[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 40

Protection of Environment


________________________

Parts 723 to 789

                         Revised as of July 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2017
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

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[[Page iii]]




                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 40:
          Chapter I--Environmental Protection Agency 
          (Continued)                                                3
  Finding Aids:
      Table of CFR Titles and Chapters........................     427
      Alphabetical List of Agencies Appearing in the CFR......     447
      List of CFR Sections Affected...........................     457

[[Page iv]]


      


                     ----------------------------

                     Cite this Code:  CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 40 CFR 723.50 refers 
                       to title 40, part 723, 
                       section 50.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, July 1, 2017), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
(LSA). For the convenience of the reader, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
an approved incorporation by reference, please contact the agency that 
issued the regulation containing that incorporation. If, after 
contacting the agency, you find the material is not available, please 
notify the Director of the Federal Register, National Archives and 
Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, 
or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
and Rules. A list of CFR titles, chapters, subchapters, and parts and an 
alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, 8601 Adelphi Road, College Park, MD 
20740-6001 or e-mail [email protected]

SALES

    The Government Publishing Office (GPO) processes all sales and 
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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, the LSA (List of 
CFR Sections Affected), The United States Government Manual, the Federal 
Register, Public Laws, Public Papers of the Presidents of the United 
States, Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format via www.ofr.gov. For more 
information, contact the GPO Customer Contact Center, U.S. Government 
Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-
mail, [email protected]
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal-
register.
    The e-CFR is a regularly updated, unofficial editorial compilation 
of CFR material and Federal Register amendments, produced by the Office 
of the Federal Register and the Government Publishing Office. It is 
available at www.ecfr.gov.

    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    July 1, 2017.

                                
                                      
                            

  

[[Page ix]]



                               THIS TITLE

    Title 40--Protection of Environment is composed of thirty-seven 
volumes. The parts in these volumes are arranged in the following order: 
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
60.499) , part 60 (60.500-end of part 60, sections), part 60 
(Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63 
(63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts 
72-79, part 80, part 81, parts 82-86, parts 87-95, parts 96-99, parts 
100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-265, 
parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts 700-
722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to 
end. The contents of these volumes represent all current regulations 
codified under this title of the CFR as of July 1, 2017.

    Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. Regulations issued by the Council on Environmental 
Quality, including an Index to Parts 1500 through 1508, appear in the 
volume containing parts 1060 to end. The OMB control numbers for title 
40 appear in Sec. 9.1 of this chapter.

    For this volume, Ann Worley was Chief Editor. The Code of Federal 
Regulations publication program is under the direction of John Hyrum 
Martinez, assisted by Stephen J. Frattini.

[[Page 1]]



                   TITLE 40--PROTECTION OF ENVIRONMENT




                  (This book contains parts 723 to 789)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Environmental Protection Agency (Continued)......         723

[[Page 3]]



         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 65 FR 
47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001.

               SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT
Part                                                                Page
723             Premanufacture notification exemptions......           5
725             Reporting requirements and review processes 
                    for microorganisms......................          27
745             Lead-based paint poisoning prevention in 
                    certain residential structures..........          73
747             Metalworking fluids.........................         140
749             Water treatment chemicals...................         145
750             Procedures for rulemaking under section 6 of 
                    the Toxic Substances Control Act........         148
761             Polychlorinated biphenyls (PCBs) 
                    manufacturing, processing, distribution 
                    in commerce, and use prohibitions.......         154
763             Asbestos....................................         285
766             Dibenzo-para-dioxins/dibenzofurans..........         380
767-769

[Reserved]

770             Formaldehyde standards for composite wood 
                    products................................         390
771-789

[Reserved]

[[Page 5]]



                SUBCHAPTER R_TOXIC SUBSTANCES CONTROL ACT





PART 723_PREMANUFACTURE NOTIFICATION EXEMPTIONS--Table of Contents



Subpart A [Reserved]

                      Subpart B_Specific Exemptions

Sec.
723.50  Chemical substances manufactured in quantities of 10,000 
          kilograms or less per year, and chemical substances with low 
          environmental releases and human exposures.
723.175  Chemical substances used in or for the manufacture or 
          processing of instant photographic and peel-apart film 
          articles.
723.250  Polymers.

    Authority: 15 U.S.C. 2604.

Subpart A [Reserved]



                      Subpart B_Specific Exemptions



Sec. 723.50  Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low environmental
releases and human exposures.

    (a) Purpose and scope. (1) This section grants an exemption from the 
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic 
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
    (i) Chemical substances manufactured in quantities of 10,000 
kilograms or less per year.
    (ii) Chemical substances with low environmental releases and human 
exposures.
    (2) To manufacture a new chemical substance under the terms of this 
exemption a manufacturer must:
    (i) Submit a notice of intent to manufacture 30 days before 
manufacture begins, as required under paragraph (e) of this section.
    (ii) Comply with all other provisions of this section.
    (3) This section does not apply to microorganisms subject to part 
725 of this chapter.
    (b) Definitions. The following definitions apply to this subpart.
    (1) Act means the Toxic Substances Control Act (15 U.S.C. 2601 et 
seq).
    (2) Consumer means a private individual who uses a chemical 
substance or any product containing the chemical substance in or around 
a permanent or temporary household or residence, during recreation, or 
for any personal use or enjoyment.
    (3) Environment has the same meaning as in section 3 of the Act (15 
U.S.C. 2602).
    (4) Environmental transformation product means any chemical 
substance resulting from the action of environmental processes on a 
parent compound that changes the molecular identity of the parent 
compound.
    (5) Metabolite means a chemical entity produced by one or more 
enzymatic or nonenzymatic reactions as a result of exposure of an 
organism to a chemical substance.
    (6) Serious acute effects means human disease processes or other 
adverse effects that have short latency periods for development, result 
from short-term exposure, or are a combination of these factors and that 
are likely to result in death, severe or prolonged incapacitation, 
disfigurement, or severe or prolonged loss of the ability to use a 
normal bodily or intellectual function with a consequent impairment of 
normal activities.
    (7) Serious chronic effects means human disease processes or other 
adverse effects that have long latency periods for development, result 
from long-term exposure, are long-term illnesses, or are a combination 
of these factors and that are likely to result in death, severe or 
prolonged incapacitation, disfigurement, or severe or prolonged loss of 
the ability to use a normal bodily or intellectual function with a 
consequent impairment of normal activities.
    (8) Significant environmental effects means:
    (i) Any irreversible damage to biological, commercial, or 
agricultural resources of importance to society;
    (ii) Any reversible damage to biological, commercial, or 
agricultural resources of importance to society if the

[[Page 6]]

damage persists beyond a single generation of the damaged resource or 
beyond a single year; or
    (iii) Any known or reasonably anticipated loss of members of an 
endangered or threatened species. Endangered or threatened species are 
those species identified as such by the Secretary of the Interior in 
accordance with the Endangered Species Act, as amended (16 U.S.C. 1531).
    (9) Site means a contiguous property unit. Property divided only by 
a public right-of-way is one site. There may be more than one 
manufacturing plant on a single site.
    (10) The terms byproduct, EPA, importer, impurity, known to or 
reasonably ascertainable, manufacture, manufacturer, new chemical 
substance, person, possession or control, and test data have the same 
meanings as in Sec. 720.3 of this chapter.
    (c) Exemption categories. Except as provided in paragraph (d) of 
this section, this exemption applies to:
    (1) Any manufacturer of a new chemical substance manufactured in 
quantities of 10,000 kilograms or less per year under the terms of this 
exemption.
    (2) Any manufacturer of a new chemical substance satisfying all of 
the following low environmental release and low human exposure 
eligibility criteria:
    (i) Consumers and the general population. For exposure of consumers 
and the general population to the new chemical substance during all 
manufacturing, processing, distribution in commerce, use, and disposal 
of the substance:
    (A) No dermal exposure.
    (B) No inhalation exposure (except as described in paragraph 
(c)(2)(iv) of this section.
    (C) Exposure in drinking water no greater than a 1 milligram per 
year (estimated average dosage resulting from drinking water exposure in 
streams from the maximum allowable concentration level from ambient 
surface water releases established under paragraph (c)(2)(iii) of this 
section or a higher concentration authorized by EPA under paragraph 
(c)(2)(iii) of this section).
    (ii) Workers. For exposure of workers to the new chemical substance 
during all manufacturing, processing, distribution in commerce, use and 
disposal of the substance:
    (A) No dermal exposure (this criterion is met if adequate dermal 
exposure controls are used in accordance with applicable EPA guidance).
    (B) No inhalation exposure (this criterion is considered to be met 
if adequate inhalation exposure controls are used in accordance with 
applicable EPA guidance).
    (iii) Ambient surface water. For ambient surface water releases, no 
releases resulting in surface water concentrations above 1 part per 
billion, calculated using the methods prescribed in Secs. 721.90 and 
721.91, unless EPA has approved a higher surface water concentration 
supported by relevant and scientifically valid data submitted to EPA in 
a notice under paragraph (e) of this section on the substance or a close 
structural analogue of the substance which demonstrates that the new 
substance will not present an unreasonable risk of injury to aquatic 
species or human health at the higher concentration.
    (iv) Incineration. For ambient air releases from incineration, no 
releases of the new chemical substance above 1 microgram per cubic meter 
maximum annual average concentration, calculated using the formula:

    (kg/day of release after treatment) multiplied by (number of release 
days per year) multiplied by (9.68  x  10-6) micrograms per 
cubic meter.

    (v) Land or groundwater. For releases to land or groundwater, no 
releases to groundwater, to land, or to a landfill unless the 
manufacturer has demonstrated to EPA's satisfaction in a notice under 
paragraph (e) of this section that the new substance has negligible 
groundwater migration potential.
    (d) Chemical substances that cannot be manufactured under this 
exemption. A new chemical substance cannot be manufactured under this 
section, notwithstanding satisfaction of the criterion of paragraphs 
(c)(1) or (c)(2) of

[[Page 7]]

this section, if EPA determines, in accordance with paragraph (g) of 
this section, that the substance, any reasonably anticipated 
metabolites, environmental transformation products, or byproducts of the 
substance, or any reasonably anticipated impurities in the substance may 
cause, under anticipated conditions of manufacture, processing, 
distribution in commerce, use, or disposal of the new chemical 
substance:
    (1) Serious acute (lethal or sublethal) effects.
    (2) Serious chronic (including carcinogenic and teratogenic) 
effects.
    (3) Significant environmental effects.
    (e) Exemption notice. (1) A manufacturer applying for an exemption 
under either paragraph (c)(1) or (c)(2) of this section must submit an 
exemption notice to EPA at least 30 days before manufacture of the new 
chemical substance begins. Exemption notices and modifications must be 
submitted to EPA on EPA Form No. 7710-25 via CDX using e-PMN software in 
the manner set forth in this paragraph. See 40 CFR 720.40(a)(2)(ii) for 
information on how to obtain e-PMN software. Notices and any related 
support documents, must be generated and completed (via CDX) using e-PMN 
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain 
e-PMN software.
    (2) The notice shall contain the information described below, 
pursuant to the referenced provisions of Sec. 720.45.
    (i) Manufacturer identity.
    (ii) Chemical identity (Sec. 720.45(a)).
    (iii) Impurities (Sec. 720.45(b)).
    (iv) Known synonyms or trade names (Sec. 720.45(c)).
    (v) Byproducts (Sec. 720.45(d)).
    (vi) Production volume (Sec. 720.45(e)). (A) Manufacturers 
submitting an exemption application under paragraph (c)(1) of this 
section will be assumed to be manufacturing at an annual production 
volume of 10,000 kilograms. Manufacturers who intend to manufacture an 
exempted substance at annual volumes of less than 10,000 kilograms and 
wish EPA to conduct its risk assessment based upon such lesser annual 
production level rather than a 10,000-kilograms level, may so specify by 
writing the lesser annual production volume in the appropriate box on 
the PMN form and marking the adjacent binding option box. Manufacturers 
who opt to specify annual production levels below 10,000 kilograms and 
who mark the production volume binding option box shall not manufacture 
more than the specific annual amount of the exempted substance unless a 
new exemption notice for a higher (up to 10,000 kgs) manufacturing 
volume is submitted and approved pursuant to this section.
    (B) Manufacturers submitting an exemption under paragraph (c)(2) of 
this section shall list the estimated maximum amount to be manufactured 
during the first year of production and the estimated maximum amount to 
be manufactured during any 12-month period during the first 3 years of 
production.
    (vii) Description of intended categories of use (Sec. 720.45(f)).
    (viii) For manufacturer-controlled sites, the manufacturer shall 
supply identity of manufacturing sites, process descriptions, and worker 
exposure and environmental release information (Sec. 720.45(g)); for 
sites not controlled by the manufacturer, processing and use operation 
descriptions, estimated number of processing and use sites, and worker 
exposure/environmental release information (Sec. 720.45(h)). A 
manufacturer applying for an exemption under paragraph (c)(1) of this 
section need not provide information on worker exposure and 
environmental release referenced in paragraphs (e)(2)(viii) of this 
section if such information is not known or not readily available to the 
manufacturer. To assist in reporting this information, manufacturers may 
obtain a copy of EPA's Guidance for Reporting Occupational Exposure and 
Environmental Release Information under 40 CFR 723.50, available from 
the Environmental Assistance Division at the address listed in paragraph 
(e)(1) of this section. Where worker exposure and environmental release 
information is not supplied by the manufacturer, EPA will generally 
apply ``bounding estimates'' (i.e., exposure estimates higher than those 
incurred by persons in the population with the highest exposure) to 
account for uncertainties in actual exposure and release scenarios.

[[Page 8]]

    (ix) Type and category of notice. The manufacturer must clearly 
indicate on the first page of the PMN form that the submission is a 
``TSCA section 5(h)(4) exemption notice,'' and must indicate whether the 
notice is being submitted under paragraph (c)(1) or (c)(2) of this 
section. Manufacturers of chemical substances that qualify for an 
exemption under both paragraph (c)(1) and (c)(2) of this section may 
apply for either exemption, but not both.
    (x) Test data (Sec. 720.50).
    (xi) Certification. In addition to the certifications required in 
EPA form 7710-25, the following certifications shall be included in 
notices under this section. The manufacturer must certify that:
    (A) The manufacturer intends to manufacture or import the new 
chemical substance for commercial purposes, other than in small 
quantities solely for research and development, under the terms of this 
section.
    (B) The manufacturer is familiar with the terms of this section and 
will comply with those terms.
    (C) The new chemical substance for which the notice is submitted 
meets all applicable exemption conditions.
    (D) For substances manufactured under paragraph (c)(1) of this 
section, the manufacturer intends to commence manufacture of the 
exempted substance for commercial purposes within 1 year of the date of 
the expiration of the 30-day review period.
    (xii) Sanitized copy of notice. (A) The manufacturer must make all 
claims of confidentiality in accordance with paragraph (l) of this 
section. If any information is claimed confidential, the manufacturer 
must submit a second copy of the notice, with all information claimed as 
confidential deleted, in accordance with paragraph (l)(3) of this 
section.
    (B) If the manufacturer does not provide the second copy, the 
submission will be considered incomplete.
    (3) Incomplete notices. If EPA receives a submission which does not 
include all of the information required under this paragraph (e) of this 
section, the submission will be determined to be incomplete by EPA. When 
a submission for a new chemical substance has been determined to be 
incomplete, a manufacturer reapplying for an exemption for the new 
chemical substance must submit a new exemption notice containing all the 
information required under this paragraph (e) of this section including 
a certification page containing an original dated signature; partial 
submissions sent to EPA to supplement notices declared incomplete will 
not be accepted. Photocopied pages from previously submitted exemption 
forms will be accepted provided that the certifications page contains an 
original dated signature.
    (f) Multiple exemption holders. (1) A manufacturer who intends to 
manufacture a substance for which an exemption under this section was 
previously approved may apply for an exemption under paragraph (c)(1) or 
(c)(2) of this section; however, EPA will not approve any subsequent 
exemption application under paragraph (c)(1) of this section unless it 
can determine that the potential human exposure to, and environmental 
release of, the new chemical substance at the higher aggregate 
production volume will not present an unreasonable risk of injury to 
human health or the environment.
    (2)(i) If EPA proposes to deny an exemption application for a 
substance for which another manufacturer currently holds an exemption, 
and that proposed denial is based exclusively on the cumulative human 
exposure or environmental release of the substance which precludes the 
EPA from determining that the subsequent applicant's activities will not 
present an unreasonable risk of injury to human health or the 
environment, the EPA will notify the first exemption holder that it 
must, within 21 days of its receipt of EPA's notice, either:
    (A) Provide a new certification that it has commenced, or that it 
will commence, manufacture of the new chemical substance under this 
section within 1 year of the expiration of its exemption review period; 
or
    (B) Withdraw its exemption for the new chemical substance.
    (ii) If the first exemption holder does not respond to the EPA's 
notice under paragraph (f)(2)(i) of this section within the prescribed 
time period, EPA shall issue a notice of ineligibility to the first 
exemption holder under the

[[Page 9]]

provisions of paragraph (h)(2) of this section.
    (g) Review period. (1) EPA will review the notice submitted under 
paragraph (e) of this section to determine whether manufacture of the 
new chemical substance is eligible for the exemption. The review period 
will end 30 days after receipt of the notice by the TSCA Document 
Control Officer. To provide additional time to address any unresolved 
issues concerning an exemption application, the exemption applicant may, 
at any time during the review period, request a suspension of the review 
period pursuant to the provisions of Sec. 720.75(b) of this chapter.
    (2) Upon expiration of the 30-day review period, if EPA has taken no 
action, the manufacturer may consider its exemption approved and begin 
to manufacture the new chemical substance under the terms described in 
its notice and in this section.
    (h) Notice of ineligibility--(1) During the review period. If the 
EPA determines during the review period that manufacture of the new 
chemical substance does not meet the terms of this section or that there 
are issues concerning toxicity or exposure that require further review 
which cannot be accomplished within the 30-day review period, EPA will 
notify the manufacturer by telephone that the substance is not eligible. 
This telephone notification will subsequently be confirmed by certified 
letter that identifies the reasons for the ineligibility determination. 
The manufacturer may not begin manufacture of the new chemical substance 
without complying with section 5(a)(1) of the Act or submitting a new 
notice under paragraph (e) of this section that satisfies EPA's 
concerns.
    (2) After the review period. (i)(A) If at any time after the review 
period specified in paragraph (g) of this section the Assistant 
Administrator for the Office of Chemical Safety and Pollution Prevention 
(``the Assistant Administrator'') makes a preliminary determination that 
manufacture of the new chemical substance does not meet the terms of 
this section, the Assistant Administrator will notify the manufacturer 
by certified letter that EPA believes that the new chemical substance 
does not meet the terms of the section.
    (B) The manufacturer may continue to manufacture, process, 
distribute in commerce, and use the substance after receiving the notice 
under paragraph (h)(2)(i)(A) of this section if the manufacturer was 
manufacturing, processing, distributing in commerce, or using the 
substance at the time of the notification and if the manufacturer 
submits objections or an explanation under paragraph (h)(2)(ii) of this 
section. Manufacturers not manufacturing, processing, distributing in 
commerce, or using the substance at the time of the notification may not 
begin manufacture until EPA makes its final determination under 
paragraph (h)(2)(iii) of this section.
    (ii) A manufacturer who has received notice under paragraph 
(h)(2)(i)(A) of this section may submit, within 15 days of receipt of 
written notification, detailed objections to the determination or an 
explanation of its diligence and good faith efforts in attempting to 
comply with the terms of this section.
    (iii) The Assistant Administrator will consider any objections or 
explanation submitted under paragraph (h)(2)(ii) of this section and 
will make a final determination. The Assistant Administrator will notify 
the manufacturer of the final determination by telephone within 15 days 
of receipt of the objections or explanation, and subsequently by 
certified letter.
    (iv) If the Assistant Administrator determines that manufacture of 
the new chemical substance meets the terms of this section, the 
manufacturer may continue or resume manufacture, processing, 
distribution in commerce, and use in accordance with the terms of this 
section.
    (v) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer did not act with due diligence and in good faith 
to meet the terms of this section, the manufacturer must cease any 
continuing manufacture, processing, distribution in commerce, and use of 
the new chemical substance within 7 days of the written notification 
under paragraph (h)(2)(iii) of this section. The manufacturer may not 
resume manufacture, processing, distribution in commerce, and use of

[[Page 10]]

the new chemical substance until it submits a notice under section 
5(a)(1) of the Act and part 720 of this chapter and the notice review 
period has ended.
    (vi) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer acted with due diligence and in good faith to meet 
the terms of this section, the manufacturer may continue manufacture, 
processing, distribution in commerce, and use of the new chemical 
substance if:
    (A) It was actually manufacturing, processing, distributing in 
commerce, or using the chemical substance at the time it received the 
notification specified in paragraph (h)(2)(i)(A) of this section.
    (B) It submits a notice on the new chemical substance under section 
5(a)(1) of the Act and part 720 of this chapter within 15 days of 
receipt of the written notification under paragraph (h)(2)(iii) of this 
section. Such manufacture, processing, distribution in commerce, and use 
may continue unless EPA takes action under section 5(e) or 5(f) of the 
Act.
    (3) Action under this paragraph does not preclude action under 
sections 7, 15, 16, or 17 of the Act.
    (i) Additional information. If the manufacturer of a new chemical 
substance under the terms of this exemption obtains test data or other 
information indicating that the new chemical substance may not qualify 
under terms of this section, the manufacturer must submit these data or 
information to EPA within 15 working days of receipt of the information. 
If, during the notice review period specified in paragraph (g) of this 
section, the submitter obtains possession, control, or knowledge of new 
information that materially adds to, changes, or otherwise makes 
significantly more complete the information included in the notice, the 
submitter must send that information to the address listed on the notice 
form within 10 days of receiving the new information, but no later than 
5 days before the end of the notice review period. The new submission 
must clearly identify the submitter and the exemption notice to which 
the new information is related. If the new information becomes available 
during the last 5 days of the notice review period, the submitter must 
immediately inform its EPA contact for that notice by telephone.
    (j) Changes in manufacturing site, use, human exposure and 
environmental release controls, and certain manufacturing volumes. (1) 
Except as provided in paragraph (j)(6) of this section, chemical 
substances manufactured under this section must be manufactured at the 
site or sites described, for the uses described, and under the human 
exposure and environmental release controls described in the exemption 
notice under paragraph (e) of this section.
    (2) Where the manufacturer lists a specific physical form in which 
the new chemical substance will be manufactured, processed, and/or used, 
the manufacturer must continue manufacturing, processing, and/or using 
the new chemical substance in either the same physical form described in 
the notice under paragraph (e), or in a physical form which will not 
increase the human exposure to or environmental release of the new 
chemical substance over those exposures or releases resulting from the 
specified physical form (e.g., a manufacturer which specifies that the 
new chemical substance will be produced in a non-volatile liquid form 
generally may not change to a respirable powder form).
    (3) The annual production volume of chemical substances manufactured 
under paragraph (c)(1) of this section for which the manufacturer 
designated a binding annual production volume pursuant to paragraph 
(e)(2)(vi) of this section must not exceed that designated volume.
    (4) Any person who manufactures a new chemical substance under 
paragraph (c)(1) or (c)(2) of this section must comply with the 
provisions of this section, including submission of a new notice under 
paragraph (e) of this section, before:
    (i) Manufacturing the new chemical substance at a site that was not 
approved in a previous exemption notice for the substance, except as 
provided in paragraph (j)(6) of this section.

[[Page 11]]

    (ii) Manufacturing the new chemical substance for a use that was not 
approved in a previous exemption notice for the substance.
    (iii) Manufacturing the new chemical substance without employing the 
human exposure and environmental release controls approved in a previous 
exemption notice for the substance.
    (iv) Manufacturing the new chemical substance in a physical form 
different than that physical form approved in a previous exemption 
notice for the substance and which form may increase the human exposure 
to, or environmental release of, the new chemical substance over those 
exposures or releases resulting from the physical form approved in the 
previous notice.
    (v) Manufacturing the chemical substance in annual production 
volumes above any volume designated by the manufacturer as binding under 
paragraph (e)(2)(vi) of this section in a previous exemption notice for 
the substance.
    (5) In an exemption notice informing EPA of a change in site, use, 
or worker protection, or environmental release controls, the 
manufacturer is not required to provide all of the same information 
submitted to EPA in a previous exemption notice for that chemical 
substance. The new exemption notice, however, must indicate the identity 
of the new chemical substance; the manufacturer's name; the name and 
telephone number of a technical contact; and location of the new site, 
new worker protection or environmental release controls, and new use 
information. The notice must also include the EPA-designated exemption 
number assigned to the previous notice and a new certification by the 
manufacturer, as described in paragraph (e)(2)(xi) of this section.
    (6)(i) A manufacturer may, without submitting a new notice, 
manufacture the new chemical substance at a site not listed in its 
exemption application under the following conditions:
    (A) the magnitude, frequency, and duration of exposure of individual 
workers to the new chemical substance at the new manufacturing site is 
equal to, or less than, the magnitude, frequency, and duration of 
exposure of the individual workers to the new chemical substance at the 
manufacturing site for which the EPA performed its original risk-
assessment pursuant to the original exemption notice; and
    (B) Either (1) at the new manufacturing site, the manufacturer does 
not release to surface waters any of the new chemical substance, or any 
waste streams containing the new chemical substance; or (2) at the new 
manufacturing site, the manufacturer maintains surface water 
concentrations of the chemical substance, resulting from direct or 
indirect discharges from the manufacturing site, at or below 1 part per 
billion, or at or below an alternative concentration level approved by 
the Agency in writing or under the procedures described in paragraph 
(c)(2)(iii) of this section, using the water concentration calculation 
method described at Secs. 721.90 and 721.91.
    (ii) The manufacturer shall notify EPA of any new manufacturing site 
no later than 30 days after the commencement of manufacture of the new 
chemical substance under the exemption at the new manufacturing site as 
follows:
    (A) The notification must contain the EPA-designated exemption 
number to which the notification applies, manufacturer identity, the 
street address of the new manufacturing site, the date on which 
manufacture commenced at the new site, the name and telephone number of 
a technical contact at the new site, any claim of confidentiality, and a 
statement that the notification is an amendment to the original 
exemption application under the terms of this section.
    (B) The notification must be submitted electronically to EPA via CDX 
as a support document to the original notification. Prior to submission 
to EPA via CDX, such notices must be generated and completed using the 
e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to 
access the e-PMN software.
    (k) Customer notification. (1) Manufacturers of new chemical 
substances described in paragraphs (c)(1) and (c)(2) of this section 
must notify processors and industrial users that the substance can be 
used only for the uses specified in the exemption notice at paragraph 
(e) of this section. The manufacturer must also inform processors and 
industrial

[[Page 12]]

users of any controls specified in the exemption notice. The 
manufacturer may notify processors and industrial users by means of a 
container labeling system, written notification, or any other method 
that adequately informs them of use restrictions or controls.
    (2) A manufacturer of a new chemical substance described in 
paragraph (c)(2) of this section may distribute the chemical substance 
only to other persons who agree in writing to not further distribute the 
substance until it has been reacted, incorporated into an article, or 
otherwise rendered into a physical form or state in which environmental 
releases and human exposures above the eligibility criteria in paragraph 
(c)(2) of this section are not likely to occur.
    (3) If the manufacturer learns that a direct or indirect customer is 
processing or using the new substance in violation of use restrictions 
or without imposing prescribed worker protection or environmental 
release controls, the manufacturer must cease distribution of the 
substance to the customer or the customer's supplier immediately unless 
the manufacturer is able to document each of the following:
    (i) That the manufacturer has, within 5 working days, notified the 
customer in writing that the customer has failed to comply with the 
conditions specified in this section and the exemption notice under 
paragraph (e) of this section.
    (ii) That, within 15 working days of notifying the customer of the 
noncompliance, the manufacturer received from the customer, in writing, 
a statement of assurance that the customer is aware of the terms of this 
section and the exemption notice and will comply with those terms.
    (4) If, after receiving a statement of assurance from a customer 
under paragraph (k)(3)(ii) of this section, the manufacturer obtains 
knowledge that the customer has again failed to comply with any of the 
conditions specified in this section or the exemption notice, the 
manufacturer shall cease supplying the new chemical substance to that 
customer and shall report the failure to comply to EPA within 15 days of 
obtaining this knowledge. Within 30 days of its receipt of the report, 
EPA will notify the manufacturer whether, and under what conditions, 
distribution of the chemical substance to the customer may resume.
    (l) Confidentiality. (1) If the manufacturer submits information to 
EPA under this section which the manufacturer claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to EPA by bracketing, circling, or 
underlining it and stamping it with ``CONFIDENTIAL'' or some other 
appropriate designation. Any information so identified will be treated 
in accordance with the procedures in part 2 of this chapter. Any 
information not claimed confidential at the time of submission may be 
made available to the public without further notice.
    (2)(i) Any person who asserts a claim of confidentiality for 
chemical identity under this paragraph (l) must provide a generic 
chemical name that is only as generic as necessary to protect the 
confidential chemical identity of the particular chemical substance. The 
name should reveal the specific chemical identity to the maximum extent 
possible.
    (ii) The generic name provided by the manufacturer will be subject 
to EPA review and approval in accordance with the procedures specified 
in Sec. 720.85(b)(6) of this chapter. The generic name provided by the 
submitter or an alternative selected by EPA under these procedures will 
be placed on a public list of substances exempt under this section.
    (3) If any information is claimed confidential, the manufacturer 
must submit a second copy of the notice with all information claimed as 
confidential deleted. EPA will place the second copy in the public file.
    (m) Exemptions granted under superseded regulations. Manufacturers 
holding exemptions granted under the superseded requirements of this 
section (as in effect on May 26, 1995) shall either continue to comply 
with those requirements (including the production volume limit) or apply 
for a new exemption pursuant to this section. EPA will not accept 
requests to amend exemptions granted under the superseded requirements; 
manufacturers wishing

[[Page 13]]

to amend such exemptions must submit a new exemption under paragraph (e) 
of this section. If a new exemption for a new chemical substance is 
granted under this exemption to the manufacturer holding an exemption 
under the superseded requirements, the exemption under the superseded 
requirements for such substance shall be void.
    (n) Recordkeeping. (1) A manufacturer of a new chemical substance 
under paragraph (c) of this section must maintain the records described 
in this paragraph at the manufacturing site or site of importation for a 
period of 5 years after their preparation.
    (2) The records must include the following to demonstrate compliance 
with this section:
    (i) Records of annual production volume and import volume.
    (ii) Records documenting compliance with the applicable requirements 
and restrictions of paragraphs (c), (e), (f), (h), (i), (j), and (k) of 
this section.
    (3) Any person who manufactures a new chemical substance under the 
terms of this section must, upon request of a duly designated 
representative of EPA, permit such person at all reasonable times to 
have access to and to copy records kept under paragraph (n)(2) of this 
section.
    (4) The manufacturer must submit the records listed in paragraph 
(n)(2) of this section to EPA upon request. Manufacturers must provide 
these records within 15 working days of receipt of such request.
    (o) Compliance. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this section is a 
violation of this section and therefore a violation of section 15 of the 
Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture or processing of a 
chemical substance in violation of this section, or act to seize any 
chemical substance manufactured or processed in violation of this 
section, or take other action under the authority of section 7 of the 
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 1616).

[60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62 
FR 17932, Apr. 11, 1997; 64 FR 31989, June 15, 1999; 71 FR 33642, June 
12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012; 78 FR 
72828, Dec. 4, 2013; 80 FR 42746, July 20, 2015]



Sec. 723.175  Chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles.

    (a) Purpose and scope. (1) This section grants an exemption from the 
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic 
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture and 
processing of new chemical substances used in or for the manufacture or 
processing of instant photographic and peel-apart film articles. This 
section does not apply to microorganisms subject to part 725 of this 
chapter.
    (2) To manufacture a new chemical substance under the terms of this 
exemption, a manufacturer of instant photographic or peel-apart film 
articles must:
    (i) Submit an exemption notice when manufacture begins under 
paragraph (i) of this section.
    (ii) Comply with certain requirements to limit exposure to the new 
chemical substance under paragraphs (e), (f), (g), and (h) of this 
section.
    (iii) Comply with all recordkeeping requirements under paragraph (j) 
of this section.
    (b) Definitions--(1) Act means the Toxic Substances Control Act (15 
U.S.C. 2601 et seq.).
    (2) An article is a manufactured item (i) which is formed to a 
specific shape or design during manufacture, (ii) which has end use 
function(s) dependent in whole or in part upon its shape or design 
during end use, and (iii) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the article and 
that may occur as described in Sec. 710.2 of this chapter except that 
fluids and particles are not considered articles regardless of shape or 
design.

[[Page 14]]

    (3) The terms byproduct, EPA, impurities, person, and site have the 
same meanings as in Sec. 710.3 of this chapter.
    (4) The term category of chemical substances has the same meaning as 
in section 26(c)(2) of the Act (15 U.S.C. 2625).
    (5) The terms chemical substance, distribute in commerce, 
distribution in commerce, environment, manufacture, new chemical 
substance, and process have the same meanings as in section 3 of the Act 
(15 U.S.C. 2602).
    (6) Director of the Office of Pollution Prevention and Toxics means 
the Director of the EPA Office of Pollution Prevention and Toxics or any 
EPA employee designated by the Office Director to carry out the Office 
Director's functions under this section.
    (7) The term exemption category means a category of chemical 
substances for which a person(s) has applied for or been granted an 
exemption under section 5(h)(4) of the Act (15 U.S.C. 2604).
    (8) The term instant photographic film article means a self-
developing photographic film article designed so that all the chemical 
substances contained in the article, including the chemical substances 
required to process the film, remain sealed during distribution and use.
    (9) Intermediate means any chemical substance which is consumed in 
whole or in part in a chemical reaction(s) used for the intentional 
manufacture of another chemical substance.
    (10) Known to or reasonably ascertainable means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know, our could obtain without unreasonable burden or cost.
    (11) The term peel-apart film article means a self-developing 
photographic film article consisting of a positive image receiving 
sheet, a light sensitive negative sheet, and a sealed reagent pod 
containing a developer reagent and designed so that all the chemical 
substances required to develop or process the film will not remain 
sealed within the article during and after the development of the film.
    (12) Photographic article means any article which will become a 
component of an instant photographic or peel-apart film article.
    (13) Special production area means a demarcated area within which 
all manufacturing, processing, and use of a new chemical substance takes 
place, except as provided in paragraph (f) of this section, in 
accordance with the requirements of paragraph (e) of this section.
    (14) Test data means:
    (i) Data from a formal or informal study, test, experiment, recorded 
observation, monitoring, or measurement.
    (ii) Information concerning the objectives, experimental methods and 
materials, protocols, results, data analyses (including risk 
assessments), and conclusions from a study, test, experiment, recorded 
observation, monitoring, or measurement.
    (15) Used in or for the manufacturing or processing of an instant 
photographic or peel-apart film article, when used to describe 
activities involving a new chemical substance, means the new chemical 
substance (i) is included in the article, or (ii) is an intermediate to 
a chemical substance included in the article or is one of a series of 
intermediates used to manufacture a chemical substance included in the 
article.
    (16) Wet mixture means a water or organic solvent-based suspension, 
solution, dispersion, or emulsion used in the manufacture of an instant 
photographic or peel-apart film article.
    (c) Exemption category. The exemption category includes new chemical 
substances used in or for the manufacture or processing of instant 
photographic or peel-apart film articles which are manufactured and 
processed under the terms of this section.
    (d) Applicability. This exemption applies only to manufacturers of 
instant photographic or peel-apart film articles who:
    (1) Manufacture the new chemical substances used in or for the 
manufacture or processing of the instant photographic or peel-apart film 
articles.
    (2) Limit manufacture and processing of a new chemical substance to 
the site(s) listed in the exemption notice for that new chemical 
substance submitted under paragraph (i) of this section.

[[Page 15]]

    (3) Comply with the requirements of paragraphs (e), (f), (g), (h), 
and (j) of this section.
    (4) Do not distribute in commerce or use a peel-apart film article 
containing a new chemical substance until submission of a premanufacture 
notice under section 5(a)(1)(A) of the Act (15 U.S.C. 2604) and until 
the review period for the notice has ended without EPA action to prevent 
distribution or use.
    (e) Conditions of manufacture and processing in the special 
production area. All manufacturing, processing, and use operations 
involving the new chemical substance must be performed in a special 
production area under the conditions set forth in this paragraph until 
the new chemical substance has been incorporated into a wet mixture, 
photographic article, or instant photographic or peel-apart film 
article.
    (1) Exposure limits. In the special production area, the ambient air 
concentration of the new chemical substance during manufacture, 
processing, and use cannot exceed an 8-hour time weighted average (TWA) 
of 10 ppm for gases and vapors and 50 mg/m\3\ for particulates, with an 
allowable TWA excursion of 50 percent above those concentrations for a 
duration of 30 minutes or less.
    (2) Respiratory protection--(i) Respirator requirement. Except as 
specified in paragraph (e)(2)(ii) of this section, each person in the 
special production area must wear an appropriate respiratory protection 
device to protect against dusts, fumes, vapors, and other airborne 
contaminants, as described in 29 CFR 1910.134. Selection of an 
appropriate respirator must be made according to the guidance of 
American National Standard Practices for Respiratory Protection Z88.2-
1969 and the NIOSH Certified Equipment List, U.S. Department of Health 
and Human Services, NIOSH publication No. 80-144.
    (ii) Waiver of respirator requirement. Employees are not required to 
wear respirators if monitoring information collected and analyzed in 
accordance with paragraph (e)(3) of this section demonstrates that the 
ambient 8-hour TWA concentration of the new chemical substance in the 
area is less than 1 ppm for gases and vapors and 5 mg/m\3\ for 
particulates with an allowable TWA excursion of 50 percent above these 
concentrations for a duration of 30 minutes or less.
    (iii) Quantitative fit test. Each respirator must be issued to a 
specific individual for personal use. A quantitative fit test must be 
performed for each respirator before its first use by that person in a 
special production area.
    (3) Monitoring--(i) When to monitor. (A) When suitable sampling and 
analytic methods exist, periodic monitoring in accordance with this 
paragraph must be done to ensure compliance with the exposure limits of 
paragraphs (e)(1) and (2)(ii) of this section.
    (B) When suitable sampling and analytic methods do not exist, 
compliance with the exposure limits of paragraph (e)(1) and the 
requirements of paragraph (e)(10) of this section must be determined by 
an evaluation of monitoring data developed for a surrogate chemical 
substance possessing comparable physical-chemical properties under 
similar manufacturing and processing conditions.
    (ii) Monitoring methods. A suitable air sampling method must permit 
personal or fixed location sampling by conventional collection methods. 
A suitable analytic method must have adequate sensitivity for the volume 
of sample available and be specific for the new chemical substance being 
monitored. If chemical-specific monitoring methods are not available, 
nonspecific methods may be used if the concentration of the new chemical 
substance is assumed to be the total concentration of chemical 
substances monitored.
    (iii) Monitoring frequency. (A) When suitable air sampling and 
analytical procedures are available, monitoring must be done in each 
special production area during the first three 8-hour work shifts 
involving the manufacture or processing of each new chemical substance. 
Thereafter, monitoring must be done in each special production area for 
at least one 8-hour period per month, during a production run in which 
the new chemical substance is manufactured or processed. Samples must be 
of such frequency and pattern as to represent with reasonable accuracy 
the mean level and maximum 30-

[[Page 16]]

minute level of employee exposure during an 8-hour work shift. In 
monitoring for an 8-hour work shift or the equivalent, samples must be 
collected periodically or continuously for the duration of the 8-hour 
work shift. Samples must be taken during a period which is likely to 
represent the maximum employee exposure.
    (B) If the manufacturer demonstrates compliance with the exposure 
limits for 3 consecutive months, further monitoring of the identical 
process must be performed only every 6 months thereafter, unless there 
is a significant change in the process, process design, or equipment. If 
there is such a change, the manufacturer must begin monitoring again 
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
    (iv) Location of monitoring. Air samples must be taken so as to 
ensure that the samples adequately represent the ambient air 
concentration of a new chemical substance present in each worker's 
breathing zone.
    (4) Engineering controls and exposure safeguards. Engineering 
controls such as, but not limited to, isolation, enclosure, local 
exhaust ventilation, and dust collection must be used to ensure 
compliance with the exposure limits prescribed in paragraphs (e)(1) or 
(e)(2)(ii) of this section.
    (5) Training, hygiene, and work practices--(i) Training. No employee 
may enter a special production area before the completion of a training 
program. The training program must be adapted to the individual 
circumstances of the manufacturer and must address: The known physical-
chemical and toxicological properties of the chemical substances handled 
in the area; procedures for using and maintaining respirators and other 
personal safeguards; applicable principles of hygiene; special handling 
procedures designed to limit personal exposure to, and inadvertent 
release of, chemical substances; and procedures for responding to 
emergencies or spills.
    (ii) Hygiene. Appropriate standards of hygiene must be observed by 
all employees handling a new chemical substance in manufacturing, 
processing, or transfer operations. The manufacturer must provide 
appropriate facilities for employee changing and wash-up. Food, 
beverages, tobacco products, and cosmetics must not be allowed in 
special production areas.
    (iii) Work practices. Operating procedures such as those related to 
chemical weighing and filtering, or the charging, discharging and clean-
up of process equipment, must be designed and conducted to ensure 
compliance with the exposure limits prescribed in paragraph (e)(1) or 
(e)(2)(ii) of this section. Written procedures and all materials 
necessary for responding to emergency situations must be immediately 
accessible to all employees in a special production area. Any spill or 
unanticipated emission must be controlled by specially trained personnel 
using the equipment and protective clothing described in paragraph 
(e)(6) of this section.
    (6) Personal protection devices. All workers engaged in the 
manufacture and processing of a new chemical substance in the special 
production area must wear suitable protective clothing or equipment, 
such as chemical-resistant coveralls, protective eyewear, and gloves.
    (7) Caution signs. Each special production area must be clearly 
posted with signs identifying the area as a special production area 
where new chemical substances are manufactured and processed under 
controlled conditions. Each sign must clearly restrict entry into the 
special production area to qualified personnel who are properly trained 
and equipped with appropriate personal exposure safeguards.
    (8) Removal for storage or transportation. A new chemical substance 
that is not incorporated into a wet mixture, photographic article, or 
instant photographic or peel-apart film article may be removed from the 
special production area for purposes of storage between operational 
steps or for purposes of transportation to another special production 
area. Such storage or transportation must be conducted in a manner that 
limits worker and environmental exposure through the use of engineering 
controls, training, hygiene, work practices, and personal protective 
devices appropriate to the chemical substance in question.

