two washing and rinsing steps are slightly different 
depending on whether a contaminated surface was relatively clean before 
the spill (see Sec. 761.372), or whether the surface was coated or 
covered with dust, dirt, grime, grease or another absorbent material 
(see Sec. 761.375).



Sec. 761.366   Cleanup equipment.

    (a) Use scrubbers and absorbent pads that are not dissolved by the 
solvents or cleaners used, and that do not shred, crumble, or leave 
visible fragments on the surface. Scrubbers and absorbent pads used to 
wash contaminated surfaces must not be reused. Scrubbers and absorbent 
pads for rinsing must not contain 2 ppm PCBs. Scrubbers and 
absorbent pads used in the second rinse of contaminated surfaces may be 
reused to wash contaminated surfaces.
    (b) Capture and contain all solvents and cleaners for reuse, 
decontamination, or disposal. Clean organic solvents contain <2 ppm 
PCBs. Clean water contains <3 ppb PCBs.



Sec. 761.369   Pre-cleaning the surface.

    If visible PCB-containing liquid is present on the surface to be 
cleaned, thoroughly wipe or mop the entire surface with absorbent paper 
or cloth until no liquid is visible on the surface.



Sec. 761.372   Specific requirements for relatively clean surfaces.

    For surfaces that do not appear dusty or grimy before a spill, such 
as glass, automobile surfaces, newly-poured concrete, and desk tops, use 
the double wash/rinse procedures in this section.
    (a) First wash. Cover the entire surface with organic solvent in 
which PCBs are soluble to at least 5 percent by weight. Contain and 
collect any runoff solvent for disposal. Scrub rough surfaces with a 
scrub brush or disposable scrubbing pad and solvent such that each 900 
cm2 (1 square foot) of the surface is always very wet for 1 
minute. Wipe smooth surfaces with a solvent-soaked, disposable absorbent 
pad such that each 900 cm2 (1 square foot) is wiped for 1 
minute. Any surface <1 square foot shall also be wiped for 1 minute. 
Wipe, mop, and/or sorb the solvent onto absorbent material until no 
visible traces of the solvent remain.
    (b) First rinse. Wet the surface with clean rinse solvent such that 
the entire surfaces is very wet for 1 minute. Drain and contain the 
solvent from the surface. Wipe the residual solvent off the drained 
surface using a clean, disposable absorbent pad until no liquid is 
visible on the surface.
    (c) Second wash. Repeat the procedures in paragraph (a) of this 
section. The rinse solvent from the first rinse (paragraph (b) of this 
section) may be used.
    (d) Second rinse. Repeat the procedures in paragraph (b) of this 
section.



Sec. 761.375   Specific requirements for surfaces coated or covered with dust, dirt, grime, grease, or another absorbent material.

    (a) First wash. Cover the entire surface with concentrated or 
industrial strength detergent or non-ionic surfactant solution. Contain 
and collect all cleaning solutions for proper disposal. Scrub rough 
surfaces with a scrub

[[Page 634]]

brush or scrubbing pad, adding cleaning solution such that the surface 
is always very wet, such that each 900 cm2 (1 square foot) is 
washed for 1 minute. Wipe smooth surfaces with a cleaning solution-
soaked disposable absorbent pad such that each 900 cm2 (1 
square foot) is wiped for 1 minute. Wash any surface <1 square foot for 
1 minute. Mop up or absorb the residual cleaner solution and suds with 
an clean, disposable, absorbent pad until the surface appears dry. This 
cleaning should remove any residual dirt, dust, grime, or other 
absorbent materials left on the surface during the first wash.
    (b) First rinse. Rinse off the wash solution with 1 gallon of clean 
water per square foot and capture the rinse water. Mop up the wet 
surface with a clean, disposable, absorbent pad until the surface 
appears dry.
    (c) Second wash. Follow the procedure in Sec. 761.372(a).
    (d) Second rinse. Follow the procedure in Sec. 761.372(b).



Sec. 761.378   Decontamination, reuse, and disposal of solvents, cleaners, and equipment.

    (a) Decontamination. Decontaminate solvents and non-porous surfaces 
on equipment in accordance with the standards and procedures in 
Sec. 761.79(b) and (c).
    (b) Reuse. A solvent may be reused so long as its PCB concentration 
is <50 ppm. Decontaminated equipment may be reused in accordance with 
Sec. 761.30(u). Store solvents and equipment for reuse in accordance 
with Sec. 761.35.
    (c) Disposal. Dispose of all solvents, cleaners, and absorbent 
materials in accordance with Sec. 761.79(g). Dispose of equipment in 
accordance with Sec. 761.61(a)(5)(v)(A), or decontaminate in accordance 
with Sec. 761.79(b) or (c). Store for disposal equipment, solvents, 
cleaners, and absorbent materials in accordance with Sec. 761.65.



   Subpart T--Comparison Study for Validating a New Performance-Based 
             Decontamination Solvent Under Sec. 761.79(d)(4)

    Source: 63 FR 35473, June 29, 1998, unless otherwise noted.



Sec. 761.380   Background.

    This subpart provides self-implementing criteria for validating the 
conditions for use in performance-based decontamination of solvents 
other than those listed in Sec. 761.79(c)(3) and (c)(4). Any person may 
use this subpart for validating either a chemical formulation or a 
product with a trade name whether or not the constituents of the product 
are proprietary.



Sec. 761.383   Applicability.

    Use the self-implementing decontamination procedure only on smooth, 
non-porous surfaces that were once in contact with liquid PCBs. 
Decontamination procedures under this subpart shall exactly parallel 
Sec. 761.79(c)(3) and (c)(4), except that the procedures described in 
Sec. 761.79(c)(3)(iii) and (c)(3)(iv) and (c)(4)(iii), (c)(4)(iv) and 
(c)(4)(vii) may be revised to contain parameters validated in accordance 
with this subpart.



Sec. 761.386   Required experimental conditions for the validation study and subsequent use during decontamination.

    The following experimental conditions apply for any solvent:
    (a) Temperature and pressure. Conduct the validation study and 
perform decontamination at room temperature (from 15  deg.C 
to 30  deg.C) and at atmospheric pressure.
    (b) Agitation. Limit the movement in the solvent to the short-term 
movement from placing the contaminated surface into the soak solvent and 
from removing the surface from the soak solvent.
    (c) Time of soak. Soak the surface for a minimum of 1 hour.
    (d) Surface conditions for the validation study. Prior to beginning 
the validation study, ensure that there are no free-flowing liquids on 
surfaces and that surfaces are dry (i.e., there are no liquids visible 
without magnification). Also ensure that surfaces are virtually free 
from non-liquid residues, corrosion, and other defects which would 
prevent the solvent from freely circulating over the surface.

[[Page 635]]

    (e) Confirmatory sampling for the validation study. Select surface 
sample locations using representative sampling or a census. Sample a 
minimum area of 100 cm2 on each individual surface in the 
validation study. Measure surface concentrations using the standard wipe 
test, as defined in Sec. 761.123, from which a standard wipe sample is 
generated for chemical analysis. Guidance for wipe sampling appears in 
the document entitled ``Wipe Sampling and Double Wash/Rinse Cleanup as 
Recommended by the Environmental Protection Agency PCB Spill Cleanup 
Policy,'' available from the TSCA Assistance Information Service, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    (f) Concentration of PCBs. The method validated may be used only to 
decontaminate surfaces containing PCBs at concentrations on which the 
validation study was performed and lower concentrations.



Sec. 761.389   Testing parameter requirements.

    There are no restrictions on the variable testing parameters 
described in this section which may be used in the validation study. The 
conditions demonstrated in the validation study for these variables 
shall become the required conditions for decontamination using the 
solvent being validated and shall replace the comparable conditions in 
Sec. 761.79(b)(3) through (b)(6). There are limited potential options 
for varying a single requirement in this section. If you change one of 
these variable requirements, change it only in the way listed in this 
section and do not change any other validated conditions. If you desire 
to change more than one of the requirements in this section, you must 
conduct a new study to validate the decontamination under the desired 
conditions.
    (a) The study apparatus is not standardized. Critical components of 
the study are the PCB material (for example MODEF or some other spiking 
solution), the volume of the soaking solvent, and the area of the 
contaminated surface. The EPA study used beakers and shallow dishes as 
the experimental vessels to contain the surface and solvent during the 
soaking process. In order to minimize surface-to-volume ratios, it is 
convenient to utilize flat contaminated surfaces and shallow solvent 
containers. During the validation study, use the same ratio of 
contaminated surface area to soak solvent volume as would be used during 
actual decontamination. It is also permissible to use a smaller surface 
area to soaking solvent volume than used in the validation study, so 
long as all other required parameters are used as validated in the 
confirmation required in Sec. 761.386 (a) through (f), and paragraphs 
(a) through (c) of this section. Do not use a larger surface-area-to-
solvent-volumes ratio or different kind of solvent based on the results 
of the validation study.
    (b) Except for the minimum soak time of 1 hour (as required in 
Sec. 761.386(c)), the length of soak time is not otherwise restricted in 
the validation study. The soak time used in the validation study, 
however, is a use requirement for subsequent decontamination using the 
solvent being validated. It is permissible to use longer soak times for 
decontamination than the soak time used in the validation study, if all 
other parameters required in Sec. 761.386, and paragraphs (a) and (c) of 
this section are used.
    (c) There is no restriction on the kind of material containing PCBs 
to use to create the surface contamination for the validation study. 
There is also no restriction on the level of starting PCB surface 
concentration. It is permissible to use lower concentrations of PCB than 
the concentration used in the validation study, if all other parameters 
required in Sec. 761.386 (a) through (f), and paragraphs (a) through (c) 
of this section are used.



Sec. 761.392   Preparing validation study samples.

    (a)(1) To validate a procedure to decontaminate a surface 
contaminated with a spill from liquid of a known concentration, 
contaminate (spike) the surface to be used in the validation study as 
follows:
    (i) Use a spiking solution made of PCBs mixed with a solvent to 
contaminate clean surfaces. Clean surfaces are surfaces having PCB 
surface concentrations <1 g/100 cm2 before 
intentionally contaminating the surface.

[[Page 636]]

    (ii) Prior to contaminating a surface for the validation study, mark 
the surface sampling area to assure that it is completely covered with 
the spiking solution.
    (iii) Deliver the spiking solution onto the surface, covering all of 
the sampling area. Contain any liquids which spill or flow off the 
surface. Allow the spiking solution to drip drain off into a container 
and then evaporate the spiking solution off the contaminated surface 
prior to beginning the validation study. Contaminate a minimum of eight 
surfaces for a complete validation study.
    (iv) As a quality control step, test at least one contaminated 
surface to determine the PCB concentration to verify that there are 
measurable surface levels of PCBs resulting from the contamination 
before soaking the surface in the decontamination solvent. The surface 
levels of PCBs on the contaminated surfaces must be 20 
g/100 cm2.
    (2) To validate a procedure to decontaminate a specified surface 
concentrations of PCBs as measured by a standard wipe sample, 
contaminate a minimum of 10 surfaces. Contaminate all the surfaces 
identically following the procedures in paragraph (a)(1) of this section 
and measure the PCB surface concentrations of at least three of the 
surfaces using a standard wipe test to establish a surface concentration 
to be included in the standard operating procedure. The surface levels 
of PCBs on the contaminated surfaces must be 20 g/
100 cm2.
    (b) [Reserved]



Sec. 761.395   A validation study.

    (a) Decontaminate the following prepared sample surfaces using the 
selected testing parameters and experimental conditions. Take a standard 
wipe sample of the decontaminated surface.
    (1) At least one uncontaminated surface. The surface levels of PCBs 
on the uncontaminated surface must be <1 g/100 cm2.
    (2) At least seven contaminated surfaces.
    (b)(1) Use SW-846, Test Methods for Evaluating Solid Waste methods 
for sample extraction and chemical analysis as follows: Use Method 
3500B/3540C or Method 3500B/3550B for the extraction and cleanup of the 
extract and Method 8082 for the chemical analysis, or methods validated 
under subpart Q of this part.
    (2) Report all validation study surface sample concentrations on the 
basis of micrograms of PCBs per 100 cm2 of surface sampled.
    (c) Following completion of the validation study, measurements from 
the contaminated surfaces must have an arithmetic mean of 10 
g/100 cm2. If the arithmetic mean is >10 g/
100 cm2, then the validation study failed and the solvent may 
not be used for decontamination under Sec. 761.79(d)(4) according to the 
parameters tested.



Sec. 761.398   Reporting and recordkeeping.

    (a) Submit validation study results to the Director, National 
Program Chemicals Division (NPCD), (7404), Office of Pollution 
Prevention and Toxics, 401 M St., SW., Washington, DC, prior to the 
first use of a new solvent for alternate decontamination under 
Sec. 761.79(d)(4). The use of a new solvent is not TSCA Confidential 
Business Information (CBI). From time to time, the Director of NPCD will 
confirm the use of validated new decontamination solvents and publish 
the new solvents and validated decontamination procedures in the Federal 
Register.
    (b) Any person may begin to use solvent validated in accordance with 
this subpart at the time results are submitted to EPA.
    (c) Record all testing parameters and experimental conditions from 
the successful validation study into a standard operating procedure 
(SOP) for reference whenever the decontamination procedure is used. 
Include in the SOP the identity of the soaking solvent, the length of 
time of the soak, and the ratio of the soak solvent to contaminated 
surface area during the soaking process. Also include in the SOP the 
maximum concentration of PCBs in the spilled material and the identity 
of the spilled material, and/or the measured maximum surface 
concentration of the

[[Page 637]]

contaminated surface used in the validation study. Record and keep the 
results of the validation study as an appendix to the SOP. Include in 
this appendix, the solvent used to make the spiking solution, the PCB 
concentration of the spiking solution used to contaminate the surfaces 
in the validation study, and all of the validation study testing 
parameters and experimental conditions.



PART 763--ASBESTOS--Table of Contents




Subparts A-C [Reserved]

Subpart D [Reserved]

           Subpart E--Asbestos-Containing Materials in Schools

Sec.
763.80  Scope and purpose.
763.83  Definitions.
763.84  General local education agency responsibilities.
763.85  Inspection and reinspections.
763.86  Sampling.
763.87  Analysis.
763.88  Assessment.
763.90  Response actions.
763.91  Operations and maintenance.
763.92  Training and periodic surveillance.
763.93  Management plans.
763.94  Recordkeeping.
763.95  Warning labels.
763.97  Compliance and enforcement.
763.98  Waiver; delegation to State.
763.99  Exclusions.

Appendix A to Subpart E--Interim Transmission Electron Microscopy 
          Analytical Methods--Mandatory and Nonmandatory--and Mandatory 
          Section to Determine Completion of Response Actions
Appendix B to Subpart E--Work Practices and Engineering Controls for--
          Small-Scale, Short-Duration Operations Maintenance and Repair 
          (O.M) Activities Involving ACM
Appendix C to Subpart E--Asbestos Model Accreditation Plan
Appendix D to Subpart E--Transport and Disposal of Asbestos Waste
Appendix E to Subpart E--Interim Method of the Determination of Asbestos 
          In Bulk Insulation Samples

Subpart F [Reserved]

                 Subpart G--Asbestos Abatement Projects

763.120  Scope.
763.121  Regulatory requirements.
763.122  Exclusions for States.
763.124  Reporting.
763.125  Enforcement.
763.126  Inspections.

Subpart H [Reserved]

Subpart I--Prohibition of the Manufacture, Importation, Processing, and 
   Distribution in Commerce of Certain Asbestos-Containing Products; 
                          Labeling Requirements

763.160  Scope.
763.163  Definitions.
763.165  Manufacture and importation prohibitions.
763.167  Processing prohibitions.
763.169  Distribution in commerce prohibitions.
763.171  Labeling requirements.
763.173  Exemptions.
763.175  Enforcement.
763.176  Inspections.
763.178  Recordkeeping.
763.179  Confidential business information claims.

    Authority: 15 U.S.C. 2605, 2607(c), 2643, and 2646.

Subparts A-C [Reserved]

Subpart D [Reserved]



           Subpart E--Asbestos-Containing Materials in Schools

    Source: 52 FR 41846, Oct. 30, 1987, unless otherwise noted.



Sec. 763.80  Scope and purpose.

    (a) This rule requires local education agencies to identify friable 
and nonfriable asbestos-containing material (ACM) in public and private 
elementary and secondary schools by visually inspecting school buildings 
for such materials, sampling such materials if they are not assumed to 
be ACM, and having samples analyzed by appropriate techniques referred 
to in this rule. The rule requires local education agencies to submit 
management plans to the Governor of their State by October 12, 1988, 
begin to implement the plans by July 9, 1989, and complete 
implementation of the plans in a timely fashion. In addition, local 
education agencies are required to use persons who have been accredited 
to conduct inspections, reinspections, develop

[[Page 638]]

management plans, or perform response actions. The rule also includes 
recordkeeping requirements. Local education agencies may contractually 
delegate their duties under this rule, but they remain responsible for 
the proper performance of those duties. Local education agencies are 
encouraged to consult with EPA Regional Asbestos Coordinators, or if 
applicable, a State's lead agency designated by the State Governor, for 
assistance in complying with this rule.
    (b) Local education agencies must provide for the transportation and 
disposal of asbestos in accordance with EPA's ``Asbestos Waste 
Management Guidance.'' For convenience, applicable sections of this 
guidance are reprinted as Appendix D of this subpart. There are 
regulations in place, however, that affect transportation and disposal 
of asbestos waste generated by this rule. The transportation of asbestos 
waste is covered by the Department of Transportation (49 CFR part 173, 
subpart J) and disposal is covered by the National Emissions Standards 
for Hazardous Air Pollutants (NESHAP) (40 CFR part 61, subpart M).



Sec. 763.83  Definitions.

    For purposes of this subpart:
    Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601, 
et seq.
    Accessible when referring to ACM means that the material is subject 
to disturbance by school building occupants or custodial or maintenance 
personnel in the course of their normal activities.
    Accredited or accreditation when referring to a person or laboratory 
means that such person or laboratory is accredited in accordance with 
section 206 of Title II of the Act.
    Air erosion means the passage of air over friable ACBM which may 
result in the release of asbestos fibers.
    Asbestos means the asbestiform varieties of: Chrysotile 
(serpentine); crocidolite (riebeckite); amosite (cum- 
mingtonitegrunerite); anthophyllite; tremolite; and actinolite.
    Asbestos-containing material (ACM) when referring to school 
buildings means any material or product which contains more than 1 
percent asbestos.
    Asbestos-containing building material (ACBM) means surfacing ACM, 
thermal system insulation ACM, or miscellaneous ACM that is found in or 
on interior structural members or other parts of a school building.
    Asbestos debris means pieces of ACBM that can be identified by 
color, texture, or composition, or means dust, if the dust is determined 
by an accredited inspector to be ACM.
    Damaged friable miscellaneous ACM means friable miscellaneous ACM 
which has deteriorated or sustained physical injury such that the 
internal structure (cohesion) of the material is inadequate or, if 
applicable, which has delaminated such that its bond to the substrate 
(adhesion) is inadequate or which for any other reason lacks fiber 
cohesion or adhesion qualities. Such damage or deterioration may be 
illustrated by the separation of ACM into layers; separation of ACM from 
the substrate; flaking, blistering, or crumbling of the ACM surface; 
water damage; significant or repeated water stains, scrapes, gouges, 
mars or other signs of physical injury on the ACM. Asbestos debris 
originating from the ACBM in question may also indicate damage.
    Damaged friable surfacing ACM means friable surfacing ACM which has 
deteriorated or sustained physical injury such that the internal 
structure (cohesion) of the material is inadequate or which has 
delaminated such that its bond to the substrate (adhesion) is 
inadequate, or which, for any other reason, lacks fiber cohesion or 
adhesion qualities. Such damage or deterioration may be illustrated by 
the separation of ACM into layers; separation of ACM from the substrate; 
flaking, blistering, or crumbling of the ACM surface; water damage; 
significant or repeated water stains, scrapes, gouges, mars or other 
signs of physical injury on the ACM. Asbestos debris originating from 
the ACBM in question may also indicate damage.
    Damaged or significantly damaged thermal system insulation ACM means 
thermal system insulation ACM on pipes, boilers, tanks, ducts, and other 
thermal system insulation equipment where the insulation has lost its 
structural integrity, or its covering, in

[[Page 639]]

whole or in part, is crushed, water-stained, gouged, punctured, missing, 
or not intact such that it is not able to contain fibers. Damage may be 
further illustrated by occasional punctures, gouges or other signs of 
physical injury to ACM; occasional water damage on the protective 
coverings/jackets; or exposed ACM ends or joints. Asbestos debris 
originating from the ACBM in question may also indicate damage.
    Encapsulation means the treatment of ACBM with a material that 
surrounds or embeds asbestos fibers in an adhesive matrix to prevent the 
release of fibers, as the encapsulant creates a membrane over the 
surface (bridging encapsulant) or penetrates the material and binds its 
components together (penetrating encapsulant).
    Enclosure means an airtight, impermeable, permanent barrier around 
ACBM to prevent the release of asbestos fibers into the air.
    Fiber release episode means any uncontrolled or unintentional 
disturbance of ACBM resulting in visible emission.
    Friable when referring to material in a school building means that 
the material, when dry, may be crumbled, pulverized, or reduced to 
powder by hand pressure, and includes previously nonfriable material 
after such previously nonfriable material becomes damaged to the extent 
that when dry it may be crumbled, pulverized, or reduced to powder by 
hand pressure.
    Functional space means a room, group of rooms, or homogeneous area 
(including crawl spaces or the space between a dropped ceiling and the 
floor or roof deck above), such as classroom(s), a cafeteria, gymnasium, 
hallway(s), designated by a person accredited to prepare management 
plans, design abatement projects, or conduct response actions.
    High-efficiency particulate air (HEPA) refers to a filtering system 
capable of trapping and retaining at least 99.97 percent of all 
monodispersed particles 0.3 m in diameter or larger.
    Homogeneous area means an area of surfacing material, thermal system 
insulation material, or miscellaneous material that is uniform in color 
and texture.
    Local education agency means:
    (1) Any local educational agency as defined in section 198 of the 
Elementary and Secondary Education Act of 1965 (20 U.S.C. 3381).
    (2) The owner of any nonpublic, nonprofit elementary, or secondary 
school building.
    (3) The governing authority of any school operated under the defense 
dependent's education system provided for under the Defense Dependents' 
Education Act of 1978 (20 U.S.C. 921, et seq.).
    Miscellaneous ACM means miscellaneous material that is ACM in a 
school building.
    Miscellaneous material means interior building material on 
structural components, structural members or fixtures, such as floor and 
ceiling tiles, and does not include surfacing material or thermal system 
insulation.
    Nonfriable means material in a school building which when dry may 
not be crumbled, pulverized, or reduced to powder by hand pressure.
    Operations and maintenance program means a program of work practices 
to maintain friable ACBM in good condition, ensure clean up of asbestos 
fibers previously released, and prevent further release by minimizing 
and controlling friable ACBM disturbance or damage.
    Potential damage means circumstances in which:
    (1) Friable ACBM is in an area regularly used by building occupants, 
including maintenance personnel, in the course of their normal 
activities.
    (2) There are indications that there is a reasonable likelihood that 
the material or its covering will become damaged, deteriorated, or 
delaminated due to factors such as changes in building use, changes in 
operations and maintenance practices, changes in occupancy, or recurrent 
damage.
    Potential significant damage means circumstances in which:
    (1) Friable ACBM is in an area regularly used by building occupants, 
including maintenance personnel, in the course of their normal 
activities.
    (2) There are indications that there is a reasonable likelihood that 
the material or its covering will become significantly damaged, 
deteriorated, or delaminated due to factors such as

[[Page 640]]

changes in building use, changes in operations and maintenance 
practices, changes in occupancy, or recurrent damage.
    (3) The material is subject to major or continuing disturbance, due 
to factors including, but not limited to, accessibility or, under 
certain circumstances, vibration or air erosion.
    Preventive measures means actions taken to reduce disturbance of 
ACBM or otherwise eliminate the reasonable likelihood of the material's 
becoming damaged or significantly damaged.
    Removal means the taking out or the stripping of substantially all 
ACBM from a damaged area, a functional space, or a homogeneous area in a 
school building.
    Repair means returning damaged ACBM to an undamaged condition or to 
an intact state so as to prevent fiber release.
    Response action means a method, including removal, encapsulation, 
enclosure, repair, operations and maintenance, that protects human 
health and the environment from friable ACBM.
    Routine maintenance area means an area, such as a boiler room or 
mechanical room, that is not normally frequented by students and in 
which maintenance employees or contract workers regularly conduct 
maintenance activities.
    School means any elementary or secondary school as defined in 
section 198 of the Elementary and Secondary Education Act of 1965 (20 
U.S.C. 2854).
    School building means:
    (1) Any structure suitable for use as a classroom, including a 
school facility such as a laboratory, library, school eating facility, 
or facility used for the preparation of food.
    (2) Any gymnasium or other facility which is specially designed for 
athletic or recreational activities for an academic course in physical 
education.
    (3) Any other facility used for the instruction or housing of 
students or for the administration of educational or research programs.
    (4) Any maintenance, storage, or utility facility, including any 
hallway, essential to the operation of any facility described in this 
definition of ``school building'' under paragraphs (1), (2), or (3).
    (5) Any portico or covered exterior hallway or walkway.
    (6) Any exterior portion of a mechanical system used to condition 
interior space.
    Significantly damaged friable miscellaneous ACM means damaged 
friable miscellaneous ACM where the damage is extensive and severe.
    Significantly damaged friable surfacing ACM means damaged friable 
surfacing ACM in a functional space where the damage is extensive and 
severe.
    State means a State, the District of Columbia, the Commonwealth of 
Puerto Rico, Guam, American Samoa, the Northern Marianas, the Trust 
Territory of the Pacific Islands, and the Virgin Islands.
    Surfacing ACM means surfacing material that is ACM.
    Surfacing material means material in a school building that is 
sprayed-on, troweled-on, or otherwise applied to surfaces, such as 
acoustical plaster on ceilings and fireproofing materials on structural 
members, or other materials on surfaces for acoustical, fireproofing, or 
other purposes.
    Thermal system insulation means material in a school building 
applied to pipes, fittings, boilers, breeching, tanks, ducts, or other 
interior structural components to prevent heat loss or gain, or water 
condensation, or for other purposes.
    Thermal system insulation ACM means thermal system insulation that 
is ACM.
    Vibration means the periodic motion of friable ACBM which may result 
in the release of asbestos fibers.



Sec. 763.84  General local education agency responsibilities.

    Each local education agency shall:
    (a) Ensure that the activities of any persons who perform 
inspections, reinspections, and periodic surveillance, develop and 
update management plans, and develop and implement response actions, 
including operations and maintenance, are carried out in accordance with 
subpart E of this part.
    (b) Ensure that all custodial and maintenance employees are properly 
trained as required by this subpart E and other applicable Federal and/
or

[[Page 641]]

State regulations (e.g., the Occupational Safety and Health 
Administration asbestos standard for construction, the EPA worker 
protection rule, or applicable State regulations).
    (c) Ensure that workers and building occupants, or their legal 
guardians, are informed at least once each school year about 
inspections, response actions, and post-response action activities, 
including periodic reinspection and surveillance activities that are 
planned or in progress.
    (d) Ensure that short-term workers (e.g., telephone repair workers, 
utility workers, or exterminators) who may come in contact with asbestos 
in a school are provided information regarding the locations of ACBM and 
suspected ACBM assumed to be ACM.
    (e) Ensure that warning labels are posted in accordance with 
Sec. 763.95.
    (f) Ensure that management plans are available for inspection and 
notification of such availability has been provided as specified in the 
management plan under Sec. 763.93(g).
    (g)(1) Designate a person to ensure that requirements under this 
section are properly implemented.
    (2) Ensure that the designated person receives adequate training to 
perform duties assigned under this section. Such training shall provide, 
as necessary, basic knowledge of:
    (i) Health effects of asbestos.
    (ii) Detection, identification, and assessment of ACM.
    (iii) Options for controlling ACBM.
    (iv) Asbestos management programs.
    (v) Relevant Federal and State regulations concerning asbestos, 
including those in this subpart E and those of the Occupational Safety 
and Health Administration, U.S. Department of Labor, the U.S. Department 
of Transportation and the U.S. Environmental Protection Agency.
    (h) Consider whether any conflict of interest may arise from the 
interrelationship among accredited personnel and whether that should 
influence the selection of accredited personnel to perform activities 
under this subpart.



Sec. 763.85  Inspection and reinspections.

    (a) Inspection. (1) Except as provided in paragraph (a)(2) of this 
section, before October 12, 1988, local education agencies shall inspect 
each school building that they lease, own, or otherwise use as a school 
building to identify all locations of friable and nonfriable ACBM.
    (2) Any building leased or acquired on or after October 12, 1988, 
that is to be used as a school building shall be inspected as described 
under paragraphs (a) (3) and (4) of this section prior to use as a 
school building. In the event that emergency use of an uninspected 
building as a school building is necessitated, such buildings shall be 
inspected within 30 days after commencement of such use.
    (3) Each inspection shall be made by an accredited inspector.
    (4) For each area of a school building, except as excluded under 
Sec. 763.99, each person performing an inspection shall:
    (i) Visually inspect the area to identify the locations of all 
suspected ACBM.
    (ii) Touch all suspected ACBM to determine whether they are friable.
    (iii) Identify all homogeneous areas of friable suspected ACBM and 
all homogeneous areas of nonfriable suspected ACBM.
    (iv) Assume that some or all of the homogeneous areas are ACM, and, 
for each homogeneous area that is not assumed to be ACM, collect and 
submit for analysis bulk samples under Secs. 763.86 and 763.87.
    (v) Assess, under Sec. 763.88, friable material in areas where 
samples are collected, friable material in areas that are assumed to be 
ACBM, and friable ACBM identified during a previous inspection.
    (vi) Record the following and submit to the person designated under 
Sec. 763.84 a copy of such record for inclusion in the management plan 
within 30 days of the inspection:
    (A) An inspection report with the date of the inspection signed by 
each accredited person making the inspection, State of accreditation, 
and if applicable, his or her accreditation number.
    (B) An inventory of the locations of the homogeneous areas where 
samples are collected, exact location where each bulk sample is 
collected, dates

[[Page 642]]

that samples are collected, homogeneous areas where friable suspected 
ACBM is assumed to be ACM, and homogeneous areas where nonfriable 
suspected ACBM is assumed to be ACM.
    (C) A description of the manner used to determine sampling 
locations, the name and signature of each accredited inspector who 
collected the samples, State of accreditation, and, if applicable, his 
or her accreditation number.
    (D) A list of whether the homogeneous areas identified under 
paragraph (a)(4)(vi)(B) of this section, are surfacing material, thermal 
system insulation, or miscellaneous material.
    (E) Assessments made of friable material, the name and signature of 
each accredited inspector making the assessment, State of accreditation, 
and if applicable, his or her accreditation number.
    (b) Reinspection. (1) At least once every 3 years after a management 
plan is in effect, each local education agency shall conduct a 
reinspection of all friable and nonfriable known or assumed ACBM in each 
school building that they lease, own, or otherwise use as a school 
building.
    (2) Each inspection shall be made by an accredited inspector.
    (3) For each area of a school building, each person performing a 
reinspection shall:
    (i) Visually reinspect, and reassess, under Sec. 763.88, the 
condition of all friable known or assumed ACBM.
    (ii) Visually inspect material that was previously considered 
nonfriable ACBM and touch the material to determine whether it has 
become friable since the last inspection or reinspection.
    (iii) Identify any homogeneous areas with material that has become 
friable since the last inspection or reinspection.
    (iv) For each homogeneous area of newly friable material that is 
already assumed to be ACBM, bulk samples may be collected and submitted 
for analysis in accordance with Secs. 763.86 and 763.87.
    (v) Assess, under Sec. 763.88, the condition of the newly friable 
material in areas where samples are collected, and newly friable 
materials in areas that are assumed to be ACBM.
    (vi) Reassess, under Sec. 763.88, the condition of friable known or 
assumed ACBM previously identified.
    (vii) Record the following and submit to the person designated under 
Sec. 763.84 a copy of such record for inclusion in the management plan 
within 30 days of the reinspection:
    (A) The date of the reinspection, the name and signature of the 
person making the reinspection, State of accreditation, and if 
applicable, his or her accreditation number, and any changes in the 
condition of known or assumed ACBM.
    (B) The exact locations where samples are collected during the 
reinspection, a description of the manner used to determine sampling 
locations, the name and signature of each accredited inspector who 
collected the samples, State of accreditation, and, if applicable, his 
or her accreditation number.
    (C) Any assessments or reassessments made of friable material, the 
name and signature of the accredited inspector making the assessments, 
State of accreditation, and if applicable, his or her accreditation 
number.
    (c) General. Thermal system insulation that has retained its 
structural integrity and that has an undamaged protective jacket or wrap 
that prevents fiber release shall be treated as nonfriable and therefore 
is subject only to periodic surveillance and preventive measures as 
necessary.



Sec. 763.86  Sampling.

    (a) Surfacing material. An accredited inspector shall collect, in a 
statistically random manner that is representative of the homogeneous 
area, bulk samples from each homogeneous area of friable surfacing 
material that is not assumed to be ACM, and shall collect the samples as 
follows:
    (1) At least three bulk samples shall be collected from each 
homogeneous area that is 1,000 ft\2\ or less, except as provided in 
Sec. 763.87(c)(2).
    (2) At least five bulk samples shall be collected from each 
homogeneous area that is greater than 1,000 ft\2\ but less than or equal 
to 5,000 ft\2\, except as provided in Sec. 763.87(c)(2).
    (3) At least seven bulk samples shall be collected from each 
homogeneous

[[Page 643]]

area that is greater than 5,000 ft\2\, except as provided in 
Sec. 763.87(c)(2).
    (b) Thermal system insulation. (1) Except as provided in paragraphs 
(b) (2) through (4) of this section and Sec. 763.87(c), an accredited 
inspector shall collect, in a randomly distributed manner, at least 
three bulk samples from each homogeneous area of thermal system 
insulation that is not assumed to be ACM.
    (2) Collect at least one bulk sample from each homogeneous area of 
patched thermal system insulation that is not assumed to be ACM if the 
patched section is less than 6 linear or square feet.
    (3) In a manner sufficient to determine whether the material is ACM 
or not ACM, collect bulk samples from each insulated mechanical system 
that is not assumed to be ACM where cement or plaster is used on 
fittings such as tees, elbows, or valves, except as provided under 
Sec. 763.87(c)(2).
    (4) Bulk samples are not required to be collected from any 
homogeneous area where the accredited inspector has determined that the 
thermal system insulation is fiberglass, foam glass, rubber, or other 
non-ACBM.
    (c) Miscellaneous material. In a manner sufficient to determine 
whether material is ACM or not ACM, an accredited inspector shall 
collect bulk samples from each homogeneous area of friable miscellaneous 
material that is not assumed to be ACM.
    (d) Nonfriable suspected ACBM. If any homogeneous area of nonfriable 
suspected ACBM is not assumed to be ACM, then an accredited inspector 
shall collect, in a manner sufficient to determine whether the material 
is ACM or not ACM, bulk samples from the homogeneous area of nonfriable 
suspected ACBM that is not assumed to be ACM.



Sec. 763.87  Analysis.

    (a) Local education agencies shall have bulk samples, collected 
under Sec. 763.86 and submitted for analysis, analyzed for asbestos 
using laboratories accredited by the National Bureau of Standards (NBS). 
Local education agencies shall use laboratories which have received 
interim accreditation for polarized light microscopy (PLM) analysis 
under the EPA Interim Asbestos Bulk Sample Analysis Quality Assurance 
Program until the NBS PLM laboratory accreditation program for PLM is 
operational.
    (b) Bulk samples shall not be composited for analysis and shall be 
analyzed for asbestos content by PLM, using the ``Interim Method for the 
Determination of Asbestos in Bulk Insulation Samples'' found at appendix 
E to subpart E of this part.
    (c)(1) A homogeneous area is considered not to contain ACM only if 
the results of all samples required to be collected from the area show 
asbestos in amounts of 1 percent or less.
    (2) A homogeneous area shall be determined to contain ACM based on a 
finding that the results of at least one sample collected from that area 
shows that asbestos is present in an amount greater than 1 percent.
    (d) The name and address of each laboratory performing an analysis, 
the date of analysis, and the name and signature of the person 
performing the analysis shall be submitted to the person designated 
under Sec. 763.84 for inclusion into the management plan within 30 days 
of the analysis.

[52 FR 41846, Oct. 30, 1987, as amended at 60 FR 31922, June 19, 1995]



Sec. 763.88  Assessment.

    (a)(1) For each inspection and reinspection conducted under 
Sec. 763.85 (a) and (c) and previous inspections specified under 
Sec. 763.99, the local education agency shall have an accredited 
inspector provide a written assessment of all friable known or assumed 
ACBM in the school building.
    (2) Each accredited inspector providing a written assessment shall 
sign and date the assessment, provide his or her State of accreditation, 
and if applicable, accreditation number, and submit a copy of the 
assessment to the person designated under Sec. 763.84 for inclusion in 
the management plan within 30 days of the assessment.
    (b) The inspector shall classify and give reasons in the written 
assessment for classifying the ACBM and suspected ACBM assumed to be ACM 
in the school building into one of the following categories:

[[Page 644]]

    (1) Damaged or significantly damaged thermal system insulation ACM.
    (2) Damaged friable surfacing ACM.
    (3) Significantly damaged friable surfacing ACM.
    (4) Damaged or significantly damaged friable miscellaneous ACM.
    (5) ACBM with potential for damage.
    (6) ACBM with potential for significant damage.
    (7) Any remaining friable ACBM or friable suspected ACBM.
    (c) Assessment may include the following considerations:
    (1) Location and the amount of the material, both in total quantity 
and as a percentage of the functional space.
    (2) Condition of the material, specifying:
    (i) Type of damage or significant damage (e.g., flaking, blistering, 
water damage, or other signs of physical damage).
    (ii) Severity of damage (e.g., major flaking, severely torn jackets, 
as opposed to occasional flaking, minor tears to jackets).
    (iii) Extent or spread of damage over large areas or large 
percentages of the homogeneous area.
    (3) Whether the material is accessible.
    (4) The material's potential for disturbance.
    (5) Known or suspected causes of damage or significant damage (e.g., 
air erosion, vandalism, vibration, water).
    (6) Preventive measures which might eliminate the reasonable 
likelihood of undamaged ACM from becoming significantly damaged.
    (d) The local education agency shall select a person accredited to 
develop management plans to review the results of each inspection, 
reinspection, and assessment for the school building and to conduct any 
other necessary activities in order to recommend in writing to the local 
education agency appropriate response actions. The accredited person 
shall sign and date the recommendation, provide his or her State of 
accreditation, and, if applicable, provide his or her accreditation 
number, and submit a copy of the recommendation to the person designated 
under Sec. 763.84 for inclusion in the management plan.



Sec. 763.90  Response actions.

    (a) The local education agency shall select and implement in a 
timely manner the appropriate response actions in this section 
consistent with the assessment conducted in Sec. 763.88. The response 
actions selected shall be sufficient to protect human health and the 
environment. The local education agency may then select, from the 
response actions which protect human health and the environment, that 
action which is the least burdensome method. Nothing in this section 
shall be construed to prohibit removal of ACBM from a school building at 
any time, should removal be the preferred response action of the local 
education agency.
    (b) If damaged or significantly damaged thermal system insulation 
ACM is present in a building, the local education agency shall:
    (1) At least repair the damaged area.
    (2) Remove the damaged material if it is not feasible, due to 
technological factors, to repair the damage.
    (3) Maintain all thermal system insulation ACM and its covering in 
an intact state and undamaged condition.
    (c)(1) If damaged friable surfacing ACM or damaged friable 
miscellaneous ACM is present in a building, the local education agency 
shall select from among the following response actions: encapsulation, 
enclosure, removal, or repair of the damaged material.
    (2) In selecting the response action from among those which meet the 
definitional standards in Sec. 763.83, the local education agency shall 
determine which of these response actions protects human health and the 
environment. For purposes of determining which of these response actions 
are the least burdensome, the local education agency may then consider 
local circumstances, including occupancy and use patterns within the 
school building, and its economic concerns, including short- and long-
term costs.
    (d) If significantly damaged friable surfacing ACM or significantly 
damaged friable miscellaneous ACM is present in a building the local 
education agency shall:
    (1) Immediately isolate the functional space and restrict access, 
unless

[[Page 645]]

isolation is not necessary to protect human health and the environment.
    (2) Remove the material in the functional space or, depending upon 
whether enclosure or encapsulation would be sufficient to protect human 
health and the environment, enclose or encapsulate.
    (e) If any friable surfacing ACM, thermal system insulation ACM, or 
friable miscellaneous ACM that has potential for damage is present in a 
building, the local education agency shall at least implement an 
operations and maintenance (O&M) program, as described under 
Sec. 763.91.
    (f) If any friable surfacing ACM, thermal system insulation ACM, or 
friable miscellaneous ACM that has potential for significant damage is 
present in a building, the local education agency shall:
    (1) Implement an O&M program, as described under Sec. 763.91.
    (2) Institute preventive measures appropriate to eliminate the 
reasonable likelihood that the ACM or its covering will become 
significantly damaged, deteriorated, or delaminated.
    (3) Remove the material as soon as possible if appropriate 
preventive measures cannot be effectively implemented, or unless other 
response actions are determined to protect human health and the 
environment. Immediately isolate the area and restrict access if 
necessary to avoid an imminent and substantial endangerment to human 
health or the environment.
    (g) Response actions including removal, encapsulation, enclosure, or 
repair, other than small-scale, short-duration repairs, shall be 
designed and conducted by persons accredited to design and conduct 
response actions.
    (h) The requirements of this subpart E in no way supersede the 
worker protection and work practice requirements under 29 CFR 1926.58 
(Occupational Safety and Health Administration (OSHA) asbestos worker 
protection standards for construction), 40 CFR part 763, subpart G (EPA 
asbestos worker protection standards for public employees), and 40 CFR 
part 61, subpart M (National Emission Standards for Hazardous Air 
Pollutants--Asbestos).
    (i) Completion of response actions. (1) At the conclusion of any 
action to remove, encapsulate, or enclose ACBM or material assumed to be 
ACBM, a person designated by the local education agency shall visually 
inspect each functional space where such action was conducted to 
determine whether the action has been properly completed.
    (2)(i) A person designated by the local education agency shall 
collect air samples using aggressive sampling as described in appendix A 
to this subpart E to monitor air for clearance after each removal, 
encapsulation, and enclosure project involving ACBM, except for projects 
that are of small-scale, short-duration.
    (ii) Local education agencies shall have air samples collected under 
this section analyzed for asbestos using laboratories accredited by the 
National Bureau of Standards to conduct such analysis using transmission 
electron microscopy (TEM) or, under circumstances permitted in this 
section, laboratories enrolled in the American Industrial Hygiene 
Association Proficiency Analytical Testing Program for phase contrast 
microscopy (PCM).
    (iii) Until the National Bureau of Standards TEM laboratory 
accreditation program is operational, local educational agencies shall 
use laboratories that use the protocol described in appendix A to 
subpart E of this part.
    (3) Except as provided in paragraphs (i)(4), and (i)(5), of this 
section, an action to remove, encapsulate, or enclose ACBM shall be 
considered complete when the average concentration of asbestos of five 
air samples collected within the affected functional space and analyzed 
by the TEM method in appendix A of this subpart E, is not statistically 
significantly different, as determined by the Z-test calculation found 
in appendix A of this subpart E, from the average asbestos concentration 
of five air samples collected at the same time outside the affected 
functional space and analyzed in the same manner, and the average 
asbestos concentration of the three field blanks described in appendix A 
of this subpart E is below the filter background level, as defined in 
appendix A of this subpart E, of 70 structures per square millimeter (70 
s/mm \2\).

[[Page 646]]

    (4) An action may also be considered complete if the volume of air 
drawn for each of the five samples collected within the affected 
functional space is equal to or greater than 1,199 L of air for a 25 mm 
filter or equal to or greater than 2,799 L of air for a 37 mm filter, 
and the average concentration of asbestos as analyzed by the TEM method 
in appendix A of this subpart E, for the five air samples does not 
exceed the filter background level, as defined in appendix A, of 70 
structures per square millimeter (70 s/mm \2\). If the average 
concentration of asbestos of the five air samples within the affected 
functional space exceeds 70 s/mm \2\, or if the volume of air in each of 
the samples is less than 1,199 L of air for a 25 mm filter or less than 
2,799 L of air for a 37 mm filter, the action shall be considered 
complete only when the requirements of paragraph (i)(3) or (i)(5), of 
this section are met.
    (5) At any time, a local education agency may analyze air monitoring 
samples collected for clearance purposes by phase contrast microscopy 
(PCM) to confirm completion of removal, encapsulation, or enclosure of 
ACBM that is greater than small-scale, short-duration and less than or 
equal to 160 square feet or 260 linear feet. The action shall be 
considered complete when the results of samples collected in the 
affected functional space and analyzed by phase contrast microscopy 
using the National Institute for Occupational Safety and Health (NIOSH) 
Method 7400 entitled ``Fibers'' published in the NIOSH Manual of 
Analytical Methods, 3rd Edition, Second Supplement, August 1987, show 
that the concentration of fibers for each of the five samples is less 
than or equal to a limit of quantitation for PCM (0.01 fibers per cubic 
centimeter (0.01 f/cm \3\) of air). The method is available for public 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW, Suite 700, Washington, DC, 20408, and the Non-Confidential 
Information Center (NCIC) (7407), Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, Room B-607 NEM, 401 M 
Street, SW., Washington, DC, 20460, between the hours of 12 p.m. and 4 
p.m. weekdays excluding legal holidays. This incorporation by reference 
was approved by the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. The method is incorporated as it 
exists on the effective date of this rule, and a notice of any change to 
the method will be published in the Federal Register.
    (6) To determine the amount of ACBM affected under paragraph (i)(5) 
of this section, the local education agency shall add the total square 
or linear footage of ACBM within the containment barriers used to 
isolate the functional space for the action to remove, encapsulate, or 
enclose the ACBM. Contiguous portions of material subject to such action 
conducted concurrently or at approximately the same time within the same 
school building shall not be separated to qualify under paragraph 
(i)(5), of this section.

[52 FR 41846, Oct. 30, 1987, as amended at 53 FR 12525, Apr. 15, 1988; 
60 FR 31922, June 19, 1995; 60 FR 34465, July 3, 1995]



Sec. 763.91  Operations and maintenance.

    (a) Applicability. The local education agency shall implement an 
operations, maintenance, and repair (O&M) program under this section 
whenever any friable ACBM is present or assumed to be present in a 
building that it leases, owns, or otherwise uses as a school building. 
Any material identified as nonfriable ACBM or nonfriable assumed ACBM 
must be treated as friable ACBM for purposes of this section when the 
material is about to become friable as a result of activities performed 
in the school building.
    (b) Worker protection. The protection provided by EPA at 40 CFR 
763.121 for worker protection during asbestos abatement projects is 
extended to employees of local education agencies who perform 
operations, maintenance, and repair (O&M) activities involving ACM and 
who are not covered by the OSHA asbestos construction standard at 29 CFR 
1926.58 or an asbestos worker approved by OSHA under section 19 of the 
Occupational Safety and Health Act. Local education agencies may consult 
appendix B of this subpart if their employees are performing operations, 
maintenance, and repair activities that are of small-scale, short-
duration.

[[Page 647]]

    (c) Cleaning--(1) Initial cleaning. Unless the building has been 
cleaned using equivalent methods within the previous 6 months, all areas 
of a school building where friable ACBM, damaged or significantly 
damaged thermal system insulation ACM, or friable suspected ACBM assumed 
to be ACM are present shall be cleaned at least once after the 
completion of the inspection required by Sec. 763.85(a) and before the 
initiation of any response action, other than O&M activities or repair, 
according to the following procedures:
    (i) HEPA-vacuum or steam-clean all carpets.
    (ii) HEPA-vacuum or wet-clean all other floors and all other 
horizontal surfaces.
    (iii) Dispose of all debris, filters, mopheads, and cloths in 
sealed, leak-tight containers.
    (2) Additional cleaning. The accredited management planner shall 
make a written recommendation to the local education agency whether 
additional cleaning is needed, and if so, the methods and frequency of 
such cleaning.
    (d) Operations and maintenance activities. The local education 
agency shall ensure that the procedures described below to protect 
building occupants shall be followed for any operations and maintenance 
activities disturbing friable ACBM:
    (1) Restrict entry into the area by persons other than those 
necessary to perform the maintenance project, either by physically 
isolating the area or by scheduling.
    (2) Post signs to prevent entry by unauthorized persons.
    (3) Shut off or temporarily modify the air-handling system and 
restrict other sources of air movement.
    (4) Use work practices or other controls, such as, wet methods, 
protective clothing, HEPA-vacuums, mini-enclosures, glove bags, as 
necessary to inhibit the spread of any released fibers.
    (5) Clean all fixtures or other components in the immediate work 
area.
    (6) Place the asbestos debris and other cleaning materials in a 
sealed, leak-tight container.
    (e) Maintenance activities other than small-scale, short-duration. 
The response action for any maintenance activities disturbing friable 
ACBM, other than small-scale, short-duration maintenance activities, 
shall be designed by persons accredited to design response actions and 
conducted by persons accredited to conduct response actions.
    (f) Fiber release episodes--(1) Minor fiber release episode. The 
local education agency shall ensure that the procedures described below 
are followed in the event of a minor fiber release episode (i.e., the 
falling or dislodging of 3 square or linear feet or less of friable 
ACBM): 5
    (i) Thoroughly saturate the debris using wet methods.
    (ii) Clean the area, as described in paragraph (e) of this section.
    (iii) Place the asbestos debris in a sealed, leak-tight container.
    (iv) Repair the area of damaged ACM with materials such as asbestos-
free spackling, plaster, cement, or insulation, or seal with latex paint 
or an encapsulant, or immediately have the appropriate response action 
implemented as required by Sec. 763.90.
    (2) Major fiber release episode. The local education agency shall 
ensure that the procedures described below are followed in the event of 
a major fiber release episode (i.e., the falling or dislodging of more 
than 3 square or linear feet of friable ACBM):
    (i) Restrict entry into the area and post signs to prevent entry 
into the area by persons other than those necessary to perform the 
response action.
    (ii) Shut off or temporarily modify the air-handling system to 
prevent the distribution of fibers to other areas in the building.
    (iii) The response action for any major fiber release episode must 
be designed by persons accredited to design response actions and 
conducted by persons accredited to conduct response actions.



Sec. 763.92  Training and periodic surveillance.

    (a) Training. (1) The local education agency shall ensure, prior to 
the implementation of the O&M provisions of the management plan, that 
all members of its maintenance and custodial staff (custodians, 
electricians, heating/air conditioning engineers, plumbers, etc.) who 
may work in a building that contains ACBM receive awareness

[[Page 648]]

training of at least 2 hours, whether or not they are required to work 
with ACBM. New custodial and maintenance employees shall be trained 
within 60 days after commencement of employment. Training shall include, 
but not be limited to:
    (i) Information regarding asbestos and its various uses and forms.
    (ii) Information on the health effects associated with asbestos 
exposure.
    (iii) Locations of ACBM identified throughout each school building 
in which they work.
    (iv) Recognition of damage, deterioration, and delamination of ACBM.
    (v) Name and telephone number of the person designated to carry out 
general local education agency responsibilities under Sec. 763.84 and 
the availability and location of the management plan.
    (2) The local education agency shall ensure that all members of its 
maintenance and custodial staff who conduct any activities that will 
result in the disturbance of ACBM shall receive training described in 
paragraph (a)(1) of this section and 14 hours of additional training. 
Additional training shall include, but not be limited to:
    (i) Descriptions of the proper methods of handling ACBM.
    (ii) Information on the use of respiratory protection as contained 
in the EPA/NIOSH Guide to Respiratory Protection for the Asbestos 
Abatement Industry, September 1986 (EPA 560/OPPTS-86-001), available 
from the Director, Environmental Assistance Division (7408), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room E-543B, 401 M St., SW., Washington, DC, 20460, Telephone: (202) 
554-1404, TDD: (202) 544-0551 and other personal protection measures.
    (iii) The provisions of this section and Sec. 763.91, Appendices A, 
B, C, D of this subpart E of this part, EPA regulations contained in 40 
CFR part 763, subpart G, and in 40 CFR part 61, subpart M, and OSHA 
regulations contained in 29 CFR 1926.58.
    (iv) Hands-on training in the use of respiratory protection, other 
personal protection measures, and good work practices.
    (3) Local education agency maintenance and custodial staff who have 
attended EPA-approved asbestos training or received equivalent training 
for O&M and periodic surveillance activities involving asbestos shall be 
considered trained for the purposes of this section.
    (b) Periodic surveillance. (1) At least once every 6 months after a 
management plan is in effect, each local education agency shall conduct 
periodic surveillance in each building that it leases, owns, or 
otherwise uses as a school building that contains ACBM or is assumed to 
contain ACBM.
    (2) Each person performing periodic surveillance shall:
    (i) Visually inspect all areas that are identified in the management 
plan as ACBM or assumed ACBM.
    (ii) Record the date of the surveillance, his or her name, and any 
changes in the condition of the materials.
    (iii) Submit to the person designated to carry out general local 
education agency responsibilities under Sec. 763.84 a copy of such 
record for inclusion in the management plan.

[52 FR 41846, Oct. 30, 1987, as amended at 60 FR 34465, July 3, 1995]



Sec. 763.93  Management plans.

