[Title 40 CFR R]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter R - TOXIC SUBSTANCES CONTROL ACT]
[From the U.S. Government Publishing Office]
40
PROTECTION OF ENVIRONMENT
17
1996-07-01
1996-07-01
false
TOXIC SUBSTANCES CONTROL ACT
R
SUBCHAPTER R
PROTECTION OF ENVIRONMENT
ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT
PART 700--GENERAL--Table of Contents
Subparts A and 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.
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 and 720.3 of this chapter, apply to
this subpart unless otherwise specified in this section. In addition,
the following definitions apply:
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.
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, or exemption application.
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
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those of the parent company (if any), are less than $40 million.
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.
(c) No fee required. Persons are exempt from remitting any fee for
submissions under Secs. 720.38 and 723.50 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.
(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
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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.
(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.
(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 Sec. 720.65(c) of this chapter.
[53 FR 31252, Aug. 17, 1988, as amended at 54 FR 21429, May 18, 1989; 58
FR 34204, June 23, 1993]
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
Sec. 720.65(c) of this chapter.
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
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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 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.
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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-ethanediylbis[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 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
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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.
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
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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.
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
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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]
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
[[Page 13]]
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).
(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]
[[Page 14]]
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 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:
[[Page 15]]
(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 a 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 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.
[[Page 16]]
(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 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
[[Page 17]]
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 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
[[Page 18]]
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 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-
[[Page 19]]
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 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
[[Page 20]]
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.
(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)-
[[Page 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.
(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
[[Page 22]]
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.
(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:
CaTa+CbTb+ . . . CnTn
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:
[[Page 23]]
(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.
(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.
[[Page 24]]
(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 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
[[Page 25]]
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.
(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]
[[Page 26]]
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 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.
[[Page 27]]
(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 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
230 South Dearborn Street, Chicago, IL 60604 (312-353-2291)
Region VI
1201 Elm Street, Dallas, TX 75270 (214-767-2734)
[[Page 28]]
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]
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
[[Page 29]]
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 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.
[[Page 30]]
(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.
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 Instructions for submitting information.
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.
[[Page 31]]
(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.
(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
[[Page 32]]
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.
(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.
[[Page 33]]
(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. 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
[[Page 34]]
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:
(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 Portlant 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.
[[Page 35]]
(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]
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
[[Page 36]]
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.
(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
[[Page 37]]
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 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.
[[Page 38]]
(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
recurring reporting periods 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).
[51 FR 21447, June 12, 1986: 51 FR 22521, June 20, 1986]
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 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 Sec. 710.2(l) and
Sec. 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.
[[Page 39]]
(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 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 Instructions for submitting information.
(a) All persons submitting written information in response to the
requirements of this subpart must use original copies of Form U
available from EPA at the address set forth in paragraph (b) of this
section.
(b) Complete instructions for completing the reporting form and
preparing a magnetic media report are given in the EPA publication
entitled ``Instructions for Reporting for 1994 Partial Updating of the
TSCA Chemical Inventory Data Base.'' Reporting forms and instruction
booklets may be obtained from the following address: TSCA Hotline
(7408), Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460, ATTN: Inventory
Update Rule, (202) 554-1404.
(c) Completed reporting forms and magnetic media must be submitted
to:
[[Page 40]]
Document Control Officer (7407), Office of Pollution Prevention and
Toxics, U.S. Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, ATTN: Inventory Update Rule.
[59 FR 30654, June 14, 1994]
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.
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
[[Page 41]]
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
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
[[Page 42]]
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 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
[[Page 43]]
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, 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 interimediate.
(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
[[Page 44]]
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 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.,
[[Page 45]]
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 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.
----------------------------------------------------------------------------------------------------------------
CAS No. Substance Effective date Reporting 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- 1/11/90 3/12/90
(tetrabromophthalimide).
37853-59-1 1,2-Bis(tribromophenoxy) ethane. 1/11/90 3/12/90
41291-34-3 Ethylene(5,6-dibromonorbornane- 1/11/90 3/12/90
2,3-dicarboximide).
52907-07-0 Ethylene bis(5,6- 1/26/94 3/28/94
dibromonorbornane-2,3-
dicarboximide).
57137-10-7 Tribrominated polystyrene...... 1/11/90 3/12/90
61262-53-1 Ethylene 1/11/90 3/12/90
bis(pentabromophenoxide).
----------------------------------------------------------------------------------------------------------------
(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
[[Page 46]]
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
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
[[Page 47]]
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.
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
2744-41-6................... (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
[[Page 48]]
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.
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
[[Page 49]]
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
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
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
[[Page 50]]
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
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
[[Page 51]]
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
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-.
[[Page 52]]
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 1: 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 : 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 was 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).
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.
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).
[[Page 53]]
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.
(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.
[[Page 54]]
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)(1) A person who, in the 10 years preceding the effective date
that a substance or mixture is added to Sec. 716.120, either had
proposed to manufacture, import, or process, or had manufactured,
imported, or processed the substance or listed mixture.
(2) A person who, at the effective date that a substance or mixture
is added to Sec. 716.120, proposes to manufacture, import, or process,
or is manufacturing, importing, or processing the substance or listed
mixture.
(3) A person who, after the effective date that a substance or
mixture is added to Sec. 716.120, proposes to manufacture, import, or
process the substance or listed mixture.
(b) [Reserved]
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,
[[Page 55]]
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.
(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.
[[Page 56]]
(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.
[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]
Sec. 716.25 Adequate file search.
The scope of a person's responsibility to search records is limited
to records where the required information is ordinarily kept, and to
records kept by the person's individual employees whose assigned duty is
to advise the person on the health and environmental effects of
chemicals. Persons are not required to search any records retired prior
to December 31, 1979 for information to comply with this subpart.
Sec. 716.30 Submission of copies of studies.