[[Page 17]]

    (9) Labeling. (i) Any new chemical substance removed from a special 
production area or stored or transported between operational steps must 
be clearly labeled. The label must show the identity of the new chemical 
substance or an appropriate identification code, a statement of any 
known hazards associated with it, a list of special handling 
instructions, first aid information, spill control directions, and where 
applicable, the appropriate U.S. Department of Transportation notations.
    (ii) No label is required if the new chemical substance has been 
incorporated into a photographic article, or if it is contained in a 
sealed reaction vessel or pipeline, or if it has been incorporated into 
an instant photographic or peel-apart film article.
    (10) Areas immediately adjacent to the special production area. The 
ambient air concentration of the new chemical substance in areas 
immediately adjacent to the special production area must not exceed the 
exposure limit established in paragraph (e)(2)(ii) of this section for 
waiver of respirator protection within the special production area. 
Periodic monitoring in accordance with paragraph (e)(3) of this section 
must be performed in immediately adjacent areas where it is reasonable 
to expect a risk of inhalation exposure.
    (f) Conditions of processing outside the special production area. A 
wet mixture may be incorporated into a photographic article or an 
instant photographic or peel-apart film article outside the special 
production area under the conditions listed in this paragraph:
    (1) Engineering controls and exposure safeguards. Engineering 
controls must limit the exposure to a new chemical substance contained 
in a wet mixture.
    (2) Training, hygiene and work practices--(i) Training. Training of 
employees involved in the handling of wet mixtures containing a new 
chemical substance must be adapted to the individual circumstances of 
the employees' activities and must address: Procedures for using 
personal exposure safeguards, applicable principles of hygiene, handling 
procedures designed to limit personal exposure, and procedures for 
responding to emergencies and spills.
    (ii) Hygiene. Appropriate standards of hygiene that limit exposure 
must be observed by all employees handling wet mixtures that contain new 
chemical substances.
    (iii) Work practices. Work practices and operating procedures must 
be designed to limit exposure to any new chemical substance contained in 
wet mixtures. Any spills or unanticipated releases of a wet mixture must 
be controlled by trained personnel wearing appropriate protective 
clothing or equipment such as gloves, eye protection, and, where 
necessary, respirators or chemically imprevious clothing.
    (3) Personal protection devices. All workers engaged in the 
processing of a wet mixture containing a new chemical substance must 
wear suitable protective clothing or equipment such as coveralls, 
protective eyewear, respirators, and gloves.
    (g) Incorporation of photographic articles into instant photographic 
and peel-apart film articles. A photographic article may be incorporated 
into the instant photographic or peel-apart film article outside the 
special production area. The manufacturer must take measures to limit 
worker and environmental exposure to new chemcial substances during 
these operations using engineering controls, training, hygiene, work 
practices, and personal protective devices.
    (h) Environmental release and waste treatment--(1) Release to land. 
Process waste from manufacturing and processing operations in the 
special production area that contain a new chemical substance are 
considered to be hazardous waste and must be handled in accordance with 
the requirements of parts 262 through 267 and parts 122 and 124 of this 
chapter.
    (2) Release to water. All wastewater or discharge which contain the 
new chemcial subtance must be appropriately pretreated before release to 
a Publicly Owned Treatment Works (POTW) or other receiving body of 
water. In the case of release to a POTW, the pretreatment must prevent 
structural damage to, obstruction of, or interference with the operation 
of the POTW. The treatment of direct release to a receiving body of 
water must be appropriate for the new chemical

[[Page 18]]

substance's physical-chemical properties and potential toxicity.
    (3) Release to air. All process emissions released to the air which 
contain the new chemical substance must be vented through control 
devices appropriate for the new chemical substance's physical-chemical 
properties and potential toxicity.
    (i) Exemption notice. An exemption notices must be submitted to EPA 
when manufacture of the new chemical substance begins.
    (1) Contents of exemption notice. The exemption notice must include 
the following information:
    (i) Manufacturer and sites. The notice must identify the 
manufacturer and the sites and locations where the new chemical 
substance and the instant photographic or peel-apart film articles will 
be manufactured and processed.
    (ii) Chemical identification. The notice must identify the new 
chemical substance as follows:
    (A) Class 1 substances. For chemical substances whose composition 
can be represented by a definite structural disagram (Class 1 
substances), the notice must provide the chemical name (preferably CAS 
or IUPAC nomenclature), the molecular formula, CAS Registry Number (if 
available), known synonyms (including trade names), and a structural 
diagram.
    (B) Class 2 substances. For chemical substances that cannot be fully 
represented by a structural diagram, (Class 2 substances), the notice 
must provide the chemical name, the molecular formula, the CAS Registry 
Number (if available), and known synonyms (including trade names). The 
notice must identify the immediate precursors and reactants by name and 
CAS Registry Number (if available). The notice must include a partial or 
incomplete structural diagram, if available.
    (C) Polymers. For a polymer, the notice must indentify monomers and 
other reactants used in the manufacture of the polymer by chemical name 
and CAS Registry Number. The notice must indicate the amount of each 
monomer used (by weight percent of total monomer); the maximum residual 
of each monomer present in the polymer; and a partial or incomplete 
structural diagram, if available. The notice must indicate the number 
average molecular weight of the polymer and characterize the anticipated 
low molecular weight species. The notice must include this information 
for each typical average molecular weight composition of the polymer to 
be manufactured.
    (iii) Impurities. The notice must identify the impurities that can 
be reasonably anticipated to be present in the new chemcial substance 
when manufactured under the exemption by name and CAS Registry Number, 
by class of substances, or by process or source. The notice also must 
estimate the maximum percent (by weight) of each impurity in the new 
chemical substance and the percent of unknown impurities present.
    (iv) Physical-chemical properties. The notice must describe the 
physical-chemical properties of the new chemical substance. Where 
specific physical-chemical data are not available, reasonable estimates 
and the techniques used to develop these estimates must be provided.
    (v) Byproducts. The notice must identify the name, CAS Registry 
number (if available), and the volume of each byproduct that would be 
manufactured during manufacture of the new chemical substance.
    (vi) Production volume. The notice must include an estimate of the 
anticipated maximum annual production volume.
    (vii) Test data. The notice must include all information and test 
data on the new chemical substance's health and environmental effects 
that are known to or reasonably ascertainable by the manufacturer.
    (viii) Identity of the article. The notice must identify and 
describe the instant photographic film article(s) or peel-apart film 
article(s) that will contain the new chemical substance.
    (ix) Release to water. The notice must include a description of the 
methods used to control and treat wastewater or discharge released to a 
POTW or other receiving body of water. The notice must also identify the 
POTW or receiving body of water.
    (x) Certification. The manufacturer must certify in the notice that 
it is familiar with the terms of the exemption

[[Page 19]]

and that the manufacture, processing, distribution, use, and disposal of 
the new chemical substance will comply with those terms.
    (2) Duplication of information in premanufacture notice. If a 
manufacturer who submits an exemption notice under this paragraph has 
already submitted, or simultaneously submits, a premanufacture notice 
under section 5(a)(1)(A) of the Act for the new chemical substance, it 
may, in lieu of submitting the information required by this paragraph, 
reference the required information to the extent it is included in the 
premanufacture notice. At a minimum, the exemption notice must identify 
the manufacturer and the new chemical substance, and contain the 
certification required by paragraph (i)(1)(x) of this section.
    (3) Address. The exemption notice must be addressed to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics 
(OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (j) Recordkeeping. (1) Manufacturers of a new chemical substance 
under this exemption must keep the following records for 30 years from 
the final date of manufacture.
    (i) Production records. Each manufacturer must maintain records of 
the annual production volume of each new chemical substance manufactured 
under the terms of the exemption. This record must indicate when 
manufacture of the new chemical substance began.
    (ii) Exposure monitoring records. Manufacturers must maintain an 
accurate record of all monitoring required by this section. Monitoring 
records may be adapted to the individual circumstances of the 
manufacturer but, at a minimum, must contain the following information: 
The chemical identity of the new chemical substance, date of the 
monitoring, the actual monitoring data for each monitoring location and 
sampling, and a reference to or description of the collection and 
analytic techniques. If the manufacturer does not monitor, the 
manufacturer must maintain a record of the reasons for not monitoring 
and the methods used to determine compliance with the exposure limits of 
paragraph (e)(1) of this section.
    (iii) Training and exposure records. For each employee engaged in 
the manufacture or processing of a new chemical substance, the company 
must develop and maintain a record of the worker's participation in 
required training. This record must also demonstrate the regular use of 
personal exposure safeguards, including the results of any personal 
exposure monitoring, the results of the quantitative fit test for the 
worker's personal respirator, and any additional information related to 
the worker's occupational exposure.
    (iv) Treatment records. Manufacturers who release treated wastewater 
or discharge containing a new chemical substance to a POTW or other 
receiving body of water must maintain records of the method of 
treatment.
    (2) The manufacturer must make the records listed in paragraph 
(j)(1) of this section available to EPA upon written request by the 
Director of the Office of Pollution Prevention and Toxics. The 
manufacturer must provide these records within 15 working days of 
receipt of this request.
    (k) Confidentiality. If the manufacturer submits information under 
paragraph (i) or (j) of this section which it claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to the Agency by bracketing, 
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or 
some other appropriate designation. Any information so identified will 
be treated in accordance with the procedures in part 2 of this chapter. 
Any information not claimed confidential at the time of submission will 
be made available to the public without further notice to the submitter.
    (l) Amendment and repeal. (1) EPA may amend or repeal any term of 
this exemption if it determines that the manufacture, processing, 
distribution, use, and disposal of new chemical substances under the 
terms of the exemption may present an unreasonable risk of injury to 
health or the environment. EPA also may amend this exemption to enlarge 
the exemption category or to reduce the restrictions or conditions of 
the exemption.

[[Page 20]]

    (2) As required by section 5(h)(4) of the Act, EPA will amend or 
repeal the substantive terms of an exemption granted under this part 
only by the formal rulemaking procedures described in section 6(c)(2) 
and (3) of the Act (15 U.S.C. 2605(c)).
    (m) Prohibition of use of the exemption. The Director of the Office 
of Pollution Prevention and Toxics may prohibit the manufacture, 
processing, distribution, use, or disposal of any new chemical substance 
under the terms of this exemption if he or she determines that the 
manufacture, processing, distribution in commerce, use, or disposal of 
the new chemical substance may present an unreasonable risk of injury to 
health or the environment.
    (n) Enforcement. (1) A failure to comply with any provision of this 
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this part is a 
violation of this regulation and therefore a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture of a new chemical 
substance in violation of this exemption or act to seize any chemical 
substances manufactured in violation of the exemption under the 
authority of section 17 of the Act (15 U.S.C. 2616).

[47 FR 24317, June 4, 1982, as amended at 53 FR 12523, Apr. 15, 1988; 60 
FR 34465, July 3, 1995; 62 FR 17932, Apr. 11, 1997; 68 FR 906, Jan. 7, 
2003; 71 FR 33642, June 12, 2006]



Sec. 723.250  Polymers.

    (a) Purpose and scope. (1) This section grants an exemption from 
certain of the premanufacture notice requirements of section 5(a)(1)(A) 
of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the 
manufacture of certain polymers. This section does not apply to 
microorganisms subject to part 725 of this chapter.
    (2) To manufacture a new chemical substance under the terms of this 
section, a manufacturer must:
    (i) Determine that the substance meets the definition of polymer in 
paragraph (b) of this section.
    (ii) Determine that the substance is not specifically excluded by 
paragraph (d) of this section.
    (iii) Ensure that the substance meets the exemption criteria of 
paragraph (e) of this section.
    (iv) Submit a report as required under paragraph (f) of this 
section.
    (v) Comply with the recordkeeping requirements of paragraph (j) of 
this section.
    (b) Definitions. In addition to the definitions under section 3 of 
the Act, 15 U.S.C. 2602, the following definitions apply to this part.
    Act means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
    Biopolymer means a polymer directly produced by living or once-
living cells or cellular components.
    Category of chemical substances has the same meaning as in section 
26(c)(2) of the Act (15 U.S.C. 2625).
    Cationic polymer means a polymer that contains a net positively 
charged atom(s) or associated groups of atoms covalently linked to its 
polymer molecule.
    Chemical substance, Director, EPA, importer, impurity, Inventory, 
known to or reasonably ascertainable, manufacture, manufacturer, 
mixture, new chemical, person, possession or control, process and test 
data have the same meanings as in Sec. 720.3 of this chapter.
    Equivalent weight of a functional group means the ratio of the 
molecular weight to the number of occurrences of that functional group 
in the molecule. It is the weight of substance that contains one 
formula-weight of the functional group.
    Fluorotelomers means the products of telomerization, which is the 
reaction of a telogen (such as pentafluoroethyl iodide) with an 
ethylenic compound (such as tetrafluoroethylene) to form low molecular 
weight polymeric compounds, which contain an array of saturated carbon 
atoms covalently bonded to each other (C-C bonds) and to fluorine atoms 
(C-F bonds). This array is predominantly a straight chain, and depending 
on the telogen used produces a compound having an even number of carbon 
atoms. However, the carbon

[[Page 21]]

chain length of the fluorotelomer varies widely. The perfluoroalkyl 
groups formed by this process are usually, but do not have to be, 
connected to the polymer through a functionalized ethylene group as 
indicated by the following structural diagram: (Rf-
CH2CH2-Anything).
    Internal monomer unit means a monomer unit that is covalently bonded 
to at least two other molecules. Internal monomer units of polymer 
molecules are chemically derived from monomer molecules that have formed 
covalent bonds between two or more other monomer molecules or other 
reactants.
    Monomer means a chemical substance that is capable of forming 
covalent bonds with two or more like or unlike molecules under the 
conditions of the relevant polymer-forming reaction used for the 
particular process.
    Monomer Unit means the reacted form of the monomer in a polymer.
    Number-average molecular weight means the arithmetic average (mean) 
of the molecular weight of all molecules in a polymer.
    Oligomer means a polymer molecule consisting of only a few monomer 
units (dimer, trimer, tetramer)
    Other reactant means a molecule linked to one or more sequences of 
monomer units but which, under the relevant reaction conditions used for 
the particular process, cannot become a repeating unit in the polymer 
structure.
    Perfluoroalkyl carboxylate (PFAC) means a group of saturated carbon 
atoms covalently bonded to each other in a linear, branched, or cyclic 
array and covalently bonded to a carbonyl moiety and where all carbon-
hydrogen (C-H) bonds have been replaced with carbon-fluorine (C-F) 
bonds. The carbonyl moiety is also covalently bonded to a hetero atom, 
typically, but not necessarily oxygen (O) or nitrogen (N).
    Perfluoroalkyl sulfonate (PFAS) means a group of saturated carbon 
atoms covalently bonded to each other in a linear, branched, or cyclic 
array and covalently bonded to a sulfonyl moiety and where all carbon - 
hydrogen (C-H) bonds have been replaced with carbon - fluorine (C-F) 
bonds. The sulfonyl moiety is also covalently bonded to a hetero atom, 
typically, but not necessarily oxygen (O) or nitrogen (N).
    Polyester means a chemical substance that meets the definition of 
polymer and whose polymer molecules contain at least two carboxylic acid 
ester linkages, at least one of which links internal monomer units 
together.
    Polymer means a chemical substance consisting of molecules 
characterized by the sequence of one or more types of monomer units and 
comprising a simple weight majority of molecules containing at least 3 
monomer units which are covalently bound to at least one other monomer 
unit or other reactant and which consists of less than a simple weight 
majority of molecules of the same molecular weight. Such molecules must 
be distributed over a range of molecular weights wherein differences in 
the molecular weight are primarily attributable to differences in the 
number of monomer units. In the context of this definition, sequence 
means that the monomer units under consideration are covalently bound to 
one another and form a continuous string within the molecule, 
uninterrupted by units other than monomer units.
    Polymer molecule means a molecule which contains a sequence of at 
least 3 monomer units which are covalently bound to at least one other 
monomer unit or other reactant.
    Reactant means a chemical substance that is used intentionally in 
the manufacture of a polymer to become chemically a part of the polymer 
composition.
    Reactive functional group means an atom or associated group of atoms 
in a chemical substance that is intended or can reasonably be 
anticipated to undergo further chemical reaction.
    Reasonably anticipated means that a knowledgeable person would 
expect a given physical or chemical composition or characteristic to 
occur based on such factors as the nature of the precursors used to 
manufacture the polymer, the type of reaction, the type of manufacturing 
process, the products produced in polymerization, the intended uses of 
the substance, or associated use conditions.

[[Page 22]]

    (c) Applicability. This section applies to manufacturers of new 
chemical substances that otherwise must submit a premanufacture notice 
to EPA under Sec. 720.22 of this chapter. New substances are eligible 
for exemption under this section if they meet the definition of 
``polymer'' in paragraph (b) of this section, and the criteria in 
paragraph (e) of this section, and if they are not excluded from the 
exemption under paragraph (d) of this section.
    (d) Polymers that cannot be manufactured under this section--(1) 
Cationic polymers. A polymer cannot be manufactured under this section 
if the polymer is a cationic polymer as defined under paragraph (b) of 
this section or if the polymer is reasonably anticipated to become a 
cationic polymer in a natural aquatic environment (e.g., rivers, lakes) 
unless:
    (i) The polymer is a solid material that is not soluble or 
dispersible in water and will be used only in the solid phase (e.g., 
polymers that will be used as ion exchange beads), or
    (ii) The combined (total) functional group equivalent weight of 
cationic groups in the polymer is equal to or greater than 5,000.
    (2) Elemental limitations. (i) A polymer manufactured under this 
section must contain as an integral part of its composition at least two 
of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and 
sulfur.
    (ii) A polymer cannot be manufactured under this section if it 
contains as an integral part of its composition, except as impurities, 
any elements other than the following:
    (A) The elements listed in paragraph (d)(2)(i) of this section.
    (B) Sodium, magnesium, aluminum, potassium, calcium, chlorine, 
bromine, and iodine as the monatomic counterions Na = , 
Mg = 2, Al = 3, K = , 
Ca = 2, Cl-, Br-, or I-.
    (C) Fluorine, chlorine, bromine, and iodine covalently bound to 
carbon.
    (D) Less than 0.20 weight percent of any combination of the atomic 
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, 
copper, zinc, tin, and zirconium.
    (3) Polymers which degrade, decompose, or depolymerize. A polymer 
cannot be manufactured under this section if the polymer is designed or 
is reasonably anticipated to substantially degrade, decompose, or 
depolymerize, including those polymers that could substantially 
decompose after manufacture and use, even though they are not actually 
intended to do so. For the purposes of this section, degradation, 
decomposition, or depolymerization mean those types of chemical change 
that convert a polymeric substance into simpler, smaller substances, 
through processes including but not limited to oxidation, hydrolysis, 
attack by solvents, heat, light, or microbial action.
    (4) Polymers manufactured or imported from monomers and reactants 
not on the TSCA Chemical Substance Inventory. A polymer cannot be 
manufactured under this section if the polymer being manufactured or 
imported is prepared from monomers and/or other reactants (that are 
either charged to the reaction vessel or incorporated in the polymer at 
levels of greater than 2 weight percent) that are not already included 
on the TSCA Chemical Substance Inventory or manufactured under an 
applicable TSCA section 5 exemption.
    (5) Water absorbing polymers with number average molecular weight 
(MW) 10,000 and greater. A polymer cannot be manufactured under this 
section if the polymer being manufactured or imported is a water 
absorbing polymer and has a number average MW greater than or equal to 
10,000 daltons. For purposes of this section, a water-absorbing polymer 
is a polymeric substance that is capable of absorbing its weight of 
water.
    (6) Polymers which contain certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length. Except as provided in 
paragraph (d)(6)(i), after February 26, 2010, a polymer cannot be 
manufactured under this section if the polymer contains as an integral 
part of its composition, except as impurities, one or more of the 
following perfluoroalkyl moieties consisting of a CF3- or longer chain 
length: Perfluoroalkyl sulfonates (PFAS), perfluoroalkyl carboxylates 
(PFAC), fluorotelomers, or perfluoroalkyl moieties that are covalently 
bound to either a carbon or sulfur atom where the carbon or sulfur atom 
is an integral part of the polymer molecule.

[[Page 23]]

    (i) Any polymer that has been manufactured previously in full 
compliance with the requirements of this section prior to February 26, 
2010 may no longer be manufactured under this section after January 27, 
2012.
    (ii) [Reserved]
    (e) Exemption criteria. To be manufactured under this section, the 
polymer must meet one of the following criteria:
    (1) Polymers with number average MW greater than or equal to 1,000 
and less than 10,000 daltons (and oligomer content less than 10 percent 
below MW 500 and less than 25 percent below MW 1,000). (i) The polymer 
must have a number average MW greater than or equal to 1,000 and less 
than 10,000 daltons and contain less than 10 percent oligomeric material 
below MW 500 and less than 25 percent oligomeric material below MW 
1,000.
    (ii) The polymer cannot contain reactive functional groups unless it 
meets one of the following criteria:
    (A) The polymer contains only the following reactive functional 
groups: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated 
olefinic groups that are considered ``ordinary,''(i.e., not specially 
activated either by being part of a larger functional group, such as a 
vinyl ether, or by other activating influences, e.g., strongly electron-
withdrawing sulfone group with which the olefinic groups interact), 
butenedioic acid groups, those conjugated olefinic groups contained in 
naturally-occurring fats, oils, and carboxylic acids, blocked 
isocyanates (including ketoxime-blocked isocyanates), thiols, 
unconjugated nitrile groups, and halogens (except that reactive halogen-
containing groups such as benzylic or allylichalides cannot be 
included).
    (B) The polymer has a combined (total) reactive group equivalent 
weight greater than or equal to 1,000 for the following reactive 
functional groups: acidhalides; acid anhydrides; aldehydes, hemiacetals; 
methylolamides,- amines or,- ureas; alkoxysilanes with alkoxy greater 
than C2-alkoxysilanes; allyl ethers; conjugated olefins; 
cyanates; epoxides; imines; or unsubstituted positions ortho or para to 
phenolic hydroxyl; or
    (C) If any reactive functional groups not included in paragraph 
(e)(1)(ii)(A) and (B) of this section are present, the combined (total) 
reactive group equivalent weight, including any groups listed in 
paragraph (e)(1)(ii)(B), is greater than or equal to 5,000.
    (2) Polymers with number average MW greater than or equal to 10,000 
(and oligomer content less than 2 percent below MW 500 and less than 5 
percent below MW 1,000) . The polymer must have a number average MW 
greater than or equal to 10,000 daltons and contain less than 2 percent 
oligomeric material below MW 500 and less than 5 percent oligomeric 
material below MW 1000.
    (3) Polyester polymers. The polymer is a polyester as defined in 
paragraph (b) of this section and is manufactured solely from one or 
more of the reactants in the following table 1:

       Table 1--List of Reactants From Which Polyester May be Made
------------------------------------------------------------------------
                  Reactant                             CAS No.
------------------------------------------------------------------------
                    Monobasic Acids and Natural Oils
  Benzoic acid.............................  65-85-0
  Canola oil...............................  120962-03-0
  Coconut oil..............................  8001-31-8*
  Corn oil.................................  8001-30-7*
  Cottonseed oil...........................  8001-29-4*
  Dodecanoic acid..........................  143-07-7
  Fats and glyceridic oils, anchovy........  128952-11-4*
  Fats and glyceridic oils, babassu........  91078-92-1*
  Fats and glyceridic oils, herring........  68153-06-0*
  Fats and glyceridic oils, menhaden.......  8002-50-4*
  Fats and glyceridic oils, sardine........  93334-41-9*
  Fats and glyceridic oils, oiticica.......  8016-35-1*
  Fatty acids,C16-18 and C18-unsatd........  67701-08-0*
  Fatty acids, castor-oil..................  61789-44-4*
  Fatty acids, coco........................  61788-47-4*
  Fatty acids, dehydrated castor-oil.......  61789-45-5*
  Fatty acids, linseed oil.................  68424-45-3*
  Fatty acids, safflower oil...............

[[Page 24]]

 
  Fatty acids, soya........................  68308-53-2*
  Fatty acids, sunflower oil...............  84625-38-7*
  Fatty acids, sunflower-oil, conjugated...  68953-27-5*
  Fatty acids, tall-oil....................  61790-12-3*
  Fatty acids, tall-oil, conjugated*.......
  Fatty acids, vegetable oil...............  61788-66-7*
  Glycerides, C16-18 and C18-unsatd........  67701-30-8*
  Heptanoic acid...........................  111-14-8
  Hexanoic acid............................  142-62-1
  Hexanoic acid, 3,3,5-trimethyl-..........  3302-10-1
  Linseed oil..............................  8001-26-1*
  Linseed oil, oxidized....................  68649-95-6*
  Nonanoic acid............................  112-05-0
  Oils, Cannabis*..........................
  Oils, palm kernel........................  8023-79-8*
  Oils, perilla............................  68132-21-8*
  Oils, walnut.............................  8024-09-7
  Safflower oil............................  8001-23-8*
  Soybean oil..............................  8001-22-7*
  Sunflower oil............................  8001-21-6*
  Tung oil.................................  8001-20-5*
 
                         Di and Tri Basic Acids:
  1,2-Benzenedicarboxylic acid.............  88-99-3
  1,3-Benzenedicarboxylic acid.............  121-91-5
  1,3-Benzenedicarboxylic acid, dimethyl     1459-93-4
   ester.
  1,4-Benzenedicarboxylic acid.............  100-21-0
  1,4-Benzenedicarboxylic acid, diethyl      636-09-9
   ester.
  1,4-Benzenedicarboxylic acid, dimethyl     120-61-6
   ester.
  1,2,4-Benzenetricarboxylic acid..........  528-44-9
  Butanedioic acid.........................  110-15-6
  Butanedioic acid, diethyl ester..........  123-25-1
  Butanedioic acid, dimethyl ester.........  106-65-0
  2-Butenedioic acid (E)-..................  110-17-8
  Decanedioic acid.........................  111-20-6
  Decanedioic acid, diethyl ester..........  110-40-7
  Decanedioic acid, dimethyl ester.........  106-79-6
  Dodecanedioic acid.......................  693-23-2
  Fatty acids, C18-unsatd., dimers.........  61788-89-4*
  Heptanedioic acid........................  111-16-0
  Heptanedioic acid, dimethyl ester........  1732-08-7
  Hexanedioic acid.........................  124-04-9
  Hexanedioic acid, dimethyl ester.........  627-93-0
  Hexanedioic acid, diethyl ester..........  141-28-6
  Nonanedioic acid.........................  123-99-9
  Nonanedioic acid, dimethyl ester.........  1732-10-1
  Nonanedioic acid, diethyl ester..........  624-17-9
  Octanedioic acid.........................  (505-48-6)
  Octanedioic acid, dimethyl ester.........  1732-09-8
  Pentanedioic acid........................  (110-94-1)
  Pentanedioic acid, dimethyl ester........  1119-40-0
  Pentanedioic acid, diethyl ester.........  818-38-2
  Undecanedioic acid.......................  1852-04-6
 
                                 Polyols
  1,3-Butanediol...........................  107-88-0
  1,4-Butanediol...........................  110-63-4
  1,4-Cyclohexanedimethanol................  105-08-8
  1,2-Ethanediol...........................  107-21-1
  Ethanol, 2,2-oxybis-.....................  111-46-6
  1,6-Hexanediol...........................  629-11-8
  1,3-Pentanediol, 2,2,4-trimethyl-........  144-19-4
  1,2-Propanediol,.........................  57-55-6
  1,3-Propanediol, 2,2-bis(hydroxymethyl)-.  115-77-5
  1,3-Propanediol, 2,2-dimethyl-...........  126-30-7
  1,3-Propanediol, 2-ethyl-2-                77-99-6
   (hydroxymethyl)-.
  1,3-Propanediol, 2-(hydroxymethyl)-2-      77-85-0
   methyl-.
  1,3-propanediol, 2-methyl................  2163-42-0
  1,2,3-Propanetriol.......................  56-81-5
  1,2,3-Propanetriol, homopolymer..........  25618-55-7
  2-Propen-1-ol, polymer with                25119-62-4
   ethenylbenzene.
 
                                Modifiers
  Acetic acid, 2,2-oxybis-.................  110-99-6

[[Page 25]]

 
  1-Butanol................................  71-36-3**
  Cyclohexanol.............................  108-93-0
  Cyclohexanol, 4,4-(1-methylethylidene)bis- 80-04-6
   .
  Ethanol, 2-(2-butoxyethoxy)-.............  112-34-5
  1-Hexanol................................  111-27-3
  Methanol, hydrolysis products with         72318-84-4*
   trichlorohexylsilane and
   trichlorophenylsilane.
  1-Phenanthrenemethanol, tetradecahydro-    13393-93-6
   1,4a-dimethyl-7-(1-methylethyl)-.
  Phenol, 4,4-(1-methylethylidene)bis-,      25036-25-3
   polymer with 2,2- [(1-
   methylethylidene)bis(4,1-
   phenyleneoxymethylene)] bis[oxirane].
  Siloxanes and Silicones, di-Me, di-Ph,     68440-65-3*
   polymers with Ph silsesquioxanes,
   methoxy-terminated.
  Siloxanes and Silicones, di-Me, methoxy    68957-04-0*
   Ph, polymers with Ph silsesquioxanes,
   methoxy-terminated.
  Siloxanes and Silicones, Me Ph, methoxy    \1\68957-06-2*
   Ph, polymers with Ph silsesquioxanes,
   methoxy- and Ph-terminated.
  Silsesquioxanes, Ph Pr...................  \1\68037-90-1*
------------------------------------------------------------------------
* Chemical substance of unknown or variable composition,complex reaction
  products, and biological materials (UVCB). The CAS Registry Numbers
  for UVCB substances are not used in CHEMICAL ABSTRACTS and its
  indexes.
** These substances may not be used in a substance manufactured from
  fumaric or maleic acid because of potential risks associated with
  esters, which may be formed by reaction of these reactants.

    (f) Exemption report for polymers manufactured under the terms of 
this section. For substances exempt under paragraphs (e)(1), (e)(2), and 
(e)(3) of this section a report of manufacture or import must be 
submitted (postmarked) by January 31 of the year subsequent to initial 
manufacture. The notice must include:
    (1) Manufacturer's name. This includes the name and address of the 
manufacturer and the name and telephone number of a technical contact.
    (2) Number of substances manufactured. Number of substances 
manufactured. The manufacturer must identify the number of polymers 
manufactured under terms of the exemption for the first time in the year 
preceding the notice.
    (g) Chemical identity information. For substances exempt under 
paragraph (e) of this section the manufacturer must to the extent known 
to or reasonably ascertainable by the manufacturer identify the 
following and maintain the records in accordance with paragraph (j) of 
this section:
    (1) A specific chemical name and CAS Registry Number (or EPA 
assigned Accession Number) for each ``reactant,'' as that term is 
defined in paragraph (b) of this section, used at any weight in the 
manufacture of the polymer. For purposes of determining chemical 
identity, the manufacturer may determine whether a reactant is used at 
greater than two weight percent according to either the weight of the 
reactant charged to the reaction vessel or the weight of the chemically 
combined (incorporated) reactant in the polymer. Manufacturers who 
choose the ``incorporated'' method must have analytical data, or 
theoretical calculations (if it can be documented that an analytical 
determination cannot be made or is not necessary), to demonstrate 
compliance with this paragraph. Reactants that introduce into the 
polymer elements, properties, or functional groups that would render the 
polymer ineligible for the exemption are not allowed at any level.
    (2) A representative structural diagram, if possible.
    (h) Certification. To manufacture a substance under the terms of 
this section, a manufacturer must as of the date of first manufacture, 
make the following certification statements and maintain them in 
accordance with paragraph (j) of this section:
    (1) The substance is manufactured or imported for a commercial 
purpose other than for research and development.
    (2) All information in the certification is truthful.
    (3) The new chemical substance meets the definition of a polymer, is 
not specifically excluded from the exemption in paragraph (d) of this 
section, and meets the conditions of the exemption in paragraph (e) of 
this section.
    (i) Exemptions granted under superseded regulations. Manufacturers 
granted exemptions under the superseded requirements of Sec. 723.250 (as 
in effect on

[[Page 26]]

May 26, 1995) shall either continue to comply with those requirements or 
follow all procedural and recordkeeping requirements pursuant to this 
section. If an exemption holder continues to follow the superseded 
regulations, the Notice of Commencement requirements apply and the 
exempt polymer will continue to be listed on the Inventory with 
exclusion criteria and exemption category restrictions on residual 
monomer/reactant and low molecular weight species content limitations.
    (j) Recordkeeping. (1) A manufacturer of a new polymer under 
paragraphs (e) of this section, must retain the records described in 
this paragraph at the manufacturing site for a period of 5 years from 
the date of commencement of manufacture or import.
    (2) The records must include the following to demonstrate compliance 
with the terms of this section:
    (i) Chemical identity information as required in paragraph (g) of 
this section.
    (ii) Information to demonstrate that the new polymer is not 
specifically excluded from the exemption.
    (iii) Records of production volume for the first 3 years of 
manufacture and the date of commencement of manufacture.
    (iv) Information to demonstrate that the new polymer meets the 
exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this 
section.
    (v) Analytical data, or theoretical calculations (if it can be 
documented that an analytical determination cannot be made or is not 
necessary), to demonstrate that the polymer meets the number-average MW 
exemption criteria in paragraphs (e)(1) or (e)(2) of this section. The 
analytical tests may include gel permeation chromatography (GPC).vapor 
pressure osmometry (VPO), or other such tests which will demonstrate 
that the polymer meets the number-average MW criterion.
    (vi) Analytical data, or theoretical calculations (if it can be 
documented that an analytical determination cannot be made or is not 
necessary), to demonstrate that the polymer meets the criteria in 
paragraphs (e)(1) or (e)(2) of this section, meets the low MW content 
criteria in paragraphs (e)(1) or (e)(2) of this section.
    (vii) If applicable, analytical data, or theoretical calculations 
(if it can be documented that an analytical determination cannot be made 
or is not necessary) required in paragraph (g) of this section for 
determining monomers or reactants charged to the reaction vessel at 
greater than 2 weight percent but incorporated at 2 weight percent or 
less in the manufactured polymer.
    (viii) The certification statements as required under paragraph (h) 
of this section.
    (3) The manufacturer must submit the records listed in paragraph 
(j)(2) of this section to EPA upon written request by EPA. The 
manufacturer must provide these records within 15 working days of 
receipt of this request. In addition, any person who manufactures a new 
chemical substance under the terms of this section, upon request of EPA, 
must permit such person at all reasonable times to have access to and to 
copy these records.
    (k) Submission of information. Information submitted to EPA under 
this section must be sent in writing to: TSCA Document Control Officer, 
(7407), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    (l) Compliance. (1) A person who manufactures or imports a new 
chemical substance and fails to comply with any provision of this 
section is in violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Using for commercial purposes a chemical substance or mixture 
which a person knew or had reason to know was manufactured, processed, 
or distributed in commerce in violation of section 5 of the Act is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by this section and 
section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).
    (4) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 
2614).
    (5) Violators may be subject to the civil and criminal penalties in 
section

[[Page 27]]

16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit 
materially misleading or false information in connection with the 
requirements of any provision of this section may be subject to 
penalties calculated as if they never filed their notices.
    (6) EPA may seek to enjoin the manufacture or processing of a 
chemical substance in violation of this section or act to seize any 
chemical substance manufactured or processed in violation of this 
section or take other actions under the authority of section 7 of the 
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
    (m) Inspections. EPA will conduct inspections under section 11 of 
the Act to assure compliance with section 5 and this section, to verify 
that information submitted to EPA under this section is true and 
correct, and to audit data submitted to EPA under this section.
    (n) Confidentiality. If a manufacturer submits information to EPA 
under this section which the manufacturer claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to EPA by bracketing, circling, or 
underlining it and stamping it with ``CONFIDENTIAL'' or some other 
appropriate designation. Any information so identified will be treated 
in accordance with the procedures in 40 CFR part 2. Any information not 
claimed confidential at the time of submission may be made available to 
the public without further notice.

[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, Apr. 11, 1997; 
75 FR 4305, Jan. 27, 2010]



PART 725_REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents



             Subpart A_General Provisions and Applicability

Sec.
725.1  Scope and purpose.
725.3  Definitions.
725.8  Coverage of this part.
725.12  Identification of microorganisms for Inventory and other listing 
          purposes.
725.15  Determining applicability when microorganism identity or use is 
          confidential or uncertain.
725.17  Consultation with EPA.

                   Subpart B_Administrative Procedures

725.20  Scope and purpose.
725.25  General administrative requirements.
725.27  Submissions.
725.28  Notice that submission is not required.
725.29  EPA acknowledgement of receipt of submission.
725.32  Errors in the submission.
725.33  Incomplete submissions.
725.36  New information.
725.40  Notice in the Federal Register.
725.50  EPA review.
725.54  Suspension of the review period.
725.56  Extension of the review period.
725.60  Withdrawal of submission by the submitter.
725.65  Recordkeeping.
725.67  Applications to exempt new microorganisms from this part.
725.70  Compliance.
725.75  Inspections.

       Subpart C_Confidentiality and Public Access to Information

725.80  General provisions for confidentiality claims.
725.85  Microorganism identity.
725.88  Uses of a microorganism.
725.92  Data from health and safety studies of microorganisms.
725.94  Substantiation requirements.
725.95  Public file.

   Subpart D_Microbial Commercial Activities Notification Requirements

725.100  Scope and purpose.
725.105  Persons who must report.
725.110  Persons not subject to this subpart.
725.150  Procedural requirements for this subpart.
725.155  Information to be included in the MCAN.
725.160  Submission of health and environmental effects data.
725.170  EPA review of the MCAN.
725.190  Notice of commencement of manufacture or import.

      Subpart E_Exemptions for Research and Development Activities

725.200  Scope and purpose.
725.205  Persons who may report under this subpart.
725.232  Activities subject to the jurisdiction of other Federal 
          programs or agencies.
725.234  Activities conducted inside a structure.
725.235  Conditions of exemption for activities conducted inside a 
          structure.
725.238  Activities conducted outside a structure.
725.239  Use of specific microorganisms in activities conducted outside 
          a structure.

[[Page 28]]

725.250  Procedural requirements for the TERA.
725.255  Information to be included in the TERA.
725.260  Submission of health and environmental effects data.
725.270  EPA review of the TERA.
725.288  Revocation or modification of TERA approval.

                 Subpart F_Exemptions for Test Marketing

725.300  Scope and purpose.
725.305  Persons who may apply under this subpart.
725.350  Procedural requirements for this subpart.
725.355  Information to be included in the TME application.
725.370  EPA review of the TME application.

           Subpart G_General Exemptions for New Microorganisms

725.400  Scope and purpose.
725.420  Recipient microorganisms.
725.421  Introduced genetic material.
725.422  Physical containment and control technologies.
725.424  Requirements for the Tier I exemption.
725.426  Applicability of the Tier I exemption.
725.428  Requirements for the Tier II exemption.
725.450  Procedural requirements for the Tier II exemption.
725.455  Information to be included in the Tier II exemption request.
725.470  EPA review of the Tier II exemption request.

Subparts H-K [Reserved]

Subpart L_Additional Procedures for Reporting on Significant New Uses of 
                             Microorganisms

725.900  Scope and purpose.
725.910  Persons excluded from reporting significant new uses.
725.912  Exemptions.
725.920  Exports and imports.
725.950  Additional recordkeeping requirements.
725.975  EPA approval of alternative control measures.
725.980  Expedited procedures for issuing significant new use rules for 
          microorganisms subject to section 5(e) orders.
725.984  Modification or revocation of certain notification 
          requirements.

       Subpart M_Significant New Uses for Specific Microorganisms

725.1000  Scope.
725.1075  Burkholderia cepacia complex.

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

    Source: 62 FR 17932, Apr. 11, 1997, unless otherwise noted.



             Subpart A_General Provisions and Applicability



Sec. 725.1  Scope and purpose.

    (a) This part establishes all reporting requirements under section 5 
of TSCA for manufacturers, importers, and processors of microorganisms 
subject to TSCA jurisdiction for commercial purposes, including research 
and development for commercial purposes. New microorganisms for which 
manufacturers and importers are required to report under section 
5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under 
section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may 
be required to report for any microorganism that EPA determines by rule 
is being manufactured, imported, or processed for a significant new use.
    (b) Any manufacturer, importer, or processor required to report 
under section 5 of TSCA (see Sec. 725.100 for new microorganisms and 
Sec. 725.900 for significant new uses) must file a Microbial Commercial 
Activity Notice (MCAN) with EPA, unless the activity is eligible for a 
specific exemption as described in this part. The general procedures for 
filing MCANs are described in subpart D of this part. The exemptions 
from the requirement to file a MCAN are for certain kinds of contained 
activities (see Secs. 725.424 and 725.428), test marketing activities 
(see Sec. 725.300), and research and development activities described in 
paragraph (c) of this section.
    (c) Any manufacturer, importer, or processor required to file a MCAN 
for research and development (R&D) activities may instead file a TSCA 
Experimental Release Application (TERA) for a specific test (see 
Sec. 725.250). A TERA is not required for certain R&D activities; 
however a TERA exemption does not extend beyond the research and 
development stage, to general commercial use of the microorganism,

[[Page 29]]

for which compliance with MCAN requirements is required. The TERA 
exemptions are for R&D activities subject to other Federal agencies or 
programs (see Sec. 725.232), certain kinds of contained R&D activities 
(see Sec. 725.234), and R&D activities using certain listed 
microorganisms (see Sec. 725.238).
    (d) New microorganisms will be added to the Inventory established 
under section 8 of TSCA once a MCAN has been received, the MCAN review 
period has expired, and EPA receives a Notice of Commencement (NOC) 
indicating that manufacture or importation has actually begun. New 
microorganisms approved for use under a TERA will not be added to the 
Inventory until a MCAN has been received, the MCAN review period has 
expired, and EPA has received an NOC.



Sec. 725.3  Definitions.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as 
definitions contained in Secs. 704.3, 720.3, and 721.3 of this chapter, 
apply to this part unless otherwise specified in this section. In 
addition, the following definitions apply to this part:
    Consolidated microbial commercial activity notice or consolidated 
MCAN means any MCAN submitted to EPA that covers more than one 
microorganism (each being assigned a separate MCAN number by EPA) as a 
result of a prenotice agreement with EPA.
    Containment and/or inactivation controls means any combination of 
engineering, mechanical, procedural, or biological controls designed and 
operated to restrict environmental release of viable microorganisms from 
a structure.
    Director means the Director of the EPA Office of Pollution 
Prevention and Toxics.
    Exemption request means any application submitted to EPA under 
subparts E, F, or G of this part.
    General commercial use means use for commercial purposes other than 
research and development.
    Genome means the sum total of chromosomal and extrachromosomal 
genetic material of an isolate and any descendants derived under pure 
culture conditions from that isolate.
    Health and safety study of a microorganism or health and safety 
study means any study of any effect of a microorganism or microbial 
mixture on health or the environment or on both, including underlying 
data and epidemiological studies, studies of occupational exposure to a 
microorganism or microbial mixture, toxicological, clinical, and 
ecological, or other studies of a microorganism or microbial mixture, 
and any test performed under the Act. Microorganism identity is always 
part of a health and safety study of a microorganism.
    (1) It is intended that the term ``health and safety study of a 
microorganism'' be interpreted broadly. Not only is information which 
arises as a result of a formal, disciplined study included, but other 
information relating to the effects of a microorganism or microbial 
mixture on health or the environment is also included. Any data that 
bear on the effects of a microorganism on health or the environment 
would be included.
    (2) Examples include:
    (i) Tests for ecological or other environmental effects on 
invertebrates, fish, or other animals, and plants, including: Acute 
toxicity tests, chronic toxicity tests, critical life stage tests, 
behavioral tests, algal growth tests, seed germination tests, plant 
growth or damage tests, microbial function tests, bioconcentration or 
bioaccumulation tests, and model ecosystem (microcosm) studies.
    (ii) Long- and short-term tests of mutagenicity, carcinogenicity, or 
teratogenicity; dermatoxicity; cumulative, additive, and synergistic 
effects; and acute, subchronic, and chronic effects.
    (iii) Assessments of human and environmental exposure, including 
workplace exposure, and impacts of a particular microorganism or 
microbial mixture on the environment, including surveys, tests, and 
studies of: Survival and transport in air, water, and soil; ability to 
exchange genetic material with other microorganisms, ability to colonize 
human or animal guts, and ability to colonize plants.

[[Page 30]]

    (iv) Monitoring data, when they have been aggregated and analyzed to 
measure the exposure of humans or the environment to a microorganism.
    (v) Any assessments of risk to health and the environment resulting 
from the manufacture, processing, distribution in commerce, use, or 
disposal of the microorganism.
    Inactivation means that living microorganisms are rendered 
nonviable.
    Institutional Biosafety Committee means the committees described in 
the NIH Guidelines in section IV.B.2.
    Intergeneric microorganism means a microorganism that is formed by 
the deliberate combination of genetic material originally isolated from 
organisms of different taxonomic genera.
    (1) The term ``intergeneric microorganism'' includes a microorganism 
which contains a mobile genetic element which was first identified in a 
microorganism in a genus different from the recipient microorganism.
    (2) The term ``intergeneric microorganism'' does not include a 
microorganism which contains introduced genetic material consisting of 
only well-characterized, non-coding regulatory regions from another 
genus.
    Introduced genetic material means genetic material that is added to, 
and remains as a component of, the genome of the recipient.
    Manufacture, import, or process for commercial purposes means:
    (1) To import, produce, manufacture, or process with the purpose of 
obtaining an immediate or eventual commercial advantage for the 
manufacturer, importer, or processor, and includes, among other things, 
``manufacture'' or ``processing'' of any amount of a microorganism or 
microbial mixture:
    (i) For commercial distribution, including for test marketing.
    (ii) For use by the manufacturer, including use for product research 
and development or as an intermediate.
    (2) The term also applies to substances that are produced 
coincidentally during the manufacture, processing, use, or disposal of 
another microorganism or microbial mixture, including byproducts that 
are separated from that other microorganism or microbial mixture and 
impurities that remain in that microorganism or microbial mixture. 
Byproducts and impurities without separate commercial value are 
nonetheless produced for the purpose of obtaining a commercial 
advantage, since they are part of the manufacture or processing of a 
microorganism for commercial purposes.
    Microbial commercial activity notice or MCAN means a notice for 
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act 
in accordance with subpart D of this part.
    Microbial mixture means any combination of microorganisms or 
microorganisms and other chemical substances, if the combination does 
not occur in nature and is not an article.
    Microorganism means an organism classified, using the 5-kingdom 
classification system of Whittacker, in the kingdoms Monera (or 
Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of 
the Plantae, and a virus or virus-like particle.
    Mobile genetic element or MGE means an element of genetic material 
that has the ability to move genetic material within and between 
organisms. ``Mobile genetic elements'' include all plasmids, viruses, 
transposons, insertion sequences, and other classes of elements with 
these general properties.
    New microorganism means a microorganism not included on the 
Inventory.
    NIH Guidelines means the National Institutes of Health (NIH) 
``Guidelines for Research Involving Recombinant DNA Molecules'' (July 5, 
1994).
    Non-coding regulatory region means a segment of introduced genetic 
material for which:
    (1) The regulatory region and any inserted flanking nucleotides do 
not code for protein, peptide, or functional ribonucleic acid molecules.
    (2) The regulatory region solely controls the activity of other 
regions that code for protein or peptide molecules or act as recognition 
sites for the initiation of nucleic acid or protein synthesis.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or analysis 
or research on, or analysis of, such substance or another substance, 
including such research or analysis for development of a product'')

[[Page 31]]

means quantities of a microorganism manufactured, imported, or processed 
or proposed to be manufactured, imported, or processed solely for 
research and development that meet the requirements of Sec. 725.234.
    Structure means a building or vessel which effectively surrounds and 
encloses the microorganism and includes features designed to restrict 
the microorganism from leaving.
    Submission means any MCAN or exemption request submitted to EPA 
under this part.
    Technically qualified individual means a person or persons:
    (1) Who, because of education, training, or experience, or a 
combination of these factors, is capable of understanding the health and 
environmental risks associated with the microorganism which is used 
under his or her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or microbiological 
research to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the 
microorganism as may be appropriate or required within the scope of 
conducting a research and development activity.
    TSCA Experimental Release Application or TERA means an exemption 
request for a research and development activity, which is not eligible 
for a full exemption from reporting under Sec. 725.232, 725.234, or 
725.238, submitted to EPA in accordance with subpart E of this part.
    Well-characterized for introduced genetic material means that the 
following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.



Sec. 725.8  Coverage of this part.

    (a) Microorganisms subject to this part. Only microorganisms which 
are manufactured, imported, or processed for commercial purposes, as 
defined in Sec. 725.3, are subject to the requirements of this part.
    (b) Microorganisms automatically included on the Inventory. 
Microorganisms that are not intergeneric are automatically included on 
the Inventory.
    (c) Microorganisms not subject to this part. The following 
microorganisms are not subject to this part, either because they are not 
subject to jurisdiction under the Act or are not subject to reporting 
under section 5 of the Act.
    (1) Any microorganism which would be excluded from the definition of 
``chemical substance'' in section 3 of the Act and Sec. 720.3(e) of this 
chapter.
    (2) Any microbial mixture as defined in Sec. 725.3. This exclusion 
applies only to a microbial mixture as a whole and not to any 
microorganisms and other chemical substances which are part of the 
microbial mixture.
    (3) Any microorganism that is manufactured and processed solely for 
export if the following conditions are met:
    (i) The microorganism is labeled in accordance with section 
12(a)(1)(B) of the Act, when the microorganism is distributed in 
commerce.
    (ii) The manufacturer and processor can document at the commencement 
of manufacturing or processing that the person to whom the microorganism 
will be distributed intends to export it or process it solely for export 
as defined in Sec. 721.3 of this chapter.



Sec. 725.12  Identification of microorganisms for Inventory and other
listing purposes.

    To identify and list microorganisms on the Inventory, both taxonomic 
designations and supplemental information will be used. The supplemental 
information required in paragraph (b) of this section will be used to 
specifically describe an individual microorganism on the Inventory. 
Submitters must provide the supplemental information required by 
paragraph (b) of this section to the extent necessary to enable a 
microorganism to be accurately and

[[Page 32]]

unambiguously identified on the Inventory.
    (a) Taxonomic designation. The taxonomic designation of a 
microorganism must be provided for the donor organism and the recipient 
microorganism to the level of strain, as appropriate. These designations 
must be substantiated by a letter from a culture collection, literature 
references, or the results of tests conducted for the purpose of 
taxonomic classification. Upon EPA's request to the submitter, data 
supporting the taxonomic designation must be provided to EPA. The 
genetic history of the recipient microorganism should be documented back 
to the isolate from which it was derived.
    (b) Supplemental information. The supplemental information described 
in paragraphs (b)(1) and (b)(2) of this section is required to the 
extent that it enables a microorganism to be accurately and 
unambiguously identified.
    (1) Phenotypic information. Phenotypic information means pertinent 
traits that result from the interaction of a microorganism's genotype 
and the environment in which it is intended to be used and may include 
intentionally added biochemical and physiological traits.
    (2) Genotypic information. Genotypic information means the pertinent 
and distinguishing genotypic characteristics of a microorganism, such as 
the identity of the introduced genetic material and the methods used to 
construct the reported microorganism. This also may include information 
on the vector construct, the cellular location, and the number of copies 
of the introduced genetic material.