    (a)(1) On or before October 12, 1988, each local education agency 
shall develop an asbestos management plan for each school, including all 
buildings that they lease, own, or otherwise use as school buildings, 
and submit the plan to an Agency designated by the Governor of the State 
in which the local education agency is located. The plan may be 
submitted in stages that cover a portion of the school buildings under 
the authority of the local education agency.
    (2) If a building to be used as part of a school is leased or 
otherwise acquired after October 12, 1988, the local education agency 
shall include the new building in the management plan for the school 
prior to its use as a school building. The revised portions of the 
management plan shall be submitted to the Agency designated by the 
Governor.
    (3) If a local education agency begins to use a building as a school 
after October 12, 1988, the local education agency shall submit a 
management plan for

[[Page 649]]

the school to the Agency designated by the Governor prior to its use as 
a school.
    (b) On or before October 17, 1987, the Governor of each State shall 
notify local education agencies in the State regarding where to submit 
their management plans. States may establish administrative procedures 
for reviewing management plans. If the Governor does not disapprove a 
management plan within 90 days after receipt of the plan, the local 
education agency shall implement the plan.
    (c) Each local education agency must begin implementation of its 
management plan on or before July 9, 1989, and complete implementation 
in a timely fashion.
    (d) Each local education agency shall maintain and update its 
management plan to keep it current with ongoing operations and 
maintenance, periodic surveillance, inspection, reinspection, and 
response action activities. All provisions required to be included in 
the management plan under this section shall be retained as part of the 
management plan, as well as any information that has been revised to 
bring the plan up-to-date.
    (e) The management plan shall be developed by an accredited 
management planner and shall include:
    (1) A list of the name and address of each school building and 
whether the school building contains friable ACBM, nonfriable ACBM, and 
friable and nonfriable suspected ACBM assumed to be ACM.
    (2) For each inspection conducted before the December 14, 1987:
    (i) The date of the inspection.
    (ii) A blueprint, diagram, or written description of each school 
building that identifies clearly each location and approximate square or 
linear footage of any homogeneous or sampling area where material was 
sampled for ACM, and, if possible, the exact locations where bulk 
samples were collected, and the dates of collection.
    (iii) A copy of the analyses of any bulk samples, dates of analyses, 
and a copy of any other laboratory reports pertaining to the analyses.
    (iv) A description of any response actions or preventive measures 
taken to reduce asbestos exposure, including if possible, the names and 
addresses of all contractors involved, start and completion dates of the 
work, and results of any air samples analyzed during and upon completion 
of the work.
    (v) A description of assessments, required to be made under 
Sec. 763.88, of material that was identified before December 14, 1987, 
as friable ACBM or friable suspected ACBM assumed to be ACM, and the 
name and signature, State of accreditation, and if applicable, 
accreditation number of each accredited person making the assessments.
    (3) For each inspection and reinspection conducted under 
Sec. 763.85:
    (i) The date of the inspection or reinspection and the name and 
signature, State of accreditation and, if applicable, the accreditation 
number of each accredited inspector performing the inspection or 
reinspection.
    (ii) A blueprint, diagram, or written description of each school 
building that identifies clearly each location and approximate square or 
linear footage of homogeneous areas where material was sampled for ACM, 
the exact location where each bulk sample was collected, date of 
collection, homogeneous areas where friable suspected ACBM is assumed to 
be ACM, and where nonfriable suspected ACBM is assumed to be ACM.
    (iii) A description of the manner used to determine sampling 
locations, and the name and signature of each accredited inspector 
collecting samples, the State of accreditation, and if applicable, his 
or her accreditation number.
    (iv) A copy of the analyses of any bulk samples collected and 
analyzed, the name and address of any laboratory that analyzed bulk 
samples, a statement that the laboratory meets the applicable 
requirements of Sec. 763.87(a) the date of analysis, and the name and 
signature of the person performing the analysis.
    (v) A description of assessments, required to be made under 
Sec. 763.88, of all ACBM and suspected ACBM assumed to be ACM, and the 
name, signature, State of accreditation, and if applicable, 
accreditation number of each accredited person making the assessments.
    (4) The name, address, and telephone number of the person designated 
under

[[Page 650]]

Sec. 763.84 to ensure that the duties of the local education agency are 
carried out, and the course name, and dates and hours of training taken 
by that person to carry out the duties.
    (5) The recommendations made to the local education agency regarding 
response actions, under Sec. 763.88(d), the name, signature, State of 
accreditation of each person making the recommendations, and if 
applicable, his or her accreditation number.
    (6) A detailed description of preventive measures and response 
actions to be taken, including methods to be used, for any friable ACBM, 
the locations where such measures and action will be taken, reasons for 
selecting the response action or preventive measure, and a schedule for 
beginning and completing each preventive measure and response action.
    (7) With respect to the person or persons who inspected for ACBM and 
who will design or carry out response actions, except for operations and 
maintenance, with respect to the ACBM, one of the following statements:
    (i) If the State has adopted a contractor accreditation program 
under section 206(b) of Title II of the Act, a statement that the 
person(s) is accredited under such plan.
    (ii) A statement that the local education agency used (or will use) 
persons who have been accredited by another State which has adopted a 
contractor accreditation plan under section 206(b) of Title II of the 
Act or is accredited by an EPA-approved course under section 206(c) of 
Title II of the Act.
    (8) A detailed description in the form of a blueprint, diagram, or 
in writing of any ACBM or suspected ACBM assumed to be ACM which remains 
in the school once response actions are undertaken pursuant to 
Sec. 763.90. This description shall be updated as response actions are 
completed.
    (9) A plan for reinspection under Sec. 763.85, a plan for operations 
and maintenance activities under Sec. 763.91, and a plan for periodic 
surveillance under Sec. 763.92, a description of the recommendation made 
by the management planner regarding additional cleaning under 
Sec. 763.91(c)(2) as part of an operations and maintenance program, and 
the response of the local education agency to that recommendation.
    (10) A description of steps taken to inform workers and building 
occupants, or their legal guardians, about inspections, reinspections, 
response actions, and post-response action activities, including 
periodic reinspection and surveillance activities that are planned or in 
progress.
    (11) An evaluation of the resources needed to complete response 
actions successfully and carry out reinspection, operations and 
maintenance activities, periodic surveillance and training.
    (12) With respect to each consultant who contributed to the 
management plan, the name of the consultant and one of the following 
statements:
    (i) If the State has adopted a contractor accreditation plan under 
section 206(b) of Title II of the Act, a statement that the consultant 
is accredited under such plan.
    (ii) A statement that the contractor is accredited by another State 
which has adopted a contractor accreditation plan under section 206(b) 
of Title II of the Act, or is accredited by an EPA-approved course 
developed under section 206(c) of Title II of the Act.
    (f) A local education agency may require each management plan to 
contain a statement signed by an accredited management plan developer 
that such person has prepared or assisted in the preparation of such 
plan or has reviewed such plan, and that such plan is in compliance with 
this subpart E. Such statement may not be signed by a person who, in 
addition to preparing or assisting in preparing the management plan, 
also implements (or will implement) the management plan.
    (g)(1) Upon submission of a management plan to the Governor for 
review, a local education agency shall keep a copy of the plan in its 
administrative office. The management plans shall be available, without 
cost or restriction, for inspection by representatives of EPA and the 
State, the public, including teachers, other school personnel and their 
representatives, and parents. The local education agency may charge a 
reasonable cost to make copies of management plans.

[[Page 651]]

    (2) Each local education agency shall maintain in its administrative 
office a complete, updated copy of a management plan for each school 
under its administrative control or direction. The management plans 
shall be available, during normal business hours, without cost or 
restriction, for inspection by representatives of EPA and the State, the 
public, including teachers, other school personnel and their 
representatives, and parents. The local education agency may charge a 
reasonable cost to make copies of management plans.
    (3) Each school shall maintain in its administrative office a 
complete, updated copy of the management plan for that school. 
Management plans shall be available for inspection, without cost or 
restriction, to workers before work begins in any area of a school 
building. The school shall make management plans available for 
inspection to representatives of EPA and the State, the public, 
including parents, teachers, and other school personnel and their 
representatives within 5 working days after receiving a request for 
inspection. The school may charge a reasonable cost to make copies of 
the management plan.
    (4) Upon submission of its management plan to the Governor and at 
least once each school year, the local education agency shall notify in 
writing parent, teacher, and employee organizations of the availability 
of management plans and shall include in the management plan a 
description of the steps taken to notify such organizations, and a dated 
copy of the notification. In the absence of any such organizations for 
parents, teachers, or employees, the local education agency shall 
provide written notice to that relevant group of the availability of 
management plans and shall include in the management plan a description 
of the steps taken to notify such groups, and a dated copy of the 
notification.
    (h) Records required under Sec. 763.94 shall be made by local 
education agencies and maintained as part of the management plan.
    (i) Each management plan must contain a true and correct statement, 
signed by the individual designated by the local education agency under 
Sec. 763.84, which certifies that the general, local education agency 
responsibilities, as stipulated by Sec. 763.84, have been met or will be 
met.



Sec. 763.94  Recordkeeping.

    (a) Records required under this section shall be maintained in a 
centralized location in the administrative office of both the school and 
the local education agency as part of the management plan. For each 
homogeneous area where all ACBM has been removed, the local education 
agency shall ensure that such records are retained for 3 years after the 
next reinspection required under Sec. 763.85(b)(1), or for an equivalent 
period.
    (b) For each preventive measure and response action taken for 
friable and nonfriable ACBM and friable and nonfriable suspected ACBM 
assumed to be ACM, the local education agency shall provide:
    (1) A detailed written description of the measure or action, 
including methods used, the location where the measure or action was 
taken, reasons for selecting the measure or action, start and completion 
dates of the work, names and addresses of all contractors involved, and 
if applicable, their State of accreditation, and accreditation numbers, 
and if ACBM is removed, the name and location of storage or disposal 
site of the ACM.
    (2) The name and signature of any person collecting any air sample 
required to be collected at the completion of certain response actions 
specified by Sec. 763.90(i), the locations where samples were collected, 
date of collection, the name and address of the laboratory analyzing the 
samples, the date of analysis, the results of the analysis, the method 
of analysis, the name and signature of the person performing the 
analysis, and a statement that the laboratory meets the applicable 
requirements of Sec. 763.90(i)(2)(ii).
    (c) For each person required to be trained under Sec. 763.92(a) (1) 
and (2), the local education agency shall provide the person's name and 
job title, the date that training was completed by that person, the 
location of the training, and the number of hours completed in such 
training.
    (d) For each time that periodic surveillance under Sec. 763.92(b) is 
performed,

[[Page 652]]

the local education agency shall record the name of each person 
performing the surveillance, the date of the surveillance, and any 
changes in the conditions of the materials.
    (e) For each time that cleaning under Sec. 763.91(c) is performed, 
the local education agency shall record the name of each person 
performing the cleaning, the date of such cleaning, the locations 
cleaned, and the methods used to perform such cleaning.
    (f) For each time that operations and maintenance activities under 
Sec. 763.91(d) are performed, the local education agency shall record 
the name of each person performing the activity, the start and 
completion dates of the activity, the locations where such activity 
occurred, a description of the activity including preventive measures 
used, and if ACBM is removed, the name and location of storage or 
disposal site of the ACM.
    (g) For each time that major asbestos activity under Sec. 763.91(e) 
is performed, the local education agency shall provide the name and 
signature, State of accreditation, and if applicable, the accreditation 
number of each person performing the activity, the start and completion 
dates of the activity, the locations where such activity occurred, a 
description of the activity including preventive measures used, and if 
ACBM is removed, the name and location of storage or disposal site of 
the ACM.
    (h) For each fiber release episode under Sec. 763.91(f), the local 
education agency shall provide the date and location of the episode, the 
method of repair, preventive measures or response action taken, the name 
of each person performing the work, and if ACBM is removed, the name and 
location of storage or disposal site of the ACM.

(Approved by the Office of Management and Budget under control number 
2070-0091)



Sec. 763.95  Warning labels.

    (a) The local education agency shall attach a warning label 
immediately adjacent to any friable and nonfriable ACBM and suspected 
ACBM assumed to be ACM located in routine maintenance areas (such as 
boiler rooms) at each school building. This shall include:
    (1) Friable ACBM that was responded to by a means other than 
removal.
    (2) ACBM for which no response action was carried out.
    (b) All labels shall be prominently displayed in readily visible 
locations and shall remain posted until the ACBM that is labeled is 
removed.
    (c) The warning label shall read, in print which is readily visible 
because of large size or bright color, as follows:

CAUTION: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND 
EQUIPMENT.



Sec. 763.97  Compliance and enforcement.

    (a) Compliance with Title II of the Act. (1) Section 207(a) of Title 
II of the Act (15 U.S.C. 2647) makes it unlawful for any local education 
agency to:
    (i) Fail to conduct inspections pursuant to section 203(b) of Title 
II of the Act, including failure to follow procedures and failure to use 
accredited personnel and laboratories.
    (ii) Knowingly submit false information to the Governor regarding 
any inspection pursuant to regulations under section 203(i) of Title II 
of the Act.
    (iii) Fail to develop a management plan pursuant to regulations 
under section 203(i) of Title II of the Act.
    (2) Section 207(a) of Title II of the Act (15 U.S.C. 2647) also 
provides that any local education agency which violates any provision of 
section 207 shall be liable for a civil penalty of not more than $5,000 
for each day during which the violation continues. For the purposes of 
this subpart, a ``violation'' means a failure to comply with respect to 
a single school building.
    (b) Compliance with Title I of the Act. (1) Section 15(1)(D) of 
Title I of the Act (15 U.S.C. 2614) makes it unlawful for any person to 
fail or refuse to comply with any requirement of Title II or any rule 
promulgated or order issued under Title II. Therefore, any person who 
violates any requirement of this subpart is in violation of section 15 
of Title I of the Act.
    (2) Section 15(3) of Title I of the Act (15 U.S.C. 2614) makes it 
unlawful for any person to fail or refuse to establish or maintain 
records, submit reports, notices or other information, or permit

[[Page 653]]

access to or copying of records, as required by this Act or a rule 
thereunder.
    (3) Section 15(4) (15 U.S.C. 2614) of Title I of the Act makes it 
unlawful for any person to fail or refuse to permit entry or inspection 
as required by section 11 of Title I of the Act.
    (4) Section 16(a) of Title I of the Act (15 U.S.C. 2615) provides 
that any person who violates any provision of section 15 of Title I of 
the Act shall be liable to the United States for a civil penalty in an 
amount not to exceed $25,000 for each such violation. Each day such a 
violation continues shall, for purposes of this paragraph, constitute a 
separate violation of section 15. A local education agency is not liable 
for any civil penalty under Title I of the Act for failing or refusing 
to comply with any rule promulgated or order issued under Title II of 
the Act.
    (c) Criminal penalties. If any violation committed by any person 
(including a local education agency) is knowing or willful, criminal 
penalties may be assessed under section 16(b) of Title I of the Act.
    (d) Injunctive relief. The Agency may obtain injunctive relief under 
section 208(b) of Title II of the Act to respond to a hazard which poses 
an imminent and substantial endangerment to human health or the 
environment or section 17 (15 U.S.C. 2616) of Title I of the Act to 
restrain any violation of section 15 of Title I of the Act or to compel 
the taking of any action required by or under Title I of the Act.
    (e) Citizen complaints. Any citizen who wishes to file a complaint 
pursuant to section 207(d) of Title II of the Act should direct the 
complaint to the Governor of the State or the EPA Asbestos Ombudsman, 
401 M Street, SW., Washington, DC 20460. The citizen complaint should be 
in writing and identified as a citizen complaint pursuant to section 
207(d) of Title II of TSCA. The EPA Asbestos Ombudsman or the Governor 
shall investigate and respond to the complaint within a reasonable 
period of time if the allegations provide a reasonable basis to believe 
that a violation of the Act has occurred.
    (f) Inspections. EPA may conduct inspections and review management 
plans under section 11 of Title I of the Act (15 U.S.C. 2610) to ensure 
compliance.



Sec. 763.98  Waiver; delegation to State.

    (a) General. (1) Upon request from a State Governor and after notice 
and comment and an opportunity for a public hearing in accordance with 
paragraphs (b) and (c) of this section, EPA may waive some or all of the 
requirements of this subpart E if the State has established and is 
implementing or intends to implement a program of asbestos inspection 
and management that contains requirements that are at least as stringent 
as the requirements of this subpart E.
    (2) A waiver from any requirement of this subpart E shall apply only 
to the specific provision for which a waiver has been granted under this 
section. All requirements of this subpart E shall apply until a waiver 
is granted under this section.
    (b) Request. Each request by a Governor to waive any requirement of 
this subpart E shall be sent with three complete copies of the request 
to the Regional Administrator for the EPA Region in which the State is 
located and shall include:
    (1) A copy of the State provisions or proposed provisions relating 
to its program of asbestos inspection and management in schools for 
which the request is made.
    (2)(i) The name of the State agency that is or will be responsible 
for administering and enforcing the requirements for which a waiver is 
requested, the names and job titles of responsible officials in that 
agency, and phone numbers where the officials can be contacted.
    (ii) In the event that more than one agency is or will be 
responsible for administering and enforcing the requirements for which a 
waiver is requested, a description of the functions to be performed by 
each agency, how the program will be coordinated by the lead agency to 
ensure consistency and effective administration in the asbestos 
inspection and management program within the State, the names and job 
titles of responsible officials in the agencies, and phone numbers where 
the officials can be contacted. The lead agency

[[Page 654]]

will serve as the central contact point for the EPA.
    (3) Detailed reasons, supporting papers, and the rationale for 
concluding that the State's asbestos inspection and management program 
provisions for which the request is made are at least as stringent as 
the requirements of this subpart E.
    (4) A discussion of any special situations, problems, and needs 
pertaining to the waiver request accompanied by an explanation of how 
the State intends to handle them.
    (5) A statement of the resources that the State intends to devote to 
the administration and enforcement of the provisions relating to the 
waiver request.
    (6) Copies of any specific or enabling State laws (enacted and 
pending enactment) and regulations (promulgated and pending 
promulgation) relating to the request, including provisions for 
assessing criminal and/or civil penalties.
    (7) Assurance from the Governor, the Attorney General, or the legal 
counsel of the lead agency that the lead agency or other cooperating 
agencies have the legal authority necessary to carry out the 
requirements relating to the request.
    (c) General notice--hearing. (1) Within 30 days after receipt of a 
request for a waiver, EPA will determine the completeness of the 
request. If EPA does not request further information within the 30-day 
period, the request will be deemed complete.
    (2) Within 30 days after EPA determines that a request is complete, 
EPA will issue for publication in the Federal Register a notice that 
announces receipt of the request, describes the information submitted 
under paragraph (b) of this section, and solicits written comment from 
interested members of the public. Comments must be submitted within 60 
days.
    (3) If, during the comment period, EPA receives a written objection 
to a Governor's request and a request for a public hearing detailing 
specific objections to the granting of a waiver, EPA will schedule a 
public hearing to be held in the affected State after the close of the 
comment period and will announce the public hearing date in the Federal 
Register before the date of the hearing. Each comment shall include the 
name and address of the person submitting the comment.
    (d) Criteria. EPA may waive some or all of the requirements of 
subpart E of this part if:
    (1) The State's lead agency and other cooperating agencies have the 
legal authority necessary to carry out the provisions of asbestos 
inspection and management in schools relating to the waiver request.
    (2) The State's program of asbestos inspection and management in 
schools relating to the waiver request and implementation of the program 
are or will be at least as stringent as the requirements of this subpart 
E.
    (3) The State has an enforcement mechanism to allow it to implement 
the program described in the waiver request.
    (4) The lead agency and any cooperating agencies have or will have 
qualified personnel to carry out the provisions relating to the waiver 
request.
    (5) The State will devote adequate resources to the administration 
and enforcement of the asbestos inspection and management provisions 
relating to the waiver request.
    (6) When specified by EPA, the State gives satisfactory assurances 
that necessary steps, including specific actions it proposes to take and 
a time schedule for their accomplishment, will be taken within a 
reasonable time to conform with applicable criteria under paragraphs (d) 
(2) through (4) of this section.
    (e) Decision. EPA will issue for publication in the Federal Register 
a notice announcing its decision to grant or deny, in whole or in part, 
a Governor's request for a waiver from some or all of the requirements 
of this subpart E within 30 days after the close of the comment period 
or within 30 days following a public hearing, whichever is applicable. 
The notice will include the Agency's reasons and rationale for granting 
or denying the Governor's request. The 30-day period may be extended if 
mutually agreed upon by EPA and the State.
    (f) Modifications. When any substantial change is made in the 
administration or enforcement of a State program

[[Page 655]]

for which a waiver was granted under this section, a responsible 
official in the lead agency shall submit such changes to EPA.
    (g) Reports. The lead agency in each State that has been granted a 
waiver by EPA from any requirement of subpart E of this part shall 
submit a report to the Regional Administrator for the Region in which 
the State is located at least once every 12 months to include the 
following information:
    (1) A summary of the State's implementation and enforcement 
activities during the last reporting period relating to provisions 
waived under this section, including enforcement actions taken.
    (2) Any changes in the administration or enforcement of the State 
program implemented during the last reporting period.
    (3) Other reports as may be required by EPA to carry out effective 
oversight of any requirement of this subpart E that was waived under 
this section.
    (h) Oversight. EPA may periodically evaluate the adequacy of a 
State's implementation and enforcement of and resources devoted to 
carrying out requirements relating to the waiver. This evaluation may 
include, but is not limited to, site visits to local education agencies 
without prior notice to the State.
    (i) Informal conference. (1) EPA may request that an informal 
conference be held between appropriate State and EPA officials when EPA 
has reason to believe that a State has failed to:
    (i) Substantially comply with the terms of any provision that was 
waived under this section.
    (ii) Meet the criteria under paragraph (d) of this section, 
including the failure to carry out enforcement activities or act on 
violations of the State program.
    (2) EPA will:
    (i) Specify to the State those aspects of the State's program 
believed to be inadequate.
    (ii) Specify to the State the facts that underlie the belief of 
inadequacy.
    (3) If EPA finds, on the basis of information submitted by the State 
at the conference, that deficiencies did not exist or were corrected by 
the State, no further action is required.
    (4) Where EPA finds that deficiencies in the State program exist, a 
plan to correct the deficiencies shall be negotiated between the State 
and EPA. The plan shall detail the deficiencies found in the State 
program, specify the steps the State has taken or will take to remedy 
the deficiencies, and establish a schedule for each remedial action to 
be initiated.
    (j) Rescission. (1) If the State fails to meet with EPA or fails to 
correct deficiencies raised at the informal conference, EPA will deliver 
to the Governor of the State and a responsible official in the lead 
agency a written notice of its intent to rescind, in whole or part, the 
waiver.
    (2) EPA will issue for publication in the Federal Register a notice 
that announces the rescission of the waiver, describes those aspects of 
the State's program determined to be inadequate, and specifies the facts 
that underlie the findings of inadequacy.



Sec. 763.99  Exclusions.

    (a) A local education agency shall not be required to perform an 
inspection under Sec. 763.85(a) in any sampling area as defined in 40 
CFR 763.103 or homogeneous area of a school building where:
    (1) An accredited inspector has determined that, based on sampling 
records, friable ACBM was identified in that homogeneous or sampling 
area during an inspection conducted before December 14, 1987. The 
inspector shall sign and date a statement to that effect with his or her 
State of accreditation and if applicable, accreditation number and, 
within 30 days after such determination, submit a copy of the statement 
to the person designated under Sec. 763.84 for inclusion in the 
management plan. However, an accredited inspector shall assess the 
friable ACBM under Sec. 763.88.
    (2) An accredited inspector has determined that, based on sampling 
records, nonfriable ACBM was identified in that homogeneous or sampling 
area during an inspection conducted before December 14, 1987. The 
inspector shall sign and date a statement to that effect with his or her 
State of accreditation and if applicable, accreditation number

[[Page 656]]

and, within 30 days after such determination, submit a copy of the 
statement to the person designated under Sec. 763.84 for inclusion in 
the management plan. However, an accredited inspector shall identify 
whether material that was nonfriable has become friable since that 
previous inspection and shall assess the newly-friable ACBM under 
Sec. 763.88.
    (3) Based on sampling records and inspection records, an accredited 
inspector has determined that no ACBM is present in the homogeneous or 
sampling area and the records show that the area was sampled, before 
December 14, 1987 in substantial compliance with Sec. 763.85(a), which 
for purposes of this section means in a random manner and with a 
sufficient number of samples to reasonably ensure that the area is not 
ACBM.
    (i) The accredited inspector shall sign and date a statement, with 
his or her State of accreditation and if applicable, accreditation 
number that the homogeneous or sampling area determined not to be ACBM 
was sampled in substantial compliance with Sec. 763.85(a).
    (ii) Within 30 days after the inspector's determination, the local 
education agency shall submit a copy of the inspector's statement to the 
EPA Regional Office and shall include the statement in the management 
plan for that school.
    (4) The lead agency responsible for asbestos inspection in a State 
that has been granted a waiver from Sec. 763.85(a) has determined that, 
based on sampling records and inspection records, no ACBM is present in 
the homogeneous or sampling area and the records show that the area was 
sampled before December 14, 1987, in substantial compliance with 
Sec. 763.85(a). Such determination shall be included in the management 
plan for that school.
    (5) An accredited inspector has determined that, based on records of 
an inspection conducted before December 14, 1987, suspected ACBM 
identified in that homogeneous or sampling area is assumed to be ACM. 
The inspector shall sign and date a statement to that effect, with his 
or her State of accreditation and if applicable, accreditation number 
and, within 30 days of such determination, submit a copy of the 
statement to the person designated under Sec. 763.84 for inclusion in 
the management plan. However, an accredited inspector shall identify 
whether material that was nonfriable suspected ACBM assumed to be ACM 
has become friable since the previous inspection and shall assess the 
newly friable material and previously identified friable suspected ACBM 
assumed to be ACM under Sec. 763.88.
    (6) Based on inspection records and contractor and clearance 
records, an accredited inspector has determined that no ACBM is present 
in the homogeneous or sampling area where asbestos removal operations 
have been conducted before December 14, 1987, and shall sign and date a 
statement to that effect and include his or her State of accreditation 
and, if applicable, accreditation number. The local education agency 
shall submit a copy of the statement to the EPA Regional Office and 
shall include the statement in the management plan for that school.
    (7) An architect or project engineer responsible for the 
construction of a new school building built after October 12, 1988, or 
an accredited inspector signs a statement that no ACBM was specified as 
a building material in any construction document for the building, or, 
to the best of his or her knowledge, no ACBM was used as a building 
material in the building. The local education agency shall submit a copy 
of the signed statement of the architect, project engineer, or 
accredited inspector to the EPA Regional Office and shall include the 
statement in the management plan for that school.
    (b) The exclusion, under paragraphs (a) (1) through (4) of this 
section, from conducting the inspection under Sec. 763.85(a) shall apply 
only to homogeneous or sampling areas of a school building that were 
inspected and sampled before October 17, 1987. The local education 
agency shall conduct an inspection under Sec. 763.85(a) of all areas 
inspected before October 17, 1987, that were not sampled or were not 
assumed to be ACM.
    (c) If ACBM is subsequently found in a homogeneous or sampling area 
of a local education agency that had been identified as receiving an 
exclusion by

[[Page 657]]

an accredited inspector under paragraphs (a) (3), (4), (5) of this 
section, or an architect, project engineer or accredited inspector under 
paragraph (a)(7) of this section, the local education agency shall have 
180 days following the date of identification of ACBM to comply with 
this subpart E.

   Appendix A to Subpart E--Interim Transmission Electron Microscopy 
Analytical Methods--Mandatory and Nonmandatory--and Mandatory Section to 
                Determine Completion of Response Actions

                             I. Introduction

    The following appendix contains three units. The first unit is the 
mandatory transmission electron microscopy (TEM) method which all 
laboratories must follow; it is the minimum requirement for analysis of 
air samples for asbestos by TEM. The mandatory method contains the 
essential elements of the TEM method. The second unit contains the 
complete non-mandatory method. The non-mandatory method supplements the 
mandatory method by including additional steps to improve the analysis. 
EPA recommends that the non-mandatory method be employed for analyzing 
air filters; however, the laboratory may choose to employ the mandatory 
method. The non-mandatory method contains the same minimum requirements 
as are outlined in the mandatory method. Hence, laboratories may choose 
either of the two methods for analyzing air samples by TEM.
    The final unit of this Appendix A to subpart E defines the steps 
which must be taken to determine completion of response actions. This 
unit is mandatory.

          II. Mandatory Transmission Electron Microscopy Method

                         A. Definitions of Terms

    1. Analytical sensitivity--Airborne asbestos concentration 
represented by each fiber counted under the electron microscope. It is 
determined by the air volume collected and the proportion of the filter 
examined. This method requires that the analytical sensitivity be no 
greater than 0.005 structures/cm\3\.
    2. Asbestiform--A specific type of mineral fibrosity in which the 
fibers and fibrils possess high tensile strength and flexibility.
    3. Aspect ratio--A ratio of the length to the width of a particle. 
Minimum aspect ratio as defined by this method is equal to or greater 
than 5:1.
    4. Bundle--A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    5. Clean area--A controlled environment which is maintained and 
monitored to assure a low probability of asbestos contamination to 
materials in that space. Clean areas used in this method have HEPA 
filtered air under positive pressure and are capable of sustained 
operation with an open laboratory blank which on subsequent analysis has 
an average of less than 18 structures/mm\2\ in an area of 0.057 mm\2\ 
(nominally 10 200-mesh grid openings) and a maximum of 53 structures/
mm\2\ for any single preparation for that same area.
    6. Cluster--A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    7. ED--Electron diffraction.
    8. EDXA--Energy dispersive X-ray analysis.
    9. Fiber--A structure greater than or equal to 0.5 m in 
length with an aspect ratio (length to width) of 5:1 or greater and 
having substantially parallel sides.
    10. Grid--An open structure for mounting on the sample to aid in its 
examination in the TEM. The term is used here to denote a 200-mesh 
copper lattice approximately 3 mm in diameter.
    11. Intersection--Nonparallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater.
    12. Laboratory sample coordinator--That person responsible for the 
conduct of sample handling and the certification of the testing 
procedures.
    13. Filter background level--The concentration of structures per 
square millimeter of filter that is considered indistinguishable from 
the concentration measured on a blank (filters through which no air has 
been drawn). For this method the filter background level is defined as 
70 structures/mm\2\.
    14. Matrix--Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    15. NSD--No structure detected.
    16. Operator--A person responsible for the TEM instrumental analysis 
of the sample.
    17. PCM--Phase contrast microscopy.
    18. SAED--Selected area electron diffraction.
    19. SEM--Scanning electron microscope.
    20. STEM--Scanning transmission electron microscope.
    21. Structure--a microscopic bundle, cluster, fiber, or matrix which 
may contain asbestos.
    22. S/cm\3\--Structures per cubic centimeter.
    23. S/mm\2\--Structures per square millimeter.
    24. TEM--Transmission electron microscope.

[[Page 658]]

                               B. Sampling

    1. The sampling agency must have written quality control procedures 
and documents which verify compliance.
    2. Sampling operations must be performed by qualified individuals 
completely independent of the abatement contractor to avoid possible 
conflict of interest (References 1, 2, 3, and 5 of Unit II.J.).
    3. Sampling for airborne asbestos following an abatement action must 
use commercially available cassettes.
    4. Prescreen the loaded cassette collection filters to assure that 
they do not contain concentrations of asbestos which may interfere with 
the analysis of the sample. A filter blank average of less than 18 s/
mm\2\ in an area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) 
and a single preparation with a maximum of 53 s/mm\2\ for that same area 
is acceptable for this method.
    5. Use sample collection filters which are either polycarbonate 
having a pore size less than or equal to 0.4 m or mixed 
cellulose ester having a pore size less than or equal to 0.45 
m.
    6. Place these filters in series with a 5.0 m backup filter 
(to serve as a diffuser) and a support pad. See the following Figure 1:

[[Page 659]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.001

    7. Reloading of used cassettes is not permitted.
    8. Orient the cassette downward at approximately 45 degrees from the 
horizontal.
    9. Maintain a log of all pertinent sampling information.

[[Page 660]]

    10. Calibrate sampling pumps and their flow indicators over the 
range of their intended use with a recognized standard. Assemble the 
sampling system with a representative filter (not the filter which will 
be used in sampling) before and after the sampling operation.
    11. Record all calibration information.
    12. Ensure that the mechanical vibrations from the pump will be 
minimized to prevent transferral of vibration to the cassette.
    13. Ensure that a continuous smooth flow of negative pressure is 
delivered by the pump by damping out any pump action fluctuations if 
necessary.
    14. The final plastic barrier around the abatement area remains in 
place for the sampling period.
    15. After the area has passed a thorough visual inspection, use 
aggressive sampling conditions to dislodge any remaining dust. (See 
suggested protocol in Unit III.B.7.d.)
    16. Select an appropriate flow rate equal to or greater than 1 liter 
per minute (L/min) or less than 10 L/min for 25 mm cassettes. Larger 
filters may be operated at proportionally higher flow rates.
    17. A minimum of 13 samples are to be collected for each testing 
site consisting of the following:
    a. A minimum of five samples per abatement area.
    b. A minimum of five samples per ambient area positioned at 
locations representative of the air entering the abatement site.
    c. Two field blanks are to be taken by removing the cap for not more 
than 30 seconds and replacing it at the time of sampling before sampling 
is initiated at the following places:
    i. Near the entrance to each abatement area.
    ii. At one of the ambient sites. (DO NOT leave the field blanks open 
during the sampling period.)
    d. A sealed blank is to be carried with each sample set. This 
representative cassette is not to be opened in the field.
    18. Perform a leak check of the sampling system at each indoor and 
outdoor sampling site by activating the pump with the closed sampling 
cassette in line. Any flow indicates a leak which must be eliminated 
before initiating the sampling operation.
    19. The following Table I specifies volume ranges to be used:

[[Page 661]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.002

    20. Ensure that the sampler is turned upright before interrupting 
the pump flow.
    21. Check that all samples are clearly labeled and that all 
pertinent information has been enclosed before transfer of the samples 
to the laboratory.
    22. Ensure that the samples are stored in a secure and 
representative location.
    23. Do not change containers if portions of these filters are taken 
for other purposes.
    24. A summary of Sample Data Quality Objectives is shown in the 
following Table II:

[[Page 662]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.003

                           C. Sample Shipment

    Ship bulk samples to the analytical laboratory in a separate 
container from air samples.

                           D. Sample Receiving

    1. Designate one individual as sample coordinator at the laboratory. 
While that individual will normally be available to receive samples, the 
coordinator may train and supervise others in receiving procedures for 
those times when he/she is not available.
    2. Bulk samples and air samples delivered to the analytical 
laboratory in the same container shall be rejected.

                          E. Sample Preparation

    1. All sample preparation and analysis shall be performed by a 
laboratory independent of the abatement contractor.
    2. Wet-wipe the exterior of the cassettes to minimize contamination 
possibilities before taking them into the clean room facility.
    3. Perform sample preparation in a well-equipped clean facility.
    Note: The clean area is required to have the following 
minimum characteristics. The area or hood must be capable of maintaining 
a positive pressure with make-up air being HEPA-filtered. The cumulative 
analytical blank concentration must average less than 18 s/mm\2\ in an 
area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) and a single 
preparation with a maximum of 53  s/mm\2\ for that same area.
    4. Preparation areas for air samples must not only be separated from 
preparation areas for bulk samples, but they must be prepared in 
separate rooms.
    5. Direct preparation techniques are required. The object is to 
produce an intact film containing the particulates of the filter surface 
which is sufficiently clear for TEM analysis.
    a. TEM Grid Opening Area measurement must be done as follows:
    i. The filter portion being used for sample preparation must have 
the surface collapsed using an acetone vapor technique.
    ii. Measure 20 grid openings on each of 20 random 200-mesh copper 
grids by placing a grid on a glass and examining it under the PCM. Use a 
calibrated graticule to measure the average field diameters. From the 
data, calculate the field area for an average grid opening.
    iii. Measurements can also be made on the TEM at a properly 
calibrated low magnification or on an optical microscope at a 
magnification of approximately 400X by using an eyepiece fitted with a 
scale that has been calibrated against a stage micrometer. Optical 
microscopy utilizing manual or automated procedures may be used 
providing instrument calibration can be verified.
    b. TEM specimen preparation from polycarbonate (PC) filters. 
Procedures as described in Unit III.G. or other equivalent methods may 
be used.
    c. TEM specimen preparation from mixed cellulose ester (MCE) 
filters.
    i. Filter portion being used for sample preparation must have the 
surface collapsed using an acetone vapor technique or the Burdette 
procedure (Ref. 7 of Unit II.J.)
    ii. Plasma etching of the collapsed filter is required. The 
microscope slide to which the collapsed filter pieces are attached is 
placed in a plasma asher. Because plasma ashers vary greatly in their 
performance, both from unit to unit and between different positions in 
the asher chamber, it is difficult to specify the conditions that should 
be used. Insufficient etching will result in a failure to expose 
embedded filters, and too much etching may result in loss of particulate 
from the surface. As an interim measure, it is recommended that the time 
for ashing of a

[[Page 663]]

known weight of a collapsed filter be established and that the etching 
rate be calculated in terms of micrometers per second. The actual 
etching time used for the particulate asher and operating conditions 
will then be set such that a 1-2 m (10 percent) layer of 
collapsed surface will be removed.
    iii. Procedures as described in Unit III. or other equivalent 
methods may be used to prepare samples.

                              F. TEM Method

    1. An 80-120 kV TEM capable of performing electron diffraction with 
a fluorescent screen inscribed with calibrated gradations is required. 
If the TEM is equipped with EDXA it must either have a STEM attachment 
or be capable of producing a spot less than 250 nm in diameter at 
crossover. The microscope shall be calibrated routinely for 
magnification and camera constant.
    2. Determination of Camera Constant and ED Pattern Analysis. The 
camera length of the TEM in ED operating mode must be calibrated before 
ED patterns on unknown samples are observed. This can be achieved by 
using a carbon-coated grid on which a thin film of gold has been 
sputtered or evaporated. A thin film of gold is evaporated on the 
specimen TEM grid to obtain zone-axis ED patterns superimposed with a 
ring pattern from the polycrystalline gold film. In practice, it is 
desirable to optimize the thickness of the gold film so that only one or 
two sharp rings are obtained on the superimposed ED pattern. Thicker 
gold film would normally give multiple gold rings, but it will tend to 
mask weaker diffraction spots from the unknown fibrous particulate. 
Since the unknown d-spacings of most interest in asbestos analysis are 
those which lie closest to the transmitted beam, multiple gold rings are 
unnecessary on zone-axis ED patterns. An average camera constant using 
multiple gold rings can be determined. The camera constant is one-half 
the diameter of the rings times the interplanar spacing of the ring 
being measured.
    3. Magnification Calibration. The magnification calibration must be 
done at the fluorescent screen. The TEM must be calibrated at the grid 
opening magnification (if used) and also at the magnification used for 
fiber counting. This is performed with a cross grating replica (e.g., 
one containing 2,160 lines/mm). Define a field of view on the 
fluorescent screen either by markings or physical boundaries. The field 
of view must be measurable or previously inscribed with a scale or 
concentric circles (all scales should be metric). A logbook must be 
maintained, and the dates of calibration and the values obtained must be 
recorded. The frequency of calibration depends on the past history of 
the particular microscope. After any maintenance of the microscope that 
involved adjustment of the power supplied to the lenses or the high-
voltage system or the mechanical disassembly of the electron optical 
column apart from filament exchange, the magnification must be 
recalibrated. Before the TEM calibration is performed, the analyst must 
ensure that the cross grating replica is placed at the same distance 
from the objective lens as the specimens are. For instruments that 
incorporate a eucentric tilting specimen stage, all specimens and the 
cross grating replica must be placed at the eucentric position.
    4. While not required on every microscope in the laboratory, the 
laboratory must have either one microscope equipped with energy 
dispersive X-ray analysis or access to an equivalent system on a TEM in 
another laboratory.
    5. Microscope settings: 80-120 kV, grid assessment 250-1,000X, then 
15,000-20,000X screen magnification for analysis.
    6. Approximately one-half (0.5) of the predetermined sample area to 
be analyzed shall be performed on one sample grid preparation and the 
remaining half on a second sample grid preparation.
    7. Individual grid openings with greater than 5 percent openings 
(holes) or covered with greater than 25 percent particulate matter or 
obviously having nonuniform loading must not be analyzed.
    8. Reject the grid if:
    a. Less than 50 percent of the grid openings covered by the replica 
are intact.
    b. The replica is doubled or folded.
    c. The replica is too dark because of incomplete dissolution of the 
filter.
    9. Recording Rules.
    a. Any continuous grouping of particles in which an asbestos fiber 
with an aspect ratio greater than or equal to 5:1 and a length greater 
than or equal to 0.5 m is detected shall be recorded on the 
count sheet. These will be designated asbestos structures and will be 
classified as fibers, bundles, clusters, or matrices. Record as 
individual fibers any contiguous grouping having 0, 1, or 2 definable 
intersections. Groupings having more than 2 intersections are to be 
described as cluster or matrix. An intersection is a nonparallel 
touching or crossing of fibers, with the projection having an aspect 
ratio of 5:1 or greater. See the following Figure 2:

[[Page 664]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.004


[[Page 665]]


[GRAPHIC] [TIFF OMITTED] TC01AP92.005

    i. Fiber. A structure having a minimum length greater than or equal 
to 0.5 m and an aspect ratio (length to width) of 5:1 or 
greater and substantially parallel sides. Note the appearance of the end 
of the fiber, i.e., whether it is flat, rounded or dovetailed.
    ii. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    iii. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    iv. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    b. Separate categories will be maintained for fibers less than 5 
m and for fibers equal to or greater than 5 m in 
length.
    c. Record NSD when no structures are detected in the field.
    d. Visual identification of electron diffraction (ED) patterns is 
required for each asbestos structure counted which would cause the

[[Page 666]]

analysis to exceed the 70 s/mm\2\ concentration. (Generally this means 
the first four fibers identified as asbestos must exhibit an 
identifiable diffraction pattern for chrysotile or amphibole.)
    e. The micrograph number of the recorded diffraction patterns must 
be reported to the client and maintained in the laboratory's quality 
assurance records. In the event that examination of the pattern by a 
qualified individual indicates that the pattern has been misidentified 
visually, the client shall be contacted.
    f. Energy Dispersive X-ray Analysis (EDXA) is required of all 
amphiboles which would cause the analysis results to exceed the 70 s/
mm\2\ concentration. (Generally speaking, the first 4 amphiboles would 
require EDXA.)
    g. If the number of fibers in the nonasbestos class would cause the 
analysis to exceed the 70 s/mm\2\ concentration, the fact that they are 
not asbestos must be confirmed by EDXA or measurement of a zone axis 
diffraction pattern.
    h. Fibers classified as chrysotile must be identified by diffraction 
or X-ray analysis and recorded on a count sheet. X-ray analysis alone 
can be used only after 70 s/mm\2\ have been exceeded for a particular 
sample.
    i. Fibers classified as amphiboles must be identified by X-ray 
analysis and electron diffraction and recorded on the count sheet. (X-
ray analysis alone can be used only after 70 s/mm\2\ have been exceeded 
for a particular sample.)
    j. If a diffraction pattern was recorded on film, record the 
micrograph number on the count sheet.
    k. If an electron diffraction was attempted but no pattern was 
observed, record N on the count sheet.
    l. If an EDXA spectrum was attempted but not observed, record N on 
the count sheet.
    m. If an X-ray analysis spectrum is stored, record the file and disk 
number on the count sheet.
    10. Classification Rules.
    a. Fiber. A structure having a minimum length greater than or equal 
to 0.5 m and an aspect ratio (length to width) of 5:1 or 
greater and substantially parallel sides. Note the appearance of the end 
of the fiber, i.e., whether it is flat, rounded or dovetailed.
    b. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    c. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    d. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    11. After finishing with a grid, remove it from the microscope, and 
replace it in the appropriate grid holder. Sample grids must be stored 
for a minimum of 1 year from the date of the analysis; the sample 
cassette must be retained for a minimum of 30 days by the laboratory or 
returned at the client's request.

                      G. Sample Analytical Sequence

    1. Under the present sampling requirements a minimum of 13 samples 
is to be collected for the clearance testing of an abatement site. These 
include five abatement area samples, five ambient samples, two field 
blanks, and one sealed blank.
    2. Carry out visual inspection of work site prior to air monitoring.
    3. Collect a minimum of 5 air samples inside the work site and 5 
samples outside the work site. The indoor and outdoor samples shall be 
taken during the same time period.
    4. Remaining steps in the analytical sequence are contained in Unit 
IV of this Appendix.

                              H. Reporting

    1. The following information must be reported to the client for each 
sample analyzed:
    a. Concentration in structures per square millimeter and structures 
per cubic centimeter.
    b. Analytical sensitivity used for the analysis.
    c. Number of asbestos structures.
    d. Area analyzed.
    e. Volume of air sampled (which must be initially supplied to lab by 
client).
    f. Copy of the count sheet must be included with the report.
    g. Signature of laboratory official to indicate that the laboratory 
met specifications of the method.
    h. Report form must contain official laboratory identification 
(e.g., letterhead).
    i. Type of asbestos.

     I. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards are to be performed 
along with the sample analysis as indicators that the materials used are 
adequate and the

[[Page 667]]

operations are within acceptable limits. In this way, the quality of the 
data is defined and the results are of known value. These checks and 
tests also provide timely and specific warning of any problems which 
might develop within the sampling and analysis operations. A description 
of these quality control/quality assurance procedures is summarized in 
the following Table III:
[GRAPHIC] [TIFF OMITTED] TC01AP92.006

    1. When the samples arrive at the laboratory, check the samples and 
documentation for completeness and requirements before initiating the 
analysis.
    2. Check all laboratory reagents and supplies for acceptable 
asbestos background levels.
    3. Conduct all sample preparation in a clean room environment 
monitored by laboratory blanks. Testing with blanks must also be done 
after cleaning or servicing the room.
    4. Prepare multiple grids of each sample.

[[Page 668]]

    5. Provide laboratory blanks with each sample batch. Maintain a 
cumulative average of these results. If there are more than 53 fibers/mm 
\2\ per 10 200-mesh grid openings, the system must be checked for 
possible sources of contamination.
    6. Perform a system check on the transmission electron microscope 
daily.
    7. Make periodic performance checks of magnification, electron 
diffraction and energy dispersive X-ray systems as set forth in Table 
III under Unit II.I.
    8. Ensure qualified operator performance by evaluation of replicate 
analysis and standard sample comparisons as set forth in Table III under 
Unit II.I.
    9. Validate all data entries.
    10. Recalculate a percentage of all computations and automatic data 
reduction steps as specified in Table III under Unit II.I.
    11. Record an electron diffraction pattern of one asbestos structure 
from every five samples that contain asbestos. Verify the identification 
of the pattern by measurement or comparison of the pattern with patterns 
collected from standards under the same conditions. The records must 
also demonstrate that the identification of the pattern has been 
verified by a qualified individual and that the operator who made the 
identification is maintaining at least an 80 percent correct visual 
identification based on his measured patterns.
    12. Appropriate logs or records must be maintained by the analytical 
laboratory verifying that it is in compliance with the mandatory quality 
assurance procedures.

                              J. References

    For additional background information on this method, the following 
references should be consulted.
    1. ``Guidance for Controlling Asbestos-Containing Materials in 
Buildings,'' EPA 560/5-85-024, June 1985.
    2. ``Measuring Airborne Asbestos Following an Abatement Action,'' 
USEPA, Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 
1985.
    3. Small, John and E. Steel. Asbestos Standards: Materials and 
Analytical Methods. N.B.S. Special Publication 619, 1982.
    4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. 
Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. 
Information Circular 8751, U.S. Bureau of Mines, 1977.
    5. Quality Assurance Handbook for Air Pollution Measurement System. 
Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and 
Development, 1977.
    6. Method 2A: Direct Measurement of Gas Volume through Pipes and 
Small Ducts. 40 CFR Part 60 Appendix A.
    7. Burdette, G.J., Health & Safety Exec. Research & Lab. Services 
Div., London, ``Proposed Analytical Method for Determination of Asbestos 
in Air.''
    8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI 
Assoc., ``Standard Operating Procedure for Determination of Airborne 
Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate 
Membrane Filters,'' WERL SOP 87-1, March 5, 1987.
    9. NIOSH Method 7402 for Asbestos Fibers, 12-11-86 Draft.
    10. Yamate, G., Agarwall, S.C., Gibbons, R.D., IIT Research 
Institute, ``Methodology for the Measurement of Airborne Asbestos by 
Electron Microscopy,'' Draft report, USEPA Contract 68-02-3266, July 
1984.
    11. ``Guidance to the Preparation of Quality Assurance Project 
Plans,'' USEPA, Office of Pollution Prevention and Toxics, 1984.

        III. Nonmandatory Transmission Electron Microscopy Method

                         A. Definitions of Terms

    1. Analytical sensitivity--Airborne asbestos concentration 
represented by each fiber counted under the electron microscope. It is 
determined by the air volume collected and the proportion of the filter 
examined. This method requires that the analytical sensitivity be no 
greater than 0.005 s/cm\3\.
    2. Asbestiform--A specific type of mineral fibrosity in which the 
fibers and fibrils possess high tensile strength and flexibility.
    3. Aspect ratio--A ratio of the length to the width of a particle. 
Minimum aspect ratio as defined by this method is equal to or greater 
than 5:1.
    4. Bundle--A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    5. Clean area--A controlled environment which is maintained and 
monitored to assure a low probability of asbestos contamination to 
materials in that space. Clean areas used in this method have HEPA 
filtered air under positive pressure and are capable of sustained 
operation with an open laboratory blank which on subsequent analysis has 
an average of less than 18 structures/mm\2\ in an area of 0.057 mm\2\ 
(nominally 10 200 mesh grid openings) and a maximum of 53 structures/
mm\2\ for no more than one single preparation for that same area.
    6. Cluster--A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    7. ED--Electron diffraction.
    8. EDXA--Energy dispersive X-ray analysis.
    9. Fiber--A structure greater than or equal to 0.5 m in 
length with an aspect ratio (length to width) of 5:1 or greater and 
having substantially parallel sides.

[[Page 669]]

    10. Grid--An open structure for mounting on the sample to aid in its 
examination in the TEM. The term is used here to denote a 200-mesh 
copper lattice approximately 3 mm in diameter.
    11. Intersection--Nonparallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater.
    12. Laboratory sample coordinator--That person responsible for the 
conduct of sample handling and the certification of the testing 
procedures.
    13. Filter background level--The concentration of structures per 
square millimeter of filter that is considered indistinguishable from 
the concentration measured on blanks (filters through which no air has 
been drawn). For this method the filter background level is defined as 
70 structures/mm\2\.
    14. Matrix--Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    15. NSD--No structure detected.
    16. Operator--A person responsible for the TEM instrumental analysis 
of the sample.
    17. PCM--Phase contrast microscopy.
    18. SAED--Selected area electron diffraction.
    19. SEM--Scanning electron microscope.
    20. STEM--Scanning transmission electron microscope.
    21. Structure--a microscopic bundle, cluster, fiber, or matrix which 
may contain asbestos.
    22. S/cm\3\--Structures per cubic centimeter.
    23. S/mm\2\--Structures per square millimeter.
    24. TEM--Transmission electron microscope.

                               B. Sampling

    1. Sampling operations must be performed by qualified individuals 
completely independent of the abatement contractor to avoid possible 
conflict of interest (See References 1, 2, and 5 of Unit III.L.) Special 
precautions should be taken to avoid contamination of the sample. For 
example, materials that have not been prescreened for their asbestos 
background content should not be used; also, sample handling procedures 
which do not take cross contamination possibilities into account should 
not be used.
    2. Material and supply checks for asbestos contamination should be 
made on all critical supplies, reagents, and procedures before their use 
in a monitoring study.
    3. Quality control and quality assurance steps are needed to 
identify problem areas and isolate the cause of the contamination (see 
Reference 5 of Unit III.L.). Control checks shall be permanently 
recorded to document the quality of the information produced. The 
sampling firm must have written quality control procedures and documents 
which verify compliance. Independent audits by a qualified consultant or 
firm should be performed once a year. All documentation of compliance 
should be retained indefinitely to provide a guarantee of quality. A 
summary of Sample Data Quality Objectives is shown in Table II of Unit 
II.B.
    4. Sampling materials.
    a. Sample for airborne asbestos following an abatement action using 
commercially available cassettes.
    b. Use either a cowling or a filter-retaining middle piece. 
Conductive material may reduce the potential for particulates to adhere 
to the walls of the cowl.
    c. Cassettes must be verified as ``clean'' prior to use in the 
field. If packaged filters are used for loading or preloaded cassettes 
are purchased from the manufacturer or a distributor, the manufacturer's 
name and lot number should be entered on all field data sheets provided 
to the laboratory, and are required to be listed on all reports from the 
laboratory.
    d. Assemble the cassettes in a clean facility (See definition of 
clean area under Unit III.A.).
    e. Reloading of used cassettes is not permitted.
    f. Use sample collection filters which are either polycarbonate 
having a pore size of less than or equal to 0.4 m or mixed 
cellulose ester having a pore size of less than or equal to 0.45 
m.
    g. Place these filters in series with a backup filter with a pore 
size of 5.0 m (to serve as a diffuser) and a support pad. See 
the following Figure 1:

[[Page 670]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.007

    h. When polycarbonate filters are used, position the highly 
reflective face such that the incoming particulate is received on this 
surface.
    i. Seal the cassettes to prevent leakage around the filter edges or 
between cassette part joints. A mechanical press may be useful to 
achieve a reproducible leak-free seal.

[[Page 671]]

Shrink fit gel-bands may be used for this purpose and are available from 
filter manufacturers and their authorized distributors.
    j. Use wrinkle-free loaded cassettes in the sampling operation.
    5. Pump setup.
    a. Calibrate the sampling pump over the range of flow rates and 
loads anticipated for the monitoring period with this flow measuring 
device in series. Perform this calibration using guidance from EPA 
Method 2A each time the unit is sent to the field (See Reference 6 of 
Unit III.L.).
    b. Configure the sampling system to preclude pump vibrations from 
being transmitted to the cassette by using a sampling stand separate 
from the pump station and making connections with flexible tubing.
    c. Maintain continuous smooth flow conditions by damping out any 
pump action fluctuations if necessary.
    d. Check the sampling system for leaks with the end cap still in 
place and the pump operating before initiating sample collection. Trace 
and stop the source of any flow indicated by the flowmeter under these 
conditions.
    e. Select an appropriate flow rate equal to or greater than 1 L/min 
or less than 10 L/min for 25 mm cassettes. Larger filters may be 
operated at proportionally higher flow rates.
    f. Orient the cassette downward at approximately 45 degrees from the 
horizontal.
    g. Maintain a log of all pertinent sampling information, such as 
pump identification number, calibration data, sample location, date, 
sample identification number, flow rates at the beginning, middle, and 
end, start and stop times, and other useful information or comments. Use 
of a sampling log form is recommended. See the following Figure 2:

[[Page 672]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.008

    h. Initiate a chain of custody procedure at the start of each 
sampling, if this is requested by the client.
    i. Maintain a close check of all aspects of the sampling operation 
on a regular basis.
    j. Continue sampling until at least the minimum volume is collected, 
as specified in the following Table I:

[[Page 673]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.009

    k. At the conclusion of sampling, turn the cassette upward before 
stopping the flow to minimize possible particle loss. If the sampling is 
resumed, restart the flow before reorienting the cassette downward. Note 
the condition of the filter at the conclusion of sampling.
    l. Double check to see that all information has been recorded on the 
data collection forms and that the cassette is securely closed and 
appropriately identified using a waterproof label. Protect cassettes in 
individual clean resealed polyethylene bags. Bags are to be used for 
storing cassette caps when they are removed for sampling purposes. Caps 
and plugs should only be removed or replaced using clean hands or clean 
disposable plastic gloves.
    m. Do not change containers if portions of these filters are taken 
for other purposes.

[[Page 674]]

    6. Minimum sample number per site. A minimum of 13 samples are to be 
collected for each testing consisting of the following:
    a. A minimum of five samples per abatement area.
    b. A minimum of five samples per ambient area positioned at 
locations representative of the air entering the abatement site.
    c. Two field blanks are to be taken by removing the cap for not more 
than 30 sec and replacing it at the time of sampling before sampling is 
initiated at the following places:
    i. Near the entrance to each ambient area.
    ii. At one of the ambient sites.
    (Note: Do not leave the blank open during the sampling period.)
    d. A sealed blank is to be carried with each sample set. This 
representative cassette is not to be opened in the field.
    7. Abatement area sampling.
    a. Conduct final clearance sampling only after the primary 
containment barriers have been removed; the abatement area has been 
thoroughly dried; and, it has passed visual inspection tests by 
qualified personnel. (See Reference 1 of Unit III.L.)
    b. Containment barriers over windows, doors, and air passageways 
must remain in place until the TEM clearance sampling and analysis is 
completed and results meet clearance test criteria. The final plastic 
barrier remains in place for the sampling period.
    c. Select sampling sites in the abatement area on a random basis to 
provide unbiased and representative samples.
    d. After the area has passed a thorough visual inspection, use 
aggressive sampling conditions to dislodge any remaining dust.
    i. Equipment used in aggressive sampling such as a leaf blower and/
or fan should be properly cleaned and decontaminated before use.
    ii. Air filtration units shall remain on during the air monitoring 
period.
    iii. Prior to air monitoring, floors, ceiling and walls shall be 
swept with the exhaust of a minimum one (1) horsepower leaf blower.
    iv. Stationary fans are placed in locations which will not interfere 
with air monitoring equipment. Fan air is directed toward the ceiling. 
One fan shall be used for each 10,000 ft \3\ of worksite.
    v. Monitoring of an abatement work area with high-volume pumps and 
the use of circulating fans will require electrical power. Electrical 
outlets in the abatement area may be used if available. If no such 
outlets are available, the equipment must be supplied with electricity 
by the use of extension cords and strip plug units. All electrical power 
supply equipment of this type must be approved Underwriter Laboratory 
equipment that has not been modified. All wiring must be grounded. 
Ground fault interrupters should be used. Extreme care must be taken to 
clean up any residual water and ensure that electrical equipment does 
not become wet while operational.
    vi. Low volume pumps may be carefully wrapped in 6-mil polyethylene 
to insulate the pump from the air. High volume pumps cannot be sealed in 
this manner since the heat of the motor may melt the plastic. The pump 
exhausts should be kept free.
    vii. If recleaning is necessary, removal of this equipment from the 
work area must be handled with care. It is not possible to completely 
decontaminate the pump motor and parts since these areas cannot be 
wetted. To minimize any problems in this area, all equipment such as 
fans and pumps should be carefully wet wiped prior to removal from the 
abatement area. Wrapping and sealing low volume pumps in 6-mil 
polyethylene will provide easier decontamination of this equipment. Use 
of clean water and disposable wipes should be available for this 
purpose.
    e. Pump flow rate equal to or greater than 1 L/min or less than 10 
L/min may be used for 25 mm cassettes. The larger cassette diameters may 
have comparably increased flow.
    f. Sample a volume of air sufficient to ensure the minimum 
quantitation limits. (See Table I of Unit III.B.5.j.)
    8. Ambient sampling.
    a. Position ambient samplers at locations representative of the air 
entering the abatement site. If makeup air entering the abatement site 
is drawn from another area of the building which is outside of the 
abatement area, place the pumps in the building, pumps should be placed 
out of doors located near the building and away from any obstructions 
that may influence wind patterns. If construction is in progress 
immediately outside the enclosure, it may be necessary to select another 
ambient site. Samples should be representative of any air entering the 
work site.
    b. Locate the ambient samplers at least 3 ft apart and protect them 
from adverse weather conditions.
    c. Sample same volume of air as samples taken inside the abatement 
site.