(a)(1) Except as provided in Secs. 716.20 and 716.50, persons must
send to EPA copies of any health and safety studies in their possession
for the substances or listed 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) 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]
Sec. 716.35 Submission of lists of studies.
(a) Except as provided in Secs. 716.20 and 716.50, persons must send
the lists described in paragraph (a) of this section to EPA for each of
the substances or listed mixtures in Sec. 716.120 which they are
manufacturing, importing, or processing; or propose to manufacture,
import, or process (including as known byproducts).
(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.
[[Page 57]]
(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.
(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]
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
[[Page 58]]
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 at any grade of purity.
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.
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
[[Page 59]]
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 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 listed mixture in Sec. 716.120 or within 60 days of
proposing to manufacture, import, or process a substance or listed
mixture if first done after the effective date of the substance's or
listed mixture's listing 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 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]
Sec. 716.65 Reporting period.
(a) The reporting period on a substance or listed mixture will
terminate no later than: 10 years after the effective date on which a
substance or listed mixture is added to Sec. 716.120; or on the removal
of the substance or listed mixture from Sec. 716.120. The Assistant
Administrator for Prevention, Pesticides and Toxic Substances has the
authority to remove a substance or listed mixture from Sec. 716.120.
(b) The EPA Office of Pollution Prevention and Toxics (OPPT) will
conduct a biennial review of all of the chemical substances and mixtures
listed in Sec. 716.120, and request from other EPA offices and certain
Federal agencies, all reasonable justifications for retaining each
substance or mixture on, or removing each substance or mixture from, the
Sec. 716.120 list. Following each such review, the Assistant
Administrator for Prevention, Pesticides and Toxic Substances will
remove any substance or mixture for which no reasonable justification
has been received to retain such substance or mixture on the
Sec. 716.120 list. The Assistant Administrator may remove a substance or
listed mixture from Sec. 716.120 by publishing, without notice and
comment, a final rule to that effect in the Federal Register. The rule
shall not be effective any earlier than 90 days after its publication.
Persons who believe that EPA should not remove a substance or listed
mixture from Sec. 716.120 may notify EPA and provide reasons for
retaining the substance or listed mixture. If a reasonable justification
for retaining a substance or listed mixture on the Sec. 716.120 list is
received, EPA will withdraw the substance from the final rule before its
effective date.
(c) Notwithstanding the termination by the sunset provision in (a)
above, removing a substance or listed mixture from Sec. 716.120 also
terminates the applicability of Sec. 716.5(a)(3) to that substance or
listed mixture so that persons first proposing to manufacture, import,
or process the substance or listed mixture after the effective date of
the removal have no reporting obligation under section 8(d) with respect
to that substance or listed mixture. The removal also terminates the
continuing obligation under Sec. 716.35(a)(2) of
[[Page 60]]
persons previously subject to the rule under Sec. 716.5(a)(2) or (3) to
notify EPA of any initiation of studies on the removed substance or
listed mixture that occur after the effective date of the removal. Only
one reporting requirement would remain in effect. Persons who have been
subject to the rule under Sec. 716.5(a)(2) or (3) and who have submitted
to EPA lists of ongoing or initiated studies under Sec. 716.35(a)(1) or
(2) must notify EPA of the completed study and submit the study
regardless of the study's completion date.
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 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.
[[Page 61]]
----------------------------------------------------------------------------------------------------------------
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 4/13/99
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 4/13/99
acid, 2-methyl-, methyl ester.
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
[[Page 62]]
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 4/13/99
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 4/13/99
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 4/13/99
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
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.
[[Page 63]]
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 4/13/99
iminobis-.
111-69-3... Hexanedinitrile................... ..................................... 6/1/87 12/19/95
111-76-2... 2-Butoxyethanol--Ethanol, 2-butoxy- ..................................... 4/13/89 4/13/99
.
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 1/11/00
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).
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 4/13/99
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
[[Page 64]]
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 12/28/04
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 12/28/04
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 1/11/00
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
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
[[Page 65]]
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 04/12/03
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 01/26/04
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-.
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)-.
[[Page 66]]
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 1/11/00
32536-52-0. Octabromodiphenyl ether........... ..................................... 1/11/90 1/11/00
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 4/13/99
ether--Propanol, (2-
methoxymethylethoxy)-.
37853-59-1. 1,2-Bis(tribromophenoxy) ethane... ..................................... 1/11/90 1/11/00
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).