Sec. 725.15  Determining applicability when microorganism identity or
use is confidential or uncertain.

    (a) Consulting EPA. Persons intending to conduct activities 
involving microorganisms may determine their obligations under this part 
by consulting the Inventory or the microorganisms and uses specified in 
Sec. 725.239 or in subpart M of this part. This section establishes 
procedures for EPA to assist persons in determining whether the 
microorganism or the use is listed on the Inventory, in Sec. 725.239 or 
in subpart M of this part.
    (1) Confidential identity or use. In some cases it may not be 
possible to directly determine if a specific microorganism is listed, 
because portions of that entry may contain generic information to 
protect confidential business information (CBI). If any portion of the 
microorganism's identity or use has been claimed as CBI, that portion 
does not appear on the public version of the Inventory, in Sec. 725.239 
or in subpart M of this part. Instead, it is contained in a confidential 
version held in EPA's Confidential Business Information Center (CBIC). 
The public versions contain generic information which masks the 
confidential business information. A person who intends to conduct an 
activity involving a microorganism or use whose entry is described with 
generic information will need to inquire of EPA whether the unreported 
microorganism or use is on the confidential version.
    (2) Uncertain microorganism identity. The current state of 
scientific knowledge leads to some imprecision in describing a 
microorganism. As the state of knowledge increases, EPA will be 
developing policies to determine whether one microorganism is equivalent 
to another. Persons intending to conduct activities involving 
microorganisms may inquire of EPA whether the microorganisms they intend 
to manufacture (including import) or process are equivalent to specific 
microorganisms described on the Inventory, in Sec. 725.239, or in 
subpart M of this part.
    (b) Requirement of bona fide intent. (1) EPA will answer the 
inquiries described in paragraph (a) of this section only if the Agency 
determines that the person has a bona fide intent to conduct the 
activity for which reporting is required or for which any exemption may 
apply.
    (2) To establish a bona fide intent to manufacture (including 
import) or process a microorganism, the person who proposes to 
manufacture (including import) or process the microorganism must submit 
the request to EPA via CDX. Prior to submission to EPA via CDX, such 
bona fide intents to manufacture (including import) or process must be 
generated and completed using e-PMN software. See 40 CFR 
720.40(a)(2)(ii) for information on how

[[Page 33]]

to access the e-PMN software. A bona fide intent to manufacture 
(including import) or process must contain the following information:
    (i) Taxonomic designations and supplemental information required by 
Sec. 725.12.
    (ii) A signed statement certifying that the submitter intends to 
manufacture (including import) or process the microorganism for 
commercial purposes.
    (iii) A description of research and development activities conducted 
with the microorganism to date, demonstration of the submitter's ability 
to produce or obtain the microorganism from a foreign manufacturer, and 
the purpose for which the person will manufacture (including import) or 
process the microorganism.
    (iv) An indication of whether a related microorganism was previously 
reviewed by EPA to the extent known by the submitter.
    (v) A specific description of the major intended application or use 
of the microorganism.
    (c) If an importer or processor cannot provide all the information 
required by paragraph (b) of this section, because it is claimed as 
confidential business information by its foreign manufacturer or 
supplier, the foreign manufacturer or supplier may supply the 
information directly to EPA.
    (d) EPA will review the information submitted by the manufacturer 
(including importer) or processor under this paragraph to determine 
whether that person has shown a bona fide intent to manufacture 
(including import) or process the microorganism. If necessary, EPA will 
compare this information to the information requested for the 
confidential microorganism under Sec. 725.85(b)(3)(iii).
    (e) In order for EPA to make a conclusive determination of the 
microorganism's status, the proposed manufacturer (including importer) 
or processor must show a bona fide intent to manufacture (including 
import) or process the microorganism and must provide sufficient 
information to establish identity unambiguously. After sufficient 
information has been provided, EPA will inform the manufacturer 
(including importer) or processor whether the microorganism is subject 
to this part and if so, which sections of this part apply.
    (f) If the microorganism is found on the confidential version of the 
Inventory, in Sec. 725.239 or in subpart M of this part, EPA will notify 
the person(s) who originally reported the microorganism that another 
person (whose identity will remain confidential, if so requested) has 
demonstrated a bona fide intent to manufacture (including import) or 
process the microorganism and therefore was told that the microorganism 
is on the Inventory, in Sec. 725.239, or in subpart M of this part.
    (g) A disclosure to a person with a bona fide intent to manufacture 
(including import) or process a particular microorganism that the 
microorganism is on the Inventory, in Sec. 725.239, or in subpart M of 
this part will not be considered a public disclosure of confidential 
business information under section 14 of the Act.
    (h) EPA will answer an inquiry on whether a particular microorganism 
is subject to this part within 30 days after receipt of a complete 
submission under paragraph (b) of this section.

[62 FR 17932, Apr. 11, 1997, as amended at 80 FR 42747, July 20, 2015]



Sec. 725.17  Consultation with EPA.

    Persons may consult with EPA, either in writing or by telephone, 
about their obligations under this part. Written consultation is 
preferred. Written inquiries should be sent to the following address: 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice 
Consultation. Persons wishing to consult with EPA by telephone should 
call (202) 554-1404; hearing impaired TDD (202) 554-0551 or e-mail: 
[email protected]



                   Subpart B_Administrative Procedures



Sec. 725.20  Scope and purpose.

    This subpart describes general administrative procedures applicable 
to

[[Page 34]]

all persons who submit MCANs and exemption requests to EPA under section 
5 of the Act for microorganisms.



Sec. 725.25  General administrative requirements.

    (a) General. (1) Each person who is subject to the notification 
provisions of this part must complete, sign, and submit a MCAN or 
exemption request containing the information as required for the 
appropriate submission under this part. Except as otherwise provided, 
each submission must include all referenced attachments. All information 
in the submission (unless certain attachments appear in the open 
scientific literature) must be in English. All information submitted 
must be true and correct.
    (2) In addition to specific information required, the submitter 
should submit all information known to or reasonably ascertainable by 
the submitter that would permit EPA to make a reasoned evaluation of the 
human health and environmental effects of the microorganism and any 
microbial mixture or article that may contain the microorganism.
    (b) Certification. Persons submitting MCANs and exemption requests 
to EPA under this part, and material related to their reporting 
obligations under this part, must attach the following statement to any 
information submitted to EPA. This statement must be signed and dated by 
an authorized official of the submitter:

    I certify that to the best of my knowledge and belief: The company 
named in this submission intends to manufacture, import, or process for 
a commercial purpose, other than in small quantities solely for research 
and development, the microorganism identified in this submission. All 
information provided in this submission is complete and truthful as of 
the date of submission. I am including with this submission all test 
data in my possession or control and a description of all other data 
known to or reasonably ascertainable by me as required by 40 CFR 725.160 
or 725.260.

    (c) Where to submit information under this part. MCANs and exemption 
requests, and any support documents related to these submissions, may 
only be submitted in a manner set forth in this paragraph. MCANs and 
exemption requests, and any related support documents, must be 
generated, completed, and submitted to EPA (via CDX) using e-PMN 
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain 
e-PMN software.
    (d) General requirements for submission of data. (1) Submissions 
under this part must include the information described in Sec. 725.155, 
Sec. 725.255, Sec. 725.355, or Sec. 725.455, as appropriate, to the 
extent such information is known to or reasonably ascertainable by the 
submitter.
    (2) In accordance with Sec. 725.160 or Sec. 725.260, as appropriate, 
the submission must also include any test data in the submitter's 
possession or control and descriptions of other data which are known to 
or reasonably ascertainable by the submitter and which concern the 
health and environmental effects of the microorganism.
    (e) Agency or joint submissions. (1) A manufacturer or importer may 
designate an agent to assist in submitting the MCAN. If so, only the 
manufacturer or importer, and not the agent, signs the certification on 
the form.
    (2) A manufacturer or importer may authorize another person, (e.g., 
a supplier or a toll manufacturer) to report some of the information 
required in the MCAN to EPA on its behalf. The manufacturer or importer 
should indicate in a cover letter accompanying the MCAN which 
information will be supplied by another person and identify that other 
person as a joint submitter where indicated in their MCAN. The other 
person supplying information (i.e., the joint submitter) may submit the 
information to EPA either in the MCAN or a Letter of Support, except 
that if the joint submitter is not incorporated, licensed, or doing 
business in the United States, the joint submitter must submit the 
information to EPA in a Letter of Support only, rather than the MCAN. 
The joint submitter must indicate in the MCAN or Letter of Support the 
identity of the manufacturer or importer. Any person who submits the 
MCAN or Letter of Support for a joint submission must sign and certify 
the MCAN or Letter of Support.
    (3) If EPA receives a submission which does not include the 
information required, which the submitter indicates that it has 
authorized another person to provide, the review period will not

[[Page 35]]

begin until EPA receives all of the required information.
    (f) Microorganisms subject to a section 4 test rule. (1) Except as 
provided in paragraph (f)(3) of this section, if a person intends to 
manufacture or import a new microorganism which is subject to the 
notification requirements of this part, and the microorganism is subject 
to a test rule promulgated under section 4 of the Act before the notice 
is submitted, section 5(b)(1) of the Act requires the person to submit 
the test data required by the testing rule with the notice. The person 
must submit the data in the form and manner specified in the test rule 
and in accordance with Sec. 725.160. If the person does not submit the 
test data, the submission is incomplete and EPA will follow the 
procedures in Sec. 725.33.
    (2) If EPA has granted the submitter an exemption under section 4(c) 
of the Act from the requirement to conduct tests and submit data, the 
person may not file a MCAN or TERA until EPA receives the test data.
    (3) If EPA has granted the submitter an exemption under section 4(c) 
of the Act and if another person previously has submitted the test data 
to EPA, the exempted person may either submit the test data or provide 
the following information as part of the notice:
    (i) The name, title, and address of the person who submitted the 
test data to EPA.
    (ii) The date the test data were submitted to EPA.
    (iii) A citation for the test rule.
    (iv) A description of the exemption and a reference identifying it.
    (g) Microorganisms subject to a section 5(b)(4) rule. (1) If a 
person:
    (i) Intends to manufacture or import a microorganism which is 
subject to the notification requirements of this part and which is 
subject to a rule issued under section 5(b)(4) of the Act; and
    (ii) Is not required by a rule issued under section 4 of the Act to 
submit test data for the microorganism before the filing of a 
submission, the person must submit to EPA data described in paragraph 
(g)(2) of this section at the time the submission is filed.
    (2) Data submitted under paragraph (g)(1) of this section must be 
data which the person submitting the notice believes show that the 
manufacture, processing, distribution in commerce, use, and disposal of 
the microorganism, or any combination of such activities, will not 
present an unreasonable risk of injury to health or the environment.
    (h) Data that need not be submitted. Specific data requirements are 
listed in subparts D, E, F, G, and L of this part. The following is a 
list of data that need not be submitted under this part:
    (1) Data previously submitted to EPA. (i) A person need not submit 
any data previously submitted to EPA with no claims of confidentiality 
if the new submission includes: the office or person to whom the data 
were submitted; the date of submission; and, if appropriate, a standard 
literature citation as specified in Sec. 725.160(a)(3)(ii).
    (ii) For data previously submitted to EPA with a claim of 
confidentiality, the person must resubmit the data with the new 
submission and any claim of confidentiality, under Sec. 725.80.
    (2) Efficacy data. This part does not require submission of any data 
related solely to product efficacy. However, including efficacy data 
will improve EPA's ability to assess the benefits of the use of the 
microorganism. This does not exempt a person from submitting any of the 
data specified in Sec. 725.160 or Sec. 725.260.
    (3) Non-U.S. exposure data. This part does not require submission of 
any data which relates only to exposure of humans or the environment 
outside the United States. This does not exclude nonexposure data such 
as data on health effects (including epidemiological studies), 
ecological effects, physical and chemical properties, or environmental 
fate characteristics.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



Sec. 725.27  Submissions.

    Each person who is required to submit information under this part 
must submit the information in the form and manner set forth in the 
appropriate subpart.
    (a) Requirements specific to MCANs are described in Secs. 725.150 
through 725.160.

[[Page 36]]

    (b) Requirements specific to TERAs are described in Secs. 725.250 
through 725.260.
    (c) Requirements specific to test marketing exemptions (TMEs) are 
described in Secs. 725.350 and 725.355.
    (d) Requirements specific to Tier I and Tier II exemptions for 
certain general commercial uses are described in Secs. 725.424 through 
725.470.
    (e) Additional requirements specific to significant new uses for 
microorganisms are described at Sec. 725.950.



Sec. 725.28  Notice that submission is not required.

    When EPA receives a MCAN or exemption request, EPA will review it to 
determine whether the microorganism is subject to the requirements of 
this part. If EPA determines that the microorganism is not subject to 
these requirements, EPA will notify the submitter that section 5 of the 
Act does not prevent the manufacture, import, or processing of the 
microorganism and that the submission is not needed.



Sec. 725.29  EPA acknowledgement of receipt of submission.

    (a) EPA will acknowledge receipt of each submission by sending a 
letter via CDX or U.S. mail to the submitter that identifies the number 
assigned to each MCAN or exemption request and the date on which the 
review period begins. The review period will begin on the date the MCAN 
or exemption request is received by the Office of Pollution Prevention 
and Toxics Document Control Officer.
    (b) The acknowledgement does not constitute a finding by EPA that 
the submission is in compliance with this part.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010]



Sec. 725.32  Errors in the submission.

    (a) Within 30 days of receipt of the submission, EPA may request 
that the submitter remedy errors in the submission. The following are 
examples of such errors:
    (1) Failure to date the submission.
    (2) Typographical errors that cause data to be misleading or answers 
to any questions to be unclear.
    (3) Contradictory information.
    (4) Ambiguous statements or information.
    (b) In the request to correct the submission, EPA will explain the 
action which the submitter must take to correct the submission.
    (c) If the submitter fails to correct the submission within 15 days 
of receipt of the request, EPA may extend the review period.



Sec. 725.33  Incomplete submissions.

    (a) A submission under this part is not complete, and the review 
period does not begin, if:
    (1) The wrong person files the submission.
    (2) The submitter does not attach and sign the certification 
statement as required by Sec. 725.25(b).
    (3) Some or all of the information in the submission or any 
attachments are not in English, except for published scientific 
literature.
    (4) The submitter does not provide information that is required by 
sections 5(d)(1)(B) and (C) of the Act and Sec. 725.160 or 725.260, as 
appropriate.
    (5) The submitter does not provide information required by 
Sec. 725.25, Sec. 725.155, Sec. 725.255, Sec. 725.355, or Sec. 725.455, 
as appropriate, or indicate that it is not known to or reasonably 
ascertainable by the submitter.
    (6) The submitter has asserted confidentiality claims and has failed 
to:
    (i) Submit a second copy of the submission with all confidential 
information deleted for the public file, as required by 
Sec. 725.80(b)(2).
    (ii) Comply with the substantiation requirements as described in 
Sec. 725.94.
    (7) The submitter does not include any information required by 
section 5(b)(1) of the Act and pursuant to a rule promulgated under 
section 4 of the Act, as required by Sec. 725.25(f).
    (8) The submitter does not submit data which the submitter believes 
show that the microorganism will not present an unreasonable risk of 
injury to health or the environment, if EPA has listed the microorganism 
under section 5(b)(4) of the Act, as required in Sec. 725.25(g).
    (9) For MCANs, the submitter does not remit the fees required by 
Sec. 700.45(b)(1) or (b)(2)(vi) of this chapter.

[[Page 37]]

    (10) The submitter does not include an identifying number and a 
payment identity number as required by Sec. 700.45(e)(3) of this 
chapter.
    (11) The submitter does not submit the notice in the manner set 
forth in Sec. 725.25(c).
    (b)(1) If EPA receives an incomplete submission under this part, the 
Director, or a designee, will notify the submitter within 30 days of 
receipt that the submission is incomplete and that the review period 
will not begin until EPA receives a complete submission.
    (2) If EPA obtains additional information during the review period 
for any submission that indicates the original submission was 
incomplete, the Director, or a designee, may declare the submission 
incomplete within 30 days after EPA obtains the additional information 
and so notify the submitter.
    (c) The notification that a submission is incomplete under paragraph 
(b) of this section will include:
    (1) A statement of the basis of EPA's determination that the 
submission is incomplete.
    (2) The requirements for correcting the incomplete submission.
    (3) Information on procedures under paragraph (d) of this section 
for filing objections to the determination or requesting modification of 
the requirements for completing the submission.
    (d) Within 10 days after receipt of notification by EPA that a 
submission is incomplete, the submitter may file written objections 
requesting that EPA accept the submission as complete or modify the 
requirements necessary to complete the submission.
    (e)(1) EPA will consider the objections filed by the submitter. The 
Director, or a designee, will determine whether the submission was 
complete or incomplete, or whether to modify the requirements for 
completing the submission. EPA will notify the submitter in writing of 
EPA's response within 10 days of receiving the objections.
    (2) If the Director, or a designee, determines, in response to the 
objection, that the submission was complete, the review period will be 
deemed suspended on the date EPA declared the submission incomplete, and 
will resume on the date that the submission is declared complete. The 
submitter need not correct the submission as EPA originally requested. 
If EPA can complete its review within the review period beginning on the 
date of the submission, the Director, or a designee, may inform the 
submitter that the running of the review period will resume on the date 
EPA originally declared it incomplete.
    (3) If the Director, or a designee, modifies the requirements for 
completing the submission or concurs with EPA's original determination, 
the review period will begin when EPA receives a complete submission.
    (f) If EPA discovers at any time that a person submitted materially 
false or misleading statements in information submitted under this part, 
EPA may find that the submission was incomplete from the date it was 
submitted, and take any other appropriate action.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010]



Sec. 725.36  New information.

    (a) During the review period, if a submitter possesses, controls, or 
knows of new information that materially adds to, changes, or otherwise 
makes significantly more complete the information included in the MCAN 
or exemption request, the submitter must send that information within 10 
days of receiving the new information, but no later than 5 days before 
the end of the review period. The new information must be sent in the 
same manner the original notice or exemption was sent, as described in 
Sec. 725.25(c)(1), (c)(2), and (c)(3).
    (b) The new submission must clearly identify the submitter, the MCAN 
or exemption request to which the new information is related, and the 
number assigned to that submission by EPA, if known to the submitter.
    (c) If the new information becomes available during the last 5 days 
of the review period, the submitter must immediately inform the EPA 
contact for that submission by telephone of the new information.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010]

[[Page 38]]



Sec. 725.40  Notice in the Federal Register.

    (a) Filing of Federal Register notice. After EPA receives a MCAN or 
an exemption request under this part, EPA will issue a notice in the 
Federal Register including the information specified in paragraph (b) of 
this section.
    (b) Contents of notice. (1) In the public interest, the specific 
microorganism identity listed in the submission will be published in the 
Federal Register unless the submitter has claimed the microorganism 
identity confidential. If the submitter claims confidentiality, a 
generic name will be published in accordance with Sec. 725.85.
    (2) The categories of use of the microorganism will be published as 
reported in the submission unless this information is claimed 
confidential. If confidentiality is claimed, the generic information 
which is submitted under Sec. 725.88 will be published.
    (3) A list of information submitted in accordance with 
Sec. 725.160(a), Sec. 725.255, Sec. 725.260, Sec. 725.355, or 
Sec. 725.455, as appropriate, will be published.
    (4) The submitter's identity will be published, unless the submitter 
has claimed it confidential.
    (c) Publication of exemption decisions. Following the expiration of 
the appropriate review period for the exemption request, EPA will issue 
a notice in the Federal Register indicating whether the request has been 
approved or denied and the reasons for the decision.



Sec. 725.50  EPA review.

    (a) MCANs. The review period specified in section 5(a) of the Act 
for MCANs runs for 90 days from the date the Document Control Officer 
receives a complete submission, or the date EPA determines the 
submission is complete under Sec. 725.33, unless the Agency extends the 
review period under section 5(c) of the Act and Sec. 725.56.
    (b) Exemption requests. The review period starts on the date the 
Document Control Officer receives a complete exemption request, or the 
date EPA determines the request is complete under Sec. 725.33, unless 
the Agency extends the review period under Sec. 725.56. The review 
periods for exemption requests run as follows:
    (1) TERAs. The review period for TERAs is 60 days.
    (2) TMEs. The review period for TMEs is 45 days.
    (3) Tier II exemption requests. The review period for Tier II 
exemption requests is 45 days.



Sec. 725.54  Suspension of the review period.

    (a) A submitter may voluntarily suspend the running of the review 
period if the Director, or a designee, agrees. If the Director does not 
agree, the review period will continue to run, and EPA will notify the 
submitter. A submitter may request a suspension at any time during the 
review period. The suspension must be for a specified period of time.
    (b)(1) Request for suspension. A request for suspension may only be 
submitted in a manner set forth in this paragraph. The request for 
suspension also may be made orally, including by telephone, to the 
submitter's EPA contact for that notice, subject to paragraph (c) of 
this section.
    (2) Submission of suspension notices. EPA will accept requests for 
suspension only if submitted in accordance with this paragraph. Requests 
for suspension, must be generated, completed, and submitted to EPA (via 
CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information 
on how to obtain e-PMN software.
    (c) An oral request for suspension may be granted by EPA for a 
maximum of 15 days only. Requests for longer suspension must only be 
submitted in the manner set forth in this paragraph.
    (d) 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 CDX submission by EPA.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



Sec. 725.56  Extension of the review period.

    (a) At any time during the review period, EPA may unilaterally 
determine that good cause exists to extend the review period specified 
for MCANs, or the exemption requests.
    (b) If EPA makes such a determination, EPA:

[[Page 39]]

    (1) Will notify the submitter that EPA is extending the review 
period for a specified length of time and state the reasons for the 
extension.
    (2) For MCANs, EPA may issue a notice for publication in the Federal 
Register which states that EPA is extending the review period and gives 
the reasons for the extension.
    (c) The total period of the extension may be for a period of up to 
the same length of time as specified for each type of submission in 
Sec. 725.50. If the initial extension is for less than the total time 
allowed, EPA may make additional extensions. However, the sum of the 
extensions may not exceed the total allowed.
    (d) The following are examples of situations in which EPA may find 
that good cause exists for extending the review period:
    (1) EPA has reviewed the submission and is seeking additional 
information.
    (2) EPA has received significant additional information during the 
review period.
    (3) The submitter has failed to correct a submission after receiving 
EPA's request under Sec. 725.32.
    (4) EPA has reviewed the submission and determined that there is a 
significant possibility that the microorganism will be regulated under 
section 5(e) or section 5(f) of the Act, but EPA is unable to initiate 
regulatory action within the initial review period.



Sec. 725.60  Withdrawal of submission by the submitter.

    (a)(1) Withdrawal of notice by the submitter. A submitter may 
withdraw a notice during the notice review period by submitting a 
statement of withdrawal in a manner set forth in this paragraph. The 
withdrawal is effective upon receipt of the CDX submission by EPA.
    (2) Submission of withdrawal notices. EPA will accept statements of 
withdrawal only if submitted in accordance with this paragraph. 
Statements of withdrawal must be generated, completed, and submitted to 
EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for 
information on how to obtain e-PMN software.
    (b) If a manufacturer, importer, or processor who withdrew a 
submission later resubmits a submission for the same microorganism, a 
new review period begins.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



Sec. 725.65  Recordkeeping.

    (a) General provisions. (1) Any person who submits a notice under 
this part must retain documentation of information in the submission, 
including:
    (i) Any data in the submitter's possession or control; and
    (ii) Records of production volume for the first 3 years of 
manufacture, import, or processing.
    (2) Any person who submits a notice under this part must retain 
documentation of the date of commencement of testing, manufacture, 
import, or processing.
    (3) Any person who is exempt from some or all of the reporting 
requirements of this part must retain documentation that supports the 
exemption.
    (4) All information required by this section must be retained for 3 
years from the date of commencement of each activity for which records 
are required under this part.
    (b) Specific requirements. In addition to the requirements of 
paragraph (a) of this section, specific recordkeeping requirements 
included in certain subparts must also be followed.
    (1) Additional recordkeeping requirements for activities conducted 
inside a structure are set forth in Sec. 725.235(h).
    (2) Additional recordkeeping requirements for TERAs are set forth in 
Sec. 725.250(f).
    (3) Additional recordkeeping requirements for TMEs are set forth in 
Sec. 725.350(c).
    (4) Additional recordkeeping requirements for Tier I exemptions 
under subpart G of this part are set forth in Sec. 725.424(a)(5).
    (5) Additional recordkeeping requirements for Tier II exemptions 
under subpart G of this part are set forth in Sec. 725.450(d).
    (6) Additional recordkeeping requirements for significant new uses 
of microorganisms reported under subpart L of this part are set forth in 
Sec. 725.850. Recordkeeping requirements may also be included when a 
microorganism and

[[Page 40]]

significant new use are added to subpart M of this part.



Sec. 725.67  Applications to exempt new microorganisms from this part.

    (a) Submission. (1) Any manufacturer or importer of a new 
microorganism may request, under TSCA section 5(h)(4), an exemption, in 
whole or in part, from this part by sending a Letter of Application in 
the manner set forth in Sec. 725.25(c).
    (2) General provisions. The Letter of Application should provide 
information to show that any activities affected by the requested 
exemption will not present an unreasonable risk of injury to health or 
the environment. This information should include data described in the 
following paragraphs.
    (i) The effects of the new microorganism on health and the 
environment.
    (ii) The magnitude of exposure of human beings and the environment 
to the new microorganism.
    (iii) The benefits of the new microorganism for various uses and the 
availability of substitutes for such uses.
    (iv) The reasonably ascertainable economic consequences of granting 
or denying the exemption, including effects on the national economy, 
small business, and technological innovation.
    (3) Specific requirements. In addition to the requirements of 
paragraph (a)(2) of this section, the specific information requirements 
of the relevant subpart under which the exemption is sought should be 
met.
    (i) Exemption from MCAN reporting under subpart D. Information 
requirements are set forth in Secs. 725.155 and 725.160.
    (ii) Exemption from TERA reporting under subpart E. Information 
requirements are set forth in Secs. 725.255 and 725.260.
    (iii) Listing a recipient microorganism as eligible for exemption 
under subpart G. Information regarding the following criteria should be 
addressed in an application to list a recipient microorganism under 
Sec. 725.420:
    (A) Identification and classification of the microorganism using 
available genotypic and phenotypic information;
    (B) Information to evaluate the relationship of the microorganism to 
any other closely related microorganisms which have a potential for 
adverse effects on health or the environment;
    (C) A history of safe commercial use for the microorganism;
    (D) Commercial uses indicating that the microorganism products might 
be subject to TSCA;
    (E) Studies which indicate the potential for the microorganism to 
cause adverse effects to health or the environment; and
    (F) Studies which indicate the survival characteristics of the 
microorganism in the environment.
    (b) Processing of the Letter of Application by EPA--(1) Grant of the 
Application. If, after consideration of the Letter of Application and 
any other relevant information available to EPA, the Assistant 
Administrator for Chemical Safety and Pollution Prevention makes a 
preliminary determination that the new microorganism will not present an 
unreasonable risk of injury to health or the environment, the Assistant 
Administrator will propose a rule to grant the exemption using the 
applicable procedures in part 750 of this chapter.
    (2) Denial of the application. If the Assistant Administrator 
decides that the preliminary determination described in paragraph (b)(1) 
of this section cannot be made, the application will be denied by 
sending the applicant a written statement with the Assistant 
Administrator's reasons for denial.
    (c) Processing of the exemption--(1) Unreasonable risk standard. 
Granting a section 5(h)(4) exemption requires a determination that the 
activities will not present an unreasonable risk of injury to health or 
the environment.
    (i) An unreasonable risk determination under the Act is an 
administrative judgment that requires balancing of the harm to health or 
the environment that a chemical substance may cause and the magnitude 
and severity of that harm, against the social and economic effects on 
society of EPA action to reduce that harm.
    (ii) A determination of unreasonable risk under section 5(h)(4) of 
the Act will examine the reasonably ascertainable economic and social 
consequences of granting or denying the exemption after consideration of 
the effect on the

[[Page 41]]

national economy, small business, technological innovation, the 
environment, and public health.
    (2) Grant of the exemption. The exemption will be granted if the 
Assistant Administrator determines, after consideration of all relevant 
evidence presented in the rulemaking proceeding described in paragraph 
(b)(1) of this section, that the new microorganism will not present an 
unreasonable risk of injury to health or the environment.
    (3) Denial of the exemption. The exemption will be denied if the 
Assistant Administrator determines, after consideration of all relevant 
evidence presented in the rulemaking proceeding described in paragraph 
(b)(1) of this section, that the determination described in paragraph 
(c)(2) of this section cannot be made. A final decision terminating the 
rulemaking proceeding will be published in the Federal Register.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 77 
FR 46292, Aug. 3, 2012]



Sec. 725.70  Compliance.

    (a) Failure to comply with any provision of this part is a violation 
of section 15 of the Act (15 U.S.C. 2614).
    (b) A person who manufactures or imports a microorganism before a 
MCAN is submitted and the MCAN review period expires is in violation of 
section 15 of the Act even if that person was not required to submit the 
MCAN under Sec. 725.105.
    (c) Using a microorganism which a person knew or had reason to know 
was manufactured, processed, or distributed in commerce in violation of 
section 5 of the Act or this part is a violation of section 15 of the 
Act (15 U.S.C. 2614).
    (d) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (e) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 
2614).
    (f) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who 
submit materially misleading or false information in connection with the 
requirements of any provision of this part may be subject to penalties 
calculated as if they never filed their submissions.
    (g) EPA may seek to enjoin the manufacture or processing of a 
microorganism in violation of this part or act to seize any 
microorganism manufactured or processed in violation of this part or 
take other actions under the authority of section 7 of the Act (15 
U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).



Sec. 725.75  Inspections.

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



       Subpart C_Confidentiality and Public Access to Information



Sec. 725.80  General provisions for confidentiality claims.

    (a) A person may assert a claim of confidentiality for any 
information submitted to EPA under this part. However,
    (1) Any person who asserts a claim of confidentiality for portions 
of the specific microorganism identity must provide the information as 
described in Sec. 725.85.
    (2) Any person who asserts a claim of confidentiality for a use of a 
microorganism must provide the information as described in Sec. 725.88.
    (3) Any person who asserts a claim of confidentiality for 
information contained in a health and safety study of a microorganism 
must provide the information described in Sec. 725.92.
    (b) Any claim of confidentiality must accompany the information when 
it is submitted to EPA.
    (1) When a person submits any information under this part, including 
any attachments, for which claims of confidentiality are made, the 
claim(s) must be asserted by circling the specific information which is 
claimed and marking the page on which that information appears with an 
appropriate designation such as ``trade secret,'' ``TSCA CBI,'' or 
``confidential business information.''

[[Page 42]]

    (2) If any information is claimed confidential, the person must 
submit two copies of the document including the claimed information.
    (i) One copy of the document must be complete. In that copy, the 
submitter must mark the information which is claimed as confidential in 
the manner prescribed in paragraph (b)(1) of this section.
    (ii) The second copy must be complete except that all information 
claimed as confidential in the first copy must be deleted. EPA will 
place the second copy in the public file.
    (iii) If the submitter does not provide the second copy, the 
submission is incomplete and the review period does not begin to run 
until EPA receives the second copy, in accordance with Sec. 725.33.
    (iv) Any information contained within the copy submitted under 
paragraph (b)(2)(ii) of this section which has been in the public file 
for more than 30 days will be presumed to be in the public domain, 
notwithstanding any assertion of confidentiality made under this 
section.
    (3) A person who submits information to EPA under this part must 
reassert a claim of confidentiality and substantiate the claim each time 
the information is submitted to EPA.
    (c) Any person asserting a claim of confidentiality under this part 
must substantiate each claim in accordance with the requirements in 
Sec. 725.94.
    (d) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent permitted 
by the Act, this subpart, and part 2 of this title.
    (e) If a submitter does not assert a claim of confidentiality for 
information at the time it is submitted to EPA, EPA may make the 
information public and place it in the public file without further 
notice to the submitter.



Sec. 725.85  Microorganism identity.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import for general commercial use--(1) When to make a 
claim. (i) A person who submits information to EPA under this part may 
assert a claim of confidentiality for portions of the specific 
microorganism identity at the time of submission of the information. 
This claim will apply only to the period prior to the commencement of 
manufacture or import for general commercial use.
    (ii) A person who submits information to EPA under this part must 
reassert a claim of confidentiality and substantiate the claim each time 
the information is submitted to EPA. For example, if a person claims 
certain information confidential in a TERA submission and wishes the 
same information to remain confidential in a subsequent TERA or MCAN 
submission, the person must reassert and resubstantiate the claim in the 
subsequent submission.
    (2) Assertion of claim. (i) A submitter may assert a claim of 
confidentiality only if the submitter believes that public disclosure 
prior to commencement of manufacture or import for general commercial 
use of the fact that anyone is initiating research and development 
activities pertaining to the specific microorganism or intends to 
manufacture or import the specific microorganism for general commercial 
use would reveal confidential business information. Claims must be 
substantiated in accordance with the requirements of Sec. 725.94(a).
    (ii) If the submission includes a health and safety study concerning 
the microorganism and if the claim for confidentiality with respect to 
the specific identity is denied in accordance with Sec. 725.92(c), EPA 
will deny a claim asserted under paragraph (a) of this section.
    (3) Development of generic name. Any person who asserts a claim of 
confidentiality for portions of the specific microorganism identity 
under this paragraph must provide one of the following items at the time 
the submission is filed:
    (i) The generic name which was accepted by EPA in the prenotice 
consultation conducted under paragraph (a)(4) of this section.
    (ii) One generic name that is only as generic as necessary to 
protect the confidential identity of the particular microorganism. The 
name should reveal the specific identity to the maximum extent possible. 
The generic

[[Page 43]]

name will be subject to EPA review and approval.
    (4) Determination by EPA. (i) Any person who intends to assert a 
claim of confidentiality for the specific identity of a new 
microorganism may seek a determination by EPA of an appropriate generic 
name for the microorganism before filing a submission. For this purpose, 
the person should submit to EPA:
    (A) The specific identity of the microorganism.
    (B) A proposed generic name(s) which is only as generic as necessary 
to protect the confidential identity of the new microorganism. The 
name(s) should reveal the specific identity of the microorganism to the 
maximum extent possible.
    (ii) Within 30 days, EPA will inform the submitter either that one 
of the proposed generic names is adequate or that none is adequate and 
further consultation is necessary.
    (5) Use of generic name. If a submitter claims microorganism 
identity as confidential under paragraph (a) of this section, and if the 
submitter complies with paragraph (a)(2) of this section, EPA will issue 
for publication in the Federal Register notice described in Sec. 725.40 
the generic name proposed by the submitter or one agreed upon by EPA and 
the submitter.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use--(1) Maintaining claim. 
Any claim of confidentiality under paragraph (a) of this section is 
applicable only until the microorganism is manufactured or imported for 
general commercial use and becomes eligible for inclusion on the 
Inventory. To maintain the confidential status of the microorganism 
identity when the microorganism is added to the Inventory, a submitter 
must reassert the confidentiality claim and substantiate the claim in 
the notice of commencement of manufacture required under Sec. 725.190.
    (i) A submitter may not claim the microorganism identity 
confidential for the period after commencement of manufacture or import 
for general commercial use unless the submitter claimed the 
microorganism identity confidential under paragraph (a) of this section 
in the MCAN submitted for the microorganism.
    (ii) A submitter may claim the microorganism identity confidential 
for the period after commencement of manufacture or import for general 
commercial use if the submitter did not claim the microorganism identity 
confidential under paragraph (a) of this section in any TERA submitted 
for the microorganism, but subsequently did claim microorganism identity 
confidential in the MCAN submitted for the microorganism.
    (2) Assertion of claim. (i) A person who believes that public 
disclosure of the fact that anyone manufactures or imports the 
microorganism for general commercial use would reveal confidential 
business information may assert a claim of confidentiality under 
paragraph (b) of this section.
    (ii) If the notice includes a health and safety study concerning the 
new microorganism, and if the claim for confidentiality with respect to 
the microorganism identity is denied in accordance with Sec. 725.92(c), 
EPA will deny a claim asserted under paragraph (b) of this section.
    (3) Requirements for assertion. Any person who asserts a 
confidentiality claim for microorganism identity must:
    (i) Comply with the requirements of paragraph (a)(3) of this section 
regarding submission of a generic name.
    (ii) Agree that EPA may disclose to a person with a bona fide intent 
to manufacture or import the microorganism the fact that the particular 
microorganism is included on the confidential Inventory for purposes of 
notification under section 5(a)(1)(A) of the Act.
    (iii) Have available and agree to furnish to EPA upon request the 
taxonomic designations and supplemental information required by 
Sec. 725.12.
    (iv) Provide a detailed written substantiation of the claim, in 
accordance with the requirements of Sec. 725.94(b).
    (4) Denial of claim. If the submitter does not meet the requirements 
of paragraph (b) of this section, EPA will deny the claim of 
confidentiality.
    (5) Acceptance of claim. (i) EPA will publish a generic name on the 
public Inventory if:

[[Page 44]]

    (A) The submitter asserts a claim of confidentiality in accordance 
with this paragraph.
    (B) No claim for confidentiality of the microorganism identity as 
part of a health and safety study has been denied in accordance with 
part 2 of this title or Sec. 725.92.
    (ii) Publication of a generic name on the public Inventory does not 
create a category for purposes of the Inventory. Any person who has a 
bona fide intent to manufacture or import a microorganism which is 
described by a generic name on the public Inventory may submit an 
inquiry to EPA under Sec. 725.15(b) to determine whether the particular 
microorganism is included on the confidential Inventory.
    (iii) Upon receipt of a request described in Sec. 725.15(b), EPA may 
require the submitter who originally asserted confidentiality for a 
microorganism to submit to EPA the information listed in paragraph 
(b)(3)(iii) of this section.
    (iv) Failure to submit any of the information required under 
paragraph (b)(3)(iii) of this section within 10 calendar days of receipt 
of a request by EPA under paragraph (b) of this section will constitute 
a waiver of the original submitter's confidentiality claim. In this 
event, EPA may place the specific microorganism identity on the public 
Inventory without further notice to the original submitter.
    (6) Use of generic name on the public Inventory. If a submitter 
asserts a claim of confidentiality under paragraph (b) of this section, 
EPA will examine the generic microorganism name proposed by the 
submitter.
    (i) If EPA determines that the generic name proposed by the 
submitter is only as generic as necessary to protect the confidential 
identity of the particular microorganism, EPA will place that generic 
name on the public Inventory.
    (ii) If EPA determines that the generic name proposed by the 
submitter is more generic than necessary to protect the confidential 
identity, EPA will propose in writing, for review by the submitter, an 
alternative generic name that will reveal the identity of the 
microorganism to the maximum extent possible.
    (iii) If the generic name proposed by EPA is acceptable to the 
submitter, EPA will place that generic name on the public Inventory.
    (iv) If the generic name proposed by EPA is not acceptable to the 
submitter, the submitter must explain in detail why disclosure of that 
generic name would reveal confidential business information and propose 
another generic name which is only as generic as necessary to protect 
the confidential identity of the microorganism. If EPA does not receive 
a response from the submitter within 30 days after the submitter 
receives the proposed name, EPA will place EPA's chosen generic name on 
the public Inventory. If the submitter does provide the information 
requested, EPA will review the response. If the submitter's proposed 
generic name is acceptable, EPA will publish that generic name on the 
public Inventory. If the submitter's proposed generic name is not 
acceptable, EPA will notify the submitter of EPA's choice of a generic 
name. Thirty days after this notification, EPA will place the chosen 
generic name on the public Inventory.



Sec. 725.88  Uses of a microorganism.

    (a) Assertion of claim. A person who submits information to EPA 
under this part on the categories or proposed categories of use of a 
microorganism may assert a claim of confidentiality for this 
information.
    (b) Requirements for claim. A submitter that asserts such a claim 
must:
    (1) Report the categories or proposed categories of use of the 
microorganism.
    (2) Provide, in nonconfidential form, a description of the uses that 
is only as generic as necessary to protect the confidential business 
information. The generic use description will be included in the Federal 
Register notice described in Sec. 725.40.
    (c) Generic use description. The person must submit the information 
required by paragraph (b) of this section by describing the uses as 
precisely as possible, without revealing the information which is 
claimed confidential, to disclose as much as possible how the use may 
result in human exposure to the microorganism or its release to the 
environment.

[[Page 45]]



Sec. 725.92  Data from health and safety studies of microorganisms.

    (a) Information other than specific microorganism identity. Except 
as provided in paragraph (b) of this section, EPA will deny any claim of 
confidentiality with respect to information included in a health and 
safety study of a microorganism, unless the information would disclose 
confidential business information concerning:
    (1) Processes used in the manufacture or processing of a 
microorganism.
    (2) Information which is not in any way related to the effects of a 
microorganism on health or the environment, such as, the name of the 
submitting company, cost or other financial data, product development or 
marketing plans, and advertising plans, for which the person submits a 
claim of confidentiality in accordance with Sec. 725.80.
    (b) Microorganism identity--(1) Claims applicable to the period 
prior to commencement of manufacture or import for general commercial 
use. A claim of confidentiality for the period prior to commencement of 
manufacture or import for general commercial use for the specific 
identity of a microorganism for which a health and safety study was 
submitted must be asserted in conjunction with a claim asserted under 
Sec. 725.85(a). The submitter must substantiate each claim in accordance 
with the requirements of Sec. 725.94(a).
    (2) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. To maintain the 
confidential status of the specific identity of a microorganism for 
which a health and safety study was submitted after commencement of 
manufacture or import for general commercial use, the claim must be 
reasserted and substantiated in conjunction with a claim under 
Sec. 725.85(b). The submitter must substantiate each claim in accordance 
with the requirements of Sec. 725.94(b).
    (c) Denial of confidentiality claim. EPA will deny a claim of 
confidentiality for microorganism identity under paragraph (b) of this 
section, unless:
    (1) The information would disclose processes used in the manufacture 
or processing of a microorganism.
    (2) The microorganism identity is not necessary to interpret a 
health and safety study.
    (d) Use of generic names. When EPA discloses a health and safety 
study containing a microorganism identity, which the submitter has 
claimed confidential, and if the Agency has not denied the claim under 
paragraph (c) of this section, EPA will identify the microorganism by 
the generic name selected under Sec. 725.85.



Sec. 725.94  Substantiation requirements.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import for general commercial use--(1) MCAN, TME, Tier I 
certification, and Tier II exemption request requirements. Any person 
who submits a MCAN, TME, Tier I certification, or Tier II exemption 
request should strictly limit confidentiality claims to that information 
which is confidential and proprietary to the business.
    (i) If any information in the submission is claimed as confidential 
business information, the submitter must substantiate each claim by 
submitting written answers to the questions in paragraphs (c), (d), and 
(e) of this section at the time the person submits the information.
    (ii) If the submitter does not provide written substantiation as 
required in paragraph (a)(1)(i) of this section, the submission will be 
considered incomplete and the review period will not begin in accordance 
with Sec. 725.33.
    (2) TERA requirements. Any person who submits a TERA, should 
strictly limit confidentiality claims to that information which is 
confidential and proprietary to the business. If any information in such 
a submission is claimed as confidential business information, the 
submitter must have available for each of those claims, and agree to 
furnish to EPA upon request, written answers to the questions in 
paragraphs (d) and (e) of this section.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. (1) If a submitter 
claimed portions of the microorganism identity confidential in the MCAN 
and wants the identity to be listed on the confidential Inventory,

[[Page 46]]

the claim must be reasserted and substantiated at the time the Notice of 
Commencement (NOC) is submitted under Sec. 725.190. Otherwise, EPA will 
list the specific microorganism identity on the public Inventory.
    (2) The submitter must substantiate the claim for confidentiality of 
the microorganism identity by answering all of the questions in 
paragraphs (c), (d), and (e) in this section. In addition, the following 
questions must be answered:
    (i) What harmful effects to the company's or institution's 
competitive position, if any, would result if EPA publishes on the 
Inventory the identity of the microorganism? How could a competitor use 
such information given the fact that the identity of the microorganism 
otherwise would appear on the TSCA Inventory with no link between the 
microorganism and the company or institution? How substantial would the 
harmful effects of disclosure be? What is the causal relationship 
between the disclosure and the harmful effects?
    (ii) Has the identity of the microorganism been kept confidential to 
the extent that competitors do not know it is being manufactured or 
imported for general commercial use by anyone?
    (c) General questions. The following questions must be answered in 
detail for each confidentiality claim:
    (1) For what period of time is a claim of confidentiality being 
asserted? If the claim is to extend until a certain event or point in 
time, indicate that event or time period. Explain why the information 
should remain confidential until such point.
    (2) Briefly describe any physical or procedural restrictions within 
the company or institution relating to the use and storage of the 
information claimed as confidential. What other steps, if any, apply to 
use or further disclosure of the information?
    (3) Has the information claimed as confidential been disclosed to 
individuals outside of the company or institution? Will it be disclosed 
to such persons in the future? If so, what restrictions, if any, apply 
to use or further disclosure of the information?
    (4) Does the information claimed as confidential appear, or is it 
referred to, in any of the following questions? If the answer is yes to 
any of these questions, indicate where the information appears and 
explain why it should nonetheless be treated as confidential.
    (i) Advertising or promotional materials for the microorganism or 
the resulting end product?
    (ii) Material safety data sheets or other similar materials for the 
microorganism or the resulting end product?
    (iii) Professional or trade publications?
    (iv) Any other media available to the public or to competitors?
    (v) Patents?
    (vi) Local, State, or Federal agency public files?
    (5) Has EPA, another Federal agency, a Federal court, or a State 
made any confidentiality determination regarding the information claimed 
as confidential? If so, provide copies of such determinations.
    (6) For each type of information claimed confidential, describe the 
harm to the company's or institution's competitive position that would 
result if this information were disclosed. Why would this harm be 
substantial? How could a competitor use such information? What is the 
causal connection between the disclosure and harm?
    (7) If EPA disclosed to the public the information claimed as 
confidential, how difficult would it be for the competitor to enter the 
market for the resulting product? Consider such constraints as capital 
and marketing cost, specialized technical expertise, or unusual 
processes.
    (d) Microorganism identity and production method. If confidentiality 
claims are asserted for the identity of the microorganism or information 
on how the microorganism is produced, the following questions must be 
answered:
    (1) Has the microorganism or method of production been patented in 
the U.S. or elsewhere? If so, why is confidentiality necessary?
    (2) Does the microorganism leave the site of production or testing 
in a form which is accessible to the public or to competitors? What is 
the cost to a competitor, in time and money, to develop appropriate use 
conditions? What factors facilitate or impede product analysis?

[[Page 47]]

    (3) For each additional type of information claimed as confidential, 
explain what harm would result from disclosure of each type of 
information if the identity of the microorganism were to remain 
confidential.
    (e) Health and safety studies of microorganisms. If confidentiality 
claims are asserted for information in a health or safety study of a 
microorganism, the following questions must be answered:
    (1) Would the disclosure of the information claimed confidential 
reveal: confidential process information, or information unrelated to 
the effects of the microorganism on health and the environment. Describe 
the causal connection between the disclosure and harm.
    (2) Does the company or institution assert that disclosure of the 
microorganism identity is not necessary to interpret any health and 
safety studies which have been submitted? If so, explain how a less 
specific identity would be sufficient to interpret the studies.