                           C. Sample Shipment

    1. Ship bulk samples in a separate container from air samples. Bulk 
samples and air samples delivered to the analytical laboratory in the 
same container shall be rejected.
    2. Select a rigid shipping container and pack the cassettes upright 
in a noncontaminating nonfibrous medium such as a bubble pack. The use 
of resealable polyethylene bags may help to prevent jostling of 
individual cassettes.
    3. Avoid using expanded polystyrene because of its static charge 
potential. Also avoid using particle-based packaging materials because 
of possible contamination.
    4. Include a shipping bill and a detailed listing of samples 
shipped, their descriptions

[[Page 675]]

and all identifying numbers or marks, sampling data, shipper's name, and 
contact information. For each sample set, designate which are the 
ambient samples, which are the abatement area samples, which are the 
field blanks, and which is the sealed blank if sequential analysis is to 
be performed.
    5. Hand-carry samples to the laboratory in an upright position if 
possible; otherwise choose that mode of transportation least likely to 
jar the samples in transit.
    6. Address the package to the laboratory sample coordinator by name 
when known and alert him or her of the package description, shipment 
mode, and anticipated arrival as part of the chain of custody and sample 
tracking procedures. This will also help the laboratory schedule timely 
analysis for the samples when they are received.

     D. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards is performed along with 
the sample analysis as indicators that the materials used are adequate 
and the operations are within acceptable limits. In this way, the 
quality of the data is defined, and the results are of known value. 
These checks and tests also provide timely and specific warning of any 
problems which might develop within the sampling and analysis 
operations. A description of these quality control/quality assurance 
procedures is summarized in the text below.
    1. Prescreen the loaded cassette collection filters to assure that 
they do not contain concentrations of asbestos which may interfere with 
the analysis of the sample. A filter blank average of less than 18 s/
mm\2\ in an area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) 
and a maximum of 53 s/mm\2\ for that same area for any single 
preparation is acceptable for this method.
    2. Calibrate sampling pumps and their flow indicators over the range 
of their intended use with a recognized standard. Assemble the sampling 
system with a representative filter--not the filter which will be used 
in sampling--before and after the sampling operation.
    3. Record all calibration information with the data to be used on a 
standard sampling form.
    4. Ensure that the samples are stored in a secure and representative 
location.
    5. Ensure that mechanical calibrations from the pump will be 
minimized to prevent transferral of vibration to the cassette.
    6. Ensure that a continuous smooth flow of negative pressure is 
delivered by the pump by installing a damping chamber if necessary.
    7. Open a loaded cassette momentarily at one of the indoor sampling 
sites when sampling is initiated. This sample will serve as an indoor 
field blank.
    8. Open a loaded cassette momentarily at one of the outdoor sampling 
sites when sampling is initiated. This sample will serve as an outdoor 
field blank.
    9. Carry a sealed blank into the field with each sample series. Do 
not open this cassette in the field.
    10. Perform a leak check of the sampling system at each indoor and 
outdoor sampling site by activating the pump with the closed sampling 
cassette in line. Any flow indicates a leak which must be eliminated 
before initiating the sampling operation.
    11. Ensure that the sampler is turned upright before interrupting 
the pump flow.
    12. Check that all samples are clearly labeled and that all 
pertinent information has been enclosed before transfer of the samples 
to the laboratory.

                           E. Sample Receiving

    1. Designate one individual as sample coordinator at the laboratory. 
While that individual will normally be available to receive samples, the 
coordinator may train and supervise others in receiving procedures for 
those times when he/she is not available.
    2. Adhere to the following procedures to ensure both the continued 
chain-of-custody and the accountability of all samples passing through 
the laboratory:
    a. Note the condition of the shipping package and data written on it 
upon receipt.
    b. Retain all bills of lading or shipping slips to document the 
shipper and delivery time.
    c. Examine the chain-of-custody seal, if any, and the package for 
its integrity.
    d. If there has been a break in the seal or substantive damage to 
the package, the sample coordinator shall immediately notify the shipper 
and a responsible laboratory manager before any action is taken to 
unpack the shipment.
    e. Packages with significant damage shall be accepted only by the 
responsible laboratory manager after discussions with the client.
    3. Unwrap the shipment in a clean, uncluttered facility. The sample 
coordinator or his or her designee will record the contents, including a 
description of each item and all identifying numbers or marks. A

[[Page 676]]

Sample Receiving Form to document this information is attached for use 
when necessary. (See the following Figure 3.)
[GRAPHIC] [TIFF OMITTED] TC01AP92.010


[[Page 677]]


    Note: The person breaking the chain-of-custody seal and itemizing 
the contents assumes responsibility for the shipment and signs documents 
accordingly.
    4. Assign a laboratory number and schedule an analysis sequence.
    5. Manage all chain-of-custody samples within the laboratory such 
that their integrity can be ensured and documented.

                          F. Sample Preparation

    1. Personnel not affiliated with the Abatement Contractor shall be 
used to prepare samples and conduct TEM analysis. Wet-wipe the exterior 
of the cassettes to minimize contamination possibilities before taking 
them to the clean sample preparation facility.
    2. Perform sample preparation in a well-equipped clean facility.
    Note: The clean area is required to have the following minimum 
characteristics. The area or hood must be capable of maintaining a 
positive pressure with make-up air being HEPA filtered. The cumulative 
analytical blank concentration must average less than 18 s/mm\2\ in an 
area of 0.057 s/mm\2\ (nominally 10 200-mesh grid openings) with no more 
than one single preparation to exceed 53 s/mm\2\ for that same area.
    3. Preparation areas for air samples must be separated from 
preparation areas for bulk samples. Personnel must not prepare air 
samples if they have previously been preparing bulk samples without 
performing appropriate personal hygiene procedures, i.e., clothing 
change, showering, etc.
    4. Preparation. Direct preparation techniques are required. The 
objective is to produce an intact carbon film containing the 
particulates from the filter surface which is sufficiently clear for TEM 
analysis. Currently recommended direct preparation procedures for 
polycarbonate (PC) and mixed cellulose ester (MCE) filters are described 
in Unit III.F.7. and 8. Sample preparation is a subject requiring 
additional research. Variation on those steps which do not substantively 
change the procedure, which improve filter clearing or which reduce 
contamination problems in a laboratory are permitted.
    a. Use only TEM grids that have had grid opening areas measured 
according to directions in Unit III.J.
    b. Remove the inlet and outlet plugs prior to opening the cassette 
to minimize any pressure differential that may be present.
    c. Examples of techniques used to prepare polycarbonate filters are 
described in Unit III.F.7.
    d. Examples of techniques used to prepare mixed cellulose ester 
filters are described in Unit III.F.8.
    e. Prepare multiple grids for each sample.
    f. Store the three grids to be measured in appropriately labeled 
grid holders or polyethylene capsules.
    5. Equipment.
    a. Clean area.
    b. Tweezers. Fine-point tweezers for handling of filters and TEM 
grids.
    c. Scalpel Holder and Curved No. 10 Surgical Blades.
    d. Microscope slides.
    e. Double-coated adhesive tape.
    f. Gummed page reinforcements.
    g. Micro-pipet with disposal tips 10 to 100 L variable 
volume.
    h. Vacuum coating unit with facilities for evaporation of carbon. 
Use of a liquid nitrogen cold trap above the diffusion pump will 
minimize the possibility of contamination of the filter surface by oil 
from the pumping system. The vacuum-coating unit can also be used for 
deposition of a thin film of gold.
    i. Carbon rod electrodes. Spectrochemically pure carbon rods are 
required for use in the vacuum evaporator for carbon coating of filters.
    j. Carbon rod sharpener. This is used to sharpen carbon rods to a 
neck. The use of necked carbon rods (or equivalent) allows the carbon to 
be applied to the filters with a minimum of heating.
    k. Low-temperature plasma asher. This is used to etch the surface of 
collapsed mixed cellulose ester (MCE) filters. The asher should be 
supplied with oxygen, and should be modified as necessary to provide a 
throttle or bleed valve to control the speed of the vacuum to minimize 
disturbance of the filter. Some early models of ashers admit air too 
rapidly, which may disturb particulates on the surface of the filter 
during the etching step.
    l. Glass petri dishes, 10 cm in diameter, 1 cm high. For prevention 
of excessive evaporation of solvent when these are in use, a good seal 
must be provided between the base and the lid. The seal can be improved 
by grinding the base and lid together with an abrasive grinding 
material.
    m. Stainless steel mesh.
    n. Lens tissue.
    o. Copper 200-mesh TEM grids, 3 mm in diameter, or equivalent.
    p. Gold 200-mesh TEM grids, 3 mm in diameter, or equivalent.
    q. Condensation washer.
    r. Carbon-coated, 200-mesh TEM grids, or equivalent.
    s. Analytical balance, 0.1 mg sensitivity.
    t. Filter paper, 9 cm in diameter.
    u. Oven or slide warmer. Must be capable of maintaining a 
temperature of 65-70  deg.C.
    v. Polyurethane foam, 6 mm thickness.
    w. Gold wire for evaporation.
    6. Reagents.
    a. General. A supply of ultra-clean, fiber-free water must be 
available for washing of all components used in the analysis. Water

[[Page 678]]

that has been distilled in glass or filtered or deionized water is 
satisfactory for this purpose. Reagents must be fiber-free.
    b. Polycarbonate preparation method--chloroform.
    c. Mixed Cellulose Ester (MCE) preparation method--acetone or the 
Burdette procedure (Ref. 7 of Unit III.L.).
    7. TEM specimen preparation from polycarbonate filters.
    a. Specimen preparation laboratory. It is most important to ensure 
that contamination of TEM specimens by extraneous asbestos fibers is 
minimized during preparation.
    b. Cleaning of sample cassettes. Upon receipt at the analytical 
laboratory and before they are taken into the clean facility or laminar 
flow hood, the sample cassettes must be cleaned of any contamination 
adhering to the outside surfaces.
    c. Preparation of the carbon evaporator. If the polycarbonate filter 
has already been carbon-coated prior to receipt, the carbon coating step 
will be omitted, unless the analyst believes the carbon film is too 
thin. If there is a need to apply more carbon, the filter will be 
treated in the same way as an uncoated filter. Carbon coating must be 
performed with a high-vacuum coating unit. Units that are based on 
evaporation of carbon filaments in a vacuum generated only by an oil 
rotary pump have not been evaluated for this application, and must not 
be used. The carbon rods should be sharpened by a carbon rod sharpener 
to necks of about 4 mm long and 1 mm in diameter. The rods are installed 
in the evaporator in such a manner that the points are approximately 10 
to 12 cm from the surface of a microscope slide held in the rotating and 
tilting device.
    d. Selection of filter area for carbon coating. Before preparation 
of the filters, a 75 mm x 50 mm microscope slide is washed and dried. 
This slide is used to support strips of filter during the carbon 
evaporation. Two parallel strips of double-sided adhesive tape are 
applied along the length of the slide. Polycarbonate filters are easily 
stretched during handling, and cutting of areas for further preparation 
must be performed with great care. The filter and the MCE backing filter 
are removed together from the cassette and placed on a cleaned glass 
microscope slide. The filter can be cut with a curved scalpel blade by 
rocking the blade from the point placed in contact with the filter. The 
process can be repeated to cut a strip approximately 3 mm wide across 
the diameter of the filter. The strip of polycarbonate filter is 
separated from the corresponding strip of backing filter and carefully 
placed so that it bridges the gap between the adhesive tape strips on 
the microscope slide. The filter strip can be held with fine-point 
tweezers and supported underneath by the scalpel blade during placement 
on the microscope slide. The analyst can place several such strips on 
the same microscope slide, taking care to rinse and wet-wipe the scalpel 
blade and tweezers before handling a new sample. The filter strips 
should be identified by etching the glass slide or marking the slide 
using a marker insoluble in water and solvents. After the filter strip 
has been cut from each filter, the residual parts of the filter must be 
returned to the cassette and held in position by reassembly of the 
cassette. The cassette will then be archived for a period of 30 days or 
returned to the client upon request.
    e. Carbon coating of filter strips. The glass slide holding the 
filter strips is placed on the rotation-tilting device, and the 
evaporator chamber is evacuated. The evaporation must be performed in 
very short bursts, separated by some seconds to allow the electrodes to 
cool. If evaporation is too rapid, the strips of polycarbonate filter 
will begin to curl, which will lead to cross-linking of the surface 
material and make it relatively insoluble in chloroform. An experienced 
analyst can judge the thickness of carbon film to be applied, and some 
test should be made first on unused filters. If the film is too thin, 
large particles will be lost from the TEM specimen, and there will be 
few complete and undamaged grid openings on the specimen. If the coating 
is too thick, the filter will tend to curl when exposed to chloroform 
vapor and the carbon film may not adhere to the support mesh. Too thick 
a carbon film will also lead to a TEM image that is lacking in contrast, 
and the ability to obtain ED patterns will be compromised. The carbon 
film should be as thin as possible and remain intact on most of the grid 
openings of the TEM specimen intact.
    f. Preparation of the Jaffe washer. The precise design of the Jaffe 
washer is not considered important, so any one of the published designs 
may be used. A washer consisting of a simple stainless steel bridge is 
recommended. Several pieces of lens tissue approximately 1.0 cm x 0.5 cm 
are placed on the stainless steel bridge, and the washer is filled with 
chloroform to a level where the meniscus contacts the underside of the 
mesh, which results in saturation of the lens tissue. See References 8 
and 10 of Unit III.L.
    g. Placing of specimens into the Jaffe washer. The TEM grids are 
first placed on a piece of lens tissue so that individual grids can be 
picked up with tweezers. Using a curved scalpel blade, the analyst 
excises three 3 mm square pieces of the carbon-coated polycarbonate 
filter from the filter strip. The three squares are selected from the 
center of the strip and from two points between the outer periphery of 
the active surface and the center. The piece of filter is placed on a 
TEM specimen grid with the shiny side of the TEM grid facing upwards, 
and the whole assembly is placed boldly onto the saturated lens tissue 
in the Jaffe washer. If carbon-coated grids are used, the filter should 
be

[[Page 679]]

placed carbon-coated side down. The three excised squares of filters are 
placed on the same piece of lens tissue. Any number of separate pieces 
of lens tissue may be placed in the same Jaffe washer. The lid is then 
placed on the Jaffe washer, and the system is allowed to stand for 
several hours, preferably overnight.
    h. Condensation washing. It has been found that many polycarbonate 
filters will not dissolve completely in the Jaffe washer, even after 
being exposed to chloroform for as long as 3 days. This problem becomes 
more serious if the surface of the filter was overheated during the 
carbon evaporation. The presence of undissolved filter medium on the TEM 
preparation leads to partial or complete obscuration of areas of the 
sample, and fibers that may be present in these areas of the specimen 
will be overlooked; this will lead to a low result. Undissolved filter 
medium also compromises the ability to obtain ED patterns. Before they 
are counted, TEM grids must be examined critically to determine whether 
they are adequately cleared of residual filter medium. It has been found 
that condensation washing of the grids after the initial Jaffe washer 
treatment, with chloroform as the solvent, clears all residual filter 
medium in a period of approximately 1 hour. In practice, the piece of 
lens tissue supporting the specimen grids is transferred to the cold 
finger of the condensation washer, and the washer is operated for about 
1 hour. If the specimens are cleared satisfactorily by the Jaffe washer 
alone, the condensation washer step may be unnecessary.
    8. TEM specimen preparation from MCE filters.
    a. This method of preparing TEM specimens from MCE filters is 
similar to that specified in NIOSH Method 7402. See References 7, 8, and 
9 of Unit III.L.
    b. Upon receipt at the analytical laboratory, the sample cassettes 
must be cleaned of any contamination adhering to the outside surfaces 
before entering the clean sample preparation area.
    c. Remove a section from any quadrant of the sample and blank 
filters.
    d. Place the section on a clean microscope slide. Affix the filter 
section to the slide with a gummed paged reinforcement or other suitable 
means. Label the slide with a water and solvent-proof marking pen.
    e. Place the slide in a petri dish which contains several paper 
filters soaked with 2 to 3 mL acetone. Cover the dish. Wait 2 to 4 
minutes for the sample filter to fuse and clear.
    f. Plasma etching of the collapsed filter is required.
    i. The microscope slide to which the collapsed filter pieces are 
attached is placed in a plasma asher. Because plasma ashers vary greatly 
in their performance, both from unit to unit and between different 
positions in the asher chamber, it is difficult to specify the 
conditions that should be used. This is one area of the method that 
requires further evaluation. Insufficient etching will result in a 
failure to expose embedded filters, and too much etching may result in 
loss of particulate from the surface. As an interim measure, it is 
recommended that the time for ashing of a known weight of a collapsed 
filter be established and that the etching rate be calculated in terms 
of micrometers per second. The actual etching time used for a particular 
asher and operating conditions will then be set such that a 1-2 
m (10 percent) layer of collapsed surface will be removed.
    ii. Place the slide containing the collapsed filters into a low-
temperature plasma asher, and etch the filter.
    g. Transfer the slide to a rotating stage inside the bell jar of a 
vacuum evaporator. Evaporate a 1 mm x 5 mm section of graphite rod onto 
the cleared filter. Remove the slide to a clean, dry, covered petri 
dish.
    h. Prepare a second petri dish as a Jaffe washer with the wicking 
substrate prepared from filter or lens paper placed on top of a 6 mm 
thick disk of clean spongy polyurethane foam. Cut a V-notch on the edge 
of the foam and filter paper. Use the V-notch as a reservoir for adding 
solvent. The wicking substrate should be thin enough to fit into the 
petri dish without touching the lid.
    i. Place carbon-coated TEM grids face up on the filter or lens 
paper. Label the grids by marking with a pencil on the filter paper or 
by putting registration marks on the petri dish lid and marking with a 
waterproof marker on the dish lid. In a fume hood, fill the dish with 
acetone until the wicking substrate is saturated. The level of acetone 
should be just high enough to saturate the filter paper without creating 
puddles.
    j. Remove about a quarter section of the carbon-coated filter 
samples from the glass slides using a surgical knife and tweezers. 
Carefully place the section of the filter, carbon side down, on the 
appropriately labeled grid in the acetone-saturated petri dish. When all 
filter sections have been transferred, slowly add more solvent to the 
wedge-shaped trough to bring the acetone level up to the highest 
possible level without disturbing the sample preparations. Cover the 
petri dish. Elevate one side of the petri dish by placing a slide under 
it. This allows drops of condensed solvent vapors to form near the edge 
rather than in the center where they would drip onto the grid 
preparation.

                              G. TEM Method

    1. Instrumentation.
    a. Use an 80-120 kV TEM capable of performing electron diffraction 
with a fluorescent screen inscribed with calibrated gradations. If the 
TEM is equipped with EDXA it must either have a STEM attachment or be 
capable of producing a spot less than 250 nm

[[Page 680]]

in diameter at crossover. The microscope shall be calibrated routinely 
(see Unit III.J.) for magnification and camera constant.
    b. While not required on every microscope in the laboratory, the 
laboratory must have either one microscope equipped with energy 
dispersive X-ray analysis or access to an equivalent system on a TEM in 
another laboratory. This must be an Energy Dispersive X-ray Detector 
mounted on TEM column and associated hardware/software to collect, save, 
and read out spectral information. Calibration of Multi-Channel Analyzer 
shall be checked regularly for A1 at 1.48 KeV and Cu at 8.04 KeV, as 
well as the manufacturer's procedures.
    i. Standard replica grating may be used to determine magnification 
(e.g., 2160 lines/mm).
    ii. Gold standard may be used to determine camera constant.
    c. Use a specimen holder with single tilt and/or double tilt 
capabilities.
    2. Procedure.
    a. Start a new Count Sheet for each sample to be analyzed. Record on 
count sheet: analyst's initials and date; lab sample number; client 
sample number microscope identification; magnification for analysis; 
number of predetermined grid openings to be analyzed; and grid 
identification. See the following Figure 4:

[[Page 681]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.011

    b. Check that the microscope is properly aligned and calibrated 
according to the manufacturer's specifications and instructions.
    c. Microscope settings: 80-120 kV, grid assessment 250-1000X, then 
15,000-20,000X screen magnification for analysis.
    d. Approximately one-half (0.5) of the predetermined sample area to 
be analyzed shall be performed on one sample grid preparation and the 
remaining half on a second sample grid preparation.
    e. Determine the suitability of the grid.

[[Page 682]]

    i. Individual grid openings with greater than 5 percent openings 
(holes) or covered with greater than 25 percent particulate matter or 
obviously having nonuniform loading shall not be analyzed.
    ii. Examine the grid at low magnification (<1000X) to determine its 
suitability for detailed study at higher magnifications.
    iii. Reject the grid if:
    (1) Less than 50 percent of the grid openings covered by the replica 
are intact.
    (2) It is doubled or folded.
    (3) It is too dark because of incomplete dissolution of the filter.
    iv. If the grid is rejected, load the next sample grid.
    v. If the grid is acceptable, continue on to Step 6 if mapping is to 
be used; otherwise proceed to Step 7.
    f. Grid Map (Optional).
    i. Set the TEM to the low magnification mode.
    ii. Use flat edge or finder grids for mapping.
    iii. Index the grid openings (fields) to be counted by marking the 
acceptable fields for one-half (0.5) of the area needed for analysis on 
each of the two grids to be analyzed. These may be marked just before 
examining each grid opening (field), if desired.
    iv. Draw in any details which will allow the grid to be properly 
oriented if it is reloaded into the microscope and a particular field is 
to be reliably identified.
    g. Scan the grid.
    i. Select a field to start the examination.
    ii. Choose the appropriate magnification (15,000 to 20,000X screen 
magnification).
    iii. Scan the grid as follows.
    (1) At the selected magnification, make a series of parallel 
traverses across the field. On reaching the end of one traverse, move 
the image one window and reverse the traverse.
    Note: A slight overlap should be used so as not to miss any part of 
the grid opening (field).
    (2) Make parallel traverses until the entire grid opening (field) 
has been scanned.
    h. Identify each structure for appearance and size.
    i. Appearance and size: Any continuous grouping of particles in 
which an asbestos fiber within aspect ratio greater than or equal to 5:1 
and a length greater than or equal to 0.5 m is detected shall 
be recorded on the count sheet. These will be designated asbestos 
structures and will be classified as fibers, bundles, clusters, or 
matrices. Record as individual fibers any contiguous grouping having 0, 
1, or 2 definable intersections. Groupings having more than 2 
intersections are to be described as cluster or matrix. See the 
following Figure 5:

[[Page 683]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.012


[[Page 684]]


[GRAPHIC] [TIFF OMITTED] TC01AP92.013

An intersection is a non-parallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater. Combinations 
such as a matrix and cluster, matrix and bundle, or bundle and cluster 
are categorized by the dominant fiber quality--cluster, bundle, and 
matrix, respectively. Separate categories will be maintained for fibers 
less than 5 m and for fibers greater than or equal to 5 
m in length. Not required, but useful, may be to record the 
fiber length in 1 m intervals. (Identify each structure 
morphologically and analyze it as it enters the ``window''.)
    (1) Fiber. A structure having a minimum length greater than 0.5 
m and an aspect ratio (length to width) of 5:1 or greater and 
substantially parallel sides. Note the appearance of the end of the 
fiber, i.e., whether it is flat, rounded or dovetailed, no 
intersections.
    (2) Bundle. A structure composed of 3 or more fibers in a parallel 
arrangement with each fiber closer than one fiber diameter.
    (3) Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group; groupings must have more than 2 intersections.

[[Page 685]]

    (4) Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    (5) NSD. Record NSD when no structures are detected in the field.
    (6) Intersection. Non-parallel touching or crossing of fibers, with 
the projection having an aspect ratio 5:1 or greater.
    ii. Structure Measurement.
    (1) Recognize the structure that is to be sized.
    (2) Memorize its location in the ``window'' relative to the sides, 
inscribed square and to other particulates in the field so this exact 
location can be found again when scanning is resumed.
    (3) Measure the structure using the scale on the screen.
    (4) Record the length category and structure type classification on 
the count sheet after the field number and fiber number.
    (5) Return the fiber to its original location in the window and scan 
the rest of the field for other fibers; if the direction of travel is 
not remembered, return to the right side of the field and begin the 
traverse again.
    i. Visual identification of Electron Diffraction (ED) patterns is 
required for each asbestos structure counted which would cause the 
analysis to exceed the 70 s/mm\2\ concentration. (Generally this means 
the first four fibers identified as asbestos must exhibit an 
identifiable diffraction pattern for chrysotile or amphibole.)
    i. Center the structure, focus, and obtain an ED pattern. (See 
Microscope Instruction Manual for more detailed instructions.)
    ii. From a visual examination of the ED pattern, obtained with a 
short camera length, classify the observed structure as belonging to one 
of the following classifications: chrysotile, amphibole, or nonasbestos.
    (1) Chrysotile: The chrysotile asbestos pattern has characteristic 
streaks on the layer lines other than the central line and some 
streaking also on the central line. There will be spots of normal 
sharpness on the central layer line and on alternate lines (2nd, 4th, 
etc.). The repeat distance between layer lines is 0.53 nm and the center 
doublet is at 0.73 nm. The pattern should display (002), (110), (130) 
diffraction maxima; distances and geometry should match a chrysotile 
pattern and be measured semiquantitatively.
    (2) Amphibole Group [includes grunerite (amosite), crocidolite, 
anthophyllite, tremolite, and actinolite]: Amphibole asbestos fiber 
patterns show layer lines formed by very closely spaced dots, and the 
repeat distance between layer lines is also about 0.53 nm. Streaking in 
layer lines is occasionally present due to crystal structure defects.
    (3) Nonasbestos: Incomplete or unobtainable ED patterns, a 
nonasbestos EDXA, or a nonasbestos morphology.
    iii. The micrograph number of the recorded diffraction patterns must 
be reported to the client and maintained in the laboratory's quality 
assurance records. The records must also demonstrate that the 
identification of the pattern has been verified by a qualified 
individual and that the operator who made the identification is 
maintaining at least an 80 percent correct visual identification based 
on his measured patterns. In the event that examination of the pattern 
by the qualified individual indicates that the pattern had been 
misidentified visually, the client shall be contacted. If the pattern is 
a suspected chrysotile, take a photograph of the diffraction pattern at 
0 degrees tilt. If the structure is suspected to be amphibole, the 
sample may have to be tilted to obtain a simple geometric array of 
spots.
    j. Energy Dispersive X-Ray Analysis (EDXA).
    i. Required of all amphiboles which would cause the analysis results 
to exceed the 70 s/mm\2\ concentration. (Generally speaking, the first 4 
amphiboles would require EDXA.)
    ii. Can be used alone to confirm chrysotile after the 70 s/mm\2\ 
concentration has been exceeded.
    iii. Can be used alone to confirm all nonasbestos.
    iv. Compare spectrum profiles with profiles obtained from asbestos 
standards. The closest match identifies and categorizes the structure.
    v. If the EDXA is used for confirmation, record the properly labeled 
spectrum on a computer disk, or if a hard copy, file with analysis data.
    vi. If the number of fibers in the nonasbestos class would cause the 
analysis to exceed the 70 s/mm\2\ concentration, their identities must 
be confirmed by EDXA or measurement of a zone axis diffraction pattern 
to establish that the particles are nonasbestos.
    k. Stopping Rules.
    i. If more than 50 asbestiform structures are counted in a 
particular grid opening, the analysis may be terminated.
    ii. After having counted 50 asbestiform structures in a minimum of 4 
grid openings, the analysis may be terminated. The grid opening in which 
the 50th fiber was counted must be completed.
    iii. For blank samples, the analysis is always continued until 10 
grid openings have been analyzed.
    iv. In all other samples the analysis shall be continued until an 
analytical sensitivity of 0.005 s/cm\3\ is reached.
    l. Recording Rules. The count sheet should contain the following 
information:
    i. Field (grid opening): List field number.
    ii. Record ``NSD'' if no structures are detected.
    iii. Structure information.

[[Page 686]]

    (1) If fibers, bundles, clusters, and/or matrices are found, list 
them in consecutive numerical order, starting over with each field.
    (2) Length. Record length category of asbestos fibers examined. 
Indicate if less than 5 m or greater than or equal to 5 
m.
    (3) Structure Type. Positive identification of asbestos fibers is 
required by the method. At least one diffraction pattern of each fiber 
type from every five samples must be recorded and compared with a 
standard diffraction pattern. For each asbestos fiber reported, both a 
morphological descriptor and an identification descriptor shall be 
specified on the count sheet.
    (4) Fibers classified as chrysotile must be identified by 
diffraction and/or X-ray analysis and recorded on the count sheet. X-ray 
analysis alone can be used as sole identification only after 70s/mm\2\ 
have been exceeded for a particular sample.
    (5) Fibers classified as amphiboles must be identified by X-ray 
analysis and electron diffraction and recorded on the count sheet. (X-
ray analysis alone can be used as sole identification only after 70s/
mm\2\ have been exceeded for a particular sample.)
    (6) If a diffraction pattern was recorded on film, the micrograph 
number must be indicated on the count sheet.
    (7) If an electron diffraction was attempted and an appropriate 
spectra is not observed, N should be recorded on the count sheet.
    (8) If an X-ray analysis is attempted but not observed, N should be 
recorded on the count sheet.
    (9) If an X-ray analysis spectrum is stored, the file and disk 
number must be recorded on the count sheet.
    m. Classification Rules.
    i. Fiber. A structure having a minimum length greater than or equal 
to 0.5 m and an aspect ratio (length to width) of 5:1 or 
greater and substantially parallel sides. Note the appearance of the end 
of the fiber, i.e., whether it is flat, rounded or dovetailed.
    ii. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    iii. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    iv. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    v. NSD. Record NSD when no structures are detected in the field.
    n. After all necessary analyses of a particle structure have been 
completed, return the goniometer stage to 0 degrees, and return the 
structure to its original location by recall of the original location.
    o. Continue scanning until all the structures are identified, 
classified and sized in the field.
    p. Select additional fields (grid openings) at low magnification; 
scan at a chosen magnification (15,000 to 20,000X screen magnification); 
and analyze until the stopping rule becomes applicable.
    q. Carefully record all data as they are being collected, and check 
for accuracy.
    r. After finishing with a grid, remove it from the microscope, and 
replace it in the appropriate grid hold. Sample grids must be stored for 
a minimum of 1 year from the date of the analysis; the sample cassette 
must be retained for a minimum of 30 days by the laboratory or returned 
at the client's request.

                      H. Sample Analytical Sequence

    1. Carry out visual inspection of work site prior to air monitoring.
    2. Collect a minimum of five air samples inside the work site and 
five samples outside the work site. The indoor and outdoor samples shall 
be taken during the same time period.
    3. Analyze the abatement area samples according to this protocol. 
The analysis must meet the 0.005 s/cm\3\ analytical sensitivity.
    4. Remaining steps in the analytical sequence are contained in Unit 
IV. of this Appendix.

                              I. Reporting

    The following information must be reported to the client. See the 
following Table II:

[[Page 687]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.014

    1. Concentration in structures per square millimeter and structures 
per cubic centimeter.
    2. Analytical sensitivity used for the analysis.
    3. Number of asbestos structures.
    4. Area analyzed.
    5. Volume of air samples (which was initially provided by client).
    6. Average grid size opening.
    7. Number of grids analyzed.
    8. Copy of the count sheet must be included with the report.

[[Page 688]]

    9. Signature of laboratory official to indicate that the laboratory 
met specifications of the AHERA method.
    10. Report form must contain official laboratory identification 
(e.g., letterhead).
    11. Type of asbestos.

                       J. Calibration Methodology

    Note: Appropriate implementation of the method requires a person 
knowledgeable in electron diffraction and mineral identification by ED 
and EDXA. Those inexperienced laboratories wishing to develop 
capabilities may acquire necessary knowledge through analysis of 
appropriate standards and by following detailed methods as described in 
References 8 and 10 of Unit III.L.
    1. Equipment Calibration. In this method, calibration is required 
for the air-sampling equipment and the transmission electron microscope 
(TEM).
    a. TEM Magnification. The magnification at the fluorescent screen of 
the TEM must be calibrated at the grid opening magnification (if used) 
and also at the magnification used for fiber counting. This is performed 
with a cross grating replica. A logbook must be maintained, and the 
dates of calibration depend on the past history of the particular 
microscope; no frequency is specified. After any maintenance of the 
microscope that involved adjustment of the power supplied to the lenses 
or the high-voltage system or the mechanical disassembly of the electron 
optical column apart from filament exchange, the magnification must be 
recalibrated. Before the TEM calibration is performed, the analyst must 
ensure that the cross grating replica is placed at the same distance 
from the objective lens as the specimens are. For instruments that 
incorporate an eucentric tilting specimen stage, all speciments and the 
cross grating replica must be placed at the eucentric position.
    b. Determination of the TEM magnification on the fluorescent screen.
    i. Define a field of view on the fluorescent screen either by 
markings or physical boundaries. The field of view must be measurable or 
previously inscribed with a scale or concentric circles (all scales 
should be metric).
    ii. Insert a diffraction grating replica (for example a grating 
containing 2,160 lines/mm) into the specimen holder and place into the 
microscope. Orient the replica so that the grating lines fall 
perpendicular to the scale on the TEM fluorescent screen. Ensure that 
the goniometer stage tilt is 0 degrees.
    iii. Adjust microscope magnification to 10,000X or 20,000X. Measure 
the distance (mm) between two widely separated lines on the grating 
replica. Note the number of spaces between the lines. Take care to 
measure between the same relative positions on the lines (e.g., between 
left edges of lines).
    Note: The more spaces included in the measurement, the more accurate 
the final calculation. On most microscopes, however, the magnification 
is substantially constant only within the central 8-10 cm diameter 
region of the fluorescent screen.
    iv. Calculate the true magnification (M) on the fluorescent screen:

        M=XG/Y

where:
X=total distance (mm) between the designated grating lines;
G=calibration constant of the grating replica (lines/mm):
Y=number of grating replica spaces counted along X.

    c. Calibration of the EDXA System. Initially, the EDXA system must 
be calibrated by using two reference elements to calibrate the energy 
scale of the instrument. When this has been completed in accordance with 
the manufacturer's instructions, calibration in terms of the different 
types of asbestos can proceed. The EDXA detectors vary in both solid 
angle of detection and in window thickness. Therefore, at a particular 
accelerating voltage in use on the TEM, the count rate obtained from 
specific dimensions of fiber will vary both in absolute X-ray count rate 
and in the relative X-ray peak heights for different elements. Only a 
few minerals are relevant for asbestos abatement work, and in this 
procedure the calibration is specified in terms of a ``fingerprint'' 
technique. The EDXA spectra must be recorded from individual fibers of 
the relevant minerals, and identifications are made on the basis of 
semiquantitative comparisons with these reference spectra.
    d. Calibration of Grid Openings.
    i. Measure 20 grid openings on each of 20 random 200-mesh copper 
grids by placing a grid on a glass slide and examining it under the PCM. 
Use a calibrated graticule to measure the average field diameter and use 
this number to calculate the field area for an average grid opening. 
Grids are to be randomly selected from batches up to 1,000.
    Note: A grid opening is considered as one field.
    ii. The mean grid opening area must be measured for the type of 
specimen grids in use. This can be accomplished on the TEM at a properly 
calibrated low magnification or on an optical microscope at a 
magnification of approximately 400X by using an eyepiece fitted with a 
scale that has been calibrated against a stage micrometer. Optical 
microscopy utilizing manual or automated procedures may be used 
providing instrument calibration can be verified.
    e. Determination of Camera Constant and ED Pattern Analysis.
    i. The camera length of the TEM in ED operating mode must be 
calibrated before ED patterns on unknown samples are observed. This can 
be achieved by using a carbon-coated grid on which a thin film of gold 
has been

[[Page 689]]

sputtered or evaporated. A thin film of gold is evaporated on the 
specimen TEM grid to obtain zone-axis ED patterns superimposed with a 
ring pattern from the polycrystalline gold film.
    ii. In practice, it is desirable to optimize the thickness of the 
gold film so that only one or two sharp rings are obtained on the 
superimposed ED pattern. Thicker gold film would normally give multiple 
gold rings, but it will tend to mask weaker diffraction spots from the 
unknown fibrous particulates. Since the unknown d-spacings of most 
interest in asbestos analysis are those which lie closest to the 
transmitted beam, multiple gold rings are unnecessary on zone-axis ED 
patterns. An average camera constant using multiple gold rings can be 
determined. The camera constant is one-half the diameter, D, of the 
rings times the interplanar spacing, d, of the ring being measured.

     K. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards is performed along with 
the sample analysis as indicators that the materials used are adequate 
and the operations are within acceptable limits. In this way, the 
quality of the data is defined and the results are of known value. These 
checks and tests also provide timely and specific warning of any 
problems which might develop within the sampling and analysis 
operations. A description of these quality control/quality assurance 
procedures is summarized in the following Table III:

[[Page 690]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.015

    1. When the samples arrive at the laboratory, check the samples and 
documentation for completeness and requirements before initiating the 
analysis.
    2. Check all laboratory reagents and supplies for acceptable 
asbestos background levels.
    3. Conduct all sample preparation in a clean room environment 
monitored by laboratory blanks and special testing after cleaning or 
servicing the room.
    4. Prepare multiple grids of each sample.
    5. Provide laboratory blanks with each sample batch. Maintain a 
cumulative average of these results. If this average is greater than 53 
f/mm \2\ per 10 200-mesh grid openings, check the system for possible 
sources of contamination.
    6. Check for recovery of asbestos from cellulose ester filters 
submitted to plasma asher.
    7. Check for asbestos carryover in the plasma asher by including a 
blank alongside the positive control sample.

[[Page 691]]

    8. Perform a systems check on the transmission electron microscope 
daily.
    9. Make periodic performance checks of magnification, electron 
diffraction and energy dispersive X-ray systems as set forth in Table 
III of Unit III.K.
    10. Ensure qualified operator performance by evaluation of replicate 
counting, duplicate analysis, and standard sample comparisons as set 
forth in Table III of Unit III.K.
    11. Validate all data entries.
    12. Recalculate a percentage of all computations and automatic data 
reduction steps as specified in Table III.
    13. Record an electron diffraction pattern of one asbestos structure 
from every five samples that contain asbestos. Verify the identification 
of the pattern by measurement or comparison of the pattern with patterns 
collected from standards under the same conditions.

The outline of quality control procedures presented above is viewed as 
the minimum required to assure that quality data is produced for 
clearance testing of an asbestos abated area. Additional information may 
be gained by other control tests. Specifics on those control procedures 
and options available for environmental testing can be obtained by 
consulting References 6, 7, and 11 of Unit III.L.

                              L. References

    For additional background information on this method the following 
references should be consulted.
    1. ``Guidelines for Controlling Asbestos-Containing Materials in 
Buildings,'' EPA 560/5-85-024, June 1985.
    2. ``Measuring Airborne Asbestos Following an Abatement Action,'' 
USEP/Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 1985.
    3. Small, John and E. Steel. Asbestos Standards: Materials and 
Analytical Methods. N.B.S. Special Publication 619, 1982.
    4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. 
Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. 
Information Circular 8751, U.S. Bureau of Mines, 1977.
    5. Quality Assurance Handbook for Air Pollution Measurement System. 
Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and 
Development, 1977.
    6. Method 2A: Direct Measurement of Gas Volume Through Pipes and 
Small Ducts. 40 CFR Part 60 Appendix A.
    7. Burdette, G.J. Health & Safety Exec., Research & Lab. Services 
Div., London, ``Proposed Analytical Method for Determination of Asbestos 
in Air.''
    8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI 
Assoc. ``Standard Operating Procedure for Determination of Airborne 
Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate 
Membrane Filters.'' WERL SOP 87-1, March 5, 1987.
    9. NIOSH. Method 7402 for Asbestos Fibers, December 11, 1986 Draft.
    10. Yamate, G., S.C. Agarwall, R.D. Gibbons, IIT Research Institute, 
``Methodology for the Measurement of Airborne Asbestos by Electron 
Microscopy.'' Draft report, USEPA Contract 68-02-3266, July 1984.
    11. Guidance to the Preparation of Quality Assurance Project Plans. 
USEPA, Office of Pollution Prevention and Toxics, 1984.

IV. Mandatory Interpretation of Transmission Electron Microscopy Results 
               to Determine Completion of Response Actions

                             A. Introduction

    A response action is determined to be completed by TEM when the 
abatement area has been cleaned and the airborne asbestos concentration 
inside the abatement area is no higher than concentrations at locations 
outside the abatement area. ``Outside'' means outside the abatement 
area, but not necessarily outside the building. EPA reasons that an 
asbestos removal contractor cannot be expected to clean an abatement 
area to an airborne asbestos concentration that is lower than the 
concentration of air entering the abatement area from outdoors or from 
other parts of the building. After the abatement area has passed a 
thorough visual inspection, and before the outer containment barrier is 
removed, a minimum of five air samples inside the abatement area and a 
minimum of five air samples outside the abatement area must be 
collected. Hence, the response action is determined to be completed when 
the average airborne asbestos concentration measured inside the 
abatement area is not statistically different from the average airborne 
asbestos concentration measured outside the abatement area.
    The inside and outside concentrations are compared by the Z-test, a 
statistical test that takes into account the variability in the 
measurement process. A minimum of five samples inside the abatement area 
and five samples outside the abatement area are required to control the 
false negative error rate, i.e., the probability of declaring the 
removal complete when, in fact, the air concentration inside the 
abatement area is significantly higher than outside the abatement area. 
Additional quality control is provided by requiring three blanks 
(filters through which no air has been drawn) to be analyzed to check 
for unusually high filter contamination that would distort the test 
results.
    When volumes greater than or equal to 1,199 L for a 25 mm filter and 
2,799 L for a 37 mm filter have been collected and the average number of 
asbestos structures on samples inside the abatement  area  is  no  
greater than 70 s/mm \2\ of filter, the response action

[[Page 692]]

may be considered complete without comparing the inside samples to the 
outside samples. EPA is permitting this initial screening test to save 
analysis costs in situations where the airborne asbestos concentration 
is sufficiently low so that it cannot be distinguished from the filter 
contamination/background level (fibers deposited on the filter that are 
unrelated to the air being sampled). The screening test cannot be used 
when volumes of less than 1,199 L for 25 mm filter or 2,799 L for a 37 
mm filter are collected because the ability to distinguish levels 
significantly different from filter background is reduced at low 
volumes.
    The initial screening test is expressed in structures per square 
millimeter of filter because filter background levels come from sources 
other than the air being sampled and cannot be meaningfully expressed as 
a concentration per cubic centimeter of air. The value of 70 s/mm\2\ is 
based on the experience of the panel of microscopists who consider one 
structure in 10 grid openings (each grid opening with an area of 0.0057 
mm\2\) to be comparable with contamination/background levels of blank 
filters. The decision is based, in part, on Poisson statistics which 
indicate that four structures must be counted on a filter before the 
fiber count is statistically distinguishable from the count for one 
structure. As more information on the performance of the method is 
collected, this criterion may be modified. Since different combinations 
of the number and size of grid openings are permitted under the TEM 
protocol, the criterion is expressed in structures per square millimeter 
of filter to be consistent across all combinations. Four structures per 
10 grid openings corresponds to approximately 70 s/mm\2\.

                    B. Sample Collection and Analysis

    1. A minimum of 13 samples is required: five samples collected 
inside the abatement area, five samples collected outside the abatement 
area, two field blanks, and one sealed blank.
    2. Sampling and TEM analysis must be done according to either the 
mandatory or nonmandatory protocols in Appendix A. At least 0.057 mm\2\ 
of filter must be examined on blank filters.

                      C. Interpretation of Results

    1. The response action shall be considered complete if either:
    a. Each sample collected inside the abatement area consists of at 
least 1,199 L of air for a 25 mm filter, or 2,799 L of air for a 37 mm 
filter, and the arithmetic mean of their asbestos structure 
concentrations per square millimeter of filter is less than or equal to 
70 s/mm\2\; or
    b. The three blank samples have an arithmetic mean of the asbestos 
structure concentration on the blank filters  that  is  less  than  or 
equal to 70 s/mm\2\ and the average airborne asbestos concentration 
measured inside the abatement area is not statistically higher than the 
average airborne asbestos concentration measured outside the abatement 
area as determined by the Z-test. The Z-test is carried out by 
calculating
[GRAPHIC] [TIFF OMITTED] TC01AP92.016

where YI is the average of the natural logarithms of the 
inside samples and YO is the average of the natural 
logarithms of the outside samples, nI is the number of inside 
samples and nO is the number of outside samples. The response 
action is considered complete if Z is less than or equal to 1.65.
    Note: When no fibers are counted, the calculated detection limit for 
that analysis is inserted for the concentration.
    2. If the abatement site does not satisfy either (1) or (2) of this 
Section C, the site must be recleaned and a new set of samples 
collected.

                    D. Sequence for Analyzing Samples

    It is possible to determine completion of the response action 
without analyzing all samples. Also, at any point in the process, a 
decision may be made to terminate the analysis of existing samples, 
reclean the abatement site, and collect a new set of samples. The 
following sequence is outlined to minimize the number of analyses needed 
to reach a decision.
    1. Analyze the inside samples.
    2. If at least 1,199 L of air for a 25 mm filter or 2,799 L of air 
for a 37 mm filter is collected for each inside sample and the 
arithmetic mean concentration of structures per square millimeter of 
filter is less than or equal to 70 s/mm\2\, the response action is 
complete and no further analysis is needed.
    3. If less than 1,199 L of air for a 25 mm filter or 2,799 L of air 
for a 37 mm filter is collected for any of the inside samples, or the 
arithmetic mean concentration of structures per square millimeter  of  
filter  is  greater  than 70 s/mm\2\, analyze the three blanks.
    4. If the arithmetic mean concentration of structures per square 
millimeter on the blank filters is greater than 70 s/mm\2\, terminate 
the analysis, identify and correct the source of blank contamination, 
and collect a new set of samples.
    5. If the arithmetic mean concentration of structures per square 
millimeter on the blank filters is less than or equal to 70 s/mm\2\, 
analyze the outside samples and perform the Z-test.

[[Page 693]]

    6. If the Z-statistic is less than or equal to 1.65, the response 
action is complete. If the Z-statistic is greater than 1.65, reclean the 
abatement site and collect a new set of samples.

[52 FR 41857, Oct. 30, 1987]

  Appendix B to Subpart E--Work Practices and Engineering Controls for 
  Small-Scale, Short-Duration Operations Maintenance and Repair (O&M) 
                        Activities Involving ACM

    This appendix is not mandatory, in that LEAs may choose to comply 
with all the requirements of 40 CFR 763.121. Section 763.91(b) extends 
the protection provided by EPA in its 40 CFR 763.121 for worker 
protection during asbestos abatement projects to employees of local 
education agencies who perform small-scale, short-duration operations, 
maintenance and repair (O&M) activities involving asbestos-containing 
materials and are not covered by the OSHA asbestos construction standard 
at 29 CFR 1926.58 or an asbestos worker protection standard adopted by a 
State as part of a State plan approved by OSHA under section 18 of the 
Occupational Safety and Health Act. Employers wishing to be exempt from 
the requirements of Sec. 763.121 (e)(6) and (f)(2)(i) may instead comply 
with the provisions of this appendix when performing small-scale, short-
duration O&M activities.

          Definition of Small-Scale, Short-Duration Activities

    For the purposes of this appendix, small-scale, short-duration 
maintenance activities are tasks such as, but not limited to:
    1. Removal of asbestos-containing insulation on pipes.
    2. Removal of small quantities of asbestos-containing insulation on 
beams or above ceilings.
    3. Replacement of an asbestos-containing gasket on a valve.
    4. Installation or removal of a small section of drywall.
    5. Installation of electrical conduits through or proximate to 
asbestos-containing materials.
    Small-scale, short-duration maintenance activities can be further 
defined, for the purposes of this subpart, by the following 
considerations:
    1. Removal of small quantities of asbestos-containing materials 
(ACM) only if required in the performance of another maintenance 
activity not intended as asbestos abatement.
    2. Removal of asbestos-containing thermal system insulation not to 
exceed amounts greater than those which can be contained in a single 
glove bag.
    3. Minor repairs to damaged thermal system insulation which do not 
require removal.
    4. Repairs to a piece of asbestos-containing wallboard.
    5. Repairs, involving encapsulation, enclosure or removal, to small 
amounts of friable asbestos-containing material only if required in the 
performance of emergency or routine maintenance activity and not 
intended solely as asbestos abatement. Such work may not exceed amounts 
greater than those which can be contained in a single prefabricated 
minienclosure. Such an enclosure shall conform spatially and 
geometrically to the localized work area, in order to perform its 
intended containment function.
    OSHA concluded that the use of certain engineering and work practice 
controls is capable of reducing employee exposures to asbestos to levels 
below the  final  standard's  action  level  (0.1 f/cm\3\). (See 51 FR 
22714, June 20, 1986.) Several controls and work practices, used either 
singly or in combination, can be employed effectively to reduce asbestos 
exposures during small maintenance and renovation operations. These 
include:
    1. Wet methods.
    2. Removal methods.
    i. Use of glove bags.
    ii. Removal of entire asbestos insulated pipes or structures.
    iii. Use of minienclosures.
    3. Enclosure of asbestos materials.
    4. Maintenance programs.
    This appendix describes these controls and work practices in detail.

   Preparation of the Area Before Renovation or Maintenance Activities

    The first step in preparing to perform a small-scale, short-duration 
asbestos renovation or maintenance task, regardless of the abatement 
method that will be used, is the removal from the work area of all 
objects that are movable to protect them from asbestos contamination. 
Objects that cannot be removed must be covered completely with 6-mil-
thick polyethylene plastic sheeting before the task begins. If objects 
have already been contaminated, they should be thoroughly cleaned with a 
High Efficiency Particulate Air (HEPA) filtered vacuum or be wet-wiped 
before they are removed from the work area or completely encased in the 
plastic.
    Wet methods. Whenever feasible, and regardless of the abatement 
method to be used (e.g., removal, enclosure, use of glove bags), wet 
methods must be used during small-scale, short-duration maintenance and 
renovation activities that involve disturbing asbestos-containing 
materials. Handling asbestos materials wet is one of the most reliable 
methods of ensuring that asbestos fibers do not become airborne, and 
this practice should therefore be used whenever feasible.

[[Page 694]]

Wet methods can be used in the great majority of workplace situations. 
Only in cases where asbestos work must be performed on live electrical 
equipment, on live steam lines, or in other areas where water will 
seriously damage materials or equipment may dry removal be performed. 
Amended water or another wetting agent should be applied by means of an 
airless sprayer to minimize the extent to which the asbestos-containing 
material is disturbed.
    Asbestos-containing material should be wetted from the initiation of 
the maintenance or renovation operation and wetting agents should be 
used continually throughout the work period to ensure that any dry 
asbestos-containing material exposed in the course of the work is wet 
and remains wet until final disposal.
    Removal of small amount of asbestos-containing materials. Several 
methods can be used to remove small amounts of asbestos-containing 
materials during small-scale, short-duration renovation or maintenance 
tasks. These include the use of glove bags, the removal of an entire 
asbestos-covered pipe or structure, and the construction of 
minienclosures. The procedures that employers must use for each of these 
operations if they wish to avail themselves of the rule's exemptions are 
described in the following sections.
    Glove bags. OSHA found that the use of glove bags to enclose the 
work area during small-scale, short-duration maintenance or renovation 
activities will result in employee exposure to asbestos that are below 
the rule's action level of 0.1 f/cm \3\. This appendix provides 
requirements for glove-bag procedures to be followed by employers 
wishing to avail themselves of the rule's exemption for each activity. 
OSHA has determined that the use of these procedures will reduce the 8-
hour time weighted average (TWA) exposure of employees involved in these 
work operations to levels below the action level and will thus provide a 
degree of employee protection equivalent to that provided by compliance 
with all provisions of the rule.
    Glove bag installation. Glove bags are approximately 40-inch-wide 
times 64-inch-long bags fitted with arms through which the work can be 
performed. When properly installed and used, they permit workers to 
remain completely isolated from the asbestos material removed or 
replaced inside the bag. Glove bags can thus provide a flexible, easily 
installed, and quickly dismantled temporary small work area enclosure 
that is ideal for small-scale asbestos renovation or maintenance jobs. 
These bags are single-use control devices that are disposed of at the 
end of each job. The bags are made of transparent 6-mil-thick 
polyethylene plastic with areas of Tyvek \1\ material (the same material 
used to make the disposal protective suits used in major asbestos 
removal, renovation, and demolition operations and in protective 
gloves). Glove bags are readily available from safety supply stores or 
specialty asbestos removal supply houses. Glove bags come pre-labelled 
with the asbestos warning label prescribed by OSHA and EPA for bags used 
to dispose of asbestos waste.
---------------------------------------------------------------------------

    \1\ Mention of trade names or commercial products does not 
constitute endorsement or recommendation for use.
---------------------------------------------------------------------------

    Glove bag equipment and supplies. Supplies and materials that are 
necessary to use glove bags effectively include:
    1. Tape to seal glove bag to the area from which asbestos is to be 
removed.
    2. Amended water or other wetting agents.
    3. An airless sprayer for the application of the wetting agent.
    4. Bridging encapsulant (a paste-like substance for coating 
asbestos) to seal the rough edges of any asbestos-containing materials 
that remain within the glove bag at the points of attachment after the 
rest of the asbestos has been removed.
    5. Tools such as razor knives, nips, and wire brushes (or other 
tools suitable for cutting wires, etc.).
    6. A HEPA filter-equipped vacuum for evacuating the glove bag (to 
minimize the release of asbestos fibers) during removal of the bag from 
the work area and for cleaning any material that may have escaped during 
the installation of the glove bag.
    7. HEPA-equipped dual-cartridge or more protective respirators for 
use by the employees involved in the removal of asbestos with the glove 
bag.
    Glove bag work practices. The proper use of glove bags requires the 
following steps:
    1. Glove bags must be installed so that they completely cover the 
pipe or other structure where asbestos work is to be done. Glove bags 
are installed by cutting the sides of the glove bag to fit the size of 
the pipe from which asbestos is to be removed. The glove bag is attached 
to the pipe by folding the open edges together and securely sealing them 
with tape. All openings in the glove bag must be sealed with duct tape 
or equivalent material. The bottom seam of the glove bag must also be 
sealed with duct tape or equivalent to prevent any leakage from the bag 
that may result from a defect in the bottom seam.
    2. The employee who is performing the asbestos removal with the 
glove bag must don at least a half mask dual-cartridge HEPA-equipped 
respirator; respirators should be worn by employees who are in close 
contact with the glove bag and who may thus be exposed as a result of 
small gaps in the seams of the bag or holes punched through the bag by a 
razor knife or a piece of wire mesh.

[[Page 695]]

    3. The removed asbestos material from the pipe or other surface that 
has fallen into the enclosed bag must be thoroughly wetted with a 
wetting agent (applied with an airless sprayer through the precut port 
provided in most gloves bags or applied through a small hole in the 
bag).
    4. Once the asbestos material has been thoroughly wetted, it can be 
removed from the pipe, beam, or other surface. The choice of tool to use 
to remove the asbestos-containing material depends on the type of 
material to be removed. Asbestos-containing materials are generally 
covered with painted canvas and/or wire mesh. Painted canvas can be cut 
with a razor knife and peeled away from the asbestos-containing material 
underneath. Once the canvas has been peeled away, the asbestos-
containing material underneath may be dry, in which case it should be 
resprayed with a wetting agent to ensure that it generates as little 
dust as possible when removed. If the asbestos-containing material is 
covered with wire mesh, the mesh should be cut with nips, tin snips, or 
other appropriate tool and removed.