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
[[Page 67]]
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
hydrocarbons with one or more epoxy functional groups.. .............. ........... 10/04/82 12/29/88
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
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
Alkyl phthalates--all alkyl esters of 1,2-
benzenedicarboxylic acid (ortho-phthalic acid)......... .............. ........... 10/04/82 10/04/92
----------------------------------------------------------------------------------------------------------------
[[Page 68]]
----------------------------------------------------------------------------------------------------------------
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)
ester................................................ 131-15-7 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, bis(2-methylpropyl)
ester................................................ 84-69-5 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, 2-butoxy-2-oxyethyl
butyl ester.......................................... 85-70-1 ........... 10/04/82 01/13/86
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-
methylnonyl ester.................................... 89-13-4 ........... 10/04/82 10/04/92
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
acid, 2,2'-[(dibutylstannylene)bis(thio)]bis-,
diisooctyl ester..................................... 25168-24-5 ........... 01/03/83 12/29/88
Dibutyltin S,S'-bis(isooctyl mercaptoacetate)--Acetic
acid, 2,2'-[(dimethylstannylene)bis(thio)]bis-,
diisooctyl ester..................................... 26636-01-1 ........... 01/03/83 12/29/88
Mono methyltin tris(isooctylmercaptoacetate) Acetic
acid, 2,2',2''-[(methylstannylidyne)tris(thio)]tris-
triisoacetyl ester................................... 54849-38-6 ........... 01/03/83 12/29/88
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
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
[[Page 69]]
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-
substituted phenols. Triaryl and mixed alkyl and aryl
esters are included but trialkyl esters are excluded... .............. ........... 10/04/82 10/04/92
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
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
ester................................................ 56803-37-3 ........... 10/04/82 10/04/92
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
diphenyl ester....................................... 34364-42-6 ........... 10/04/82 10/04/92
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
(serpentine); crocidolite (riebeckite); amosite
(cummingtonite--grunerite); anthophyllite; tremolite;
and actinolite......................................... .............. ........... 10/04/82 10/04/92
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
Bisazobiphenyl dyes derived from benzidine and its
congeners, ortho-toluidine (dimethylbenzidine) and
dianisidine (dimethoxybenzidine)....................... .............. ........... 10/04/82 10/04/92
Benoic acid, 2-[[2-amino-6-[[4-[(-carboxy-4-
hydroxphenyl) azo[-3,3-dimethoxy[1,1-biphenyl]-4-
yl]azo]-5-hydroxy-7-sulfo-1-naphthalenylazo]-5-nitro-
, trisodium salt..................................... 6739-62-4 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[2-amino-8-hydroxy-6-sulfo-1-
naphthalenyl) azo] [1,1-biphenyl]-4-yl]-azo]-2-
hydroxy-, disodium salt.............................. 2429-84-7 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[7-amino-1-hydroxy-3-sulfo-2-
naphthalenyl)azo] [1,1-biphenyl]-4-yl]azo]-2-hydroxy-
, disodium salt...................................... 2429-82-5 ........... 10/04/82 10/04/92
[[Page 70]]
Benzoic acid, 5-[[4-[(1-amino-4-sulfo-2-
naphthalenyl)azo] [1,1-biphenyl]-4-yl]azo]-2-hydroxy-
, disodium salt...................................... 2429-79-0 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[[2,6-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............... 2429-81-4 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[(2,6-diamino-3-methyl-5-
sulfophenyl)azo]-3,3-dimethyl[1,1-biphenyl]-4-yl]azo]-
2-hydroxy-, disodium salt............................ 6637-88-3 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[[2,6-diamino-3-methyl-5-[(4-
sulfophenyl)azo]phenyl]azo][1,1-biphenyl]-4-yl]azo]-2-
hydroxy-, disodium salt.............................. 2586-58-5 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[[2,6-diamino-3-methyl-5-[(4-
sulfophenyl)azo]phenyl]azo]1,1-biphenyl]-4-yl]azo]-2-
hydroxy-3-methly-, disodium salt..................... 6360-54-9 ........... 10/04/82 10/04/92
Benzoic acid, 5-[[4-[[2,4-dihydroxy-3-[(4-
sulfophenyl)azo]phenyl]azo] [1,1-biphenyl]-4-yl]azo]-
2-hydroxy-, disodium salt............................ 2893-80-3 ........... 10/04/82 10/04/92
Benzoic acid, 3,3-[(3,7-disulfo-1,5-naphthalene-
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............. 8014-91-3 ........... 10/04/82 10/04/92
[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-
diyl)bis[3-oxo-...................................... 91-96-3 ........... 10/04/82 10/04/92
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-
sulfophenyl)azo]phenyl]azo][1,1-biphenyl]-4-yl]azo]-2-
hydroxybenzoato(4-)]-, disodium...................... 16071-86-6 ........... 10/04/82 10/04/92
Cuprate(3-), [-[7-[[3,3-dihydroxy-4-[[1-
hydroxy-6-(phenylamino)-3-sulfo-2-naphthalenyl]azo]
[1,1-biphenyl]-4-yl]azo]-8-hydroxy-1,6-
naphthalenedisulfonato(7-)]]di-, trisodium........... 6656-03-7 ........... 10/04/82 10/04/92
Cuprate(4-), [-[[6,6-[3,3-dihydroxy[1,1-
biphenyl]-4-4-diyl)bis(azo)]bis[4-amino-5-hydroxy-1,3-
naphthalendisulfonato]](8-)]]di-, tetrasodium........ 16143-79-6 ........... 10/04/82 10/04/92
2-Naphthalenecarboxamide, N,N-(3,3-dimethoxy[1,1-
biphenyl]-4,4-diyl)bis[3-hydroxy-.................... 91-92-9 ........... 10/04/82 10/04/92
1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-
[[4-[(2hydroxy-1-naphthalenyl)azo]-3,3-dimethoxy[1,1-
biphenyl]-4-yl]azo]-, disodium salt.................. 2586-57-4 ........... 10/04/82 10/04/92
1,3-Naphthalenedisulfonic acid, 6,6-[(3,3-
dimethoxy[1,1-biphenyl]-4,4diyl)bis(azo)]bis[4-amino-
5-hydroxy-, tetrasodium salt......................... 2610-05-1 ........... 10/04/82 10/04/92
1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-
ethoxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-7-hydroxy-
, disodium salt...................................... 3530-19-6- ........... 10/04/82 10/04/92
1,3-Naphthalenedisulfonic acid, 8-[[4'-[4-
ethoxyphenyl)azo]-3,3'-dimethyl] [1,1'-biphenyl]-4-
yl]azo]-7-hydroxy-, disodium salt.................... 6358-29-8 ........... 10/04/82 10/04/92
1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4-
[[(4-methylphenyl) sulfonyl]oxy]phenyl]-azo] [1,1'-
biphenyl]-4-yl]azo]-, disodium salt.................. 3567-65-5 ........... 10/04/82 10/04/92
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....... 2429-73-4 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-
diamino-5-methylphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-
5-hydroxy-6-(phenylazo)-, disodium salt.............. 2429-83-6 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-
diaminophenyl)azo] [1,1'-biphenyl]-4-yl]azo] 5-
hydroxy-6-(phenylazo)-, disodium salt................ 1937-37-7 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-
6[[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]-
azo]-3-[(4-nitrophenyl)azo]-, disodium salt.......... 4335-09-5 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-