Sec. 725.95  Public file.

    All information submitted, including any health and safety study of 
a microorganism and other supporting documentation, will become part of 
the public file for that submission, unless such materials are claimed 
confidential. In addition, EPA may add materials to the public file, 
unless such materials are claimed confidential. Publically available 
docket materials are available at the addresses in Sec. 700.17(b)(1) and 
(2) of this chapter

[62 FR 17932, Apr. 11, 1997, 77 FR 46292, Aug. 3, 2012]



   Subpart D_Microbial Commercial Activities Notification Requirements



Sec. 725.100  Scope and purpose.

    (a) This subpart establishes procedures for submission of a notice 
to EPA under section 5(a) of the Act for persons who manufacture, 
import, or process microorganisms for commercial purposes. This notice 
is called a Microbial Commercial Activity Notice (MCAN). It is expected 
that MCANs will in general only be submitted for microorganisms intended 
for general commercial use. Persons who manufacture, import, or process 
a microorganism in small quantities solely for research and development 
as defined in Sec. 725.3 are not required to submit a notice to EPA. 
Persons who manufacture, import, or process a microorganism for research 
and development activities that do not fit the definition of small 
quantities solely for research and development may nonetheless qualify 
for more limited reporting requirements in subpart E, including the TERA 
which can be used for review of research and development involving 
environmental release.
    (b) Persons subject to MCAN submission are described in 
Sec. 725.105.
    (c) Exclusions and exemptions specific to MCAN submissions are 
described in Sec. 725.110.
    (d) Submission requirements applicable specifically to MCANs are 
described at Sec. 725.150.
    (e) Data requirements for MCANs are set forth in Secs. 725.155 and 
725.160.
    (f) EPA review procedures specific to MCANs are set forth in 
Sec. 725.170.
    (g) Subparts A through C of this part apply to any MCAN submitted 
under this subpart.



Sec. 725.105  Persons who must report.

    (a) Manufacturers of new microorganisms. (1) MCAN submission is 
required for any person who intends to manufacture for commercial 
purposes in the United States a new microorganism. Exclusions are 
described in Sec. 725.110.
    (2) If a person contracts with a manufacturer to produce or process 
a new microorganism and the manufacturer produces or processes the 
microorganism exclusively for that person, and that person specifies the 
identity of the microorganism, and controls the total amount produced 
and the basic technology for the plant process, then that person must 
submit the MCAN. If it is unclear who must report, EPA should be 
contacted to determine who must submit the MCAN.
    (3) Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a MCAN.
    (b) Importers of new microorganisms. (1) MCAN submission is required 
for a person who intends to import into the

[[Page 48]]

United States for commercial purposes a new microorganism. Exclusions 
are described in Sec. 725.110.
    (2) When several persons are involved in an import transaction, the 
MCAN must be submitted by the principal importer. If no one person fits 
the principal importer definition in a particular transaction, the 
importer should contact EPA to determine who must submit the MCAN for 
that transaction.
    (3) Except as otherwise provided in paragraph (b)(4) of this 
section, the provisions of this subpart D apply to each person who 
submits a MCAN for a new microorganism which such person intends to 
import for a commercial purpose. In addition, each importer must comply 
with paragraph (b)(4) of this section.
    (4) EPA will hold the principal importer, or the importer that EPA 
determines must submit the MCAN when there is no principal importer 
under paragraph (b)(2) of this section, liable for complying with this 
part, for completing the MCAN, and for the completeness and truthfulness 
of all information which it submits.
    (c) Manufacturers, importers, or processors of microorganisms for a 
significant new use. MCAN submission is required for any person who 
intends to manufacture, import, or process for commercial purposes a 
microorganism identified as having one or more significant new uses in 
subpart M of this part, and who intends either to engage in a designated 
significant new use of the microorganism or intends to distribute it in 
commerce. Persons excluded from reporting on significant new uses of 
microorganisms and additional procedures for reporting are described in 
subpart L of this part.



Sec. 725.110  Persons not subject to this subpart.

    Persons are not subject to the requirements of this subpart for the 
following activities:
    (a) Manufacturing, importing, or processing solely for research and 
development microorganisms that meet the requirements for an exemption 
under subpart E of this part.
    (b) Manufacturing, importing, or processing microorganisms for test 
marketing activities which have been granted an exemption under subpart 
F of this part.
    (c) Manufacturing or importing new microorganisms under the 
conditions of a Tier I or Tier II exemption under subpart G of this 
part.



Sec. 725.150  Procedural requirements for this subpart.

    General requirements for all MCANs under this part are contained in 
subparts A through C of this part. In addition, the following 
requirements apply to MCANs submitted under this subpart:
    (a) When to submit a MCAN. A MCAN must be submitted at least 90 
calendar days prior to manufacturing or importing a new microorganism 
and at least 90 calendar days prior to manufacturing, importing, or 
processing a microorganism for a significant new use.
    (b) Section 5(b) of the Act. The submitter must comply with any 
applicable requirement of section 5(b) of the Act for the submission of 
test data.
    (c) Contents of a MCAN. Each person who submits a MCAN under this 
subpart must provide the information and test data described in 
Secs. 725.155 and 725.160.
    (d) Recordkeeping. Each person who submits a MCAN under this subpart 
must comply with the recordkeeping requirements of Sec. 725.65.



Sec. 725.155  Information to be included in the MCAN.

    (a) Each person who is required by this part to submit a MCAN must 
include the information specified in paragraphs (c) through (h) of this 
section, to the extent it is known to or reasonably ascertainable by 
that person. However, no person is required to include information which 
relates solely to exposure of humans or ecological populations outside 
of the United States.
    (b) Each person should also submit, in writing, all other 
information known to or reasonably ascertainable by that person that 
would permit EPA to make a reasoned evaluation of the health and 
environmental effects of the microorganism, or any microbial mixture or 
article, including information

[[Page 49]]

on its effects on humans, animals, plants, and other microorganisms, and 
in the environment. The information to be submitted under this subpart 
includes the information listed in paragraphs (c) through (h) of this 
section relating to the manufacture, processing, distribution in 
commerce, use, and disposal of the new microorganism.
    (c) Submitter identification. (1) The name and headquarters address 
of the submitter.
    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (d) Microorganism identity information. Persons must submit 
sufficient information to allow the microorganism to be accurately and 
unambiguously identified for listing purposes as required by 
Sec. 725.12.
    (1) Description of the recipient microorganism and the new 
microorganism. (i) Data substantiating the taxonomy of the recipient 
microorganism and the new microorganism to the level of strain, as 
appropriate. In lieu of data, EPA will accept a letter from a culture 
collection substantiating taxonomy, provided EPA, upon request to the 
submitter, may have access to the data supporting the taxonomic 
designation.
    (ii) Information on the morphological and physiological features of 
the new microorganism.
    (iii) Other specific data by which the new microorganism may be 
uniquely identified for Inventory purposes.
    (2) Genetic construction of the new microorganism. (i) Data 
substantiating the taxonomy of the donor organism(s). In lieu of data, 
EPA will accept a letter from a culture collection substantiating 
taxonomy, provided EPA, upon request to the submitter, may have access 
to the data supporting the taxonomic designation.
    (ii) Description of the traits for which the new microorganism has 
been selected or developed and other traits known to have been added or 
modified.
    (iii) A detailed description of the genetic construction of the new 
microorganism, including the technique used to modify the microorganism 
(e.g., fusion of cells, injection of DNA, electroporation or chemical 
poration, or methods used for induced mutation and selection). The 
description should include, for example, a description of the introduced 
genetic material, including any regulatory sequences and structural 
genes and the products of those genes; how the introduced genetic 
material is expected to affect behavior of the recipient; expression, 
alteration, and stability of the introduced genetic material; methods 
for vector construction and introduction; and a description of the 
regulatory and structural genes that are components of the introduced 
genetic material, including genetic maps of the introduced sequences.
    (3) Phenotypic and ecological characteristics. (i) Habitat, 
geographical distribution, and source of the recipient microorganism.
    (ii) Survival and dissemination under relevant environmental 
conditions including a description of methods for detecting the new or 
recipient microorganism(s) in the environment and the sensitivity limit 
of detection for these techniques.
    (iii) A description of anticipated biological interactions with and 
effects on target organisms and other organisms such as competitors, 
prey, hosts, symbionts, parasites, and pathogens; a description of host 
range; a description of pathogenicity, infectivity, toxicity, virulence, 
or action as a vector of pathogens; and capacity for genetic transfer 
under laboratory and relevant environmental conditions.
    (iv) A description of anticipated involvement in biogeochemical or 
biological cycling processes, involvement in rate limiting steps in 
mineral or nutrient cycling, or involvement in inorganic compounds 
cycling (such as possible sequestration or transformation of heavy 
metals).
    (e) Byproducts. A description of the byproducts resulting from the 
manufacture, processing, use, and disposal of the new microorganism.
    (f) Total production volume. The estimated maximum amount of the new 
microorganism intended to be manufactured or imported during the first 
year of production and the estimated maximum amount to be manufactured 
or imported during any consecutive 12-month period during the first 3 
years of production. This estimate may be by

[[Page 50]]

weight or volume and should include an estimation of viability (i.e., 
viable cells per unit volume or colony forming units per unit dry 
weight).
    (g) Use information. A description of intended categories of use by 
function and application, the estimated percent of production volume 
devoted to each category of use, and the percent of the new 
microorganism in the formulation for each commercial or consumer use.
    (h) Worker exposure and environmental release. (1) For sites 
controlled by the submitter:
    (i) The identity of sites where the new microorganism will be 
manufactured, processed, or used. For purposes of this section, the site 
for a person who imports a new microorganism is the site of the 
operating unit within the person's organization which is directly 
responsible for importing the new microorganism and which controls the 
import transaction. The import site may in some cases be the 
organization's headquarters office in the United States.
    (ii) A process description of each manufacture, processing, and use 
operation, which includes a diagram of the major unit operations and 
conversions, the identity and entry point of all feedstocks, and the 
identity of any possible points of release of the new microorganism from 
the process, including a description of all controls, including 
engineering controls, used to prevent such releases.
    (iii) Worker exposure information, including worker activities, 
physical form of process streams which contain the new microorganism to 
which workers may be exposed, the number of workers, and the duration of 
activities.
    (iv) Information on release of the new microorganism to the 
environment, including the quantity and media of release and type of 
control technology used.
    (v) A narrative description of the intended transport of the new 
microorganism, including the means of transport, containment methods to 
be used during transport, and emergency containment procedures to be 
followed in case of accidental release.
    (vi) Procedures for disposal of any articles, waste, clothing, or 
other equipment involved in the activity, including procedures for 
inactivation of the new microorganism, containment, disinfection, and 
disposal of contaminated items.
    (2) For sites not controlled by the submitter, a description of each 
type of processing and use operation involving the new microorganism, 
including identification of the estimated number of processing or use 
sites, situations in which worker exposure to and/or environmental 
release of the new microorganism will occur, the number of workers 
exposed and the duration of exposure; procedures for transport of the 
new microorganism and for disposal, including procedures for 
inactivation of the new microorganism; and control measures which limit 
worker exposure and environmental release.



Sec. 725.160  Submission of health and environmental effects data.

    (a) Test data on the new microorganism in the possession or control 
of the submitter. (1) Except as provided in Sec. 725.25(h), and in 
addition to the information required by Sec. 725.155(d)(3), each MCAN 
must contain all test data in the submitter's possession or control 
which are related to the effects on health or the environment of any 
manufacture, processing, distribution in commerce, use, or disposal of 
the new microorganism or any microbial mixture or article containing the 
new microorganism, or any combination of such activities. This includes 
test data concerning the new microorganism in a pure culture or 
formulated form as used or as intended to be used in one of the 
activities listed above.
    (2) A full report or standard literature citation must be submitted 
for the following types of test data:
    (i) Health effects data.
    (ii) Ecological effects data.
    (iii) Physical and chemical properties data.
    (iv) Environmental fate characteristics.
    (v) Monitoring data and other test data related to human exposure to 
or environmental release of the new microorganism.
    (3)(i) If the data do not appear in the open scientific literature, 
the submitter must provide a full report. A full report includes the 
experimental

[[Page 51]]

methods and materials, results, discussion and data analysis, 
conclusions, references, and the name and address of the laboratory that 
developed the data.
    (ii) If the data appear in the open scientific literature, the 
submitter need only provide a standard literature citation. A standard 
literature citation includes author, title, periodical name, date of 
publication, volume, and page numbers.
    (4)(i) If a study, report, or test is incomplete when a person 
submits a MCAN, the submitter must identify the nature and purpose of 
the study; name and address of the laboratory developing the data; 
progress to date; types of data collected, significant preliminary 
results; and anticipated completion date.
    (ii) If a test or experiment is completed before the MCAN review 
period ends, the person must submit the study, report, or test, as 
specified in paragraph (a)(3)(i) of this section, to the address listed 
in Sec. 725.25(c) within 10 days of receiving it, but no later than 5 
days before the end of the review period. If the test or experiment is 
completed during the last 5 days of the review period, the submitter 
must immediately inform its EPA contact for that submission by 
telephone.
    (5) For test data in the submitter's possession or control which are 
not listed in paragraph (a)(2) of this section, a person is not required 
to submit a complete report. The person must submit a summary of the 
data. If EPA so requests, the person must submit a full report within 10 
days of the request, but no later than 5 days before the end of the 
review period.
    (6) All test data described under paragraph (a) of this section are 
subject to these requirements, regardless of their age, quality, or 
results.
    (b) Other data concerning the health and environmental effects of 
the new microorganism that are known to or reasonably ascertainable by 
the submitter. (1) Except as provided in Sec. 725.25(h), and in addition 
to the information required by Sec. 725.155(c)(3), any person who 
submits a MCAN must describe the following data, including any data from 
a health and safety study of a microorganism, if the data are related to 
effects on health or the environment of any manufacture, processing, 
distribution in commerce, use, or disposal of the microorganism, of any 
microbial mixture or article containing the new microorganism, or of any 
combination of such activities:
    (i) Any data, other than test data, in the submitter's possession or 
control.
    (ii) Any data, including test data, which are not in the submitter's 
possession or control, but which are known to or reasonably 
ascertainable by the submitter. For the purposes of this section, data 
are known to or reasonably ascertainable by the submitter if the data 
are known to any of its employees or other agents who are associated 
with the research and development, test marketing, or commercial 
marketing of the microorganism.
    (2) Data that must be described include data concerning the new 
microorganism in a pure culture or formulated form as used or as 
intended to be used in one of the activities listed in paragraph (b)(1) 
of this section.
    (3) The description of data reported under paragraph (b) of this 
section must include:
    (i) If the data appear in the open scientific literature, a standard 
literature citation, which includes the author, title, periodical name, 
date of publication, volume, and pages.
    (ii) If the data are not available in the open scientific 
literature, a description of the type of data and summary of the 
results, if available, and the names and addresses of persons the 
submitter believes may have possession or control of the data.
    (4) All data described in paragraph (b) of this section are subject 
to these requirements, regardless of their age, quality, or results; and 
regardless of whether they are complete at the time the MCAN is 
submitted.



Sec. 725.170  EPA review of the MCAN.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of MCANs submitted under this subpart:
    (a) Length of the review period. The MCAN review period specified in 
section 5(a) of the Act runs for 90 days from the date the Document 
Control

[[Page 52]]

Officer for the Office of Pollution Prevention and Toxics receives a 
complete MCAN, or the date EPA determines the MCAN is complete under 
Sec. 725.33, unless the Agency extends the period under section 5(c) of 
the Act and Sec. 725.56.
    (b) Notice of expiration of MCAN review period. (1) EPA will notify 
the submitter that the MCAN review period has expired or that EPA has 
completed its review of the MCAN. Expiration of the review period does 
not constitute EPA approval or certification of the new microorganism, 
and does not mean that EPA may not take regulatory action against the 
microorganism in the future.
    (2) After expiration of the MCAN review period, in the absence of 
regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, 
the submitter may manufacture or import the microorganism even if the 
submitter has not received notice of expiration.
    (3) Early notification that EPA has completed its review does not 
permit commencement of manufacture or import prior to the expiration of 
the 90-day MCAN review period.
    (c) No person submitting a MCAN in response to the requirements of 
this subpart may manufacture, import, or process a microorganism subject 
to this subpart until the review period, including all extensions and 
suspensions, has expired.



Sec. 725.190  Notice of commencement of manufacture or import.

    (a) Applicability. Any person who commences the manufacture or 
import of a new microorganism for nonexempt, commercial purposes for 
which that person previously submitted a section 5(a) notice under this 
part must submit a notice of commencement (NOC) of manufacture or 
import.
    (b) When to report. (1) If manufacture or import for nonexempt, 
commercial purposes begins on or after May 27, 1997, the submitter must 
submit the NOC to EPA no later than 30 calendar days after the first day 
of such manufacture or import.
    (2) If manufacture or import for nonexempt, commercial purposes 
began or will begin before May 27, 1997, the submitter must submit the 
NOC by May 27, 1997.
    (3) Submission of an NOC prior to the commencement of manufacture or 
import is a violation of section 15 of the Act.
    (c) Information to be reported. The NOC must contain the following 
information: Specific microorganism identity, MCAN number, and the date 
when manufacture or import commences. If the person claimed 
microorganism identity confidential in the MCAN, and wants the identity 
to be listed on the confidential Inventory, the claim must be reasserted 
and resubstantiated in accordance with Sec. 725.85(b). Otherwise, EPA 
will list the specific microorganism identity on the public Inventory.
    (d) How to submit. All notices of commencement must be generated, 
completed, and submitted to EPA (via CDX) using e-PMN software. See 40 
CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



      Subpart E_Exemptions for Research and Development Activities



Sec. 725.200  Scope and purpose.

    (a) This subpart describes exemptions from the reporting 
requirements under subpart D of this part for research and development 
activities involving microorganisms.
    (b) In lieu of complying with subpart D of this part, persons 
described in Sec. 725.205 may submit a TSCA Experimental Release 
Application (TERA) for research and development activities involving 
microorganisms or otherwise comply with this subpart.
    (c) Exemptions from part 725 are provided at Secs. 725.232, 725.234, 
and 725.238.
    (d) Submission requirements specific for TERAs are described at 
Sec. 725.250.
    (e) Data requirements for TERAs are set forth in Secs. 725.255 and 
725.260.
    (f) EPA review procedures specific for TERAs are set forth in 
Secs. 725.270 and 725.288.
    (g) Subparts A through C of this part apply to any submission under 
this subpart.

[[Page 53]]



Sec. 725.205  Persons who may report under this subpart.

    (a) Commercial research and development activities involving new 
microorganisms or significant new uses of microorganisms are subject to 
reporting under this part unless they qualify for an exemption under 
this part.
    (b) Commercial purposes for research and development means that the 
activities are conducted with the purpose of obtaining an immediate or 
eventual commercial advantage for the researcher and would include:
    (1) All research and development activities which are funded 
directly, in whole or in part, by a commercial entity regardless of who 
is actually conducting the research. Indications that the research and 
development activities are funded directly, in whole or in part, may 
include, but are not limited to:
    (i) Situations in which a commercial entity contracts directly with 
a university or researcher; or
    (ii) Situations in which a commercial entity gives a conditional 
grant where the commercial entity holds patent rights, or establishes a 
joint venture where the commercial entity holds patent or licensing 
rights; or
    (iii) Any other situation in which the commercial entity intends to 
obtain an immediate or eventual commercial advantage for the commercial 
entity and/or the researcher.
    (2) Research and development activities that are not funded directly 
by a commercial entity, if the researcher intends to obtain an immediate 
or eventual commercial advantage. Indications that the researcher 
intends to obtain an immediate or eventual commercial advantage may 
include, but are not limited to:
    (i) The research is directed toward developing a commercially viable 
improvement of a product already on the market; or
    (ii) The researcher has sought or is seeking commercial funding for 
the purpose of developing a commercial application; or
    (iii) The researcher or university has sought or is seeking a patent 
to protect a commercial application which the research is developing; or
    (iv) Other evidence that the researcher is aware of a commercial 
application for the research and has directed the research toward 
developing that application.
    (c) Certain research and development activities involving 
microorganisms subject to jurisdiction under the Act are exempt from 
reporting under this part. A person conducting research and development 
activities which meet the conditions for the exemptions described in 
Secs. 725.232, 725.234, or 725.238 is exempt from TERA reporting under 
this subpart.
    (d) A microorganism is not exempt from reporting under subpart D of 
this part if any amount of the microorganism, including as part of a 
mixture, is processed, distributed in commerce, or used, for any 
commercial purpose other than research and development.
    (e) Quantities of the inactivated microorganism, or mixtures or 
articles containing the inactivated microorganism, remaining after 
completion of research and development activities may be disposed of as 
a waste in accordance with applicable Federal, State, and local 
regulations.
    (f) A person who manufactures, imports, or processes a microorganism 
solely for research and development is not required to comply with the 
requirements of this section if:
    (1) The person is manufacturing a microbial pesticide identified in 
Sec. 172.45(c), or
    (2) The person is manufacturing a microbial pesticide for which an 
Experimental Use Permit is required, pursuant to Sec. 172.3; or
    (3) The person is manufacturing a microbial pesticide for which a 
notification or an Experimental Use Permit is not required to be 
submitted.



Sec. 725.232  Activities subject to the jurisdiction of other Federal programs or agencies.

    This part does not apply to any research and development activity 
that meets all of the following conditions.
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec. 725.3.

[[Page 54]]

    (c)(1) The person receives research funds from another Federal 
agency, and the funds are awarded on the condition that the research 
will be conducted in accordance with the relevant portions of the NIH 
Guidelines, or
    (2) A Federal agency or program otherwise imposes the legally 
binding requirement that the research is to be conducted in accordance 
with relevant portions of the NIH Guidelines.



Sec. 725.234  Activities conducted inside a structure.

    A person who manufactures, imports, or processes a microorganism is 
not subject to the reporting requirements under subpart D of this part 
if all of the following conditions are met:
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) The microorganism is used by, or directly under the supervision 
of, a technically qualified individual, as defined in Sec. 725.3. The 
technically qualified individual must maintain documentation of the 
procedures selected to comply with paragraph (d) of this section and 
must ensure that the procedures are used.
    (c) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec. 725.3.
    (d) Containment and/or inactivation controls. (1) Selection and use 
of containment and/or inactivation controls inside a structure for a 
particular microorganism shall take into account the following:
    (i) Factors relevant to the organism's ability to survive in the 
environment.
    (ii) Potential routes of release in air, solids and liquids; in or 
on waste materials and equipment; in or on people, including maintenance 
and custodial personnel; and in or on other organisms, such as insects 
and rodents.
    (iii) Procedures for transfer of materials between facilities.
    (2) The technically qualified individual's selection of containment 
and/or inactivation controls shall be approved and certified by an 
authorized official (other than the TQI) of the institution that is 
conducting the test prior to the commencement of the test.
    (3) Records shall be developed and maintained describing the 
selection and use of containment and/or inactivation controls, as 
specified in Sec. 725.235(c). These records, which must be maintained at 
the location where the research and development activity is being 
conducted, shall be submitted to EPA upon written request and within the 
time frame specified in EPA's request.
    (4) Subsequent to EPA review of records in accordance with paragraph 
(d)(3) of this section, changes to the containment/inactivation controls 
selected under paragraph (d)(1) of this section must be made upon EPA 
order. Failure to comply with EPA's order shall result in automatic loss 
of eligibility for an exemption under this section.
    (e) The manufacturer, importer, or processor notifies all persons in 
its employ or to whom it directly distributes the microorganism, who are 
engaged in experimentation, research, or analysis on the microorganism, 
including the manufacture, processing, use, transport, storage, and 
disposal of the microorganism associated with research and development 
activities, of any risk to health, identified under Sec. 725.235(a), 
which may be associated with the microorganism. The notification must be 
made in accordance with Sec. 725.235(b).



Sec. 725.235  Conditions of exemption for activities conducted inside a
structure.

    (a) Determination of risks. To determine whether notification under 
Sec. 725.234(e) is required, the manufacturer, importer, or processor 
must do one of the following:
    (1) For research conducted in accordance with the NIH Guidelines, 
the manufacturer, importer, or processor must meet the conditions laid 
out at IV-B-4-d of the NIH Guidelines; or
    (2) For all other research conducted in accordance with 
Sec. 725.234, the manufacturer, importer, or processor must review and 
evaluate the following information to determine whether there is reason 
to believe there is any risk to health which may be associated with the 
microorganism:
    (i) Information in its possession or control concerning any 
significant adverse reaction of persons exposed to

[[Page 55]]

the microorganism which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer, importer, or 
processor by a supplier or any other person concerning a health risk 
believed to be associated with the microorganism.
    (iii) Health and environmental effects data in its possession or 
control concerning the microorganism.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under TSCA section 4, 5, or 6 of the Act that applies to 
the microorganism and of which the manufacturer, importer, or processor 
has knowledge.
    (b) Notification to employees and others. (1) The manufacturer, 
importer, or processor must notify the persons identified in 
Sec. 725.234(e) by means of a container labeling system, conspicuous 
placement of notices in areas where exposure may occur, written 
notification to each person potentially exposed, or any other method of 
notification which adequately informs persons of health risks which the 
manufacturer, importer, or processor has reason to believe may be 
associated with the microorganism, as determined under paragraph (a) of 
this section.
    (2) If the manufacturer, importer, or processor distributes a 
microorganism manufactured, imported, or processed under this section to 
persons not in its employ, the manufacturer, importer, or processor must 
in written form:
    (i) Notify those persons that the microorganism is to be used only 
for research and development purposes and the requirements of 
Sec. 725.234 are to be met.
    (ii) Provide the notice of health risks specified in paragraph 
(b)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer, importer, or processor.
    (c) Recordkeeping. (1) For research conducted in accordance with the 
NIH Guidelines, a person who manufactures, imports, or processes a 
microorganism under this section must retain the following records:
    (i) Documentation that the NIH Guidelines have been adhered to. Such 
documentation shall include:
    (A) For experiments subject to Institutional Biosafety Committee 
review, or notification simultaneous with initiation of the experiment, 
the information submitted for review or notification, along with 
standard laboratory records, shall satisfy the recordkeeping 
requirements specified in Sec. 725.234(d)(3).
    (B) For experiments exempt from Institutional Biosafety Committee 
review or notification simultaneous with initiation of the experiment, 
documentation of the exemption, along with standard laboratory records, 
shall satisfy the recordkeeping requirement specified in 
Sec. 725.234(d)(3).
    (ii) Documentation of how the following requirements are satisfied 
under the NIH Guidelines:
    (A) Copies or citations to information reviewed and evaluated to 
determine the need to make any notification of risk.
    (B) Documentation of the nature and method of notification of risk, 
including copies of any labels or written notices used.
    (C) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the microorganism, the amount distributed, 
and copies of the notifications required.
    (2) For all other research conducted in accordance with 
Sec. 725.234, a person who manufacturers, imports, or processes a 
microorganism under this section, must maintain the following records:
    (i) Records describing selection and use of containment and/or 
inactivation controls required by Sec. 725.234(d)(3) and certification 
by an authorized official required by Sec. 725.234(d)(2) for each 
microorganism.
    (ii) Copies or citations to information reviewed and evaluated under 
paragraph (a) of this section to determine the need to make any 
notification of risk.
    (iii) Documentation of the nature and method of notification under 
paragraph (b)(1) of this section, including copies of any labels or 
written notices used.
    (iv) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of

[[Page 56]]

the microorganism, the amount distributed, and copies of the 
notifications required under paragraph (b)(2) of this section.



Sec. 725.238  Activities conducted outside a structure.

    (a) Exemption. (1) Research and development activities involving 
intentional testing in the environment of certain microorganisms listed 
in Sec. 725.239 may be conducted without prior review by EPA if all of 
the conditions of this section and Sec. 725.239 are met.
    (2) The research and development activity involving a microorganism 
listed in Sec. 725.239 must be conducted by, or directly under the 
supervision of, a technically qualified individual, as defined in 
Sec. 725.3.
    (b) Certification. To be eligible for the exemption under this 
section, a manufacturer or importer must submit to EPA prior to 
initiation of the activity a document signed by an authorized official 
containing the following information:
    (1) Name, address, and telephone number of the manufacturer or 
importer.
    (2) Location, estimated duration, and planned start date of the 
test.
    (3) Certification of the following:
    (i) Compliance with the conditions of the exemption specified for 
the microorganism in Sec. 725.239.
    (ii) If state and/or local authorities have been notified of the 
activity, evidence of notification.
    (c) Recordkeeping. Persons who conduct research and development 
activities under this section must comply with the recordkeeping 
requirements of Sec. 725.65 and retain documentation that supports their 
compliance with the requirements of this section and the specific 
requirements for the microorganism listed in Sec. 725.239.



Sec. 725.239  Use of specific microorganisms in activities conducted
outside a structure.

    (a) Bradyrhizobium japonicum. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Bradyrhizobium japonicum:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Bradyrhizobium japonicum.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c).
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Bradyrhizobium japonicum.
    (b) Rhizobium meliloti. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Rhizobium meliloti:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Rhizobium meliloti.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c) of 
this part.
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited

[[Page 57]]

to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Rhizobium meliloti.



Sec. 725.250  Procedural requirements for the TERA.

    General requirements for all submissions under this part are 
contained in subparts A through C of this part. In addition, the 
following requirements apply to TERAs submitted under this subpart:
    (a) When to submit the TERA. Each person who is eligible to submit a 
TERA under this subpart must submit the TERA at least 60 calendar days 
before the person intends to initiate the proposed research and 
development activity.
    (b) Contents of the TERA. Each person who submits a TERA under this 
subpart must provide the information and test data described in 
Secs. 725.255 and 725.260. In addition, the submitter must supply 
sufficient information to enable EPA to evaluate the effects of all 
activities for which approval is requested.
    (c) A person may submit a TERA for one or more microorganisms and 
one or more research and development activities, including a research 
program.
    (d) EPA will either approve the TERA, with or without conditions, or 
disapprove it under procedures established in this subpart.
    (e) The manufacturer, importer, or processor who receives a TERA 
approval must comply with all terms of the approval, as well as 
conditions described in the TERA, and remains liable for compliance with 
all terms and conditions, regardless of who conducts the research and 
development activity. Any person conducting the research and development 
activity approved under the TERA must comply with all terms of the TERA 
approval, as well as the conditions described in the TERA.
    (f) Recordkeeping. Persons submitting a TERA must comply with the 
recordkeeping requirements of Sec. 725.65. In addition, the following 
requirements apply to TERAs:
    (1) Each person submitting a TERA under this part must retain 
documentation of information contained in the TERA for a period of 3 
years from the date that the results of the study are submitted to the 
Agency.
    (2) Summaries of all data, conclusions, and reports resulting from 
the conduct of the research and development activity under the TERA must 
be submitted to the EPA address identified in Sec. 725.25(c) within 1 
year of the termination of the activity.



Sec. 725.255  Information to be included in the TERA.

    (a) To review a TERA, EPA must have sufficient information to permit 
a reasoned evaluation of the health and environmental effects of the 
planned test in the environment. The person seeking EPA approval must 
submit all information known to or reasonably ascertainable by the 
submitter on the microorganism(s) and the research and development 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will be useful for EPA's 
risk assessment. The TERA must be in writing and must include at least 
the information described in the following paragraphs.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.

[[Page 58]]

    (c) Persons applying for a TERA, must include the submitter 
identification and microorganism identity information required for MCANs 
in Sec. 725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TERA must submit phenotypic and 
ecological characteristics information required in Sec. 725.155(d)(3) as 
it relates directly to the conditions of the proposed research and 
development activity.
    (e) Persons applying for a TERA must also submit the following 
information about the proposed research and development activity:
    (1) A detailed description of the proposed research and development 
activity. (i) The objectives and significance of the activity and a 
rationale for testing the microorganisms in the environment.
    (ii) Number of microorganisms released (including viability per 
volume if applicable) and the method(s) of application or release.
    (iii) Characteristics of the test site(s), including location, 
geographical, physical, chemical, and biological features, proximity to 
human habitation or activity, and description of site characteristics 
that would influence dispersal or confinement.
    (iv) Target organisms (if the microorganism(s) to be tested has an 
intended target), including identification of each target organism and 
anticipated mechanism and result of interaction.
    (v) Planned start date and duration of each activity.
    (vi) If State and/or local authorities have been notified of the 
activity, evidence of notification.
    (2) Information on monitoring, confinement, mitigation, and 
emergency termination procedures. (i) Confinement procedures for the 
activity, access and security measures, and procedures for routine 
termination of the activity.
    (ii) Mitigation and emergency procedures.
    (iii) Measures to detect and control potential adverse effects.
    (iv) Name of principal investigator and chief of site personnel 
responsible for emergency procedures.
    (v) Personal protective equipment, engineering controls, and 
procedures to be followed to minimize dispersion of the microorganism(s) 
by people, machinery, or equipment.
    (vi) Procedures for disposal of any articles, waste, clothing, 
machinery, or other equipment involved in the experimental release, 
including methods for inactivation of the microorganism(s), containment, 
disinfection, and disposal of contaminated items.



Sec. 725.260  Submission of health and environmental effects data.

    Each TERA must contain all available data concerning actual or 
potential effects on health or the environment of the new microorganism 
that are in the possession or control of the submitter and a description 
of other data known to or reasonably ascertainable by the submitter that 
will permit a reasoned evaluation of the planned test in the 
environment. The data must be reported in the manner described in 
Sec. 725.160(a)(3) and (b)(3).



Sec. 725.270  EPA review of the TERA.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of applications submitted under this 
subpart:
    (a) Length of the review period. (1) The review period for the TERA 
will be 60 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete TERA, or 
the date EPA determines the TERA is complete under Sec. 725.33, unless 
EPA finds good cause for an extension under Sec. 725.56.
    (2) A submitter shall not proceed with the research and development 
activity described in the TERA unless and until EPA provides written 
approval of the TERA. A submitter may receive early approval if a review 
is completed in less than 60 days.
    (b) EPA decision regarding proposed TERA activity. (1) A decision 
concerning a TERA under this subpart will be made by the Administrator, 
or a designee.
    (2) If EPA determines that the proposed research and development 
activity for the microorganism does not present an unreasonable risk of 
injury to health or the environment, EPA will notify the submitter that 
the TERA is

[[Page 59]]

approved and that the submitter can proceed with the proposed research 
and development activity described in the TERA.
    (3) EPA may include requirements and conditions in its approval of 
the TERA that would be stated in the TERA approval under paragraph (c) 
of this section.
    (4) If EPA concludes that it cannot determine that the proposed 
research and development activity described in the TERA will not present 
an unreasonable risk of injury to health or the environment, EPA will 
deny the TERA and will provide reasons for the denial in writing.
    (c) TERA approval. (1) A TERA approval issued by EPA under this 
section is legally binding on the TERA submitter.
    (2) When EPA approves a TERA, the submitter must conduct the 
research and development activity only as described in the TERA and in 
accordance with any requirements and conditions prescribed by EPA in its 
approval of the TERA.
    (3) Any person who fails to conduct the research and development 
activity as described in the TERA and in accordance with any 
requirements and conditions prescribed by EPA in its approval of the 
TERA under this section, shall be in violation of sections 5 and 15 of 
the Act and be subject to civil and criminal penalties under section 16 
of the Act.



Sec. 725.288  Revocation or modification of TERA approval.

    (a) Significant questions about risk. (1) If, after approval of a 
TERA under this subpart, EPA receives information which raises 
significant questions about EPA's determination that the activity does 
not present an unreasonable risk of injury to health or the environment, 
EPA will notify the submitter in writing of those questions.
    (2) The submitter may, within 10 days of receipt of EPA's notice, 
provide in writing additional information or arguments concerning the 
significance of the questions and whether EPA should modify or revoke 
the approval of the TERA.
    (3) After considering any such information and arguments, EPA will 
decide whether to change its determination regarding approval of the 
TERA.
    (i) If EPA determines that the activity will not present an 
unreasonable risk of injury to health or the environment, it will notify 
the submitter in writing. To make this finding, EPA may prescribe 
additional conditions which must be followed by the submitter.
    (ii) If EPA determines that it can no longer conclude that the 
activity will not present an unreasonable risk of injury to health or 
the environment, it will notify the submitter in writing that EPA is 
revoking its approval and state its reasons. In that event, the 
submitter must terminate the research and development activity within 48 
hours of receipt of the notice in accordance with directions provided by 
EPA in the notice.
    (b) Evidence of unreasonable risk. (1) If, after approval of a TERA 
under this subpart, EPA determines that the proposed research and 
development activity will present an unreasonable risk of injury to 
health or the environment, EPA will notify the submitter in writing and 
state its reasons.
    (2) In the notice, EPA may prescribe additional safeguards to 
address or reduce the risk, or may instruct the submitter to suspend the 
research and development activities.
    (3) Within 48 hours, the submitter must implement the instructions 
contained in the notice. The submitter may then submit additional 
information or arguments concerning the matters raised by EPA and 
whether EPA should modify or revoke the approval of the TERA in 
accordance with paragraph (a)(2) of this section.
    (4) EPA will consider the information and arguments in accordance 
with paragraph (a)(3) of this section.
    (5) Following consideration of the information and arguments under 
paragraph (a)(3) of this section, if EPA notifies the submitter that the 
R&D activity must be suspended or terminted, the submitter may resume 
the activity only upon written notice from EPA that EPA has approved 
resumption of the activity. In approving resumption of an activity, EPA 
may prescribe additional conditions which must be followed by the 
submitter.

[[Page 60]]

    (c) Modifications. If, after approval of a TERA under this subpart, 
the submitter concludes that it is necessary to alter the conduct of the 
research and development activity in a manner which would result in the 
activity being different from that described in the TERA agreement and 
any conditions EPA prescribed in its approval, the submitter must inform 
the EPA contact for the TERA and may not modify the activity without the 
approval of EPA.



                 Subpart F_Exemptions for Test Marketing



Sec. 725.300  Scope and purpose.

    (a) This subpart describes exemptions from the reporting 
requirements under subpart D of this part for test marketing activities 
involving microorganisms.
    (b) In lieu of complying with subpart D of this part, persons 
described in Sec. 725.305 may submit an application for a test marketing 
exemption (TME).
    (c) Submission requirements specific for TME applications are 
described at Sec. 725.350.
    (d) Data requirements for TME applications are set forth in 
Sec. 725.355.
    (e) EPA review procedures specific for TMEs are set forth in 
Sec. 725.370.
    (f) Subparts A through C of this part apply to any submission under 
this subpart.



Sec. 725.305  Persons who may apply under this subpart.

    A person identified in this section may apply for a test marketing 
exemption. EPA may grant the exemption if the person demonstrates that 
the microorganism will not present an unreasonable risk of injury to 
health or the environment as a result of the test marketing. A person 
may apply under this subpart for the following test marketing 
activities:
    (a) A person who intends to manufacture or import for commercial 
purposes a new microorganism.
    (b) A person who intends to manufacture, import, or process for 
commercial purposes a microorganism identified in subpart M of this part 
for a significant new use.



Sec. 725.350  Procedural requirements for this subpart.

    General requirements for all submissions under this part are 
contained in subparts A through C of this part. In addition, the 
following requirements apply to applications submitted under this 
subpart:
    (a) Prenotice consultation. EPA strongly suggests that for a TME, 
the applicant contact EPA for a prenotice consultation regarding 
eligibility for a TME.
    (b) When to submit a TME application. Each person who is eligible to 
apply for a TME under this subpart must submit the application at least 
45 calendar days before the person intends to commence the test 
marketing activity.
    (c) Recordkeeping. Each person who is granted a TME must comply with 
the recordkeeping requirements of Sec. 725.65. In addition, any person 
who obtains a TME must retain documentation of compliance with any 
restrictions imposed by EPA when it grants the TME. This information 
must be retained for 3 years from the final date of manufacture or 
import under the exemption.



Sec. 725.355  Information to be included in the TME application.

    (a) To review a TME application, EPA must have sufficient 
information to permit a reasoned evaluation of the health and 
environmental effects of the planned test marketing activity. The person 
seeking EPA approval must submit all information known to or reasonably 
ascertainable by the person on the microorganism and the test marketing 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will demonstrate that the 
microorganism will not present an unreasonable risk of injury to health 
or the environment as a result of the test marketing. The TME 
application must be in writing and must include at least the information 
described in paragraphs (b), (c), (d), and (e) of this section.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TME must submit the submitter 
identification

[[Page 61]]

and microorganism identity information required for MCANs in 
Sec. 725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TME must submit phenotypic and ecological 
characteristics information required in Sec. 725.155(d)(3) as it relates 
directly to the conditions of the proposed test marketing activity.
    (e) Persons applying for a TME must also submit the following 
information about the proposed test marketing activity:
    (1) Proposed test marketing activity. (i) The maximum quantity of 
the microorganism which the applicant will manufacture or import for 
test marketing.
    (ii) The maximum number of persons who may be provided the 
microorganism during test marketing.
    (iii) The maximum number of persons who may be exposed to the 
microorganism as a result of test marketing, including information 
regarding duration and route of such exposures.
    (iv) A description of the test marketing activity, including its 
duration and how it can be distinguished from full-scale commercial 
production and research and development activities.
    (2) Health and environmental effects data. All existing data 
regarding health and environmental effects of the microorganism must be 
reported in accordance with Sec. 725.160.



Sec. 725.370  EPA review of the TME application.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of TME applications submitted under this 
subpart:
    (a) No later than 45 days after EPA receives a TME, the Agency will 
either approve or deny the application.
    (b) A submitter may only proceed with test marketing activities 
after receipt of EPA approval.
    (c) In approving a TME application, EPA may impose any restrictions 
necessary to ensure that the microorganism will not present an 
unreasonable risk of injury to health and the environment as a result of 
test marketing.



           Subpart G_General Exemptions for New Microorganisms



Sec. 725.400  Scope and purpose.

    (a) This subpart describes exemptions from reporting under subpart D 
of this part, and from review under this part altogether, for 
manufacturing and importing of certain new microorganisms for commercial 
purposes.
    (b) Recipient microorganisms eligible for the tiered exemption from 
review under this part are listed in Sec. 725.420.
    (c) Criteria for the introduced genetic material contained in the 
new microorganisms are described in Sec. 725.421.
    (d) Physical containment and control technologies are described in 
Sec. 725.422.
    (e) The conditions for the Tier I exemption are listed in 
Sec. 725.424.
    (f) In lieu of complying with subpart D of this part, persons using 
recipient microorganisms eligible for the tiered exemption may submit a 
Tier II exemption request. The limited reporting requirements for the 
Tier II exemption, including data requirements, are described in 
Secs. 725.450 and 725.455.
    (g) EPA review procedures for the Tier II exemption are set forth in 
Sec. 725.470.
    (h) Subparts A through C of this part apply to any submission under 
this subpart.



Sec. 725.420  Recipient microorganisms.

    The following recipient microorganisms are eligible for either 
exemption under this subpart:
    (a) Acetobacter aceti.
    (b) Aspergillus niger.
    (c) Aspergillus oryzae.
    (d) Bacillus licheniformis.
    (e) Bacillus subtilis.
    (f) Clostridium acetobutylicum.
    (g) Escherichia coli K-12.
    (h) Penicillium roqueforti.
    (i) Saccharomyces cerevisiae.
    (j) Saccharomyces uvarum.



Sec. 725.421  Introduced genetic material.

    For a new microorganism to qualify for either exemption under this 
subpart, introduced genetic material must meet all of the criteria 
listed in this section.

[[Page 62]]

    (a) Limited in size. The introduced genetic material must consist 
only of the following:
    (1) The structural gene(s) of interest.
    (2) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (3) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (4) The nucleotide sequences needed for vector transfer.
    (5) The nucleotide sequences needed for vector maintenance.
    (b) Well-characterized. For introduced genetic material, well-
characterized means that the following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.
    (c) Poorly mobilizable. The ability of the introduced genetic 
material to be transferred and mobilized is inactivated, with a 
resulting frequency of transfer of less than 10-8 transfer 
events per recipient.
    (d) Free of certain sequences. (1) The introduced genetic material 
must not contain a functional portion of any of the toxin-encoding 
sequences described in this paragraph (d).
    (i) For the purposes of this section, a functional portion of a 
toxin-encoding sequence means any sequence which codes for a polypeptide 
that has one of the following effects:
    (A) It directly or indirectly contributes to toxic effects in 
humans. Directly contributes to toxic effects in humans means those 
sequences encoding polypeptides that have direct toxicity to target 
cells. An example of a sequence which directly contributes to toxic 
effects in humans is one which encodes the portion of diphtheria toxin, 
listed in paragraph (d)(2) of this section, capable of interacting with 
elongation factor 2, leading to inhibition of protein synthesis in 
target respiratory, heart, kidney, and nerve tissues. Indirectly 
contributes to toxic effects in humans means a sequence whose encoded 
polypeptide is not directly toxic to target cells, yet still adversely 
affects humans. An example of a sequence which indirectly contributes to 
toxic effects is the sequence which encodes the portion of the botulinum 
toxin, listed in paragraph (d)(3) of this section, capable of blocking 
the release of acetylcholine from gangliosides. Botulinum toxin affects 
neuromuscular junctions by its blockage of acetylcholine release, 
leading to irreversible relaxation of muscles and respiratory arrest.
    (B) It binds a toxin or toxin precursor to target human cells.
    (C) It facilitates intracellular transport of a toxin in target 
human cells.
    (ii) While these toxins are listed (with synonyms in parentheses) in 
paragraphs (d)(2) through (d)(7) of this section according to the source 
organism, it is use of the nucleotide sequences that encode the toxins 
that is being restricted and not the use of the source organisms. The 
source organisms are listed to provide specificity in identification of 
sequences whose use is restricted. Although similar or identical 
sequences may be isolated from organisms other than those listed below 
in paragraphs (d)(2) through (d)(7) of this section, these comparable 
toxin sequences, regardless of the organism from which they are derived, 
must not be included in the introduced genetic material.
    (2) Sequences for protein synthesis inhibitor.

 
              Sequence Source                        Toxin Name
 
Corynebacterium diphtheriae & C. ulcerans   Diphtheria toxin
Pseudomonas aeruginosa                      Exotoxin A
Shigella dysenteriae                        Shigella toxin (Shiga toxin,
                                             Shigella dysenteriae type I
                                             toxin, Vero cell toxin)
Abrus precatorius, seeds                    Abrin
Ricinus communis, seeds                     Ricin
 

    (3) Sequences for neurotoxins.