A wetting agent must then be used to spray any layer of dry material 
that is exposed beneath the mesh, the surface of the stripped underlying 
structure, and the inside of the glove bag.
    5. After removal of the layer of asbestos-containing material, the 
pipe or surface from which asbestos has been removed must be thoroughly 
cleaned with a wire brush and wet-wiped with a wetting agent until no 
traces of the asbestos-containing material can be seen.
    6. Any asbestos-containing insulation edges that have been exposed 
as a result of the removal or maintenance activity must be encapsulated 
with bridging encapsulant to ensure that the edges do not release 
asbestos fibers to the atmosphere after the glove bag has been removed.
    7. When the asbestos removal and encapsulation have been completed, 
a vacuum hose from a HEPA filtered vacuum must be inserted into the 
glove bag through the port to remove any air in the bag that may contain 
asbestos fibers. When the air has been removed from the bag, the bag 
should be squeezed tightly (as close to the top as possible), twisted, 
and sealed with tape, to keep the asbestos materials safely in the 
bottom of the bag. The HEPA vacuum can then be removed from the bag and 
the glove bag itself can be removed from the work area to be disposed of 
properly.
    Minienclosures. In some instances, such as removal of asbestos from 
a small ventilation system or from a short length of duct, a glove bag 
may not be either large enough or of the proper shape to enclose the 
work area. In such cases, a minienclosure can be built around the area 
where small-scale, short-duration asbestos maintenance or renovation 
work is to be performed. Such enclosures should be constructed of 6-mil-
thick polyethylene plastic sheeting and can be small enough to restrict 
entry to the asbestos work area to one worker.
    For example, a minienclosure can be built in a small utility closet 
when asbestos-containing duct covering is to be removed. The enclosure 
is constructed by:
    1. Affixing plastic sheeting to the walls with spray adhesive and 
tape.
    2. Covering the floor with plastic and sealing the plastic covering 
the floor to the plastic on the walls.
    3. Sealing any penetrations such as pipes or electrical conducts 
with tape.
    4. Constructing a small change room (approximately 3 feet square) 
made of 6-mil-thick polyethylene plastic supported by 2-inch by 4-inch 
lumber (the plastic should be attached to the lumber supports with 
staples or spray adhesive and tape).
    The change room should be contiguous to the minienclosure, and is 
necessary to allow the worker to vacuum off his protective coveralls and 
remove them before leaving the work area. While inside minienclosure, 
the worker should wear Tyvek \1\ disposable coveralls and use the 
appropriate HEPA-filtered dual-cartridge or more protective respiratory 
protection.
    The advantages of minienclosures are that they limit the spread of 
asbestos contamination, reduce the potential exposure of bystanders and 
other workers who may be working in adjacent areas, and are quick and 
easy to install. The disadvantage of minienclosures is that they may be 
too small to contain the equipment necessary to create a negative 
pressure within the enclosure; however the double layer of plastic 
sheeting will serve to restrict the release of asbestos fibers to the 
area outside the enclosure.
    Removal of entire structures. When pipes are insulated with 
asbestos-containing materials, removal of the entire pipe may be more 
protective, easier, and more cost-effective than stripping the asbestos 
insulation from the pipe. Before such a pipe is cut, the asbestos-
containing insulation must be wrapped with 6-mil polyethylene plastic 
and securely sealed with duct tape or equivalent. This plastic covering 
will prevent asbestos fibers from becoming airborne as a result of the 
vibration created by the power saws used to cut the pipe. If possible, 
the pipes should be cut at locations that are not insulated to avoid 
disturbing the asbestos. If a pipe is completely insulated with 
asbestos-containing materials, small sections should be stripped using 
the glove-bag method described above before the pipe is cut at the 
stripped sections.
    Enclosure. The decision to enclose rather than remove asbestos-
containing material from an area depends on the building owner's 
preference, i.e., for removal or containment.

[[Page 696]]

Owners consider such factors as cost effectiveness, the physical 
configuration of the work area, and the amount of traffic in the area 
when determining which abatement method to use.
    If the owner chooses to enclose the structure rather than to remove 
the asbestos-containing material insulating it, a solid structure 
(airtight walls and ceilings) must be built around the asbestos covered 
pipe or structure to prevent the release of asbestos-containing 
materials into the area beyond the enclosure and to prevent disturbing 
these materials by casual contact during future maintenance operations.
    Such a permanent (i.e., for the life of the building) enclosure 
should be built of new construction materials and should be impact 
resistant and airtight. Enclosure walls should be made of tongue-and-
groove boards, boards with spine joints, or gypsum boards having taped 
seams. The underlying structure must be able to support the weight of 
the enclosure. (Suspended ceilings with laid-in panels do not provide 
airtight enclosures and should not be used to enclose structures covered 
with asbestos-containing materials.) All joints between the walls and 
ceiling of the enclosure should be caulked to prevent the escape of 
asbestos fibers. During the installation of enclosures, tools that are 
used (such as drills or rivet tools) should be equipped with HEPA-
filtered vacuums. Before constructing the enclosure, all electrical 
conduits, telephone lines, recessed lights, and pipes in the area to be 
enclosed should be moved to ensure that the enclosure will not have to 
be re-opened later for routine or emergency maintenance. If such lights 
or other equipment cannot be moved to a new location for logistic 
reasons, or if moving them will disturb the asbestos-containing 
materials, removal rather than enclosure of the asbestos-containing 
materials is the appropriate control method to use.
    Maintenance program. An asbestos maintenance program must be 
initiated in all facilities that have friable asbestos-containing 
materials. Such a program should include:
    1. Development of an inventory of all asbestos-containing materials 
in the facility.
    2. Periodic examination of all asbestos-containing materials to 
detect deterioration.
    3. Written procedures for handling asbestos materials during the 
performance of small-scale, short-duration maintenance and renovation 
activities.
    4. Written procedures for asbestos disposal.
    5. Written procedures for dealing with asbestos-related emergencies.

Members of the building's maintenance engineering staff (electricians, 
heating/air conditioning engineers, plumbers, etc.) who may be required 
to handle asbestos-containing materials should be trained in safe 
procedures. Such training should include at a minimum:
    1. Information regarding types of ACM and its various uses and 
forms.
    2. Information on the health effects associated with asbestos 
exposure.
    3. Descriptions of the proper methods of handling asbestos-
containing materials.
    4. Information on the use of HEPA-equipped dual-cartridge 
respirators and other personal protection during maintenance activities.
    Prohibited activities. The training program for the maintenance 
engineering staff should describe methods of handling asbestos-
containing materials as well as routine maintenance activities that are 
prohibited when asbestos-containing materials are involved. For example, 
maintenance staff employees should be instructed:
    1. Not to drill holes in asbestos-containing materials.
    2. Not to hang plants or pictures on structures covered with 
asbestos-containing materials.
    3. Not to sand asbestos-containing floor tile.
    4. Not to damage asbestos-containing materials while moving 
furniture or other objects.
    5. Not to install curtains, drapes, or dividers in such a way that 
they damage asbestos-containing materials.
    6. Not to dust floors, ceilings, moldings or other surfaces in 
asbestos-contaminated environments with a dry brush or sweep with a dry 
broom.
    7. Not to use an ordinary vacuum to clean up asbestos-containing 
debris.
    8. Not to remove ceiling tiles below asbestos-containing materials 
without wearing the proper respiratory protection, clearing the area of 
other people, and observing asbestos removal waste disposal procedures.
    9. Not to remove ventilation system filters dry.
    10. Not to shake ventilation system filters.

[52 FR 41894, Oct. 30, 1987]

       Appendix C to Subpart E--Asbestos Model Accreditation Plan

             I. Asbestos Model Accreditation Plan for States

    The Asbestos Model Accreditation Plan (MAP) for States has eight 
components:
    (A) Definitions
    (B) Initial Training
    (C) Examinations
    (D) Continuing Education
    (E) Qualifications
    (F) Recordkeeping Requirements for Training Providers
    (G) Deaccreditation
    (H) Reciprocity
A. Definitions
    For purposes of Appendix C:
    1. ``Friable asbestos-containing material (ACM)'' means any material 
containing more

[[Page 697]]

than one percent asbestos which has been applied on ceilings, walls, 
structural members, piping, duct work, or any other part of a building, 
which when dry, may be crumbled, pulverized, or reduced to powder by 
hand pressure. The term includes non-friable asbestos-containing 
material after such previously non-friable material becomes damaged to 
the extent that when dry it may be crumbled, pulverized, or reduced to 
powder by hand pressure.
    2. ``Friable asbestos-containing building material (ACBM)'' means 
any friable ACM that is in or on interior structural members or other 
parts of a school or public and commercial building.
    3. ``Inspection'' means an activity undertaken in a school building, 
or a public and commercial building, to determine the presence or 
location, or to assess the condition of, friable or non-friable 
asbestos-containing building material (ACBM) or suspected ACBM, whether 
by visual or physical examination, or by collecting samples of such 
material. This term includes reinspections of friable and non-friable 
known or assumed ACBM which has been previously identified. The term 
does not include the following:
    a. Periodic surveillance of the type described in 40 CFR 763.92(b) 
solely for the purpose of recording or reporting a change in the 
condition of known or assumed ACBM;
    b. Inspections performed by employees or agents of Federal, State, 
or local government solely for the purpose of determining compliance 
with applicable statutes or regulations; or
    c. visual inspections of the type described in 40 CFR 763.90(i) 
solely for the purpose of determining completion of response actions.
    4. ``Major fiber release episode'' means any uncontrolled or 
unintentional disturbance of ACBM, resulting in a visible emission, 
which involves the falling or dislodging of more than 3 square or linear 
feet of friable ACBM.
    5. ``Minor fiber release episode'' means any uncontrolled or 
unintentional disturbance of ACBM, resulting in a visible emission, 
which involves the falling or dislodging of 3 square or linear feet or 
less of friable ACBM.
    6. ``Public and commercial building'' means the interior space of 
any building which is not a school building, except that the term does 
not include any residential apartment building of fewer than 10 units or 
detached single-family homes. The term includes, but is not limited to: 
industrial and office buildings, residential apartment buildings and 
condominiums of 10 or more dwelling units, government-owned buildings, 
colleges, museums, airports, hospitals, churches, preschools, stores, 
warehouses and factories. Interior space includes exterior hallways 
connecting buildings, porticos, and mechanical systems used to condition 
interior space.
    7. ``Response action'' means a method, including removal, 
encapsulation, enclosure, repair, and operation and maintenance, that 
protects human health and the environment from friable ACBM.
    8. ``Small-scale, short-duration activities (SSSD)'' are tasks such 
as, but not limited to:
    a. Removal of asbestos-containing insulation on pipes.
    b. Removal of small quantities of asbestos-containing insulation on 
beams or above ceilings.
    c. Replacement of an asbestos-containing gasket on a valve.
    d. Installation or removal of a small section of drywall.
    e. Installation of electrical conduits through or proximate to 
asbestos-containing materials.
    SSSD can be further defined by the following considerations:
    f. Removal of small quantities of ACM only if required in the 
performance of another maintenance activity not intended as asbestos 
abatement.
    g. Removal of asbestos-containing thermal system insulation not to 
exceed amounts greater than those which can be contained in a single 
glove bag.
    h. Minor repairs to damaged thermal system insulation which do not 
require removal.
    i. Repairs to a piece of asbestos-containing wallboard.
    j. Repairs, involving encapsulation, enclosure, or removal, to small 
amounts of friable ACM only if required in the performance of emergency 
or routine maintenance activity and not intended solely as asbestos 
abatement. Such work may not exceed amounts greater than those which can 
be contained in a single prefabricated mini-enclosure. Such an enclosure 
shall conform spatially and geometrically to the localized work area, in 
order to perform its intended containment function.

                           B. Initial Training

    Training requirements for purposes of accreditation are specified 
both in terms of required subjects of instruction and in terms of length 
of training. Each initial training course has a prescribed curriculum 
and number of days of training. One day of training equals 8 hours, 
including breaks and lunch. Course instruction must be provided by EPA 
or State-approved instructors. EPA or State instructor approval shall be 
based upon a review of the instructor's academic credentials and/or 
field experience in asbestos abatement.
    Beyond the initial training requirements, individual States may wish 
to consider requiring additional days of training for purposes of 
supplementing hands-on activities or for reviewing relevant state 
regulations.

[[Page 698]]

States also may wish to consider the relative merits of a worker 
apprenticeship program. Further, they might consider more stringent 
minimum qualification standards for the approval of training 
instructors. EPA recommends that the enrollment in any given course be 
limited to 25 students so that adequate opportunities exist for 
individual hands-on experience.
    States have the option to provide initial training directly or 
approve other entities to offer training. The following requirements are 
for the initial training of persons required to have accreditation under 
TSCA Title II.
    Training requirements for each of the five accredited disciplines 
are outlined below. Persons in each discipline perform a different job 
function and distinct role. Inspectors identify and assess the condition 
of ACBM, or suspect ACBM. Management planners use data gathered by 
inspectors to assess the degree of hazard posed by ACBM in schools to 
determine the scope and timing of appropriate response actions needed 
for schools. Project designers determine how asbestos abatement work 
should be conducted. Lastly, workers and contractor/supervisors carry 
out and oversee abatement work. In addition, a recommended training 
curriculum is also presented for a sixth discipline, which is not 
federally-accredited, that of ``Project Monitor.'' Each accredited 
discipline and training curriculum is separate and distinct from the 
others. A person seeking accreditation in any of the five accredited MAP 
disciplines cannot attend two or more courses concurrently, but may 
attend such courses sequentially.
    In several instances, initial training courses for a specific 
discipline (e.g., workers, inspectors) require hands-on training. For 
asbestos abatement contractor/supervisors and workers, hands-on training 
should include working with asbestos-substitute materials, fitting and 
using respirators, use of glovebags, donning protective clothing, and 
constructing a decontamination unit as well as other abatement work 
activities.

                               1. Workers

    A person must be accredited as a worker to carry out any of the 
following activities with respect to friable ACBM in a school or public 
and commercial building: (1) A response action other than a SSSD 
activity, (2) a maintenance activity that disturbs friable ACBM other 
than a SSSD activity, or (3) a response action for a major fiber release 
episode. All persons seeking accreditation as asbestos abatement workers 
shall complete at least a 4-day training course as outlined below. The 
4-day worker training course shall include lectures, demonstrations, at 
least 14 hours of hands-on training, individual respirator fit testing, 
course review, and an examination. Hands-on training must permit workers 
to have actual experience performing tasks associated with asbestos 
abatement. A person who is otherwise accredited as a contractor/
supervisor may perform in the role of a worker without possessing 
separate accreditation as a worker.
    Because of cultural diversity associated with the asbestos 
workforce, EPA recommends that States adopt specific standards for the 
approval of foreign language courses for abatement workers. EPA further 
recommends the use of audio-visual materials to complement lectures, 
where appropriate.
    The training course shall adequately address the following topics:
    (a) Physical characteristics of asbestos. Identification of 
asbestos, aerodynamic characteristics, typical uses, and physical 
appearance, and a summary of abatement control options.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
periods for asbestos-related diseases; a discussion of the relationship 
of asbestos exposure to asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Employee personal protective equipment. Classes and 
characteristics of respirator types; limitations of respirators; proper 
selection, inspection; donning, use, maintenance, and storage procedures 
for respirators; methods for field testing of the facepiece-to-face seal 
(positive and negative-pressure fit checks); qualitative and 
quantitative fit testing procedures; variability between field and 
laboratory protection factors that alter respiratory fit (e.g., facial 
hair); the components of a proper respiratory protection program; 
selection and use of personal protective clothing; use, storage, and 
handling of non-disposable clothing; and regulations covering personal 
protective equipment.
    (d) State-of-the-art work practices. Proper work practices for 
asbestos abatement activities, including descriptions of proper 
construction; maintenance of barriers and decontamination enclosure 
systems; positioning of warning signs; lock-out of electrical and 
ventilation systems; proper working techniques for minimizing fiber 
release; use of wet methods; use of negative pressure exhaust 
ventilation equipment; use of high-efficiency particulate air (HEPA) 
vacuums; proper clean-up and disposal procedures; work practices for 
removal, encapsulation, enclosure, and repair of ACM; emergency 
procedures for sudden releases; potential exposure situations; transport 
and disposal procedures; and recommended and prohibited work practices.

[[Page 699]]

    (e) Personal hygiene. Entry and exit procedures for the work area; 
use of showers; avoidance of eating, drinking, smoking, and chewing (gum 
or tobacco) in the work area; and potential exposures, such as family 
exposure.
    (f) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire and explosion 
hazards, scaffold and ladder hazards, slips, trips, and falls, and 
confined spaces.
    (g) Medical monitoring. OSHA and EPA Worker Protection Rule 
requirements for physical examinations, including a pulmonary function 
test, chest X-rays, and a medical history for each employee.
    (h) Air monitoring. Procedures to determine airborne concentrations 
of asbestos fibers, focusing on how personal air sampling is performed 
and the reasons for it.
    (i) Relevant Federal, State, and local regulatory requirements, 
procedures, and standards. With particular attention directed at 
relevant EPA, OSHA, and State regulations concerning asbestos abatement 
workers.
    (j) Establishment of respiratory protection programs.
    (k) Course review. A review of key aspects of the training course.

                        2. Contractor/Supervisors

    A person must be accredited as a contractor/supervisor to supervise 
any of the following activities with respect to friable ACBM in a school 
or public and commercial building: (1) A response action other than a 
SSSD activity, (2) a maintenance activity that disturbs friable ACBM 
other than a SSSD activity, or (3) a response action for a major fiber 
release episode. All persons seeking accreditation as asbestos abatement 
contractor/supervisors shall complete at least a 5-day training course 
as outlined below. The training course must include lectures, 
demonstrations, at least 14 hours of hands-on training, individual 
respirator fit testing, course review, and a written examination. Hands-
on training must permit supervisors to have actual experience performing 
tasks associated with asbestos abatement.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    Asbestos abatement supervisors include those persons who provide 
supervision and direction to workers performing response actions. 
Supervisors may include those individuals with the position title of 
foreman, working foreman, or leadman pursuant to collective bargaining 
agreements. At least one supervisor is required to be at the worksite at 
all times while response actions are being conducted. Asbestos workers 
must have access to accredited supervisors throughout the duration of 
the project.
    The contractor/supervisor training course shall adequately address 
the following topics:
    (a) The physical characteristics of asbestos and asbestos-containing 
materials. Identification of asbestos, aerodynamic characteristics, 
typical uses, physical appearance, a review of hazard assessment 
considerations, and a summary of abatement control options.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; synergism between 
cigarette smoking and asbestos exposure; and latency period for 
diseases.
    (c) Employee personal protective equipment. Classes and 
characteristics of respirator types; limitations of respirators; proper 
selection, inspection, donning, use, maintenance, and storage procedures 
for respirators; methods for field testing of the facepiece-to-face seal 
(positive and negative-pressure fit checks); qualitative and 
quantitative fit testing procedures; variability between field and 
laboratory protection factors that alter respiratory fit (e.g., facial 
hair); the components of a proper respiratory protection program; 
selection and use of personal protective clothing; and use, storage, and 
handling of non-disposable clothing; and regulations covering personal 
protective equipment.
    (d) State-of-the-art work practices. Proper work practices for 
asbestos abatement activities, including descriptions of proper 
construction and maintenance of barriers and decontamination enclosure 
systems; positioning of warning signs; lock-out of electrical and 
ventilation systems; proper working techniques for minimizing fiber 
release; use of wet methods; use of negative pressure exhaust 
ventilation equipment; use of HEPA vacuums; and proper clean-up and 
disposal procedures. Work practices for removal, encapsulation, 
enclosure, and repair of ACM; emergency procedures for unplanned 
releases; potential exposure situations; transport and disposal 
procedures; and recommended and prohibited work practices. New 
abatement-related techniques and methodologies may be discussed.
    (e) Personal hygiene. Entry and exit procedures for the work area; 
use of showers; and avoidance of eating, drinking, smoking, and chewing 
(gum or tobacco) in the work area. Potential exposures, such as family 
exposure, shall also be included.
    (f) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire and explosion 
hazards, scaffold and ladder hazards, slips, trips, and falls, and 
confined spaces.

[[Page 700]]

    (g) Medical monitoring. OSHA and EPA Worker Protection Rule 
requirements for physical examinations, including a pulmonary function 
test, chest X-rays and a medical history for each employee.
    (h) Air monitoring. Procedures to determine airborne concentrations 
of asbestos fibers, including descriptions of aggressive air sampling, 
sampling equipment and methods, reasons for air monitoring, types of 
samples and interpretation of results.
    EPA recommends that transmission electron microscopy (TEM) be used 
for analysis of final air clearance samples, and that sample analyses be 
performed by laboratories accredited by the National Institute of 
Standards and Technology's (NIST) National Voluntary Laboratory 
Accreditation Program (NVLAP).
    (i) Relevant Federal, State, and local regulatory requirements, 
procedures, and standards, including:
    (i) Requirements of TSCA Title II.
    (ii) National Emission Standards for Hazardous Air Pollutants (40 
CFR part 61), Subparts A (General Provisions) and M (National Emission 
Standard for Asbestos).
    (iii) OSHA standards for permissible exposure to airborne 
concentrations of asbestos fibers and respiratory protection (29 CFR 
1910.134).
    (iv) OSHA Asbestos Construction Standard (29 CFR 1926.58). (v)EPA 
Worker Protection Rule, (40 CFR part 763, Subpart G).
    (j) Respiratory Protection Programs and Medical Monitoring Programs.
    (k) Insurance and liability issues. Contractor issues; worker's 
compensation coverage and exclusions; third-party liabilities and 
defenses; insurance coverage and exclusions.
    (l) Recordkeeping for asbestos abatement projects. Records required 
by Federal, State, and local regulations; records recommended for legal 
and insurance purposes.
    (m) Supervisory techniques for asbestos abatement activities. 
Supervisory practices to enforce and reinforce the required work 
practices and discourage unsafe work practices.
    (n) Contract specifications. Discussions of key elements that are 
included in contract specifications.
    (o) Course review. A review of key aspects of the training course.

                              3. Inspector

    All persons who inspect for ACBM in schools or public and commercial 
buildings must be accredited. All persons seeking accreditation as an 
inspector shall complete at least a 3-day training course as outlined 
below. The course shall include lectures, demonstrations, 4 hours of 
hands-on training, individual respirator fit-testing, course review, and 
a written examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate. Hands-on training should include conducting 
a simulated building walk-through inspection and respirator fit testing. 
The inspector training course shall adequately address the following 
topics:
    (a) Background information on asbestos. Identification of asbestos, 
and examples and discussion of the uses and locations of asbestos in 
buildings; physical appearance of asbestos.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
periods for asbestos-related diseases; a discussion of the relationship 
of asbestos exposure to asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Functions/qualifications and role of inspectors. Discussions of 
prior experience and qualifications for inspectors and management 
planners; discussions of the functions of an accredited inspector as 
compared to those of an accredited management planner; discussion of 
inspection process including inventory of ACM and physical assessment.
    (d) Legal liabilities and defenses. Responsibilities of the 
inspector and management planner; a discussion of comprehensive general 
liability policies, claims-made, and occurrence policies, environmental 
and pollution liability policy clauses; state liability insurance 
requirements; bonding and the relationship of insurance availability to 
bond availability.
    (e) Understanding building systems. The interrelationship between 
building systems, including: an overview of common building physical 
plan layout; heat, ventilation, and air conditioning (HVAC) system 
types, physical organization, and where asbestos is found on HVAC 
components; building mechanical systems, their types and organization, 
and where to look for asbestos on such systems; inspecting electrical 
systems, including appropriate safety precautions; reading blueprints 
and as-built drawings.
    (f) Public/employee/building occupant relations. Notifying employee 
organizations about the inspection; signs to warn building occupants; 
tact in dealing with occupants and the press; scheduling of inspections 
to minimize disruptions; and education of building occupants about 
actions being taken.
    (g) Pre-inspection planning and review of previous inspection 
records. Scheduling the inspection and obtaining access; building record 
review; identification of probable homogeneous areas from blueprints or 
as-built drawings; consultation with maintenance or building personnel; 
review of previous inspection, sampling, and abatement records of a 
building; the role of the inspector in exclusions for previously 
performed inspections.

[[Page 701]]

    (h) Inspecting for friable and non-friable ACM and assessing the 
condition of friable ACM. Procedures to follow in conducting visual 
inspections for friable and non-friable ACM; types of building materials 
that may contain asbestos; touching materials to determine friability; 
open return air plenums and their importance in HVAC systems; assessing 
damage, significant damage, potential damage, and potential significant 
damage; amount of suspected ACM, both in total quantity and as a 
percentage of the total area; type of damage; accessibility; material's 
potential for disturbance; known or suspected causes of damage or 
significant damage; and deterioration as assessment factors.
    (i) Bulk sampling/documentation of asbestos. Detailed discussion of 
the ``Simplified Sampling Scheme for Friable Surfacing Materials (EPA 
560/5-85-030a October 1985)''; techniques to ensure sampling in a 
randomly distributed manner for other than friable surfacing materials; 
sampling of non-friable materials; techniques for bulk sampling; 
inspector's sampling and repair equipment; patching or repair of damage 
from sampling; discussion of polarized light microscopy; choosing an 
accredited laboratory to analyze bulk samples; quality control and 
quality assurance procedures. EPA's recommendation that all bulk samples 
collected from school or public and commercial buildings be analyzed by 
a laboratory accredited under the NVLAP administered by NIST.
    (j) Inspector respiratory protection and personal protective 
equipment. Classes and characteristics of respirator types; limitations 
of respirators; proper selection, inspection; donning, use, maintenance, 
and storage procedures for respirators; methods for field testing of the 
facepiece-to-face seal (positive and negative-pressure fit checks); 
qualitative and quantitative fit testing procedures; variability between 
field and laboratory protection factors that alter respiratory fit 
(e.g., facial hair); the components of a proper respiratory protection 
program; selection and use of personal protective clothing; use, 
storage, and handling of non-disposable clothing.
    (k) Recordkeeping and writing the inspection report. Labeling of 
samples and keying sample identification to sampling location; 
recommendations on sample labeling; detailing of ACM inventory; 
photographs of selected sampling areas and examples of ACM condition; 
information required for inclusion in the management plan required for 
school buildings under TSCA Title II, section 203 (i)(1). EPA recommends 
that States develop and require the use of standardized forms for 
recording the results of inspections in schools or public or commercial 
buildings, and that the use of these forms be incorporated into the 
curriculum of training conducted for accreditation.
    (l) Regulatory review. The following topics should be covered: 
National Emission Standards for Hazardous Air Pollutants (NESHAP; 40 CFR 
part 61, Subparts A and M); EPA Worker Protection Rule (40 CFR part 763, 
Subpart G); OSHA Asbestos Construction Standard (29 CFR 1926.58); OSHA 
respirator requirements (29 CFR 1910.134); the Asbestos-Containing 
Materials in School Rule (40 CFR part 763, Subpart E; applicable State 
and local regulations, and differences between Federal and State 
requirements where they apply, and the effects, if any, on public and 
nonpublic schools or commercial or public buildings.
    (m) Field trip. This includes a field exercise, including a walk-
through inspection; on-site discussion about information gathering and 
the determination of sampling locations; on-site practice in physical 
assessment; classroom discussion of field exercise.
    (n) Course review. A review of key aspects of the training course.

                          4. Management Planner

    All persons who prepare management plans for schools must be 
accredited. All persons seeking accreditation as management planners 
shall complete a 3-day inspector training course as outlined above and a 
2-day management planner training course. Possession of current and 
valid inspector accreditation shall be a prerequisite for admission to 
the management planner training course. The management planner course 
shall include lectures, demonstrations, course review, and a written 
examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    TSCA Title II does not require accreditation for persons performing 
the management planner role in public and commercial buildings. 
Nevertheless, such persons may find this training and accreditation 
helpful in preparing them to design or administer asbestos operations 
and maintenance programs for public and commercial buildings.
    The management planner training course shall adequately address the 
following topics:
    (a) Course overview. The role and responsibilities of the management 
planner; operations and maintenance programs; setting work priorities; 
protection of building occupants.
    (b) Evaluation/interpretation of survey results. Review of TSCA 
Title II requirements for inspection and management plans for school 
buildings as given in section 203(i)(1) of TSCA Title II; interpretation 
of field data and laboratory results; comparison of field inspector's 
data sheet with laboratory results and site survey.
    (c) Hazard assessment. Amplification of the difference between 
physical assessment and

[[Page 702]]

hazard assessment; the role of the management planner in hazard 
assessment; explanation of significant damage, damage, potential damage, 
and potential significant damage; use of a description (or decision 
tree) code for assessment of ACM; assessment of friable ACM; 
relationship of accessibility, vibration sources, use of adjoining 
space, and air plenums and other factors to hazard assessment.
    (d) Legal implications. Liability; insurance issues specific to 
planners; liabilities associated with interim control measures, in-house 
maintenance, repair, and removal; use of results from previously 
performed inspections.
    (e) Evaluation and selection of control options. Overview of 
encapsulation, enclosure, interim operations and maintenance, and 
removal; advantages and disadvantages of each method; response actions 
described via a decision tree or other appropriate method; work 
practices for each response action; staging and prioritizing of work in 
both vacant and occupied buildings; the need for containment barriers 
and decontamination in response actions.
    (f) Role of other professionals. Use of industrial hygienists, 
engineers, and architects in developing technical specifications for 
response actions; any requirements that may exist for architect sign-off 
of plans; team approach to design of high-quality job specifications.
    (g) Developing an operations and maintenance (O&M) plan. Purpose of 
the plan; discussion of applicable EPA guidance documents; what actions 
should be taken by custodial staff; proper cleaning procedures; steam 
cleaning and HEPA vacuuming; reducing disturbance of ACM; scheduling O&M 
for off-hours; rescheduling or canceling renovation in areas with ACM; 
boiler room maintenance; disposal of ACM; in-house procedures for ACM--
bridging and penetrating encapsulants; pipe fittings; metal sleeves; 
polyvinyl chloride (PVC), canvas, and wet wraps; muslin with straps, 
fiber mesh cloth; mineral wool, and insulating cement; discussion of 
employee protection programs and staff training; case study in 
developing an O&M plan (development, implementation process, and 
problems that have been experienced).
    (h) Regulatory review. Focusing on the OSHA Asbestos Construction 
Standard found at 29 CFR 1926.58; the National Emission Standard for 
Hazardous Air Pollutants (NESHAP) found at 40 CFR part 61, Subparts A 
(General Provisions) and M (National Emission Standard for Asbestos); 
EPA Worker Protection Rule found at 40 CFR part 763, Subpart G; TSCA 
Title II; applicable State regulations.
    (i) Recordkeeping for the management planner. Use of field 
inspector's data sheet along with laboratory results; on-going 
recordkeeping as a means to track asbestos disturbance; procedures for 
recordkeeping. EPA recommends that States require the use of 
standardized forms for purposes of management plans and incorporate the 
use of such forms into the initial training course for management 
planners.
    (j) Assembling and submitting the management plan. Plan requirements 
for schools in TSCA Title II section 203(i)(1); the management plan as a 
planning tool.
    (k) Financing abatement actions. Economic analysis and cost 
estimates; development of cost estimates; present costs of abatement 
versus future operation and maintenance costs; Asbestos School Hazard 
Abatement Act grants and loans.
    (l) Course review. A review of key aspects of the training course.

                           5. Project Designer

    A person must be accredited as a project designer to design any of 
the following activities with respect to friable ACBM in a school or 
public and commercial building: (1) A response action other than a SSSD 
maintenance activity, (2) a maintenance activity that disturbs friable 
ACBM other than a SSSD maintenance activity, or (3) a response action 
for a major fiber release episode. All persons seeking accreditation as 
a project designer shall complete at least a minimum 3-day training 
course as outlined below. The project designer course shall include 
lectures, demonstrations, a field trip, course review and a written 
examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    The abatement project designer training course shall adequately 
address the following topics:
    (a) Background information on asbestos. Identification of asbestos; 
examples and discussion of the uses and locations of asbestos in 
buildings; physical appearance of asbestos.
    (b) Potential health effects related to asbestos exposure. Nature of 
asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
period of asbestos-related diseases; a discussion of the relationship 
between asbestos exposure and asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Overview of abatement construction projects. Abatement as a 
portion of a renovation project; OSHA requirements for notification of 
other contractors on a multi-employer site (29 CFR 1926.58).
    (d) Safety system design specifications. Design, construction, and 
maintenance of containment barriers and decontamination enclosure 
systems; positioning of warning signs; electrical and ventilation system 
lock-

[[Page 703]]

out; proper working techniques for minimizing fiber release; entry and 
exit procedures for the work area; use of wet methods; proper techniques 
for initial cleaning; use of negative-pressure exhaust ventilation 
equipment; use of HEPA vacuums; proper clean-up and disposal of 
asbestos; work practices as they apply to encapsulation, enclosure, and 
repair; use of glove bags and a demonstration of glove bag use.
    (e) Field trip. A visit to an abatement site or other suitable 
building site, including on-site discussions of abatement design and 
building walk-through inspection. Include discussion of rationale for 
the concept of functional spaces during the walk-through.
    (f) Employee personal protective equipment. Classes and 
characteristics of respirator types; limitations of respirators; proper 
selection, inspection; donning, use, maintenance, and storage procedures 
for respirators; methods for field testing of the facepiece-to-face seal 
(positive and negative-pressure fit checks); qualitative and 
quantitative fit testing procedures; variability between field and 
laboratory protection factors that alter respiratory fit (e.g., facial 
hair); the components of a proper respiratory protection program; 
selection and use of personal protective clothing; use, storage, and 
handling of non-disposable clothing.
    (g) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire, and explosion 
hazards.
    (h) Fiber aerodynamics and control. Aerodynamic characteristics of 
asbestos fibers; importance of proper containment barriers; settling 
time for asbestos fibers; wet methods in abatement; aggressive air 
monitoring following abatement; aggressive air movement and negative-
pressure exhaust ventilation as a clean-up method.
    (i) Designing abatement solutions. Discussions of removal, 
enclosure, and encapsulation methods; asbestos waste disposal.
    (j) Final clearance process. Discussion of the need for a written 
sampling rationale for aggressive final air clearance; requirements of a 
complete visual inspection; and the relationship of the visual 
inspection to final air clearance.
    EPA recommends the use of TEM for analysis of final air clearance 
samples. These samples should be analyzed by laboratories accredited 
under the NIST NVLAP.
    (k) Budgeting/cost estimating. Development of cost estimates; 
present costs of abatement versus future operation and maintenance 
costs; setting priorities for abatement jobs to reduce costs.
    (l) Writing abatement specifications. Preparation of and need for a 
written project design; means and methods specifications versus 
performance specifications; design of abatement in occupied buildings; 
modification of guide specifications for a particular building; worker 
and building occupant health/medical considerations; replacement of ACM 
with non-asbestos substitutes.
    (m) Preparing abatement drawings. Significance and need for 
drawings, use of as-built drawings as base drawings; use of inspection 
photographs and on-site reports; methods of preparing abatement 
drawings; diagramming containment barriers; relationship of drawings to 
design specifications; particular problems related to abatement 
drawings.
    (n) Contract preparation and administration.
    (o) Legal/liabilities/defenses. Insurance considerations; bonding; 
hold-harmless clauses; use of abatement contractor's liability 
insurance; claims made versus occurrence policies.
    (p) Replacement. Replacement of asbestos with asbestos-free 
substitutes.
    (q) Role of other consultants. Development of technical 
specification sections by industrial hygienists or engineers; the multi-
disciplinary team approach to abatement design.
    (r) Occupied buildings. Special design procedures required in 
occupied buildings; education of occupants; extra monitoring 
recommendations; staging of work to minimize occupant exposure; 
scheduling of renovation to minimize exposure.
    (s) Relevant Federal, State, and local regulatory requirements, 
procedures and standards, including, but not limited to:
    (i) Requirements of TSCA Title II.
    (ii) National Emission Standards for Hazardous Air Pollutants, (40 
CFR part 61) subparts A (General Provisions) and M (National Emission 
Standard for Asbestos).
    (iii) OSHA Respirator Standard found at 29 CFR 1910.134.
    (iv) EPA Worker Protection Rule found at 40 CFR part 763, subpart G.
    (v) OSHA Asbestos Construction Standard found at 29 CFR 1926.58.
    (vi) OSHA Hazard Communication Standard found at 29 CFR 1926.59.
    (t) Course review. A review of key aspects of the training course.

                           6. Project Monitor

    EPA recommends that States adopt training and accreditation 
requirements for persons seeking to perform work as project monitors. 
Project monitors observe abatement activities performed by contractors 
and generally serve as a building owner's representative to ensure that 
abatement work is completed according to specification and in compliance 
with all relevant statutes and regulations. They may also perform the 
vital role of air monitoring for purposes of determining final 
clearance. EPA recommends that a State seeking to accredit individuals 
as project monitors consider adopting a minimum 5-day training course 
covering the topics outlined below. The course

[[Page 704]]

outlined below consists of lectures and demonstrations, at least 6 hours 
of hands-on training, course review, and a written examination. The 
hands-on training component might be satisfied by having the student 
simulate participation in or performance of any of the relevant job 
functions or activities (or by incorporation of the workshop component 
described in item ``n'' below of this unit).
    EPA recommends that the project monitor training course adequately 
address the following topics:
    (a) Roles and responsibilities of the project monitor. Definition 
and responsibilities of the project monitor, including regulatory/
specification compliance monitoring, air monitoring, conducting visual 
inspections, and final clearance monitoring.
    (b) Characteristics of asbestos and asbestos-containing materials. 
Typical uses of asbestos; physical appearance of asbestos; review of 
asbestos abatement and control techniques; presentation of the health 
effects of asbestos exposure, including routes of exposure, dose-
response relationships, and latency periods for asbestos-related 
diseases.
    (c) Federal asbestos regulations. Overview of pertinent EPA 
regulations, including: NESHAP, 40 CFR part 61, subparts A and M; AHERA, 
40 CFR part 763, subpart E; and the EPA Worker Protection Rule, 40 CFR 
part 763, subpart G. Overview of pertinent OSHA regulations, including: 
Construction Industry Standard for Asbestos, 29 CFR 1926.58; Respirator 
Standard, 29 CFR 1910.134; and the Hazard Communication Standard, 29 CFR 
1926.59. Applicable State and local asbestos regulations; regulatory 
interrelationships.
    (d) Understanding building construction and building systems. 
Building construction basics, building physical plan layout; 
understanding building systems (HVAC, electrical, etc.); layout and 
organization, where asbestos is likely to be found on building systems; 
renovations and the effect of asbestos abatement on building systems.
    (e) Asbestos abatement contracts, specifications, and drawings. 
Basic provisions of the contract; relationships between principle 
parties, establishing chain of command; types of specifications, 
including means and methods, performance, and proprietary and 
nonproprietary; reading and interpreting records and abatement drawings; 
discussion of change orders; common enforcement responsibilities and 
authority of project monitor.
    (f) Response actions and abatement practices. Pre-work inspections; 
pre-work considerations, precleaning of the work area, removal of 
furniture, fixtures, and equipment; shutdown/modification of building 
systems; construction and maintenance of containment barriers, proper 
demarcation of work areas; work area entry/exit, hygiene practices; 
determining the effectiveness of air filtration equipment; techniques 
for minimizing fiber release, wet methods, continuous cleaning; 
abatement methods other than removal; abatement area clean-up 
procedures; waste transport and disposal procedures; contingency 
planning for emergency response.
    (g) Asbestos abatement equipment. Typical equipment found on an 
abatement project; air filtration devices, vacuum systems, negative 
pressure differential monitoring; HEPA filtration units, theory of 
filtration, design/construction of HEPA filtration units, qualitative 
and quantitative performance of HEPA filtration units, sizing the 
ventilation requirements, location of HEPA filtration units, qualitative 
and quantitative tests of containment barrier integrity; best available 
technology.
    (h) Personal protective equipment. Proper selection of respiratory 
protection; classes and characteristics of respirator types, limitations 
of respirators; proper use of other safety equipment, protective 
clothing selection, use, and proper handling, hard/bump hats, safety 
shoes; breathing air systems, high pressure v. low pressure, testing for 
Grade D air, determining proper backup air volumes.
    (i) Air monitoring strategies. Sampling equipment, sampling pumps 
(low v. high volume), flow regulating devices (critical and limiting 
orifices), use of fibrous aerosol monitors on abatement projects; 
sampling media, types of filters, types of cassettes, filter 
orientation, storage and shipment of filters; calibration techniques, 
primary calibration standards, secondary calibration standards, 
temperature/pressure effects, frequency of calibration, recordkeeping 
and field work documentation, calculations; air sample analysis, 
techniques available and limitations of AHERA on their use, transmission 
electron microscopy (background to sample preparation and analysis, air 
sample conditions which prohibit analysis, EPA's recommended technique 
for analysis of final air clearance samples), phase contrast microscopy 
(background to sample preparation, and AHERA's limits on the use of 
phase contrast microscopy), what each technique measures; analytical 
methodologies, AHERA TEM protocol, NIOSH 7400, OSHA reference method 
(non clearance), EPA recommendation for clearance (TEM); sampling 
strategies for clearance monitoring, types of air samples (personal 
breathing zone v. fixed-station area) sampling location and objectives 
(pre-abatement, during abatement, and clearance monitoring), number of 
samples to be collected, minimum and maximum air volumes, clearance 
monitoring (post-visual-inspection) (number of samples required, 
selection of sampling locations, period of sampling, aggressive 
sampling, interpretations of sampling results, calculations), quality 
assurance; special sampling problems, crawl spaces, acceptable samples 
for laboratory

[[Page 705]]

analysis, sampling in occupied buildings (barrier monitoring).
    (j) Safety and health issues other than asbestos. Confined-space 
entry, electrical hazards, fire and explosion concerns, ladders and 
scaffolding, heat stress, air contaminants other than asbestos, fall 
hazards, hazardous materials on abatement projects.
    (k) Conducting visual inspections. Inspections during abatement, 
visual inspections using the ASTM E1368 document; conducting inspections 
for completeness of removal; discussion of ``how clean is clean?''
    (l) Legal responsibilities and liabilities of project monitors. 
Specification enforcement capabilities; regulatory enforcement; 
licensing; powers delegated to project monitors through contract 
documents.
    (m) Recordkeeping and report writing. Developing project logs/daily 
logs (what should be included, who sees them); final report preparation; 
recordkeeping under Federal regulations.
    (n) Workshops (6 hours spread over 3 days). Contracts, 
specifications, and drawings: This workshop could consist of each 
participant being issued a set of contracts, specifications, and 
drawings and then being asked to answer questions and make 
recommendations to a project architect, engineer or to the building 
owner based on given conditions and these documents.
    Air monitoring strategies/asbestos abatement equipment: This 
workshop could consist of simulated abatement sites for which sampling 
strategies would have to be developed (i.e., occupied buildings, 
industrial situations). Through demonstrations and exhibition, the 
project monitor may also be able to gain a better understanding of the 
function of various pieces of equipment used on abatement projects (air 
filtration units, water filtration units, negative pressure monitoring 
devices, sampling pump calibration devices, etc.).
    Conducting visual inspections: This workshop could consist, ideally, 
of an interactive video in which a participant is ``taken through'' a 
work area and asked to make notes of what is seen. A series of questions 
will be asked which are designed to stimulate a person's recall of the 
area. This workshop could consist of a series of two or three videos 
with different site conditions and different degrees of cleanliness.

                             C. Examinations

    1. Each State shall administer a closed book examination or 
designate other entities such as State-approved providers of training 
courses to administer the closed-book examination to persons seeking 
accreditation who have completed an initial training course. 
Demonstration testing may also be included as part of the examination. A 
person seeking initial accreditation in a specific discipline must pass 
the examination for that discipline in order to receive accreditation. 
For example, a person seeking accreditation as an abatement project 
designer must pass the State's examination for abatement project 
designer.
    States may develop their own examinations, have providers of 
training courses develop examinations, or use standardized examinations 
developed for purposes of accreditation under TSCA Title II. In 
addition, States may supplement standardized examinations with questions 
about State regulations. States may obtain commercially developed 
standardized examinations, develop standardized examinations 
independently, or do so in cooperation with other States, or with 
commercial or non-profit providers on a regional or national basis. EPA 
recommends the use of standardized, scientifically-validated testing 
instruments, which may be beneficial in terms of both promoting 
competency and in fostering accreditation reciprocity between States.
    Each examination shall adequately cover the topics included in the 
training course for that discipline. Each person who completes a 
training course, passes the required examination, and fulfills whatever 
other requirements the State imposes must receive an accreditation 
certificate in a specific discipline. Whether a State directly issues 
accreditation certificates, or authorizes training providers to issue 
accreditation certificates, each certificate issued to an accredited 
person must contain the following minimum information:
    a. A unique certificate number
    b. Name of accredited person
    c. Discipline of the training course completed.
    d. Dates of the training course.
    e. Date of the examination.
    f. An expiration date of 1 year after the date upon which the person 
successfully completed the course and examination.
    g. The name, address, and telephone number of the training provider 
that issued the certificate.
    h. A statement that the person receiving the certificate has 
completed the requisite training for asbestos accreditation under TSCA 
Title II.
    States or training providers who reaccredit persons based upon 
completion of required refresher training must also provide 
accreditation certificates with all of the above information, except the 
examination date may be omitted if a State does not require a refresher 
examination for reaccreditation.
    Where a State licenses accredited persons but has authorized 
training providers to issue accreditation certificates, the State may 
issue licenses in the form of photo-identification cards. Where this 
applies, EPA recommends that the State licenses should include all of 
the same information required for the accreditation certificates. A 
State

[[Page 706]]

may also choose to issue photo-identification cards in addition to the 
required accreditation certificates.
    Accredited persons must have their initial and current accreditation 
certificates at the location where they are conducting work.
    2. The following are the requirements for examination in each 
discipline:
    a. Worker:
    i. 50 multiple-choice questions
    ii. Passing score: 70 percent correct
    b. Contractor/Supervisor:
    i. 100 multiple-choice questions
    ii. Passing score: 70 percent correct
    c. Inspector:
    i. 50 Multiple-choice questions
    ii. Passing score: 70 percent correct
    d. Management Planner:
    i. 50 Multiple-choice questions
    ii. Passing score: 70 percent correct
    e. Project Designer:
    i. 100 multiple-choice questions
    ii. Passing score: 70 percent correct

                         D. Continuing Education

    For all disciplines, a State's accreditation program shall include 
annual refresher training as a requirement for reaccreditation as 
indicated below:
    1. Workers: One full day of refresher training.
    2. Contractor/Supervisors: One full day of refresher training.
    3. Inspectors: One half-day of refresher training.
    4. Management Planners: One half-day of inspector refresher training 
and one half-day of refresher training for management planners.
    5. Project Designers: One full day of refresher training.
    The refresher courses shall be specific to each discipline. 
Refresher courses shall be conducted as separate and distinct courses 
and not combined with any other training during the period of the 
refresher course. For each discipline, the refresher course shall review 
and discuss changes in Federal, State, and local regulations, 
developments in state-of-the-art procedures, and a review of key aspects 
of the initial training course as determined by the State. After 
completing the annual refresher course, persons shall have their 
accreditation extended for an additional year from the date of the 
refresher course. A State may consider requiring persons to pass 
reaccreditation examinations at specific intervals (for example, every 3 
years).
    EPA recommends that States formally establish a 12-month grace 
period to enable formerly accredited persons with expired certificates 
to complete refresher training and have their accreditation status 
reinstated without having to re-take the initial training course.

                            E. Qualifications

    In addition to requiring training and an examination, a State may 
require candidates for accreditation to meet other qualification and/or 
experience standards that the State considers appropriate for some or 
all disciplines. States may choose to consider requiring qualifications 
similar to the examples outlined below for inspectors, management 
planners and project designers. States may modify these examples as 
appropriate. In addition, States may want to include some requirements 
based on experience in performing a task directly as a part of a job or 
in an apprenticeship role. They may also wish to consider additional 
criteria for the approval of training course instructors beyond those 
prescribed by EPA.
    1. Inspectors: Qualifications - possess a high school diploma. 
States may want to require an Associate's Degree in specific fields 
(e.g., environmental or physical sciences).
    2. Management Planners: Qualifications - Registered architect, 
engineer, or certified industrial hygienist or related scientific field.
    3. Project Designers: Qualifications - registered architect, 
engineer, or certified industrial hygienist.
    4. Asbestos Training Course Instructor: Qualifications - academic 
credentials and/or field experience in asbestos abatement.
    EPA recommends that States prescribe minimum qualification standards 
for training instructors employed by training providers.

          F. Recordkeeping Requirements for Training Providers

    All approved providers of accredited asbestos training courses must 
comply with the following minimum recordkeeping requirements.
    1. Training course materials. A training provider must retain copies 
of all instructional materials used in the delivery of the classroom 
training such as student manuals, instructor notebooks and handouts.
    2. Instructor qualifications. A training provider must retain copies 
of all instructors' resumes, and the documents approving each instructor 
issued by either EPA or a State. Instructors must be approved by either 
EPA or a State before teaching courses for accreditation purposes. A 
training provider must notify EPA or the State, as appropriate, in 
advance whenever it changes course instructors. Records must accurately 
identify the instructors that taught each particular course for each 
date that a course is offered.
    3. Examinations. A training provider must document that each person 
who receives an accreditation certificate for an initial training course 
has achieved a passing score on the examination. These records must 
clearly indicate the date upon which the exam was

[[Page 707]]

administered, the training course and discipline for which the exam was 
given, the name of the person who proctored the exam, a copy of the 
exam, and the name and test score of each person taking the exam. The 
topic and dates of the training course must correspond to those listed 
on that person's accreditation certificate. States may choose to apply 
these same requirements to examinations for refresher training courses.
    4. Accreditation certificates. The training providers or States, 
whichever issues the accreditation certificate, shall maintain records 
that document the names of all persons who have been awarded 
certificates, their certificate numbers, the disciplines for which 
accreditation was conferred, training and expiration dates, and the 
training location. The training provider or State shall maintain the 
records in a manner that allows verification by telephone of the 
required information.
    5. Verification of certificate information. EPA recommends that 
training providers of refresher training courses confirm that their 
students possess valid accreditation before granting course admission. 
EPA further recommends that training providers offering the initial 
management planner training course verify that students have met the 
prerequisite of possessing valid inspector accreditation at the time of 
course admission.
    6. Records retention and access. (a) The training provider shall 
maintain all required records for a minimum of 3 years. The training 
provider, however, may find it advantageous to retain these records for 
a longer period of time.
    (b) The training provider must allow reasonable access to all of the 
records required by the MAP, and to any other records which may be 
required by States for the approval of asbestos training providers or 
the accreditation of asbestos training courses, to both EPA and to State 
Agencies, on request. EPA encourages training providers to make this 
information equally accessible to the general public.
    (c) If a training provider ceases to conduct training, the training 
provider shall notify the approving government body (EPA or the State) 
and give it the opportunity to take possession of that providers 
asbestos training records.

                           G. Deaccreditation

    1. States must establish criteria and procedures for deaccrediting 
persons accredited as workers, contractor/supervisors, inspectors, 
management planners, and project designers. States must follow their own 
administrative procedures in pursuing deaccreditation actions. At a 
minimum, the criteria shall include:
    (a) Performing work requiring accreditation at a job site without 
being in physical possession of initial and current accreditation 
certificates;
    (b) Permitting the duplication or use of one's own accreditation 
certificate by another;
    (c) Performing work for which accreditation has not been received; 
or
    (d) Obtaining accreditation from a training provider that does not 
have approval to offer training for the particular discipline from 
either EPA or from a State that has a contractor accreditation plan at 
least as stringent as the EPA MAP.
    EPA may directly pursue deaccreditation actions without reliance on 
State deaccreditation or enforcement authority or actions. In addition 
to the above-listed situations, the Administrator may suspend or revoke 
the accreditation of persons who have been subject to a final order 
imposing a civil penalty or convicted under section 16 of TSCA, 15 
U.S.C. 2615 or 2647, for violations of 40 CFR part 763, or section 113 
of the Clean Air Act, 42 U.S.C. 7413, for violations of 40 CFR part 61, 
subpart M.
    2. Any person who performs asbestos work requiring accreditation 
under section 206(a) of TSCA, 15 U.S.C. 2646(a), without such 
accreditation is in violation of TSCA. The following persons are not 
accredited for purposes of section 206(a) of TSCA:
    (a) Any person who obtains accreditation through fraudulent 
representation of training or examination documents;
    (b) Any person who obtains training documentation through fraudulent 
means;
    (c) Any person who gains admission to and completes refresher 
training through fraudulent representation of initial or previous 
refresher training documentation; or
    (d) Any person who obtains accreditation through fraudulent 
representation of accreditation requirements such as education, 
training, professional registration, or experience.

                             H. Reciprocity

    EPA recommends that each State establish reciprocal arrangements 
with other States that have established accreditation programs that meet 
or exceed the requirements of the MAP. Such arrangements might address 
cooperation in licensing determinations, the review and approval of 
training programs and/or instructors, candidate testing and exam 
administration, curriculum development, policy formulation, compliance 
monitoring, and the exchange of information and data. The benefits to be 
derived from these arrangements include a potential cost-savings from 
the reduction of duplicative activity and the attainment of a more 
professional accredited workforce as States are able to refine and 
improve the effectiveness of their programs based upon the experience 
and methods of other States.

[[Page 708]]

        II. EPA Approval Process for State Accreditation Programs

    A. States may seek approval for a single discipline or all 
disciplines as specified in the MAP. For example, a State that currently 
only requires worker accreditation may receive EPA approval for that 
discipline alone. EPA encourages States that currently do not have 
accreditation requirements for all disciplines required under section 
206(b)(2) of TSCA, 15 U.S.C. 2646(b)(2), to seek EPA approval for those 
disciplines the State does accredit. As States establish accreditation 
requirements for the remaining disciplines, the requested information 
outlined below should be submitted to EPA as soon as possible. Any State 
that had an accreditation program approved by EPA under an earlier 
version of the MAP may follow the same procedures to obtain EPA approval 
of their accreditation program under this MAP.
    B. Partial approval of a State Program for the accreditation of one 
or more disciplines does not mean that the State is in full compliance 
with TSCA where the deadline for that State to have adopted a State Plan 
no less stringent than the MAP has already passed. State Programs which 
are at least as stringent as the MAP for one or more of the accredited 
disciplines may, however, accredit persons in those disciplines only.
    C. States seeking EPA approval or reapproval of accreditation 
programs shall submit the following information to the Regional Asbestos 
Coordinator at their EPA Regional office:
    1. A copy of the legislation establishing or upgrading the State's 
accreditation program (if applicable).
    2. A copy of the State's accreditation regulations or revised 
regulations.
    3. A letter to the Regional Asbestos Coordinator that clearly 
indicates how the State meets the program requirements of this MAP. 
Addresses for each of the Regional Asbestos Coordinators are shown 
below:
EPA, Region I, (ATC-111) Asbestos Coordinator, JFK Federal Bldg., 
Boston, MA 02203-2211, (617) 565-3836.
EPA, Region II, (MS-500), Asbestos Coordinator, 2890 Woodbridge Ave., 
Edison, NJ 08837-3679, (908) 321-6671.
EPA, Region III, (3AT-33), Asbestos Coordinator, 841 Chestnut Bldg., 
Philadelphia, PA 19107, (215) 597-3160.
EPA, Region IV, Asbestos Coordinator, 345 Courtland St., N.E., Atlanta, 
GA 30365, (404) 347-5014.
EPA, Region V, (SP-14J), Asbestos Coordinator, 77 W. Jackson Blvd., 
Chicago, IL 60604-3590, (312) 886-6003.
EPA, Region VI, (6T-PT), Asbestos Coordinator, 1445 Ross Ave. Dallas, TX 
75202-2744, (214) 655-7244.
EPA, Region VII, (ARTX/ASBS), Asbestos Coordinator, 726 Minnesota Ave., 
Kansas City, KS 66101, (913) 551-7020.
EPA, Region VIII, (8AT-TS), Asbestos Coordinator, 1 Denver Place, Suite 
500 999 - 18th St., Denver, CO 80202-2405, (303) 293-1442.
EPA, Region IX, (A-4-4), Asbestos Coordinator, 75 Hawthorne St., San 
Francisco, CA 94105, (415) 744-1128.
EPA, Region X, (AT-083), Asbestos Coordinator, 1200 Sixth Ave., Seattle, 
WA 98101, (206) 553-4762.
    EPA maintains a listing of all those States that have applied for 
and received EPA approval for having accreditation requirements that are 
at least as stringent as the MAP for one or more disciplines. Any 
training courses approved by an EPA-approved State Program are 
considered to be EPA-approved for purposes of accreditation.

                    III. Approval of Training Courses

    Individuals or groups wishing to sponsor training courses for 
disciplines required to be accredited under section 206(b)(1)(A) of 
TSCA, 15 U.S.C. 2646(b)(1)(A), may apply for approval from States that 
have accreditation program requirements that are at least as stringent 
as this MAP. For a course to receive approval, it must meet the 
requirements for the course as outlined in this MAP, and any other 
requirements imposed by the State from which approval is being sought. 
Courses that have been approved by a State with an accreditation program 
at least as stringent as this MAP are approved under section 206(a) of 
TSCA, 15 U.S.C. 2646(a), for that particular State, and also for any 
other State that does not have an accreditation program as stringent as 
this MAP.

                   A. Initial Training Course Approval

    A training provider must submit the following minimum information to 
a State as part of its application for the approval of each training 
course:
    1. The course provider's name, address, and telephone number.
    2. A list of any other States that currently approve the training 
course.
    3. The course curriculum.
    4. A letter from the provider of the training course that clearly 
indicates how the course meets the MAP requirements for:
    a. Length of training in days.
    b. Amount and type of hands-on training.
    c. Examination (length, format, and passing score).
    d. Topics covered in the course.
    5. A copy of all course materials (student manuals, instructor 
notebooks, handouts, etc.).
    6. A detailed statement about the development of the examination 
used in the course.