[[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo)-
6-(phenylazo)-, disodium salt........................ 3626-28-6 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]-
4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium
salt................................................. 2602-46-2 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-
dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-
amino-4-hydroxy-, tetrasodium salt................... 2429-74-5 ........... 10/04/82 10/04/92
[[Page 71]]
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl-
[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-
hydroxy-, tetrasodium salt........................... 72-57-1 ........... 10/04/82 10/04/92
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl-
[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis-[4,5-dihydroxy-
, tetrasodium salt................................... 2150-54-1 ........... 10/04/82 10/04/92
1-Naphthalenesulfonic acid, 3-[[4'[(6-amino-1-hydroxy-
3-sulfo-2-naphthalenyl)azo]-3,3'-dimethoxy[1,1'-
biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt........ 6449-35-0 ........... 10/04/82 10/04/92
1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-
diyl-4,4'-diyl)bis(azo)]bis[(4-amino-,disodium salt.. 573-58-0 ........... 10/04/82 10/04/92
1-Naphthalenesulfonic acid, 3,3'-[3,3'-dimethoxy-[1,1'-
biphenyl]-4,4'-diyl)bis(azo)]bis[4-hydroxy-, disodium
salt................................................. 2429-71-2 ........... 10/04/82 10/04/92
1-Naphthalenesulfonic acid, 3,3'-[(3,3'dimethyl[1,1'-
biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-,disodium
salt................................................. 992-59-6 ........... 10/04/82 10/04/92
Chlorinated benzenes, mono-, di-, tri-, tetra-, and
penta-................................................. .............. ........... 10/04/82 10/04/92
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
naphthalene (empirical formula) C10HxCly where x+y=8... .............. ........... 10/04/82 12/29/88
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
chlorinated paraffin waxes, with chlorine content of 35
percent through 70 percent by weight................... .............. ........... 10/04/82 10/04/92
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
(mixed isomers) and the ortho (1,2-), meta (1,3-) and
para (1,4-) isomers.................................... .............. ........... 04/29/83 12/29/88
Benzene, 1-ethyl-2-methyl-............................ 611-14-3 ........... 04/29/83 12/29/88
Fluoroalkenes--This category is defined as fluroalkenes
of the general formula: CnH2n-xFx where n equals 2 to
3 and X equals 1 to 6.................................. .............. ........... 04/29/83 04/29/93
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 72]]
----------------------------------------------------------------------------------------------------------------
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)
ester................................................ 5493-45-8 ........... 10/04/82 10/04/92
Disiloxane, 1,1,3,3-tetramethyl-1,3-bis[3-
oxiranylmethoxy)propyl]-............................. 126-80-7 ........... 10/04/82 10/04/92
2,4-Imidazolidinedione, 5,5-dimethyl-3-[2-
(oxiranylmethoxy)propyl]-1-(oxiranylmethyl)-......... 32568-89-1 ........... 10/04/82 10/04/92
2,4-Imidazolidenedione, 3,3'-[2-(oxiranylmethoxy)-1,3-
propanediyl]bis[5,5-dimethyl-1-(oxiranyl-methyl)-.... 38304-52-8 ........... 10/04/82 10/04/92
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
(methyleneoxymethylene)]bis-......................... 14228-73-0 ........... 10/04/82 10/04/92
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-
propanediyl)bis(oxymethylene)]bis-................... 17557-23-2 ........... 10/04/82 10/04/92
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-
(4,1-phenyleneoxymethylene)]tetrakis-................ 7328-97-4 ........... 10/04/82 10/04/92
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-
(oxymethylene)]tris-................................. 68959-23-9 ........... 10/04/82 10/04/92
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-
phenyleneoxymethylene)]bis-.......................... 54208-63-8 ........... 10/04/82 10/04/92
Oxirane, [(1-methylethoxy)methyl]-.................... 4016-14-2 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[(1-methylethylidene)bis[4,1-phenyl-
eneoxy[1-(butoxymethyl)-2,1-
ethanediyl]oxymethylene]]bis-........................ 71033-08-4 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1-methylethylidene) bis(4,1-phenyl-
eneoxymethylene)]bis-................................ 1675-54-3 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[(1-methylethylidene)bis(4,1-phenyl-
eneoxymethylene)[bis-, homopolymer................... 25085-99-8 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[(1-methylethylidene)bis[4,1-
phenyleneoxy-3,1-propanediyloxy-4,1-phenylene(1-
methylethylidene)-4,1-phenyleneoxymethylene]]bis-.... 72319-24-5 ........... 10/04/82 10/04/92
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 73]]
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-
phenylene]bis(methylene)]bis-........................ 13561-08-5 ........... 10/04/82 10/04/92
Oxirane, 2,2-[[[2-oxiranylmethyoxy)
phenyl]methylene]bis(4,1-phenyl-eneoxymethylene)]bis- 67786-03-2 ........... 10/04/82 10/04/92
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, 2,2,2-[1,2,3-propanetriyl
tris(oxymethylene)]tris-............................. 13236-02-7 ........... 10/04/82 10/04/92
Oxirane, [(2-propenyloxy)methyl]-..................... 106-92-3 ........... 10/04/82 10/04/92
Oxirane, 2,2,2-[propylidynetris (4,1-
phenyleneoxymethylene)]tris-......................... 68517-02-2 ........... 10/04/82 10/04/92
Oxirane, [(tetradecyloxy)methyl]-..................... 38954-75-5 ........... 10/04/82 10/04/92
Oxiranecarboxylic acid, 3-methyl-3-phenyl-, ethyl
ester................................................ 77-83-8 ........... 10/04/82 10/04/92
Poly(oxy-1,2-ethanediyl),--[4-
oxiranylmethyoxy)benzoyl]--[[4-
oxiranylmethoxy)benzoyl]oxy]-........................ 69943-75-5 ........... 10/04/82 10/04/92
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-
(oxiranylmethoxy)propyl]-............................ 71808-64-5 ........... 10/04/82 10/04/92
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-
(oxiranylmethoxy)propyl]-............................ 69155-42-6 ........... 10/04/82 10/04/92
Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[3-(oxiranyl-
methoxy)propyl]-..................................... 7422-52-8 ........... 10/04/82 10/04/92
Halogenated alkyl epoxides--halogenated noncyclic
aliphatic hydrocarbons with one or more epoxy
functional groups...................................... .............. ........... 10/04/82 12/29/88
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
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-
tridecafluoroheptyl)-................................ 38565-52-5 ........... 10/04/82 12/29/88
[[Page 74]]
Phenylenediamines (Benzenediamines). This category is
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................................... .............. ........... 04/29/83 04/29/93
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 75]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special
Category CAS No. (exemptions for category) Exemptions Effective Date Sunset Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aldehydes:......................................