 
              Sequence Source                        Toxin Name
 
Clostridium botulinum                       Neurotoxins A, B, C1, D, E,
                                             F, G (Botulinum toxins,
                                             botulinal toxins)

[[Page 63]]

 
Clostridium tetani                          Tetanus toxin
                                             (tetanospasmin)
Proteus mirabilis                           Neurotoxin
Staphylococcus aureus                       Alpha toxin (alpha lysin)
Yersinia pestis                             Murine toxin
 
  Snake toxins                              ............................
Bungarus caeruleus                          Caeruleotoxin
Bungarus multicinctus                       Beta-bungarotoxin
                                             (phospholipase)
Crotalus spp.                               Crotoxin (phospholipase)
Dendroaspis viridis                         Neurotoxin
Naja naja varieties                         Neurotoxin
Notechia scutatus                           Notexin (phospholipase)
Oxyuranus scutellatus                       Taipoxin
 
  Invertebrate toxins
Chironex fleckeri                           Neurotoxin
Androctnus australis                        Neurotoxin
Centruroides sculpturatus                   Neurotoxin
 

    (4) Sequences for oxygen labile cytolysins.

 
              Sequence Source                        Toxin Name
 
Bacillus alve                               Alveolysin
Bacillus cereus                             Cereolysin
Bacillus laterosporus                       Laterosporolysin
Bacillus thuringiensis                      Thuringiolysin
Clostridium bifermentans                    Lysin
Clostridium botulinum                       Lysin
Clostridium caproicum                       Lysin
Clostridium chauvoei                        Delta-toxin
Clostridium histolyticum                    Epsilon-toxin
Clostridium novyi                           Gamma-toxin
Clostridium oedematiens                     Delta-toxin
Clostridium perfringens                     Theta-toxin (Perfringolysin)
Clostridium septicum                        Delta-toxin
Clostridium sordellii                       Lysin
Clostridium tetani                          Tetanolysin
Listeria monocytogenes                      Listeriolysin (A B)
Streptococcus pneumoniae                    Pneumolysin
Streptococcus pyogene                       Streptolysin O (SLO)
 

    (5) Sequences for toxins affecting membrane function.

 
              Sequence Source                        Toxin Name
 
Bacillus anthracis                          Edema factor (Factors I II);
                                             Lethal factor (Factors II
                                             III)
Bacillus cereus                             Enterotoxin (diarrheagenic
                                             toxin, mouse lethal factor)
Bordetella pertussis                        Adenylate cyclase (Heat-
                                             labile factor); Pertussigen
                                             (pertussis toxin, islet
                                             activating factor,
                                             histamine sensitizing
                                             factor, lymphocytosis
                                             promoting factor)
Clostridium botulinum                       C2 toxin
Clostridium difficile                       Enterotoxin (toxin A)
Clostridium perfringens                     Beta-toxin; Delta-toxin
Escherichia coli & other                    Heat-labile enterotoxins
 Enterobacteriaceae spp.                     (LT); Heat-stable
                                             enterotoxins (STa, ST1
                                             subtypes ST1a ST1b; also
                                             STb, STII)
Legionella pneumophila                      Cytolysin
Vibrio cholerae & Vibrio mimicus            Cholera toxin (choleragen)
 

    (6) Sequences that affect membrane integrity.

 
              Sequence Source                        Toxin Name
 
Clostridium bifermentans & other            Lecithinase
 Clostridium spp
Clostridium perfringens                     Alpha-toxin (phospholipase
                                             C, lecithinase);
                                             Enterotoxin
Corynebacterium pyogenes & other            Cytolysin (phospholipase C),
 Corynebacterium spp.                        Ovis toxin
                                             (sphingomyelinase D)
Staphylococcus aureus                       Beta-lysin (beta toxin)
 

    (7) Sequences that are general cytotoxins.

 
              Sequence Source                        Toxin Name
 
Adenia digitata                             Modeccin
Aeromonas hydrophila                        Aerolysin (beta-lysin,
                                             cytotoxic lysin)
Clostridium difficile                       Cytotoxin (toxin B)
Clostridium perfringens                     Beta-toxin; Epsilon-toxin;
                                             Kappa-toxin
Escherichia coli & other                    Cytotoxin (Shiga-like toxin,
 Enterobacteriaceae spp.                     Vero cell toxin)
Pseudomonas aeruginosa                      Proteases
Staphylococcus aureus                       Gamma lysin (Gamma toxin);
                                             Enterotoxins (SEA, SEB,
                                             SEC, SED SEE); Pyrogenic
                                             exotoxins A B; Toxic shock
                                             syndrome toxins (TSST-1)
Staphylococcus aureus & Pseudomonas         Leucocidin (leukocidin,
 aeruginosa                                  cytotoxin)
Streptococcus pyogenes                      Streptolysin S (SLS);
                                             Erythrogenic toxins
                                             (scarlet fever toxins,
                                             pyrogenic exotoxins)
Yersinia enterocolitica                     Heat-stable enterotoxins
                                             (ST)
 



Sec. 725.422  Physical containment and control technologies.

    The manufacturer must meet all of the following criteria for 
physical containment and control technologies for any facility in which 
the new microorganism will be used for a Tier I exemption; these 
criteria also serve as guidance for a Tier II exemption.
    (a) Use a structure that is designed and operated to contain the new 
microorganism.
    (b) Control access to the structure.
    (c) Provide written, published, and implemented procedures for the 
safety of personnel and control of hygiene.
    (d) Use inactivation procedures demonstrated and documented to be 
effective against the new microorganism contained in liquid and solid 
wastes prior to disposal of the wastes. The inactivation procedures must 
reduce viable microbial populations by at least 6 logs in liquid and 
solid wastes.
    (e) Use features known to be effective in minimizing viable 
microbial populations in aerosols and exhaust gases released from the 
structure, and document use of such features.

[[Page 64]]

    (f) Use systems for controlling dissemination of the new 
microorganism through other routes, and document use of such features.
    (g) Have in place emergency clean-up procedures.



Sec. 725.424  Requirements for the Tier I exemption.

    (a) Conditions of exemption. The manufacture or import of a new 
microorganism for commercial purposes is not subject to review under 
this part if all of the following conditions are met for all activities 
involving the new microorganism:
    (1) The recipient microorganism is listed in and meets any 
requirements specified in Sec. 725.420.
    (2) The introduced genetic material meets the criteria under 
Sec. 725.421.
    (3) The physical containment and control technologies of any 
facility in which the microorganism will be manufactured, processed, or 
used meet the criteria under Sec. 725.422.
    (4) The manufacturer or importer submits a certification described 
in paragraph (b) of this section to EPA at least 10 days before 
commencing initial manufacture or import of a new microorganism derived 
from a recipient microorganism listed in Sec. 725.420.
    (5) The manufacturer or importer complies with the recordkeeping 
requirements of Sec. 725.65 and maintains records for the initial and 
subsequent uses of the new microorganism that verify compliance with the 
following:
    (i) The certifications made in paragraph (b) of this section.
    (ii) All the eligibility criteria for the Tier I exemption including 
the criteria for the recipient microorganism, the introduced genetic 
material, the physical containment and control technologies.
    (b) Certification. To be eligible for the Tier I exemption under 
this subpart, the manufacturer or importer must submit to EPA a document 
signed by a responsible company official containing the information 
listed in this paragraph.
    (1) Name and address of manufacturer or importer.
    (2) Date when manufacture or import is expected to begin.
    (3) The identification (genus, species) of the recipient 
microorganism listed in Sec. 725.420 which is being used to create the 
new microorganism which will be used under the conditions of the Tier I 
exemption.
    (4) Certification of the following:
    (i) Compliance with the introduced genetic material criteria 
described in Sec. 725.421.
    (ii) Compliance with the containment requirements described in 
Sec. 725.422, including the provision in paragraph (a)(3) of this 
section.
    (5) The site of waste disposal and the type of permits for disposal, 
the permit numbers and the institutions issuing the permits.
    (6) The certification statement required in Sec. 725.25(b). 
Certification of submission of test data is not required for the Tier I 
exemption.



Sec. 725.426  Applicability of the Tier I exemption.

    The Tier I exemption under Sec. 725.424 applies only to a 
manufacturer or importer of a new microorganism that certifies that the 
microorganism will be used in all cases in compliance with 
Secs. 725.420, 725.421, and 725.422.



Sec. 725.428  Requirements for the Tier II exemption.

    The manufacturer or importer of a new microorganism for commercial 
purposes may submit to EPA a Tier II exemption request in lieu of a MCAN 
under subpart D of this part if all of the following conditions are met:
    (a) The recipient microorganism is listed in and meets any 
requirements specified in Sec. 725.420.
    (b) The introduced genetic material meets the criteria under 
Sec. 725.421.
    (c) Adequate physical containment and control technologies are used. 
The criteria listed under Sec. 725.422 for physical containment and 
control technologies of facilities should be used as guidance to satisfy 
the Tier II exemption request data requirements listed at 
Sec. 725.455(d). EPA will review proposed process and containment 
procedures as part of the submission for a Tier II exemption under this 
section.

[[Page 65]]



Sec. 725.450  Procedural requirements for the Tier II exemption.

    General requirements for all submissions under this part are 
contained in Sec. 725.25. In addition, the following requirements apply 
to requests submitted under this subpart:
    (a) Prenotice consultation. EPA strongly suggests that for a Tier II 
exemption, the submitter contact the Agency for a prenotice consultation 
regarding eligibility for the exemption.
    (b) When to submit the Tier II exemption request. Each person who is 
eligible to submit a Tier II exemption request under this subpart must 
submit the request at least 45 calendar days before the person intends 
to commence manufacture or import.
    (c) Contents of the Tier II exemption request. Each person who 
submits a request under this subpart must provide the information 
described in Secs. 725.428 and 725.455, as well as information known to 
or reasonably ascertainable by the person that would permit EPA to 
determine that use of the microorganism, under the conditions specified 
in the request, will not present an unreasonable risk of injury to 
health or the environment.
    (d) Recordkeeping. Each person who submits a request under this 
subpart must comply with the recordkeeping requirements of Sec. 725.65. 
In addition, the submitter should maintain records which contain 
information that verifies compliance with the following:
    (1) The certifications made in the request.
    (2) All the eligibility criteria for the Tier II exemption request 
including the criteria for the recipient microorganism, the introduced 
genetic material, the physical containment and control technologies.



Sec. 725.455  Information to be included in the Tier II exemption request.

    The submitter must indicate clearly that the submission is a Tier II 
exemption request for a microorganism instead of the MCAN under subpart 
D of this part and must submit the following information:
    (a) Submitter identification. (1) The name and headquarters address 
of the submitter.
    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (b) Microorganism identity information. (1) Identification (genus, 
species, and strain) of the recipient microorganism. Genus, species 
designation should be substantiated by a letter from a culture 
collection or a brief summary of the results of tests conducted for 
taxonomic identification.
    (2) Type of genetic modification and the function of the introduced 
genetic material.
    (3) Site of insertion.
    (4) Certification of compliance with the introduced genetic material 
criteria described in Sec. 725.421.
    (c) Production volume. Production volume, including total liters per 
year, and the maximum cell concentration achieved during the production 
process.
    (d) Process and containment information. (1) A description of the 
process including the following:
    (i) Identity and location of the manufacturing site(s).
    (ii) Process flow diagram illustrating the production process, 
including downstream separations, and indicating the containment 
envelope around the appropriate equipment.
    (iii) Identities and quantities of feedstocks.
    (iv) Sources and quantities of potential releases to both the 
workplace and environment, and a description of engineering controls, 
inactivation procedures, and other measures which will reduce worker 
exposure and environmental releases.
    (v) A description of procedures which will be undertaken to prevent 
fugitive emissions, i.e. leak detection and repair program.
    (vi) A description of procedures/safeguards to prevent and mitigate 
accidental releases to the workplace and the environment.
    (2) Certification of those elements of the containment criteria 
described in Sec. 725.422 with which the manufacturer is in compliance, 
including stating by number the elements with which the manufacturer is 
in full compliance.
    (e) The site of waste disposal and the type of permits for disposal, 
the permit

[[Page 66]]

numbers and the institutions issuing the permits.
    (f) The certification statement required in Sec. 725.25(b). 
Certification of submission of test data is not required for the Tier II 
exemption.



Sec. 725.470  EPA review of the Tier II exemption request.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of Tier II exemption requests submitted 
under this subpart:
    (a) Length of the review period. The review period for the request 
will be 45 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete request, 
or the date EPA determines the request is complete under Sec. 725.33, 
unless the Agency extends the review period for good cause under 
Sec. 725.56.
    (b) Criteria for review. EPA will review the request to determine 
that the new microorganism complies with Sec. 725.428 and that its 
manufacture, processing, use, and disposal as described in the request 
will not present an unreasonable risk of injury to health or the 
environment.
    (c) EPA decision regarding the Tier II exemption request. A decision 
concerning a request under this subpart will be made by the 
Administrator, or a designee.
    (d) Determination that the microorganism is ineligible for a Tier II 
review. (1) EPA may determine that the manufacturer or importer is not 
eligible for Tier II review, because the microorganism does not meet the 
criteria under Sec. 725.428 or the Administrator, or a designee, decides 
that there is insufficient information to determine that the conditions 
of manufacture, processing, use, or disposal of the microorganism as 
described in the request will not present an unreasonable risk to health 
or the environment.
    (2) If the Agency makes this determination, the Administrator, or a 
designee will notify the manufacturer or importer by telephone, followed 
by a letter, that the request has been denied. The letter will explain 
reasons for the denial.
    (3) If the request is denied, the manufacturer or importer may 
submit the information necessary to constitute a MCAN under subpart D of 
this part.
    (e) Approval or denial of the Tier II exemption request. (1) No 
later than 45 days after EPA receives a request, the Agency will either 
approve or deny the request.
    (2) In approving a request, EPA may impose any restrictions 
necessary to ensure that the microorganism will not present an 
unreasonable risk of injury to health and the environment as a result of 
general commercial use.
    (f) EPA may seek to enjoin the manufacture or import of a 
microorganism in violation of this subpart, or act to seize any 
microorganism manufactured or imported in violation of this section or 
take other actions under the authority of sections 7 or 17 of the Act.
    (g) A manufacturer or importer may only proceed after receipt of EPA 
approval.

Subparts H-K [Reserved]



Subpart L_Additional Procedures for Reporting on Significant New Uses of 
                             Microorganisms



Sec. 725.900  Scope and purpose.

    (a) This subpart describes additional provisions governing 
submission of MCANs for microorganisms subject to significant new use 
rules identified in subpart M of this part.
    (b) Manufacturers, importers, and processors described in 
Sec. 725.105(c) must submit a MCAN under subpart D of this part for 
significant new uses of microorganisms described in subpart M of this 
part, unless they are excluded under Sec. 725.910 or Sec. 725.912.
    (c) Section 725.920 discusses exports and imports.
    (d) Additional recordkeeping requirements specific to significant 
new uses of microorganisms are described in Sec. 725.950.
    (e) Section 725.975 describes how EPA will approve alternative means 
of complying with significant new use requirements designated in subpart 
M of this part.

[[Page 67]]

    (f) Expedited procedures for promulgating significant new use 
requirements under subpart M of this part for microorganisms subject to 
section 5(e) orders are discussed in Secs. 725.980 and 725.984.
    (g) This subpart L contains provisions governing submission and 
review of notices for the microorganisms and significant new uses 
identified in subpart M of this part. The provisions of this subpart L 
apply to the microorganisms and significant new uses identified in 
subpart M of this part, except to the extent that they are specifically 
modified or supplanted by specific requirements in subpart M of this 
part. In the event of a conflict between the provisions of this subpart 
L and the provisions of subpart M of this part, the provisions of 
subpart M of this part shall govern.
    (h) The provisions of subparts A through F of this part also apply 
to subparts L and M of this part. For purposes of subparts L and M of 
this part, wherever the words ``microorganism'' or ``new microorganism'' 
appear in subparts A through F of this part, it shall mean the 
microorganism subject to subparts L and M of this part. In the event of 
a conflict between the provisions of subparts A through F and the 
provisions of subparts L and M of this part, the provisions of subparts 
L and M of this part shall govern.



Sec. 725.910  Persons excluded from reporting significant new uses.

    (a) A person who intends to manufacture, import, or process a 
microorganism identified in subpart M of this part and who intends to 
distribute it in commerce is not required to submit a MCAN under subpart 
D of this part, if that person can document one or more of the following 
as to each recipient of the microorganism from that person:
    (1) That the person has notified the recipient, in writing, of the 
specific section in subpart M of this part which identifies the 
microorganism and its designated significant new uses, or
    (2) That the recipient has knowledge of the specific section in 
subpart M of this part which identifies the microorganism and its 
designated significant new uses, or
    (3) That the recipient cannot undertake any significant new use 
described in the specific section in subpart M of this part.
    (b) The manufacturer, importer, or processor described in paragraph 
(a) of this section must submit a MCAN under subpart D of this part, if 
such person has knowledge at the time of commercial distribution of the 
microorganism identified in the specific section in subpart M of this 
part that a recipient intends to engage in a designated significant new 
use of that microorganism without submitting a MCAN under this part.
    (c) A person who processes a microorganism identified in a specific 
section in subpart M of this part for a significant new use of that 
microorganism is not required to submit a MCAN if that person can 
document each of the following:
    (1) That the person does not know the specific microorganism 
identity of the microorganism being processed, and
    (2) That the person is processing the microorganism without 
knowledge that the microorganism is identified in subpart M of this 
part.
    (d)(1) If at any time after commencing distribution in commerce of a 
microorganism identified in a specific section in subpart M of this 
part, a person who manufactures, imports, or processes a microorganism 
described in subpart M of this part and distributes it in commerce has 
knowledge that a recipient of the microorganism is engaging in a 
significant new use of that microorganism designated in that section 
without submitting a MCAN under this part, the person is required to 
cease supplying the microorganism to that recipient and to submit a MCAN 
for that microorganism and significant new use, unless the person is 
able to document each of the following:
    (i) That the person has notified the recipient and EPA enforcement 
authorities (at the address in paragraph (d)(1)(iii) of this section), 
in writing within 15 working days of the time the person develops 
knowledge that the recipient is engaging in a significant new use, that 
the recipient is engaging in a significant new use without submitting a 
MCAN.

[[Page 68]]

    (ii) That, within 15 working days of notifying the recipient as 
described in paragraph (d)(1)(i) of this section, the person received 
from the recipient, in writing, a statement of assurance that the 
recipient is aware of the terms of the applicable section in subpart M 
of this part and will not engage in the significant new use.
    (iii) That the person has promptly provided EPA enforcement 
authorities with a copy of the recipient's statement of assurance 
described in paragraph (d)(1)(ii) of this section. The copy must be sent 
to the Director, Office of Compliance (2221A), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    (2) If EPA notifies the manufacturer, importer, or processor that 
the recipient is engaging in a significant new use after providing the 
statement of assurance described in paragraph (d)(1)(ii) of this section 
and without submitting a MCAN under this part, the manufacturer, 
importer, or processor shall immediately cease distribution to that 
recipient until the manufacturer, importer, or processor or the 
recipient has submitted a MCAN under this part and the MCAN review 
period has ended.
    (3) If, after receiving a statement of assurance from a recipient 
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or 
processor has knowledge that the recipient is engaging in a significant 
new use without submitting a MCAN under this part, the manufacturer, 
importer, or processor must immediately cease distributing the 
microorganism to that recipient and notify EPA enforcement authorities 
at the address identified in paragraph (d)(1)(iii) of this section. The 
manufacturer, importer, or processor may not resume distribution to that 
recipient until any one of the following has occurred:
    (i) The manufacturer, importer, or processor has submitted a MCAN 
under this part and the MCAN review period has ended.
    (ii) The recipient has submitted a MCAN under this part and the MCAN 
review period has ended.
    (iii) The manufacturer, importer, or processor has received notice 
from EPA enforcement authorities that it may resume distribution to that 
recipient.



Sec. 725.912  Exemptions.

    Persons identified in Sec. 725.105(c) are not required to submit a 
MCAN under subpart D of this part for a microorganism identified in 
subpart M of this part, unless otherwise specified in a specific section 
in subpart M, if:
    (a) The person submits a MCAN for the microorganism prior to the 
promulgation date of the section in subpart M of this part which 
identifies the microorganism, and the person receives written 
notification of compliance from EPA prior to the effective date of such 
section. The MCAN submitter must comply with any applicable requirement 
of section 5(b) of the Act. The MCAN must include the information and 
test data specified in section 5(d)(1) of the Act. For purposes of this 
exemption, the specific section in subpart M of this part which 
identifies the microorganism and Secs. 725.3, 725.15, 725.65, 725.70, 
725.75, 725.100, and 725.900 apply; after the effective date of the 
section in subpart M of this part which identifies the microorganism, 
Secs. 725.105 and 725.910 apply and Sec. 725.920 continues to apply. EPA 
will provide the MCAN submitter with written notification of compliance 
only if one of the following occurs:
    (1) EPA is unable to make the finding that the activities described 
in the MCAN will or may present an unreasonable risk of injury to health 
or the environment under reasonably foreseeable circumstances, or
    (2) EPA and the person negotiate a consent order under section 5(e) 
of the Act, such order to take effect on the effective date of the 
section in subpart M of this part which identifies the microorganism.
    (b) The person is operating under the terms of a consent order 
issued under section 5(e) of the Act applicable to that person. If a 
provision of such section 5(e) order is inconsistent with a specific 
significant new use identified in subpart M of this part, abiding by the 
provision of the section 5(e) order exempts the person from submitting a 
MCAN for that specific significant new use.

[[Page 69]]



Sec. 725.920  Exports and imports.

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



Sec. 725.950  Additional recordkeeping requirements.

    Persons submitting a MCAN for a significant new use of a 
microorganism must comply with the recordkeeping requirements of 
Sec. 725.65. In addition, the following requirements apply:
    (a) At the time EPA adds a microorganism to subpart M of this part, 
EPA may specify appropriate recordkeeping requirements. Each 
manufacturer, importer, and processor of the microorganism shall 
maintain the records for 3 years from the date of their creation.
    (b) The records required to be maintained under this section may 
include the following:
    (1) Records documenting the information contained in the MCAN 
submitted to EPA.
    (2) Records documenting the manufacture and importation volume of 
the microorganism and the corresponding dates of manufacture and import.
    (3) Records documenting volumes of the microorganism purchased 
domestically by processors of the microorganism, names and addresses of 
suppliers and corresponding dates of purchase.
    (4) Records documenting the names and addresses (including shipment 
destination address, if different) of all persons outside the site of 
manufacture or import to whom the manufacturer, importer, or processor 
directly sells or transfers the microorganism, the date of each sale or 
transfer, and the quantity of the microorganism sold or transferred on 
such date.



Sec. 725.975  EPA approval of alternative control measures.

    (a) In certain sections of subpart M of this part, significant new 
uses for the identified microorganisms are described as the failure to 
establish and implement programs providing for the use of either: 
specific measures to control worker exposure to or release of 
microorganisms which are identified in such sections, or alternative 
measures to control worker exposure or environmental release which EPA 
has determined provide substantially the same degree of protection as 
the specified control measures. Persons who manufacture, import, or 
process a microorganism identified in such sections and who intend to 
employ alternative measures to control worker exposure or environmental 
release must submit a request to EPA for a determination of equivalency 
before commencing manufacture, import, or processing involving the 
alternative control measures.
    (b) Persons submitting a request for a determination of equivalency 
to EPA under this part must submit the request to EPA (via CDX) using e-
PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to 
obtain e-PMN software. Support documents related to these requests must 
also be submitted to EPA via CDX using e-PMN software. A request for a 
determination of equivalency must contain:
    (1) The name of the submitter.
    (2) The specific identity of the microorganism.
    (3) The citation for the specific section in subpart M of this part 
which pertains to the microorganism for which the request is being 
submitted.
    (4) A detailed description of the activities involved.
    (5) The specifications of the alternative worker exposure control 
measures or environmental release control measures.
    (6) A detailed analysis explaining why such alternative control 
measures provide substantially the same degree of protection as the 
specific control measures identified in the specific section in subpart 
M of this part which

[[Page 70]]

pertains to the microorganism for which the request is being submitted.
    (7) The data and information described in Secs. 725.155 and 725.160. 
If such data and information have already been submitted to EPA's Office 
of Pollution Prevention and Toxics, the submitter need only document 
that it was previously submitted, to whom, and the date it was 
submitted.
    (c) Requests for determinations of equivalency will be reviewed by 
EPA within 45 days. Determinations under this paragraph will be made by 
the Director, or a designee. Notice of the results of such 
determinations will be mailed to the submitter.
    (d) If EPA notifies the submitter under paragraph (c) of this 
section that EPA has determined that the alternative control measures 
provide substantially the same degree of protection as the specified 
control measures identified in the specific section of subpart M of this 
part which pertains to the microorganism for which the request is being 
submitted, the submitter may commence manufacture, import, or processing 
in accordance with the specifications for alternative worker exposure 
control measures or environmental release control measures identified in 
the submitter's request, and may alter any corresponding notification to 
workers to reflect such alternative controls. Deviations from the 
activities described in the EPA notification constitute a significant 
new use and are subject to the requirements of this part.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



Sec. 725.980  Expedited procedures for issuing significant new use rules
for microorganisms subject to section 5(e) orders.

    (a) Selection of microorganisms. (1) In accordance with the 
expedited process specified in this section, EPA will issue significant 
new use notification requirements for each new microorganism that, after 
MCAN review under subpart D of this part, becomes subject to a final 
order issued under section 5(e) of the Act, except for an order that 
prohibits manufacture and import of the microorganism, unless EPA 
determines that significant new use notification requirements are not 
needed for the microorganism.
    (2) If EPA determines that significant new use notifications 
requirements are not needed for a microorganism that is subject to a 
final order issued under section 5(e) of the Act, EPA will issue a 
notice in the Federal Register explaining why the significant new use 
requirements are not needed.
    (b) Designation of requirements. (1) The significant new use 
notification and other specific requirements will be based on and be 
consistent with the provisions included in the final order issued for 
the microorganism under section 5(e) of the Act. EPA may also designate 
additional activities as significant new uses which will be subject to 
notification.
    (2) Significant new use requirements and other specific requirements 
designated under this section will be listed in subpart M of this part. 
For each microorganism, subpart M of this part will identify:
    (i) The microorganism name.
    (ii) The activities designated as significant new uses.
    (iii) Other specific requirements applicable to the microorganism, 
including recordkeeping requirements or any other requirements included 
in the final section 5(e) order.
    (c) Procedures for issuing significant new use rules--(1) Possible 
processes. EPA will issue significant new use rules (SNURs) under this 
section by one of the following three processes: direct final 
rulemaking, interim final rulemaking, or notice and comment rulemaking. 
EPA will use the direct final rulemaking process to issue significant 
new use rules unless it determines that, in a particular case, one of 
the other processes is more appropriate.
    (2) Notice in the Federal Register. Federal Register documents 
issued to propose or establish significant new uses under this section 
will contain the following:
    (i) The microorganism identity or, if its specific identity is 
claimed confidential, an appropriate generic microorganism name and an 
accession number assigned by EPA.
    (ii) The MCAN number.

[[Page 71]]

    (iii) A summary of EPA's findings under section 5(e)(1)(A) of the 
Act for the final order issued under section 5(e).
    (iv) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (v) Any modification of subpart L of this part applicable to the 
specific microorganism and significant new uses.
    (vi) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (3) Direct final rulemaking. (i) EPA will use direct final 
rulemaking to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. EPA will issue a final rule in the Federal Register 
following its decision to develop a significant new use rule under this 
section for a specific new microorganism.
    (ii) The Federal Register document will state that, unless written 
notice is received by EPA within 30 days of publication that someone 
wishes to submit adverse or critical comments, the rule will be 
effective 60 days from the date of publication. The written notice of 
intent to submit adverse or critical comments should state which SNUR(s) 
will be the subject of the adverse or critical comments, if several 
SNURs are established through the direct final rule. If notice is 
received within 30 days that someone wishes to submit adverse or 
critical comments, the section(s) of the direct final rule containing 
the SNUR(s) for which a notice of intent to comment was received will be 
withdrawn by EPA issuing a document in the final rule section of the 
Federal Register, and a proposal will be published in the proposed rule 
section of the Federal Register. The proposal will establish a 30-day 
comment period.
    (iii) If EPA, having considered any timely comments submitted in 
response to the proposal, decides to establish notification requirements 
under this section, EPA will issue a final rule adding the microorganism 
to subpart M of this part and designating the significant new uses 
subject to notification.
    (4) Interim final rulemaking. (i) EPA will use the interim final 
rulemaking procedure to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. The Agency will issue an interim final rule in the 
Federal Register following its decision to develop a significant new use 
rule for a specific new microorganism. The document will state EPA's 
reasons for using the interim final rulemaking procedure.
    (A) The significant new use rule will take effect on the date of 
publication.
    (B) Persons will be given 30 days from the date of publication to 
submit comments.
    (ii) Interim final rules issued under this section shall cease to be 
in effect 180 days after publication unless, within the 180-day period, 
EPA issues a final rule in the Federal Register responding to any 
written comments received during the 30-day comment period specified in 
paragraph (c)(4)(i)(B) of this section and promulgating final 
significant new use notification requirements and other requirements for 
the microorganism.
    (5) Notice and comment rulemaking. (i) EPA will use a notice and 
comment procedure to issue a significant new use rule, when EPA is 
designating additional activities which are not provisions included in 
the final order issued for the microorganism under section 5(e) of the 
Act as significant new uses which will be subject to notification. EPA 
will issue a proposal in the Federal Register following its decision to 
develop a significant new use rule under this section for a specific new 
microorganism. Persons will be given 30 days to comment on whether EPA 
should establish notification requirements for the microorganism under 
this part.
    (ii) If EPA, having considered any timely comments, decides to 
establish notification requirements under this

[[Page 72]]

section, EPA will issue a final rule adding the microorganism to subpart 
M of this part and designating the significant new uses subject to 
notification.
    (d) Schedule for issuing significant new use rules. (1) Unless EPA 
determines that a significant new use rule should not be issued under 
this section, EPA will issue a proposed rule, a direct final rule, or an 
interim final rule within 180 days of receipt of a valid notice of 
commencement under Sec. 725.190.
    (2) If EPA receives adverse or critical significant comments 
following publication of a proposed or interim final rule, EPA will 
either withdraw the rule or issue a final rule addressing the comments 
received.



Sec. 725.984  Modification or revocation of certain notification
requirements.

    (a) Criteria for modification or revocation. EPA may at any time 
modify or revoke significant new use notification requirements for a 
microorganism which has been added to subpart M of this part using the 
procedures of Sec. 725.980. Such action may be taken under this section 
if EPA makes one of the following determinations, unless other 
information shows that the requirements should be retained:
    (1) Test data or other information obtained by EPA provide a 
reasonable basis for concluding that activities designated as 
significant new uses of the microorganism will not present an 
unreasonable risk of injury to health or the environment.
    (2) EPA has promulgated a rule under section 4 or 6 of the Act, or 
EPA or another agency has taken action under another law, for the 
microorganism that eliminates the need for significant new use 
notification under section 5(a)(2) of the Act.
    (3) EPA has received MCANs for some or all of the activities 
designated as significant new uses of the microorganism and, after 
reviewing such MCANs, concluded that there is no need to require 
additional notice from persons who propose to engage in identical or 
similar activities.
    (4) EPA has examined new information, or has reexamined the test 
data or other information supporting its finding under section 
5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no 
longer exists for the findings that activities involving the 
microorganism may present an unreasonable risk of injury to health or 
the environment required under section 5(e)(1)(A) of the Act.
    (5) Certain activities involving the microorganism have been 
designated as significant new uses pending the completion of testing, 
and adequate test data developed in accordance with applicable 
procedures and criteria have been submitted to EPA.
    (b) Procedures for limitation or revocation. Modification or 
revocation of significant new use notification requirements for a 
microorganism that has been added to subpart M of this part using the 
procedures described in Sec. 725.980 may occur either at EPA's 
initiative or in response to a written request.
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a microorganism that 
has been added to subpart M of this part using the procedures described 
in Sec. 725.980. The request must be accompanied by information 
sufficient to support the request. Persons submitting a request to EPA 
under this part must submit the request to EPA (via CDX) using e-PMN 
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain 
e-PMN software. Support documents related to these requests must also be 
submitted to EPA via CDX using e-PMN software.
    (2) The Director, or a designee, will consider the request, make a 
determination whether to initiate rulemaking to modify the requirements, 
and notify the requester of that determination by certified letter. If 
the request is denied, the letter will explain why EPA has concluded 
that the significant new use notification requirements for that 
microorganism should remain in effect.
    (3) If EPA concludes that significant new use notification 
requirements for a microorganism should be limited or revoked, EPA will 
propose the changes in a notice in the Federal Register,

[[Page 73]]

briefly describe the grounds for the action, and provide interested 
parties an opportunity to comment.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013]



       Subpart M_Significant New Uses for Specific Microorganisms



Sec. 725.1000  Scope.

    This subpart identifies uses of microorganisms which EPA has 
determined to be significant new uses under the authority of section 
5(a)(2) of the Toxic Substances Control Act.



Sec. 725.1075  Burkholderia cepacia complex.

    (a) Microorganism and significant new uses subject to reporting. (1) 
The microorganisms identified as the Burkholderia cepacia complex 
defined as containing the following nine species, Burkholderia cepacia, 
Burkholderia multivorans, Burkholderia stabilis, Burkholderia 
vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia, 
Burkholderia cepacia genomovar VIII (Burkholderia anthina), and 
Burkholderia cepacia genomovars III and VI are subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new use is any use other than research and 
development in the degradation of chemicals via injection into 
subsurface groundwater.
    (b) [Reserved]

[68 FR 35320, June 13, 2003]



PART 745_LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL
STRUCTURES--Table of Contents



Subparts A-C [Reserved]

                   Subpart D_Lead-Based Paint Hazards

Sec.
745.61  Scope and applicability.
745.63  Definitions.
745.65  Lead-based paint hazards.

                Subpart E_Residential Property Renovation

745.80  Purpose.
745.81  Effective dates.
745.82  Applicability.
745.83  Definitions.
745.84  Information distribution requirements.
745.85  Work practice standards.
745.86  Recordkeeping and reporting requirements.
745.87  Enforcement and inspections.
745.88  Recognized test kits.
745.89  Firm certification.
745.90  Renovator certification and dust sampling technician 
          certification.
745.91  Suspending, revoking, or modifying an individual's or firm's 
          certification.
745.92  Fees for the accreditation of renovation and dust sampling 
          technician training and the certification of renovation firms.

 Subpart F_Disclosure of Known Lead-Based Paint and/or Lead-Based Paint 
           Hazards Upon Sale or Lease of Residential Property

745.100  Purpose.
745.101  Scope and applicability.
745.102  Effective dates.
745.103  Definitions.
745.107  Disclosure requirements for sellers and lessors.
745.110  Opportunity to conduct an evaluation.
745.113  Certification and acknowledgment of disclosure.
745.115  Agent responsibilities.
745.118  Enforcement.
745.119  Impact on State and local requirements.

Subparts G-K [Reserved]

                  Subpart L_Lead-Based Paint Activities

745.220  Scope and applicability.
745.223  Definitions.
745.225  Accreditation of training programs: target housing and child-
          occupied facilities.
745.226  Certification of individuals and firms engaged in lead-based 
          paint activities: target housing and child-occupied 
          facilities.
745.227  Work practice standards for conducting lead-based paint 
          activities: target housing and child-occupied facilities.
745.228  Accreditation of training programs: public and commercial 
          buildings, bridges and superstructures. [Reserved]
745.229  Certification of individuals and firms engaged in lead-based 
          paint activities: public and commercial buildings, bridges and 
          superstructures. [Reserved]
745.230  Work practice standards for conducting lead-based paint 
          activities: public and commercial buildings, bridges and 
          superstructures. [Reserved]
745.233  Lead-based paint activities requirements.
745.235  Enforcement.

[[Page 74]]

745.237  Inspections.
745.238  Fees for accreditation and certification of lead-based paint 
          activities.
745.239  Effective dates.

Subparts M-P [Reserved]

               Subpart Q_State and Indian Tribal Programs

745.320  Scope and purpose.
745.323  Definitions.
745.324  Authorization of State or Tribal programs.
745.325  Lead-based paint activities: State and Tribal program 
          requirements.
745.326  Renovation: State and Tribal program requirements.
745.327  State or Indian Tribal lead-based paint compliance and 
          enforcement programs.
745.339  Effective date.

    Authority: 15 U.S.C. 2605, 2607, 2681-2692 and 42 U.S.C. 4852d.

    Source: 61 FR 9085, Mar. 6, 1996, unless otherwise noted.

Subparts A-C [Reserved]



                   Subpart D_Lead-Based Paint Hazards

    Source: 66 FR 1237, Jan. 5, 2001, unless otherwise noted.



Sec. 745.61  Scope and applicability.

    (a) This subpart identifies lead-based paint hazards.
    (b) The standards for lead-based paint hazards apply to target 
housing and child-occupied facilities.
    (c) Nothing in this subpart requires the owner of property(ies) 
subject to these standards to evaluate the property(ies) for the 
presence of lead-based paint hazards or take any action to control these 
conditions if one or more of them is identified.



Sec. 745.63  Definitions.

    The following definitions apply to part 745.
    Arithmetic mean means the algebraic sum of data values divided by 
the number of data values (e.g., the sum of the concentration of lead in 
several soil samples divided by the number of samples).
    Chewable surface means an interior or exterior surface painted with 
lead-based paint that a young child can mouth or chew. A chewable 
surface is the same as an ``accessible surface'' as defined in 42 U.S.C. 
4851b(2)). Hard metal substrates and other materials that cannot be 
dented by the bite of a young child are not considered chewable.
    Common area group means a group of common areas that are similar in 
design, construction, and function. Common area groups include, but are 
not limited to hallways, stairwells, and laundry rooms.
    Concentration means the relative content of a specific substance 
contained within a larger mass, such as the amount of lead (in 
micrograms per gram or parts per million by weight) in a sample of dust 
or soil.
    Deteriorated paint means any interior or exterior paint or other 
coating that is peeling, chipping, chalking or cracking, or any paint or 
coating located on an interior or exterior surface or fixture that is 
otherwise damaged or separated from the substrate.
    Dripline means the area within 3 feet surrounding the perimeter of a 
building.
    Friction surface means an interior or exterior surface that is 
subject to abrasion or friction, including, but not limited to, certain 
window, floor, and stair surfaces.
    Impact surface means an interior or exterior surface that is subject 
to damage by repeated sudden force such as certain parts of door frames.
    Interior window sill means the portion of the horizontal window 
ledge that protrudes into the interior of the room.
    Lead-based paint hazard means hazardous lead-based paint, dust-lead 
hazard or soil-lead hazard as identified in Sec. 745.65.
    Loading means the quantity of a specific substance present per unit 
of surface area, such as the amount of lead in micrograms contained in 
the dust collected from a certain surface area divided by the surface 
area in square feet or square meters.
    Mid-yard means an area of a residential yard approximately midway 
between the dripline of a residential building and the nearest property 
boundary or between the driplines of a residential building and another 
building on the same property.

[[Page 75]]

    Play area means an area of frequent soil contact by children of less 
than 6 years of age as indicated by, but not limited to, such factors 
including the following: the presence of play equipment (e.g., 
sandboxes, swing sets, and sliding boards), toys, or other children's 
possessions, observations of play patterns, or information provided by 
parents, residents, care givers, or property owners.
    Residential building means a building containing one or more 
residential dwellings.
    Room means a separate part of the inside of a building, such as a 
bedroom, living room, dining room, kitchen, bathroom, laundry room, or 
utility room. To be considered a separate room, the room must be 
separated from adjoining rooms by built-in walls or archways that extend 
at least 6 inches from an intersecting wall. Half walls or bookcases 
count as room separators if built-in. Movable or collapsible partitions 
or partitions consisting solely of shelves or cabinets are not 
considered built-in walls. A screened in porch that is used as a living 
area is a room.
    Soil sample means a sample collected in a representative location 
using ASTM E1727, ``Standard Practice for Field Collection of Soil 
Samples for Lead Determination by Atomic Spectrometry Techniques,'' or 
equivalent method.
    Weighted arithmetic mean means the arithmetic mean of sample results 
weighted by the number of subsamples in each sample. Its purpose is to 
give influence to a sample relative to the surface area it represents. A 
single surface sample is comprised of a single subsample. A composite 
sample may contain from two to four subsamples of the same area as each 
other and of each single surface sample in the composite. The weighted 
arithmetic mean is obtained by summing, for all samples, the product of 
the sample's result multiplied by the number of subsamples in the 
sample, and dividing the sum by the total number of subsamples contained 
in all samples. For example, the weighted arithmetic mean of a single 
surface sample containing 60 mg/ft\2\, a composite sample (three 
subsamples) containing 100 mg/ft\2\, and a composite sample (4 
subsamples) containing 110 mg/ft\2\ is 100 mg/ft\2\. This result is 
based on the equation [60 + (3*100) + (4*110)]/(1 + 3 + 4).
    Window trough means, for a typical double-hung window, the portion 
of the exterior window sill between the interior window sill (or stool) 
and the frame of the storm window. If there is no storm window, the 
window trough is the area that receives both the upper and lower window 
sashes when they are both lowered. The window trough is sometimes 
referred to as the window ``well.''
    Wipe sample means a sample collected by wiping a representative 
surface of known area, as determined by ASTM E1728, ``Standard Practice 
for Field Collection of Settled Dust Samples Using Wipe Sampling Methods 
for Lead Determination by Atomic Spectrometry Techniques, or equivalent 
method, with an acceptable wipe material as defined in ASTM E 1792, 
``Standard Specification for Wipe Sampling Materials for Lead in Surface 
Dust.''



Sec. 745.65  Lead-based paint hazards.

    (a) Paint-lead hazard. A paint-lead hazard is any of the following:
    (1) Any lead-based paint on a friction surface that is subject to 
abrasion and where the lead dust levels on the nearest horizontal 
surface underneath the friction surface (e.g., the window sill, or 
floor) are equal to or greater than the dust-lead hazard levels 
identified in paragraph (b) of this section.
    (2) Any damaged or otherwise deteriorated lead-based paint on an 
impact surface that is caused by impact from a related building 
component (such as a door knob that knocks into a wall or a door that 
knocks against its door frame.
    (3) Any chewable lead-based painted surface on which there is 
evidence of teeth marks.
    (4) Any other deteriorated lead-based paint in any residential 
building or child-occupied facility or on the exterior of any 
residential building or child-occupied facility.
    (b) Dust-lead hazard. A dust-lead hazard is surface dust in a 
residential dwelling or child-occupied facility that contains a mass-
per-area concentration of lead equal to or exceeding 40 mg/ft\2\

[[Page 76]]

on floors or 250 mg/ft\2\ on interior window sills based on wipe 
samples.
    (c) Soil-lead hazard. A soil-lead hazard is bare soil on residential 
real property or on the property of a child-occupied facility that 
contains total lead equal to or exceeding 400 parts per million (mg/g) 
in a play area or average of 1,200 parts per million of bare soil in the 
rest of the yard based on soil samples.
    (d) Work practice requirements. Applicable certification, occupant 
protection, and clearance requirements and work practice standards are 
found in regulations issued by EPA at 40 CFR part 745, subpart L and in 
regulations issued by the Department of Housing and Urban Development 
(HUD) at 24 CFR part 35, subpart R. The work practice standards in those 
regulations do not apply when treating paint-lead hazards of less than:
    (1) Two square feet of deteriorated lead-based paint per room or 
equivalent,
    (2) Twenty square feet of deteriorated paint on the exterior 
building, or
    (3) Ten percent of the total surface area of deteriorated paint on 
an interior or exterior type of component with a small surface area.



                Subpart E_Residential Property Renovation

    Source: 63 FR 29919, June 1, 1998, unless otherwise noted.



Sec. 745.80  Purpose.

    This subpart contains regulations developed under sections 402 and 
406 of the Toxic Substances Control Act (15 U.S.C. 2682 and 2686) and 
applies to all renovations performed for compensation in target housing 
and child-occupied facilities. The purpose of this subpart is to ensure 
the following:
    (a) Owners and occupants of target housing and child-occupied 
facilities receive information on lead-based paint hazards before these 
renovations begin; and
    (b) Individuals performing renovations regulated in accordance with 
Sec. 745.82 are properly trained; renovators and firms performing these 
renovations are certified; and the work practices in Sec. 745.85 are 
followed during these renovations.

[73 FR 21758, Apr. 22, 2008]



Sec. 745.81  Effective dates.

    (a) Training, certification and accreditation requirements and work 
practice standards. The training, certification and accreditation 
requirements and work practice standards in this subpart are applicable 
in any State or Indian Tribal area that does not have a renovation 
program that is authorized under subpart Q of this part. The training, 
certification and accreditation requirements and work practice standards 
in this subpart will become effective as follows:
    (1) Training programs. Effective June 23, 2008, no training program 
may provide, offer, or claim to provide training or refresher training 
for EPA certification as a renovator or a dust sampling technician 
without accreditation from EPA under Sec. 745.225. Training programs may 
apply for accreditation under Sec. 745.225 beginning April 22, 2009.
    (2) Firms. (i) Firms may apply for certification under Sec. 745.89 
beginning October 22, 2009.
    (ii) On or after April 22, 2010, no firm may perform, offer, or 
claim to perform renovations without certification from EPA under 
Sec. 745.89 in target housing or child-occupied facilities, unless the 
renovation qualifies for one of the exceptions identified in 
Sec. 745.82(a) or (c).
    (3) Individuals. On or after April 22, 2010, all renovations must be 
directed by renovators certified in accordance with Sec. 745.90(a) and 
performed by certified renovators or individuals trained in accordance 
with Sec. 745.90(b)(2) in target housing or child-occupied facilities, 
unless the renovation qualifies for one of the exceptions identified in 
Sec. 745.82(a) or (c).
    (4) Work practices. (i) On or after April 22, 2010 and before July 
6, 2010 all renovations must be performed in accordance with the work 
practice standards in Sec. 745.85 and the associated recordkeeping 
requirements in Sec. 745.86 (b)(6) in target housing or child-occupied 
facilities, unless the renovation qualifies for one of the exceptions 
identified in Sec. 745.82(a). This does not apply to renovations in 
target housing for which

[[Page 77]]

the firm performing the renovation has obtained a statement signed by 
the owner that the renovation will occur in the owner's residence, no 
child under age 6 resides there, the housing is not a child-occupied 
facility, and the owner acknowledges that the work practices to be used 
during the renovation will not necessarily include all of the lead-safe 
work practices contained in EPA's renovation, repair, and painting rule. 
For the purposes of this section, a child resides in the primary 
residence of his or her custodial parents, legal guardians, and foster 
parents. A child also resides in the primary residence of an informal 
caretaker if the child lives and sleeps most of the time at the 
caretaker's residence.
    (ii) On or after July 6, 2010, all renovations must be performed in 
accordance with the work practice standards in Sec. 745.85 and the 
associated recordkeeping requirements in Sec. 745.86(b)(1) and (b)(6) in 
target housing or child-occupied facilities, unless the renovation 
qualifies for the exception identified in Sec. 745.82(a).
    (5) The suspension and revocation provisions in Sec. 745.91 are 
effective April 22, 2010.
    (b) Renovation-specific pamphlet. Before December 22, 2008, 
renovators or firms performing renovations in States and Indian Tribal 
areas without an authorized program may provide owners and occupants 
with either of the following EPA pamphlets: Protect Your Family From 
Lead in Your Home or Renovate Right: Important Lead Hazard Information 
for Families, Child Care Providers and Schools. After that date, 
Renovate Right: Important Lead Hazard Information for Families, Child 
Care Providers and Schools must be used exclusively.
    (c) Pre-Renovation Education Rule. With the exception of the 
requirement to use the pamphlet entitled Renovate Right: Important Lead 
Hazard Information for Families, Child Care Providers and Schools, the 
provisions of the Pre-Renovation Education Rule in this subpart have 
been in effect since June 1999.