[[Page 709]]

    7. Names and qualifications of all course instructors. Instructors 
must have academic and/or field experience in asbestos abatement.
    8. A description of and an example of the numbered certificates 
issued to students who attend the course and pass the examination.

                  B. Refresher Training Course Approval

    The following minimum information is required for approval of 
refresher training courses by States:
    1. The length of training in half-days or days.
    2. The topics covered in the course.
    3. A copy of all course materials (student manuals, instructor 
notebooks, handouts, etc.).
    4. The names and qualifications of all course instructors. 
Instructors must have academic and/or field experience in asbestos 
abatement.
    5. A description of and an example of the numbered certificates 
issued to students who complete the refresher course and pass the 
examination, if required.

                C. Withdrawal of Training Course Approval

    States must establish criteria and procedures for suspending or 
withdrawing approval from accredited training programs. States should 
follow their own administrative procedures in pursuing actions for 
suspension or withdrawal of approval of training programs. At a minimum, 
the criteria shall include:
    (1) Misrepresentation of the extent of a training course's approval 
by a State or EPA;
    (2) Failure to submit required information or notifications in a 
timely manner;
    (3) Failure to maintain requisite records;
    (4) Falsification of accreditation records, instructor 
qualifications, or other accreditation information; or
    (5) Failure to adhere to the training standards and requirements of 
the EPA MAP or State Accreditation Program, as appropriate.
    In addition to the criteria listed above, EPA may also suspend or 
withdraw a training course's approval where an approved training course 
instructor, or other person with supervisory authority over the delivery 
of training has been found in violation of other asbestos regulations 
administered by EPA. An administrative or judicial finding of violation, 
or execution of a consent agreement and order under 40 CFR 22.18, 
constitutes evidence of a failure to comply with relevant statutes or 
regulations. States may wish to adopt this criterion modified to include 
their own asbestos statutes or regulations. EPA may also suspend or 
withdraw approval of training programs where a training provider has 
submitted false information as a part of the self-certification required 
under Unit V.B. of the revised MAP.
    Training course providers shall permit representatives of EPA or the 
State which approved their training courses to attend, evaluate, and 
monitor any training course without charge. EPA or State compliance 
inspection staff are not required to give advance notice of their 
inspections. EPA may suspend or withdraw State or EPA approval of a 
training course based upon the criteria specified in this Unit III.C.

  IV. EPA Procedures for Suspension or Revocation of Accreditation or 
                        Training Course Approval.

    A. If the Administrator decides to suspend or revoke the 
accreditation of any person or suspend or withdraw the approval of a 
training course, the Administrator will notify the affected entity of 
the following:
    1. The grounds upon which the suspension, revocation, or withdrawal 
is based.
    2. The time period during which the suspension, revocation, or 
withdrawal is effective, whether permanent or otherwise.
    3. The conditions, if any, under which the affected entity may 
receive accreditation or approval in the future.
    4. Any additional conditions which the Administrator may impose.
    5. The opportunity to request a hearing prior to final Agency action 
to suspend or revoke accreditation or suspend or withdraw approval.
    B. If a hearing is requested by the accredited person or training 
course provider pursuant to the preceding paragraph, the Administrator 
will:
    1. Notify the affected entity of those assertions of law and fact 
upon which the action to suspend, revoke, or withdraw is based.
    2. Provide the affected entity an opportunity to offer written 
statements of facts, explanations, comments, and arguments relevant to 
the proposed action.
    3. Provide the affected entity such other procedural opportunities 
as the Administrator may deem appropriate to ensure a fair and impartial 
hearing.
    4. Appoint an EPA attorney as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific case.
    C. The Presiding Officer appointed pursuant to the preceding 
paragraph shall:
    1. Conduct a fair, orderly, and impartial hearing, without 
unnecessary delay.
    2. Consider all relevant evidence, explanation, comment, and 
argument submitted pursuant to the preceding paragraph.
    3. Promptly notify the affected entity of his or her decision and 
order. Such an order is a final Agency action.

[[Page 710]]

    D. If the Administrator determines that the public health, interest, 
or welfare warrants immediate action to suspend the accreditation of any 
person or the approval of any training course provider, the 
Administrator will:
    1. Notify the affected entity of the grounds upon which the 
emergency suspension is based;
    2. Notify the affected entity of the time period during which the 
emergency suspension is effective.
    3. Notify the affected entity of the Administrator's intent to 
suspend or revoke accreditation or suspend or withdraw training course 
approval, as appropriate, in accordance with Unit IV.A. above. If such 
suspension, revocation, or withdrawal notice has not previously been 
issued, it will be issued at the same time the emergency suspension 
notice is issued.
    E. Any notice, decision, or order issued by the Administrator under 
this section, and any documents filed by an accredited person or 
approved training course provider in a hearing under this section, shall 
be available to the public except as otherwise provided by section 14 of 
TSCA or by 40 CFR part 2. Any such hearing at which oral testimony is 
presented shall be open to the public, except that the Presiding Officer 
may exclude the public to the extent necessary to allow presentation of 
information which may be entitled to confidential treatment under 
section 14 of TSCA or 40 CFR part 2.

                       V. Implementation Schedule

    The various requirements of this MAP become effective in accordance 
with the following schedules:

              A. Requirements applicable to State Programs

    1. Each State shall adopt an accreditation plan that is at least as 
stringent as this MAP within 180 days after the commencement of the 
first regular session of the legislature of the State that is convened 
on or after April 4, 1994.
    2. If a State has adopted an accreditation plan at least as 
stringent as this MAP as of April 4, 1994, the State may continue to:
    a. Conduct TSCA training pursuant to this MAP.
    b. Approve training course providers to conduct training and to 
issue accreditation that satisfies the requirements for TSCA 
accreditation under this MAP.
    c. Issue accreditation that satisfies the requirements for TSCA 
accreditation under this MAP.
    3. A State that had complied with an earlier version of the MAP, but 
has not adopted an accreditation plan at least as stringent as this MAP 
by April 4, 1994, may:
    a. Conduct TSCA training which remains in compliance with the 
requirements of Unit V.B. of this MAP. After such training has been 
self-certified in accordance with Unit V.B. of this MAP, the State may 
issue accreditation that satisfies the requirement for TSCA 
accreditation under this MAP.
    b. Sustain its approval for any training course providers to conduct 
training and issue TSCA accreditation that the State had approved before 
April 4, 1994, and that remain in compliance with Unit V.B. of this MAP.
    c. Issue accreditation pursuant to an earlier version of the MAP 
that provisionally satisfies the requirement for TSCA accreditation 
until October 4, 1994.
    Such a State may not approve new TSCA training course providers to 
conduct training or to issue TSCA accreditation that satisfies the 
requirements of this MAP until the State adopts an accreditation plan 
that is at least as stringent as this MAP.
    4. A State that had complied with an earlier version of the MAP, but 
fails to adopt a plan as stringent as this MAP by the deadline 
established in Unit V.A.1., is subject to the following after that 
deadline date:
    a. The State loses any status it may have held as an EPA-approved 
State for accreditation purposes under section 206 of TSCA, 15 U.S.C. 
2646.
    b. All training course providers approved by the State lose State 
approval to conduct training and issue accreditation that satisfies the 
requirements for TSCA accreditation under this MAP.
    c. The State may not:
    i. Conduct training for accreditation purposes under section 206 of 
TSCA, 15 U.S.C. 2646.
    ii. Approve training course providers to conduct training or issue 
accreditation that satisfies the requirements for TSCA accreditation; or
    iii. Issue accreditation that satisfies the requirement for TSCA 
accreditation.
    EPA will extend EPA-approval to any training course provider that 
loses State approval because the State does not comply with the 
deadline, so long as the provider is in compliance with Unit V.B. of 
this MAP, and the provider is approved by a State that had complied with 
an earlier version of the MAP as of the day before the State loses its 
EPA approval.
    5. A State that does not have an accreditation program that 
satisfies the requirements for TSCA accreditation under either an 
earlier version of the MAP or this MAP, may not:
    a. Conduct training for accreditation purposes under section 206 of 
TSCA, 15 U.S.C. 2646;
    b. Approve training course providers to conduct training or issue 
accreditation that

[[Page 711]]

satisfies the requirements for TSCA accreditation; or
    c. Issue accreditation that satisfies the requirement for TSCA 
accreditation.

      B. Requirements applicable to Training Courses and Providers

    As of October 4, 1994, an approved training provider must certify to 
EPA and to any State that has approved the provider for TSCA 
accreditation, that each of the provider's training courses complies 
with the requirements of this MAP. The written submission must document 
in specific detail the changes made to each training course in order to 
comply with the requirements of this MAP and clearly state that the 
provider is also in compliance with all other requirements of this MAP, 
including the new recordkeeping and certificate provisions. Each 
submission must include the following statement signed by an authorized 
representative of the training provider: ``Under civil and criminal 
penalties of law for the making or submission of false or fraudulent 
statements or representations (18 U.S.C. 1001 and 15 U.S.C. 2615), I 
certify that the training described in this submission complies with all 
applicable requirements of Title II of TSCA, 40 CFR part 763, Appendix C 
to Subpart E, as revised, and any other applicable Federal, state, or 
local requirements.'' A consolidated self-certification submission from 
each training provider that addresses all of its approved training 
courses is permissible and encouraged.
    The self-certification must be sent via registered mail, to EPA 
Headquarters at the following address: Attn. Self-Certification Program, 
Field Programs Branch, Chemical Management Division (7404), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. A duplicate copy of the complete 
submission must also be sent to any States from which approval had been 
obtained.
    The timely receipt of a complete self-certification by EPA and all 
approving States shall have the effect of extending approval under this 
MAP to the training courses offered by the submitting provider. If a 
self-certification is not received by the approving government bodies on 
or before the due date, the affected training course is not approved 
under this MAP. Such training providers must then reapply for approval 
of these training courses pursuant to the procedures outlined in Unit 
III.

            C. Requirements applicable to Accredited Persons.

    Persons accredited by a State with an accreditation program no less 
stringent than an earlier version of the MAP or by an EPA-approved 
training provider as of April 3, 1994, are accredited in accordance with 
the requirements of this MAP, and are not required to retake initial 
training. They must continue to comply with the requirements for annual 
refresher training in Unit I.D. of the revised MAP.

          D. Requirements applicable to Non-Accredited Persons.

    In order to perform work requiring accreditation under TSCA Title 
II, persons who are not accredited by a State with an accreditation 
program no less stringent than an earlier version of the MAP or by an 
EPA-approved training provider as of April 3, 1994, must comply with the 
upgraded training requirements of this MAP by no later than October 4, 
1994. Non-accredited persons may obtain initial accreditation on a 
provisional basis by successfully completing any of the training 
programs approved under an earlier version of the MAP, and thereby 
perform work during the first 6 months after this MAP takes effect. 
However, by October 4, 1994, these persons must have successfully 
completed an upgraded training program that fully complies with the 
requirements of this MAP in order to continue to perform work requiring 
accreditation under section 206 of TSCA, 15 U.S.C. 2646.

[59 FR 5251, Feb. 3, 1994, as amended at 60 FR 31922, June 19, 1995]

    Appendix D to Subpart E--Transport and Disposal of Asbestos Waste

    For the purposes of this appendix, transport is defined as all 
activities from receipt of the containerized asbestos waste at the 
generation site until it has been unloaded at the disposal site. Current 
EPA regulations state that there must be no visible emissions to the 
outside air during waste transport. However, recognizing the potential 
hazards and subsequent liabilities associated with exposure, the 
following additional precautions are recommended.
    Recordkeeping. Before accepting wastes, a transporter should 
determine if the waste is properly wetted and containerized. The 
transporter should then require a chain-of-custody form signed by the 
generator. A chain-of-custody form may include the name and address of 
the generator, the name and address of the pickup site, the estimated 
quantity of asbestos waste, types of containers used, and the 
destination of the waste. The chain-of-custody form should then be 
signed over to a disposal site operator to transfer responsibility for 
the asbestos waste. A copy of the form signed by the disposal site 
operator should be maintained by the transporter as evidence of receipt 
at the disposal site.

[[Page 712]]

    Waste handling. A transporter should ensure that the asbestos waste 
is properly contained in leak-tight containers with appropriate labels, 
and that the outside surfaces of the containers are not contaminated 
with asbestos debris adhering to the containers. If there is reason to 
believe that the condition of the asbestos waste may allow significant 
fiber release, the transporter should not accept the waste. Improper 
containerization of wastes is a violation of the NESHAPs regulation and 
should be reported to the appropriate EPA Regional Asbestos NESHAPs 
contact below:

                                Region I

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region I, 
JFK Federal Building, Boston, MA 02203, (617) 223-3266.

                                Region II

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region II, 26 Federal Plaza, New York, NY 10007, (212) 264-6770.

                               Region III

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region 
III, 841 Chestnut Street, Philadelphia, PA 19107, (215) 597-9325.

                                Region IV

    Asbestos NESHAPs Contact, Air, Pesticide & Toxic Management, USEPA, 
Region IV, 345 Courtland Street, NE., Atlanta, GA 30365, (404) 347-4298.

                                Region V

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region V, 
77 West Jackson Boulevard, Chicago, IL 60604, (312) 353-6793.

                                Region VI

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region VI, 1445 Ross Avenue, Dallas, TX 75202, (214) 655-7229.

                               Region VII

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region VII, 726 Minnesota Avenue, Kansas City, KS 66101, (913) 236-2896.

                               Region VIII

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region VIII, 999 18th Street, Suite 500, Denver, CO 80202, (303) 293-
1814.

                                Region IX

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region IX, 
215 Fremont Street, San Francisco, CA 94105, (415) 974-7633.

                                Region X

    Asbestos NESHAPs Contact, Air & Toxics Management Division, USEPA, 
Region X, 1200 Sixth Avenue, Seattle, WA 98101, (206) 442-2724.

    Once the transporter is satisfied with the condition of the asbestos 
waste and agrees to handle it, the containers should be loaded into the 
transport vehicle in a careful manner to prevent breaking of the 
containers. Similarly, at the disposal site, the asbestos waste 
containers should be transferred carefully to avoid fiber release.
    Waste transport. Although there are no regulatory specifications 
regarding the transport vehicle, it is recommended that vehicles used 
for transport of containerized asbestos waste have an enclosed carrying 
compartment or utilize a canvas covering sufficient to contain the 
transported waste, prevent damage to containers, and prevent fiber 
release. Transport of large quantities of asbestos waste is commonly 
conducted in a 20-cubic-yard ``roll off'' box, which should also be 
covered. Vehicles that use compactors to reduce waste volume should not 
be used because these will cause the waste containers to rupture. Vacuum 
trucks used to transport waste slurry must be inspected to ensure that 
water is not leaking from the truck.
    Disposal involves the isolation of asbestos waste material in order 
to prevent fiber release to air or water. Landfilling is recommended as 
an environmentally sound isolation method because asbestos fibers are 
virtually immobile in soil. Other disposal techniques such as 
incineration or chemical treatment are not feasible due to the unique 
properties of asbestos. EPA has established asbestos disposal 
requirements for active and inactive disposal sites under NESHAPs (40 
CFR Part 61, subpart M) and specifies general requirements for solid 
waste disposal under RCRA (40 CFR Part 257). Advance EPA notification of 
the intended disposal site is required by NESHAPs.
    Selecting a disposal facility. An acceptable disposal facility for 
asbestos wastes must adhere to EPA's requirements of no visible 
emissions to the air during disposal, or minimizing emissions by 
covering the waste within 24 hours. The minimum required cover is 6 
inches of nonasbestos material, normally soil, or a dust-suppressing 
chemical. In addition to these Federal requirements, many state or local 
government agencies require more stringent handling procedures. These 
agencies usually supply a list of ``approved'' or licensed asbestos 
disposal sites upon request. Solid waste control

[[Page 713]]

agencies are listed in local telephone directories under state, county, 
or city headings. A list of state solid waste agencies may be obtained 
by calling the RCRA hotline: 1-800-424-9346 (382-3000 in Washington, 
DC). Some landfill owners or operators place special requirements on 
asbestos waste, such as placing all bagged waste into 55-gallon metal 
drums. Therefore, asbestos removal contractors should contact the 
intended landfill before arriving with the waste.
    Receiving asbestos waste. A landfill approved for receipt of 
asbestos waste should require notification by the waste hauler that the 
load contains asbestos. The landfill operator should inspect the loads 
to verify that asbestos waste is properly contained in leak-tight 
containers and labeled appropriately. The appropriate EPA Regional 
Asbestos NESHAPs Contact should be notified if the landfill operator 
believes that the asbestos waste is in a condition that may cause 
significant fiber release during disposal. In situations when the wastes 
are not properly containerized, the landfill operator should thoroughly 
soak the asbestos with a water spray prior to unloading, rinse out the 
truck, and immediately cover the wastes with nonasbestos material prior 
to compacting the waste in the landfill.
    Waste deposition and covering. Recognizing the health dangers 
associated with asbestos exposure, the following procedures are 
recommended to augment current federal requirements:
     Designate a separate area for asbestos waste disposal. 
Provide a record for future landowners that asbestos waste has been 
buried there and that it would be hazardous to attempt to excavate that 
area. (Future regulations may require property deeds to identify the 
location of any asbestos wastes and warn against excavation.)
     Prepare a separate trench to receive asbestos wastes. The 
size of the trench will depend upon the quantity and frequency of 
asbestos waste delivered to the disposal site. The trenching technique 
allows application of soil cover without disturbing the asbestos waste 
containers. The trench should be ramped to allow the transport vehicle 
to back into it, and the trench should be as narrow as possible to 
reduce the amount of cover required. If possible, the trench should be 
aligned perpendicular to prevailing winds.
     Place the asbestos waste containers into the trench 
carefully to avoid breaking them. Be particularly careful with plastic 
bags because when they break under pressure asbestos particles can be 
emitted.
     Completely cover the containerized waste within 24 hours 
with a minimum of 6 inches of nonasbestos material. Improperly 
containerized waste is a violation of the NESHAPs and EPA should be 
notified.
    However, if improperly containerized waste is received at the 
disposal site, it should be covered immediately after unloading. Only 
after the wastes, including properly containerized wastes, are 
completely covered, can the wastes be compacted or other heavy equipment 
run over it. During compacting, avoid exposing wastes to the air or 
tracking asbestos material away from the trench.
     For final closure of an area containing asbestos waste, 
cover with at least an additional 30 inches of compacted nonasbestos 
material to provide a 36-inch final cover. To control erosion of the 
final cover, it should be properly graded and vegetated. In areas of the 
United States where excessive soil erosion may occur or the frost line 
exceeds 3 feet, additional final cover is recommended. In desert areas 
where vegetation would be difficult to maintain, 3-6 inches of well 
graded crushed rock is recommended for placement on top of the final 
cover.
    Controlling public access. Under the current NESHAPs regulation, EPA 
does not require that a landfill used for asbestos disposal use warning 
signs or fencing if it meets the requirement to cover asbestos wastes. 
However, under RCRA, EPA requires that access be controlled to prevent 
exposure of the public to potential health and safety hazards at the 
disposal site. Therefore, for liability protection of operators of 
landfills that handle asbestos, fencing and warning signs are 
recommended to control public access when natural barriers do not exist. 
Access to a landfill should be limited to one or two entrances with 
gates that can be locked when left unattended. Fencing should be 
installed around the perimeter of the disposal site in a manner adequate 
to deter access by the general public. Chain-link fencing, 6-ft high and 
topped with a barbed wire guard, should be used. More specific fencing 
requirements may be specified by local regulations. Warning signs should 
be displayed at all entrances and at intervals of 330 feet or less along 
the property line of the landfill or perimeter of the sections where 
asbestos waste is deposited. The sign should read as follows:

                      ASBESTOS WASTE DISPOSAL SITE

        BREATHING ASBESTOS DUST MAY CAUSE LUNG DISEASE AND CANCER

    Recordkeeping. For protection from liability, and considering 
possible future requirements for notification on disposal site deeds, a 
landfill owner should maintain documentation of the specific location 
and quantity of the buried asbestos wastes. In addition, the estimated 
depth of the waste below the surface should be recorded whenever a 
landfill section is closed. As mentioned previously, such information 
should be recorded in the

[[Page 714]]

land deed or other record along with a notice warning against excavation 
of the area.

[52 FR 41897, Oct. 30, 1987, as amended at 62 FR 1834, Jan. 14, 1997]

Appendix E to Subpart E--Interim Method of the Determination of Asbestos 
                       in Bulk Insulation Samples

                  Section 1, Polarized Light Microscopy

                    1.1  Principle and Applicability

    Bulk samples of building materials taken for asbestos identification 
are first examined for homogeneity and preliminary fiber identification 
at low magnification. Positive identification of suspect fibers is made 
by analysis of subsamples with the polarized light microscope.
    The principles of optical mineralogy are well established.\1\ \2\ A 
light microscope equipped with two polarizing filters is used to observe 
specific optical characteristics of a sample. The use of plane polarized 
light allows the determination of refractive indices along specific 
crystallographic axes. Morphology and color are also observed. A 
retardation plate is placed in the polarized light path for 
determination of the sign of elongation using orthoscopic illumination. 
Orientation of the two filters such that their vibration planes are 
perpendicular (crossed polars) allows observation of the birefringence 
and extinction characteristics of anisotropic particles.
    Quantitative analysis involves the use of point counting. Point 
counting is a standard technique in petrography for determining the 
relative areas occupied by separate minerals in thin sections of rock. 
Background information on the use of point counting \2\ and the 
interpretation of point count data \3\ is available.
    This method is applicable to all bulk samples of friable insulation 
materials submitted for identification and quantitation of asbestos 
components.

                               1.2  Range

    The point counting method may be used for analysis of samples 
containing from 0 to 100 percent asbestos. The upper detection limit is 
100 percent. The lower detection limit is less than 1 percent.

                           1.3  Interferences

    Fibrous organic and inorganic constituents of bulk samples may 
interfere with the identification and quantitation of the asbestos 
mineral content. Spray-on binder materials may coat fibers and affect 
color or obscure optical characteristics to the extent of masking fiber 
identity. Fine particles of other materials may also adhere to fibers to 
an extent sufficient to cause confusion in identification. Procedures 
that may be used for the removal of interferences are presented in 
Section 1.7.2.2.

                       1.4  Precision and Accuracy

    Adequate data for measuring the accuracy and precision of the method 
for samples with various matrices are not currently available. Data 
obtained for samples containing a single asbestos type in a simple 
matrix are available in the EPA report Bulk Sample Analysis for Asbestos 
Content: Evaluation of the Tentative Method.\4\

                             1.5  Apparatus

                         1.5.1  Sample Analysis

    A low-power binocular microscope, preferably stereoscopic, is used 
to examine the bulk insulation sample as received.
 Microscope: binocular, 10-45X (approximate).
 Light Source: incandescent or fluorescent.
 Forceps, Dissecting Needles, and Probes
 Glassine Paper or Clean Glass Plate
    Compound microscope requirements: A polarized light microscope 
complete with polarizer, analyzer, port for wave retardation plate, 
360 deg. graduated rotating stage, substage condenser, lamp, and lamp 
iris.
 Polarized Light Microscope: described above.
 Objective Lenses: 10X, 20X, and 40X or near equivalent.
 Dispersion Staining Objective Lens (optional)
 Ocular Lens: 10X minimum.
 Eyepiece Reticle: cross hair or 25 point Chalkley Point Array.
 Compensator Plate: 550 millimicron retardation.

                        1.5.2  Sample Preparation

    Sample preparation apparatus requirements will depend upon the type 
of insulation sample under consideration. Various physical and/or 
chemical means may be employed for an adequate sample assessment.
 Ventilated Hood or negative pressure glove box.
 Microscope Slides
 Coverslips
 Mortar and Pestle: agate or porcelain. (optional)
 Wylie Mill (optional)
 Beakers and Assorted Glassware (optional)
 Certrifuge (optional)
 Filtration apparatus (optional)
 Low temperature asher (optional)

                              1.6  Reagents

                        1.6.1  Sample Preparation

 Distilled Water (optional)
 Dilute CH3COOH: ACS reagent grade (optional)
 Dilute HCl: ACS reagent grade (optional)

[[Page 715]]

 Sodium metaphosphate (NaPO3)6 (optional)

                       1.6.2  Analytical Reagents

    Refractive Index Liquids: 1.490-1.570, 1.590-1.720 in increments of 
0.002 or 0.004.
 Refractive Index Liquids for Dispersion Staining: high-
dispersion series, 1.550, 1.605, 1.630 (optional).
 UICC Asbestos Reference Sample Set: Available from: UICC MRC 
Pneumoconiosis Unit, Llandough Hospital, Penarth, Glamorgan CF6 1XW, UK, 
and commercial distributors.
 Tremolite-asbestos (source to be determined)
 Actinolite-asbestos (source to be determined)

                             1.7  Procedures

    Note: Exposure to airborne asbestos fibers is a health hazard. Bulk 
samples submitted for analysis are usually friable and may release 
fibers during handling or matrix reduction steps. All sample and slide 
preparations should be carried out in a ventilated hood or glove box 
with continuous airflow (negative pressure). Handling of samples without 
these precautions may result in exposure of the analyst and 
contamination of samples by airborne fibers.

                             1.7.1  Sampling

    Samples for analysis of asbestos content shall be taken in the 
manner prescribed in Reference 5 and information on design of sampling 
and analysis programs may be found in Reference 6. If there are any 
questions about the representative nature of the sample, another sample 
should be requested before proceeding with the analysis.

                             1.7.2  Analysis

                       1.7.2.1  Gross Examination

    Bulk samples of building materials taken for the identification and 
quantitation of asbestos are first examined for homogeneity at low 
magnification with the aid of a stereomicroscope. The core sample may be 
examined in its container or carefully removed from the container onto a 
glassine transfer paper or clean glass plate. If possible, note is made 
of the top and bottom orientation. When discrete strata are identified, 
each is treated as a separate material so that fibers are first 
identified and quantified in that layer only, and then the results for 
each layer are combined to yield an estimate of asbestos content for the 
whole sample.

                       1.7.2.2  Sample Preparation

    Bulk materials submitted for asbestos analysis involve a wide 
variety of matrix materials. Representative subsamples may not be 
readily obtainable by simple means in heterogeneous materials, and 
various steps may be required to alleviate the difficulties encountered. 
In most cases, however, the best preparation is made by using forceps to 
sample at several places from the bulk material. Forcep samples are 
immersed in a refractive index liquid on a microscope slide, teased 
apart, covered with a cover glass, and observed with the polarized light 
microscope.
    Alternatively, attempts may be made to homogenize the sample or 
eliminate interferences before further characterization. The selection 
of appropriate procedures is dependent upon the samples encountered and 
personal preference. The following are presented as possible sample 
preparation steps.
    A mortar and pestle can sometimes be used in the size reduction of 
soft or loosely bound materials though this may cause matting of some 
samples. Such samples may be reduced in a Wylie mill. Apparatus should 
be clean and extreme care exercised to avoid cross-contamination of 
samples. Periodic checks of the particle sizes should be made during the 
grinding operation so as to preserve any fiber bundles present in an 
identifiable form. These procedures are not recommended for samples that 
contain amphibole minerals or vermiculite. Grinding of amphiboles may 
result in the separation of fiber bundles or the production of cleavage 
fragments with aspect ratios greater than 3:1. Grinding of vermiculite 
may also produce fragments with aspect ratios greater than 3:1.
    Acid treatment may occasionally be required to eliminate 
interferences. Calcium carbonate, gypsum, and bassanite (plaster) are 
frequently present in sprayed or trowelled insulations. These materials 
may be removed by treatment with warm dilute acetic acid. Warm dilute 
hydrochloric acid may also be used to remove the above materials. If 
acid treatment is required, wash the sample at least twice with 
distilled water, being careful not to lose the particulates during 
decanting steps. Centrifugation or filtration of the suspension will 
prevent significant fiber loss. The pore size of the filter should be 
0.45 micron or less. Caution: prolonged acid contact with the sample may 
alter the optical characteristics of chrysotile fibers and should be 
avoided.
    Coatings and binding materials adhering to fiber surfaces may also 
be removed by treatment with sodium metaphosphate.\7\ Add 10 mL of 10g/L 
sodium metaphosphate solution to a small (0.1 to 0.5 mL) sample of bulk 
material in a 15-mL glass centrifuge tube. For approximately 15 seconds 
each, stir the mixture on a vortex mixer, place in an ultrasonic bath 
and then shake by hand. Repeat the series. Collect the dispersed solids 
by centrifugation at 1000 rpm for 5 minutes. Wash the sample three times 
by suspending in 10 mL distilled water and recentrifuging. After 
washing, resuspend the pellet in 5 mL distilled water, place a drop of 
the suspension on a microscope slide, and dry the slide at 110  deg.C.

[[Page 716]]

    In samples with a large portion of cellulosic or other organic 
fibers, it may be useful to ash part of the sample and view the residue. 
Ashing should be performed in a low temperature asher. Ashing may also 
be performed in a muffle furnace at temperatures of 500  deg.C or lower. 
Temperatures of 550  deg.C or higher will cause dehydroxylation of the 
asbestos minerals, resulting in changes of the refractive index and 
other key parameters. If a muffle furnace is to be used, the furnace 
thermostat should be checked and calibrated to ensure that samples will 
not be heated at temperatures greater than 550  deg.C.
    Ashing and acid treatment of samples should not be used as standard 
procedures. In order to monitor possible changes in fiber 
characteristics, the material should be viewed microscopically before 
and after any sample preparation procedure. Use of these procedures on 
samples to be used for quantitation requires a correction for percent 
weight loss.

                      1.7.2.3  Fiber Identification

    Positive identification of asbestos requires the determination of 
the following optical properties.
 Morphology
 Color and pleochroism
 Refractive indices
 Birefringence
 Extinction characteristics
 Sign of elongation

Table 1-1 lists the above properties for commercial asbestos fibers. 
Figure 1-1 presents a flow diagram of the examination procedure. Natural 
variations in the conditions under which deposits of asbestiform 
minerals are formed will occasionally produce exceptions to the 
published values and differences from the UICC standards. The sign of 
elongation is determined by use of the compensator plate and crossed 
polars. Refractive indices may be determined by the Becke line test. 
Alternatively, dispersion staining may be used. Inexperienced operators 
may find that the dispersion staining technique is more easily learned, 
and should consult Reference 9 for guidance. Central stop dispersion 
staining colors are presented in Table 1-2. Available high-dispersion 
(HD) liquids should be used.

                                Table 1-1--Optical Properties of Asbestoc Fibers
----------------------------------------------------------------------------------------------------------------
                                             Refrac- tive indicesb
      Mineral        Morphology, colora  -----------------------------  Birefring-    Extinction       Sign of
                                                         ence                       elonation
----------------------------------------------------------------------------------------------------------------
Chrysotile          Wavy fibers. Fiber    1.493-1.560  1.517-1.562f           .008  | to fiber            +
 (asbestiform        bundles have                       (normally                    length.            (length
 serpentine).        splayed ends and                   1.556).                                           slow)
                     ``kinks''. Aspect
                     ratio typically
                     >10:1. Colorless3,
                     nonpleochroic.
Amosite             Straight, rigid       1.635-1.696  1.655-1.729f      .020-.033  | to fiber            +
 (asbestiform        fibers. Aspect                     (normally                    length.            (length
 grunerite).         ratio typically                    1.696-1.710.                                      slow)
                     >10:1. Colorless to
                     brown,
                     nonpleochroic or
                     weakly so. Opaque
                     inclusions may be
                     present.
Crocidolite         Straight, rigid       1.654-1.701  1.668-1.7173e     .014-.016  | to fiber            -
 (asbestiform        fibers. Thick                      (normally                    length.            (length
 Riebeckite).        fibers and bundles                 close to                                          fast)
                     common, blue to                    1.700).
                     purple-blue in
                     color. Pleochroic.
                     Birefringence is
                     generally masked by
                     blue color.
Anthophyllite-      Straight fibers and   1.596-1.652  1.615-1.676f..    .019-.024  | to fiber            +
 asbestos.           acicular cleavage                                               length.            (length
                     fragments.d Some                                                                     slow)
                     composite fibers.
                     Aspect ratio <10:1.
                     Colorless to light
                     brown.
Tremolite-          Normally present as   1.599-1.668  1.622-1.688f..    .023-.020  Oblique               +
 actinolite-         acicular or                                                     extinction,        (length
 asbestos.           prismatic cleavage                                              10-20 deg.           slow)
                     fragments.d Single                                              for
                     crystals                                                        fragments.
                     predominate, aspect                                             Composite
                     ratio <10:1.                                                    fibers show|
                     Colorless to pale                                               extinction.
                     green.
----------------------------------------------------------------------------------------------------------------
a From reference 5; colors cited are seen by observation with plane polarized light.
b From references 5 and 8.

[[Page 717]]

 
c Fibers subjected to heating may be brownish.
d Fibers defined as having aspect ratio >3:1.
e  to fiber length.
f |To fiber length.

[GRAPHIC] [TIFF OMITTED] TC01AP92.017


[[Page 718]]


                              Table 1-2--Central Stop Dispersion Staining Colors a
----------------------------------------------------------------------------------------------------------------
                 Mineral                    RI Liquid                              |
----------------------------------------------------------------------------------------------------------------
Chrysotile...............................   1.550 HD    Blue.......................  Blue-magenta
Amosite..................................   1.680       Blue-magenta to pale blue..  Golden-yellow
                                            1.550HD     Yellow to white............  Yellow to white
Crocidoliteb.............................   1.700       Red magenta................  Blue-magenta
                                            1.550HD     Yellow to white............  Yellow to white
Anthophyllite............................   1.605HD     Blue.......................  Gold to gold-magenta
Tremolite................................   1.605HD c   Pale blue..................  Gold
Actinolite...............................   1.605HD     Gold-magenta to blue.......  Gold
                                            1.630HD c   Magenta....................  Golden-yellow
----------------------------------------------------------------------------------------------------------------
a From reference 9.
b Blue absorption color.
c Oblique extinction view.

                1.7.2.4  Quantitation of Asbestos Content

    Asbestos quantitation is performed by a point-counting procedure or 
an equivalent estimation method. An ocular reticle (cross-hair or point 
array) is used to visually superimpose a point or points on the 
microscope field of view. Record the number of points positioned 
directly above each kind of particle or fiber of interest. Score only 
points directly over asbestos fibers or nonasbestos matrix material. Do 
not score empty points for the closest particle. If an asbestos fiber 
and a matrix particle overlap so that a point is superimposed on their 
visual intersection, a point is scored for both categories. Point 
counting provides a determination of the area percent asbestos. Reliable 
conversion of area percent to percent of dry weight is not currently 
feasible unless the specific gravities and relative volumes of the 
materials are known.
    For the purpose of this method, ``asbestos fibers'' are defined as 
having an aspect ratio greater than 3:1 and being positively identified 
as one of the minerals in Table 1-1.
    A total of 400 points superimposed on either asbestos fibers or 
nonasbestos matrix material must be counted over at least eight 
different preparations of representative subsamples. Take eight forcep 
samples and mount each separately with the appropriate refractive index 
liquid. The preparation should not be heavily loaded. The sample should 
be uniformly dispersed to avoid overlapping particles and allow 25-50 
percent empty area within the fields of view. Count 50 nonempty points 
on each preparation, using either
 A cross-hair reticle and mechanical stage; or
 A reticle with 25 points (Chalkley Point Array) and counting at 
least 2 randomly selected fields.

For samples with mixtures of isotropic and anisotropic materials 
present, viewing the sample with slightly uncrossed polars or the 
addition of the compensator plate to the polarized light path will allow 
simultaneous discrimination of both particle types. Quantitation should 
be performed at 100X or at the lowest magnification of the polarized 
light microscope that can effectively distinguish the sample components. 
Confirmation of the quantitation result by a second analyst on some 
percentage of analyzed samples should be used as standard quality 
control procedure.
    The percent asbestos is calculated as follows:
% asbestos=(a/n) 100%

where

a=number of asbestos counts,
n=number of nonempty points counted (400).
    If a=0, report ``No asbestos detected.'' If 0< a3, report 
``<1% asbestos''.
    The value reported should be rounded to the nearest percent.

                             1.8  References

    1. Paul F. Kerr, Optical Mineralogy, 4th ed., New York, McGraw-Hill, 
1977.
    2. E. M. Chamot and C. W. Mason, Handbook of Chemical Microscopy, 
Volume One, 3rd ed., New York: John Wiley & Sons, 1958.
    3. F. Chayes, Petrographic Modal Analysis: An Elementary Statistical 
Appraisal, New York: John Wiley & Sons, 1956.
    4. E. P. Brantly, Jr., K. W. Gold, L. E. Myers, and D. E. Lentzen, 
Bulk Sample Analysis for Asbestos Content: Evaluation of the Tentative 
Method, U.S. Environmental Protection Agency, October 1981.
    5. U.S. Environmental Protection Agency, Asbestos-Containing 
Materials in School Buildings: A Guidance Document, Parts 1 and 2, EPA/
OPPT No. C00090, March 1979.
    6. D. Lucas, T. Hartwell, and A. V. Rao, Asbestos-Containing 
Materials in School Buildings: Guidance for Asbestos Analytical 
Programs, EPA 560/13-80-017A, U.S. Environmental Protection Agency, 
December 1980, 96 pp.
    7. D. H. Taylor and J. S. Bloom, Hexametaphosphate pretreatment of 
insulation samples for identification of fibrous constituents, 
Microscope, 28, 1980.
    8. W. J. Campbell, R. L. Blake, L. L. Brown, E. E. Cather, and J. J. 
Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties: 
Mineralogical Definitions and Identification-Characterization, U.S. 
Bureau of Mines Information Circular 8751, 1977.
    9. Walter C. McCrone, Asbestos Particle Atlas, Ann Arbor: Ann Arbor 
Science Publishers, June 1980.

[[Page 719]]

                   Section 2, X-Ray Powder Diffraction

                    2.1  Principle and Applicability

    The principle of X-ray powder diffraction (XRD) analysis is well 
established.1 2Any solid, crystalline material will 
diffract an impingent beam of parallel, monochromatic X-rays whenever 
Bragg's Law,

 = 2d sin ,

is satisfied for a particular set of planes in the crystal lattice, 
where

 = the X-ray wavelength, A;
d = the interplanar spacing of the set of reflecting lattice planes, A; 
          and
 = the angle of incidence between the X-ray beam and the 
          reflecting lattice planes.

By appropriate orientation of a sample relative to the incident X-ray 
beam, a diffraction pattern can be generated that, in most cases, will 
be uniquely characteristic of both the chemical composition and 
structure of the crystalline phases present.
    Unlike optical methods of analysis, however, XRD cannot determine 
crystal morphology. Therefore, in asbestos analysis, XRD does not 
distinguish between fibrous and nonfibrous forms of the serpentine and 
amphibole minerals (Table 2-1). However, when used in conjunction with 
optical methods such as polarized light microscopy (PLM), XRD techniques 
can provide a reliable analytical method for the identification and 
characterization of asbestiform minerals in bulk materials.
    For qualitative analysis by XRD methods, samples are initially 
scanned over limited diagnostic peak regions for the serpentine 
(7.4 A) and amphibole (8.2-8.5 A) minerals (Table 2-2). 
Standard slow-scanning methods for bulk sample analysis may be used for 
materials shown by PLM to contain significant amounts of asbestos (>5-10 
percent). Detection of minor or trace amounts of asbestos may require 
special sample preparation and step-scanning analysis. All samples that 
exhibit diffraction peaks in the diagnostic regions for asbestiform 
minerals are submitted to a full (5 deg.-60 deg. 2; 1 deg. 
2/min) qualitative XRD scan, and their diffraction patterns 
are compared with standard reference powder diffraction patterns 
3to verify initial peak assignments and to identify possible 
matrix interferences when subsequent quantitative analysis will be 
performed.

    Table 2-1--The Asbestos Minerals and Their Nonasbestiform Analogs
------------------------------------------------------------------------
                Asbestiform                        Nonasbestiform
------------------------------------------------------------------------
SERPENTINE
  Chrysotile                                Antigorite, lizardite
AMPHIBOLE
  Anthophyllite asbestos                    Anthophyllite
  Cummingtonite-grunerite asbestos          Cummingtonite-grunerite
   (``Amosite'')
  Crocidolite                               Riebeckite
  Tremolite asbestos                        Tremolite
  Actinolite asbestos                       Actinolite
------------------------------------------------------------------------


                         Table 2-2--Principal Lattice Spacings of Asbestiform Minerals a
----------------------------------------------------------------------------------------------------------------
                                            Principal d-spacings (A) and relative
                                                         intensities                  JCPDS Powder diffraction
                 Minerals                 ----------------------------------------         file\3\ number
 
----------------------------------------------------------------------------------------------------------------
Chrysotile...............................     7.37100       3.6570       4.5750    21-543b
                                              7.36100       3.6680       2.4565    25-645
                                              7.10100       2.3380       3.5570    22-1162 (theoretical)
``Amosite''..............................     8.33100       3.0670       2.75670   17-745 (nonfibrous)
                                              8.22100       3.06085      3.2570    27-1170 (UICC)
Anthophyllite............................     3.05100       3.2460       8.2655    9-455
                                              3.06100       8.3370       3.2350    16-401 (synthetic)
Anthophyllite............................     2.72100       2.54100      3.48080   25-157
Crocidolite..............................     8.35100       3.1055       2.72035   27-1415 (UICC)
Tremolite................................     8.38100       3.12100      2.70590   13-437b
                                              2.706100      3.1495       8.4340    20-1310b (synthetic)
                                              3.13100       2.70660      8.4440    23-666 (synthetic mixture
                                                                                    with richterite)
----------------------------------------------------------------------------------------------------------------
aThis information is intended as a guide, only. Complete powder diffraction data, including mineral type and
  source, should be referred to, to ensure comparability of sample and reference materials where possible.
  Additional precision XRD data on amosite, crocidolite, tremolite, and chrysotile are available from the U.S.
  Bureaus of Mines.\4\
bFibrosity questionable.

    Accurate quantitative analysis of asbestos in bulk samples by XRD is 
critically dependent on particle size distribution, crystallite size, 
preferred orientation and matrix absorption effects, and comparability 
of standard reference and sample materials. The most intense diffraction 
peak that has been shown to be free from interference by prior 
qualitative XRD analysis is selected for quantitation of each 
asbestiform mineral. A ``thin-layer'' method of analysis 5 6 
is recommended in which, subsequent to comminution of the bulk material 
to 10 m by suitable cryogenic milling techniques, 
an accurately known amount of the sample is deposited on a silver 
membrane filter. The mass of

[[Page 720]]

asbestiform material is determined by measuring the integrated area of 
the selected diffraction peak using a step-scanning mode, correcting for 
matrix absorption effects, and comparing with suitable calibration 
standards. Alternative ``thick-layer'' or bulk methods,7 8 
may be used for semiquantitative analysis.
    This XRD method is applicable as a confirmatory method for 
identification and quantitation of asbestos in bulk material samples 
that have undergone prior analysis by PLM or other optical methods.

                       2.2  Range and Sensitivity

    The range of the method has not been determined.
    The sensitivity of the method has not been determined. It will be 
variable and dependent upon many factors, including matrix effects 
(absoprtion and interferences), diagnostic reflections selected, and 
their relative intensities.

                            2.3  Limitations

                          2.3.1  Interferences

    Since the fibrous and nonfibrous forms of the serpentine and 
amphibole minerals (Table 2-1) are indistinguishable by XRD techniques 
unless special sample preparation techniques and instrumentation are 
used,9 the presence of nonasbestiform serpentines and 
amphiboles in a sample will pose severe interference problems in the 
identification and quantitative analysis of their asbestiform analogs.
    The use of XRD for identification and quantitation of asbestiform 
minerals in bulk samples may also be limited by the presence of other 
interfering materials in the sample. For naturally occurring materials 
the commonly associated asbestos-related mineral interferences can 
usually be anticipated. However, for fabricated materials the nature of 
the interferences may vary greatly (Table 2-3) and present more serious 
problems in identification and quantitation.10 Potential 
interferences are summarized in Table 2-4 and include the following:
 Chlorite has major peaks at 7.19 A and 3.58 A That interfere 
with both the primary (7.36 A) and secondary (3.66 A) peaks for 
chrysotile. Resolution of the primary peak to give good quantitative 
results may be possible when a step-scanning mode of operation is 
employed.
 Halloysite has a peak at 3.63 A that interferes with the 
secondary (3.66 A) peak for chrysotile.
 Kaolinite has a major peak at 7.15 A that may interfere with 
the primary peak of chrysotile at 7.36 A when present at concentrations 
of >10 percent. However, the secondary chrysotile peak at 3.66 A may be 
used for quantitation.
 Gypsum has a major peak at 7.5 A that overlaps the 7.36 A peak 
of chrysotile when present as a major sample constituent. This may be 
removed by careful washing with distilled water, or be heating to 300 
deg.C to convert gypsum to plaster of paris.
 Cellulose has a broad peak that partially overlaps the 
secondary (3.66 A) chrysotile peak.8
 Overlap of major diagnostic peaks of the amphibole 
asbestos minerals, amosite, anthophyllite, crocidolite, and tremolite, 
at approximately 8.3 A and 3.1 A causes mutual interference when these 
minerals occur in the presence of one another. In some instances, 
adquate resolution may be attained by using step-scanning methods and/or 
by decreasing the collimator slit width at the X-ray port.

     Table 2-3--Common Constituents in Insulation and Wall Materials

A. Insulation materials

    Chrysotile
    ``Amosite''
    Crocidolite
    *Rock wool
    *Slag wool
    *Fiber glass
    Gypsum (CaSO4 
& 
2H2 O)
    Vermiculite (micas)
    *Perlite
    Clays (kaolin)
    *Wood pulp
    *Paper fibers (talc, clay, carbonate fillers)
    Calcium silicates (synthetic)
    Opaques (chromite, magnetite inclusions in serpentine)
    Hematite (inclusions in ``amosite'')
    Magnesite
    *Diatomaceous earth

B. Spray finishes or paints

    Bassanite
    Carbonate minerals (calcite, dolomite, vaterite)
    Talc
    Tremolite
    Anthophyllite
    Serpentine (including chrysotile)
    Amosite
    Crocidolite
    *Mineral wool
    *Rock wool
    *Slag wool
    *Fiber glass
    Clays (kaolin)
    Micas
    Chlorite
    Gypsum (CaSO4 
& 
2H2 O)
    Quartz
    *Organic binders and thickeners
    Hyrdomagnesite
    Wollastonite
    Opaques (chromite, magnetite inclusions in serpentine)
    Hematite (inclusions in ``amosite'')

[[Page 721]]

    *Amorphous materials----contribute only to overall scattered 
radiation and increased background radiation.

      Table 2-4--Interferences in XRD Analysis Asbestiform Minerals
------------------------------------------------------------------------
                                        Primary
                                      diagnostic
                                         peaks
        Asbestiform mineral          (approximate       Interference
                                      d-spacings,
                                         in A)
------------------------------------------------------------------------
Serpentine
  Chrysotile                              7.4      Nonasbestiform
                                                    serpentines
                                                    (antigorite,
                                                    lizardite)
                                                   Chlorite
                                                   Kaolinite
                                                   Gypsum
                                          3.7      Chlorite
                                                   Halloysite
                                                   Cellulose
Amphibole
  ``Amosite''                             3.1      Nonasbestiform
  Anthophyllite <3-ln }>                            amphiboles
  Crocidolite                                       (cummingtonite-
  Tremolite                                         grunerite,
                                                    anthophyllite,
                                                    riebeckite,
                                                    tremolite)
                                                   Mutual interferences
                                                   Carbonates
                                                   Talc
                                          8.3      Mutual interferences
------------------------------------------------------------------------

 Carbonates may also interfere with quantitative analysis of the 
amphibole asbestos minerals, amosite, anthophyllite, crocidolite, and 
tremolite. Calcium carbonate (CaCO3) has a peak at 3.035 A 
that overlaps major amphibole peaks at approximately 3.1 A when present 
in concentrations of >5 percent. Removal of carbonates with a dilute 
acid wash is possible; however, if present, chrysotile may be partially 
dissolved by this treatment.11
 A major talc peak at 3.12 A interferes with the primary 
tremolite peak at this same position and with secondary peaks of 
crocidolite (3.10 A), amosite (3.06 A), and anthophyllite (3.05 A). In 
the presence of talc, the major diagnostic peak at approximately 8.3 A 
should be used for quantitation of these asbestiform minerals.
    The problem of intraspecies and matrix interferences is further 
aggravated by the variability of the silicate mineral powder diffraction 
patterns themselves, which often makes definitive identification of the 
asbestos minerals by comparison with standard reference diffraction 
patterns difficult. This variability results from alterations in the 
crystal lattice associated with differences in isomorphous substitution 
and degree of crystallinity. This is especially true for the amphiboles. 
These minerals exhibit a wide variety of very similar chemical 
compositions, with the result being that their diffraction patterns are 
chracterized by having major (110) reflections of the monoclinic 
amphiboles and (210) reflections of the orthorhombic anthophyllite 
separated by less than 0.2 A.12

                       2.3.2  Matrix Effects

    If a copper X-ray source is used, the presence of iron at high 
concentrations in a sample will result in significant X-ray 
fluorescence, leading to loss of peak intensity along with increased 
background intensity and an overall decrease in sensitivity. This 
situation may be corrected by choosing an X-ray source other than 
copper; however, this is often accompanied both by loss of intensity and 
by decreased resolution of closely spaced reflections. Alternatively, 
use of a diffracted beam monochromator will reduce background 
fluorescent raditation, enabling weaker diffraction peaks to be 
detected.
    X-ray absorption by the sample matrix will result in overall 
attenuation of the diffracted beam and may seriously interfere with 
quantitative analysis. Absorption effects may be minimized by using 
sufficiently ``thin'' samples for analysis.5 13 14 
However, unless absorption effects are known to be the same for both 
samples and standards, appropriate corrections should be made by 
referencing diagnostic peak areas to an internal standard 7 8 
or filter substrate (Ag) peak.5 6

                  2.3.3  Particle Size Dependence

    Because the intensity of diffracted X-radiation is particle-size 
dependent, it is essential for accurate quantitative analysis that both 
sample and standard reference materials have similar particle size 
distributions. The optimum particle size range for quantitative analysis 
of asbestos by XRD has been reported to be 1 to 10  m.15 
Comparability of sample and standard reference material particle size 
distributions should be verified by optical microscopy (or another 
suitable method) prior to analysis.

                  2.3.4  Preferred Orientation Effects

    Preferred orientation of asbestiform minerals during sample 
preparation often poses a serious problem in quantitative analysis by 
XRD. A number of techniques have been developed for reducing preferred 
orientation effects in ``thick layer'' samples.7 8 15 
However, for ``thin'' samples on membrane filters, the preferred 
orientation effects seem to be both reproducible and favorable to 
enhancement of the principal diagnostic reflections of asbestos 
minerals, actually increasing the overall sensitivity of the 
method.12 14 (Further investigation into preferred 
orientation effects in both thin layer and bulk samples is required.)

        2.3.5  Lack of Suitably Characterized Standard Materials

    The problem of obtaining and characterizing suitable reference 
materials for asbestos analysis is clearly recognized. NIOSH has

[[Page 722]]

recently directed a major research effort toward the preparation and 
characterization of analytical reference materials, including asbestos 
standards; 16 17 however, these are not available in 
large quantities for routine analysis.
    In addition, the problem of ensuring the comparability of standard 
reference and sample materials, particularly regarding crystallite size, 
particle size distribution, and degree of crystallinity, has yet to be 
adequately addressed. For example, Langer et al.18 have 
observed that in insulating matrices, chrysotile tends to break open 
into bundles more frequently than amphiboles. This results in a line-
broadening effect with a resultant decrease in sensitivity. Unless this 
effect is the same for both standard and sample materials, the amount of 
chrysotile in the sample will be underestimated by XRD analysis. To 
minimize this problem, it is recommended that standardized matrix 
reduction procedures be used for both sample and standard materials.

                       2.4  Precision and Accuracy

    Precision of the method has not been determined.
    Accuracy of the method has not been determined.

                             2.5  Apparatus

                        2.5.1  Sample Preparation

    Sample preparation apparatus requirements will depend upon the 
sample type under consideration and the kind of XRD analysis to be 
performed.
 Mortar and Pestle: Agate or porcelain.
 Razor Blades
 Sample Mill: SPEX, Inc., freezer mill or equivalent.
 Bulk Sample Holders
 Silver Membrane Filters: 25-mm diameter, 0.45- m pore 
size. Selas Corp. of America, Flotronics Div., 1957 Pioneer Road, 
Huntington Valley, PA 19006.
 Microscope Slides
 Vacuum Filtration Apparatus: Gelman No. 1107 or equivalent, and 
side-arm vacuum flask.
 Microbalance
 Ultrasonic Bath or Probe: Model W140, Ultrasonics, Inc., 
operated at a power density of approximately 0.1 W/mL, or equivalent.
 Volumetric Flasks: 1-L volume.
 Assorted Pipettes
 Pipette Bulb
 Nonserrated Forceps
 Polyethylene Wash Bottle
 Pyrex Beakers: 50-mL volume.
 Desiccator
 Filter Storage Cassettes
 Magnetic Stirring Plate and Bars
 Porcelain Crucibles
 Muffle Furnace or Low Temperature Asher

                         2.5.2  Sample Analysis

    Sample analysis requirements include an X-ray diffraction unit, 
equipped with:
 Constant Potential Generator; Voltage and mA Stabilizers
 Automated Diffractometer with Step-Scanning Mode
 Copper Target X-Ray Tube: High intensity, fine focus, 
          preferably.
 X-Ray Pulse Height Selector
 X-Ray Detector (with high voltage power supply): Scintillation 
          or proportional counter.
 Focusing Graphite Crystal Monochromator; or Nickel Filter (if 
          copper source is used, and iron fluorescence is not a serious 
          problem).
 Data Output Accessories:
     Strip Chart Recorder
     Decade Scaler/Timer
     Digital Printer
 Sample Spinner (optional).
 Instrument Calibration Reference Specimen: -quartz 
reference crystal (Arkansas quartz standard, 180-147-00, Philips 
Electronics Instruments, Inc., 85 McKee Drive, Mahwah, NJ 07430) or 
equivalent.

                              2.6  Reagents

                   2.6.1  Standard Reference Materials

    The reference materials listed below are intended to serve as a 
guide. Every attempt should be made to acquire pure reference materials 
that are comparable to sample materials being analyzed.
 Chrysotile: UICC Canadian, or NIEHS Plastibest. (UICC reference 
materials available from: UICC, MRC Pneumoconiosis Unit, Llandough 
Hospital, Penarth, Glamorgan, CF61XW, UK).
 Crocidolite: UICC
 Amosite: UICC
 Anthophyllite: UICC
 Tremolite Asbestos: Wards Natural Science Establishment, 
Rochester, N.Y.; Cyprus Research Standard, Cyprus Research, 2435 
Military Ave., Los Angeles, CA 90064 (washed with dilute HCl to remove 
small amount of calcite impurity); India tremolite, Rajasthan State, 
India.
 Actinolite Asbestos

                             2.6.2  Adhesive

    Tape, petroleum jelly, etc. (for attaching silver membrane filters 
to sample holders).

                            2.6.3  Surfactant

    1 percent aerosol OT aqueous solution or equivalent.

                           2.6.4  Isopropanol

    ACS Reagent Grade.

[[Page 723]]

                             2.7  Procedure

                             2.7.1  Sampling

    Samples for analysis of asbestos content shall be collected as 
specified in EPA Guidance Document C0090, Asbestos-Containing Materials 
in School Buildings.10

                          2.7.2  Analysis

    All samples must be analyzed initially for asbestos content by PLM. 
XRD should be used as an auxiliary method when a second, independent 
analysis is requested.
    Note: Asbestos is a toxic substance. All handling of dry materials 
should be performed in an operating fume hood.