Acetaldehyde.................................. 75-07-0...................................... ................. 9/30/91 9/30/01
Acetaldehyde, chloro-......................... 107-20-0..................................... ................. 9/30/91 9/30/01
Acetaldehyde, (1,3-dihydro-1,3,3-trimethyl-2H- 84-83-3...................................... ................. 9/30/91 9/30/01
indol-2-ylidene).
Acetaldehyde, trichloro-...................... 75-87-6...................................... ................. 9/30/91 9/30/01
Benzaldehyde.................................. 100-52-7..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 3-bromo-........................ 3132-99-8.................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-butyl-........................ 1200-14-2.................................... ................. 9/30/91 12/19/95
Benzaldehyde, 2-chloro-....................... 89-98-5...................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-chloro-....................... 104-88-1..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-(diethylamino)-............... 120-21-8..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-(diethylamino)-2-hydroxy-..... 17754-90-4................................... ................. 9/30/91 9/30/01
Benzaldehyde, 2,4-dihydroxy-.................. 95-01-2...................................... ................. 9/30/91 12/19/95
Benzaldehyde, 2,5-dimethoxy-.................. 93-02-7...................................... ................. 9/30/91 9/30/01
Benzaldehyde, 3,4-dimethoxy-.................. 120-14-9..................................... ................. 9/30/91 9/30/01
Benzaldehyde, (dimethylamino)-................ 28602-27-9................................... ................. 9/30/91 12/19/95
Benzaldehyde, 4-(dimethylamino)-.............. 100-10-7..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-ethoxy-....................... 10031-82-0................................... ................. l9/30/91 12/19/95
Benzaldehyde, 3-ethoxy-4-hydroxy-............. 121-32-4..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 2-hydroxy-...................... 90-02-8...................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-hydroxy-...................... 123-08-0..................................... ................. 9/30/91 12/19/95
Benzaldehyde, 4-hydroxy-3-methoxy-............ 121-33-5..................................... ................. 9/30/91 9/30/01
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 9/30/01
Benzaldehyde, methyl-......................... 1334-78-7.................................... ................. 9/30/91 12/19/95
Benzaldehyde, 4-methyl-....................... 104-87-0..................................... ................. 9/30/91 9/30/01
Benzaldehyde, 2-nitro-........................ 552-89-6..................................... ................. 9/30/91 12/19/95
Benzaldehyde, 3-phenoxy-...................... 39515-51-0................................... ................. 9/30/91 9/30/01
Benzaldehyde, 4-(trifluoromethyl)-............ 455-19-6..................................... ................. 9/30/91 12/19/95
Benzeneacetaldehyde........................... 122-78-1..................................... ................. 9/30/91 9/30/01
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 9/30/01
methylethyl)-.
1,3-Benzodioxole-5-carboxaldehyde............. 120-57-0..................................... ................. 9/30/91 9/30/01
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 9/30/01
3-Cyclohexene-1-carboxaldehyde................ 100-50-5..................................... ................. 9/30/91 9/30/01
3-Cyclohexene-1-carboxaldehyde, dimethyl-..... 27939-60-2................................... ................. 9/30/91 9/30/01
3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4- 31906-04-4................................... ................. 9/30/91 9/30/01
methylpentyl)-.
3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4- 52475-86-2................................... ................. 9/30/91 9/30/01
methyl-3-pentenyl)-.
3-Cyclohexene-1-carboxaldehyde, 1-methyl-4-(4- 66327-54-6................................... ................. 9/30/91 9/30/01
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 9/30/01
.
Decanal....................................... 112-31-2..................................... ................. 9/30/91 9/30/01
[[Page 76]]
4a(4H)-Dibenzofurancarboxaldehyde, 126-15-8..................................... ................. 9/30/91 9/30/01
1,5a,6,9,9a,9b-hexahydro-.