[73 FR 21758, Apr. 22, 2008, as amended at 75 FR 24818, May 6, 2010]



Sec. 745.82  Applicability.

    (a) This subpart applies to all renovations performed for 
compensation in target housing and child-occupied facilities, except for 
the following:
    (1) Renovations in target housing or child-occupied facilities in 
which a written determination has been made by an inspector or risk 
assessor (certified pursuant to either Federal regulations at 
Sec. 745.226 or a State or Tribal certification program authorized 
pursuant to Sec. 745.324) that the components affected by the renovation 
are free of paint or other surface coatings that contain lead equal to 
or in excess of 1.0 milligrams/per square centimeter (mg/cm\2\) or 0.5% 
by weight, where the firm performing the renovation has obtained a copy 
of the determination.
    (2) Renovations in target housing or child-occupied facilities in 
which a certified renovator, using an EPA recognized test kit as defined 
in Sec. 745.83 and following the kit manufacturer's instructions, has 
tested each component affected by the renovation and determined that the 
components are free of paint or other surface coatings that contain lead 
equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the 
components make up an integrated whole, such as the individual stair 
treads and risers of a single staircase, the renovator is required to 
test only one of the individual components, unless the individual 
components appear to have been repainted or refinished separately.
    (3) Renovations in target housing or child-occupied facilities in 
which a certified renovator has collected a paint chip sample from each 
painted component affected by the renovation and a laboratory recognized 
by EPA pursuant to section 405(b) of TSCA as being capable of performing 
analyses for lead compounds in paint chip samples has determined that 
the samples are free of paint or other surface coatings that contain 
lead equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the 
components make up an integrated whole, such as the individual stair 
treads and risers of a single staircase, the renovator is required to 
test only one of the individual components, unless the individual 
components appear to have

[[Page 78]]

been repainted or refinished separately.
    (b) The information distribution requirements in Sec. 745.84 do not 
apply to emergency renovations, which are renovation activities that 
were not planned but result from a sudden, unexpected event (such as 
non-routine failures of equipment) that, if not immediately attended to, 
presents a safety or public health hazard, or threatens equipment and/or 
property with significant damage. Interim controls performed in response 
to an elevated blood lead level in a resident child are also emergency 
renovations. Emergency renovations other than interim controls are also 
exempt from the warning sign, containment, waste handling, training, and 
certification requirements in Secs. 745.85, 745.89, and 745.90 to the 
extent necessary to respond to the emergency. Emergency renovations are 
not exempt from the cleaning requirements of Sec. 745.85(a)(5), which 
must be performed by certified renovators or individuals trained in 
accordance with Sec. 745.90(b)(2), the cleaning verification 
requirements of Sec. 745.85(b), which must be performed by certified 
renovators, and the recordkeeping requirements of Sec. 745.86(b)(6) and 
(b)(7).

[73 FR 21758, Apr. 22, 2008, as amended at 75 FR 24818, May 6, 2010; 76 
FR 47938, Aug. 5, 2011]



Sec. 745.83  Definitions.

    For purposes of this part, the definitions in Sec. 745.103 as well 
as the following definitions apply:
    Administrator means the Administrator of the Environmental 
Protection Agency.
    Child-occupied facility means a building, or portion of a building, 
constructed prior to 1978, visited regularly by the same child, under 6 
years of age, on at least two different days within any week (Sunday 
through Saturday period), provided that each day's visit lasts at least 
3 hours and the combined weekly visits last at least 6 hours, and the 
combined annual visits last at least 60 hours. Child-occupied facilities 
may include, but are not limited to, day care centers, preschools and 
kindergarten classrooms. Child-occupied facilities may be located in 
target housing or in public or commercial buildings. With respect to 
common areas in public or commercial buildings that contain child-
occupied facilities, the child-occupied facility encompasses only those 
common areas that are routinely used by children under age 6, such as 
restrooms and cafeterias. Common areas that children under age 6 only 
pass through, such as hallways, stairways, and garages are not included. 
In addition, with respect to exteriors of public or commercial buildings 
that contain child-occupied facilities, the child-occupied facility 
encompasses only the exterior sides of the building that are immediately 
adjacent to the child-occupied facility or the common areas routinely 
used by children under age 6.
    Cleaning verification card means a card developed and distributed, 
or otherwise approved, by EPA for the purpose of determining, through 
comparison of wet and dry disposable cleaning cloths with the card, 
whether post-renovation cleaning has been properly completed.
    Component or building component means specific design or structural 
elements or fixtures of a building or residential dwelling that are 
distinguished from each other by form, function, and location. These 
include, but are not limited to, interior components such as: Ceilings, 
crown molding, walls, chair rails, doors, door trim, floors, fireplaces, 
radiators and other heating units, shelves, shelf supports, stair 
treads, stair risers, stair stringers, newel posts, railing caps, 
balustrades, windows and trim (including sashes, window heads, jambs, 
sills or stools and troughs), built in cabinets, columns, beams, 
bathroom vanities, counter tops, and air conditioners; and exterior 
components such as: Painted roofing, chimneys, flashing, gutters and 
downspouts, ceilings, soffits, fascias, rake boards, cornerboards, 
bulkheads, doors and door trim, fences, floors, joists, lattice work, 
railings and railing caps, siding, handrails, stair risers and treads, 
stair stringers, columns, balustrades, windowsills or stools and 
troughs, casings, sashes and wells, and air conditioners.
    Dry disposable cleaning cloth means a commercially available dry, 
electrostatically charged, white disposable

[[Page 79]]

cloth designed to be used for cleaning hard surfaces such as uncarpeted 
floors or counter tops.
    Firm means a company, partnership, corporation, sole proprietorship 
or individual doing business, association, or other business entity; a 
Federal, State, Tribal, or local government agency; or a nonprofit 
organization.
    HEPA vacuum means a vacuum cleaner which has been designed with a 
high-efficiency particulate air (HEPA) filter as the last filtration 
stage. A HEPA filter is a filter that is capable of capturing 
particulates of 0.3 microns with 99.97% efficiency. The vacuum cleaner 
must be designed so that all the air drawn into the machine is expelled 
through the HEPA filter with none of the air leaking past it. HEPA 
vacuums must be operated and maintained in accordance with the 
manufacturer's instructions.
    Interim controls means a set of measures designed to temporarily 
reduce human exposure or likely exposure to lead-based paint hazards, 
including specialized cleaning, repairs, maintenance, painting, 
temporary containment, ongoing monitoring of lead-based paint hazards or 
potential hazards, and the establishment and operation of management and 
resident education programs.
    Minor repair and maintenance activities are activities, including 
minor heating, ventilation or air conditioning work, electrical work, 
and plumbing, that disrupt 6 square feet or less of painted surface per 
room for interior activities or 20 square feet or less of painted 
surface for exterior activities where none of the work practices 
prohibited or restricted by Sec. 745.85(a)(3) are used and where the 
work does not involve window replacement or demolition of painted 
surface areas. When removing painted components, or portions of painted 
components, the entire surface area removed is the amount of painted 
surface disturbed. Jobs, other than emergency renovations, performed in 
the same room within the same 30 days must be considered the same job 
for the purpose of determining whether the job is a minor repair and 
maintenance activity.
    Painted surface means a component surface covered in whole or in 
part with paint or other surface coatings.
    Pamphlet means the EPA pamphlet titled Renovate Right: Important 
Lead Hazard Information for Families, Child Care Providers and Schools 
developed under section 406(a) of TSCA for use in complying with section 
406(b) of TSCA, or any State or Tribal pamphlet approved by EPA pursuant 
to 40 CFR 745.326 that is developed for the same purpose. This includes 
reproductions of the pamphlet when copied in full and without revision 
or deletion of material from the pamphlet (except for the addition or 
revision of State or local sources of information). Before December 22, 
2008, the term ``pamphlet'' also means any pamphlet developed by EPA 
under section 406(a) of TSCA or any State or Tribal pamphlet approved by 
EPA pursuant to Sec. 745.326.
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any Indian Tribe, 
State, or political subdivision thereof; any interstate body; and any 
department, agency, or instrumentality of the Federal Government.
    Recognized test kit means a commercially available kit recognized by 
EPA under Sec. 745.88 as being capable of allowing a user to determine 
the presence of lead at levels equal to or in excess of 1.0 milligrams 
per square centimeter, or more than 0.5% lead by weight, in a paint 
chip, paint powder, or painted surface.
    Renovation means the modification of any existing structure, or 
portion thereof, that results in the disturbance of painted surfaces, 
unless that activity is performed as part of an abatement as defined by 
this part (40 CFR 745.223). The term renovation includes (but is not 
limited to): The removal, modification or repair of painted surfaces or 
painted components (e.g., modification of painted doors, surface 
restoration, window repair, surface preparation activity (such as 
sanding, scraping, or other such activities that may generate paint 
dust)); the removal of building components (e.g., walls, ceilings, 
plumbing, windows); weatherization projects (e.g., cutting holes in

[[Page 80]]

painted surfaces to install blown-in insulation or to gain access to 
attics, planing thresholds to install weather-stripping), and interim 
controls that disturb painted surfaces. A renovation performed for the 
purpose of converting a building, or part of a building, into target 
housing or a child-occupied facility is a renovation under this subpart. 
The term renovation does not include minor repair and maintenance 
activities.
    Renovator means an individual who either performs or directs workers 
who perform renovations. A certified renovator is a renovator who has 
successfully completed a renovator course accredited by EPA or an EPA-
authorized State or Tribal program.
    Training hour means at least 50 minutes of actual learning, 
including, but not limited to, time devoted to lecture, learning 
activities, small group activities, demonstrations, evaluations, and 
hands-on experience.
    Wet disposable cleaning cloth means a commercially available, pre-
moistened white disposable cloth designed to be used for cleaning hard 
surfaces such as uncarpeted floors or counter tops.
    Vertical containment means a vertical barrier consisting of plastic 
sheeting or other impermeable material over scaffolding or a rigid 
frame, or an equivalent system of containing the work area. Vertical 
containment is required for some exterior renovations but it may be used 
on any renovation.
    Wet mopping system means a device with the following 
characteristics: A long handle, a mop head designed to be used with 
disposable absorbent cleaning pads, a reservoir for cleaning solution, 
and a built-in mechanism for distributing or spraying the cleaning 
solution onto a floor, or a method of equivalent efficacy.
    Work area means the area that the certified renovator establishes to 
contain the dust and debris generated by a renovation.

[63 FR 29919, June 1, 1998, as amended at 73 FR 21758, Apr. 22, 2008; 76 
FR 47938, Aug. 5, 2011]



Sec. 745.84  Information distribution requirements.

    (a) Renovations in dwelling units. No more than 60 days before 
beginning renovation activities in any residential dwelling unit of 
target housing, the firm performing the renovation must:
    (1) Provide the owner of the unit with the pamphlet, and comply with 
one of the following:
    (i) Obtain, from the owner, a written acknowledgment that the owner 
has received the pamphlet.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (2) In addition to the requirements in paragraph (a)(1) of this 
section, if the owner does not occupy the dwelling unit, provide an 
adult occupant of the unit with the pamphlet, and comply with one of the 
following:
    (i) Obtain, from the adult occupant, a written acknowledgment that 
the occupant has received the pamphlet; or certify in writing that a 
pamphlet has been delivered to the dwelling and that the firm performing 
the renovation has been unsuccessful in obtaining a written 
acknowledgment from an adult occupant. Such certification must include 
the address of the unit undergoing renovation, the date and method of 
delivery of the pamphlet, names of the persons delivering the pamphlet, 
reason for lack of acknowledgment (e.g., occupant refuses to sign, no 
adult occupant available), the signature of a representative of the firm 
performing the renovation, and the date of signature.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (b) Renovations in common areas. No more than 60 days before 
beginning renovation activities in common areas of multi-unit target 
housing, the firm performing the renovation must:
    (1) Provide the owner with the pamphlet, and comply with one of the 
following:
    (i) Obtain, from the owner, a written acknowledgment that the owner 
has received the pamphlet.
    (ii) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (2) Comply with one of the following. (i) Notify in writing, or 
ensure written notification of, each affected unit and make the pamphlet 
available upon request prior to the start of renovation. Such 
notification shall be accomplished by distributing written notice to 
each affected unit. The notice shall

[[Page 81]]

describe the general nature and locations of the planned renovation 
activities; the expected starting and ending dates; and a statement of 
how the occupant can obtain the pamphlet and a copy of the records 
required by Sec. 745.86(c) and (d), at no cost to the occupants, or
    (ii) While the renovation is ongoing, post informational signs 
describing the general nature and locations of the renovation and the 
anticipated completion date. These signs must be posted in areas where 
they are likely to be seen by the occupants of all of the affected 
units. The signs must be accompanied by a posted copy of the pamphlet or 
information on how interested occupants can review a copy of the 
pamphlet or obtain a copy from the renovation firm at no cost to 
occupants. The signs must also include information on how interested 
occupants can review a copy of the records required by Sec. 745.86(c) 
and (d) or obtain a copy from the renovation firm at no cost to the 
occupants.
    (3) Prepare, sign, and date a statement describing the steps 
performed to notify all occupants of the intended renovation activities 
and to provide the pamphlet.
    (4) If the scope, locations, or expected starting and ending dates 
of the planned renovation activities change after the initial 
notification, and the firm provided written initial notification to each 
affected unit, the firm performing the renovation must provide further 
written notification to the owners and occupants providing revised 
information on the ongoing or planned activities. This subsequent 
notification must be provided before the firm performing the renovation 
initiates work beyond that which was described in the original notice.
    (c) Renovations in child-occupied facilities. No more than 60 days 
before beginning renovation activities in any child-occupied facility, 
the firm performing the renovation must:
    (1)(i) Provide the owner of the building with the pamphlet, and 
comply with one of the following:
    (A) Obtain, from the owner, a written acknowledgment that the owner 
has received the pamphlet.
    (B) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (ii) If the child-occupied facility is not the owner of the 
building, provide an adult representative of the child-occupied facility 
with the pamphlet, and comply with one of the following:
    (A) Obtain, from the adult representative, a written acknowledgment 
that the adult representative has received the pamphlet; or certify in 
writing that a pamphlet has been delivered to the facility and that the 
firm performing the renovation has been unsuccessful in obtaining a 
written acknowledgment from an adult representative. Such certification 
must include the address of the child-occupied facility undergoing 
renovation, the date and method of delivery of the pamphlet, names of 
the persons delivering the pamphlet, reason for lack of acknowledgment 
(e.g., representative refuses to sign), the signature of a 
representative of the firm performing the renovation, and the date of 
signature.
    (B) Obtain a certificate of mailing at least 7 days prior to the 
renovation.
    (2) Provide the parents and guardians of children using the child-
occupied facility with the pamphlet, information describing the general 
nature and locations of the renovation and the anticipated completion 
date, and information on how interested parents or guardians of children 
frequenting the child-occupied facility can review a copy of the records 
required by Sec. 745.86(c) and (d) or obtain a copy from the renovation 
firm at no cost to the occupants by complying with one of the following:
    (i) Mail or hand-deliver the pamphlet and the renovation information 
to each parent or guardian of a child using the child-occupied facility.
    (ii) While the renovation is ongoing, post informational signs 
describing the general nature and locations of the renovation and the 
anticipated completion date. These signs must be posted in areas where 
they can be seen by the parents or guardians of the children frequenting 
the child-occupied facility. The signs must be accompanied by a posted 
copy of the pamphlet or information on how interested parents or 
guardians of children frequenting the child-occupied facility can review 
a

[[Page 82]]

copy of the pamphlet or obtain a copy from the renovation firm at no 
cost to the parents or guardians. The signs must also include 
information on how interested parents or guardians of children 
frequenting the child-occupied facility can review a copy of the records 
required by Sec. 745.86(c) and (d) or obtain a copy from the renovation 
firm at no cost to the parents or guardians.
    (3) The renovation firm must prepare, sign, and date a statement 
describing the steps performed to notify all parents and guardians of 
the intended renovation activities and to provide the pamphlet.
    (d) Written acknowledgment. The written acknowledgments required by 
paragraphs (a)(1)(i), (a)(2)(i), (b)(1)(i), (c)(1)(i)(A), and 
(c)(1)(ii)(A) of this section must:
    (1) Include a statement recording the owner or occupant's name and 
acknowledging receipt of the pamphlet prior to the start of renovation, 
the address of the unit undergoing renovation, the signature of the 
owner or occupant as applicable, and the date of signature.
    (2) Be either a separate sheet or part of any written contract or 
service agreement for the renovation.
    (3) Be written in the same language as the text of the contract or 
agreement for the renovation or, in the case of non-owner occupied 
target housing, in the same language as the lease or rental agreement or 
the pamphlet.

[63 FR 29919, June 1, 1998. Redesignated and amended at 73 FR 21760, 
Apr. 22, 2008; 75 FR 24818, May 6, 2010]



Sec. 745.85  Work practice standards.

    (a) Standards for renovation activities. Renovations must be 
performed by certified firms using certified renovators as directed in 
Sec. 745.89. The responsibilities of certified firms are set forth in 
Sec. 745.89(d) and the responsibilities of certified renovators are set 
forth in Sec. 745.90(b).
    (1) Occupant protection. Firms must post signs clearly defining the 
work area and warning occupants and other persons not involved in 
renovation activities to remain outside of the work area. To the extent 
practicable, these signs must be in the primary language of the 
occupants. These signs must be posted before beginning the renovation 
and must remain in place and readable until the renovation and the post-
renovation cleaning verification have been completed. If warning signs 
have been posted in accordance with 24 CFR 35.1345(b)(2) or 29 CFR 
1926.62(m), additional signs are not required by this section.
    (2) Containing the work area. Before beginning the renovation, the 
firm must isolate the work area so that no dust or debris leaves the 
work area while the renovation is being performed. In addition, the firm 
must maintain the integrity of the containment by ensuring that any 
plastic or other impermeable materials are not torn or displaced, and 
taking any other steps necessary to ensure that no dust or debris leaves 
the work area while the renovation is being performed. The firm must 
also ensure that containment is installed in such a manner that it does 
not interfere with occupant and worker egress in an emergency.
    (i) Interior renovations. The firm must:
    (A) Remove all objects from the work area, including furniture, 
rugs, and window coverings, or cover them with plastic sheeting or other 
impermeable material with all seams and edges taped or otherwise sealed.
    (B) Close and cover all ducts opening in the work area with taped-
down plastic sheeting or other impermeable material.
    (C) Close windows and doors in the work area. Doors must be covered 
with plastic sheeting or other impermeable material. Doors used as an 
entrance to the work area must be covered with plastic sheeting or other 
impermeable material in a manner that allows workers to pass through 
while confining dust and debris to the work area.
    (D) Cover the floor surface, including installed carpet, with taped-
down plastic sheeting or other impermeable material in the work area 6 
feet beyond the perimeter of surfaces undergoing renovation or a 
sufficient distance to contain the dust, whichever is greater. Floor 
containment measures may stop at the edge of the vertical barrier when 
using a vertical containment system consisting of impermeable barriers

[[Page 83]]

that extend from the floor to the ceiling and are tightly sealed at 
joints with the floor, ceiling and walls.
    (E) Use precautions to ensure that all personnel, tools, and other 
items, including the exteriors of containers of waste, are free of dust 
and debris before leaving the work area.
    (ii) Exterior renovations. The firm must:
    (A) Close all doors and windows within 20 feet of the renovation. On 
multi-story buildings, close all doors and windows within 20 feet of the 
renovation on the same floor as the renovation, and close all doors and 
windows on all floors below that are the same horizontal distance from 
the renovation.
    (B) Ensure that doors within the work area that will be used while 
the job is being performed are covered with plastic sheeting or other 
impermeable material in a manner that allows workers to pass through 
while confining dust and debris to the work area.
    (C) Cover the ground with plastic sheeting or other disposable 
impermeable material extending 10 feet beyond the perimeter of surfaces 
undergoing renovation or a sufficient distance to collect falling paint 
debris, whichever is greater, unless the property line prevents 10 feet 
of such ground covering. Ground containment measures may stop at the 
edge of the vertical barrier when using a vertical containment system.
    (D) If the renovation will affect surfaces within 10 feet of the 
property line, the renovation firm must erect vertical containment or 
equivalent extra precautions in containing the work area to ensure that 
dust and debris from the renovation does not contaminate adjacent 
buildings or migrate to adjacent properties. Vertical containment or 
equivalent extra precautions in containing the work area may also be 
necessary in other situations in order to prevent contamination of other 
buildings, other areas of the property, or adjacent buildings or 
properties.
    (3) Prohibited and restricted practices. The work practices listed 
below are prohibited or restricted during a renovation as follows:
    (i) Open-flame burning or torching of painted surfaces is 
prohibited.
    (ii) The use of machines designed to remove paint or other surface 
coatings through high speed operation such as sanding, grinding, power 
planing, needle gun, abrasive blasting, or sandblasting, is prohibited 
on painted surfaces unless such machines have shrouds or containment 
systems and are equipped with a HEPA vacuum attachment to collect dust 
and debris at the point of generation. Machines must be operated so that 
no visible dust or release of air occurs outside the shroud or 
containment system.
    (iii) Operating a heat gun on painted surfaces is permitted only at 
temperatures below 1,100 degrees Fahrenheit.
    (4) Waste from renovations--(i) Waste from renovation activities 
must be contained to prevent releases of dust and debris before the 
waste is removed from the work area for storage or disposal. If a chute 
is used to remove waste from the work area, it must be covered.
    (ii) At the conclusion of each work day and at the conclusion of the 
renovation, waste that has been collected from renovation activities 
must be stored under containment, in an enclosure, or behind a barrier 
that prevents release of dust and debris out of the work area and 
prevents access to dust and debris.
    (iii) When the firm transports waste from renovation activities, the 
firm must contain the waste to prevent release of dust and debris.
    (5) Cleaning the work area. After the renovation has been completed, 
the firm must clean the work area until no dust, debris or residue 
remains.
    (i) Interior and exterior renovations. The firm must:
    (A) Collect all paint chips and debris and, without dispersing any 
of it, seal this material in a heavy-duty bag.
    (B) Remove the protective sheeting. Mist the sheeting before folding 
it, fold the dirty side inward, and either tape shut to seal or seal in 
heavy-duty bags. Sheeting used to isolate contaminated rooms from non-
contaminated rooms must remain in place until after the cleaning and 
removal of other sheeting. Dispose of the sheeting as waste.

[[Page 84]]

    (ii) Additional cleaning for interior renovations. The firm must 
clean all objects and surfaces in the work area and within 2 feet of the 
work area in the following manner, cleaning from higher to lower:
    (A) Walls. Clean walls starting at the ceiling and working down to 
the floor by either vacuuming with a HEPA vacuum or wiping with a damp 
cloth.
    (B) Remaining surfaces. Thoroughly vacuum all remaining surfaces and 
objects in the work area, including furniture and fixtures, with a HEPA 
vacuum. The HEPA vacuum must be equipped with a beater bar when 
vacuuming carpets and rugs.
    (C) Wipe all remaining surfaces and objects in the work area, except 
for carpeted or upholstered surfaces, with a damp cloth. Mop uncarpeted 
floors thoroughly, using a mopping method that keeps the wash water 
separate from the rinse water, such as the 2-bucket mopping method, or 
using a wet mopping system.
    (b) Standards for post-renovation cleaning verification--(1) 
Interiors. (i) A certified renovator must perform a visual inspection to 
determine whether dust, debris or residue is still present. If dust, 
debris or residue is present, these conditions must be removed by re-
cleaning and another visual inspection must be performed.
    (ii) After a successful visual inspection, a certified renovator 
must:
    (A) Verify that each windowsill in the work area has been adequately 
cleaned, using the following procedure.
    (1) Wipe the windowsill with a wet disposable cleaning cloth that is 
damp to the touch. If the cloth matches or is lighter than the cleaning 
verification card, the windowsill has been adequately cleaned.
    (2) If the cloth does not match and is darker than the cleaning 
verification card, re-clean the windowsill as directed in paragraphs 
(a)(5)(ii)(B) and (a)(5)(ii)(C) of this section, then either use a new 
cloth or fold the used cloth in such a way that an unused surface is 
exposed, and wipe the surface again. If the cloth matches or is lighter 
than the cleaning verification card, that windowsill has been adequately 
cleaned.
    (3) If the cloth does not match and is darker than the cleaning 
verification card, wait for 1 hour or until the surface has dried 
completely, whichever is longer.
    (4)After waiting for the windowsill to dry, wipe the windowsill with 
a dry disposable cleaning cloth. After this wipe, the windowsill has 
been adequately cleaned.
    (B) Wipe uncarpeted floors and countertops within the work area with 
a wet disposable cleaning cloth. Floors must be wiped using an 
application device with a long handle and a head to which the cloth is 
attached. The cloth must remain damp at all times while it is being used 
to wipe the surface for post-renovation cleaning verification. If the 
surface within the work area is greater than 40 square feet, the surface 
within the work area must be divided into roughly equal sections that 
are each less than 40 square feet. Wipe each such section separately 
with a new wet disposable cleaning cloth. If the cloth used to wipe each 
section of the surface within the work area matches the cleaning 
verification card, the surface has been adequately cleaned.
    (1) If the cloth used to wipe a particular surface section does not 
match the cleaning verification card, re-clean that section of the 
surface as directed in paragraphs (a)(5)(ii)(B) and (a)(5)(ii)(C) of 
this section, then use a new wet disposable cleaning cloth to wipe that 
section again. If the cloth matches the cleaning verification card, that 
section of the surface has been adequately cleaned.
    (2) If the cloth used to wipe a particular surface section does not 
match the cleaning verification card after the surface has been re-
cleaned, wait for 1 hour or until the entire surface within the work 
area has dried completely, whichever is longer.
    (3) After waiting for the entire surface within the work area to 
dry, wipe each section of the surface that has not yet achieved post-
renovation cleaning verification with a dry disposable cleaning cloth. 
After this wipe, that section of the surface has been adequately 
cleaned.
    (iii) When the work area passes the post-renovation cleaning 
verification, remove the warning signs.

[[Page 85]]

    (2) Exteriors. A certified renovator must perform a visual 
inspection to determine whether dust, debris or residue is still present 
on surfaces in and below the work area, including windowsills and the 
ground. If dust, debris or residue is present, these conditions must be 
eliminated and another visual inspection must be performed. When the 
area passes the visual inspection, remove the warning signs.
    (c) Optional dust clearance testing. Cleaning verification need not 
be performed if the contract between the renovation firm and the person 
contracting for the renovation or another Federal, State, Territorial, 
Tribal, or local law or regulation requires:
    (1) The renovation firm to perform dust clearance sampling at the 
conclusion of a renovation covered by this subpart.
    (2) The dust clearance samples are required to be collected by a 
certified inspector, risk assessor or dust sampling technician.
    (3) The renovation firm is required to re-clean the work area until 
the dust clearance sample results are below the clearance standards in 
Sec. 745.227(e)(8) or any applicable State, Territorial, Tribal, or 
local standard.
    (d) Activities conducted after post-renovation cleaning 
verification. Activities that do not disturb paint, such as applying 
paint to walls that have already been prepared, are not regulated by 
this subpart if they are conducted after post-renovation cleaning 
verification has been performed.

[73 FR 21761, Apr. 22, 2008, as amended at 76 FR 47938, Aug. 5, 2011]



Sec. 745.86  Recordkeeping and reporting requirements.

    (a) Firms performing renovations must retain and, if requested, make 
available to EPA all records necessary to demonstrate compliance with 
this subpart for a period of 3 years following completion of the 
renovation. This 3-year retention requirement does not supersede longer 
obligations required by other provisions for retaining the same 
documentation, including any applicable State or Tribal laws or 
regulations.
    (b) Records that must be retained pursuant to paragraph (a) of this 
section shall include (where applicable):
    (1) Records or reports certifying that a determination had been made 
that lead-based paint was not present on the components affected by the 
renovation, as described in Sec. 745.82(a). These records or reports 
include:
    (i) Reports prepared by a certified inspector or certified risk 
assessor (certified pursuant to either Federal regulations at 
Sec. 745.226 or an EPA-authorized State or Tribal certification 
program).
    (ii) Records prepared by a certified renovator after using EPA-
recognized test kits, including an identification of the manufacturer 
and model of any test kits used, a description of the components that 
were tested including their locations, and the result of each test kit 
used.
    (iii) Records prepared by a certified renovator after collecting 
paint chip samples, including a description of the components that were 
tested including their locations, the name and address of the NLLAP-
recognized entity performing the analysis, and the results for each 
sample.
    (2) Signed and dated acknowledgments of receipt as described in 
Sec. 745.84(a)(1)(i), (a)(2)(i), (b)(1)(i), (c)(1)(i)(A), and 
(c)(1)(ii)(A).
    (3) Certifications of attempted delivery as described in 
Sec. 745.84(a)(2)(i) and (c)(1)(ii)(A).
    (4) Certificates of mailing as described in Sec. 745.84(a)(1)(ii), 
(a)(2)(ii), (b)(1)(ii), (c)(1)(i)(B), and (c)(1)(ii)(B).
    (5) Records of notification activities performed regarding common 
area renovations, as described in Sec. 745.84(b)(3) and (b)(4), and 
renovations in child-occupied facilities, as described in 
Sec. 745.84(c)(2).
    (6) Documentation of compliance with the requirements of 
Sec. 745.85, including documentation that a certified renovator was 
assigned to the project, that the certified renovator provided on-the-
job training for workers used on the project, that the certified 
renovator performed or directed workers who performed all of the tasks 
described in Sec. 745.85(a), and that the certified renovator performed 
the post-

[[Page 86]]

renovation cleaning verification described in Sec. 745.85(b). If the 
renovation firm was unable to comply with all of the requirements of 
this rule due to an emergency as defined in Sec. 745.82, the firm must 
document the nature of the emergency and the provisions of the rule that 
were not followed. This documentation must include a copy of the 
certified renovator's training certificate, and a certification by the 
certified renovator assigned to the project that:
    (i) Training was provided to workers (topics must be identified for 
each worker).
    (ii) Warning signs were posted at the entrances to the work area.
    (iii) If test kits were used, that the specified brand of kits was 
used at the specified locations and that the results were as specified.
    (v) The work area was contained by:
    (A) Removing or covering all objects in the work area (interiors).
    (B) Closing and covering all HVAC ducts in the work area 
(interiors).
    (C) Closing all windows in the work area (interiors) or closing all 
windows in and within 20 feet of the work area (exteriors).
    (D) Closing and sealing all doors in the work area (interiors) or 
closing and sealing all doors in and within 20 feet of the work area 
(exteriors).
    (E) Covering doors in the work area that were being used to allow 
passage but prevent spread of dust.
    (F) Covering the floor surface, including installed carpet, with 
taped-down plastic sheeting or other impermeable material in the work 
area 6 feet beyond the perimeter of surfaces undergoing renovation or a 
sufficient distance to contain the dust, whichever is greater 
(interiors) or covering the ground with plastic sheeting or other 
disposable impermeable material anchored to the building extending 10 
feet beyond the perimeter of surfaces undergoing renovation or a 
sufficient distance to collect falling paint debris, whichever is 
greater, unless the property line prevents 10 feet of such ground 
covering, weighted down by heavy objects (exteriors).
    (G) Installing (if necessary) vertical containment to prevent 
migration of dust and debris to adjacent property (exteriors).
    (iv) If paint chip samples were collected, that the samples were 
collected at the specified locations, that the specified NLLAP-
recognized laboratory analyzed the samples, and that the results were as 
specified.
    (vi) Waste was contained on-site and while being transported off-
site.
    (vii) The work area was properly cleaned after the renovation by:
    (A) Picking up all chips and debris, misting protective sheeting, 
folding it dirty side inward, and taping it for removal.
    (B) Cleaning the work area surfaces and objects using a HEPA vacuum 
and/or wet cloths or mops (interiors).
    (viii) The certified renovator performed the post-renovation 
cleaning verification (the results of which must be briefly described, 
including the number of wet and dry cloths used).
    (c)(1) When the final invoice for the renovation is delivered or 
within 30 days of the completion of the renovation, whichever is 
earlier, the renovation firm must provide information pertaining to 
compliance with this subpart to the following persons:
    (i) The owner of the building; and, if different,
    (ii) An adult occupant of the residential dwelling, if the 
renovation took place within a residential dwelling, or an adult 
representative of the child-occupied facility, if the renovation took 
place within a child-occupied facility.
    (2) When performing renovations in common areas of multi-unit target 
housing, renovation firms must post the information required by this 
subpart or instructions on how interested occupants can obtain a copy of 
this information. This information must be posted in areas where it is 
likely to be seen by the occupants of all of the affected units.
    (3) The information required to be provided by paragraph (c) of this 
section may be provided by completing the sample form titled ``Sample 
Renovation Recordkeeping Checklist'' or a similar form containing the 
test kit information required by Sec. 745.86(b)(1)(ii) and the training 
and work practice compliance information required by Sec. 745.86(b)(6).

[[Page 87]]

    (d) If dust clearance sampling is performed in lieu of cleaning 
verification as permitted by Sec. 745.85(c), the renovation firm must 
provide, when the final invoice for the renovation is delivered or 
within 30 days of the completion of the renovation, whichever is 
earlier, a copy of the dust sampling report to:
    (1) The owner of the building; and, if different,
    (2) An adult occupant of the residential dwelling, if the renovation 
took place within a residential dwelling, or an adult representative of 
the child-occupied facility, if the renovation took place within a 
child-occupied facility.
    (3) When performing renovations in common areas of multi-unit target 
housing, renovation firms must post these dust sampling reports or 
information on how interested occupants of the housing being renovated 
can obtain a copy of the report. This information must be posted in 
areas where they are likely to be seen by the occupants of all of the 
affected units.

[73 FR 21761, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76 
FR 47939, Aug. 5, 2011]



Sec. 745.87  Enforcement and inspections.

    (a) Failure or refusal to comply with any provision of this subpart 
is a violation of TSCA section 409 (15 U.S.C. 2689).
    (b) Failure or refusal to establish and maintain records or to make 
available or permit access to or copying of records, as required by this 
subpart, is a violation of TSCA sections 15 and 409 (15 U.S.C. 2614 and 
2689).
    (c) Failure or refusal to permit entry or inspection as required by 
40 CFR 745.87 and TSCA section 11 (15 U.S.C. 2610) is a violation of 
sections 15 and 409 (15 U.S.C. 2614 and 2689).
    (d) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.
    (e) Lead-based paint is assumed to be present at renovations covered 
by this subpart. EPA may conduct inspections and issue subpoenas 
pursuant to the provisions of TSCA section 11 (15 U.S.C. 2610) to ensure 
compliance with this subpart.

[63 FR 29919, June 1, 1998, as amended at 73 FR 21763, Apr. 22, 2008]



Sec. 745.88  Recognized test kits.

    (a) Effective June 23, 2008, EPA recognizes the test kits that have 
been determined by National Institute of Standards and Technology 
research to meet the negative response criteria described in paragraph 
(c)(1) of this section. This recognition will last until EPA publicizes 
its recognition of the first test kit that meets both the negative 
response and positive response criteria in paragraph (c) of this 
section.
    (b) No other test kits will be recognized until they are tested 
through EPA's Environmental Technology Verification Program or other 
equivalent EPA approved testing program.
    (1) Effective September 1, 2008, to initiate the testing process, a 
test kit manufacturer must submit a sufficient number of kits, along 
with the instructions for using the kits, to EPA. The test kit 
manufacturer should first visit the following website for information on 
where to apply: http://www.epa.gov/etv/howtoapply.html.
    (2) After the kit has been tested through the Environmental 
Technology Verification Program or other equivalent approved EPA testing 
program, EPA will review the report to determine whether the required 
criteria have been met.
    (3) Before September 1, 2010, test kits must meet only the negative 
response criteria in paragraph (c)(1) of this section. The recognition 
of kits that meet only this criteria will last until EPA publicizes its 
recognition of the first test kits that meets both of the criteria in 
paragraph (c) of this section.
    (4) After September 1, 2010, test kits must meet both of the 
criteria in paragraph (c) of this section.
    (5) If the report demonstrates that the kit meets the required 
criteria, EPA will issue a notice of recognition to the kit 
manufacturer, provide them with the report, and post the information on 
EPA's website.
    (6) If the report demonstrates that the kit does not meet the 
required criteria, EPA will notify the kit manufacturer and provide them 
with the report.
    (c) Response criteria--(1) Negative response criteria. For paint 
containing lead at or above the regulated level, 1.0

[[Page 88]]

mg/cm\2\ or 0.5% by weight, a demonstrated probability (with 95% 
confidence) of a negative response less than or equal to 5% of the time.
    (2) Positive response criteria. For paint containing lead below the 
regulated level, 1.0 mg/cm\2\ or 0.5% by weight, a demonstrated 
probability (with 95% confidence) of a positive response less than or 
equal to 10% of the time.

[73 FR 21763, Apr. 22, 2008]



Sec. 745.89  Firm certification.

    (a) Initial certification. (1) Firms that perform renovations for 
compensation must apply to EPA for certification to perform renovations 
or dust sampling. To apply, a firm must submit to EPA a completed 
``Application for Firms,'' signed by an authorized agent of the firm, 
and pay at least the correct amount of fees. If a firm pays more than 
the correct amount of fees, EPA will reimburse the firm for the excess 
amount.
    (2) After EPA receives a firm's application, EPA will take one of 
the following actions within 90 days of the date the application is 
received:
    (i) EPA will approve a firm's application if EPA determines that it 
is complete and that the environmental compliance history of the firm, 
its principals, or its key employees does not show an unwillingness or 
inability to maintain compliance with environmental statutes or 
regulations. An application is complete if it contains all of the 
information requested on the form and includes at least the correct 
amount of fees. When EPA approves a firm's application, EPA will issue 
the firm a certificate with an expiration date not more than 5 years 
from the date the application is approved. EPA certification allows the 
firm to perform renovations covered by this section in any State or 
Indian Tribal area that does not have a renovation program that is 
authorized under subpart Q of this part.
    (ii) EPA will request a firm to supplement its application if EPA 
determines that the application is incomplete. If EPA requests a firm to 
supplement its application, the firm must submit the requested 
information or pay the additional fees within 30 days of the date of the 
request.
    (iii) EPA will not approve a firm's application if the firm does not 
supplement its application in accordance with paragraph (a)(2)(ii) of 
this section or if EPA determines that the environmental compliance 
history of the firm, its principals, or its key employees demonstrates 
an unwillingness or inability to maintain compliance with environmental 
statutes or regulations. EPA will send the firm a letter giving the 
reason for not approving the application. EPA will not refund the 
application fees. A firm may reapply for certification at any time by 
filing a new, complete application that includes the correct amount of 
fees.
    (b) Re-certification. To maintain its certification, a firm must be 
re-certified by EPA every 5 years.
    (1) Timely and complete application. To be re-certified, a firm must 
submit a complete application for re-certification. A complete 
application for re-certification includes a completed ``Application for 
Firms'' which contains all of the information requested by the form and 
is signed by an authorized agent of the firm, noting on the form that it 
is submitted as a re-certification. A complete application must also 
include at least the correct amount of fees. If a firm pays more than 
the correct amount of fees, EPA will reimburse the firm for the excess 
amount.
    (i) An application for re-certification is timely if it is 
postmarked 90 days or more before the date the firm's current 
certification expires. If the firm's application is complete and timely, 
the firm's current certification will remain in effect until its 
expiration date or until EPA has made a final decision to approve or 
disapprove the re-certification application, whichever is later.
    (ii) If the firm submits a complete re-certification application 
less than 90 days before its current certification expires, and EPA does 
not approve the application before the expiration date, the firm's 
current certification will expire and the firm will not be able to 
conduct renovations until EPA approves its re-certification application.
    (iii) If the firm fails to obtain recertification before the firm's 
current certification expires, the firm must not perform renovations or 
dust sampling

[[Page 89]]

until it is certified anew pursuant to paragraph (a) of this section.
    (2) EPA action on an application. After EPA receives a firm's 
application for re-certification, EPA will review the application and 
take one of the following actions within 90 days of receipt:
    (i) EPA will approve a firm's application if EPA determines that it 
is timely and complete and that the environmental compliance history of 
the firm, its principals, or its key employees does not show an 
unwillingness or inability to maintain compliance with environmental 
statutes or regulations. When EPA approves a firm's application for re-
certification, EPA will issue the firm a new certificate with an 
expiration date 5 years from the date that the firm's current 
certification expires. EPA certification allows the firm to perform 
renovations or dust sampling covered by this section in any State or 
Indian Tribal area that does not have a renovation program that is 
authorized under subpart Q of this part.
    (ii) EPA will request a firm to supplement its application if EPA 
determines that the application is incomplete.
    (iii) EPA will not approve a firm's application if it is not 
received or is not complete as of the date that the firm's current 
certification expires, or if EPA determines that the environmental 
compliance history of the firm, its principals, or its key employees 
demonstrates an unwillingness or inability to maintain compliance with 
environmental statutes or regulations. EPA will send the firm a letter 
giving the reason for not approving the application. EPA will not refund 
the application fees. A firm may reapply for certification at any time 
by filing a new application and paying the correct amount of fees.
    (c) Amendment of certification. A firm must amend its certification 
within 90 days of the date a change occurs to information included in 
the firm's most recent application. If the firm fails to amend its 
certification within 90 days of the date the change occurs, the firm may 
not perform renovations or dust sampling until its certification is 
amended.
    (1) To amend a certification, a firm must submit a completed 
``Application for Firms,'' signed by an authorized agent of the firm, 
noting on the form that it is submitted as an amendment and indicating 
the information that has changed. The firm must also pay at least the 
correct amount of fees.
    (2) If additional information is needed to process the amendment, or 
the firm did not pay the correct amount of fees, EPA will request the 
firm to submit the necessary information or fees. The firm's 
certification is not amended until the firm complies with the request.
    (3) Amending a certification does not affect the certification 
expiration date.
    (d) Firm responsibilities. Firms performing renovations must ensure 
that:
    (1) All individuals performing renovation activities on behalf of 
the firm are either certified renovators or have been trained by a 
certified renovator in accordance with Sec. 745.90.
    (2) A certified renovator is assigned to each renovation performed 
by the firm and discharges all of the certified renovator 
responsibilities identified in Sec. 745.90.
    (3) All renovations performed by the firm are performed in 
accordance with the work practice standards in Sec. 745.85.
    (4) The pre-renovation education requirements of Sec. 745.84 have 
been performed.
    (5) The recordkeeping requirements of Sec. 745.86 are met.

[73 FR 21764, Apr. 22, 2008]



Sec. 745.90  Renovator certification and dust sampling technician
certification.

    (a) Renovator certification and dust sampling technician 
certification. (1) To become a certified renovator or certified dust 
sampling technician, an individual must successfully complete the 
appropriate course accredited by EPA under Sec. 745.225 or by a State or 
Tribal program that is authorized under subpart Q of this part. The 
course completion certificate serves as proof of certification. EPA 
renovator certification allows the certified individual to perform 
renovations covered by this section in any State or Indian Tribal area 
that does not have a renovation program that is authorized under subpart 
Q of this part. EPA dust

[[Page 90]]

sampling technician certification allows the certified individual to 
perform dust clearance sampling under Sec. 745.85(c) in any State or 
Indian Tribal area that does not have a renovation program that is 
authorized under subpart Q of this part.
    (2) Individuals who have successfully completed an accredited 
abatement worker or supervisor course, or individuals who successfully 
completed an EPA, HUD, or EPA/HUD model renovation training course 
before October 4, 2011 may take an accredited refresher renovator 
training course that includes hands-on training in lieu of the initial 
renovator training course to become a certified renovator.
    (3) Individuals who have successfully completed an accredited lead-
based paint inspector or risk assessor course October 4, 2011 may take 
an accredited refresher dust sampling technician course in lieu of the 
initial training to become a certified dust sampling technician. 
Individuals who are currently certified as lead-based paint inspectors 
or risk assessors may act as certified dust sampling technicians without 
further training.
    (4) To maintain renovator certification or dust sampling technician 
certification, an individual must complete a renovator or dust sampling 
technician refresher course accredited by EPA under Sec. 745.225 or by a 
State or Tribal program that is authorized under subpart Q of this part 
within 5 years of the date the individual completed the initial course 
described in paragraph (a)(1) of this section. If the individual does 
not complete a refresher course within this time, the individual must 
re-take the initial course to become certified again. Individuals who 
complete a renovator course accredited by EPA or an EPA authorized 
program on or before March 31, 2010, must complete a renovator refresher 
course accredited by EPA or an EPA authorized program on or before March 
31, 2016, to maintain renovator certification. Individuals who completed 
a renovator course accredited by EPA or an EPA authorized program 
between April 1, 2010 and March 31, 2011, will have one year added to 
their original 5-year certification. Individuals who take a renovator 
refresher course that does not include hands-on training will be 
certified for 3 years from the date they complete the training. 
Individuals who take a refresher training course that includes hands-on 
training will be certified for 5 years. Individuals who take the 
renovator refresher without hands-on training must, for their next 
refresher course, take a refresher course that includes hands-on 
training to maintain renovator certification.
    (b) Renovator responsibilities. Certified renovators are responsible 
for ensuring compliance with Sec. 745.85 at all renovations to which 
they are assigned. A certified renovator:
    (1) Must perform all of the tasks described in Sec. 745.85(b) and 
must either perform or direct workers who perform all of the tasks 
described in Sec. 745.85(a).
    (2) Must provide training to workers on the work practices required 
by Sec. 745.85(a) that they will be using in performing their assigned 
tasks.
    (3) Must be physically present at the work site when the signs 
required by Sec. 745.85(a)(1) are posted, while the work area 
containment required by Sec. 745.85(a)(2) is being established, and 
while the work area cleaning required by Sec. 745.85(a)(5) is performed.
    (4) Must regularly direct work being performed by other individuals 
to ensure that the work practices required by Sec. 745.85(a) are being 
followed, including maintaining the integrity of the containment 
barriers and ensuring that dust or debris does not spread beyond the 
work area.
    (5) Must be available, either on-site or by telephone, at all times 
that renovations are being conducted.
    (6) When requested by the party contracting for renovation services, 
must use an acceptable test kit to determine whether components to be 
affected by the renovation contain lead-based paint.
    (7) Must have with them at the work site copies of their initial 
course completion certificate and their most recent refresher course 
completion certificate.
    (8) Must prepare the records required by Sec. 745.86(b)(1)(ii) and 
(6).
    (c) Dust sampling technician responsibilities. When performing 
optional dust clearance sampling under

[[Page 91]]

Sec. 745.85(c), a certified dust sampling technician:
    (1) Must collect dust samples in accordance with Sec. 745.227(e)(8), 
must send the collected samples to a laboratory recognized by EPA under 
TSCA section 405(b), and must compare the results to the clearance 
levels in accordance with Sec. 745.227(e)(8).
    (2) Must have with them at the work site copies of their initial 
course completion certificate and their most recent refresher course 
completion certificate.