                       2.7.2.1  Sample Preparation

    The method of sample preparation required for XRD analysis will 
depend on: (1) The condition of the sample received (sample size, 
homogeneity, particle size distribution, and overall composition as 
determined by PLM); and (2) the type of XRD analysis to be performed 
(qualitative, quantitative, thin layer or bulk).
    Bulk materials are usually received as inhomogeneous mixtures of 
complex composition with very wide particle size distributions. 
Preparation of a homogeneous, representative sample from asbestos-
containing materials is particularly difficult because the fibrous 
nature of the asbestos minerals inhibits mechanical mixing and stirring, 
and because milling procedures may cause adverse lattice alterations.
    A discussion of specific matrix reduction procedures is given below. 
Complete methods of sample preparation are detailed in Sections 2.7.2.2 
and 2.7.2.3.
    Note: All samples should be examined microscopically before and 
after each matrix reduction step to monitor changes in sample particle 
size, composition, and crystallinity, and to ensure sample 
representativeness and homogeneity for analysis.
    2.7.2.1.1  Milling-- Mechanical milling of asbestos materials has 
been shown to decrease fiber crystallinity, with a resultant decrease in 
diffraction intensity of the specimen; the degree of lattice alteration 
is related to the duration and type of milling 
process.19,&thnsp;22 Therefore, all milling times should be 
kept to a minimum.
    For qualitative analysis, particle size is not usually of critical 
importance and initial characterization of the material with a minimum 
of matrix reduction is often desirable to document the composition of 
the sample as received. Bulk samples of very large particle size (>2-3 
mm) should be comminuted to 100 m. A mortar and 
pestle can sometimes be used in size reduction of soft or loosely bound 
materials though this may cause matting of some samples. Such samples 
may be reduced by cutting with a razor blade in a mortar, or by grinding 
in a suitable mill (e.g., a microhammer mill or equivalent). When using 
a mortar for grinding or cutting, the sample should be moistened with 
ethanol, or some other suitable wetting agent, to minimize exposures.
    For accurate, reproducible quantitative analysis, the particle size 
of both sample and standard materials should be reduced to 
10 m (see Section 2.3.3). Dry ball milling at 
liquid nitrogen temperatures (e.g., Spex Freezer Mill, or equivalent) 
for a maximum time of 10 min. is recommended to obtain satisfactory 
particle size distributions while protecting the integrity of the 
crystal lattice.5Bulk samples of very large particle size may 
require grinding in two stages for full matrix reduction to <10 
m.8, 16
    Final particle size distributions should always be verified by 
optical microscopy or another suitable method.
    2.7.2.1.2  Low temperature ashing-- For materials shown by PLM to 
contain large amounts of gypsum, cellulosic, or other organic materials, 
it may be desirable to ash the samples prior to analysis to reduce 
background radiation or matrix interference. Since chrysotile undergoes 
dehydroxylation at temperatures between 550  deg.C and and 650  deg.C, 
with subsequent transformation to forsterite,23, 24 
ashing temperatures should be kept below 500  deg.C. Use of a low 
temperature asher is recommended. In all cases, calibration of the oven 
is essential to ensure that a maximum ashing temperature of 500  deg.C 
is not exceeded.
    2.7.2.1.3  Acid leaching--Because of the interference caused by 
gypsum and some carbonates in the detection of asbestiform minerals by 
XRD (see Section 2.3.1), it may be necessary to remove these 
interferents by a simple acid leaching procedure prior to analysis (see 
Section 1.7.2.2).

                      2.7.2.2  Qualitative Analysis

    2.7.2.2.1  Initial screening of bulk material-- Qualitative analysis 
should be performed on a representative, homogeneous portion of the 
sample with a minimum of sample treatment.
    1. Grind and mix the sample with a mortar and pestle (or equivalent 
method, see Section 2.7.2.1.1.) to a final particle size sufficiently 
small (100 m) to allow adequate packing into the 
sample holder.
    2. Pack the sample into a standard bulk sample holder. Care should 
be taken to ensure that a representative portion of the milled sample is 
selected for analysis. Particular care should be taken to avoid possible 
size segregation of the sample. (Note: Use of a back-packing method 
25 of bulk sample preparation may reduce preferred 
orientation effects.)
    3. Mount the sample on the diffractometer and scan over the 
diagnostic peak regions for the serpentine (67.4 A) and 
amphibole (8.2-

[[Page 724]]

8.5 A) minerals (see Table 2-2). The X-ray diffraction equipment should 
be optimized for intensity. A slow scanning speed of 1 deg. 23or 
those of other well-characterized reference materials). Principal 
lattice spacings of asbestiform minerals are given in Table 2-2; common 
constituents of bulk insulation and wall materials are listed in Table 
2-3.
    2.7.2.2.2  Detection of minor or trace constituents-- Routine 
screening of bulk materials by XRD may fail to detect small 
concentrations (<5 percent) of asbestos. The limits of detection will, 
in general, be improved if matrix absorption effects are minimized, and 
if the sample particle size is reduced to the optimal 1 to 10 m 
range, provided that the crystal lattice is not degraded in the milling 
process. Therefore, in those instances where confirmation of the 
presence of an asbestiform mineral at very low levels is required, or 
where a negative result from initial screening of the bulk material by 
XRD (see Section 2.7.2.2.1) is in conflict with previous PLM results, it 
may be desirable to prepare the sample as described for quantitative 
analysis (see Section 2.7.2.3) and step-scan over appropriate 25A thick-layer or bulk method involving pelletizing 
the sample may be used for semiquantitative analysis; 
7,8however, this method requires the addition of an internal 
standard, use of a specially fabricated sample press, and relatively 
large amounts of standard reference materials. Additional research is 
required to evaluate the comparability of thin- and thick-layer methods 
for quantitative asbestos analysis.
    For quantitative analysis by thin-layer methods, the following 
procedure is recommended:
    1. Mill and size all or a substantial representative portion of the 
sample as outlined in Section 2.7.2.1.1.
    2. Dry at 100  deg.C for 2 hr; cool in a desiccator.
    3. Weigh accurately to the nearest 0.01 mg.
    4. Samples shown by PLM to contain large amounts of cellulosic or 
other organic materials, gypsum, or carbonates, should be submitted to 
appropriate matrix reduction procedures described in Sections 2.7.2.1.2 
and 2.7.2.1.3. After ashing and/or acid treatment, repeat the drying and 
weighing procedures described above, and determine the percent weight 
loss; L.
    5. Quantitatively transfer an accurately weighed amount (50-100 mg) 
of the sample to a 1-L volumetric flask with approximately 200 mL 
isopropanol to which 3 to 4 drops of surfactant have been added.
    6. Ultrasonicate for 10 min at a power density of approximately 0.1 
W/mL, to disperse the sample material.
    7. Dilute to volume with isopropanol.
    8. Place flask on a magnetic stirring plate. Stir.
    9. Place a silver membrane filter on the filtration apparatus, apply 
a vacuum, and attach the reservoir. Release the vacuum and add several 
milliliters of isopropanol to the reservoir. Vigorously hand shake the 
asbestos suspension and immediately withdraw an aliquot from the center 
of the suspension so that total sample weight, WT, on the 
filter will be approximately 1 mg. Do not adjust the volume in the pipet 
by expelling part of the suspension; if more than the desired aliquot is 
withdrawn, discard the aliquot and resume the procedure with a clean 
pipet. Transfer the aliquot to the reservoir. Filter rapidly under 
vacuum. Do not wash the reservoir walls. Leave the filter apparatus 
under vacuum until dry. Remove the reservoir, release the vacuum, and 
remove the filter with forceps. (Note: Water-soluble matrix 
interferences such as gypsum may be removed at this time by careful 
washing of the filtrate with distilled water. Extreme care should be 
taken not to disturb the sample.)
    10. Attach the filter to a flat holder with a suitable adhesive and 
place on the diffractometer. Use of a sample spinner is recommended.
    11. For each asbestos mineral to be quantitated select a reflection 
(or reflections) that has been shown to be free from interferences by 
prior PLM or qualitative XRD analysis and that can be used unambiguously 
as an index of the amount of material present in the sample (see Table 
2-2).
    12. Analyze the selected diagnostic reflection(s) by step scanning 
in increments of 0.02 deg. 2a, is the difference between the peak 
integrated count and the total background count.
    13. Determine the net count, IAg, of the filter 2.36 A 
silver peak following the procedure in step 12. Remove the filter from 
the holder, reverse it, and reattach it to the holder. Determine the net 
count for the unattenuated silver peak, IAg. Scan times may 
be less for measurement of silver peaks than for sample peaks; however, 
they should be constant throughout the analysis.
    14. Normalize all raw, net intensities (to correct for instrument 
instabilities) by referencing them to an external standard (e.g., the 
3.34 A peak of an -quartz reference crystal). After each 
unknown is scanned, determine the net count, Ir, of the 
reference specimen following the procedure in step 12. Determine the 
normalized intensities by dividing the peak intensities by Ir:
[GRAPHIC] [TIFF OMITTED] TC01AP92.018

                         2.8  Calibration

               2.8.1  Preparation of Calibration Standards

    1. Mill and size standard asbestos materials according to the 
procedure outlined in Section 2.7.2.1.1. Equivalent, standardized matrix 
reduction and sizing techniques should be used for both standard and 
sample materials.
    2. Dry at 100  deg.C for 2 hr; cool in a desiccator.
    3. Prepare two suspensions of each standard in isopropanol by 
weighing approximately 10 and 50 mg of the dry material to the nearest 
0.01 mg. Quantitatively transfer each to a 1-L volumetric flask with 
approximately 200 mL isopropanol to which a few drops of surfactant have 
been added.
    4. Ultrasonicate for 10 min at a power density of approximately 0.1 
W/mL, to disperse the asbestos material.
    5. Dilute to volume with isopropanol.
    6. Place the flask on a magnetic stirring plate. Stir.
    7. Prepare, in triplicate, a series of at least five standard 
filters to cover the desired analytical range, using appropriate 
aliquots of the 10 and 50 mg/L suspensions and the following procedure.
    Mount a silver membrane filter on the filtration apparatus. Place a 
few milliliters of isopropanol in the reservoir. Vigorously hand shake 
the asbestos suspension and immediately withdraw an aliquot from the 
center of the suspension. Do not adjust the volume in the pipet by 
expelling part of the suspension; if more than the desired aliquot is 
withdrawn, discard the aliquot and resume the procedure with a clean 
pipet. Transfer the aliquot to the reservoir. Keep the tip of the pipet 
near the surface of the isopropanol. Filter rapidly under vacuum. Do not 
wash the sides of the reservoir. Leave the vacuum on for a time 
sufficient to dry the filter. Release the vacuum and remove the filter 
with forceps.

                2.8.2  Analysis of Calibration Standards

    1. Mount each filter on a flat holder. Perform step scans on 
selected diagnostic reflections of the standards and reference specimen 
using the procedure outlined in Section 2.7.2.3, step 12, and the same 
conditions as those used for the samples.
    2. Determine the normalized intensity for each peak measured, 
Istd, as outlined in Section 2.7.2.3, step 14.

                            2.9  Calculations

    For each asbestos reference material, calculate the exact weight 
deposited on each standard filter from the concentrations of the 
standard suspensions and aliquot volumes. Record the weight, w, of each 
standard. Prepare a calibration curve by regressing I2std on 
w. Poor reproducibility (plus-minus15 percent RSD) at any 
given level indicates problems in the sample preparation technique, and 
a need for new standards. The data should fit a straight line equation.
    Determine the slope, m, of the calibration curve in counts/
microgram. The intercept, b, of the line with the Istd axis 
should be approximately zero. A large negative intercept indicates an 
error in determining the background. This may arise from incorrectly 
measuring the baseline or from interference by another phase at the 
angle of background measurement. A large positive intercept indicates an 
error in determining the baseline or that an impurity is included in the 
measured peak.
    Using the normalized intensity, IAg, for the attenuated 
silver peak of a sample, and the corresponding normalized intensity from 
the unattenuated silver peak, IAg, of the sample filter, 
calculate the transmittance, T, for each sample as follows:\26\ \27\
[GRAPHIC] [TIFF OMITTED] TC01AP92.019

    Determine the correction factor, f(T), for each sample according to 
the formula:

                                    -R (ln T)
                   f (T)            --------
                        =
                                      l-TR
 

where

[[Page 726]]


                               sin Ag
                    R =             --------
                                sin a
 

Ag=angular position of the measured silver peak 
          (from Bragg's Law), and
a=angular position of the diagnostic asbestos peak.
    Calculate the weight, Wa, in micrograms, of the asbestos 
material analyzed for in each sample, using the appropriate calibration 
data and absorption corrections:
[GRAPHIC] [TIFF OMITTED] TC01AP92.020

    Calculate the percent composition, Pa, of each asbestos 
mineral analyzed for in the parent material, from the total sample 
weight, WT, on the filter:

                                   Wa (1-.01L)
                    Pa =           ----------           x 100
                                       WT
 

where

Pa=percent asbestos mineral in parent material;
Wa=mass of asbestos mineral on filter, in g;
WT=total sample weight on filter, in g;
L=percent weight loss of parent material on ashing and/or acid treatment 
          (see Section 2.7.2.3).

                            2.10  References

    1. H. P. Klug and L. E. Alexander, X-ray Diffraction Procedures for 
Polycrystalline and Amorphous Materials, 2nd ed., New York: John Wiley 
and Sons, 1979.
    2. L. V. Azaroff and M. J. Buerger, The Powder Method of X-ray 
Crystallography, New York: McGraw-Hill, 1958.
    3. JCPDS-International Center for Diffraction Data Powder 
Diffraction File, U.S. Department of Commerce, National Bureau of 
Standards, and Joint Committee on Powder Diffraction Studies, 
Swarthmore, PA.
    4. W. J. Campbell, C. W. Huggins, and A. G. Wylie, Chemical and 
Physical Characterization of Amosite, Chrysotile, Crocidolite, and 
Nonfibrous Tremolite for National Institute of Environmental Health 
Sciences Oral Ingestion Studies, U.S. Bureau of Mines Report of 
Investigation RI8452, 1980.
    5. B. A. Lange and J. C. Haartz, Determination of microgram 
quantities of asbestos by X-ray diffraction: Chrysotile in thin dust 
layers of matrix material, Anal. Chem., 51(4):520-525, 1979.
    6. NIOSH Manual of Analytical Methods, Volume 5, U.S. Dept. HEW, 
August 1979, pp. 309-1 to 309-9.
    7. H. Dunn and J. H. Stewart, Jr., Quantitative determination of 
chrysotile in building materials, The Microscope, 29(1), 1981.
    8. M. Taylor, Methods for the quantitative determination of asbestos 
and quartz in bulk samples using X-ray diffraction, The Analyst, 
103(1231):1009-1020, 1978.
    9. L. Birks, M. Fatemi, J. V. Gilfrich, and E. T. Johnson, 
Quantitative Analysis of Airborne Asbestos by X-ray Diffraction, Naval 
Research Laboratory Report 7879, Naval Research Laboratory, Washington, 
DC, 1975.
    10. U.S. Environmental Protection Agency, Asbestos-Containing 
Materials in School Buildings: A Guidance Document, Parts 1 and 2, EPA/
OPPT No. C00090, March 1979.
    11. J. B. Krause and W. H. Ashton, Misidentification of asbestos in 
talc, pp. 339-353, in: Proceedings of Workshop on Asbestos: Definitions 
and Measurement Methods (NBS Special Publication 506), C. C. Gravatt, P. 
D. LaFleur, and K. F. Heinrich (eds.), Washington, DC: National 
Measurement Laboratory, National Bureau of Standards, 1977 (issued 
1978).
    12. H. D. Stanley, The detection and identification of asbestos and 
asbesti-form minerals in talc, pp. 325-337, in Proceedings of Workshop 
on Asbestos: Definitions and Measurement Methods (NBS Special 
Publication 506), C. C. Gravatt, P. D. LaFleur, and K. F. Heinrich 
(eds.), Washington, DC, National Measurement Laboratory, National Bureau 
of Standards, 1977 (issued 1978).
    13. A. L. Rickards, Estimation of trace amounts of chrysotile 
asbestos by X-ray diffraction, Anal. Chem., 44(11):1872-3, 1972.
    14. P. M. Cook, P. L. Smith, and D. G. Wilson, Amphibole fiber 
concentration and determination for a series of community air samples: 
use of X-ray diffraction to supplement electron microscope analysis, in: 
Electron Microscopy and X-ray Applications to Environmental and 
Occupation Health Analysis, P. A. Russell and A. E. Hutchings (eds.), 
Ann Arbor: Ann Arbor Science Publications, 1977.
    15. A. N. Rohl and A. M. Langer, Identification and quantitation of 
asbestos in talc, Environ. Health Perspectives, 9:95-109, 1974.
    16. J. L. Graf, P. K. Ase, and R. G. Draftz, Preparation and 
Characterization of Analytical Reference Minerals, DHEW (NIOSH) 
Publication No. 79-139, June 1979.
    17. J. C. Haartz, B. A. Lange, R. G. Draftz, and R. F. Scholl, 
Selection and characterization of fibrous and nonfibrous amphiboles for 
analytical methods development, pp. 295-312, in: Proceedings of Workshop 
on Asbestos: Definitions and Measurement Methods (NBS Special 
Publication 506), C. C. Gravatt, P. D. LaFleur, and K. F. Heinrich 
(eds.), Washington, DC: National Measurement Laboratory, National Bureau 
of Standards, 1977 (issued 1978).
    18. Personal communication, A. M. Langer, Environmental Sciences 
Laboratory, Mount

[[Page 727]]

Sinai School of Medicine of the City University of New York, New York, 
New York.
    19. A. M. Langer, M. S. Wolff, A. N. Rohl, and I. J. Selikoff, 
Variation of properties of chrysotile asbestos subjected to milling, J. 
Toxicol. and Environ. Health, 4:173-188, 1978.
    20. A. M. Langer, A. D. Mackler, and F. D. Pooley, Electron 
microscopical investigation of asbestos fibers, Environ. Health 
Perspect., 9:63-80, 1974.
    21. E. Occella and G. Maddalon, X-ray diffraction characteristics of 
some types of asbestos in relation to different techniques of 
comminution, Med. Lavoro, 54(10):628-636, 1963.
    22. K. R. Spurny, W. Stober, H. Opiela, and and G. Weiss, On the 
problem of milling and ultrasonic treatment of asbestos and glass fibers 
in biological and analytical applications, Am. Ind. Hyg. Assoc. J., 
41:198-203, 1980.
    23. L. G. Berry and B. Mason, Mineralogy, San Francisco: W. H. 
Greeman & Co., 1959.
    24. J. P. Schelz, The detection of chrysotile asbestos at low levels 
in talc by differential thermal analysis, Thermochimica Acta, 8:197-204, 
1974.
    25. Reference 1, pp. 372-374.
    26. J. Leroux, Staub-Reinhalt Luft, 29:26 (English), 1969.
    27. J. A. Leroux, B. C. Davey, and A. Paillard, Am. Ind. Hyg. Assoc. 
J., 34:409, 1973.

[47 FR 23369, May 27, 1982; 47 FR 38535, Sept. 1, 1982; Redesignated at 
60 FR 31922, June 19, 1995]

Subpart F [Reserved]



                 Subpart G--Asbestos Abatement Projects

    Source: 52 FR 5623, Feb. 25, 1987, unless otherwise noted.



Sec. 763.120  Scope

    (a) This part establishes requirements which must be followed during 
asbestos abatement projects by employers of State and local government 
employees not covered by the Asbestos Standard of the Occupational 
Safety and Health Administration (OSHA), 29 CFR 1926.58, an Asbestos 
Standard adopted by a State as part of a State plan approved by OSHA 
under section 18 of the Occupational Safety and Health Act, or a State 
asbestos regulation which EPA has determined to be comparable to or more 
stringent than this part. The rule covers those employees who take part 
in asbestos abatement work.
    (b) [Reserved]



Sec. 763.121  Regulatory requirements.

    (a) [Reserved]
    (b) Definitions. Action level means an airborne concentration of 
asbestos of 0.1 fiber per cubic centimeter (f/cc) of air calculated as 
an 8-hour time-weighted average.
    Administrator means the Administrator, U.S. Environmental Protection 
Agency, or designee.
    Asbestos means the asbestiform varieties of chrysotile (serpentine); 
crocidolite (riebeckite); amosite (cummingtonite--grunerite); tremolite; 
anthophyllite, and actinolite.
    Asbestos abatement project means any activity involving the removal, 
enclosure, or encapsulation of friable asbestos material.
    Authorized person means any person authorized by the employer and 
required by work duties to be present in regulated areas.
    Clean room means an uncontaminated room having facilities for the 
storage of employees' street clothing and uncontaminated materials and 
equipment.
    Competent person means one who is capable of identifying existing 
asbestos hazards in the workplace and who has the authority to take 
prompt corrective measures to eliminate them. The duties of the 
competent person include at least the following: Establishing the 
negative-pressure enclosure, ensuring its integrity, and controlling 
entry to and exit from the enclosure; supervising any employee exposure 
monitoring required by this subpart, ensuring that all employees working 
within such an enclosure wear the appropriate personal protective 
equipment, are trained in the use of appropriate methods of exposure 
control, and use the hygiene facilities and decontamination procedures 
specified in this subpart; and ensuring that engineering controls in use 
are in proper operating condition and are functioning properly.
    Decontamination area means an enclosed area adjacent and connected 
to the regulated area and consisting of an equipment room, shower area, 
and clean room, which is used for the decontamination of workers, 
materials, and equipment contaminated with asbestos.

[[Page 728]]

    Demolition means the wrecking or taking out of any load-supporting 
structural member and any related razing, removing, or stripping of 
asbestos products.
    Emergency project means a project involving the removal, enclosure, 
or encapsulation of friable asbestos-containing material that was not 
planned but results from a sudden unexpected event.
    Employee exposure means that exposure to airborne asbestos would 
occur if the employee were not using respiratory protective equipment.
    Employer means the public department, agency, or entity which hires 
an employee. The term includes, but is not limited to, any State, 
County, City, or other local governmental entity which operates or 
administers schools, a department of health or human services, a 
library, a police department, a fire department, or similar public 
service agencies or offices.
    Equipment room (change room) means a contaminated room located 
within the decontamination area that is supplied with impermeable bags 
or containers for the disposal of contaminated protective clothing and 
equipment.
    Fiber means a particulate form of asbestos, 5 micrometers or longer, 
with a length-to-diameter ratio of at least 3 to 1.
    Friable asbestos material means any material containing more than 1 
percent asbestos by weight which, when dry, may be crumbled, pulverized, 
or reduced to powder by hand pressure.
    High-efficiency particulate air (HEPA) filter means a filter capable 
of trapping and retaining at least 99.97 percent of all monodispersed 
particles of 0.3 micrometer in diameter or larger.
    Regulated area means an area established by the employer to 
demarcate areas where airborne concentrations of asbestos exceed or can 
reasonably be expected to exceed the permissible exposure limit. The 
regulated area may take the form of: (1) A temporary enclosure, as 
required by paragraph (e)(6) of this section, or (2) an area demarcated 
in any manner that minimizes the number of employees exposed to 
asbestos.
    Removal means the taking out or stripping of asbestos or materials 
containing asbestos.
    Renovation means the modifying of any existing structure, or portion 
thereof, where exposure to airborne asbestos may result.
    Repair means overhauling, rebuilding, reconstructing, or 
reconditioning of structures or substrates where asbestos is present.
    (c) Permissible exposure limit (PEL). The employer shall ensure that 
no employee is exposed to an airborne concentration of asbestos in 
excess of 0.2 fiber per cubic centimeter of air as an 8-hour time-
weighted average (TWA), as determined by the method prescribed in 
appendix A of this section, or by an equivalent method.
    (d) Communication among employers. On multi-employer worksites, an 
employer performing asbestos work requiring the establishment of a 
regulated area shall inform other employers (as defined by this subpart 
and by 29 U.S.C. section 652(5)) on the site of the nature of the 
employer's work with asbestos and of the existence of and requirements 
pertaining to regulated areas.
    (e) Regulated areas--(1) General. The employer shall establish a 
regulated area in work areas where airborne concentrations of asbestos 
exceed or can reasonably be expected to exceed the permissible exposure 
limit prescribed in paragraph (c) of this section.
    (2) Demarcation. The regulated area shall be demarcated in any 
manner that minimizes the number of persons within the area and protects 
persons outside the area from exposure to airborne concentrations of 
asbestos in excess of the permissible exposure limit.
    (3) Access. Access to regulated areas shall be limited to authorized 
persons.
    (4) Respirators. All persons entering a regulated area shall be 
supplied with a respirator, selected in accordance with paragraph (h)(2) 
of this section.
    (5) Prohibited activities. The employer shall ensure that employees 
do not eat, drink, smoke, chew tobacco or gum, or apply cosmetics in the 
regulated area.
    (6) Requirements for asbestos removal, demolition, and renovation 
operations. (i) Wherever feasible, the employer shall establish 
negative-pressure enclosures

[[Page 729]]

before commencing removal, demolition, and renovation operations.
    (ii) The employer shall designate a competent person to perform or 
supervise the following duties:
    (A) Set up the enclosure.
    (B) Ensure the integrity of the enclosure.
    (C) Control entry to and exit from the enclosure.
    (D) Supervise all employee exposure monitoring required by this 
section.
    (E) Ensure that employees working within the enclosure wear 
respirators and protective clothing as required by paragraphs (h) and 
(i) of this section.
    (F) Ensure that employees are trained in the use of engineering 
controls, work practices, and personal protective equipment.
    (G) Ensure that employees use the hygiene facilities and observe the 
decontamination procedures specified in paragraph (j) of this section.
    (H) Ensure that engineering controls are functioning properly.
    (iii)(A) In addition to the qualifications specified in paragraph 
(b) of this section, the competent person shall be trained in all 
aspects of asbestos abatement, the contents of this subpart, the 
identification of asbestos and its removal procedures, and other 
practices for reducing the hazard. Such training shall be obtained in a 
comprehensive course, such as a course conducted by an EPA Asbestos 
Training Center, or an equivalent course.
    (B) For small-scale, short-duration operations, such as pipe repair, 
valve replacement, installing electrical conduits, installing or 
removing drywall, roofing, and other general building maintenance or 
renovation, the employer is not required to comply with the requirements 
of paragraph (e)(6) of this section.
    (f) Exposure monitoring--(1) General. (i) Each employer who has a 
workplace or work operation covered by this subpart shall perform 
monitoring to determine accurately the airborne concentrations of 
asbestos to which employees may be exposed.
    (ii) Determinations of employee exposure shall be made from 
breathing zone air samples that are representative of the 8-hour TWA of 
each employee.
    (iii) Representative 8-hour TWA employee exposure shall be 
determined on the basis of one or more samples representing fullshift 
exposure for employees in each work area.
    (2) Initial monitoring. (i) Each employer who has a workplace or 
work operation covered by this subpart, except as provided for in 
paragraphs (f)(2) (ii) and (iii) of this section, shall perform initial 
monitoring at the initiation of each asbestos job to determine 
accurately the airborne concentrations of asbestos to which employees 
may be exposed.
    (ii) The employer may demonstrate that employee exposures are below 
the action level by means of objective data demonstrating that the 
product or material containing asbestos cannot release airborne fibers 
in concentrations exceeding the action level under those work conditions 
having the greatest potential for releasing asbestos.
    (iii) Where the employer has monitored each asbestos job, and the 
data were obtained during work operations conducted under workplace 
conditions closely resembling the processes, type of material, control 
methods, work practices, and environmental conditions used and 
prevailing in the employer's current operations, the employer may rely 
on such earlier monitoring results to satisfy the requirements of 
paragraph (f)(2)(i) of this section.
    (3) Periodic monitoring within regulated areas. (i) The employer 
shall conduct daily monitoring that is representative of the exposure of 
each employee who is assigned to work within a regulated area.
    (ii) When all employees within a regulated area are equipped with 
supplied-air respirators operated in the positive-pressure mode, the 
employer may dispense with the daily monitoring required by this 
paragraph.
    (4) Termination of monitoring. If the periodic monitoring required 
by paragraph (f)(3)(i) of this section reveals that employee exposures, 
as indicated by statistically reliable measurements, are below the 
action level, the employer may discontinue monitoring for those 
employees whose exposures are represented by such monitoring.

[[Page 730]]

    (5) Method of monitoring. (i) All samples taken to satisfy the 
monitoring requirements of paragraph (f) of this section shall be 
personal samples collected following the procedures specified in 
appendix A of this section.
    (ii) All samples taken to satisfy the monitoring requirements of 
paragraph (f) of this section shall be evaluated using the EPA/OSHA 
Reference Method (ORM) specified in appendix A, or an equivalent 
counting method.
    (iii) If an equivalent method to the ORM is used, the employer shall 
ensure that the method meets the following criteria:
    (A) Replicate exposure data used to establish equivalency are 
collected in side-by-side field and laboratory comparisons.
    (B) The comparison indicates that 90 percent of the samples 
collected in the range 0.5 to 2.0 times the permissible limit have an 
accuracy range of plus or minus 25 percent of the ORM results with a 95 
percent confidence level as demonstrated by a statistically valid 
protocol.
    (C) The equivalent method is documented and the results of the 
comparison testing are maintained.
    (iv) To satisfy the monitoring requirements of paragraph (f) of this 
section, employers shall rely on the results of monitoring analysis 
performed by laboratories that have instituted quality assurance 
programs that include the elements prescribed in appendix A of this 
section.
    (6) Employee notification of monitoring results. (i) The employer 
shall notify affected employees of the monitoring results that represent 
the employees' exposure as soon as possible following receipt of 
monitoring results.
    (ii) The employer shall notify affected employees of the results of 
monitoring representing the employees' exposure in writing either 
individually or by posting at a centrally located place that is 
accessible to affected employees.
    (7) Observation of monitoring. (i) The employer shall provide 
affected employees or their designated representatives an opportunity to 
observe any monitoring of employee exposure to asbestos conducted in 
accordance with this section
    (ii) When observation of the monitoring of employee exposure to 
asbestos requires entry into an area where the use of protective 
clothing or equipment is required, the observer shall be provided with 
and be required to use such clothing and equipment and shall comply with 
all other applicable safety and health procedures.
    (g) Methods of compliance--(1) Engineering controls and work 
practices. (i) The employer shall use one or any combination of the 
following control methods to achieve compliance with the permissible 
exposure limit prescribed by paragraph (c) of this section:
    (A) Local exhaust ventilation equipped with HEPA filter dust 
collection systems.
    (B) General ventilation systems.
    (C) Vacuum cleaners equipped with HEPA filters.
    (D) Enclosure or isolation of processes producing asbestos dust.
    (E) Use of wet methods, wetting agents, or removal encapsulants to 
control employee exposures during asbestos handling, mixing, removal, 
cutting, application, and cleanup.
    (F) Prompt disposal of wastes contaminated with asbestos in leak-
tight containers.
    (G) Use of work practices or other engineering controls that the 
Administrator can show to be feasible.
    (ii) Wherever the feasible engineering and work practice controls 
described in this paragraph are not sufficient to reduce employee 
exposure to or below the limit prescribed in paragraph (c) of this 
section, the employer shall use them to reduce employee exposure to the 
lowest levels attainable by these controls and shall supplement them by 
the use of respiratory protection that complies with the requirements of 
paragraph (h) of this section.
    (2) Prohibitions. (i) High-speed abrasive disc saws that are not 
equipped with appropriate engineering controls shall not be used for 
work related to asbestos.
    (ii) Compressed air shall not be used to remove asbestos materials 
containing asbestos unless the compressed air is used in conjunction 
with an enclosed ventilation system designed to capture the dust cloud 
created by the compressed air.

[[Page 731]]

    (iii) Materials containing asbestos shall not be applied by spray 
methods.
    (3) Employee rotation. The employer shall not use employee rotation 
as a means of compliance with the exposure limit prescribed in paragraph 
(c) of this section.
    (h) Respiratory protection--(1) General. The employer shall provide 
respirators, and ensure that they are used, where required by this 
section. Respirators shall be used in the following circumstances:
    (i) During the interval necessary to install or implement feasible 
engineering and work practice controls.
    (ii) In work operations such as maintenance and repair activities, 
or other activities for which engineering and work practice controls are 
not feasible.
    (iii) In work situations where feasible engineering and work 
practice controls are not yet sufficient to reduce exposure to or below 
the exposure limit.
    (iv) In emergencies.
    (2) Respirator selection. (i) Where respirators are used, the 
employer shall select and provide, at no cost to the employee, the 
appropriate respirator as specified in Table 1 in paragraph (h)(2)(iv) 
of this section, and shall ensure that the employee uses the respirator 
provided.
    (ii) The employer shall select respirators from among those jointly 
approved as being acceptable for protection by the Mine Safety and 
Health Administration (MSHA) and the National Institute for Occupational 
Safety and Health (NIOSH) under the provisions of 30 CFR part 11.
    (iii) The employer shall provide a powered, air-purifying respirator 
in lieu of any negative-pressure respirator specified in Table 1 
whenever:
    (A) An employee chooses to use this type of respirator; and
    (B) This respirator will provide adequate protection to the 
employee.
    (iv) Table 1--Respiratory Protection for Asbestos Fibers.

           Table 1--Respiratory Protection for Asbestos Fibers
------------------------------------------------------------------------
   Airborne concentration of asbestos           Required respirator
------------------------------------------------------------------------
Not in excess of 2 f/cc (10 x PEL)......  1. Half-mask air-purifying
                                           respirator other than a
                                           disposable respirator
                                           equipped with high-efficiency
                                           filters.
Not in excess of 10 f/cc (50 x PEL).....  1. Full facepiece air-
                                           purifying respirator equipped
                                           with high-efficiency filters.
Not in excess of 20 f/cc (100 x PEL)....  1. Any powered air-purifying
                                           respirator equipped with high-
                                           efficiency filters.
                                          2. Any supplied-air respirator
                                           operated in continuous flow
                                           mode.
Not in excess of 200 f/cc (1,000 x PEL).  1. Full facepiece supplied-air
                                           respirator operated in
                                           pressure demand mode.
Greater than 200 f/cc (>1,000 x PEL) or   1. Full facepiece supplied air
 unknown concentration.                    respirator operated in
                                           pressure demand mode equipped
                                           with an auxilliary positive
                                           pressure selfcontained
                                           breathing apparatus.
------------------------------------------------------------------------

    Note: a. Respirators assigned for higher environmental 
concentrations may be used at lower concentrations.
    b. A high-efficiency filter means a filter that is at least 99.97 
percent efficient against mono-dispersed particles of 0.3 micrometers in 
diameter or larger.
    (3) Respirator program. (i) Where respiratory protection is used, 
the employee shall institute a respirator program. This should include 
all information and guidance necessary for their proper selection, use, 
and care. Possible emergency uses of respirators should be anticipated 
and planned for.
    (ii) The employer shall permit each employee who uses a filter 
respirator to change the filter elements whenever an increase in 
breathing resistance is detected and shall maintain an adequate supply 
of filter elements for this purpose.
    (iii) Employees who wear respirators shall be permitted to leave 
work areas to wash their faces and respirator facepieces whenever 
necessary to prevent skin irritation associated with respirator use.
    (iv) No employee shall be assigned to tasks requiring the use of 
respirators if, based on his or her most recent examination, an 
examining physician determines that the employee will be unable to 
function normally wearing a respirator, or that the safety or health of 
the employee or of other employees will be impaired by the use of a 
respirator. Such employee shall be assigned to another job or given the 
opportunity to transfer to a different position, the duties of which he 
or she is

[[Page 732]]

able to perform, with the same employer, in the same geographical area, 
and with the same seniority, status, and rate of pay he or she had just 
prior to such transfer, if such a different position is available.
    (4) Respirator fit testing. (i) The employer shall ensure that the 
respirator issued to the employee exhibits the least possible facepiece 
leakage and that the respirator is fitted properly.
    (ii) Employers shall perform either quantitative or qualitative face 
fit tests at the time of initial fitting and at least every 6 months 
thereafter for each employee wearing a negative-pressure respirator. The 
qualitative fit tests may be used only for testing the fit of half-mask 
respirators where they are permitted to be worn, and shall be conducted 
in accordance with appendix C of this section. The tests shall be used 
to select facepieces that provide the required protection as prescribed 
in Table 1.
    (i) Protective clothing--(1) General. The employer shall provide and 
require the use of protective clothing, such as coveralls or similar 
whole-body clothing, head coverings, gloves, and foot coverings for any 
employee exposed to airborne concentrations of asbestos that exceed the 
permissible exposure limit prescribed in paragraph (c) of this section.
    (2) Laundering. (i) The employer shall ensure that laundering of 
contaminated clothing is done so as to prevent the release of airborne 
asbestos in excess of the exposure limit prescribed in paragraph (c) of 
this section.
    (ii) Any employer who gives contaminated clothing to another person 
for laundering shall inform such person of the requirement in paragraph 
(i)(2)(i) of this section effectively to prevent the release of airborne 
asbestos in excess of the exposure limit prescribed in paragraph (c) of 
this section.
    (3) Contaminated clothing. Contaminated clothing shall be 
transported in sealed impermeable bags, or other closed, impermeable 
containers, and be labeled in accordance with paragraph (k) of this 
section.
    (4) Protective clothing for removal, demolition, and renovation 
operations. (i) The competent person shall periodically examine 
worksuits worn by employees for rips or tears that may occur during 
performance of work.
    (ii) When rips or tears are detected while an employee is working 
within a negative-pressure enclosure, rips and tears shall be 
immediately mended, or the worksuit shall be immediately replaced.
    (j) Hygiene facilities and practices--(1) General. (i)(A) The 
employer shall provide clean change areas for employees required to work 
in regulated areas or required by paragraph (i)(1) of this section to 
wear protective clothing.
    (B) In lieu of the change area requirement specified in paragraph 
(j)(1)(i), the employer may permit employees engaged in small-scale, 
short-duration operations, as described in paragraph (e)(6) of this 
section, to clean their protective clothing with a portable HEPA-
equipped vacuum before such employees leave the area where maintenance 
was performed.
    (ii) The employer shall ensure that change areas are equipped with 
separate storage facilities for protective clothing and street clothing.
    (iii) Whenever food or beverages are consumed at the worksite and 
employees are exposed to airborne concentrations of asbestos in excess 
of the permissible exposure limit, the employer shall provide lunch 
areas in which the airborne concentrations of asbestos are below the 
action level.
    (2) Requirements for removal, demolition, and renovation 
operations--(i) Decontamination area. Except for small-scale, short-
duration operations, as described in paragraph (e)(6) of this section, 
the employer shall establish a decontamination area that is adjacent and 
connected to the regulated area for the decontamination of employees 
contaminated with asbestos. The decontamination area shall consist of an 
equipment room, shower area, and clean room in series. The employer 
shall ensure that employees enter and exit the regulated area through 
the decontamination area.
    (ii) Clean room. The clean room shall be equipped with a locker or 
appropriate storage container for each employee's use.
    (iii) Shower area. Where feasible, shower facilities shall be 
provided. The showers shall be contiguous both to the

[[Page 733]]

equipment room and the clean change room, unless the employer can 
demonstrate that this location is not feasible. Where the employer can 
demonstrate that it is not feasible to locate the shower between the 
equipment room and the clean change room, the employer shall ensure that 
employees:
    (A) Remove asbestos contamination from their worksuits using a HEPA 
vacuum before proceeding to a shower that is not contiguous to the work 
area; or
    (B) Remove their contaminated worksuits, don clean worksuits, and 
proceed to a shower that is not contiguous to the work area.
    (iv) Equipment room. The equipment room shall be supplied with 
impermeable, labeled bags and containers for the containment and 
disposal of contaminated protective clothing and equipment.
    (v) Decontamination area entry procedures. (A) The employer shall 
ensure that employees:
    (1) Enter the decontamination area through the clean room.
    (2) Remove and deposit street clothing within a locker provided for 
their use.
    (3) Put on protective clothing and respiratory protection before 
leaving the clean room.
    (B) The employer shall ensure that employees pass through the 
equipment room before entering the enclosure.
    (vi) Decontamination area exit procedures. (A) The employer shall 
ensure that employees remove all gross contamination and debris from 
their protective clothing before leaving the regulated area.
    (B) The employer shall ensure that employees remove their protective 
clothing in the equipment room and deposit the clothing in labeled 
impermeable bags or containers.
    (C) The employer shall ensure that employees do not remove their 
respirators in the equipment room.
    (D) The employer shall ensure that employees shower prior to 
entering the clean room.
    (E) The employer shall ensure that, after showering, employees enter 
the clean room before changing into street clothes.
    (k) Communication of hazards to employees--(1) Signs. (i) Warning 
signs that demarcate the regulated area shall be provided and displayed 
at each location where airborne concentrations of asbestos may be in 
excess of the exposure limit prescribed in paragraph (c) of this 
section. Signs shall be posted at such a distance from such a location 
that an employee may read the signs and take necessary protective steps 
before entering the area marked by the signs.
    (ii) The warning signs required by paragraph (k)(1)(i) of this 
section shall bear the following information:

DANGER
ASBESTOS
CANCER AND LUNG DISEASE HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED IN THIS AREA

    (2) Labels. (i) Labels shall be affixed to all products containing 
asbestos and to all containers containing such products, including waste 
containers. Where feasible, installed asbestos products shall contain a 
visible label.
    (ii) Labels shall be printed in large, bold letters on a contrasting 
background.
    (iii) Labels shall be used and shall contain the following 
information:

DANGER
CONTAINS ASBESTOS FIBERS
AVOID CREATING DUST
CANCER AND LUNG DISEASE HAZARD

    (iv) [Reserved]
    (v) Labels shall contain a warning statement against breathing 
airborne asbestos fibers.
    (vi) The provisions for labels required by paragraph (k)(2)(i) of 
this section do not apply where:
    (A) Asbestos fibers have been modified by a bonding agent, coating, 
binder, or other material, provided that the manufacturer can 
demonstrate that, during any reasonably foreseeable use, handling, 
storage, disposal, processing, or transportation, no airborne 
concentrations of asbestos fibers in excess of the action level will be 
released or
    (B) Asbestos is present in a product in concentrations less than 0.1 
percent by weight.
    (3) Employee information and training. (i) The employer shall 
institute a

[[Page 734]]

training program for all employees exposed to airborne concentrations of 
asbestos at or above the action level and shall ensure their 
participation in the program.
    (ii) Training shall be provided prior to or at the time of initial 
assignment, [unless the employee has received equivalent training within 
the previous 12 months] and at least annually thereafter.
    (iii) The training program shall be conducted in a manner that the 
employee is able to understand. The employer shall ensure that each 
employee is informed of the following:
    (A) Methods of recognizing asbestos.
    (B) The health effects associated with asbestos exposure.
    (C) The relationship between smoking and asbestos in producing lung 
cancer.
    (D) The nature of operations that could result in exposure to 
asbestos, the importance of necessary protective controls to minimize 
exposure including, as applicable, engineering controls, work practices, 
respirators, housekeeping procedures, hygiene facilities, protective 
clothing, decontamination procedures, emergency procedures, and waste 
disposal procedures, and any necessary instruction in the use of these 
controls and procedures.
    (E) The purpose, proper use, fitting instructions, and limitations 
of respirators.
    (F) The appropriate work practices for performing the asbestos job; 
and
    (G) Medical surveillance program requirements; and
    (H) The content of this subpart, including appendices.
    (4) Access to training materials. (i) The employer shall make 
readily available to all affected employees without cost all written 
materials relating to the employee training program, including a copy of 
this regulation.
    (ii) The employer shall provide to the Administrator upon request, 
all information and training materials relating to the employee 
information and training program.
    (l) Housekeeping--(1) Vacuuming. Where vacuuming methods are 
selected, HEPA filtered vacuuming equipment must be used. The equipment 
shall be used and emptied in a manner that minimizes the reentry of 
asbestos into the workplace.
    (2) Waste disposal. Asbestos waste, scrap, debris, bags, containers, 
equipment, and contaminated clothing consigned for disposal shall be 
collected and disposed of in sealed, labeled, impermeable bags or other 
closed, labeled, impermeable containers.
    (m) Medical surveillance--(1) General--(i) Employees covered. The 
employer shall institute a medical surveillance program for all 
employees engaged in work involving levels of asbestos at or above the 
action level for 30 or more days per year, or who are required by this 
section to wear negative-pressure respirators.
    (ii) Examination by a physician. (A) The employer shall ensure that 
all medical examinations and procedures are performed by or under the 
supervision of a licensed physician, and are provided at no cost to the 
employee and at a reasonable time and place.
    (B) Persons other than such licensed physicians who administer the 
pulmonary function testing required by this section shall complete a 
training course in spirometry sponsored by an appropriate academic or 
professional institution.
    (2) Medical examinations and consultation--(i) Frequency. The 
employer shall make available medical examinations and consultations to 
each employee covered under paragraph (m)(1)(i) of this section on the 
following schedules:
    (A) Prior to assignment of the employee to an area where negative-
pressure respirators are worn.
    (B)(1) When the employee is assigned to an area where exposure to 
asbestos may be at or above the action level for 30 or more days per 
year, a medical examination must be given within 10 working days 
following the thirtieth day of exposure.
    (2) No medical examination is required of any employee if adequate 
records show that the employee has been examined in accordance with this 
paragraph within the past 1-year period.
    (C) At least annually thereafter.
    (D) If the examining physician determines that any of the 
examinations should be provided more frequently

[[Page 735]]

than specified, the employer shall provide such examinations to affected 
employees at the frequencies specified by the physician.
    (ii) Content. Medical examinations made available pursuant to 
paragraphs (m)(2)(i) (A), (B), and (C) of this section shall include:
    (A) A medical and work history with special emphasis directed to the 
pulmonary, cardiovascular, and gastrointestinal systems.
    (B) On initial examination, the standardized questionnaire contained 
in appendix D, part 1 of this section and, on annual examination, the 
abbreviated standardized questionnaire contained in appendix D, part 2 
of this section.
    (C) A physical examination directed to the pulmonary and 
gastrointestinal systems, including a chest roentgenogram to be 
administered at the discretion of the physician, and pulmonary function 
tests of forced vital capacity (FVC) and forced expiratory volume at one 
second (FEV1). Interpretation and classification of chest 
roentgenograms shall be conducted in accordance with appendix E of this 
section.
    (D) Any other examinations or tests deemed necessary by the 
examining physician.
    (3) Information provided to the physician. The employer shall 
provide the following information to the examining physician:
    (i) A copy of this rule and Appendices D and E of this section.
    (ii) A description of the affected employee's duties as they relate 
to the employee's exposure.
    (iii) The employee's representative exposure level or anticipated 
exposure level.
    (iv) A description of any personal protective and respiratory 
equipment used or to be used.
    (v) Information from previous medical examinations of the affected 
employee that is not otherwise available to the examining physician.
    (4) Physician's written opinion. (i) The employer shall obtain a 
written opinion from the examining physician. This written opinion shall 
contain the results of the medical examination and shall include:
    (A) The physician's opinion as to whether the employee has any 
detected medical conditions that would place the employee at an 
increased risk of material health impairment from exposure to asbestos.
    (B) Any recommended limitations on the employee or on the use of 
personal protective equipment such as respirators.
    (C) A statement that the employee has been informed by the physician 
of the results of the medical examinations and of any medical conditions 
that may result from asbestos exposure.
    (ii) The employer shall instruct the physician not to reveal in the 
written opinion given to the employer specific findings or diagnoses 
unrelated to occupational exposure to asbestos.
    (iii) The employer shall provide a copy of the physician's written 
opinion to the affected employee within 30 days from its receipt.
    (n) Recordkeeping--(1) Objective data for exempted operations. (i) 
Where the employer has relied on objective data that demonstrate that 
products made from or containing asbestos are not capable of releasing 
fibers of asbestos in concentrations at or above the action level under 
the expected conditions of processing, use, or handling to exempt such 
operations from the initial monitoring requirements under paragraph 
(f)(2) of this section, the employer shall establish and maintain an 
accurate record of objective data reasonably relied upon in support of 
the exemption.
    (ii) The record shall include at least the following information:
    (A) The product qualifying for exemption.
    (B) The source of the objective data.
    (C) The testing protocol, results of testing, and/or analysis of the 
material for the release of asbestos.
    (D) A description of the operation exempted and how the data support 
the exemption.
    (E) Other data relevant to the operations, materials, processing, or 
employee exposures covered by the exemption.
    (iii) The employer shall maintain this record for the duration of 
the employer's reliance upon such objective data.

[[Page 736]]

    (2) Exposure measurements. (i)(A) The employer shall keep an 
accurate record of all measurements taken to monitor employee exposure 
to asbestos as prescribed in paragraph (f) of this section.
    (B) The employer may utilize the services of competent organizations 
such as employee associations to maintain the records required by this 
section.
    (ii) This record shall include at least the following information:
    (A) The date of measurement.
    (B) The operation involving exposure to asbestos that is being 
monitored.
    (C) Sampling and analytical methods used and evidence of their 
accuracy.
    (D) Number, duration, and results of samples taken.
    (E) Type of protective devices worn, if any.
    (F) Name, social security number, and exposure of the employees 
whose exposures are represented.
    (iii) The employer shall maintain this record for at least 30 years.
    (3) Medical surveillance. (i) The employer shall establish and 
maintain an accurate record for each employee subject to medical 
surveillance by paragraph (m) of this section.
    (ii) The record shall include at least the following information:
    (A) The name and social security number of the employee.
    (B) A copy of the employee's medical examination results, including 
the medical history, questionnaire responses, results of any tests, and 
physician's recommendations.
    (C) Physician's written opinions.
    (D) Any employee medical complaints related to exposure to asbestos.
    (E) A copy of the information provided to the physician as required 
by paragraph (m) of this section.
    (iii) The employer shall ensure that this record is maintained for 
the duration of employment plus 30 years.
    (4) Training records. The employer shall maintain all employee 
training records for 1 year beyond the last date of employment by that 
employer.
    (5) Availability. (i) The employer, upon request, shall make all 
records required to be maintained by this section available to the 
Administrator for examination and copying.
    (ii) The employer, upon request, shall make any exposure records 
required by paragraphs (f) and (n) of this section available for 
examination and copying to affected employees, former employees, 
designated representatives, and the Administrator.
    (iii) The employer, upon request, shall make employee medical 
records required by paragraphs (m) and (n) of this section available for 
examination and copying to the subject employee, anyone having the 
specific written consent of the subject employee, and the Administrator.
    (6) Transfer of records. Whenever the employer ceases to operate and 
there is no successor employer to receive and retain the records for the 
prescribed period, the employer shall notify the Administrator at least 
90 days prior to disposal and, upon request, transmit them to the 
Administrator.
    (o) Effective date. This section shall become effective March 27, 
1987.
    (p) Appendices. (1) Appendices A, C, D, and E to this section are 
incorporated as part of this section and the contents of these 
appendices are mandatory.
    (2) Appendix B to this section is informational and is not intended 
to create any additional obligations not otherwise imposed or to detract 
from any existing obligations.

    Appendix A To Sec. 763.121--EPA/OSHA Reference Method--Mandatory

    This mandatory appendix specifies the procedure for analyzing air 
samples for asbestos and specifies quality control procedures that must 
be implemented by laboratories performing the analysis. The sampling and 
analytical methods described below represent the elements of the 
available monitoring methods essential to achieve adequate employee 
exposure monitoring while allowing employers to use methods that are 
already established within their organizations. All employers who are 
required to conduct air monitoring under Sec. 763.121(f) are required to 
utilize analytical laboratories that use this procedure, or an 
equivalent method for collecting and analyzing samples.

                    Sampling and Analytical Procedure

    1. The sampling medium for air samples shall be mixed cellulose 
ester filter membranes. These shall be designated by the manufacturer as 
suitable for asbestos counting. See below for rejection of blanks.

[[Page 737]]

    2. The preferred collection device shall be the 25-mm diameter 
cassette with an open-faced 50-mm electrically conductive extension 
cowl. The 37-mm cassette may be used if necessary, but only if written 
justification for the need to use the 37-mm filter cassette accompanies 
the sample results in the employee's exposure monitoring record.
    3. An air flow rate between 0.5 liter/min and 2.5 liters/min shall 
be selected for the 25-mm cassette. If the 37-mm cassette is used, an 
air flow rate between 1 liter/min and 2.5 liters/min shall be selected.
    4. Where possible, a sufficient air volume for each air sample shall 
be collected to yield between 100 and 1,300 fibers per square millimeter 
on the membrane filter. If a filter darkens in appearance or if loose 
dust is seen on the filter, a second sample shall be started.
    5. Ship the samples in a rigid container with sufficient packing 
material to prevent dislodging the collected fibers. Packing material 
that has a high electrostatic charge on its surface (e.g., expanded 
polystyrene) cannot be used because such material can cause loss of 
fibers to the sides of the cassette.
    6. Calibrate each personal sampling pump before and after use with a 
representative filter cassette installed between the pump and the 
calibration devices.
    7. Personal samples shall be taken in the ``breathing zone'' of the 
employee (i.e., attached to or near the collar or lapel near the 
worker's face).
    8. Fiber counts shall be made by positive phase contrast using a 
microscope with an 8 to 10 X eyepiece and a 40 to 45 X objective for a 
total magnification of approximately 400 X and a numerical aperture of 
0.65 to 0.75. The microscope shall also be fitted with a green or blue 
filter.
    9. The microscope shall be fitted with a Walton-Beckett eyepiece 
graticule calibrated for a field diameter of 100 micrometers 
( 2 micrometers).
    10. The phase-shift detection limit of the microscope shall be about 
3 degrees measured using the HSE phase shift test slide as outlined 
below.
    a. Place the test slide on the microscope stage and center it under 
the phase objective.
    b. Bring the blocks of grooved lines into focus.
    Note: The slide consists of seven sets of grooved lines (ca. 20 
grooves to each block) in descending order of visibility from sets 1 to 
7, seven being the least visible. The requirements for asbestos counting 
are that the microscope optics must resolve the grooved lines in set 3 
completely, although they may appear somewhat faint, and that the 
grooved lines in sets 6 and 7 must be invisible. Sets 4 and 5 must be at 
least partially visible but may vary slightly in visibility between 
microscopes. A microscope that fails to meet these requirements has 
either too low or too high a resolution to be used for asbestos 
counting.
    c. If the image deteriorates, clean and adjust the microscope 
optics. If the problem persists, consult the microscope manufacturer.
    11. Each set of samples taken will include 10 percent blanks or a 
minimum of 2 blanks. The blank results shall be averaged and subtracted 
from the analytical results before reporting. Any samples represented by 
a blank having a fiber count in excess of 7 fibers/100 fields shall be 
rejected.
    12. The samples shall be mounted by the acetone/triacetin method or 
a method with an equivalent index of refraction and similar clarity.
    13. Observe the following counting rules.
    a. Count only fiber equal to or longer than 5 micrometers. Measure 
the length of curved fibers along the curve.
    b. In the absence of other information, count all particles as 
asbestos that have a length-to-width ratio (aspect ratio) of 3:1 or 
greater.
    c. Fibers lying entirely within the boundary of the Walton-Beckett 
graticule field shall receive a count of 1. Fibers crossing the boundary 
once, having one end within the circle, shall receive the count of one-
half (\1/2\). Do not count any fiber that crosses the graticule boundary 
more than once. Reject and do not count any other fibers even though 
they may be visible outside the graticule area.
    d. Count bundles of fibers as one fiber unless individual fibers can 
be identified by observing both ends of an individual fiber.
    e. Count enough graticule fields to yield 100 fibers. Count a 
minimum of 20 fields; stop counting at 100 fields regardless of fiber 
count.
    14. Blind recounts shall be conducted at the rate of 10 percent.

                       Quality Control Procedures

    1. Intralaboratory program. Each laboratory and/or each company with 
more than one microscopist counting slides shall establish a 
statistically designed quality assurance program involving blind 
recounts and comparisons between microscopists to monitor the 
variability of counting by each microscopist and between microscopists. 
In a company with more than one laboratory, the program shall include 
all laboratories and shall also evaluate the laboratory-to-laboratory 
variability.
    2. Interlaboratory program. Each laboratory analyzing asbestos 
samples for compliance determination shall implement an interlaboratory 
quality assurance program that as a minimum includes participation of at 
least two other independent laboratories. Each laboratory shall 
participate in round robin testing at least once every 6 months with at

[[Page 738]]

least all the other laboratories in its interlaboratory quality 
assurance group. Each laboratory shall submit slides typical of its own 
work load for use in this program. The round robin shall be designed and 
results analyzed using appropriate statistical methodology.
    3. All individuals performing asbestos analysis must have taken the 
NIOSH course for sampling and evaluating airborne asbestos dust or an 
equivalent course.
    4. When the use of different microscopes contributes to differences 
between counters and laboratories, the effect of the different 
microscope shall be evaluated and the microscope shall be replaced, as 
necessary.
    5. Current results of these quality assurance programs shall be 
posted in each laboratory to keep the microscopists informed.