Dodecanal..................................... 112-54-9..................................... ................. 9/30/91 9/30/01
Ethanedial.................................... 107-22-2..................................... ................. 9/30/91 9/30/01
Heptanal...................................... 111-71-7..................................... ................. 9/30/91 9/30/01
Heptanal, 2-(phenylmethylene)-................ 122-40-7..................................... ................. 9/30/91 9/30/01
5-Heptenal, 2,6-dimethyl-..................... 106-72-9..................................... ................. 9/30/91 12/19/95
Hexanal, 2-ethyl-............................. 123-05-7..................................... ................. 9/30/91 9/30/01
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 9/30/01
1-Naphthalene carboxaldehyde.................. 66-77-3...................................... ................. 9/30/91 12/19/95
Nonanal....................................... 124-19-6..................................... ................. 9/30/91 9/30/01
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 9/30/01
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 9/30/01
Octanal, 7-methoxy-3,7-dimethyl-.............. 3613-30-7.................................... ................. 9/30/91 9/30/01
Octanal, 2-(phenylmethylene)-................. 101-86-0..................................... ................. 9/30/91 9/30/01
6-Octenal, 3,7-dimethyl-...................... 106-23-0..................................... ................. 9/30/91 9/30/01
6-Octenal, 3,7-dimethyl-, (S)-................ 5949-05-3.................................... ................. 9/30/91 12/19/95
Pentanal...................................... 110-62-3..................................... ................. 9/30/91 9/30/01
Pentanedial................................... 111-30-8..................................... ................. 9/30/91 9/30/01
1-Piperidinecarboxaldehyde.................... 2591-86-8.................................... ................. 9/30/91 9/30/01
Propanal...................................... 123-38-6..................................... ................. 9/30/91 9/30/01
Propanal, 3-hydroxy-2,2-dimethyl-............. 597-31-9..................................... ................. 9/30/91 9/30/01
2-Propenal, 2-methyl-......................... 78-85-3...................................... ................. 9/30/91 12/19/95
Propanal, 3-(methylthio)-..................... 3268-49-3.................................... ................. 9/30/91 9/30/01
2-Propenal.................................... 107-02-8..................................... ................. 9/30/91 9/30/01
2-Propenal, 3- 4-(1,1-dimethylethyl)phenyl -2- 13586-68-0................................... ................. 9/30/91 9/30/01
methyl-.
2-Propenal, 3-(2-methoxyphenyl)-.............. 1504-74-1.................................... ................. 9/30/91 9/30/01
2-Propenal, 2-methyl-......................... 78-85-3...................................... ................. 9/30/91 9/30/01
2-Propenal, 2-methyl-3-phenyl-................ 101-39-3..................................... ................. 9/30/91 9/30/01
2-Propenal, 3-phenyl-......................... 104-55-2..................................... ................. 9/30/91 9/30/01
2-Propenal, 3-phenyl-, monopentyl deriv....... 1331-92-6.................................... ................. 9/30/91 9/30/01
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 9/30/01
Undecanal, 2-methyl-.......................... 110-41-8..................................... ................. 9/30/91 9/30/01
9-Undecenal................................... 143-14-6..................................... ................. 9/30/91 12/19/95
10-Undecenal.................................. 112-45-8..................................... ................. 9/30/91 9/30/01
Alkyl-, Chloro-, and Hydroxymethyl Diaryl
Ethers:.
Benzene, 1-(bromomethyl)-3-phenoxy-........... 51632-16-7................................... ................. 04/12/93 04/12/03
Benzenemethanol, 3-phenoxy-,.................. 13826-35-2................................... ................. 04/12/93 04/12/03
Benzenemethanol, 3-phenoxy-, acetate.......... 50789-44-1................................... ................. 4/12/93 12/19/95
Benzene, 1-methyl-3-phenoxy-.................. 3586-14-9.................................... ................. 04/12/93 04/12/03
Benzene, 1,1'-oxybis[dodecyl-................. 69834-19-1................................... ................. 4/12/93 12/19/95
[[Page 77]]
Benzene, 1,1,-oxybis[methyl-.................. 28299-41-4................................... ................. 04/12/93 04/12/03
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 04/12/03
(trifluoromethyl)phenoxy]-,.
Benzoic acid, 3-[2-chloro-4- 72242-48-3................................... ................. 04/12/93 04/12/03
(trifluoromethyl)phenoxy], potassium salt.
1,1-Biphenyl, phenoxy-........................ 28984-89-6................................... ................. 04/12/93 04/12/03
2-Chloro-1-(3-methylphenoxy)-4- 42874-96-4................................... ................. 04/12/93 04/12/03
(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 04/12/03
(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 10/29/00
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 3/29/06
) applies
2-Butylphenol................................. 3180-09-4.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
2-tert-Butylphenol............................ 88-18-6...................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-n-Butylphenol............................... 1638-22-8.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-sec-Butylphenol............................. 99-71-8...................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-tert-Butylphenol............................ 98-54-4...................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Decaethylene glycol 4-isoctylphenyl ether..... 2315-66-4.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-Dodecylphenol............................... 104-43-8..................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Dodecylphenol (mixed isomers)................. 1331-57-3.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Dedecylphenol (mixed isomers)................. 27193-86-8................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
[[Page 78]]
Hexaethylene glycol 4-isoctylphenyl ether..... 2497-58-7.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Isobutylphenol (mixed isomers)................ 31195-95-6................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Isononylphenol (mixed isomers)................ 11066-49-2................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-(1-Methylbutyl)phenol....................... 94-06-4...................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
(1-Methylheptyl)phenol (mixed isomers)........ 27985-70-2................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-(1-Methyloctyl)phenol....................... 17404-66-9................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Nonylphenol (mixed isomers)................... 1300-16-9.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
25154-52-3................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-Nonylphenol................................. 104-40-5..................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Branched 4-nonylphenol (mixed isomers)........ 84852-15-3................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
2-Octylphenol................................. 949-13-3..................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-Octylphenol................................. 1806-26-4.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-Pentylphenol................................ 14938-35-3................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
4-tert-Pentylphenol........................... 80-46-6...................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Polyethylene glycol mono(octyl)phenyl ether... 9036-19-5.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Polyethylene glycol 4-(tert-octyl)phenyl ether 9002-93-1.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Poly(oxy-1,2-ethanediyl), - 68987-90-6................................... Sec. 716.20(b)(4 3/29/96 3/29/06
(octylphenyl)--hydroxy-, branched. ) applies
2-(1,1,3,3-Tetramethylbutyl)phenol............ 3884-95-5.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
(1,1,3,3-Tetramethylbutyl)phenol (mixed 1322-69-6.................................... Sec. 716.20(b)(4 3/29/96 3/29/06
isomers). ) applies
27193-28-8................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
29932-96-5................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
30105-54-5................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
62744-41-6................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
[[Page 79]]
4-(2,2,3,3-Tetramethylbutyl)phenol............ 54932-78-4................................... Sec. 716.20(b)(4 3/29/96 3/29/06
) applies
Brominated flame retardants:....................