[73 FR 21765, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76 
FR 47939, Aug. 5, 2011; 80 FR 20446, Apr. 16, 2015; 81 FR 7995, Feb. 17, 
2016]



Sec. 745.91  Suspending, revoking, or modifying an individual's or 
firm's certification.

    (a)(1) Grounds for suspending, revoking, or modifying an 
individual's certification. EPA may suspend, revoke, or modify an 
individual's certification if the individual fails to comply with 
Federal lead-based paint statutes or regulations. EPA may also suspend, 
revoke, or modify a certified renovator's certification if the renovator 
fails to ensure that all assigned renovations comply with Sec. 745.85. 
In addition to an administrative or judicial finding of violation, 
execution of a consent agreement in settlement of an enforcement action 
constitutes, for purposes of this section, evidence of a failure to 
comply with relevant statutes or regulations.
    (2) Grounds for suspending, revoking, or modifying a firm's 
certification. EPA may suspend, revoke, or modify a firm's certification 
if the firm:
    (i) Submits false or misleading information to EPA in its 
application for certification or re-certification.
    (ii) Fails to maintain or falsifies records required in Sec. 745.86.
    (iii) Fails to comply, or an individual performing a renovation on 
behalf of the firm fails to comply, with Federal lead-based paint 
statutes or regulations. In addition to an administrative or judicial 
finding of violation, execution of a consent agreement in settlement of 
an enforcement action constitutes, for purposes of this section, 
evidence of a failure to comply with relevant statutes or regulations.
    (b) Process for suspending, revoking, or modifying certification. 
(1) Prior to taking action to suspend, revoke, or modify an individual's 
or firm's certification, EPA will notify the affected entity in writing 
of the following:
    (i) The legal and factual basis for the proposed suspension, 
revocation, or modification.
    (ii) The anticipated commencement date and duration of the 
suspension, revocation, or modification.
    (iii) Actions, if any, which the affected entity may take to avoid 
suspension, revocation, or modification, or to receive certification in 
the future.
    (iv) The opportunity and method for requesting a hearing prior to 
final suspension, revocation, or modification.
    (2) If an individual or firm requests a hearing, EPA will:
    (i) Provide the affected entity an opportunity to offer written 
statements in response to EPA's assertions of the legal and factual 
basis for its proposed action.
    (ii) Appoint an impartial official of EPA as Presiding Officer to 
conduct the hearing.
    (3) The Presiding Officer will:
    (i) Conduct a fair, orderly, and impartial hearing within 90 days of 
the request for a hearing.
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted.
    (iii) Notify the affected entity in writing within 90 days of 
completion of the hearing of his or her decision and order. Such an 
order is a final agency action which may be subject to judicial review. 
The order must contain the commencement date and duration of the 
suspension, revocation, or modification.
    (4) If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the certification of any individual 
or firm prior to the opportunity for a hearing, it will:
    (i) Notify the affected entity in accordance with paragraph 
(b)(1)(i) through (b)(1)(iii) of this section, explaining why it is 
necessary to suspend the entity's certification before an opportunity 
for a hearing.

[[Page 92]]

    (ii) Notify the affected entity of its right to request a hearing on 
the immediate suspension within 15 days of the suspension taking place 
and the procedures for the conduct of such a hearing.
    (5) Any notice, decision, or order issued by EPA under this section, 
any transcript or other verbatim record of oral testimony, and any 
documents filed by a certified individual or firm in a hearing under 
this section will be available to the public, except as otherwise 
provided by section 14 of TSCA or by part 2 of this title. Any such 
hearing at which oral testimony is presented will be open to the public, 
except that the Presiding Officer may exclude the public to the extent 
necessary to allow presentation of information which may be entitled to 
confidential treatment under section 14 of TSCA or part 2 of this title.
    (6) EPA will maintain a publicly available list of entities whose 
certification has been suspended, revoked, modified, or reinstated.
    (7) Unless the decision and order issued under paragraph (b)(3)(iii) 
of this section specify otherwise:
    (i) An individual whose certification has been suspended must take a 
refresher training course (renovator or dust sampling technician) in 
order to make his or her certification current.
    (ii) An individual whose certification has been revoked must take an 
initial renovator or dust sampling technician course in order to become 
certified again.
    (iii) A firm whose certification has been revoked must reapply for 
certification after the revocation ends in order to become certified 
again. If the firm's certification has been suspended and the suspension 
ends less than 5 years after the firm was initially certified or re-
certified, the firm does not need to do anything to re-activate its 
certification.

[73 FR 21765, Apr. 22, 2008]



Sec. 745.92  Fees for the accreditation of renovation and dust sampling
technician training and the certification of renovation firms.

    (a) Persons who must pay fees. Fees in accordance with paragraph (b) 
of this section must be paid by:
    (1) Training programs--(i) Non-exempt training programs. All non-
exempt training programs applying to EPA for the accreditation and re-
accreditation of training programs in one or more of the following 
disciplines: Renovator, dust sampling technician.
    (ii) Exemption. No fee shall be imposed on any training program 
operated by a State, federally recognized Indian Tribe, local 
government, or non-profit organization. This exemption does not apply to 
the certification of firms or individuals.
    (2) Firms. All firms applying to EPA for certification and re-
certification to conduct renovations.
    (b) Fee amounts--(1) Certification and accreditation fees. Initial 
and renewal certification and accreditation fees are specified in the 
following table:


------------------------------------------------------------------------
                                                       Re-accreditation
                                                        (every 4 years,
        Training Program             Accreditation        see 40 CFR
                                                       745.225(f)(1) for
                                                           details)
------------------------------------------------------------------------
Initial Renovator or Dust         $560                $340
 Sampling Technician Course
------------------------------------------------------------------------
Refresher Renovator or Dust       $400                $310
 Sampling Technician Course
------------------------------------------------------------------------
Renovation Firm                   Certification       Re-certification
                                                       (every 5 years
                                                       see 40 CFR
                                                       745.89(b))
------------------------------------------------------------------------
Firm                              $300                $300
Combined Renovation and Lead-     $550                $550
 based Paint Activities Firm
 Application
Combined Renovation and Lead-     $20                 $20
 based Paint Activities Tribal
 Firm Application
Tribal Firm                       $20                 $20
------------------------------------------------------------------------



[[Page 93]]

    (2) Lost certificate. A $15 fee will be charged for the replacement 
of a firm certificate.
    (c) Certificate replacement. Firms seeking certificate replacement 
must:
    (1) Complete the applicable portions of the ``Application for 
Firms'' in accordance with the instructions provided.
    (2) Submit the application and a payment of $15 in accordance with 
the instructions provided with the application package.
    (3) Accreditation or certification amendments. No fee will be 
charged for accreditation or certification amendments.
    (d) Failure to remit fees. (1) EPA will not provide certification, 
re-certification, accreditation, or re-accreditation for any firm or 
training program that does not remit fees described in paragraph (b) of 
this section in accordance with the procedures specified in 40 CFR 
745.89.
    (2) EPA will not replace a certificate for any firm that does not 
remit the $15 fee in accordance with the procedures specified in 
paragraph (c) of this section.

[74 FR 11869, Mar. 20, 2009, as amended at 76 FR 47939, Aug. 5, 2011]



 Subpart F_Disclosure of Known Lead-Based Paint and/or Lead-Based Paint 
           Hazards Upon Sale or Lease of Residential Property



Sec. 745.100  Purpose.

    This subpart implements the provisions of 42 U.S.C. 4852d, which 
impose certain requirements on the sale or lease of target housing. 
Under this subpart, a seller or lessor of target housing shall disclose 
to the purchaser or lessee the presence of any known lead-based paint 
and/or lead-based paint hazards; provide available records and reports; 
provide the purchaser or lessee with a lead hazard information pamphlet; 
give purchasers a 10-day opportunity to conduct a risk assessment or 
inspection; and attach specific disclosure and warning language to the 
sales or leasing contract before the purchaser or lessee is obligated 
under a contract to purchase or lease target housing.



Sec. 745.101  Scope and applicability.

    This subpart applies to all transactions to sell or lease target 
housing, including subleases, with the exception of the following:
    (a) Sales of target housing at foreclosure.
    (b) Leases of target housing that have been found to be lead-based 
paint free by an inspector certified under the Federal certification 
program or under a federally accredited State or tribal certification 
program. Until a Federal certification program or federally accredited 
State certification program is in place within the State, inspectors 
shall be considered qualified to conduct an inspection for this purpose 
if they have received certification under any existing State or tribal 
inspector certification program. The lessor has the option of using the 
results of additional test(s) by a certified inspector to confirm or 
refute a prior finding.
    (c) Short-term leases of 100 days or less, where no lease renewal or 
extension can occur.
    (d) Renewals of existing leases in target housing in which the 
lessor has previously disclosed all information required under 
Sec. 745.107 and where no new information described in Sec. 745.107 has 
come into the possession of the lessor. For the purposes of this 
paragraph, renewal shall include both renegotiation of existing lease 
terms and/or ratification of a new lease.



Sec. 745.102  Effective dates.

    The requirements in this subpart take effect in the following 
manner:
    (a) For owners of more than four residential dwellings, the 
requirements shall take effect on September 6, 1996.
    (b) For owners of one to four residential dwellings, the 
requirements shall take effect on December 6, 1996.



Sec. 745.103  Definitions.

    The following definitions apply to this subpart.
    The Act means the Residential Lead-Based Paint Hazard Reduction Act 
of 1992, 42 U.S.C. 4852d.
    Agent means any party who enters into a contract with a seller or 
lessor,

[[Page 94]]

including any party who enters into a contract with a representative of 
the seller or lessor, for the purpose of selling or leasing target 
housing. This term does not apply to purchasers or any purchaser's 
representative who receives all compensation from the purchaser.
    Available means in the possession of or reasonably obtainable by the 
seller or lessor at the time of the disclosure.
    Common area means a portion of a building generally accessible to 
all residents/users including, but not limited to, hallways, stairways, 
laundry and recreational rooms, playgrounds, community centers, and 
boundary fences.
    Contract for the purchase and sale of residential real property 
means any contract or agreement in which one party agrees to purchase an 
interest in real property on which there is situated one or more 
residential dwellings used or occupied, or intended to be used or 
occupied, in whole or in part, as the home or residence of one or more 
persons.
    EPA means the Environmental Protection Agency.
    Evaluation means a risk assessment and/or inspection.
    Foreclosure means any of the various methods, statutory or 
otherwise, known in different jurisdictions, of enforcing payment of a 
debt, by the taking and selling of real property.
    Housing for the elderly means retirement communities or similar 
types of housing reserved for households composed of one or more persons 
62 years of age or more at the time of initial occupancy.
    HUD means the U.S. Department of Housing and Urban Development.
    Inspection means:
    (1) A surface-by-surface investigation to determine the presence of 
lead-based paint as provided in section 302(c) of the Lead-Based Paint 
Poisoning and Prevention Act [42 U.S.C. 4822], and
    (2) The provision of a report explaining the results of the 
investigation.
    Lead-based paint means paint or other surface coatings that contain 
lead equal to or in excess of 1.0 milligram per square centimeter or 0.5 
percent by weight.
    Lead-based paint free housing means target housing that has been 
found to be free of paint or other surface coatings that contain lead 
equal to or in excess of 1.0 milligram per square centimeter or 0.5 
percent by weight.
    Lead-based paint hazard means any condition that causes exposure to 
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible 
surfaces, friction surfaces, or impact surfaces that would result in 
adverse human health effects as established by the appropriate Federal 
agency.
    Lessee means any entity that enters into an agreement to lease, 
rent, or sublease target housing, including but not limited to 
individuals, partnerships, corporations, trusts, government agencies, 
housing agencies, Indian tribes, and nonprofit organizations.
    Lessor means any entity that offers target housing for lease, rent, 
or sublease, including but not limited to individuals, partnerships, 
corporations, trusts, government agencies, housing agencies, Indian 
tribes, and nonprofit organizations.
    Owner means any entity that has legal title to target housing, 
including but not limited to individuals, partnerships, corporations, 
trusts, government agencies, housing agencies, Indian tribes, and 
nonprofit organizations, except where a mortgagee holds legal title to 
property serving as collateral for a mortgage loan, in which case the 
owner would be the mortgagor.
    Purchaser means an entity that enters into an agreement to purchase 
an interest in target housing, including but not limited to individuals, 
partnerships, corporations, trusts, government agencies, housing 
agencies, Indian tribes, and nonprofit organizations.
    Reduction means measures designed to reduce or eliminate human 
exposure to lead-based paint hazards through methods including interim 
controls and abatement.
    Residential dwelling means:
    (1) A single-family dwelling, including attached structures such as 
porches and stoops; or
    (2) A single-family dwelling unit in a structure that contains more 
than one separate residential dwelling unit, and

[[Page 95]]

in which each such unit is used or occupied, or intended to be used or 
occupied, in whole or in part, as the residence of one or more persons.
    Risk assessment means an on-site investigation to determine and 
report the existence, nature, severity, and location of lead-based paint 
hazards in residential dwellings, including:
    (1) Information gathering regarding the age and history of the 
housing and occupancy by children under age 6;
    (2) Visual inspection;
    (3) Limited wipe sampling or other environmental sampling 
techniques;
    (4) Other activity as may be appropriate; and
    (5) Provision of a report explaining the results of the 
investigation.
    Secretary means the Secretary of Housing and Urban Development.
    Seller means any entity that transfers legal title to target 
housing, in whole or in part, in return for consideration, including but 
not limited to individuals, partnerships, corporations, trusts, 
government agencies, housing agencies, Indian tribes, and nonprofit 
organizations. The term ``seller'' also includes:
    (1) An entity that transfers shares in a cooperatively owned 
project, in return for consideration; and
    (2) An entity that transfers its interest in a leasehold, in 
jurisdictions or circumstances where it is legally permissible to 
separate the fee title from the title to the improvement, in return for 
consideration.
    Target housing means any housing constructed prior to 1978, except 
housing for the elderly or persons with disabilities (unless any child 
who is less than 6 years of age resides or is expected to reside in such 
housing) or any 0-bedroom dwelling.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601.
    0-bedroom dwelling means any residential dwelling in which the 
living area is not separated from the sleeping area. The term includes 
efficiencies, studio apartments, dormitory housing, military barracks, 
and rentals of individual rooms in residential dwellings.



Sec. 745.107  Disclosure requirements for sellers and lessors.

    (a) The following activities shall be completed before the purchaser 
or lessee is obligated under any contract to purchase or lease target 
housing that is not otherwise an exempt transaction pursuant to 
Sec. 745.101. Nothing in this section implies a positive obligation on 
the seller or lessor to conduct any evaluation or reduction activities.
    (1) The seller or lessor shall provide the purchaser or lessee with 
an EPA-approved lead hazard information pamphlet. Such pamphlets include 
the EPA document entitled Protect Your Family From Lead in Your Home 
(EPA #747-K-94-001) or an equivalent pamphlet that has been approved for 
use in that State by EPA.
    (2) The seller or lessor shall disclose to the purchaser or lessee 
the presence of any known lead-based paint and/or lead-based paint 
hazards in the target housing being sold or leased. The seller or lessor 
shall also disclose any additional information available concerning the 
known lead-based paint and/or lead-based paint hazards, such as the 
basis for the determination that lead-based paint and/or lead-based 
paint hazards exist, the location of the lead-based paint and/or lead-
based paint hazards, and the condition of the painted surfaces.
    (3) The seller or lessor shall disclose to each agent the presence 
of any known lead-based paint and/or lead-based paint hazards in the 
target housing being sold or leased and the existence of any available 
records or reports pertaining to lead-based paint and/or lead-based 
paint hazards. The seller or lessor shall also disclose any additional 
information available concerning the known lead-based paint and/or lead-
based paint hazards, such as the basis for the determination that lead-
based paint and/or lead-based paint hazards exist, the location of the 
lead-based paint and/or lead-based paint hazards, and the condition of 
the painted surfaces.
    (4) The seller or lessor shall provide the purchaser or lessee with 
any records or reports available to the seller or lessor pertaining to 
lead-based paint and/or lead-based paint hazards in the target housing 
being sold or

[[Page 96]]

leased. This requirement includes records or reports regarding common 
areas. This requirement also includes records or reports regarding other 
residential dwellings in multifamily target housing, provided that such 
information is part of an evaluation or reduction of lead-based paint 
and/or lead-based paint hazards in the target housing as a whole.
    (b) If any of the disclosure activities identified in paragraph (a) 
of this section occurs after the purchaser or lessee has provided an 
offer to purchase or lease the housing, the seller or lessor shall 
complete the required disclosure activities prior to accepting the 
purchaser's or lessee's offer and allow the purchaser or lessee an 
opportunity to review the information and possibly amend the offer.



Sec. 745.110  Opportunity to conduct an evaluation.

    (a) Before a purchaser is obligated under any contract to purchase 
target housing, the seller shall permit the purchaser a 10-day period 
(unless the parties mutually agree, in writing, upon a different period 
of time) to conduct a risk assessment or inspection for the presence of 
lead-based paint and/or lead-based paint hazards.
    (b) Not withstanding paragraph (a) of this section, a purchaser may 
waive the opportunity to conduct the risk assessment or inspection by so 
indicating in writing.



Sec. 745.113  Certification and acknowledgment of disclosure.

    (a) Seller requirements. Each contract to sell target housing shall 
include an attachment containing the following elements, in the language 
of the contract (e.g., English, Spanish):
    (1) A Lead Warning Statement consisting of the following language:

    Every purchaser of any interest in residential real property on 
which a residential dwelling was built prior to 1978 is notified that 
such property may present exposure to lead from lead-based paint that 
may place young children at risk of developing lead poisoning. Lead 
poisoning in young children may produce permanent neurological damage, 
including learning disabilities, reduced intelligence quotient, 
behavioral problems, and impaired memory. Lead poisoning also poses a 
particular risk to pregnant women. The seller of any interest in 
residential real property is required to provide the buyer with any 
information on lead-based paint hazards from risk assessments or 
inspections in the seller's possession and notify the buyer of any known 
lead-based paint hazards. A risk assessment or inspection for possible 
lead-based paint hazards is recommended prior to purchase.

    (2) A statement by the seller disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being 
sold or indicating no knowledge of the presence of lead-based paint and/
or lead-based paint hazards. The seller shall also provide any 
additional information available concerning the known lead-based paint 
and/or lead-based paint hazards, such as the basis for the determination 
that lead-based paint and/or lead-based paint hazards exist, the 
location of the lead-based paint and/or lead-based paint hazards, and 
the condition of the painted surfaces.
    (3) A list of any records or reports available to the seller 
pertaining to lead-based paint and/or lead-based paint hazards in the 
housing that have been provided to the purchaser. If no such records or 
reports are available, the seller shall so indicate.
    (4) A statement by the purchaser affirming receipt of the 
information set out in paragraphs (a)(2) and (a)(3) of this section and 
the lead hazard information pamphlet required under 15 U.S.C. 2696.
    (5) A statement by the purchaser that he/she has either:
    (i) Received the opportunity to conduct the risk assessment or 
inspection required by Sec. 745.110(a); or
    (ii) Waived the opportunity.
    (6) When one or more agents are involved in the transaction to sell 
target housing on behalf of the seller, a statement that:
    (i) The agent has informed the seller of the seller's obligations 
under 42 U.S.C. 4852d; and
    (ii) The agent is aware of his/her duty to ensure compliance with 
the requirements of this subpart.
    (7) The signatures of the sellers, agents, and purchasers certifying 
to the accuracy of their statements to the best of their knowledge, 
along with the dates of signature.

[[Page 97]]

    (b) Lessor requirements. Each contract to lease target housing shall 
include, as an attachment or within the contract, the following 
elements, in the language of the contract (e.g., English, Spanish):
    (1) A Lead Warning Statement with the following language:

    Housing built before 1978 may contain lead-based paint. Lead from 
paint, paint chips, and dust can pose health hazards if not managed 
properly. Lead exposure is especially harmful to young children and 
pregnant women. Before renting pre-1978 housing, lessors must disclose 
the presence of lead-based paint and/or lead-based paint hazards in the 
dwelling. Lessees must also receive a federally approved pamphlet on 
lead poisoning prevention.

    (2) A statement by the lessor disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being 
leased or indicating no knowledge of the presence of lead-based paint 
and/or lead-based paint hazards. The lessor shall also disclose any 
additional information available concerning the known lead-based paint 
and/or lead-based paint hazards, such as the basis for the determination 
that lead-based paint and/or lead-based paint hazards exist, the 
location of the lead-based paint and/or lead-based paint hazards, and 
the condition of the painted surfaces.
    (3) A list of any records or reports available to the lessor 
pertaining to lead-based paint and/or lead-based paint hazards in the 
housing that have been provided to the lessee. If no such records or 
reports are available, the lessor shall so indicate.
    (4) A statement by the lessee affirming receipt of the information 
set out in paragraphs (b)(2) and (b)(3) of this section and the lead 
hazard information pamphlet required under 15 U.S.C. 2696.
    (5) When one or more agents are involved in the transaction to lease 
target housing on behalf of the lessor, a statement that:
    (i) The agent has informed the lessor of the lessor as obligations 
under 42 U.S.C. 4852d; and
    (ii) The agent is aware of his/her duty to ensure compliance with 
the requirements of this subpart.
    (6) The signatures of the lessors, agents, and lessees, certifying 
to the accuracy of their statements, to the best of their knowledge, 
along with the dates of signature.
    (c) Retention of Certification and Acknowledgment Information. (1) 
The seller, and any agent, shall retain a copy of the completed 
attachment required under paragraph (a) of this section for no less than 
3 years from the completion date of the sale. The lessor, and any agent, 
shall retain a copy of the completed attachment or lease contract 
containing the information required under paragraph (b) of this section 
for no less than 3 years from the commencement of the leasing period.
    (2) This recordkeeping requirement is not intended to place any 
limitations on civil suits under the Act, or to otherwise affect a 
lessee's or purchaser's rights under the civil penalty provisions of 42 
U.S.C. 4852d(b)(3).
    (d) The seller, lessor, or agent shall not be responsible for the 
failure of a purchaser's or lessee's legal representative (where such 
representative receives all compensation from the purchaser or lessee) 
to transmit disclosure materials to the purchaser or lessee, provided 
that all required parties have completed and signed the necessary 
certification and acknowledgment language required under paragraphs (a) 
and (b) of this section.



Sec. 745.115  Agent responsibilities.

    (a) Each agent shall ensure compliance with all requirements of this 
subpart. To ensure compliance, the agent shall:
    (1) Inform the seller or lessor of his/her obligations under 
Secs. 745.107, 745.110, and 745.113.
    (2) Ensure that the seller or lessor has performed all activities 
required under Secs. 745.107, 745.110, and 745.113, or personally ensure 
compliance with the requirements of Secs. 745.107, 745.110, and 745.113.
    (b) If the agent has complied with paragraph (a)(1) of this section, 
the agent shall not be liable for the failure to disclose to a purchaser 
or lessee the presence of lead-based paint and/or lead-based paint 
hazards known by a seller or lessor but not disclosed to the agent.

[[Page 98]]



Sec. 745.118  Enforcement.

    (a) Any person who knowingly fails to comply with any provision of 
this subpart shall be subject to civil monetary penalties in accordance 
with the provisions of 42 U.S.C. 3545 and 24 CFR part 30.
    (b) The Secretary is authorized to take such action as may be 
necessary to enjoin any violation of this subpart in the appropriate 
Federal district court.
    (c) Any person who knowingly violates the provisions of this subpart 
shall be jointly and severally liable to the purchaser or lessee in an 
amount equal to 3 times the amount of damages incurred by such 
individual.
    (d) In any civil action brought for damages pursuant to 42 U.S.C. 
4852d(b)(3), the appropriate court may award court costs to the party 
commencing such action, together with reasonable attorney fees and any 
expert witness fees, if that party prevails.
    (e) Failure or refusal to comply with Sec. 745.107 (disclosure 
requirements for sellers and lessors), Sec. 745.110 (opportunity to 
conduct an evaluation), Sec. 745.113 (certification and acknowledgment 
of disclosure), or Sec. 745.115 (agent responsibilities) is a violation 
of 42 U.S.C. 4852d(b)(5) and of TSCA section 409 (15 U.S.C. 2689).
    (f) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation. For 
purposes of enforcing this subpart, the penalty for each violation 
applicable under 15 U.S.C. 2615 shall not be more than $11,000 for all 
violations occuring after July 28, 1997; all violations occuring on or 
prior to that date are subject to a penalty not more than $10,000.

[61 FR 9085, Mar. 6, 1996, as amended at 62 FR 35041, June 27, 1997]



Sec. 745.119  Impact on State and local requirements.

    Nothing in this subpart shall relieve a seller, lessor, or agent 
from any responsibility for compliance with State or local laws, 
ordinances, codes, or regulations governing notice or disclosure of 
known lead-based paint or lead-based paint hazards. Neither HUD nor EPA 
assumes any responsibility for ensuring compliance with such State or 
local requirements.

Subparts G-K [Reserved]



                  Subpart L_Lead-Based Paint Activities

    Source: 61 FR 45813, Aug. 29, 1996, unless otherwise noted.



Sec. 745.220  Scope and applicability.

    (a) This subpart contains procedures and requirements for the 
accreditation of training programs for lead-based paint activities and 
renovations, procedures and requirements for the certification of 
individuals and firms engaged in lead-based paint activities, and work 
practice standards for performing such activities. This subpart also 
requires that, except as discussed below, all lead-based paint 
activities, as defined in this subpart, be performed by certified 
individuals and firms.
    (b) This subpart applies to all individuals and firms who are 
engaged in lead-based paint activities as defined in Sec. 745.223, 
except persons who perform these activities within residential dwellings 
that they own, unless the residential dwelling is occupied by a person 
or persons other than the owner or the owner's immediate family while 
these activities are being performed, or a child residing in the 
building has been identified as having an elevated blood lead level. 
This subpart applies only in those States or Indian Country that do not 
have an authorized State or Tribal program pursuant to Sec. 745.324 of 
subpart Q.
    (c) Each department, agency, and instrumentality of the executive, 
legislative, and judicial branches of the Federal Government having 
jurisdiction over any property or facility, or engaged in any activity 
resulting, or which may result, in a lead-based paint hazard, and each 
officer, agent, or employee thereof shall be subject to, and comply 
with, all Federal, State, interstate, and local requirements, both 
substantive and procedural, including the requirements of this subpart 
regarding lead-based paint, lead-based paint activities, and lead-based 
paint hazards.

[[Page 99]]

    (d) While this subpart establishes specific requirements for 
performing lead-based paint activities should they be undertaken, 
nothing in this subpart requires that the owner or occupant undertake 
any particular lead-based paint activity.

[61 FR 45813, Aug. 29, 1996, as amended at 73 FR 21766, Apr. 22, 2008]



Sec. 745.223  Definitions.

    The definitions in subpart A apply to this subpart. In addition, the 
following definitions apply.
    Abatement means any measure or set of measures designed to 
permanently eliminate lead-based paint hazards. Abatement includes, but 
is not limited to:
    (1) The removal of paint and dust, the permanent enclosure or 
encapsulation of lead-based paint, the replacement of painted surfaces 
or fixtures, or the removal or permanent covering of soil, when lead-
based paint hazards are present in such paint, dust or soil; and
    (2) All preparation, cleanup, disposal, and post-abatement clearance 
testing activities associated with such measures.
    (3) Specifically, abatement includes, but is not limited to:
    (i) Projects for which there is a written contract or other 
documentation, which provides that an individual or firm will be 
conducting activities in or to a residential dwelling or child-occupied 
facility that:
    (A) Shall result in the permanent elimination of lead-based paint 
hazards; or
    (B) Are designed to permanently eliminate lead-based paint hazards 
and are described in paragraphs (1) and (2) of this definition.
    (ii) Projects resulting in the permanent elimination of lead-based 
paint hazards, conducted by firms or individuals certified in accordance 
with Sec. 745.226, unless such projects are covered by paragraph (4) of 
this definition;
    (iii) Projects resulting in the permanent elimination of lead-based 
paint hazards, conducted by firms or individuals who, through their 
company name or promotional literature, represent, advertise, or hold 
themselves out to be in the business of performing lead-based paint 
activities as identified and defined by this section, unless such 
projects are covered by paragraph (4) of this definition; or
    (iv) Projects resulting in the permanent elimination of lead-based 
paint hazards, that are conducted in response to State or local 
abatement orders.
    (4) Abatement does not include renovation, remodeling, landscaping 
or other activities, when such activities are not designed to 
permanently eliminate lead-based paint hazards, but, instead, are 
designed to repair, restore, or remodel a given structure or dwelling, 
even though these activities may incidentally result in a reduction or 
elimination of lead-based paint hazards. Furthermore, abatement does not 
include interim controls, operations and maintenance activities, or 
other measures and activities designed to temporarily, but not 
permanently, reduce lead-based paint hazards.
    Accredited training program means a training program that has been 
accredited by EPA pursuant to Sec. 745.225 to provide training for 
individuals engaged in lead-based paint activities.
    Adequate quality control means a plan or design which ensures the 
authenticity, integrity, and accuracy of samples, including dust, soil, 
and paint chip or paint film samples. Adequate quality control also 
includes provisions for representative sampling.
    Business day means Monday through Friday with the exception of 
Federal holidays.
    Certified firm means a company, partnership, corporation, sole 
proprietorship, association, or other business entity that performs 
lead-based paint activities to which EPA has issued a certificate of 
approval pursuant to Sec. 745.226(f).
    Certified inspector means an individual who has been trained by an 
accredited training program, as defined by this section, and certified 
by EPA pursuant to Sec. 745.226 to conduct inspections. A certified 
inspector also samples for the presence of lead in dust and soil for the 
purposes of abatement clearance testing.
    Certified abatement worker means an individual who has been trained 
by an accredited training program, as defined by this section, and 
certified by EPA

[[Page 100]]

pursuant to Sec. 745.226 to perform abatements.
    Certified project designer means an individual who has been trained 
by an accredited training program, as defined by this section, and 
certified by EPA pursuant to Sec. 745.226 to prepare abatement project 
designs, occupant protection plans, and abatement reports.
    Certified risk assessor means an individual who has been trained by 
an accredited training program, as defined by this section, and 
certified by EPA pursuant to Sec. 745.226 to conduct risk assessments. A 
risk assessor also samples for the presence of lead in dust and soil for 
the purposes of abatement clearance testing.
    Certified supervisor means an individual who has been trained by an 
accredited training program, as defined by this section, and certified 
by EPA pursuant to Sec. 745.226 to supervise and conduct abatements, and 
to prepare occupant protection plans and abatement reports.
    Child-occupied facility means a building, or portion of a building, 
constructed prior to 1978, visited regularly by the same child, 6 years 
of age or under, on at least two different days within any week (Sunday 
through Saturday period), provided that each day's visit lasts at least 
3 hours and the combined weekly visit lasts at least 6 hours, and the 
combined annual visits last at least 60 hours. Child-occupied facilities 
may include, but are not limited to, day-care centers, preschools and 
kindergarten classrooms.
    Clearance levels are values that indicate the maximum amount of lead 
permitted in dust on a surface following completion of an abatement 
activity.
    Common area means a portion of a building that is generally 
accessible to all occupants. Such an area may include, but is not 
limited to, hallways, stairways, laundry and recreational rooms, 
playgrounds, community centers, garages, and boundary fences.
    Component or building component means specific design or structural 
elements or fixtures of a building, residential dwelling, or child-
occupied facility that are distinguished from each other by form, 
function, and location. These include, but are not limited to, interior 
components such as: ceilings, crown molding, walls, chair rails, doors, 
door trim, floors, fireplaces, radiators and other heating units, 
shelves, shelf supports, stair treads, stair risers, stair stringers, 
newel posts, railing caps, balustrades, windows and trim (including 
sashes, window heads, jambs, sills or stools and troughs), built in 
cabinets, columns, beams, bathroom vanities, counter tops, and air 
conditioners; and exterior components such as: painted roofing, 
chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias, 
rake boards, cornerboards, bulkheads, doors and door trim, fences, 
floors, joists, lattice work, railings and railing caps, siding, 
handrails, stair risers and treads, stair stringers, columns, 
balustrades, window sills or stools and troughs, casings, sashes and 
wells, and air conditioners.
    Containment means a process to protect workers and the environment 
by controlling exposures to the lead-contaminated dust and debris 
created during an abatement.
    Course agenda means an outline of the key topics to be covered 
during a training course, including the time allotted to teach each 
topic.
    Course test means an evaluation of the overall effectiveness of the 
training which shall test the trainees' knowledge and retention of the 
topics covered during the course.
    Course test blue print means written documentation identifying the 
proportion of course test questions devoted to each major topic in the 
course curriculum.
    Deteriorated paint means paint that is cracking, flaking, chipping, 
peeling, or otherwise separating from the substrate of a building 
component.
    Discipline means one of the specific types or categories of lead-
based paint activities identified in this subpart for which individuals 
may receive training from accredited programs and become certified by 
EPA. For example, ``abatement worker'' is a discipline.
    Distinct painting history means the application history, as 
indicated by its visual appearance or a record of application, over 
time, of paint or other surface coatings to a component or room.
    Documented methodologies are methods or protocols used to sample for 
the presence of lead in paint, dust, and soil.

[[Page 101]]

    Elevated blood lead level (EBL) means an excessive absorption of 
lead that is a confirmed concentration of lead in whole blood of 20 mg/
dl (micrograms of lead per deciliter of whole blood) for a single venous 
test or of 15-19 mg/dl in two consecutive tests taken 3 to 4 months 
apart.
    Encapsulant means a substance that forms a barrier between lead-
based paint and the environment using a liquid-applied coating (with or 
without reinforcement materials) or an adhesively bonded covering 
material.
    Encapsulation means the application of an encapsulant.
    Enclosure means the use of rigid, durable construction materials 
that are mechanically fastened to the substrate in order to act as a 
barrier between lead-based paint and the environment.
    Guest instructor means an individual designated by the training 
program manager or principal instructor to provide instruction specific 
to the lecture, hands-on activities, or work practice components of a 
course.
    Hands-on skills assessment means an evaluation which tests the 
trainees' ability to satisfactorily perform the work practices and 
procedures identified in Sec. 745.225(d), as well as any other skill 
taught in a training course.
    Hazardous waste means any waste as defined in 40 CFR 261.3.
    Inspection means a surface-by-surface investigation to determine the 
presence of lead-based paint and the provision of a report explaining 
the results of the investigation.
    Interim certification means the status of an individual who has 
successfully completed the appropriate training course in a discipline 
from an accredited training program, as defined by this section, but has 
not yet received formal certification in that discipline from EPA 
pursuant to Sec. 745.226. Interim certifications expire 6 months after 
the completion of the training course, and is equivalent to a 
certificate for the 6-month period.
    Interim controls means a set of measures designed to temporarily 
reduce human exposure or likely exposure to lead-based paint hazards, 
including specialized cleaning, repairs, maintenance, painting, 
temporary containment, ongoing monitoring of lead-based paint hazards or 
potential hazards, and the establishment and operation of management and 
resident education programs.
    Lead-based paint means paint or other surface coatings that contain 
lead equal to or in excess of 1.0 milligrams per square centimeter or 
more than 0.5 percent by weight.
    Lead-based paint activities means, in the case of target housing and 
child-occupied facilities, inspection, risk assessment, and abatement, 
as defined in this subpart.
    Lead-based paint activities courses means initial and refresher 
training courses (worker, supervisor, inspector, risk assessor, project 
designer) provided by accredited training programs.
    Lead-based paint hazard means any condition that causes exposure to 
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible 
surfaces, friction surfaces, or impact surfaces that would result in 
adverse human health effects as identified by the Administrator pursuant 
to TSCA section 403.
    Lead-hazard screen is a limited risk assessment activity that 
involves limited paint and dust sampling as described in 
Sec. 745.227(c).
    Living area means any area of a residential dwelling used by one or 
more children age 6 and under, including, but not limited to, living 
rooms, kitchen areas, dens, play rooms, and children's bedrooms.
    Local government means a county, city, town, borough, parish, 
district, association, or other public body (including an agency 
comprised of two or more of the foregoing entities) created under State 
law.
    Multi-family dwelling means a structure that contains more than one 
separate residential dwelling unit, which is used or occupied, or 
intended to be used or occupied, in whole or in part, as the home or 
residence of one or more persons.
    Nonprofit means an entity which has demonstrated to any branch of 
the Federal Government or to a State, municipal, tribal or territorial 
government, that no part of its net earnings inure to the benefit of any 
private shareholder or individual.

[[Page 102]]

    Paint in poor condition means more than 10 square feet of 
deteriorated paint on exterior components with large surface areas; or 
more than 2 square feet of deteriorated paint on interior components 
with large surface areas (e.g., walls, ceilings, floors, doors); or more 
than 10 percent of the total surface area of the component is 
deteriorated on interior or exterior components with small surface areas 
(window sills, baseboards, soffits, trim).
    Permanently covered soil means soil which has been separated from 
human contact by the placement of a barrier consisting of solid, 
relatively impermeable materials, such as pavement or concrete. Grass, 
mulch, and other landscaping materials are not considered permanent 
covering.
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any Indian Tribe, 
State, or political subdivision thereof; any interstate body; and any 
department, agency, or instrumentality of the Federal government.
    Principal instructor means the individual who has the primary 
responsibility for organizing and teaching a particular course.
    Recognized laboratory means an environmental laboratory recognized 
by EPA pursuant to TSCA section 405(b) as being capable of performing an 
analysis for lead compounds in paint, soil, and dust.
    Reduction means measures designed to reduce or eliminate human 
exposure to lead-based paint hazards through methods including interim 
controls and abatement.
    Residential dwelling means (1) a detached single family dwelling 
unit, including attached structures such as porches and stoops; or (2) a 
single family dwelling unit in a structure that contains more than one 
separate residential dwelling unit, which is used or occupied, or 
intended to be used or occupied, in whole or in part, as the home or 
residence of one or more persons.
    Risk assessment means (1) an on-site investigation to determine the 
existence, nature, severity, and location of lead-based paint hazards, 
and (2) the provision of a report by the individual or the firm 
conducting the risk assessment, explaining the results of the 
investigation and options for reducing lead-based paint hazards.
    Start date means the first day of any lead-based paint activities 
training course or lead-based paint abatement activity.
    Start date provided to EPA means the start date included in the 
original notification or the most recent start date provided to EPA in 
an updated notification.
    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the 
Canal Zone, American Samoa, the Northern Mariana Islands, or any other 
territory or possession of the United States.
    Target housing means any housing constructed prior to 1978, except 
housing for the elderly or persons with disabilities (unless any one or 
more children age 6 years or under resides or is expected to reside in 
such housing for the elderly or persons with disabilities) or any 0-
bedroom dwelling.
    Training curriculum means an established set of course topics for 
instruction in an accredited training program for a particular 
discipline designed to provide specialized knowledge and skills.
    Training hour means at least 50 minutes of actual learning, 
including, but not limited to, time devoted to lecture, learning 
activities, small group activities, demonstrations, evaluations, and/or 
hands-on experience.
    Training manager means the individual responsible for administering 
a training program and monitoring the performance of principal 
instructors and guest instructors.
    Training provider means any organization or entity accredited under 
Sec. 745.225 to offer lead-based paint activities courses.
    Visual inspection for clearance testing means the visual examination 
of a residential dwelling or a child-occupied facility following an 
abatement to determine whether or not the abatement has been 
successfully completed.

[[Page 103]]

    Visual inspection for risk assessment means the visual examination 
of a residential dwelling or a child-occupied facility to determine the 
existence of deteriorated lead-based paint or other potential sources of 
lead-based paint hazards.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31097, June 9, 1999; 66 
FR 1239, Jan. 5, 2001; 69 FR 18495, Apr. 8, 2004]



Sec. 745.225  Accreditation of training programs: target housing and
child occupied facilities.

    (a) Scope. (1) A training program may seek accreditation to offer 
courses in any of the following disciplines: Inspector, risk assessor, 
supervisor, project designer, abatement worker, renovator, and dust 
sampling technician. A training program may also seek accreditation to 
offer refresher courses for each of the above listed disciplines.
    (2) Training programs may first apply to EPA for accreditation of 
their lead-based paint activities courses or refresher courses pursuant 
to this section on or after August 31, 1998. Training programs may first 
apply to EPA for accreditation of their renovator or dust sampling 
technician courses or refresher courses pursuant to this section on or 
after April 22, 2009.
    (3) A training program must not provide, offer, or claim to provide 
EPA- accredited lead-based paint activities courses without applying for 
and receiving accreditation from EPA as required under paragraph (b) of 
this section on or after March 1, 1999. A training program must not 
provide, offer, or claim to provide EPA-accredited renovator or dust 
sampling technician courses without applying for and receiving 
accreditation from EPA as required under paragraph (b) of this section 
on or after June 23, 2008.
    (4) Accredited training programs, training program managers, and 
principal instructors must comply with all of the requirements of this 
section including approved terms of the application and all of the 
requirements and limitations specified in any accreditation documents 
issued to training programs.
    (b) Application process. The following are procedures a training 
program must follow to receive EPA accreditation to offer lead-based 
paint activities courses, renovator courses, or dust sampling technician 
courses:
    (1) A training program seeking accreditation shall submit a written 
application to EPA containing the following information:
    (i) The training program's name, address, and telephone number.
    (ii) A list of courses for which it is applying for accreditation. 
For the purposes of this section, courses taught in different languages 
and electronic learning courses are considered different courses, and 
each must independently meet the accreditation requirements.
    (iii) The name and documentation of the qualifications of the 
training program manager.
    (iv) The name(s) and documentation of qualifications of any 
principal instructor(s).
    (v) A statement signed by the training program manager certifying 
that the training program meets the requirements established in 
paragraph (c) of this section. If a training program uses EPA-
recommended model training materials, or training materials approved by 
a State or Indian Tribe that has been authorized by EPA under subpart Q 
of this part, the training program manager shall include a statement 
certifying that, as well.
    (vi) If a training program does not use EPA-recommended model 
training materials, its application for accreditation shall also 
include:
    (A) A copy of the student and instructor manuals, or other materials 
to be used for each course.
    (B) A copy of the course agenda for each course.
    (C) When applying for accreditation of a course in a language other 
than English, a signed statement from a qualified, independent 
translator that they had compared the course to the English language 
version and found the translation to be accurate.
    (vii) All training programs shall include in their application for 
accreditation the following:
    (A) A description of the facilities and equipment to be used for 
lecture and hands-on training.
    (B) A copy of the course test blueprint for each course.