Appendix B to Sec. 763.121--Detailed Procedure for Asbestos Sampling and 
                         Analysis--Non-Mandatory

    This appendix contains a detailed procedure for sampling and 
analysis and includes those critical elements specified in Appendix A of 
this section. Employers are not required to use this procedure, but they 
are required to use Appendix A of this section. The purpose of Appendix 
B of this section is to provide a detailed step-by-step sampling and 
analysis procedure that conforms to the elements specified in Appendix A 
of this section. Since this procedure may also standardize the analysis 
and reduce variability, EPA encourages employers to use this appendix.
    Technique: Microscopy, Phase Contrast.
    Analyte: Fibers (manual count).
    Sample Preparation: Acetone/triacetin method.
    Calibration: Phase-shift detection limit about 3 degrees.
    Range: 100 to 1,300 fibers/mm \2\ filter area.
    Estimated Limit of Detection: 7 fibers/mm \2\ filter area.
    Sampler: Filter (0.8-1.2  m mixed cellulose ester membrane, 
25-mm diameter).
    Flow Rate: 0.5 L/min to 2.5 L/min (25-mm cassette); 1.0 L/min to 2.5 
L/min (37-mm cassette).
    Sample Volume: Adjust to obtain 100 to 1,300 fibers/mm \2\.
    Shipment: Routine.
    Sample Stability: Indefinite.
    Blanks: 10% of samples (minimum 2).
    Standard Analytical Error: 0.25.
    Applicability: The working range is 0.02 f/cc (1920-L air sample) to 
1.25 f/cc (400-L sample). The method gives an index of airborne asbestos 
fibers but may be used for other materials such as fibrous glass by 
inserting suitable parameters into the counting rules. The method does 
not differentiate between asbestos and other fibers. Asbestos fibers 
less than ca. 0.25  m diameter will not be detected by this 
method.
    Interferences: Any other airborne fiber may interfere since all 
particles meeting the counting criteria are counted. Chain-like 
particles may appear fibrous. High levels of nonfibrous dust particles 
may obscure fibers in the field of view and raise the detection limit.
    Reagents:
    1. Acetone.
    2. Triacetin (glycerol triacetate), reagent grade.
    Special Precautions: Acetone is an extremely flammable liquid and 
precautions must be taken not to ignite it. Heating of acetone must be 
done in a ventilated laboratory fume hood using a flameless, spark-free 
heat source.
    Equipment:
    1. Collection device: 25-mm cassette with 50-mm electrically 
conductive extension cowl with cellulose ester filter, 0.8 to 1.2 mm 
pore size and backup pad.
    Note: Analyze representative filters for fiber background before use 
and discard the filter lot if more than 5 fibers/100 fields are found.
    2. Personal sampling pump, greater than or equal to 0.5 l/min, with 
flexible connecting tubing.
    3. Microscope, phase contrast, with green or blue filter, 8 to 10X 
eyepiece, and 40 to 45X phase objective (total magnification ca. 400X); 
numerical aperture=0.65 to 0.75.
    4. Slides, glass, single-frosted, pre-cleaned, 25 x 75 mm.
    5. Cover slips, 25 x 25 mm, No. 1\1/2\ unless otherwise specified by 
microscope manufacturer.
    6. Knife, 1 surgical steel, curved blade.
    7. Tweezers.
    8. Flask, Guth-type, insulated neck, 250 to 500 mL (with single-
holed rubber stopper and elbow-jointed glass tubing, 16 to 22 cm long).
    9. Hotplate, spark-free, stirring type; heating mantle; or infrared 
lamp and magnetic stirrer.
    10. Syringe, hypodermic, with 22-gauge needle.
    11. Graticule, Walton-Beckett type with 100  m diameter 
circular field at the specimen plane (area=0.00785 mm \2\), (Type G-22).
    Note: The graticule is custom-made for each microscope.
    12. HSE/NPL phase contrast test slide, Mark II.
    13. Telescope, ocular phase-ring centering.
    14. Stage micrometer (0.01 mm divisions).

                                Sampling

    1. Calibrate each personal sampling pump with a representative 
sampler in line.
    2. Fasten the sampler to the worker's lapel as close as possible to 
the worker's mouth. Remove the top cover from the end of the cowl 
extension (open face) and orient face

[[Page 739]]

down. Wrap the joint between the extender and the monitor's body with 
shrink tape to prevent air leaks.
    3. Submit at least two blanks (or 10 percent of the total samples, 
whichever is greater) for each set of samples. Remove the caps from the 
field blank cassettes and store the caps and cassettes in a clean area 
(bag or box) during the sampling period. Replace the caps in the 
cassettes when sampling is completed.
    4. Sample at 0.5 L/min or greater. Do not exceed 1 mg total dust 
loading on the filter. Adjust sampling flow rate, Q (L/min), and time to 
produce a fiber density, E (fibers/ mm\2\), of 100 to 1,300 fibers/m\2\ 
[3.85 x 10\4\ to 5 x 10\5\ fibers per 25-mm filter with effective 
collection area (Ac=385 mm\2\)] for optimum counting 
precision (see step 21 below). Calculate the minimum sampling time, 
t minimum (min) at the action level (one-half of the current 
standard), L (f/cc) of the fibrous aerosol being sampled:

 
                                                        (Ac)(E)
          minimum                   =        ---------------------------
                                                       (Q)(L)10
 

    5. Remove the field monitor at the end of sampling, replace the 
plastic top cover and small end caps, and store the monitor.
    6. Ship the samples in a rigid container with sufficient packing 
material to prevent jostling or damage.
    Note: Do not use polystyrene foam in the shipping container because 
of electrostatic forces which may cause fiber loss from the sample 
filter.

                           Sample Preparation

    Note: The object is to produce samples with a smooth (nongrainy) 
background in a medium with a refractive index equal to or less than 
1.46. The method below collapses the filter for easier focusing and 
produces permanent mounts which are useful for quality control and 
interlaboratory comparison. Other mounting techniques meeting the above 
criteria may also be used, e.g., the nonpermanent field mounting 
technique used in P & CAM 239.
    7. Ensure that the glass slides and cover slips are free of dust and 
fibers.
    8. Place 40 to 60 ml of acetone into a Guth-type flask. Stopper the 
flask with a single-hole rubber stopper through which a glass tube 
extends 5 to 8 cm into the flask. The portion of the glass tube that 
exits the top of the stopper (8 to 10 cm) is bent downward in an elbow 
that makes an angle of 20 to 30 degrees with the horizontal.
    9. Place the flask in a stirring hotplate or wrap in a heating 
mantle. Heat the acetone gradually to its boiling temperature (ca. 58  
deg. C).
    Caution. The acetone vapor must be generated in a ventilated fume 
hood away from all open flames and spark sources. Alternate heating 
methods can be used, providing no open flame or sparks are present.
    10. Mount either the whole sample filter or a wedge cut from the 
sample filter on a clean glass slide.
    a. Cut wedges of ca. 25 percent of the filter area with a curved-
blade steel surgical knife using a rocking motion to prevent tearing.
    b. Place the filter or wedge, dust side up, on the slide. Static 
electricity will usually keep the filter on the slide until it is 
cleared.
    c. Hold the glass slide supporting the filter approximately 1 to 2 
cm from the glass tube port where the acetone vapor is escaping from the 
heated flask. The acetone vapor stream should cause a condensation spot 
on the glass slide ca. 2 to 3 cm in diameter. Move the glass slide 
gently in the vapor stream. The filter should clear in 2 to 5 sec. If 
the filter curls, distorts, or is otherwise rendered unusable, the vapor 
stream is probably not strong enough. Periodically wipe the outlet port 
with tissue to prevent liquid acetone dripping onto the filter.
    d. Using the hypodermic syringe with a 22-gauge needle, place 1 to 2 
drops of triacetin on the filter. Gently lower a clean 25-mm square 
cover slip down onto the filter at a slight angle to reduce the 
possibility of forming bubbles. If too many bubbles form or the amount 
of triacetin is insufficient, the cover slip may become detached within 
a few hours.
    e. Glue the edges of the cover slip to the glass slide using a 
lacquer or nail polish.
    Note: If clearing is slow, the slide preparation may be heated on a 
hotplate (surface temperature 50 deg. C) for 15 min. to hasten clearing. 
Counting may proceed immediately after clearing and mounting are 
completed.

                     Calibration and Quality Control

    11. Calibration of the Walton-Beckett graticule. The diameter, 
dc (mm), of the circular counting area and the disc diameter 
must be specified when ordering the graticule.
    a. Insert any available graticule into the eyepiece and focus so 
that the graticule lines are sharp and clear.
    b. Set the appropriate interpupillary distance and, if applicable, 
reset the binocular head adjustment so that the magnification remains 
constant.
    c. Install the 40 to 45 X phase objective.
    d. Place a stage micrometer on the microscope object stage and focus 
the microscope on the graduated lines.
    e. Measure the magnified grid length, Lo (um), using the 
stage micrometer.
    f. Remove the graticule from the microscope and measure its actual 
grid length, La (mm). This can best be accomplished by using 
a stage fitted with verniers.

[[Page 740]]

    g. Calculate the circle diameter, dc (mm), for the 
Walton-Beckett graticule:

 
                                              La x D
                                    dc    = ---------
                                                Lo
 

    Example: If Lo=108 um, La=2.93 mm and D=100 
um, then dc=2.71 mm.
    h. Check the field diameter, D(acceptable range 100 mm 2 
mm) with a stage micrometer upon receipt of the graticule from the 
manufacturer. Determine field area (mm\2\).
    12. Microscope adjustments. Follow the manufacturer's instructions 
and also the following:
    a. Adjust the light source for even illumination across the field of 
view at the condenser iris.
    Note: Kohler illumination is preferred, where available.
    b. Focus on the particulate material to be examined.
    c. Make sure that the field iris is in focus, centered on the 
sample, and open only enough to fully illuminate the field of view.
    d. Use the telescope ocular supplied by the manufacturer to ensure 
that the phase rings (annular diaphragm and phase-shifting elements) are 
concentric.
    13. Check the phase-shift detection limit of the microscope 
periodically.
    a. Remove the HSE/NPL phase-contrast test slide from its shipping 
container and center it under the phase objective.
    b. Bring the blocks of grooved lines into focus.
    Note: The slide consists of seven sets of grooves (ca. 20 grooves to 
each block) in descending order of visibility from sets 1 to 7. The 
requirements for counting are that the microscope optics must resolve 
the grooved lines in set 3 completely, although they may appear somewhat 
faint, and that the grooved lines in sets 6 to 7 must be invisible. Sets 
4 and 5 must be at least partially visible but may vary slightly in 
visibility between microscopes. A microscope which fails to meet these 
requirements has either too low or too high a resolution to be used for 
asbestos counting.
    c. If the image quality deteriorates, clean the microscope optics 
and, if the problem persists, consult the microscope manufacturer.
    14. Quality control of fiber counts.
    a. Prepare and count field blanks along with the field samples. 
Report the counts on each blank. Calculate the mean of the field blank 
counts and subtract this value from each sample count before reporting 
the results.

    Note 1: The identity of the blank filters should be unknown to the 
counter until all counts have been completed.
    Note 2: If a field blank yields fiber counts greater than 7 fibers/
100 fields, report possible contamination of the samples.

    b. Perform blind recounts by the same counter on 10 percent of 
filters counted (slides relabeled by a person other than the counter).
    15. Use the following test to determine whether a pair of counts on 
the same filter should be rejected because of possible bias. This 
statistic estimates the counting repeatability at the 95 percent 
confidence level. Discard the sample if the difference between the two 
counts exceeds 2.77 (F)sr where F=average of the two fiber 
counts and sr=relative standard deviation, which should be 
derived by each laboratory based on historical in-house data.
    Note: If a pair of counts is rejected as a result of this test, 
recount the remaining samples in the set and test the new counts against 
the first counts. Discard all rejected paired counts.
    16. Enroll each new counter in a training course that compares 
performance of counters on a variety of samples using this procedure.
    Note: To ensure good reproducibility, all laboratories engaged in 
asbestos counting are required to participate in the Proficiency 
Analytical Testing (PAT) Program and should routinely participate with 
other asbestos fiber counting laboratories in the exchange of field 
samples to compare performance of counters.

                               Measurement

    17. Place the slide on the mechanical stage of the calibrated 
microscope with the center of the filter under the objective lens. Focus 
the microscope on the plane of the filter.
    18. Regularly check phase-ring alignment and Kohler illumination.
    19. The following are the counting rules:
    a. Count only fibers longer than 5 um. Measure the length of curved 
fibers along the curve.
    b. Count only fibers with a length-to-width ratio equal to or 
greater than 3:1.
    c. For fibers that cross the boundary of the graticule field, do the 
following:
    (1) Count any fiber longer than 5 um that lies entirely within the 
graticule area.
    (2) Count as \1/2\ fiber any fiber with only one end lying within 
the graticule area.
    (3) Do not count any fiber that crosses the graticule boundary more 
than once.
    (4) Reject and do not count all other fibers.
    d. Count bundles of fibers as one fiber unless individual fibers can 
be identified by observing both ends of a fiber.
    e. Count enough graticule fields to yield 100 fibers. Count a 
minimum of 20 fields. Stop at 100 fields regardless of fiber count.
    20. Start counting from one end of the filter and progress along a 
radial line to the

[[Page 741]]

other end, shift either up or down on the filter, and continue in the 
reverse direction. Select fields randomly by looking away from the 
eyepiece briefly while advancing the mechanical stage. When an 
agglomerate covers ca. \1/6\ or more of the field of view, reject the 
field and select another. Do not report rejected fields in the number of 
total fields counted.
    Note: When counting a field, continuously scan a range of focal 
planes by moving the fine focus knob to detect very fine fibers which 
have become embedded in the filter. The small-diameter fibers will be 
very faint but are an important contribution to the total count.

                              Calculations

    21. Calculate and report fiber density on the filter, E (fibers/
mm2); by dividing the total fiber count, F; minus the mean 
field blank count, B, by the number of fields, n; and the field area, 
Af (0.00785 mm2 for a properly calibrated Walton-
Beckett graticule):

 
                       E=(F/nf-(B/nb) fibers/mm\2\
-------------------------------------------------------------------------
                                   Af
 

where:
  nf--number of fields in submission sample
  nb--number of fields in bulk sample

    22. Calculate the concentration, C (f/cc), of fibers in the air 
volume sampled, V (L), using the effective collection area of the 
filter, Ac (385 mm2 for a 25-mm filter):

 
                                           (E)(Ac)
                                    C=  ------------
                                           V(103)
 

    Note: Periodically check and adjust the value of Ac, if 
necessary.

  Appendix C to Sec. 763.121--Qualitative and Quantitative Fit Testing 
                          Procedures--Mandatory

                     Qualitative Fit Test Protocols

                       I. Isoamyl Acetate Protocol

    A. Odor Threshold Screening. 1. Three 1-liter glass jars with metal 
lids (e.g. Mason or Bell jars) are required.
    2. Odor-free water (e.g. distilled or spring water) at approximately 
25 deg. shall be used for the solutions.
    3. The isoamyl acetate (IAA) (also known as isopentyl acetate) stock 
solution is prepared by adding 1 cc of pure IAA to 800 cc of odor-free 
water in a 1-liter jar and shaking for 30 seconds. This solution shall 
be prepared new at least weekly.
    4. The screening test shall be conducted in a room separate from the 
room used for actual fit testing. The two rooms shall be well ventilated 
but shall not be connected to the same recirculating ventilation system.
    5. The odor test solution is prepared in a second jar by placing 0.4 
cc of the stock solution into 500 cc of odor-free water using a clean 
dropper or pipette. Shake for 30 seconds and allow to stand for two to 
three minutes so that the IAA concentration above the liquid may reach 
equilibrium. This solution may be used for only one day.
    6. A test blank is prepared in a third jar by adding 500 cc of odor-
free water.
    7. The odor test and test blank jars shall be labeled 1 and 2 for 
jar identification. If the labels are put on the lids they can be 
periodically peeled, dried off and switched to maintain the integrity of 
the test.
    8. The following instructions shall be typed on a card and placed on 
the table in front of the two test jars (i.e. 1 and 2): ``The purpose of 
this test is to determine if you can smell banana oil at a low 
concentration. The two bottles in front of you contain water. One of 
these bottles also contains a small amount of banana oil. Be sure the 
covers are on tight, then shake each bottle for two seconds. Unscrew the 
lid of each bottle, one at a time, and sniff at the mouth of the bottle. 
Indicate to the test conductor which bottle contains banana oil.''
    9. The mixtures used in the IAA odor detection test shall be 
prepared in an area separate from where the test is performed, in order 
to prevent olfactory fatigue in the subject.
    10. If the test subject is unable to identify correctly the jar 
containing the odor test solution, the IAA qualitative fit test may not 
be used.
    11. If the test subject correctly identifies the jar containing the 
odor test solution, the test subject may proceed to respirator selection 
and fit testing.
    B. Respirator selection. 1. The test subject shall be allowed to 
pick the most comfortable respirator from a selection including 
respirators of various sizes from different manufacturers. The selection 
shall include at least five sizes of elastomeric half facepieces, from 
at least two manufacturers.
    2. The selection process shall be conducted in a room separate from 
the fit-test chamber to prevent odor fatigue. Prior to the selection 
process, the test subject shall be shown how to put on a respirator, how 
it should be positioned on the face, how to set strap tension and how to 
determine a ``comfortable'' respirator. A mirror shall be available to 
assist the subject in evaluating the fit and positioning of the 
respirator. This instruction may not constitute the subject's formal 
training on respirator use, as it is only a review.
    3. The test subject should understand that the employee is being 
asked to select the respirator which provides the most comfortable fit. 
Each respirator represents a different

[[Page 742]]

size and shape and, if fitted properly and used properly, will provide 
adequate protection.
    4. The test subject holds each facepiece up to the face and 
eliminates those which obviously do not give a comfortable fit. 
Normally, selection will begin with a half-mask and if a good fit cannot 
be found, the subject will be asked to test the full facepiece 
respirators. (A small percentage of users will not be able to wear any 
half-mask.)
    5. The more comfortable facepieces are noted; the most comfortable 
mask is donned and worn at least five minutes to assess comfort. All 
donning and adjustments of the facepieces shall be performed by the test 
subject without assistance from the test conductor or other person. 
Assistance in assessing comfort can be given by discussing the points of 
6 below. If the test subject is not familiar with using a particular 
respirator, the test subject shall be directed to don the mask several 
times and to adjust the straps each time to become adept at setting 
proper tension on the straps.
    6. Assessment of comfort shall include reviewing the following 
points with the test subject and allowing the test subject adequate time 
to determine the comfort of the respirator:
     Positioning of mask on nose.
     Room for eye protection.
     Room to talk
     Positioning mask on face and cheeks.
    7. The following criteria shall be used to help determine the 
adequacy of the respirator fit:
     Chin properly placed.
     Strap tension.
     Fit across nose bridge.
     Distance from nose to chin.
     Tendency to slip.
     Self-observation in mirror.
    8. The test subject shall conduct the conventional negative and 
positive-pressure fit checks (e.g. see ANSI Z88.2-1980). Before 
conducting the negative- or positive-pressure test, the subject shall be 
told to ``seat'' the mask by rapidly moving the head from side-to-side 
and up and down, while taking a few deep breaths.
    9. The test subject is now ready for fit testing.
    10. After passing the fit test, the test subject shall be questioned 
again regarding the comfort of the respirator. If it has become 
uncomfortable, another model of respirator shall be tried.
    11. The employee shall be given the opportunity to select a 
different facepiece and be retested if the chosen facepiece becomes 
increasingly uncomfortable at any time.
    C. Fit test. 1. The fit test chamber shall be similar to a clear 55 
gallon drum liner suspended inverted over a 2 foot diameter frame, so 
that the top of the chamber is about 6 inches above the test subject's 
head. The inside top center of the chamber shall have a small hook 
attached.
    2. Each respirator used for the fitting and fit testing shall be 
equipped with organic vapor cartridges or offer protection against 
organic vapors. The cartridges or masks shall be changed at least 
weekly.
    3. After selection, donning, and properly adjusting a respirator, 
the test subject shall wear it to the fit testing room. This room shall 
be separate from the room used for odor threshold screening and 
respirator selection, and shall be well ventilated, as by an exhaust fan 
or lab hood, to prevent general room contamination.
    4. A copy of the following test exercises and rainbow passage shall 
be taped to the inside of the test chamber:

                             Test Exercises

    i. Breathe normally.
    ii. Breathe deeply. Be certain breaths are deep and regular.
    iii. Turn head all the way from one side to the other. Inhale on 
each side. Be certain movement is complete. Do not bump the respirator 
against the shoulders.
    iv. Nod head up-and-down. Inhale when head is in the full up 
position (looking toward ceiling). Be certain motions are complete and 
made about every second. Do not bump the respirator on the chest.
    v. Talking. Talk aloud and slowly for several minutes. The following 
paragraph is called the Rainbow Passage. Reading it will result in a 
wide range of facial movements, and thus be useful to satisfy this 
requirement. Alternative passages which serve the same purpose may also 
be used.
    vi. Jogging in place.
    vii. Breathe normally.
    Rainbow Passage. When the sunlight strikes raindrops in the air, 
they act like a prism and form a rainbow. The rainbow is a division of 
white light into many beautiful colors. These take the shape of a long 
round arch, with its path high above, and its two ends apparently beyond 
the horizon. There is, according to legend, a boiling pot of gold at one 
end. People look, but no one ever finds it. When a man looks for 
something beyond reach, his friends say he is looking for the pot of 
gold at the end of the rainbow.
    5. Each test subject shall wear the respirator for at least 10 
minutes before starting the fit test.
    6. Upon entering the test chamber, the test subject shall be given a 
6 inch by 5 inch piece of paper towel or other porous absorbent single 
ply material, folded in half and wetted with three-quarters of one cc of 
pure IAA. The test subject shall hang the wet towel on the hook at the 
top of the chamber.
    7. Allow two minutes for the IAA test concentration to be reached 
before starting the fit-test exercises. This would be an appropriate 
time to talk with the test subject, to

[[Page 743]]

explain the fit test, the importance of cooperation, the purpose for the 
head exercises, or to demonstrate some of the exercises.
    8. Each exercise described in 4 above shall be performed for at 
least one minute.
    9. If at any time during the test, the subject detects the banana-
like odor of IAA, the test has failed. The subject shall quickly exit 
from the test chamber and leave the test area to avoid olfactory 
fatigue.
    10. If the test is failed, the subject shall return to the selection 
room and remove the respirator, repeat the odor sensitivity test, select 
and put on another respirator, return to the test chamber, and again 
begin the procedure described in the c(4) through c(8) above. The 
process continues until a respirator that fits well has been found. 
Should the odor sensitivity test be failed, the subject shall wait about 
5 minutes before retesting. Odor sensitivity will usually have returned 
by this time.
    11. If a person cannot pass the fit test described above wearing a 
half-mask respirator from the available selection, full facepiece models 
must be used.
    12. When a respirator is found that passes the test, the subject 
breaks the faceseal and takes a breath before exiting the chamber. This 
is to assure that the reason the test subject is not smelling the IAA is 
the good fit of the respirator facepiece seal and not olfactory fatigue.
    13. When the test subject leaves the chamber, the subject shall 
remove the saturated towel and return it to the person conducting the 
test. To keep the area from becoming contaminated, the used towels shall 
be kept in a self-sealing bag so there is no significant IAA 
concentration buildup in the test chamber during subsequent tests.
    14. At least two facepieces shall be selected for the IAA test 
protocol. The test subject shall be given the opportunity to wear them 
for one week to choose the one which is more comfortable to wear.
    15. Persons who have successfully passed this fit test with a half-
mask respirator may be assigned the use of the test respirator in 
atmospheres with up to 10 times the PEL of airborne asbestos.
    16. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface.
    17. If hair growth or apparel interfere with a satisfactory fit, 
then they shall be altered or removed so as to eliminate interference 
and allow a satisfactory fit. If a satisfactory fit is still not 
attained, the test subject must use a positive-pressure respirator such 
as powered air-purifying respirators, supplied air respirator, or self-
contained breathing apparatus.
    18. If a test subject exhibits difficulty in breathing during the 
tests, she or he shall be referred to a physician trained in respirator 
diseases or pulmonary medicine to determine whether the test subject can 
wear a respirator while performing her or his duties.
    19. Qualitative fit testing shall be repeated at least every six 
months.
    20. In addition, because the sealing of the respirator may be 
affected, qualitative fit testing shall be repeated immediately when the 
test subject has a:
    (1) Weight change of 20 pounds or more,
    (2) Significant facial scarring in the area of the facepiece seal.
    (3) Significant dental changes; i.e., multiple extractions without 
prosthesis, or acquiring dentures.
    (4) Reconstructive or cosmetic surgery, or
    (5) Any other condition that may interfere with facepiece sealing.
    D. Recordkeeping. A summary of all test results shall be maintained 
in each office for 3 years. The summary shall include:
    (1) Name of test subject.
    (2) Date of testing.
    (3) Name of the test conductor.
    (4) Respirators selected (indicate manufacturer, model, size and 
approval number).
    (5) Testing agent.

                 II. Saccharin Solution Aerosol Protocol

    A. Respirator selection. Respirators shall be selected as described 
in section IB (respirator selection) above, except that each respirator 
shall be equipped with a particulate filter.
    B. Taste threshold screening. 1. An enclosure about head and 
shoulders shall be used for threshold screening (to determine if the 
individual can taste saccharin) and for fit testing. The enclosure shall 
be approximately 12 inches in diameter by 14 inches tall with at least 
the front clear to allow free movement of the head when a respirator is 
worn.
    2. The test enclosure shall have a three-quarter inch hole in front 
of the test subject's nose and mouth area to accommodate the nebulizer 
nozzle.
    3. The entire screening and testing procedure shall be explained to 
the test subject prior to conducting the screening test.
    4. During the threshold screening test, the test subject shall don 
the test enclosure and breathe with mouth open with tongue extended.
    5. Using a DeVilbiss Model 40 Inhalation Medication Nebulizer or 
equivalent, the test conductor shall spray the threshold check solution 
into the enclosure. This nebulizer shall be clearly marked to 
distinquish it from the fit test solution nebulizer.
    6. The threshold check solution consists of 0.83 gram of sodium 
saccharin, USP in water. It can be prepared by putting 1 cc of the test 
solution (see C.7 below) in 100 cc of water.
    7. To produce the aerosol, the nebulizer bulb is firmly squeezed so 
that it collapses completely, then is released and allowed to expand 
fully.

[[Page 744]]

    8. Ten squeezes of the nebulizer bulb are repeated rapidly and then 
the test subject is asked whether the saccharin can be tasted.
    9. If the first response is negative, ten more squeezes of the 
nebulizer bulb are repeated rapidly and the test subject is again asked 
whether the saccharin can be tasted.
    10. If the second response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
saccharin can be tasted.
    11. The test conductor will take note of the number of squeezes 
required to elicit a taste response.
    12. If the saccharin is not tasted after 30 squeezes (Step 10), the 
saccharin fit test cannot be performed on the test subject.
    13. If a taste response is elicited, the test subject shall be asked 
to take note of the taste for reference in the fit test.
    14. Correct use of the nebulizer means that approximately 1 cc of 
liquid is used at a time in the nebulizer body.
    15. The nebulizer shall be thoroughly rinsed in water, shaken dry, 
and refilled at least every four hours.
    C. Fit Test. 1. The test subject shall don and adjust the respirator 
without assistance from any person.
    2. The fit test uses the same enclosure described in IIB above.
    3. Each test subject shall wear the respirator for at least 10 
minutes before starting the fit test.
    4. The test subject shall don the enclosure while wearing the 
respirator selected in section IB above. This respirator shall be 
properly adjusted and equipped with a particulate filter.
    5. The test subject may not eat, drink (except plain water), or chew 
gum for 15 minutes before the test.
    6. A second DeVilbiss Model 40 Inhalation Medication Nebulizer is 
used to spray the fit test solution into the enclosure. This nebulizer 
shall be clearly marked to distinquish it from the screening test 
solution nebulizer.
    7. The fit test solution is prepared by adding 83 grams of sodium 
saccharin to 100 cc of warm water.
    8. As before, the test subject shall breathe with mouth open and 
tongue extended.
    9. The nebulizer is inserted into the hole in the front of the 
enclosure and the fit test solution is sprayed into the enclosure using 
the same technique as for the taste threshold screening and the same 
number of squeezes required to elicit a taste response in the screening. 
(See B.8 through B.10 above).
    10. After generation of the aerosol, read the following instructions 
to the test subject. The test subject shall perform the exercises for 
one minute each.
    i. Breathe normally.
    ii. Breathe deeply. Be certain breaths are deep and regular.
    iii. Turn head all the way from one side to the other. Be certain 
movement is complete. Inhale on each side. Do not bump the respirator 
against the shoulders.
    iv. Nod head up-and-down. Be certain motions are complete. Inhale 
when head is in the full up position (when looking toward the ceiling). 
Do not bump the respirator on the chest.
    v. Talking. Talk aloud and slowly for several minutes. The following 
paragraph is called the Rainbow Passage. Reading it will result in a 
wide range of facial movements, and thus be useful to satisfy this 
requirement. Alternative passages which serve the same purpose may also 
be used.
    Rainbow Passage. When the sunlight strikes raindrops in the air, 
they act like a prism and form a rainbow. The rainbow is a division of 
white light into many beautiful colors. These take the shape of a long 
round arch, with its path high above, and its two ends apparently beyond 
the horizon. There is, according to legend, a boiling pot of gold at one 
end. People look, but no one ever finds it. When a man looks for 
something beyond his reach, his friends say he is looking for the pot of 
gold at the end of the rainbow.
    vi. Jogging in place.
    vii. Breathe normally.
    11. At the beginning of each exercise, the aerosol concentration 
shall be replenished using one-half the number of squeezes as initially 
described in C.9.
    12. The test subject shall indicate to the test conductor, if at any 
time during the fit test, the taste of saccharin is detected.
    13. If the saccharin is detected, the fit is deemed unsatisfactory 
and a different respirator shall be tried.
    14. At least two facepieces shall be selected by the saccharin 
solution aerosol test protocol. The test subject shall be given the 
opportunity to wear them for one week to choose the one which is more 
comfortable to wear.
    15. Successful completion of the test protocol shall allow the use 
of the half mask tested respirator in contaminated atmospheres up to 10 
times the PEL of asbestos. In other words this protocol may be used to 
assign protection factors no higher than ten.
    16. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface.
    17. If hair growth or apparel interfere with a satisfactory fit, 
then they shall be altered or removed so as to eliminate interference 
and allow a satisfactory fit. If a satisfactory fit is still not 
attained, the test subject must use a positive-pressure respirator such 
as powered air-purifying respirators, supplied air respirator, or self-
contained breathing apparatus.
    18. If a test subject exhibits difficulty in breathing during the 
tests, she or he shall be

[[Page 745]]

referred to a physician trained in respirator diseases or pulmonary 
medicine to determine whether the test subject can wear a respirator 
while performing her or his duties.
    19. Qualitative fit testing shall be repeated at least every six 
months.
    20. In addition, because the sealing of the respirator may be 
affected, qualitative fit testing shall be repeated immediately when the 
test subject has a:
    (1) Weight change of 20 pounds or more,
    (2) Significant facial scarring in the area of the facepiece seal,
    (3) Significant dental changes; i.e., multiple extractions without 
prosthesis, or acquiring dentures,
    (4) Reconstructive or cosmetic surgery, or
    (5) Any other condition that may interfere with facepiece sealing.
    D. Recordkeeping. A summary of all test results shall be maintained 
in each office for 3 years. The summary shall include:
    (1) Name of test subject.
    (2) Date of testing.
    (3) Name of test conductor.
    (4) Respirators selected (indicate manufacturer, model, size and 
approval number).
    (5) Testing agent.

                       III. Irritant Fume Protocol

    A. Respirator selection. Respirators shall be selected as described 
in section IB above, except that each respirator shall be equipped with 
a high-efficiency cartridge.
    B. Fit test. 1. The test subject shall be allowed to smell a weak 
concentration of the irritant smoke to familiarize the subject with the 
characteristic odor.
    2. The test subject shall properly don the respirator selected as 
above, and wear it for at least 10 minutes before starting the fit test.
    3. The test conductor shall review this protocol with the test 
subject before testing.
    4. The test subject shall perform the conventional positive pressure 
and negative pressure fit checks (see ANSI Z88.2 1980). Failure of 
either check shall be cause to select an alternate respirator.
    5. Break both ends of a ventilation smoke tube containing stannic 
oxychloride, such as the MSA part 5645, or equivalent. Attach a short 
length of tubing to one end of the smoke tube. Attach the other end of 
the smoke tube to a low pressure air pump set to deliver 200 milliliters 
per minute.
    6. Advise the test subject that the smoke can be irritating to the 
eyes and instruct the subject to keep the eyes closed while the test is 
performed.
    7. The test conductor shall direct the stream of irritant smoke from 
the tube towards the faceseal area of the test subject. The person 
conducting the test shall begin with the tube at least 12 inches from 
the facepiece and gradually move to within one inch, moving around the 
whole perimeter of the mask.
    8. The test subject shall be instructed to do the following 
exercises while the respirator is being challenged by the smoke. Each 
exercise shall be performed for one minute.
    i. Breathe normally.
    ii. Breathe deeply. Be certain breaths are deep and regular.
    iii. Turn head all the way from one side to the other. Be certain 
movement is complete. Inhale on each side. Do not bump the respirator 
against the shoulders.
    iv. Nod head up-and-down. Be certain motions are complete and made 
every second. Inhale when head is in the full up position (looking 
toward ceiling). Do not bump the respirator against the chest.
    v. Talking. Talk aloud and slowly for several minutes. The following 
paragraph is called the Rainbow Passage. Repeating it after the test 
conductor (keeping eyes closed) will result in a wide range of facial 
movements, and thus be useful to satisfy this requirement. Alternative 
passages which serve the same purpose may also be used.
    Rainbow Passage. When the sunlight strikes raindrops in the air, 
they act like a prism and form a rainbow. The rainbow is a division of 
white light into many beautiful colors. These take the shape of a long 
round arch, with its path high above, and its two ends apparently beyond 
the horizon. There is, according to legend, a boiling pot of gold at one 
end. People look, but no one ever finds it. When a man looks for 
something beyond his reach, his friends say he is looking for the pot of 
gold at the end of the rainbow.
    vi. Jogging in place.
    vii. Breathe normally.
    9. The test subject shall indicate to the test conductor if the 
irritant smoke is detected. If smoke is detected, the test conductor 
shall stop the test. In this case, the tested respirator is rejected and 
another respirator shall be selected.
    10. Each test subject passing the smoke test (i.e. without detecting 
the smoke) shall be given a sensitivity check of smoke from the same 
tube to determine if the test subject reacts to the smoke. Failure to 
evoke a response shall void the fit test.
    11. Steps B4, B9, B10 of this fit test protocol shall be performed 
in a location with exhaust ventilation sufficient to prevent general 
contamination of the testing area by the test agents.
    12. At least two facepieces shall be selected by the irritant fume 
test protocol. The test subject shall be given the opportunity to wear 
them for one week to choose the one which is more comfortable to wear.
    13. Respirators successfully tested by the protocol may be used in 
contaminated atmospheres up to ten times the PEL of asbestos.

[[Page 746]]

    14. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface.
    15. If hair growth or apparel interfere with a satisfactory fit, 
then they shall be altered or removed so as to eliminate interference 
and allow a satisfactory fit. If a satisfactory fit is still not 
attained, the test subject must use a positive-pressure respirator such 
as powered air-purifying respirators, supplied air respirator, or self-
contained breathing apparatus.
    16. If a test subject exhibits difficulty in breathing during the 
tests, she or he shall be referred to a physician trained in respiratory 
diseases or pulmonary medicine to determine whether the test subject can 
wear a respirator while performing her or his duties.
    17. Qualitative fit testing shall be repeated at least every six 
months.
    18. In addition, because the sealing of the respirator may be 
affected, qualitative fit testing shall be repeated immediately when the 
test subject has a:
    (1) Weight change of 20 pounds or more,
    (2) Significant facial scarring in the area of the facepiece seal,
    (3) Significant dental changes; i.e., multiple extractions without 
prosthesis, or acquiring dentures,
    (4) Reconstructive or cosmetic surgery, or
    (5) Any other condition that may interfere with facepiece sealing.
    C. Recordkeeping. A summary of all test results shall be maintained 
in each office for 3 years. The summary shall include:
    (1) Name of test subject.
    (2) Date of testing.
    (3) Name of test conductor.
    (4) Respirators selected (indicate manufacturer, model, size and 
approval number).
    (5) Testing agent.

                    Quantitative Fit Test Procedures

                               1. General

    a. The method applies to the negative-pressure nonpowered air-
purifying respirators only.
    b. The employer shall assign one individual who shall assume the 
full responsibility for implementing the respirator quantitative fit 
test program.

                             2. Definitions

    a. ``Quantitative Fit Test'' means the measurement of the 
effectiveness of a respirator seal in excluding the ambient atmosphere. 
The test is performed by dividing the measured concentration of 
challenge agent in a test chamber by the measured concentration of the 
challenge agent inside the respirator facepiece when the normal air 
purifying element has been replaced by an essentially perfect purifying 
element.
    b. ``Challenge Agent'' means the air contaminant introduced into a 
test chamber so that its concentration inside and outside the respirator 
may be compared.
    c. ``Test Subject'' means the person wearing the respirator for 
quantitative fit testing.
    d. ``Normal Standing Position'' means standing erect and straight 
with arms down along the sides and looking straight ahead.
    e. ``Fit Factor'' means the ratio of challenge agent concentration 
outside with respect to the inside of a respirator inlet covering 
(facepiece or enclosure).

                              3. Apparatus

    a. Instrumentation. Corn oil, sodium chloride or other appropriate 
aerosol generation, dilution, and measurement systems shall be used for 
quantitative fit test.
    b. Test chamber. The test chamber shall be large enough to permit 
all test subjects to perform freely all required exercises without 
distributing the challenge agent concentration or the measurement 
apparatus. The test chamber shall be equipped and constructed so that 
the challenge agent is effectively isolated from the ambient air yet 
uniform in concentration throughout the chamber.
    c. When testing air-purifying respirators, the normal filter or 
cartridge element shall be replaced with a high-efficiency particulate 
filter supplied by the same manufacturer.
    d. The sampling instrument shall be selected so that a strip chart 
record may be made of the test showing the rise and fall of challenge 
agent concentration with each inspiration and expiration at fit factors 
of at least 2,000.
    e. The combination of substitute air-purifying elements (if any), 
challenge agent, and challenge agent concentration in the test chamber 
shall be such that the test subject is not exposed in excess of PEL to 
the challenge agent at any time during the testing process.
    f. The sampling port on the test specimen respirator shall be placed 
and constructed so that there is no detectable leak around the port, a 
free air flow is allowed into the sampling line at all times and so 
there is no interference with the fit or performance of the respirator.
    g. The test chamber and test set-up shall permit the person 
administering the test to observe one test subject inside the chamber 
during the test.
    h. The equipment generating the challenge atmosphere shall maintain 
the concentration of challenge agent constant within a 10 percent 
variation for the duration of the test.
    i. The time lag (interval between an event and its being recorded on 
the strip chart) of the instrumentation may not exceed 2 seconds.
    j. The tubing for the test chamber atmosphere and for the respirator 
sampling port

[[Page 747]]

shall be the same diameter, length and material. It shall be kept as 
short as possible. The smallest diameter tubing recommended by the 
manufacturer shall be used.
    k. The exhaust flow from the test chamber shall pass through a high-
efficiency filter before release to the room.
    l. When sodium chloride aerosol is used, the relative humidity 
inside the test chamber shall not exceed 50 percent.

                       4. Procedural Requirements

    a. The fitting of half-mask respirators should be started with those 
having multiple sizes and a variety of interchangeable cartridges and 
canisters such as the MSA Comfo II-M, North M, Survivair M, A-O M, or 
Scott-M. Use either of the tests outlined below to assure that the 
facepiece is properly adjusted.
    (1) Positive pressure test. With the exhaust port(s) blocked, the 
negative pressure of slight inhalation should remain constant for 
several seconds.
    (2) Negative pressure test. With the intake port(s) blocked, the 
negative pressure of slight inhalation should remain constant for 
several seconds.
    b. After a facepiece is adjusted, the test subject shall wear the 
facepiece for at least 5 minutes before conducting a qualitative test by 
using either of the methods described below and using the exercise 
regime described in 5.a., b., c., d. and e.
    (1) Isoamyl acetate test. When using organic vapor cartridges, the 
test subject who can smell the odor should be unable to detect the odor 
of isoamyl acetate squirted into the air near the most vulnerable 
portions of the facepiece seal. In a location which is separated from 
the test area, the test subject shall be instructed to close her/his 
eyes during the test period. A combination cartridge or canister with 
organic vapor and high-efficiency filters shall be used when available 
for the particular mask being tested. The test subject shall be given an 
opportunity to smell the odor of isoamyl acetate before the test is 
conducted.
    (2) Irritant fume test. When using high-efficiency filters, the test 
subject should be unable to detect the odor of irritant fume (stannic 
chloride or titanium tetrachloride ventilation smoke tubes) squirted 
into the air near the most vulnerable portions of the facepiece seal. 
The test subject shall be instructed to close her/his eyes during the 
test period.
    c. The test subject may enter the quantitative testing chamber only 
if she or he has obtained a satisfactory fit as stated in 4.b. of this 
Appendix.
    d. Before the subject enters the test chamber, a reasonably stable 
challenge agent concentration shall be measured in the test chamber.
    e. Immediately after the subject enters the test chamber, the 
challenge agent concentration inside the respirator shall be measured to 
ensure that the peak penetration does not exceed 5 percent for a half-
mask and 1 percent for a full facepiece.
    f. A stable challenge agent concentration shall be obtained prior to 
the actual start of testing.
    g. Respirator restraining straps may not be overtightened for 
testing. The straps shall be adjusted by the wearer to give a reasonably 
comfortable fit typical of normal use.

                           5. Exercise Regime

    Prior to entering the test chamber, the test subject shall be given 
complete instructions as to her/his part in the test procedures. The 
test subject shall perform the following exercises, in the order given, 
for each independent test.
    a. Normal Breathing (NB). In the normal standing position, without 
talking, the subject shall breathe normally for at least one minute.
    b. Deep Breathing (DB). In the normal standing position the subject 
shall do deep breathing for at least one minute pausing so as not to 
hyperventilate.
    c. Turning head side to side (SS). Standing in place the subject 
shall slowly turn his/her head from side between the extreme positions 
to each side. The head shall be held at each extreme position for at 
least 5 seconds. Perform for at least three complete cycles.
    d. Moving head up and down (UD). Standing in place, the subject 
shall slowly move his/her head up and down between the extreme position 
straight up and the extreme position straight down. The head shall be 
held at each extreme position for at least 5 seconds. Perform for at 
least three complete cycles.
    e. Reading (R). The subject (keeping eyes closed) shall repeat after 
the test conductor or the `rainbow passage' at the end of this section. 
The subject shall talk slowly aloud so as to be heard clearly by the 
test conductor or monitor.
    f. Grimace (G). The test subject shall grimace, smile, frown, and 
generally contort the face using the facial muscles. Continue for at 
least 15 seconds.
    g. Bend over and touch toes (B). The test subject shall bend at the 
waist and touch toes and return to upright position. Repeat for at least 
30 seconds.
    h. Jogging in place (J). The test subject shall jog in place for at 
least 30 seconds.
    i. Normal Breathing (NB). Same as exercise a.
    Rainbow Passage. When the sunlight strikes raindrops in the air, 
they act like a prism and form a rainbow. The rainbow is a division of 
white light into many beautiful colors. These take the shape of a long 
round arch, with its path high above, and its two ends apparently beyond 
the horizon. There

[[Page 748]]

is, according to legend, a boiling pot of gold at one end. People look, 
but no one ever finds it. When a man looks for something beyond reach, 
his friends say he is looking for the pot of gold at the end of the 
rainbow.

                         6. Termination of Test

    The test shall be terminated whenever any single peak penetration 
exceeds 5 percent for halfmasks and 1 percent for full facepieces. The 
test subject may be refitted and retested. If two of the three required 
tests are terminated, the fit shall be deemed inadequate.

                      7. Calculation of Fit Factors

    a. The fit factor determined by the quantitative fit test equals the 
average concentration inside the respirator.
    b. The average test chamber concentration is the arithmetic average 
of the test chamber concentration at the beginning and the end of the 
test.
    c. The average peak concentration of the challenge agent inside the 
respirator shall be the arithmetic average peak concentrations for each 
of the nine exercises of the test which are computed as the arithmetic 
average of the peak concentrations found for each breath during the 
exercise.
    d. The average peak concentration for an exercise may be determined 
graphically if there is not a great variation in the peak concentrations 
during a single exercise.

                    8. Interpretation of Test Results

    The fit factor measured by the quantitative fit testing shall be the 
lowest of the three protection factors resulting from three independent 
tests.

                          9. Other Requirements

    a. The test subject shall not be permitted to wear a halfmask or 
full facepiece mask if the minimum fit factor of 100 or 1,000, 
respectively, cannot be obtained. If hair growth or apparel interfere 
with a satisfactory fit, then they shall be altered or removed so as to 
eliminate interference and allow a satisfactory fit. If a satisfactory 
fit is still not attained, the test subject must use a positive-pressure 
respirator such as powered air-purifying respirators, supplied air 
respirator, or self-contained breathing apparatus.
    b. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface.
    c. If a test subject exhibits difficulty in breathing during the 
tests, she or he shall be referred to a physician trained in respirator 
diseases or pulmonary medicine to determine whether the test subject can 
wear a respirator while performing her or his duties.
    d. The test subject shall be given the opportunity to wear the 
assigned respirator for one week. If the respirator does not provide a 
satisfactory fit during actual use, the test subject may request another 
QNFT which shall be performed immediately.
    e. A respirator fit factor card shall be issued to the test subject 
with the following information:
    (1) Name.
    (2) Date of fit test.
    (3) Protection factors obtained through each manufacturer, model and 
approval number of respirator tested.
    (4) Name and signature of the person that conducted the test.
    f. Filters used for qualitative or quantitative fit testing shall be 
replaced weekly, whenever increased breathing resistance is encountered, 
or when the test agent has altered the integrity of the filter media. 
Organic vapor cartridges/canisters shall be replaced daily or sooner if 
there is any indication of breakthrough by the test agent.

                              10. Retesting

    In addition, because the sealing of the respirator may be affected, 
quantitative fit testing shall be repeated immediately when the test 
subject has a:
    a. Weight change of 20 pounds or more,
    b. Significant facial scarring in the area of the facepiece seal,
    c. Significant dental changes; i.e., multiple extractions without 
prosthesis, or acquiring dentures,
    d. Reconstructive or cosmetic surgery, or
    e. Any other condition that may interfere with facepiece sealing.

                            11. Recordkeeping

    A summary of all test results shall be maintained for 3 years. The 
summary shall include:
    a. Name of test subject.
    b. Date of testing.
    c. Name of the test conductor.
    d. Fit factors obtained from every respirator tested (indicate 
manufacturer, model, size and approval number).

      Appendix D to Sec. 763.121--Medical Questionnaires--Mandatory

    This mandatory appendix contains the medical questionnaires that 
must be administered to all employees who are exposed to asbestos above 
the action level, and who will therefore be included in their employer's 
medical surveillance program. Part 1 of the appendix contains the 
Initial Medical Questionnaire, which must be obtained for all new hires 
who will be covered by the medical surveillance requirements. Part 2 
includes the abbreviated Periodical Medical Questionnaire, which must be 
administered to all employees who are provided periodic medical 
examinations under the medical surveillance provisions of the standard.

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 Appendix E to Sec. 763.121--Interpretation and Classification of Chest 
                        Roentgenograms--Mandatory

    (a) Chest roentgenograms shall be interpreted and classified in 
accordance with a professionally accepted classification system and 
recorded on an interpretation form following the format of the CDC/NIOSH 
(M) 2.8 form. As a minimum, the content within the boldlines of this 
form (items 1 through 4) shall be included. This form is not to be 
submitted to NIOSH.
    (b) Roentgenograms shall be interpreted and classified only by a B-
reader, a board eligible/certified radiologist, or an experienced 
physician with known expertise in pneumoconioses.
    (c) All interpreters, whenever interpreting chest roentgenograms 
made under this section, shall have immediately available for reference 
a complete set of the ILO-U/C International Classification of 
Radiographs for Pneumoconioses, 1980.

[52 FR 5623, Feb. 25, 1987; 52 FR 10817, Mar. 30, 1987; 53 FR 1022, Jan. 
15, 1988]



Sec. 763.122  Exclusions for States.

    (a) The States of Idaho, Kansas, Oklahoma, and Wisconsin have 6 
months or such other reasonable time as suggested by the particular 
State and approved by the Director of the Office of Pollution Prevention 
and Toxics to make their regulations comparable to or more stringent 
than this part, and to submit their regulations to EPA's Office of 
Pollution Prevention and Toxics for review. If in such reasonable time 
after March 27, 1987, any of these States have not so revised their 
regulations and submitted them to EPA, State and local government 
employees in such States shall be covered by the requirements of this 
part.
    (b) Any other State that wishes to be excluded from this rule shall 
send a copy of a regulation which it considers to be comparable to or 
more stringent than this part to EPA's Office of Pollution Prevention 
and Toxics for review. EPA will review the regulation and

[[Page 761]]

tentatively determine whether the regulation is comparable to or more 
stringent than this part. If EPA makes a positive tentative 
determination, EPA will propose an amendment to this rule excluding that 
State from coverage. Interested persons may comment on the proposed 
exclusion during the period for public comment. After considering any 
comments, EPA may promulgate the final amendment to the rule.



Sec. 763.124  Reporting.

    (a) Employers subject to this rule must report to the Regional 
Asbestos Coordinator for the EPA Region in which the asbestos abatement 
project is located at least 10 days before they begin any asbestos 
abatement project, except one that involves less than either 3 linear 
feet or 3 square feet of friable asbestos material, and an emergency 
project. Employers must report any emergency project covered by this 
rule as soon as possible but in no case more than 48 hours after the 
project begins. A list of the EPA Regional Offices is given under 
Sec. 1.7(b) of this chapter.
    (b) The report must include:
    (1) The employer's name and address.
    (2) The location, including street address, of the asbestos 
abatement project.
    (3) The scheduled starting and completion dates for the asbestos 
abatement project.
    (c) If a report is mailed to EPA, the report must be postmarked at 
least 10 days before the asbestos abatement project begins unless the 
report is for an emergency project. In such a case, the report must be 
postmarked as soon as possible but in no case more than 48 hours after 
the project begins.
    (d) Employers do not have to report under this section if they 
submit a notice to EPA under the National Emission Standard for 
Asbestos, Sec. 61.146 of this chapter, at least 10 days before they 
begin the asbestos abatement project and that notice clearly indicates 
that employees covered by this rule will perform some or all of the 
asbestos abatement work.

[47 FR 23369, May 27, 1982, as amended at 58 FR 34205, June 23, 1993]



Sec. 763.125  Enforcement.

    (a) Failure to comply with any provision of this part is a violation 
of section 15 of the Act (15 U.S.C. 2614).
    (b) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (c) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (d) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (e) EPA may seek to enjoin an asbestos abatement project in 
violation of this part, or take other actions under the authority of 
section 7 or 17 of the Act (15 U.S.C. 2606 or 2616).



Sec. 763.126  Inspections.

    EPA will conduct inspections under section 11 of the Act (15 U.S.C. 
2610) to ensure compliance with this part.

Subpart H [Reserved]



Subpart I--Prohibition of the Manufacture, Importation, Processing, and 
   Distribution in Commerce of Certain Asbestos-Containing Products; 
                          Labeling Requirements

    Source: 54 FR 29507, July 12, 1989, unless otherwise noted.



Sec. 763.160  Scope.

    This subpart prohibits the manufacture, importation, processing, and 
distribution in commerce of the asbestos-containing products identified 
and at the dates indicated in Secs. 763.165, 763.167, and 763.169. This 
subpart requires that products subject to this rule's bans, but not yet 
subject to a ban on distribution in commerce, be labeled. This subpart 
also includes general exemptions and procedures for requesting 
exemptions from the provisions of this subpart.



Sec. 763.163  Definitions.

    For purposes of this subpart:

[[Page 762]]

    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    Agency means the United States Environmental Protection Agency.
    Asbestos means the asbestiform varieties of: chrysotile 
(serpentine); crocidolite (riebeckite); amosite (cummingtonite-
grunerite); tremolite; anthophyllite; and actinolite.
    Asbestos-containing product means any product to which asbestos is 
deliberately added in any concentration or which contains more than 1.0 
percent asbestos by weight or area.
    Chemical substance, has the same meaning as in section 3 of the Act.
    Commerce has the same meaning as in section 3 of the Act.
    Commercial paper means an asbestos-containing product which is made 
of paper intended for use as general insulation paper or muffler paper. 
Major applications of commercial papers are insulation against fire, 
heat transfer, and corrosion in circumstances that require a thin, but 
durable, barrier.
    Corrugated paper means an asbestos-containing product made of 
corrugated paper, which is often cemented to a flat backing, may be 
laminated with foils or other materials, and has a corrugated surface. 
Major applications of asbestos corrugated paper include: thermal 
insulation for pipe coverings; block insulation; panel insulation in 
elevators; insulation in appliances; and insulation in low-pressure 
steam, hot water, and process lines.
    Customs territory of the United States means the 50 States, Puerto 
Rico, and the District of Columbia.
    Distribute in commerce has the same meaning as in section 3 of the 
Act, but the term does not include actions taken with respect to an 
asbestos-containing product (to sell, resale, deliver, or hold) in 
connection with the end use of the product by persons who are users 
(persons who use the product for its intended purpose after it is 
manufactured or processed). The term also does not include distribution 
by manufacturers, importers, and processors, and other persons solely 
for purposes of disposal of an asbestos-containing product.
    Flooring felt means an asbestos-containing product which is made of 
paper felt intended for use as an underlayer for floor coverings, or to 
be bonded to the underside of vinyl sheet flooring.
    Import means to bring into the customs territory of the United 
States, except for: (1) Shipment through the customs territory of the 
United States for export without any use, processing, or disposal within 
the customs territory of the United States; or (2) entering the customs 
territory of the United States as a component of a product during normal 
personal or business activities involving use of the product.
    Importer means anyone who imports a chemical substance, including a 
chemical substance as part of a mixture or article, into the customs 
territory of the United States. Importer includes the person primarily 
liable for the payment of any duties on the merchandise or an authorized 
agent acting on his or her behalf. The term includes as appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20.
    (4) The transferee, if the right to withdraw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144.
    Manufacture means to produce or manufacture in the United States.
    Manufacturer means a person who produces or manufactures in the 
United States.
    New uses of asbestos means commercial uses of asbestos not 
identified in Sec. 763.165 the manufacture, importation or processing of 
which would be initiated for the first time after August 25, 1989.
    Person means any natural person, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof, or any 
municipality; any interstate body and any department, agency, or 
instrumentality of the Federal Government.
    Process has the same meaning as in section 3 of the Act.
    Processor has the same meaning as in section 3 of the Act.

[[Page 763]]

    Rollboard means an asbestos-containing product made of paper that is 
produced in a continuous sheet, is flexible, and is rolled to achieve a 
desired thickness. Asbestos rollboard consists of two sheets of asbestos 
paper laminated together. Major applications of this product include: 
office partitioning; garage paneling; linings for stoves and electric 
switch boxes; and fire-proofing agent for security boxes, safes, and 
files.
    Specialty paper means an asbestos-containing product that is made of 
paper intended for use as filters for beverages or other fluids or as 
paper fill for cooling towers. Cooling tower fill consists of asbestos 
paper that is used as a cooling agent for liquids from industrial 
processes and air conditioning systems.
    State has the same meaning as in section 3 of the Act.
    Stock-on-hand means the products which are in the possession, 
direction, or control of a person and are intended for distribution in 
commerce.
    United States has the same meaning as in section 3 of the Act.

[59 FR 33208, June 28, 1994]



Sec. 763.165  Manufacture and importation prohibitions.

    (a) After August 27, 1990, no person shall manufacture or import the 
following asbestos-containing products, either for use in the United 
States or for export: flooring felt and new uses of asbestos.
    (b) After August 26, 1996, no person shall manufacture or import the 
following asbestos-containing products, either for use in the United 
States or for export: commercial paper, corrugated paper, rollboard, and 
specialty paper.
    (c) The import prohibitions of this subpart do not prohibit:
    (1) The import into the customs territory of the United States of 
products imported solely for shipment outside the customs territory of 
the United States, unless further repackaging or processing of the 
product is performed in the United States; or
    (2) Activities involving purchases or acquisitions of small 
quantities of products made outside the customs territory of the United 
States for personal use in the United States.

[59 FR 33209, June 28, 1994]



Sec. 763.167  Processing prohibitions.

    (a) After August 27, 1990, no person shall process for any use, 
either in the United States or for export, any of the asbestos-
containing products listed at Sec. 763.165(a).
    (b) After August 26, 1996, no person shall process for any use, 
either in the United States or for export, any of the asbestos-
containing products listed at Sec. 763.165(b).

[59 FR 33209, June 28, 1994]



Sec. 763.169  Distribution in commerce prohibitions.