Alkanes, C10-18, bromochloro-................. 68955-41-9................................... ................. 10/29/90 12/19/95
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 10/29/00
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 10/29/00
Benzene, 1,2-dichloro-4-isocyanato-........... 102-36-3..................................... ................. 10/29/90 10/29/00
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 10/29/00
Benzene, 2-isocyanato-1,3-bis(1-methylethyl)-. 28178-42-9................................... ................. 10/29/90 11/09/93
[[Page 80]]
Benzene, 2-isocyanato-1,3-dimethyl-, ester.... 28556-81-2................................... ................. 10/29/90 11/09/93
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 10/29/00
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 10/29/00
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 3/11/04
) applies
n-Amyl acetate................................ 628-63-7..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
o-Anisidine................................... 90-04-0...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Benzyl chloride............................... 100-44-7..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
sec-Butyl acetate............................. 105-46-4..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
tert-Butyl acetate............................ 540-88-5..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
sec-Butyl alcohol............................. 78-92-2...................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
tert-Butyl alcohol............................ 75-65-0...................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
t-Butylcatechol............................... 98-29-3...................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
o-sec-butylphenol............................. 89-72-5...................................... ................. 3/11/94 3/11/04
Camphor....................................... 76-22-2...................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
[[Page 81]]
Carbon disulfide.............................. 75-15-0...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Catechol...................................... 120-80-9..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
a-Chloroacetophenone.......................... 532-27-4..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Chlorobenzene................................. 108-90-7..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
o-Chlorotoluene............................... 95-49-8...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Cyclohexene................................... 110-83-8..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Cyclohexanol.................................. 108-93-0..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Cyclopentadiene............................... 542-92-7..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Cyclopentane.................................. 287-92-3..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Diacetone alcohol............................. 123-42-2..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Dibutyl phosphate............................. 107-66-4..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
1,2-Dichloroethylene.......................... 540-59-0..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Dicylcopentadiene............................. 77-73-6...................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Dimethyl acetamide............................ 127-19-5..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Dimethylaniline............................... 121-69-7..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Dimethyl sulfate.............................. 77-78-1...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
m-Dinitrobenzene.............................. 99-65-0...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
o-Dinitrobenzene.............................. 528-29-0..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
p-Dinitrobenzene.............................. 100-25-4..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
2,4-Dinitrotoluene............................ 121-14-2..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Diphenylamine................................. 122-39-4..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) 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 3/11/04
) applies
Ethyl ether................................... 60-29-7...................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Heptane (n-Heptane)........................... 142-82-5..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
[[Page 82]]
Indene........................................ 95-13-6...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Isoamyl acetate............................... 123-92-2..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
N-Isopropylaniline............................ 768-52-5..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
p-Methoxyphenol............................... 150-76-5..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Methyl acetate................................ 79-20-9...................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Methylcyclohexane............................. 108-87-2..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Methyl formate................................ 107-31-3..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Methyl isoamyl ketone......................... 110-12-3..................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
p-Nitroaniline................................ 100-01-6..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
p-Nitrochlorobenzene.......................... 100-00-5..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
1-Nitropropane................................ 108-03-2..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
2-Nitropropane................................ 79-46-9...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
m-Nitrotoluene................................ 99-08-1...................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
o-Nitrotoluene................................ 88-72-2...................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
p-Nitrotoluene................................ 99-99-0...................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Nonane........................................ 111-84-2..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Pentane....................................... 109-66-0..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Phenylhydrazine............................... 100-63-0..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Propylene glycol dinitrate.................... 6423-43-4.................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
Sodium bisulfite.............................. 7631-90-5.................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Sodium metabisulfite.......................... 7681-57-4.................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Tetrahydrofuran............................... 109-99-9..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
m-Toluidine................................... 108-44-1..................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
[[Page 83]]
Vinylidene chloride........................... 75-35-4...................................... Sec. 716.20(b)(3 8/4/95 8/4/05
) and (b)(4)
apply
Vinyl toluene................................. 25013-15-4................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) applies
p-Xylene...................................... 106-42-3..................................... Sec. 716.20(b)(3 1/26/94 1/26/04
) applies
Xylidine...................................... 1300-73-8.................................... Sec. 716.20(b)(3 3/11/94 3/11/04
) 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
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 10/12/03
Decamethylcyclopentasiloxane.................. 541-02-6..................................... 10/12/93 10/12/03
Decamethyltetrasiloxane....................... 141-62-8..................................... 10/12/93 10/12/03
Dimethyldiphenylsiloxane...................... 68083-14-7................................... 10/12/93 10/12/03
Dimethylhydropolylsiloxane.................... 68037-59-2................................... 10/12/93 10/12/03
Dimethylmethyl 3,3,3-trifluoropropyl siloxane. 115361-68-7.................................. 10/12/93 10/12/03
Dimethylmethylvinylsiloxane................... 67762-94-1................................... 10/12/93 10/12/03
Dimethylpolysiloxanes......................... 68037-74-1................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Dimethyl silicones and siloxanes.............. 63148-62-9................................... 10/12/93 10/12/03
Dimethyl silicones and siloxane, reaction 67762-90-7................................... Sec. 716.20(b)(2 10/12/93 10/12/03
products with silica. ) applies
Docosamethylcycloundecasiloxane............... 18766-38-6................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Docosamethyldecasiloxane...................... 556-70-7..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Dodecamethylcyclohexasiloxane................. 540-97-6..................................... 10/12/93 10/12/03
Dodecamethylpentasiloxane..................... 141-63-9..................................... 10/12/93 10/12/03
Dotetracontamethyleicosasiloxane.............. 150027-00-2.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Dotriacontamethylcyclohexadecasiloxane........ 150026-95-2.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Dotriacontamethylpentadecasiloxane............ 2471-11-6.................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Eicosamethylcyclodecasiloxane................. 18772-36-6................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Eicosamethylnonasiloxane...................... 2652-13-3.................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