    (a) After August 25, 1992, no person shall distribute in commerce, 
either for use in the United States or for export, any of the asbestos-
containing products listed at Sec. 763.165(a).
    (b) After August 25, 1997, no person shall distribute in commerce, 
either for use in the United States or for export, any of the asbestos-
containing products listed at Sec. 763.165(b).
    (c) A manufacturer, importer, processor, or any other person who is 
subject to a ban on distribution in commerce in paragraph (a) or (b) of 
this section must, within 6 months of the effective date of the ban of a 
specific asbestos-containing product from distribution in commerce, 
dispose of all their remaining stock-on-hand of that product, by means 
that are in compliance with applicable local, State, and Federal 
restrictions which are current at that time.

[59 FR 33209, June 28, 1994]



Sec. 763.171  Labeling requirements.

    (a) After August 27, 1990, manufacturers, importers, and processors 
of all asbestos-containing products that are identified in 
Sec. 763.165(a) shall label the products as specified in this subpart at 
the time of manufacture, import, or processing. This requirement 
includes labeling all manufacturers', importers', and processors' stock-
on-hand as of August 27, 1990.
    (b) After August 25, 1995, manufacturers, importers, and processors 
of all asbestos-containing products that are

[[Page 764]]

identified in Sec. 763.165(b), shall label the products as specified in 
this subpart at the time of manufacture, import, or processing. This 
requirement includes labeling all manufacturers', importers', and 
processors' stock-on-hand as of August 25, 1995.
    (c) The label shall be placed directly on the visible exterior of 
the wrappings and packaging in which the product is placed for sale, 
shipment, or storage. If the product has more than one layer of external 
wrapping or packaging, the label must be attached to the innermost layer 
adjacent to the product. If the innermost layer of product wrapping or 
packaging does not have a visible exterior surface larger than 5 square 
inches, either a tag meeting the requirements of paragraph (d) of this 
section must be securely attached to the product's innermost layer of 
product wrapping or packaging, or a label must be attached to the next 
outer layer of product packaging or wrapping. Any products that are 
distributed in commerce to someone other than the end user, shipped, or 
stored without packaging or wrapping must be labeled or tagged directly 
on a visible exterior surface of the product as described in paragraph 
(d) of this section.
    (d)(1) Labels must be either printed directly on product packaging 
or in the form of a sticker or tag made of plastic, paper, metal, or 
other durable substances. Labels must be attached in such a manner that 
they cannot be removed without defacing or destroying them. Product 
labels shall appear as in paragraph (d)(2) of this section and consist 
of block letters and numerals of color that contrasts with the 
background of the label or tag. Labels shall be sufficiently durable to 
equal or exceed the life, including storage and disposal, of the product 
packaging or wrapping. The size of the label or tag must be at least 
15.25 cm (6 inches) on each side. If the product packaging is too small 
to accommodate a label of this size, the label may be reduced in size 
proportionately to the size of the product packaging or wrapping down to 
a minimum 2.5 cm (1 inch) on each side if the product wrapping or 
packaging has a visible exterior surface larger than 5 square inches.
    (2) Products subject to this subpart shall be labeled in English as 
follows:

                                 NOTICE

    This product contains ASBESTOS. The U.S. Environmental Protection 
Agency has banned the distribution in U.S. commerce of this product 
under section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) as 
of (insert effective date of ban on distribution in commerce). 
Distribution of this product in commerce after this date and 
intentionally removing or tampering with this label are violations of 
Federal law.
    (e) No one may intentionally remove, deface, cover, or otherwise 
obscure or tamper with a label or sticker that has been applied in 
compliance with this section, except when the product is used or 
disposed of.

[59 FR 33209, June 28, 1994]



Sec. 763.173  Exemptions.

    (a) Persons who are subject to the prohibitions imposed by 
Secs. 763.165, 763.167, or 763.169 may file an application for an 
exemption. Persons whose exemption applications are approved by the 
Agency may manufacture, import, process, or distribute in commerce the 
banned product as specified in the Agency's approval of the application. 
No applicant for an exemption may continue the banned activity that is 
the subject of an exemption application after the effective date of the 
ban unless the Agency has granted the exemption or the applicant 
receives an extension under paragraph (b)(4) or (5) of this section.
    (b) Application filing dates. (1) Applications for products affected 
by the prohibitions under Secs. 763.165(a) and 763.167(a) may be 
submitted at any time and will be either granted or denied by EPA as 
soon as is feasible.
    (2) Applications for products affected by the ban under 
Sec. 763.169(a) may be submitted at any time and will be either granted 
or denied by EPA as soon as is feasible.
    (3) Applications for products affected by the ban under 
Secs. 763.165(b) and 763.167(b) may not be submitted prior to February 
27, 1995. Complete applications received after that date, but before 
August 25, 1995, will be either granted or denied by the Agency prior to 
the effective date of the ban for the

[[Page 765]]

product. Applications received after August 25, 1995, will be either 
granted or denied by EPA as soon as is feasible.
    (4) Applications for products affected by the ban under 
Sec. 763.169(b) may not be submitted prior to February 26, 1996. 
Complete applications received after that date, but before August 26, 
1996, will be either granted or denied by the Agency prior to the 
effective date of the ban for the product. Applications received after 
August 26, 1996, will be either granted or denied by EPA as soon as is 
feasible.
    (5) The Agency will consider an application for an exemption from a 
ban under Sec. 763.169 for a product at the same time the applicant 
submits an application for an exemption from a ban under Sec. 763.165 or 
Sec. 763.167 for that product. EPA will grant an exemption at that time 
from a ban under Sec. 763.169 if the Agency determines it appropriate to 
do so.
    (6) If the Agency denies an application less than 30 days before the 
effective date of a ban for a product, the applicant can continue the 
activity for 30 days after receipt of the denial from the Agency.
    (7) If the Agency fails to meet the deadlines stated in paragraphs 
(b)(3) and (b)(4) of this section for granting or denying a complete 
application in instances in which the deadline is before the effective 
date of the ban to which the application applies, the applicant will be 
granted an extension of 1 year from the Agency's deadline date. During 
this extension period the applicant may continue the activity that is 
the subject of the exemption application. The Agency will either grant 
or deny the application during the extension period. The extension 
period will terminate either on the date the Agency grants the 
application or 30 days after the applicant receives the Agency's denial 
of the application. However, no extension will be granted if the Agency 
is scheduled to grant or deny an application at some date after the 
effective date of the ban, pursuant to the deadlines stated in 
paragraphs (b)(3) and (b)(4) of this section.
    (c) Where to file. All applications must be submitted to the 
following location: TSCA Docket Receipts Office (7407), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Rm E-G99, 401 M St., SW., Washington, DC 20460, ATTENTION: Asbestos 
Exemption. For information regarding the submission of exemptions 
containing information claimed as confidential business information 
(CBI), see Sec. 763.179.
    (d) Content of application and criteria for decisionmaking.
    (1) Content of application. Each application must contain the 
following:
    (i) Name, address, and telephone number of the applicant.
    (ii) Description of the manufacturing, import, processing, and/or 
distribution in commerce activity for which an exemption is requested, 
including a description of the asbestos-containing product to be 
manufactured, imported, processed, or distributed in commerce.
    (iii) Identification of locations at which the exempted activity 
would take place.
    (iv) Length of time requested for exemption (maximum length of an 
exemption is 4 years).
    (v) Estimated amount of asbestos to be used in the activity that is 
the subject of the exemption application.
    (vi) Data demonstrating the exposure level over the life cycle of 
the product that is the subject of the application.
    (vii) Data concerning:
    (A) The extent to which non-asbestos substitutes for the product 
that is the subject of the application fall significantly short in 
performance under necessary product standards or requirements, including 
laws or ordinances mandating product safety standards.
    (B) The costs of non-asbestos substitutes relative to the costs of 
the asbestos-containing product and, in the case in which the product is 
a component of another product, the effect on the cost of the end use 
product of using the substitute component.
    (C) The extent to which the product or use serves a high-valued use.
    (viii) Evidence of demonstrable good faith attempts by the applicant 
to develop and use a non-asbestos substance or product which may be 
substituted for the asbestos-containing product or the asbestos in the 
product or use that is the subject to the application.
    (ix) Evidence, in addition to that provided in the other information 
required

[[Page 766]]

with the application, showing that the continued manufacture, 
importation, processing, distribution in commerce, and use, as 
applicable, of the product will not present an unreasonable risk of 
injury to human health.
    (2) Criteria for decision (existing products). After considering all 
the information provided by an applicant under paragraphs (d)(1) and (e) 
of this section, and any other information available to EPA, EPA will 
grant an exemption from the prohibitions in Secs. 763.165, 763.167, or 
763.169 for an applicant's asbestos-containing product only if EPA 
determines both of the following:
    (i) The applicant has made good faith attempts to develop and use a 
non-asbestos substance or product which may be substituted for the 
asbestos-containing product or the asbestos in the product or use, and 
those attempts have failed to produce a substitute or a substitute that 
results in a product that can be economically produced.
    (ii) Continued manufacturing, processing, distribution in commerce, 
and use, as applicable, of the product will not present an unreasonable 
risk of injury to human health.
    (3) Criteria for decision (new products). Requests to develop and 
use an asbestos substance or product will be treated as a petition 
pursuant to section 21 of TSCA.
    (e) The Agency reserves the right to request further information 
from an exemption applicant if necessary to complete the Agency's 
evaluation of an application.
    (f) Upon receipt of a complete application, the Agency will issue a 
notice in the Federal Register announcing its receipt and invite public 
comments on the merits of the application.
    (g) If the application does not include all of the information 
required in paragraph (d) of this section, the Agency will return it to 
the applicant as incomplete and any resubmission of the application will 
be considered a new application for purposes of the availability of any 
extension period. If the application is substantially inadequate to 
allow the Agency to make a reasoned judgment on any of the information 
required in paragraph (d) of this section and the Agency chooses to 
request additional information from the applicant, the Agency may also 
determine that an extension period provided for in paragraph (b)(5) of 
this section is unavailable to the applicant.
    (h) When denying an application, the Agency will notify the 
applicant by registered mail of its decision and rationale. Whenever 
possible, the Agency will send this letter prior to the appropriate ban. 
This letter will be considered a final Agency action for purposes of 
judicial review. A notice announcing the Agency's denial of the 
application will be published in the Federal Register.
    (i) If the Agency proposes to approve an exemption, it will issue a 
notice in the Federal Register announcing this intent and invite public 
comments. If, after considering any timely comments received, the Agency 
approves an exemption, its decision will be published in the Federal 
Register. This notice will be considered a final Agency action for 
purposes of judicial review.
    (j) The length of an exemption period will be specified by the 
agency when it approves the exemption. To extend an exemption period 
beyond the period stipulated by EPA, applicants must submit a new 
application to the Agency, following the application procedures 
described in this section. Applications may not be submitted prior to 15 
months before the expiration of the exemption period, unless stated 
otherwise in the notice granting the exemption. Applications received 
between 15 months and 1 year before the end of the exemption period will 
be either granted or denied by the Agency before the end of the 
exemption period. Applications received after the date 1 year prior to 
the end of the exemption period will be either granted or denied by the 
Agency as soon as is feasible. Applicants may not continue the activity 
that is the subject of the renewal application after the date of the end 
of the exemption period.

[54 FR 29507, July 12, 1989; 54 FR 37531, Sept. 11, 1989, as amended at 
54 FR 46898, Nov. 8, 1989; 59 FR 33210, June 28, 1994]



Sec. 763.175  Enforcement.

    (a) Failure to comply with any provision of this subpart is a 
violation of section 15 of the Act (15 U.S.C. 2614).

[[Page 767]]

    (b) Failure or refusal to establish and maintain records, or to 
permit access to or copying of records as required by section 11 of the 
Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 
2614).
    (c) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (d) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (e) The Agency may seek to enjoin the manufacture, import, 
processing, or distribution in commerce of asbestos-containing products 
in violation of this subpart, or act to seize any asbestos-containing 
products manufactured, imported, processed, or distributed in commerce 
in violation of this subpart, or take any other actions under the 
authority of section 7 or 17 of the Act (15 U.S.C. 2606 or 2616) that 
are appropriate.



Sec. 763.176  Inspections.

    The Agency will conduct inspections under section 11 of the Act (15 
U.S.C. 2610) to ensure compliance with this subpart.



Sec. 763.178  Recordkeeping.

    (a) Inventory. (1) Each person who is subject to the prohibitions 
imposed by Secs. 763.165 and 763.167 must perform an inventory of the 
stock-on-hand of each banned product as of the effective date of the ban 
for that product for the applicable activity.
    (2) The inventory shall be in writing and shall include the type of 
product, the number of product units currently in the stock-on-hand of 
the person performing the inventory, and the location of the stock.
    (3) Results of the inventory for a banned product must be maintained 
by the person for 3 years after the effective date of the Sec. 763.165 
or Sec. 763.167 ban on the product.
    (b) Records. (1) Each person whose activities are subject to the 
bans imposed by Secs. 763.165, 763.167, and 763.169 for a product must, 
between the effective date of the Sec. 763.165 or Sec. 763.167 ban on 
the product and the Sec. 763.169 ban on the product, keep records of all 
commercial transactions regarding the product, including the dates of 
purchases and sales and the quantities purchased or sold. These records 
must be maintained for 3 years after the effective date of the 
Sec. 763.169 ban for the product.
    (2) Each person who is subject to the requirements of Sec. 763.171 
must, for each product required to be labeled, maintain a copy of the 
label used in compliance with Sec. 763.171. These records must be 
maintained for 3 years after the effective date of the ban on 
distribution in commerce for the product for which the Sec. 763.171 
requirements apply.

[54 FR 29507, July 12, 1989, as amended by 54 FR 46898, Nov. 8, 1989; 58 
FR 34205, June 23, 1993]



Sec. 763.179  Confidential business information claims.

    (a) Applicants for exemptions under Sec. 763.173 may assert a 
Confidential Business Information (CBI) claim for information in an 
exemption application or supplement submitted to the Agency under this 
subpart only if the claim is asserted in accordance with this section, 
and release of the information would reveal trade secrets or 
confidential commercial or financial information, as provided in section 
14(a) of the Act. Information covered by a CBI claim will be treated in 
accordance with the procedures set forth in 40 CFR part 2, subpart B. 
The Agency will place all information not claimed as CBI in the manner 
described in this section in a public file without further notice to the 
applicant.
    (b) Applicants may assert CBI claims only at the time they submit a 
completed exemption application and only in the specified manner. If no 
such claim accompanies the information when it is received by the 
Agency, the information may be made available to the public without 
further notice to the applicant. Submitters that claim information as 
business confidential must do so by writing the word ``Confidential'' at 
the top of the page on which the information appears and by underlining, 
circling, or placing brackets ([ ]) around the information claimed CBI.
    (c) Applicants who assert a CBI claim for submitted information must 
provide the Agency with two copies of

[[Page 768]]

their exemption application. The first copy must be complete and contain 
all information being claimed as CBI. The second copy must contain only 
information not claimed as CBI. The Agency will place the second copy of 
the submission in a public file. Failure to furnish a second copy of the 
submission when information is claimed as CBI in the first copy will be 
considered a presumptive waiver of the claim of confidentiality. The 
Agency will notify the applicant by certified mail that a finding of a 
presumptive waiver of the claim of confidentiality has been made. The 
applicant has 30 days from the date of receipt of notification to submit 
the required second copy. Failure to submit the second copy will cause 
the Agency to place the first copy in a public file.
    (d) Applicants must substantiate all claims of CBI at the time the 
applicant asserts the claim, i.e., when the exemption application or 
supplement is submitted, by responding to the questions in paragraph (e) 
of this section. Failure to provide substantiation of a claim at the 
time the applicant submits the application will result in a waiver of 
the CBI claim, and the information may be disclosed to the public 
without further notice to the applicant.
    (e) Applicants who assert any CBI claims must substantiate all 
claims by providing detailed responses to the following:
    (1) Is this information subject to a patent or patent application in 
the United States or elsewhere? If so, why is confidentiality necessary?
    (2) For what period do you assert a claim of confidentiality? If the 
claim is to extend until a certain event or point in time, please 
indicate that event or time period. Explain why such information should 
remain confidential until such point.
    (3) Has the information that you are claiming as confidential been 
disclosed to persons outside of your company? Will it be disclosed to 
such persons in the future? If so, what restrictions, if any, apply to 
use or further disclosure of the information?
    (4) Briefly describe measures taken by your company to guard against 
undesired disclosure of the information you are claiming as confidential 
to others.
    (5) Does the information claimed as confidential appear or is it 
referred to in advertising or promotional materials for the product or 
the resulting end product, safety data sheets or other similar materials 
for the product or the resulting end product, professional or trade 
publications, or any other media available to the public or to your 
competitors? If you answered yes, indicate where the information 
appears.
    (6) If the Agency disclosed the information you are claiming as 
confidential to the public, how difficult would it be for the competitor 
to enter the market for your product? Consider in your answer such 
constraints as capital and marketing cost, specialized technical 
expertise, or unusual processes.
    (7) Has the Agency, another Federal agency, or a Federal court made 
any confidentiality determination regarding this information? If so, 
provide copies of such determinations.
    (8) How would your company's competitive position be harmed if the 
Agency disclosed this information? Why should such harm be considered 
substantial? Describe the causal relationship between the disclosure and 
harm.
    (9) In light of section 14(b) of TSCA, if you have claimed 
information from a health and safety study as confidential, do you 
assert that disclosure of this information would disclose a process used 
in the manufacturing or processing of a product or information unrelated 
to the effects of asbestos on human health and the environment? If your 
answer is yes, explain.



PART 766--DIBENZO-PARA-DIOXINS/DIBENZOFURANS--Table of Contents




                      Subpart A--General Provisions

Sec.
766.1  Scope and purpose.
766.2  Applicability and duration of this part.
766.3  Definitions.
766.5  Compliance.
766.7  Submission of information.
766.10  Test standards.
766.12  Testing guidelines.

[[Page 769]]

766.14  Contents of protocols.
766.16  Developing the analytical test method.
766.18  Method sensitivity.

       Subpart B--Specific Chemical Testing/Reporting Requirements

766.20  Who must test.
766.25  Chemical substances for testing.
766.27  Congeners and LOQs for which quantitation is required.
766 28  Expert review of protocols.
766.32  Exclusions and waivers.
766.35  Reporting requirements.
766.38  Reporting on precursor chemical substances.

    Authority: 15 U.S.C. 2603 and 2607.

    Source: 52 FR 21437, June 5, 1987, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 766.1  Scope and purpose.

    (a) This part identifies requirements for testing under section 4 of 
the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603, to ascertain 
whether certain specified chemical substances may be contaminated with 
halogenated dibenzodioxins (HDDs)/dibenzofurans (HDFs) as defined in 
Sec. 766.3, and requirements for reporting under section 8 of TSCA, 15 
U.S.C. 2607.
    (b) Section 766.35(b) requires manufacturers and processors of 
chemical substances identified in Sec. 766.25 to submit to EPA:
    (1) Any existing test data showing analysis of the chemical 
substances for concentrations of HDDs/HDFs, applicable protocols, and 
the results of the analysis for HDDs/HDFs, (2) allegations of 
significant adverse reactions to HDDs/HDFs, compiled in accordance with 
part 717 of this chapter, and (3) health and safety studies on the HDDs/
HDFs, in accordance with applicable provisions of part 716 of this 
chapter.
    (c) Section 766.35(a) requires manufacturers and, under certain 
circumstances, processors of chemical substances identified in 
Sec. 766.25 to submit letters of intent to test and protocols for the 
analysis of the chemical substances for the presence of HDDs/HDFs. 
Section 766.20 requires these manufacturers and processors to test their 
chemical substances for the presence of HDDs/HDFs. Any submissions must 
be in accordance with the EPA Procedures Governing Testing Consent 
Agreements and Test Rules contained in part 790 of this chapter and any 
modifications to such procedures contained in this part.
    (d) Section 766.32 specifies conditions under which persons required 
to test may request an exclusion or waiver from testing.
    (e) Deadlines for submission to EPA of protocols, reports, studies, 
and test results are specified in part 790, subpart C and Sec. 766.35.
    (f) Sections 766.10, 766.12, 766.14, 766.16, and 766.18 prescribe 
analytical methods required; Sec. 766.27 prescribes target levels of 
quantitation (LOQ) for each congener for which quantitation is required.
    (g) If results of existing tests or tests performed under this part 
indicate the presence of HDDs/HDFs in the identified chemical substance 
above the LOQ specified in Sec. 766.27, Sec. 766.35(c) requires the 
following additional reporting on the specified chemicals: production, 
process, use, exposure and disposal data under section 8(a) of TSCA; 
health and safety studies under section 8(d) of TSCA; and reports of 
allegations of significant adverse reactions under section 8(c) of TSCA. 
In some cases, additional reporting may be required of manufacturers 
reporting no contamination of the identified chemical substances under 
Sec. 766.35(c)(2).
    (h) Section 766.38 requires manufacturers of chemical substances 
produced from chemical substances identified as possible precursors to 
HDD/HDF formation, to report on chemical substances produced from such 
precursors.



Sec. 766.2  Applicability and duration of this part.

    (a) Chemical substances subject to testing. (1) This part is 
applicable to each person who, at any time during the duration of this 
part, manufactures (and/or imports), or processes, a chemical substance 
identified under Sec. 766.25.
    (2) The duration of this part for any testing requirement for any 
chemical substance is the period commencing with the effective date of 
this part to the end of the reimbursement period, as defined in 
Sec. 766.3, for each chemical substance. All reporting requirements

[[Page 770]]

for any chemical substance listed under Sec. 766.25 shall be in effect 
for the same period as the testing requirement.
    (b) Precursor chemical substances. (1) This part is applicable to 
each person who manufactures (and/or imports) a chemical substance from 
any precursor chemical substance identified in Sec. 766.38.
    (2) The requirement for precursor reporting under Sec. 766.38 shall 
be in effect until three years after the effective date of this part.
    (3) Small manufacturers are exempt from reporting process and 
reaction condition data on chemical substances made from precursor 
chemical substances listed under Sec. 766.38.



Sec. 766.3  Definitions.

    The definitions in section 3 of TSCA and the definitions of 
Secs. 704.3, 716.3, 717.3, and 790.3 of this chapter also apply to this 
part.
    Congener means any one particular member of a class of chemical 
substances. A specific congener is denoted by unique chemical structure, 
for example 2,3,7,8-tetrachlorodibenzofuran.
    Dibenzofuran means any of a family of compounds which has as a 
nucleus a triple-ring structure consisting of two benzene rings 
connected through a pair of bridges between the benzene rings. The 
bridges are a carbon-carbon bridge and a carbon-oxygen-carbon bridge at 
both substitution positions.
    Dibenzo-p-dioxin or dioxin means any of a family of compounds which 
has as a nucleus a triple-ring structure consisting of two benzene rings 
connected through a pair of oxygen atoms.
    Guidelines means the Midwest Research Institute (MRI) publication 
Guidelines for the Determination of Polyhalogenated Dioxins and 
Dibenzofurans in Commercial Products, EPA contract No. 68-02-3938; MRI 
Project No. 8201-A(41), 1985.
    HDD or 2,3,7,8-HDD means any of the dibenzo-p-dioxins totally 
chlorinated or totally brominated at the following positions on the 
molecular structure: 2,3,7,8; 1,2,3,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8; 
1,2,3,7,8,9; and 1,2,3,4,7,8,9.
    HDF or 2,3,7,8-HDF means any of the dibenzofurans totally 
chlorinated or totally brominated at the following positions on the 
molecular structure: 2,3,7,8; 1,2,3,7,8; 2,3,4,7,8; 1,2,3,4,7,8; 
1,2,3,6,7,8; 1,2,3,7,8,9; 2,3,4,6,7,8; 1,2,3,4,6,7,8; and 1,2,3,4,7,8,9.
    Homolog means a group of isomers that have the same degree of 
halogenation. For example, the homologous class of tetrachlorodibenzo-p-
dioxins consists of all dibenzo-p-dioxins containing four chlorine 
atoms. When the homologous classes discussed in this part are referred 
to, the following abbreviations for the prefix denoting the number of 
halogens are used:
    tetra-, T (4 atoms)
    penta-, Pe (5 atoms)
    hexa-, Hx (6 atoms)
    hepta-, Hp (7 atoms)

    HRGC means high resolution gas chromatography.
    HRMS means high resolution mass spectrometry.
    Level of quantitation or LOQ means the lowest concentration at which 
HDDs/HDFs can be reproducibly measured in a specific chemical substance 
within specified confidence limits, as described in this part.
    Polybrominated dibenzofurans refers to any member of a class of 
dibenzofurans with two to eight bromine substituents.
    Polybrominated dibenzo-p-dioxin or PBDD means to any member of a 
class of dibenzo-p-dioxins with two to eight bromine substituents.
    Polychlorinated dibenzofuran means any member of a class of 
dibenzofurans with two to eight chlorine substituents.
    Polychlorinated dibenzo-p-dioxin or PCDD means any member of a class 
of dibenzo-p-dioxins with two to eight chlorine substituents.
    Polyhalogenated dibenzofuran or PHDF means any member of a class of 
dibenzofurans containing two to eight chlorine, bromine, or a 
combination of chlorine and bromine substituents.
    Polyhalogenated dibenzo-p-dioxin or PHDD means any member of a class 
of dibenzo-p-dioxins containing two to eight chlorine substituents or 
two to eight bromine substituents.
    Positive test result means: (1) Any resolvable gas chromatographic 
peak for any 2,3,7,8-HDD or HDF which exceeds the LOQ listed under 
Sec. 766.27 for that

[[Page 771]]

congener, or (2) exceeds LOQs approved by EPA under Sec. 766.28.
    Precursor means a chemical substance which is not contaminated due 
to the process conditions under which it is manufactured, but because of 
its molecular structure, and under favorable process conditions, it may 
cause or aid the formation of HDDs/HDFs in other chemicals in which it 
is used as a feedstock or intermediate.
    QA means quality assurance.
    QC means quality control.
    Reimbursement period means the period that begins when the data from 
the last test to be completed under this part for a specific chemical 
substance listed in Sec. 766.25 is submitted to EPA, and ends after an 
amount of time equal to that which had been required to develop that 
data or 5 years, whichever is later.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.



Sec. 766.5  Compliance.

    Any person who fails or refuses to comply with any aspect of this 
part is in violation of section 15 of TSCA. Section 15(1) makes it 
unlawful for any person to fail or refuse to comply with any rule or 
order issued under section 4. Section 15(3) makes it unlawful for any 
person to fail or refuse to submit information required under this part. 
Section 16 provides that a violation of section 15 renders a person 
liable to the United States for a civil penalty and possible criminal 
prosecution. Under section 17 of TSCA, the district courts of the United 
States have jurisdiction to restrain any violation of section 15.



Sec. 766.7  Submission of information.

    All information (including letters of intent, protocols, data, 
forms, studies, and allegations) submitted to EPA under this part must 
bear the applicable Code of Federal Regulations (CFR) section number 
(e.g., Sec. 766.20) and must be addressed to: Document Control Office, 
(7407), Information Management Division, Office of Polution Prevention 
and Toxics, Environmental Protection Agency, 401 M Street, SW., 
Washington, DC 20460, ATTN: Dioxin/Furan Report.

[52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]



Sec. 766.10  Test standards.

    Testing required under subpart B of this part must be performed 
using the protocols submitted to and reviewed by the EPA expert panel 
established under Sec. 766.28. All new data, documentation, records, 
protocols, specimens, and reports generated as a result of testing under 
subpart B of this part must be fully developed and retained in 
accordance with part 792 of this chapter. These items must be made 
available during an inspection or submitted to EPA upon request by EPA 
or its authorized representative. Laboratories conducting testing for 
submission to EPA in response to a test rule promulgated under section 4 
of TSCA must adhere to the TSCA Good Laboratory Practices (GLPs) 
published in part 792 of this chapter. Sponsors must notify the 
laboratory that the testing is being conducted pursuant to TSCA section 
4. Sponsors are also responsible for ensuring that laboratories 
conducting the testing abide by the TSCA GLP standards. At the time test 
data are submitted, manufacturers must submit a certification to EPA 
that the laboratory performing the testing adhered to the TSCA GLPs.



Sec. 766.12  Testing guidelines.

    Analytical test methods must be developed using methods equivalent 
to those described or reviewed in Guidelines for the Determination of 
Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans in Commercial 
Products. Copies are available from the Director, Environmental 
Assistance Division (7408), Office of Pollution Prevention and Toxics, 
U.S.Environmental Protection Agency, Room E-543B, 401 M St., SW., 
Washington, DC, 20460, Telephone: (202) 554-1404, TDD: (202) 544-0551. 
Copies are also located in the public docket for this part (Docket No. 
OPPTS-83002) and are available for inspection in the Non-Confidential 
Information Center (NCIC) (7407), Office of Pollution Prevention and 
Toxics, U.S. Environmental Protection Agency, Room B-607 NEM, 401 M 
Street, SW., Washington, DC, 20460, between the hours of 12 p.m. and 4 
p.m. weekdays excluding legal holidays.

[60 FR 34466, July 3, 1995]

[[Page 772]]



Sec. 766.14  Contents of protocols.

    Protocols should include all parts of the Quality Assurance Plan for 
Measurement of Brominated or Chlorinated Dibenzofurans and 
Dibenzodioxins, as stated in the Guidelines. For each chemical substance 
and each process, the manufacturer must submit a statement of how many 
grades of the chemical substance it produces, a justification for 
selection of the specific grade of chemical substance for testing, 
specific plans for collection of samples from the process stream, naming 
the point of collection, the method of collecting the sample, and an 
estimate of how well the samples will represent the material to be 
characterized; a description of how control samples (blanks) and HDD/
HDF-reinforced control samples, or isotopically labeled compounds 
(standards) and duplicate samples will be handled; a description of the 
chemical extraction and clean up procedures to be used; how extraction 
efficiency and measurement efficiency will be established; and a 
description of instrument hardware and operating conditions, including 
type and source of columns, carrier gas and flow rate, operating 
temperature range, and ion source temperature.



Sec. 766.16  Developing the analytical test method.

    Because of the matrix differences of the chemicals listed for 
testing, no one method for sample selection, preparation, extraction and 
clean up is prescribed. For analysis, High Resolution Gas Chromatography 
(HRGC) with High Resolution Mass Spectrometry (HRMS) is the method of 
choice, but other methods may be used if they can be demonstrated to 
reach the target LOQs as well as HRGC/HRMS.
    (a) Sample selection. The chemical product to be tested should be 
sampled so that the specimens collected for analysis are representative 
of the whole. Additional guidance for sample selection is provided under 
Sec. 766.12.
    (b) Sample preparation. The sample must be mechanically homogenized 
and subsampled as necessary. Subsamples must be spiked or reinforced 
with surrogate compounds or with standard stock solutions, and the 
surrogates or standards must be thoroughly incorporated by mechanical 
agitation. Additional guidance is provided under Sec. 766.12.
    (c) Sample extraction and cleanup. The spiked samples must be 
treated to separate the HDDs/HDFs from the sample matrix. Methods are 
reviewed in the Guidelines under Sec. 766.12, but the final method or 
methods are left to the discretion of the analyst, provided the 
instrumental response of the surrogates meets the criteria listed in the 
Quality Assurance Plan for Measurement of Brominated or Chlorinated 
Dibenzofurans and Dibenzodioxins, Appendixes B and C of the Guidelines. 
Cleanup techniques are described in the Guidelines. These are chosen at 
the discretion of the analyst to meet the requirements of the chemical 
matrix.
    (d) Analysis. The method of choice is High Resolution Gas 
Chromatographic/High Resolution Mass Spectrometric Determination, (HRGC/
HRMS) but alternate methods may be used if the manufacturer can 
demonstrate that the method will reach the target LOQs as well as HRGC/
HRMS. Specific operating requirements are found in the Guidelines.



Sec. 766.18  Method sensitivity.

    The target level of quantitation required under Sec. 766.27 for each 
HDD/HDF congener is the level which must be attempted for each resolved 
HRGC peak for that congener. For at least one product sample, at least 
two analyses of the same isotopically labeled HDD/HDF internal 
calibration standards spiked to a final product concentration equal to 
the LOQ for that congener must be reproducibly extracted, cleaned up, 
and quantified to within 20 percent of each other. For each 
spiked product sample, the signal to noise ratio for the calibration 
standard peaks after complete extraction and cleanup must be 10:1 or 
greater. The recovery of the internal calibration standards in the 
extracted and cleaned up product samples must be within 50 to 150 
percent of the amount spiked, and the results must be corrected for 
recovery.

[[Page 773]]



       Subpart B--Specific Chemical Testing/Reporting Requirements



Sec. 766.20  Who must test.

    (a) Any person who manufactures, imports, or processes a chemical 
substance listed in Sec. 766.25 must test that chemical substance and 
must submit appropriate information to EPA according to the schedules 
described in Sec. 766.35. Chemical substances manufactured, imported or 
processed between January 1, 1984 and the date of promulgation of this 
part are subject to testing upon the effective date of this part. All 
other chemical substances are subject to testing immediately upon 
manufacture, import or processing. EPA expects that only manufacturers 
and importers will perform testing, and that the cost of testing will be 
passed on to processors through the pricing mechanism, thereby enabling 
them to share in the cost of testing. However, processors will be called 
upon to sponsor testing should manufacturers and importers fail to do 
so. A processor may apply for an exemption from testing upon 
certification to EPA that a manufacturer or importer is testing the 
chemical substance which that person processes.
    (b) If no manufacturer or importer described in Sec. 766.20 submits 
a letter of intent to perform testing within the period described under 
Sec. 766.35(a), or an exemption application under Sec. 790.45(a), or a 
request for an exclusion or waiver under Sec. 766.32, EPA will issue a 
notice in the Federal Register to notify all processors of that chemical 
substance. The notice will state that EPA has not received any of the 
documents described in the previous sentence, and that current 
processors will have 30 days to submit either a letter of intent to 
perform the test or submit an exemption application.
    (c) If no manufacturer, importer or processor submits a letter of 
intent to perform testing of a specific chemical substance produced by a 
specific process, EPA will notify all manufacturers, importers, and 
processors, either by notice in the Federal Register or by letter, that 
all exemption applications will be denied and that within 30 days all 
manufacturers, importers, and processors will be in violation of this 
part until a proposed study plan is submitted for required testing.
    (d) Manufacturers, importers, and processors who are subject to this 
part must comply with the test rule development and exemption procedures 
in part 790 of this chapter, except as modified in this part.



Sec. 766.25  Chemical substances for testing.

    (a) Listing of chemical substances. Chemical substances required to 
be tested for HDDs/HDFs under this rule are listed in this section. The 
listing is by Chemical Abstracts Service (CAS) Number and common name.

    Note: For purposes of guidance only, EPA lists the chemical 
substances subject to testing under this part in two classes--those 
known to be manufactured or imported between January 1, 1984, and 
promulgation of this part, and those not known to be manufactured or 
imported at the time of promulgation of this part.
    (1) Chemicals substances known to be manufactured between January 1, 
1984 and date of promulgation of this part.

------------------------------------------------------------------------
   CAS No.                           Chemical name
------------------------------------------------------------------------
79-94-7.....  Tetrabromobisphenol-A.
118-75-2....  2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4-dione.
118-79-6....  2,4,6-Tribromophenol.
120-83-2....  2,4-Dichlorophenol.
1163-19-5...  Decabromodiphenyloxide.
4162-45-2...  Tetrabromobisphenol-A-bisethoxylate.
21850-44-2..  Tetrabromobisphenol-A-bis-2,3-dibromopropyl ether.
25327-89-3..  Allyl ether of tetrabromobisphenol-A.
32534-81-9..  Pentabromodiphenyloxide.
32536-52-0..  Octabromodiphenyloxide.
37853-59-1..  1,2-Bis(tribromophenoxy)-ethane.
55205-38-4..  Tetrabromobisphenol-A diacrylate.
------------------------------------------------------------------------

    (2) Chemicals not known to be manufactured between January 1, 1984 
and the date of promulgation of this part.

------------------------------------------------------------------------
   CAS No.                           Chemical name
------------------------------------------------------------------------
79-95-8.....  Tetrachlorobisphenol-A.
87-10-5.....  3,4',5-Tribromosalicylanilide.
87-65-0.....  2,6-Dichlorophenol.
95-77-2.....  3,4-Dichlorophenol.
95-95-4.....  2,4,5-Trichlorophenol.
99-28-5.....  2,6-Dibromo-4-nitrophenol.
120-36-5....  2[2,4-(Dichlorophenoxy)]-propionic acid.
320-72-9....  3,5-Dichlorosalicyclic acid.
488-47-1....  Tetrabromocatechol.
576-24-9....  2,3-Dichlorophenol.
583-78-8....  2,5-Dichlorophenol.
608-71-9....  Pentabromophenol.
615-58-7....  2,4-Dibromophenol.
933-75-5....  2,3,6-Trichlorophenol.
1940-42-7...  4-Bromo-2,5-dichlorophenol.
2577-72-2...  3,5-Dibromosalicylanilide.

[[Page 774]]

 
3772-94-9...  Pentachlorophenyl laurate.
37853-61-5..  Bismethylether of tetrabromobisphenol-A.
              Alkylamine tetrachlorophenate.
              Tetrabromobisphenol-B.
------------------------------------------------------------------------

    (b) Grade to be tested. If the same process is used to manufacture 
all grades of the same chemical substance, only one grade need be 
tested. The grade to be tested must be the grade subject to the most 
intense heat and alkalinity for the longest duration of time, 
manufactured under each different process. If the heat, alkalinity and 
duration of reaction do not differ for various grades, the test 
substance must be the grade of chemical substance with the highest 
volume of sales.



Sec. 766.27  Congeners and LOQs for which quantitation is required.

    Quantitation at the target LOQ shown for each of the following HDDs/
HDFs which may be present in the chemical substances is required for the 
chemical substances listed under Sec. 766.25. Analysis must take place 
for either chlorinated or brominated dibenzodioxins or dibenzofurans, 
whichever is predominantly expected to occur in the chemical substance 
to be tested. Only chlorinated and brominated congeners need be 
quantified; for chemical substances containing predominantly chlorine 
atoms, only congeners totally chlorinated at the numbered positions need 
be quantified; for chemical substances containing predominantly bromine 
atoms, only congeners totally brominated at the numbered positions need 
be quantified.

------------------------------------------------------------------------
        Chlorinated dioxins          Brominated dioxins         LOQ
------------------------------------------------------------------------
2,3,7,8-TCDD......................  2,3,7,8-TBDD........  0.1 ppb.
1,2,3,7,8-PeCDD...................  1,2,3,7,8-PeBDD.....  0.5 ppb.
1,2,3,4,7.8-HxCDD.................  1,2,3,4,7,8-HxBDD...  2.5 ppb.
1,2,3,6,7,8-HxCDD.................  1,2,3,6,7,8-HxBDD...  2.5 ppb.
1,2,3,7,8,9-HxCDD.................  1,2,3,7,8,9-HxBDD...  2.5 ppb.
1,2,3,4,6,7,8-HpCDD...............  1,2,3,4,6,7,8-HpBDD.  100 ppb.
2,3,7,8-TCDF......................  2,3,7,8-TBDF........  1 ppb.
1,2,3,7,8-PeCDF...................  1,2,3,7,8-PeBDF.....  5 ppb.
2,3,4,7,8-PeCDF...................  2,3,4,7,8-PeBDF.....  5 ppb.
1,2,3,4,7,8-HxCDF.................  1,2,3,4,7,8-HxBDF...  25 ppb.
1,2,3,6,7,8-HxCDF.................  1,2,3,6,7,8-HxBDF...  25 ppb.
1,2,3,7,8,9-HxCDF.................  1,2,3,7,8,9-HxBDF...  25 ppb.
2,3,4,6,7,8-HxCDF.................  2,3,4,6,7,8-HxBDF...  25 ppb.
1,2,3,4,6,7,8-HpCDF...............  1,2,3,4,6,7,8-HpBDF.  1 ppm.
1,2,3,4,7,8,9-HpCDF...............  1,2,3,4,7,8,9-HpBDF.  1 ppm.
------------------------------------------------------------------------



Sec. 766.28  Expert review of protocols.

    EPA will gather a panel of experts in analysis of chemical matrices 
for HDDs/HDFs to review the protocols for testing submitted to EPA. The 
panel members will be employees of EPA and/or of other U.S. Government 
agencies who have had experience in analysis of chemical matrices and/or 
chemical wastes for HDDs/HDFs. The panel will recommend to the Director, 
EPA Office of Pollution Prevention and Toxics, whether the protocol 
submitted is likely to allow analysis down to the target LOQs, or if 
not, whether the protocol represents a good faith effort on the part of 
the tester to achieve the lowest possible LOQs. The final determination 
to accept or reject the protocol will be made by the Director, Office of 
Pollution Prevention and Toxics. EPA will review the submitted protocols 
as rapidly as possible and will complete the review within 90 days after 
receipt. EPA may require submission of revised protocols. Comments and 
recommendations will be transmitted to the submitter, and if revisions 
are required, a final protocol must be submitted to EPA within 90 days 
after EPA transmits such recommendations.



Sec. 766.32  Exclusions and waivers.

    (a) Reasons for exclusions and waivers. Any person subject to the 
testing requirements of this part may request an exclusion or waiver 
from testing for any one of the following reasons:
    (1) Exclusions may be granted if. (i) Testing of the appropriate 
grade of the chemical substance has already been carried out, either 
analytical testing at the lowest LOQ possible, with appropriate QA/QC, 
or a well-designed bioassay with appropriate QA/QC or;
    (ii) Process and reaction conditions of the chemical substance such 
that no HDDs/HDFs could be produced under those conditions;
    (2) Waivers may be granted if. (i) A responsible company official 
certifies that the chemical substance is produced only in quantities of 
100 kilograms or less per year, only for research and development 
purposes; or
    (ii) In the judgement of EPA, the cost of testing would drive the 
chemical substance off the market, or prevent

[[Page 775]]

resumption of manufacture or import of the chemical substance, if it is 
not currently manufactured, and the chemical substance will be produced 
so that no unreasonable risk will occur due to its manufacture, import, 
processing, distribution, use, or disposal. (In this case, the 
manufacturer must submit to EPA all data supporting the determination.)
    (iii) Waivers may be appropriately conditioned with respect to such 
factors as time and conditions of manufacture or use. The grade of 
decabromodiphenyl oxide produced by Dow Chemical Company (Dow) for the 
National Toxicology Program (NTP) bioassay on that chemical is excluded 
from the testing requirement under this part. Provided, however, that 
this exclusion will not apply if Dow fails to supply to EPA within 60 
days of the effective date of this section evidence showing which grade 
was used for the NTP bioassay.
    (b) Timing. Exclusion or waiver requests and detailed supporting 
data must be submitted to EPA within 60 days from the effective date of 
this part for persons manufacturing, importing or processing a chemical 
substance as of the date of promulgation, or 60 days prior to the date 
of resumption of manufacture or import for a chemical substance produced 
by a specific process if the chemical substance is not manufactured, 
imported or processed as of the date of promulgation.
    (c) Publication. Within 10 days of receipt of any exclusion or 
waiver request, EPA will issue in the Federal Register a notice of such 
receipt. EPA will also issue a notice of its decision on each exclusion 
or waiver request within 60 days of receipt.
    (d) Decision. The EPA Director of the Office of Pollution Prevention 
and Toxics will make the decision to grant or deny waivers or 
exclusions.



Sec. 766.35  Reporting requirements.

    (a) Letters of intent, exemption applications, and protocols--(1) 
Letters of Intent. (i) Persons who have manufactured or imported 
chemical substances listed under Sec. 766.25 between January 1, 1984, 
and the effective date of this part are required to submit under 
Sec. 790.45 of this chapter a letter of intent to test or an exemption 
application. These letters must be submitted no later than September 3, 
1987.
    (ii) Persons who commence manufacture, import or processing of a 
chemical substance listed under Sec. 766.25 that has not been 
manufactured, imported or processed between January 1, 1984 and the 
effective date of this part must submit under Sec. 790.45 of this 
chapter, within 60 days after the commencement of manufacture, import, 
or processing of the chemical substance, a letter of intent to test or 
an exemption application.
    (iii) Persons who commence manufacture, import or processing of a 
chemical substance listed under Sec. 766.25 between the effective date 
of this part and the end of the reimbursement period for that particular 
chemical substance produced by a specific process must submit under 
Sec. 790.45 of this chapter, within 60 days after the commencement of 
manufacture, import or processing of the chemical substance, a letter of 
intent to test or an exemption application.
    (2) Protocols. (i) Each person who is manufacturing or processing a 
chemical substance listed in Sec. 766.25 as of the effective date of 
this part who submits a notice of intent to test under Sec. 766.35(a)(1) 
must submit a protocol for the test as follows:
    (A) The protocols for each chlorinated chemical substance produced 
by each process to be tested must be submitted to EPA no later than 12 
months after the effective date of this part.
    (B) The protocol for each brominated chemical substance produced by 
each process to be tested must be submitted to EPA no later than 24 
months after the effective date of this part except for the following 
chemicals.
    (1) The deadline for submitting the protocols for 
tetrabromobisphenol-A (CAS No. 79-94-7); 2,4,6 tribromophenol (CAS. No. 
118-79-6); decabromodiphenyloxide (CAS No. 1163-19-5); and 1,2-
bis(tribromophenoxy)-ethane (CAS No. 37853-59-1) is January 31, 1991.
    (2) The deadline for submitting protocols for octabromodiphenyloxide 
(CAS No. 32536-52-0) and allyl ether of tetrabromobisphenol-A (CAS No. 
25327-89-3) is January 31, 1991.

[[Page 776]]

    (3) The deadline for submitting protocols for 
pentabromodiphenyloxide (CAS No. 32534-81-9) is February 6, 1995. The 
deadline for submitting tetrabromobisphenol-A-bisethoxylate (CAS No. 
4126-45-2) is January 31, 1991.
    (4) The deadline for submitting protocols for 3,4',5-
tribromosalicylanilide (CAS No. 87-10-5) is September 5, 1990.
    (ii) For chemical substances produced by a specific process not 
manufactured or processed as of the effective date of this part, a 
person who begins manufacture and submits a notice of intent to test 
must submit protocols for the test as follows:
    (A) Except as noted for the submitter and substance specified in the 
following table, protocols for testing must be submitted 12 months after 
manufacture or importation begins for chlorinated chemical substances.

----------------------------------------------------------------------------------------------------------------
 CAS No.               Submitter                              Chemical                          Due date
----------------------------------------------------------------------------------------------------------------
118-75-2.  Rhone-Poulenc....................  2,3,5,6-tetrachloro-2,5-cyclohexaniene-   March 4, 1994
                                               1,4-dione.
----------------------------------------------------------------------------------------------------------------


    (B) Protocols for testing must be submitted 24 months after 
manufacture begins for brominated chemical substances.
    (iii) For persons who have been granted exemptions, waivers or 
exclusions from testing, protocols must be submitted 12 months after 
expiration of the exemption, waiver or exclusion for chlorinated 
chemical substances, and 24 months after expiration of the exemption, 
waiver or exclusion for brominated chemical substances.
    (b) Information that must be submitted to EPA. (1) Persons who 
manufacture or import a chemical substance listed under Sec. 766.25 must 
report no later than October 5, 1987 or 90 days after the person first 
manufactures or imports the chemical substance, whichever is later, the 
results of all existing test data which show that chemical substance has 
been tested for the presence of HDDs/HDFs.
    (2) Any manufacturer or importer of a chemical substance listed in 
Sec. 766.25 in possession of unpublished health and safety studies on 
HDDs/HDFs is required to submit copies of such studies to EPA no later 
than October 5, 1987 or 90 days after the person first manufactures or 
imports the chemical substance, whichever is later. The following 
provisions of part 716 of this chapter apply to submission of these 
studies: Secs. 716.3, 716.10(a) (1) and (4); 716.20(a) (1), (2), (3), 
(4), (7), (8) and (10); 716.25; 716.30; 716.35(a) (1), (2), and (4) [if 
applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; and 
716.60(a)(2).
    (3) No later than October 5, 1987 or 90 days after the person first 
manufactures or imports the substance listed in Sec. 766.25, any 
manufacturer or importer of a chemical substance listed in Sec. 766.25 
must submit records required to be held under part 717 of this chapter 
on any HDDs/HDFs.
    (4) Test results. (i) Test results must be submitted to EPA not 
later than 270 days after EPA's transmission of comments or 180 days 
after a final protocol is submitted to EPA, whichever is shorter, except 
as noted for the submitters and substances specified in the following 
table:

----------------------------------------------------------------------------------------------------------------
     CAS No.           Submitter                 Chemical                     Due Date           Effective Date
----------------------------------------------------------------------------------------------------------------
79-94-7.........  Great Lakes         Tetrabromobisphenol-A           May 26, 1992              May 28, 1993
 
79-94-7.........  Ethyl               Tetrabromobisphenol-A           August 10, 1992           May 28, 1993
 
79-94-7.........  Ameribrom           Tetrabromobisphenol-A           April 15, 1994            September 29,
                                                                                                 1995
 
87-10-5.........  Pfister             3,4',5-tribromosalicylanilide   45 days after protocol    May 28, 1993
                                                                       approval
 
118-75-2........  Rhone-Poulenc Inc.  2,3,5,6-tetrachloro-2,5-        July 5, 1996              June 30, 1997
                                       cyclohexadiene-1,4-dione
 
118-79-6........  Great Lakes         2,4,6-Tribromophenol            May 26, 1992              May 28, 1993
 
1163-19-5.......  Ameribrom           Decabromodiphenyloxide          April 15, 1994            September 29,
                                                                                                 1995
 

[[Page 777]]

 
1163-19-5.......  Ethyl               Decabromodiphenyloxide          May 26, 1992              May 28, 1993
 
1163-19-5.......  Great Lakes         Decabromodiphenyloxide          May 26, 1992              May 28, 1993
 
4162-45-2.......  Great Lakes         Tetrabromobisphenol-A-          June 2, 1993              September 8,
                                       bisethoxylate                                             1994
 
25327-89-3......  Great Lakes         Allyl Ether of                  August 10, 1992           May 28, 1993
                                       Tetrabromobisphenol-A
 
32534-81-9......  Great Lakes         Pentabromodiphenyloxide          March 22, 1993           September 8,
                                                                                                 1994
 
32534-81-9......  Akzo Chemicals      Pentabromodiphenyloxide         February 6, 1995          September 29,
                   Inc.                                                                          1995
 
32534-81-9......  Ameribrom           Pentabromodiphenyloxide          March 22, 1993           September 8,
                                                                                                 1994
 
32536-52-0......  Ameribrom           Octabromodiphenyloxide          January 8, 1993           September 29,
                                                                                                 1995
 
32536-52-0......  Ethyl               Octabromodiphenyloxide          May 15, 1994              May 28, 1993
 
32536-52-0......  Great Lakes         Octabromodiphenyloxide          May 26, 1992              May 28, 1993
 
37853-59-1......  Great Lakes         1,2-bis(tribromophenoxy)ethane  January 24, 1995          September 29,
                                                                                                 1995
----------------------------------------------------------------------------------------------------------------

    (ii) For purposes of reporting test results to EPA, and for further 
reporting triggered by a positive test result under Sec. 766.35(c), a 
positive test result is defined at Sec. 766.3.
    (iii) Reporting of test results must follow procedures set out in 
part 790 of this chapter, except as modified in this part.
    (c) Information required to be submitted to EPA after submission of 
a positive test result. (1) Any person who submits a positive test 
result for a specific chemical substance listed under Sec. 766.25 must 
submit to EPA no later than 90 days after the date of submission of the 
positive test result the following:
    (i) A completed form (EPA 7710-51) for that chemical substance. The 
form and instructions are available from the Environmental Assistance 
Division (7408), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC, 20460. 
One form must be submitted for each chemical substance for which a 
positive test result has been submitted.
    (ii) Health and safety studies for the chemical substance for which 
a positive test result has been reported. The following provisions of 
part 716 of this chapter apply to submission of these studies: 
Secs. 716.3; 716.10 (a) (1), (2), (3) and (4); 716.20; 716.25; 716.30; 
716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and (c); 716.40 
(a) and (b); 716.50; 716.55; 716.60(a)(2).
    (iii) Copies of records on the chemical substances required to be 
held under part 717 of this chapter.
    (2) If a positive test result on a chemical substance is received 
from one person but not from others, EPA may issue a notice in the 
Federal Register listing that chemical substance and requiring any 
person manufacturing, importing or processing that chemical substance 
who has not submitted a positive test result to submit the information 
required in Part II of EPA Form 7710-51. Such a notice will be published 
only if EPA needs additional process data to make a determination of 
unreasonable risk.
    (d)-(e)  [Reserved]
    (f) Effective date. (1) The effective date of this final rule is 
July 6, 1987, except for paragraphs (a)(2)(i)(B) introductory text, 
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), (a)(2)(i)(B)(3), (a)(2)(i)(B)(4), the 
table in paragraph (a)(2)(ii)(A), and the table in paragraph (b)(4)(i) 
of this section.
    (2) The effective date for paragraph (a)(2)(i)(B) introductory text, 
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and (a)(2)(i)(B)(4), is May 21, 1991. 
The effective date of paragraphs (a)(2)(i)(B)(3), and the table in 
paragraph (a)(2)(ii)(A) is September 29, 1995. The effective date of 
paragraph (b)(4)(i) introductory text is May 28, 1993, and the effective 
date of the entries in the table in paragraph (b)(4)(i) is shown in the 
effective dates column of the table.

[[Page 778]]

    (3) The guidelines and other test methods cited in this rule are 
referenced as they exist on the effective date of the final rule.

[52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57 
FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June 
23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 31922, June 19, 1995; 60 FR 
50433, Sept. 29, 1995; 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 30, 
1997]



Sec. 766.38  Reporting on precursor chemical substances.

    (a) Identification of precursor chemical substances. Precursor 
chemical substances are produced under conditions that will not yield 
HDDs and HDFs, but their molecular structure is conducive to HDD/HDF 
formation under favorable reaction conditions when they are used to 
produce other chemicals or products. The following precursor chemical 
substances are identified by Chemical Abstract Service (CAS) number and 
name.

------------------------------------------------------------------------
             CAS No.                           Chemical name
------------------------------------------------------------------------
85-22-3..........................  Pentabromoethylbenzene.
87-61-6..........................  1,2,3-Trichlorobenzene.
87-84-3..........................  1,2,3,4,5-Pentabromo-6-chloro-
                                    cyclohexane.
89-61-2..........................  1,4-Dichloro-2-nitrobenzene.
89-64-5..........................  4-Chloro-2-nitrophenol.
89-69-0..........................  2,4,5-Trichloronitrobenzene.
92-04-6..........................  2-Chloro-4-phenylphenol.
94-74-6..........................  4-Chloro-o-toloxy acetic acid.
94-81-5..........................  4-(2-Methyl-4-chlorophenoxy) butyric
                                    acid.
95-50-1..........................  o-Dichlorobenzene.
95-56-7..........................  o-Bromophenol.
95-57-8..........................  o-Chlorophenol.
95-88-5..........................  4-Chlororesorcinol.
95-94-3..........................  1,2,4,5-Tetrachlorobenzene.
97-50-7..........................  5-Chloro-2,4-dimethoxyaniline.
99-30-9..........................  2,6-Dichloro-4-nitroaniline.
99-54-7..........................  1,2-Dichloro-4-nitrobenzene.
106-46-7.........................  p-Dichlorobenzene.
108-70-3.........................  1,3,5-Trichlorobenzene.
108-86-1.........................  Bromobenzene.
108-90-7.........................  Chlorobenzene.
117-18-0.........................  1,2,4,5-Tetrachloro-3-nitrobenzene.
120-82-1.........................  1,2,4-Trichlorobenzene.
348-51-6.........................  o-Chorofluorobenzene.
350-30-1.........................  3-Chloro-4-fluoronitrobenzene.
615-67-8.........................  Chlorohydroquinone.
626-39-1.........................  1,3,5-Tribromobenzene.
827-94-1.........................  2,6-Dibromo-4-nitroaniline.
------------------------------------------------------------------------

    (b) Persons required to report. All persons who manufacture or 
import a chemical product produced using any of the chemical substances 
listed in paragraph (a) of this section as feedstocks or intermediates 
must report no later than September 29, 1987. Small manufacturers and 
those manufacturers and importers who produce the precursor chemical 
substances in quantities of 100 kilograms or less per year only for 
research and development purposes are not required to report under this 
section
    (c) Data to be reported. Manufacturers and importers of chemical 
products made from precursor chemical substances identified in paragraph 
(a) of this section must report process and reaction condition data on 
Part II of EPA Form 7710-51 for each chemical product. A separate EPA 
Form 7710-51 must be submitted for each chemical product reported, and 
the precursor chemical substance used must be identified. All forms must 
be submitted to EPA no later than September 29, 1987.

[52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]



PARTS 767-789 [Reserved]