[[Page 84]]
Hexacosamethylcyclotridecasiloxane............ 23732-94-7................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Hexacosamethyldodecasiloxane.................. 2471-08-1.................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Hexadecamethylcyclooctasiloxane............... 556-68-3..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Hexadecamethylheptasiloxane................... 541-01-5..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Hexamethylcyclotrisiloxane.................... 541-05-9..................................... 10/12/93 10/12/03
Hexamethyldisilazane.......................... 999-97-3..................................... 10/12/93 10/12/03
Hexamethyldisiloxane.......................... 107-46-0..................................... 10/12/93 10/12/03
Hexatriacontamethylcyclooctadecasiloxane...... 23523-12-8................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Hexatriacontamethylheptadecasiloxane.......... 18844-04-7................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Methylpolysiloxane............................ 9004-73-3.................................... 10/12/93 10/12/03
Methylvinylcyclosiloxane...................... 2554-06-5.................................... 10/12/93 10/12/03
Siloxanes and silicones, di-Me, hydroxy- 70131-67-8................................... Sec. 716.20(b)(2 10/12/93 10/12/03
terminated. ) applies
Octacosamethylcyclotetradecasiloxane.......... 149050-40-8.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Octacosamethyltridecasiloxane................. 2471-09-2.................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Octadecamethylcyclononasiloxane............... 556-71-8..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Octadecamethyloctasiloxane.................... 556-69-4..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Octamethyltrisiloxane......................... 107-51-7..................................... 10/12/93 10/12/03
Octaphenylcyclotetrasiloxane.................. 546-56-5..................................... 10/12/93 10/12/03
Octatriacontamethylcyclononadecasiloxane...... 150026-97-4.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Octatriacontamethyloctadecasiloxane........... 36938-52-0................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Polymethyloctadecylsiloxane................... not available................................ Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetracontamethylcycloeicosasiloxane........... 150026-98-5.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetracontamethylnonadecasiloxane.............. 150026-99-6.................................. Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetracosamethylcyclododecasiloxane............ 18919-94-3................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetracosamethylundecasiloxane................. 107-53-9..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetradecamethylcycloheptasiloxane............. 107-50-6..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Tetradecamethylhexasiloxane................... 107-52-8..................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
[[Page 85]]
Tetramethylcyclotetrasiloxane................. 2370-88-9.................................... 10/12/93 10/12/03
Tetramethyldivinyldisiloxane.................. 2627-95-4.................................... 10/12/93 10/12/03
Tetratriacontamethylcycloheptadecasiloxane.... 150026-96-3.................................. 10/12/93 10/12/03
Tetratriacontamethylhexadecasiloxane.......... 36938-50-8................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Triacontamethylcyclopentadecasiloxane......... 23523-14-0................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Triacontamethyltetradecasiloxane.............. 2471-10-5.................................... Sec. 716.20(b)(2 10/12/93 10/12/03
) applies
Trifluoropropylmethylcyclotrisiloxane......... 2374-14-3.................................... 10/12/93 10/12/03
Substantially produced chemicals in need of
subchronic tests:.
Acetoacetanilide.............................. 102-01-2..................................... ................. 9/30/91 12/19/95
4-(Acetylamino)benzenesulfonyl chloride....... 121-60-8..................................... ................. 9/30/91 9/30/01
2-(2-Aminoethoxy)-ethanol..................... 929-06-6..................................... ................. 6/30/92 6/30/02
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 9/30/01
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 9/30/01
1,3-Dicyanobenzene............................ 626-17-5..................................... ................. 9/30/91 9/30/01
Diethylene glycol dimethyl ether.............. 111-96-6..................................... ................. 9/30/91 9/30/01
4-Ethoxynitrobenzene.......................... 100-29-8..................................... ................. 9/30/91 9/30/01
2-Ethylanthraquinone.......................... 84-51-5...................................... ................. 9/30/91 12/19/95
Hexa(methoxymethyl) melamine.................. 3089-11-0.................................... ................. 9/30/91 9/30/01
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 9/30/01
2-(4-Morpholinyldithio)-benzothiazole......... 95-32-9...................................... ................. 9/30/91 12/19/95
Naphthalenedicarboxylic anhydride............. 81-84-5...................................... ................. 9/30/91 9/30/01
1-Naphthol.................................... 90-15-3...................................... ................. 9/30/91 12/19/95
p,p'-Oxybis(benzenesulfonylhydrazide)......... 80-51-3...................................... ................. 9/30/91 9/30/01
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 9/30/01
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
[[Page 86]]
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
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]
Editorial Note: 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.
[[Page 87]]
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 servere 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.
[[Page 88]]
(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, 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.
[[Page 89]]
(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]
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
[[Page 90]]
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 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
[[Page 91]]
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.
(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
[[Page 92]]
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., 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.
[[Page 93]]
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.
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. 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]
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.
[[Page 94]]
(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.
(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
[[Page 95]]
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 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
[[Page 96]]
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, 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.
[[Page 97]]
(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]
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
[[Page 98]]
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:
(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
[[Page 99]]
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 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
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\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.)
[[Page 100]]
(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 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
[[Page 101]]
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.
(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
[[Page 102]]
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.
(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
[[Page 103]]
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 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.
[[Page 104]]
(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
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
[[Page 105]]
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.
(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
[[Page 106]]
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:
(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
[[Page 107]]
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.
(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.
[[Page 108]]
(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.
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
[[Page 109]]
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.
(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
[[Page 110]]
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 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
[[Page 111]]
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 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.
[[Page 112]]
(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).
(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
[[Page 113]]
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 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
[[Page 114]]
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 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:
[[Page 115]]
(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.
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) Informaton 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]
[[Page 116]]
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 (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
[[Page 117]]
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]
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).