[[Page 104]]

    (C) A description of the activities and procedures that will be used 
for conducting the assessment of hands-on skills for each course.
    (D) A copy of the quality control plan as described in paragraph 
(c)(9) of this section.
    (2) If a training program meets the requirements in paragraph (c) of 
this section, then EPA shall approve the application for accreditation 
no more than 180 days after receiving a complete application from the 
training program. In the case of approval, a certificate of 
accreditation shall be sent to the applicant. In the case of 
disapproval, a letter describing the reasons for disapproval shall be 
sent to the applicant. Prior to disapproval, EPA may, at its discretion, 
work with the applicant to address inadequacies in the application for 
accreditation. EPA may also request additional materials retained by the 
training program under paragraph (i) of this section. If a training 
program's application is disapproved, the program may reapply for 
accreditation at any time.
    (3) A training program may apply for accreditation to offer courses 
or refresher courses in as many disciplines as it chooses. A training 
program may seek accreditation for additional courses at any time as 
long as the program can demonstrate that it meets the requirements of 
this section.
    (4) A training program applying for accreditation must submit the 
appropriate fees in accordance with Sec. 745.238.
    (c) Requirements for the accreditation of training programs. A 
training program accredited by EPA to offer lead-based paint activities 
courses, renovator courses, or dust sampling technician courses must 
meet the following requirements:
    (1) The training program shall employ a training manager who has:
    (i) At least 2 years of experience, education, or training in 
teaching workers or adults; or
    (ii) A bachelor's or graduate degree in building construction 
technology, engineering, industrial hygiene, safety, public health, 
education, business administration or program management or a related 
field; or
    (iii) Two years of experience in managing a training program 
specializing in environmental hazards; and
    (iv) Demonstrated experience, education, or training in the 
construction industry including: Lead or asbestos abatement, painting, 
carpentry, renovation, remodeling, occupational safety and health, or 
industrial hygiene.
    (2) The training manager shall designate a qualified principal 
instructor for each course who has:
    (i) Demonstrated experience, education, or training in teaching 
workers or adults; and
    (ii) Successfully completed at least 16 hours of any EPA-accredited 
or EPA-authorized State or Tribal-accredited lead-specific training for 
instructors of lead-based paint activities courses or 8 hours of any 
EPA-accredited or EPA-authorized State or Tribal-accredited lead-
specific training for instructors of renovator or dust sampling 
technician courses; and
    (iii) Demonstrated experience, education, or training in lead or 
asbestos abatement, painting, carpentry, renovation, remodeling, 
occupational safety and health, or industrial hygiene.
    (3) The principal instructor shall be responsible for the 
organization of the course, course delivery, and oversight of the 
teaching of all course material. The training manager may designate 
guest instructors as needed for a portion of the course to provide 
instruction specific to the lecture, hands-on activities, or work 
practice components of a course. However, the principal instructor is 
primarily responsible for teaching the course materials and must be 
present to provide instruction (or oversight of portions of the course 
taught by guest instructors) for the course for which he has been 
designated the principal instructor.
    (4) The following documents shall be recognized by EPA as evidence 
that training managers and principal instructors have the education, 
work experience, training requirements or demonstrated experience, 
specifically listed in paragraphs (c)(1) and (c)(2) of this section. 
This documentation must be submitted with the accreditation application 
and retained by the training program as required by the recordkeeping 
requirements contained in

[[Page 105]]

paragraph (i) of this section. Those documents include the following:
    (i) Official academic transcripts or diploma as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Certificates from train-the-trainer courses and lead-specific 
training courses, as evidence of meeting the training requirements.
    (5) The training program shall ensure the availability of, and 
provide adequate facilities for, the delivery of the lecture, course 
test, hands-on training, and assessment activities. This includes 
providing training equipment that reflects current work practices and 
maintaining or updating the equipment and facilities as needed.
    (6) To become accredited in the following disciplines, the training 
program shall provide training courses that meet the following training 
requirements:
    (i) The inspector course shall last a minimum of 24 training hours, 
with a minimum of 8 hours devoted to hands-on training activities. The 
minimum curriculum requirements for the inspector course are contained 
in paragraph (d)(1) of this section.
    (ii) The risk assessor course shall last a minimum of 16 training 
hours, with a minimum of 4 hours devoted to hands-on training 
activities. The minimum curriculum requirements for the risk assessor 
course are contained in paragraph (d)(2) of this section.
    (iii) The supervisor course shall last a minimum of 32 training 
hours, with a minimum of 8 hours devoted to hands-on activities. The 
minimum curriculum requirements for the supervisor course are contained 
in paragraph (d)(3) of this section.
    (iv) The project designer course shall last a minimum of 8 training 
hours. The minimum curriculum requirements for the project designer 
course are contained in paragraph (d)(4) of this section.
    (v) The abatement worker course shall last a minimum of 16 training 
hours, with a minimum of 8 hours devoted to hands-on training 
activities. The minimum curriculum requirements for the abatement worker 
course are contained in paragraph (d)(5) of this section.
    (vi) The renovator course must last a minimum of 8 training hours, 
with a minimum of 2 hours devoted to hands-on training activities. The 
minimum curriculum requirements for the renovator course are contained 
in paragraph (d)(6) of this section.
    (vii) The dust sampling technician course must last a minimum of 8 
training hours, with a minimum of 2 hours devoted to hands-on training 
activities. The minimum curriculum requirements for the dust sampling 
technician course are contained in paragraph (d)(7) of this section.
    (viii) Electronic learning and other alternative course delivery 
methods are permitted for the classroom portion of renovator, dust 
sampling technician, or lead-based paint activities courses but not the 
hands-on portion of these courses, or for final course tests or 
proficiency tests described in paragraph (c)(7) of this section. 
Electronic learning courses must comply with the following requirements:
    (A) A unique identifier must be assigned to each student for them to 
use to launch and re-launch the course.
    (B) The training provider must track each student's course log-ins, 
launches, progress, and completion, and maintain these records in 
accordance with paragraph (i) of this section.
    (C) The course must include periodic knowledge checks equivalent to 
the number and content of the knowledge checks contained in EPA's model 
course, but at least 16 over the entire course. The knowledge checks 
must be successfully completed before the student can go on to the next 
module.
    (D) There must be a test of at least 20 questions at the end of the 
electronic learning portion of the course, of which 80% must be answered 
correctly by the student for successful completion of the electronic 
learning portion of the course. The test must be designed so that 
students to do not receive feedback on their test answers until after 
they have completed and submitted the test.
    (E) Each student must be able to save or print a copy of an 
electronic learning course completion certificate. The

[[Page 106]]

electronic certificate must not be susceptible to easy editing.
    (7) For each course offered, the training program shall conduct 
either a course test at the completion of the course, and if applicable, 
a hands-on skills assessment, or in the alternative, a proficiency test 
for that discipline. Each student must successfully complete the hands-
on skills assessment and receive a passing score on the course test to 
pass any course, or successfully complete a proficiency test.
    (i) The training manager is responsible for maintaining the validity 
and integrity of the hands-on skills assessment or proficiency test to 
ensure that it accurately evaluates the trainees' performance of the 
work practices and procedures associated with the course topics 
contained in paragraph (d) of this section.
    (ii) The training manager is responsible for maintaining the 
validity and integrity of the course test to ensure that it accurately 
evaluates the trainees' knowledge and retention of the course topics.
    (iii) The course test shall be developed in accordance with the test 
blueprint submitted with the training accreditation application.
    (8) The training program shall issue unique course completion 
certificates to each individual who passes the training course. The 
course completion certificate shall include:
    (i) The name, a unique identification number, and address of the 
individual.
    (ii) The name of the particular course that the individual 
completed.
    (iii) Dates of course completion/test passage.
    (iv) For initial inspector, risk assessor, project designer, 
supervisor, or abatement worker course completion certificates, the 
expiration date of interim certification, which is 6 months from the 
date of course completion.
    (v) The name, address, and telephone number of the training program.
    (vi) The language in which the course was taught.
    (vii) For renovator and dust sampling technician course completion 
certificates, a photograph of the individual. The photograph must be an 
accurate and recognizable image of the individual. As reproduced on the 
certificate, the photograph must not be smaller than 1 square inch.
    (viii) For renovator course completion certificates, the expiration 
date of certification.
    (9) The training manager shall develop and implement a quality 
control plan. The plan shall be used to maintain and improve the quality 
of the training program over time. This plan shall contain at least the 
following elements:
    (i) Procedures for periodic revision of training materials and the 
course test to reflect innovations in the field.
    (ii) Procedures for the training manager's annual review of 
principal instructor competency.
    (10) Courses offered by the training program must teach the work 
practice standards contained in Sec. 745.85 or Sec. 745.227, as 
applicable, in such a manner that trainees are provided with the 
knowledge needed to perform the renovations or lead-based paint 
activities they will be responsible for conducting.
    (11) The training manager shall be responsible for ensuring that the 
training program complies at all times with all of the requirements in 
this section.
    (12) The training manager shall allow EPA to audit the training 
program to verify the contents of the application for accreditation as 
described in paragraph (b) of this section.
    (13) The training manager must provide notification of renovator, 
dust sampling technician, or lead-based paint activities courses 
offered.
    (i) The training manager must provide EPA with notification of all 
renovator, dust sampling technician, or lead-based paint activities 
courses offered except for any renovator course without hands-on 
training delivered via electronic learning. The original notification 
must be received by EPA at least 7 business days prior to the start date 
of any renovator, dust sampling technician, or lead-based paint 
activities course.
    (ii) The training manager must provide EPA updated notification when 
renovator, dust sampling technician, or lead-based paint activities 
courses will begin on a date other than the start date specified in the 
original notification, as follows:

[[Page 107]]

    (A) For renovator, dust sampling technician, or lead-based paint 
activities courses beginning prior to the start date provided to EPA, an 
updated notification must be received by EPA at least 7 business days 
before the new start date.
    (B) For renovator, dust sampling technician, or lead-based paint 
activities courses beginning after the start date provided to EPA, an 
updated notification must be received by EPA at least 2 business days 
before the start date provided to EPA.
    (iii) The training manager must update EPA of any change in location 
of renovator, dust sampling technician, or lead-based paint activities 
courses at least 7 business days prior to the start date provided to 
EPA.
    (iv) The training manager must update EPA regarding any course 
cancellations, or any other change to the original notification. Updated 
notifications must be received by EPA at least 2 business days prior to 
the start date provided to EPA.
    (v) Each notification, including updates, must include the 
following:
    (A) Notification type (original, update, cancellation).
    (B) Training program name, EPA accreditation number, address, and 
telephone number.
    (C) Course discipline, type (initial/refresher), and the language in 
which instruction will be given.
    (D) Date(s) and time(s) of training.
    (E) Training location(s) telephone number, and address.
    (F) Principal instructor's name.
    (G) Training manager's name and signature.
    (vi) Notification must be accomplished using any of the following 
methods: Written notification, or electronically using the Agency's 
Central Data Exchange (CDX). Written notification of lead-based paint 
activities course schedules can be accomplished by using either the 
sample form titled ``Lead-Based Paint Training Notification'' or a 
similar form containing the information required in paragraph (c)(13)(v) 
of this section. All written notifications must be delivered to EPA by 
U.S. Postal Service, fax, commercial delivery service, or hand delivery 
(persons submitting notification by U.S. Postal Service are reminded 
that they should allow 3 additional business days for delivery in order 
to ensure that EPA receives the notification by the required date). 
Instructions and sample forms can be obtained from the NLIC at 1-800-
424-LEAD(5323), or on the Internet at http://www.epa.gov/lead. Hearing- 
or speech-impaired persons may reach the above telephone number through 
TTY by calling the toll-free Federal Relay Service at 1-800-877-8339.
    (vii) Renovator, dust sampling technician, or lead-based paint 
activities courses must not begin on a date, or at a location other than 
that specified in the original notification unless an updated 
notification identifying a new start date or location is submitted, in 
which case the course must begin on the new start date and/or location 
specified in the updated notification.
    (viii) No training program shall provide renovator, dust sampling 
technician, or lead-based paint activities courses without first 
notifying EPA of such activities in accordance with the requirements of 
this paragraph.
    (14) The training manager must provide notification following 
completion of renovator, dust sampling technician, or lead-based paint 
activities courses.
    (i) The training manager must provide EPA notification after the 
completion of any renovator, dust sampling, or lead-based paint 
activities course. This notification must be received by EPA no later 
than 10 business days following course completion. Notifications for any 
e-learning renovator refresher course that does not include hands-on 
training must be submitted via the Central Data Exchange no later than 
the 10th day of the month and include all students trained in the 
previous month.
    (ii) The notification must include the following:
    (A) Training program name, EPA accreditation number, address, and 
telephone number.
    (B) Course discipline and type (initial/refresher).
    (C) Date(s) of training.
    (D) The following information for each student who took the course:
    (1) Name.
    (2) Address.
    (3) Date of birth.

[[Page 108]]

    (4) Course completion certificate number.
    (5) Course test score.
    (6) For renovator or dust sampling technician courses, a digital 
photograph of the student.
    (7) For renovator refresher courses, the expiration date of 
certification.
    (E) Training manager's name and signature.
    (iii) Notification must be accomplished using any of the following 
methods: Written notification, or electronically using the Agency's 
Central Data Exchange (CDX). Written notification following renovator, 
dust sampling technician, or lead-based paint activities training 
courses can be accomplished by using either the sample form titled 
``Lead-Based Paint Training Course Follow-up'' or a similar form 
containing the information required in paragraph (c)(14)(ii) of this 
section. All written notifications must be delivered to EPA by U.S. 
Postal Service, fax, commercial delivery service, or hand delivery 
(persons submitting notification by U.S. Postal Service are reminded 
that they should allow 3 additional business days for delivery in order 
to ensure that EPA receives the notification by the required date). 
Instructions and sample forms can be obtained from the NLIC at 1-800-
424-LEAD (5323), or on the Internet at http://www.epa.gov/lead.
    (d) Minimum training curriculum requirements. A training program 
accredited by EPA to offer lead-based paint courses in the specific 
disciplines listed in this paragraph (d) must ensure that its courses of 
study include, at a minimum, the following course topics.
    (1) Inspector. Instruction in the topics described in paragraphs 
(d)(1)(iv), (v), (vi), and (vii) of this section must be included in the 
hands-on portion of the course.
    (i) Role and responsibilities of an inspector.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State, and local 
regulations and guidance that pertains to lead-based paint and lead- 
based paint activities.
    (iv) Lead-based paint inspection methods, including selection of 
rooms and components for sampling or testing.
    (v) Paint, dust, and soil sampling methodologies.
    (vi) Clearance standards and testing, including random sampling.
    (vii) Preparation of the final inspection report.
    (viii) Recordkeeping.
    (2) Risk assessor. Instruction in the topics described in paragraphs 
(d)(2)(iv), (vi), and (vii) of this section must be included in the 
hands-on portion of the course.
    (i) Role and responsibilities of a risk assessor.
    (ii) Collection of background information to perform a risk 
assessment.
    (iii) Sources of environmental lead contamination such as paint, 
surface dust and soil, water, air, packaging, and food.
    (iv) Visual inspection for the purposes of identifying potential 
sources of lead-based paint hazards.
    (v) Lead hazard screen protocol.
    (vi) Sampling for other sources of lead exposure.
    (vii) Interpretation of lead-based paint and other lead sampling 
results, including all applicable Federal or State guidance or 
regulations pertaining to lead-based paint hazards.
    (viii) Development of hazard control options, the role of interim 
controls, and operations and maintenance activities to reduce lead-based 
paint hazards.
    (ix) Preparation of a final risk assessment report.
    (3) Supervisor. Instruction in the topics described in paragraphs 
(d)(3)(v), (vii), (viii), (ix), and (x) of this section must be included 
in the hands-on portion of the course.
    (i) Role and responsibilities of a supervisor.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State, and local 
regulations and guidance that pertain to lead-based paint abatement.
    (iv) Liability and insurance issues relating to lead-based paint 
abatement.
    (v) Risk assessment and inspection report interpretation.
    (vi) Development and implementation of an occupant protection plan 
and abatement report.

[[Page 109]]

    (vii) Lead-based paint hazard recognition and control.
    (viii) Lead-based paint abatement and lead-based paint hazard 
reduction methods, including restricted practices.
    (ix) Interior dust abatement/cleanup or lead-based paint hazard 
control and reduction methods.
    (x) Soil and exterior dust abatement or lead-based paint hazard 
control and reduction methods.
    (xi) Clearance standards and testing.
    (xii) Cleanup and waste disposal.
    (xiii) Recordkeeping.
    (4) Project designer. (i) Role and responsibilities of a project 
designer.
    (ii) Development and implementation of an occupant protection plan 
for large-scale abatement projects.
    (iii) Lead-based paint abatement and lead-based paint hazard 
reduction methods, including restricted practices for large-scale 
abatement projects.
    (iv) Interior dust abatement/cleanup or lead hazard control and 
reduction methods for large-scale abatement projects.
    (v) Clearance standards and testing for large scale abatement 
projects.
    (vi) Integration of lead-based paint abatement methods with 
modernization and rehabilitation projects for large scale abatement 
projects.
    (5) Abatement worker. Instruction in the topics described in 
paragraphs (d)(5)(iv), (v), (vi), and (vii) of this section must be 
included in the hands-on portion of the course.
    (i) Role and responsibilities of an abatement worker.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State and local regulations 
and guidance that pertain to lead-based paint abatement.
    (iv) Lead-based paint hazard recognition and control.
    (v) Lead-based paint abatement and lead-based paint hazard reduction 
methods, including restricted practices.
    (vi) Interior dust abatement methods/cleanup or lead-based paint 
hazard reduction.
    (vii) Soil and exterior dust abatement methods or lead-based paint 
hazard reduction.
    (6) Renovator. Instruction in the topics described in paragraphs 
(d)(6)(iv), (vi), (vii), and (viii) of this section must be included in 
the hands-on portion of the course.
    (i) Role and responsibility of a renovator.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on EPA, HUD, OSHA, and other Federal, 
State, and local regulations and guidance that pertains to lead-based 
paint and renovation activities.
    (iv) Procedures for using acceptable test kits to determine whether 
paint is lead-based paint.
    (v) Procedures for collecting a paint chip sample and sending it to 
a laboratory recognized by EPA under section 405(b) of TSCA.
    (vi) Renovation methods to minimize the creation of dust and lead-
based paint hazards.
    (vii) Interior and exterior containment and cleanup methods.
    (viii) Methods to ensure that the renovation has been properly 
completed, including cleaning verification and clearance testing.
    (ix) Waste handling and disposal.
    (x) Providing on-the-job training to other workers.
    (xi) Record preparation.
    (7) Dust sampling technician. Instruction in the topics described in 
paragraphs (d)(6)(iv) and (vi) of this section must be included in the 
hands-on portion of the course.
    (i) Role and responsibility of a dust sampling technician.
    (ii) Background information on lead and its adverse health effects.
    (iii) Background information on Federal, State, and local 
regulations and guidance that pertains to lead-based paint and 
renovation activities.
    (iv) Dust sampling methodologies.
    (v) Clearance standards and testing.
    (vi) Report preparation.
    (e) Requirements for the accreditation of refresher training 
programs. A training program may seek accreditation to offer refresher 
training courses in any of the following disciplines: Inspector, risk 
assessor, supervisor, project designer, abatement worker, renovator, and 
dust sampling technician. A training program accredited by EPA to offer

[[Page 110]]

refresher training must meet the following minimum requirements:
    (1) Each refresher course shall review the curriculum topics of the 
full-length courses listed under paragraph (d) of this section, as 
appropriate. In addition, to become accredited to offer refresher 
training courses, training programs shall ensure that their courses of 
study include, at a minimum, the following:
    (i) An overview of current safety practices relating to lead-based 
paint in general, as well as specific information pertaining to the 
appropriate discipline.
    (ii) Current laws and regulations relating to lead-based paint in 
general, as well as specific information pertaining to the appropriate 
discipline.
    (iii) Current technologies relating to lead-based paint in general, 
as well as specific information pertaining to the appropriate 
discipline.
    (2) Refresher courses for inspector, risk assessor, supervisor, and 
abatement worker must last a minimum of 8 training hours. Refresher 
courses for project designer, renovator, and dust sampling technician 
must last a minimum of 4 training hours. Refresher courses for all 
disciplines except renovator and project designer must include a hands-
on component. Renovators must take a refresher course that includes 
hands-on training at least every other recertification.
    (3) Except for renovator and project designer courses, for all other 
courses offered, the training program shall conduct a hands-on 
assessment. With the exception of project designer courses, the training 
program shall conduct a course test at the completion of the course. 
Renovators must take a refresher course that includes hands-on training 
at least every other recertification.
    (4) A training program may apply for accreditation of a refresher 
course concurrently with its application for accreditation of the 
corresponding training course as described in paragraph (b) of this 
section. If so, EPA shall use the approval procedure described in 
paragraph (b) of this section. In addition, the minimum requirements 
contained in paragraphs (c)(1) through (5), (c)(6)(viii) and (c)(7) 
through (14), and (e)(1) through (3) of this section shall also apply.
    (5) A training program seeking accreditation to offer refresher 
training courses only shall submit a written application to EPA 
containing the following information:
    (i) The refresher training program's name, address, and telephone 
number.
    (ii) A list of courses for which it is applying for accreditation.
    (iii) The name and documentation of the qualifications of the 
training program manager.
    (iv) The name(s) and documentation of the qualifications of the 
principal instructor(s).
    (v) A statement signed by the training program manager certifying 
that the refresher training program meets the minimum requirements 
established in paragraph (c) of this section, except for the 
requirements in paragraph (c)(6) of this section. If a training program 
uses EPA-developed model training materials, or training materials 
approved by a State or Indian Tribe that has been authorized by EPA 
under Sec. 745.324 to develop its refresher training course materials, 
the training manager shall include a statement certifying that, as well.
    (vi) If the refresher training course materials are not based on 
EPA-developed model training materials, the training program's 
application for accreditation shall include:
    (A) A copy of the student and instructor manuals to be used for each 
course.
    (B) A copy of the course agenda for each course.
    (vii) All refresher training programs shall include in their 
application for accreditation the following:
    (A) A description of the facilities and equipment to be used for 
lecture and hands-on training.
    (B) A copy of the course test blueprint for each course.
    (C) A description of the activities and procedures that will be used 
for conducting the assessment of hands-on skills for each course (if 
applicable).
    (D) A copy of the quality control plan as described in paragraph 
(c)(9) of this section.
    (viii) The requirements in paragraphs (c)(1) through (5), 
(c)(6)(viii) and (c)(7)

[[Page 111]]

through (14) of this section apply to refresher training providers.
    (ix) If a refresher training program meets the requirements listed 
in this paragraph, then EPA shall approve the application for 
accreditation no more than 180 days after receiving a complete 
application from the refresher training program. In the case of 
approval, a certificate of accreditation shall be sent to the applicant. 
In the case of disapproval, a letter describing the reasons for 
disapproval shall be sent to the applicant. Prior to disapproval, EPA 
may, at its discretion, work with the applicant to address inadequacies 
in the application for accreditation. EPA may also request additional 
materials retained by the refresher training program under paragraph (i) 
of this section. If a refresher training program's application is 
disapproved, the program may reapply for accreditation at any time.
    (f) Re-accreditation of training programs. (1) Unless re-accredited, 
a training program's accreditation, including refresher training 
accreditation, shall expire 4 years after the date of issuance. If a 
training program meets the requirements of this section, the training 
program shall be reaccredited.
    (2) A training program seeking re-accreditation shall submit an 
application to EPA no later than 180 days before its accreditation 
expires. If a training program does not submit its application for re-
accreditation by that date, EPA cannot guarantee that the program will 
be re-accredited before the end of the accreditation period.
    (3) The training program's application for re-accreditation shall 
contain:
    (i) The training program's name, address, and telephone number.
    (ii) A list of courses for which it is applying for re-
accreditation.
    (iii) The name and qualifications of the training program manager.
    (iv) The name(s) and qualifications of the principal instructor(s).
    (v) A description of any changes to the training facility, equipment 
or course materials since its last application was approved that 
adversely affects the students' ability to learn.
    (vi) A statement signed by the program manager stating:
    (A) That the training program complies at all times with all 
requirements in paragraphs (c) and (e) of this section, as applicable; 
and
    (B) The recordkeeping and reporting requirements of paragraph (i) of 
this section shall be followed.
    (vii) A payment of appropriate fees in accordance with Sec. 745.238.
    (4) Upon request, the training program shall allow EPA to audit the 
training program to verify the contents of the application for re-
accreditation as described in paragraph (f)(3) of this section.
    (g) Suspension, revocation, and modification of accredited training 
programs. (1) EPA may, after notice and an opportunity for hearing, 
suspend, revoke, or modify training program accreditation, including 
refresher training accreditation, if a training program, training 
manager, or other person with supervisory authority over the training 
program has:
    (i) Misrepresented the contents of a training course to EPA and/or 
the student population.
    (ii) Failed to submit required information or notifications in a 
timely manner.
    (iii) Failed to maintain required records.
    (iv) Falsified accreditation records, instructor qualifications, or 
other accreditation-related information or documentation.
    (v) Failed to comply with the training standards and requirements in 
this section.
    (vi) Failed to comply with Federal, State, or local lead-based paint 
statutes or regulations.
    (vii) Made false or misleading statements to EPA in its application 
for accreditation or re-accreditation which EPA relied upon in approving 
the application.
    (2) In addition to an administrative or judicial finding of 
violation, execution of a consent agreement in settlement of an 
enforcement action constitutes, for purposes of this section, evidence 
of a failure to comply with relevant statutes or regulations.
    (h) Procedures for suspension, revocation or modification of 
training program accreditation. (1) Prior to taking action

[[Page 112]]

to suspend, revoke, or modify the accreditation of a training program, 
EPA shall notify the affected entity in writing of the following:
    (i) The legal and factual basis for the suspension, revocation, or 
modification.
    (ii) The anticipated commencement date and duration of the 
suspension, revocation, or modification.
    (iii) Actions, if any, which the affected entity may take to avoid 
suspension, revocation, or modification, or to receive accreditation in 
the future.
    (iv) The opportunity and method for requesting a hearing prior to 
final EPA action to suspend, revoke or modify accreditation.
    (v) Any additional information, as appropriate, which EPA may 
provide.
    (2) If a hearing is requested by the accredited training program, 
EPA shall:
    (i) Provide the affected entity an opportunity to offer written 
statements in response to EPA's assertions of the legal and factual 
basis for its proposed action, and any other explanations, comments, and 
arguments it deems relevant to the proposed action.
    (ii) Provide the affected entity such other procedural opportunities 
as EPA may deem appropriate to ensure a fair and impartial hearing.
    (iii) Appoint an official of EPA as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific matter.
    (3) The Presiding Officer appointed pursuant to paragraph (h)(2) of 
this section shall:
    (i) Conduct a fair, orderly, and impartial hearing within 90 days of 
the request for a hearing.
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted.
    (iii) Notify the affected entity in writing within 90 days of 
completion of the hearing of his or her decision and order. Such an 
order is a final agency action which may be subject to judicial review.
    (4) If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the accreditation of any training 
program prior to the opportunity for a hearing, it shall:
    (i) Notify the affected entity of its intent to immediately suspend 
training program accreditation for the reasons listed in paragraph 
(g)(1) of this section. If a suspension, revocation, or modification 
notice has not previously been issued pursuant to paragraph (g)(1) of 
this section, it shall be issued at the same time the emergency 
suspension notice is issued.
    (ii) Notify the affected entity in writing of the grounds for the 
immediate suspension and why it is necessary to suspend the entity's 
accreditation before an opportunity for a suspension, revocation or 
modification hearing.
    (iii) Notify the affected entity of the anticipated commencement 
date and duration of the immediate suspension.
    (iv) Notify the affected entity of its right to request a hearing on 
the immediate suspension within 15 days of the suspension taking place 
and the procedures for the conduct of such a hearing.
    (5) Any notice, decision, or order issued by EPA under this section, 
any transcripts or other verbatim record of oral testimony, and any 
documents filed by an accredited training program in a hearing under 
this section shall be available to the public, except as otherwise 
provided by section 14 of TSCA or by 40 CFR part 2. Any such hearing at 
which oral testimony is presented shall be open to the public, except 
that the Presiding Officer may exclude the public to the extent 
necessary to allow presentation of information which may be entitled to 
confidential treatment under section 14 of TSCA or 40 CFR part 2.
    (6) The public shall be notified of the suspension, revocation, 
modification or reinstatement of a training program's accreditation 
through appropriate mechanisms.
    (7) EPA shall maintain a list of parties whose accreditation has 
been suspended, revoked, modified or reinstated.
    (i) Training program recordkeeping requirements. (1) Accredited 
training programs shall maintain, and make available to EPA, upon 
request, the following records:
    (i) All documents specified in paragraph (c)(4) of this section that 
demonstrate the qualifications listed in

[[Page 113]]

paragraphs (c)(1) and (c)(2) of this section of the training manager and 
principal instructors.
    (ii) Current curriculum/course materials and documents reflecting 
any changes made to these materials.
    (iii) The course test blueprint.
    (iv) Information regarding how the hands-on assessment is conducted 
including, but not limited to:
    (A) Who conducts the assessment.
    (B) How the skills are graded.
    (C) What facilities are used.
    (D) The pass/fail rate.
    (v) The quality control plan as described in paragraph (c)(9) of 
this section.
    (vi) Results of the students' hands-on skills assessments and course 
tests, and a record of each student's course completion certificate.
    (vii) Any other material not listed in paragraphs (i)(1)(i) through 
(i)(1)(vi) of this section that was submitted to EPA as part of the 
program's application for accreditation.
    (viii) For renovator refresher and dust sampling technician 
refresher courses, a copy of each trainee's prior course completion 
certificate showing that each trainee was eligible to take the refresher 
course.
    (ix) For course modules delivered in an electronic format, a record 
of each student's log-ins, launches, progress, and completion, and a 
copy of the electronic learning completion certificate for each student.
    (2) The training program must retain records pertaining to 
renovator, dust sampling technician and lead-based paint activities 
courses at the address specified on the training program accreditation 
application (or as modified in accordance with paragraph (i)(3) of this 
section) for the following minimum periods:
    (i) Records pertaining to lead-based paint activities courses must 
be retained for a minimum of 3 years and 6 months.
    (ii) Records pertaining to renovator or dust sampling technician 
courses offered before April 22, 2010 must be retained until July 1, 
2015.
    (iii) Records pertaining to renovator or dust sampling technician 
courses offered on or after April 22, 2010 must be retained for a 
minimum of 5 years.
    (3) The training program shall notify EPA in writing within 30 days 
of changing the address specified on its training program accreditation 
application or transferring the records from that address.
    (j) Amendment of accreditation. (1) A training program must amend 
its accreditation within 90 days of the date a change occurs to 
information included in the program's most recent application. If the 
training program fails to amend its accreditation within 90 days of the 
date the change occurs, the program may not provide renovator, dust 
sampling technician, or lead-based paint activities training until its 
accreditation is amended.
    (2) To amend an accreditation, a training program must submit a 
completed ``Accreditation Application for Training Providers,'' signed 
by an authorized agent of the training provider, noting on the form that 
it is submitted as an amendment and indicating the information that has 
changed.
    (3) Training managers, principal instructors, permanent training 
locations. If the amendment includes a new training program manager, any 
new or additional principal instructor(s), or any new permanent training 
location(s), the training provider is not permitted to provide training 
under the new training manager or offer courses taught by any new 
principal instructor(s) or at the new training location(s) until EPA 
either approves the amendment or 30 days have elapsed, whichever occurs 
earlier. Except:
    (i) If the amendment includes a new training program manager or new 
or additional principal instructor that was identified in a training 
provider accreditation application that EPA has already approved under 
this section, the training provider may begin to provide training under 
the new training manager or offer courses taught by the new principal 
instructor on an interim basis as soon as the provider submits the 
amendment to EPA. The training provider may continue to provide training 
under the new training manager or offer courses taught by the new 
principal instructor if EPA approves the amendment or if EPA does not 
disapprove the amendment within 30 days.

[[Page 114]]

    (ii) If the amendment includes a new permanent training location, 
the training provider may begin to provide training at the new permanent 
training location on an interim basis as soon as the provider submits 
the amendment to EPA. The training provider may continue to provide 
training at the new permanent training location if EPA approves the 
amendment or if EPA does not disapprove the amendment within 30 days.

[76 FR 47939, Aug. 5, 2011, as amended at 81 FR 7995, Feb. 17, 2016]



Sec. 745.226  Certification of individuals and firms engaged in 
lead-based paint activities: target housing and child-occupied
facilities.

    (a) Certification of individuals. (1) Individuals seeking 
certification by EPA to engage in lead-based paint activities must 
either:
    (i) Submit to EPA an application demonstrating that they meet the 
requirements established in paragraphs (b) or (c) of this section for 
the particular discipline for which certification is sought; or
    (ii) Submit to EPA an application with a copy of a valid lead-based 
paint activities certification (or equivalent) from a State or Tribal 
program that has been authorized by EPA pursuant to subpart Q of this 
part.
    (2) Individuals may first apply to EPA for certification to engage 
in lead-based paint activities pursuant to this section on or after 
March 1, 1999.
    (3) Following the submission of an application demonstrating that 
all the requirements of this section have been meet, EPA shall certify 
an applicant as an inspector, risk assessor, supervisor, project 
designer, or abatement worker, as appropriate.
    (4) Upon receiving EPA certification, individuals conducting lead-
based paint activities shall comply with the work practice standards for 
performing the appropriate lead-based paint activities as established in 
Sec. 745.227.
    (5) It shall be a violation of TSCA for an individual to conduct any 
of the lead-based paint activities described in Sec. 745.227 after March 
1, 2000, if that individual has not been certified by EPA pursuant to 
this section to do so.
    (6) Individuals applying for certification must submit the 
appropriate fees in accordance with Sec. 745.238.
    (b) Inspector, risk assessor or supervisor. (1) To become certified 
by EPA as an inspector, risk assessor, or supervisor, pursuant to 
paragraph (a)(1)(i) of this section, an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Pass the certification exam in the appropriate discipline 
offered by EPA; and,
    (iii) Meet or exceed the following experience and/or education 
requirements:
    (A) Inspectors. (1) No additional experience and/or education 
requirements.
    (2) [Reserved]
    (B) Risk assessors. (1) Successful completion of an accredited 
training course for inspectors; and
    (2) Bachelor's degree and 1 year of experience in a related field 
(e.g., lead, asbestos, environmental remediation work, or construction), 
or an Associates degree and 2 years experience in a related field (e.g., 
lead, asbestos, environmental remediation work, or construction); or
    (3) Certification as an industrial hygienist, professional engineer, 
registered architect and/or certification in a related engineering/
health/environmental field (e.g., safety professional, environmental 
scientist); or
    (4) A high school diploma (or equivalent), and at least 3 years of 
experience in a related field (e.g., lead, asbestos, environmental 
remediation work or construction).
    (C) Supervisor: (1) One year of experience as a certified lead-based 
paint abatement worker; or
    (2) At least 2 years of experience in a related field (e.g., lead, 
asbestos, or environmental remediation work) or in the building trades.
    (2) The following documents shall be recognized by EPA as evidence 
of meeting the requirements listed in (b)(2)(iii) of this paragraph:
    (i) Official academic transcripts or diploma, as evidence of meeting 
the education requirements.

[[Page 115]]

    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) In order to take the certification examination for a particular 
discipline an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the education and/or experience requirements in 
paragraph (b)(1)(iii) of this section.
    (4) The course completion certificate shall serve as interim 
certification for an individual until the next available opportunity to 
take the certification exam. Such interim certification shall expire 6 
months after issuance.
    (5) After passing the appropriate certification exam and submitting 
an application demonstrating that he/she meets the appropriate training, 
education, and/or experience prerequisites described in paragraph (b)(1) 
of this section, an individual shall be issued a certificate by EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (6) An individual may take the certification exam no more than three 
times within 6 months of receiving a course completion certificate.
    (7) If an individual does not pass the certification exam and 
receive a certificate within 6 months of receiving his/her course 
completion certificate, the individual must retake the appropriate 
course from an accredited training program before reapplying for 
certification from EPA.
    (c) Abatement worker and project designer. (1) To become certified 
by EPA as an abatement worker or project designer, pursuant to paragraph 
(a)(1)(i) of this section, an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the following additional experience and/or 
education requirements:
    (A) Abatement workers. (1) No additional experience and/or education 
requirements.
    (2) [Reserved]
    (B) Project designers. (1) Successful completion of an accredited 
training course for supervisors.
    (2) Bachelor's degree in engineering, architecture, or a related 
profession, and 1 year of experience in building construction and design 
or a related field; or
    (3) Four years of experience in building construction and design or 
a related field.
    (2) The following documents shall be recognized by EPA as evidence 
of meeting the requirements listed in this paragraph:
    (i) Official academic transcripts or diploma, as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) The course completion certificate shall serve as an interim 
certification until certification from EPA is received, but shall be 
valid for no more than 6 months from the date of completion.
    (4) After successfully completing the appropriate training courses 
and meeting any other qualifications described in paragraph (c)(1) of 
this section, an individual shall be issued a certificate from EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (d) Certification based on prior training. (1) Any individual who 
received training in a lead-based paint activity between October 1, 
1990, and March 1, 1999 shall be eligible for certification by EPA under 
the alternative procedures contained in this paragraph. Individuals who 
have received lead-based paint activities training at an EPA-authorized 
State or Tribal accredited

[[Page 116]]

training program shall also be eligible for certification by EPA under 
the following alternative procedures:
    (i) Applicants for certification as an inspector, risk assessor, or 
supervisor shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets or exceeds the education 
and/or experience requirements in paragraph (b)(1)(iii) of this section.
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (D) Pass a certification exam administered by EPA for the 
appropriate discipline.
    (ii) Applicants for certification as an abatement worker or project 
designer shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets the education and/or 
experience requirements in paragraphs (c)(1) of this section; and
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (2) Individuals shall have until March 1, 2000, to apply to EPA for 
certification under the above procedures. After that date, all 
individuals wishing to obtain certification must do so through the 
procedures described in paragraph (a), and paragraph (b) or (c) of this 
section, according to the discipline for which certification is being 
sought.
    (e) Re-certification. (1) To maintain certification in a particular 
discipline, a certified individual shall apply to and be re-certified by 
EPA in that discipline by EPA either:
    (i) Every 3 years if the individual completed a training course with 
a course test and hands-on assessment; or
    (ii) Every 5 years if the individual completed a training course 
with a proficiency test.
    (2) An individual shall be re-certified if the individual 
successfully completes the appropriate accredited refresher training 
course and submits a valid copy of the appropriate refresher course 
completion certificate.
    (3) Individuals applying for re-certification must submit the 
appropriate fees in accordance with Sec. 745.238.
    (f) Certification of firms. (1) All firms which perform or offer to 
perform any of the lead-based paint activities described in Sec. 745.227 
after March 1, 2000, shall be certified by EPA.
    (2) A firm seeking certification shall submit to EPA a letter 
attesting that the firm shall only employ appropriately certified 
employees to conduct lead-based paint activities, and that the firm and 
its employees shall follow the work practice standards in Sec. 745.227 
for conducting lead-based paint activities.
    (3) From the date of receiving the firm's letter requesting 
certification, EPA shall have 90 days to approve or disapprove the 
firm's request for certification. Within that time, EPA shall respond 
with either a certificate of approval or a letter describing the reasons 
for a disapproval.
    (4) The firm shall maintain all records pursuant to the requirements 
in Sec. 745.227.
    (5) Firms may first apply to EPA for certification to engage in 
lead-based paint activities pursuant to this section on or after March 
1, 1999.
    (6) Firms applying for certification must submit the appropriate 
fees in accordance with Sec. 745.238.
    (7) To maintain certification a firm shall submit appropriate fees 
in accordance with Sec. 745.238 every 3 years.
    (g) Suspension, revocation, and modification of certifications of 
individuals engaged in lead-based paint activities. (1) EPA may, after 
notice and opportunity for hearing, suspend, revoke, or modify an 
individual's certification if an individual has:
    (i) Obtained training documentation through fraudulent means.
    (ii) Gained admission to and completed an accredited training 
program through misrepresentation of admission requirements.
    (iii) Obtained certification through misrepresentation of 
certification requirements or related documents dealing with education, 
training, professional registration, or experience.

[[Page 117]]

    (iv) Performed work requiring certification at a job site without 
having proof of certification.
    (v) Permitted the duplication or use of the individual's own 
certificate by another.
    (vi) Performed work for which certification is required, but for 
which appropriate certification has not been received.
    (vii) Failed to comply with the appropriate work practice standards 
for lead-based paint activities at Sec. 745.227.
    (viii) Failed to comply with Federal, State, or local lead-based 
paint statutes or regulations.
    (2) In addition to an administrative or judicial finding of 
violation, for purposes of this section only, execution of a consent 
agreement in settlement of an enforcement action constitutes evidence of 
a failure to comply with relevant statutes or regulations.
    (h) Suspension, revocation, and modification of certifications of 
firms engaged in lead-based paint activities. (1) EPA may, after notice 
and opportunity for hearing, suspend, revoke, or modify a firm's 
certification if a firm has:
    (i) Performed work requiring certification at a job site with 
individuals who are not certified.
    (ii) Failed to comply with the work practice standards established 
in Sec. 745.227.
    (iii) Misrepresented facts in its letter of application for 
certification to EPA.
    (iv) Failed to maintain required records.
    (v) Failed to comply with Federal, State, or local lead-based paint 
statutes or regulations.
    (2) In addition to an administrative or judicial finding of 
violation, for purposes of this section only, execution of a consent 
agreement in settlement of an enforcement action constitutes evidence of 
a failure to comply with relevant statutes or regulations.
    (i) Procedures for suspension, revocation, or modification of the 
certification of individuals or firms.
    (1) If EPA decides to suspend, revoke, or modify the certification 
of any individual or firm, it shall notify the affected entity in 
writing of the following:
    (i) The legal and factual basis for the suspension, revocation, or 
modification.
    (ii) The commencement date and duration of the suspension, 
revocation, or modification.
    (iii) Actions, if any, which the affected entity may take to avoid 
suspension, revocation, or modification or to receive certification in 
the future.
    (iv) The opportunity and method for requesting a hearing prior to 
final EPA action to suspend, revoke, or modify certification.
    (v) Any additional information, as appropriate, which EPA may 
provide.
    (2) If a hearing is requested by the certified individual or firm, 
EPA shall:
    (i) Provide the affected entity an opportunity to offer written 
statements in response to EPA's assertion of the legal and factual basis 
and any other explanations, comments, and arguments it deems relevant to 
the proposed action.
    (ii) Provide the affected entity such other procedural opportunities 
as EPA may deem appropriate to ensure a fair and impartial hearing.
    (iii) Appoint an official of EPA as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific matter.
    (3) The Presiding Officer shall:
    (i) Conduct a fair, orderly, and impartial hearing within 90 days of 
the request for a hearing;
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted; and
    (iii) Notify the affected entity in writing within 90 days of 
completion of the hearing of his or her decision and order. Such an 
order is a final EPA action subject to judicial review.
    (4) If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the certification of any individual 
or firm prior to the opportunity for a hearing, it shall:
    (i) Notify the affected entity of its intent to immediately suspend 
certification for the reasons listed in paragraph (h)(1) of this 
section. If a suspension, revocation, or modification notice has not 
previously been issued, it

[[Page 118]]

shall be issued at the same time the immediate suspension notice is 
issued.
    (ii) Notify the affected entity in writing of the grounds upon which 
the immediate suspension is based and why it is necessary to suspend the 
entity's accreditation before an opportunity for a hearing to suspend, 
revoke, or modify the individual's or firm's certification.
    (iii) Notify the affected entity of the commencement date and 
duration of the immediate suspension.
    (iv) Notify the affected entity of its right to request a hearing on 
the immediate suspension within 15 days of the suspension taking place 
and the procedures for the conduct of such a hearing.
    (5) Any notice, decision, or order issued by EPA under this section, 
transcript or other verbatim record of oral testimony, and any documents 
filed by a certified individual or firm in a hearing under this section 
shall be available to the public, except as otherwise provided by 
section 14 of TSCA or by part 2 of this title. Any such hearing at which 
oral testimony is presented shall be open to the public, except that the 
Presiding Officer may exclude the public to the extent necessary to 
allow presentation of information which may be entitled to confidential 
treatment under section 14 of TSCA or part 2 of this title.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31098, June 9, 1999; 64 
FR 42851, Aug. 6, 1999]



Sec. 745.227  Work practice standards for conducting lead-based paint
activities: target housing and child-occupied facilities.

    (a) Effective date, applicability, and terms. (1) Beginning on March 
1, 2000, all lead-based paint activities shall be performed pursuant to 
the work practice standards contained in this section.
    (2) When performing any lead-based paint activity described by the 
certified individual as an inspection, lead-hazard screen, risk 
assessment or abatement, a certified individual must perform that 
activity in compliance with the appropriate requirements below.
    (3) Documented methodologies that are appropriate for this section 
are found in the following: The U.S. Department of Housing and Urban 
Development (HUD) Guidelines for the Evaluation and Control of Lead-
Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-
Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil; the EPA 
Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA 
report number 7474-R-95-001); Regulations, guidance, methods or 
protocols issued by States and Indian Tribes that have been authorized 
by EPA; and other equivalent methods and quidelines.
    (4) Clearance levels are appropriate for the purposes of this 
section may be found in the EPA Guidance on Residential Lead-Based 
Paint, Lead-Contaminated Dust, and Lead Contaminiated Soil or other 
equivalent guidelines.
    (b) Inspection. (1) An inspection shall be conducted only by a 
person certified by EPA as an inspector or risk assessor and, if 
conducted, must be conducted according to the procedures in this 
paragraph.
    (2) When conducting an inspection, the following locations shall be 
selected according to documented methodologies and tested for the 
presence of lead-based paint:
    (i) In a residential dwelling and child-occupied facility, each 
component with a distinct painting history and each exterior component 
with a distinct painting history shall be tested for lead-based paint, 
except those components that the inspector or risk assessor determines 
to have been replaced after 1978, or to not contain lead-based paint; 
and
    (ii) In a multi-family dwelling or child-occupied facility, each 
component with a distinct painting history in every common area, except 
those components that the inspector or risk assessor determines to have 
been replaced after 1978, or to not contain lead-based paint.
    (3) Paint shall be sampled in the following manner: (i) The analysis 
of paint to determine the presence of lead shall be conducted using 
documented methodologies which incorporate adequate quality control 
procedures; and/or

[[Page 119]]

    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) The certified inspector or risk assessor shall prepare an 
inspection report which shall include the following information:
    (i) Date of each inspection.
    (ii) Address of building.
    (iii) Date of construction.
    (iv) Apartment numbers (if applicable).
    (v) Name, address, and telephone number of the owner or owners of 
each residential dwelling or child-occupied facility.
    (vi) Name, signature, and certification number of each certified 
inspector and/or risk assessor conducting testing.
    (vii) Name, address, and telephone number of the certified firm 
employing each inspector and/or risk assessor, if applicable.
    (viii) Each testing method and device and/or sampling procedure 
employed for paint analysis, including quality control data and, if 
used, the serial number of any x-ray fluorescence (XRF) device.
    (ix) Specific locations of each painted component tested for the 
presence of lead-based paint.
    (x) The results of the inspection expressed in terms appropriate to 
the sampling method used.
    (c) Lead hazard screen. (1) A lead hazard screen shall be conducted 
only by a person certified by EPA as a risk assessor.
    (2) If conducted, a lead hazard screen shall be conducted as 
follows:
    (i) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (ii) A visual inspection of the residential dwelling or child-
occupied facility shall be conducted to:
    (A) Determine if any deteriorated paint is present, and
    (B) Locate at least two dust sampling locations.
    (iii) If deteriorated paint is present, each surface with 
deteriorated paint, which is determined, using documented methodologies, 
to be in poor condition and to have a distinct painting history, shall 
be tested for the presence of lead.
    (iv) In residential dwellings, two composite dust samples shall be 
collected, one from the floors and the other from the windows, in rooms, 
hallways or stairwells where one or more children, age 6 and under, are 
most likely to come in contact with dust.
    (v) In multi-family dwellings and child-occupied facilities, in 
addition to the floor and window samples required in paragraph 
(c)(1)(iii) of this section, the risk assessor shall also collect 
composite dust samples from common areas where one or more children, age 
6 and under, are most likely to come into contact with dust.
    (3) Dust samples shall be collected and analyzed in the following 
manner:
    (i) All dust samples shall be taken using documented methodologies 
that incorporate adequate quality control procedures.
    (ii) All collected dust samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) Paint shall be sampled in the following manner: (i) The analysis 
of paint to determine the presence of lead shall be conducted using 
documented methodologies which incorporate adequate quality control 
procedures; and/or
    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (5) The risk assessor shall prepare a lead hazard screen report, 
which shall include the following information:
    (i) The information required in a risk assessment report as 
specified in paragraph (d) of this section, including paragraphs 
(d)(11)(i) through (d)(11)(xiv), and excluding paragraphs (d)(11)(xv) 
through (d)(11)(xviii) of this section. Additionally, any background 
information collected pursuant to paragraph (c)(2)(i) of this section 
shall be included in the risk assessment report; and

[[Page 120]]

    (ii) Recommendations, if warranted, for a follow-up risk assessment, 
and as appropriate, any further actions.
    (d) Risk assessment. (1) A risk assessment shall be conducted only 
by a person certified by EPA as a risk assessor and, if conducted, must 
be conducted according to the procedures in this paragraph.
    (2) A visual inspection for risk assessment of the residential 
dwelling or child-occupied facility shall be undertaken to locate the 
existence of deteriorated paint, assess the extent and causes of the 
deterioration, and other potential lead-based paint hazards.
    (3) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (4) The following surfaces which are determined, using documented 
methodologies, to have a distinct painting history, shall be tested for 
the presence of lead:
    (i) Each friction surface or impact surface with visibly 
deteriorated paint; and
    (ii) All other surfaces with visibly deteriorated paint.
    (5) In residential dwellings, dust samples (either composite or 
single-surface samples) from the interior window sill(s) and floor shall 
be collected and analyzed for lead concentration in all living areas 
where one or more children, age 6 and under, are most likely to come 
into contact with dust.
    (6) For multi-family dwellings and child-occupied facilities, the 
samples required in paragraph (d)(4) of this section shall be taken. In 
addition, interior window sill and floor dust samples (either composite 
or single-surface samples) shall be collected and analyzed for lead 
concentration in the following locations:
    (i) Common areas adjacent to the sampled residential dwelling or 
child-occupied facility; and
    (ii) Other common areas in the building where the risk assessor 
determines that one or more children, age 6 and under, are likely to 
come into contact with dust.
    (7) For child-occupied facilities, interior window sill and floor 
dust samples (either composite or single-surface samples) shall be 
collected and analyzed for lead concentration in each room, hallway or 
stairwell utilized by one or more children, age 6 and under, and in 
other common areas in the child-occupied facility where one or more 
children, age 6 and under, are likely to come into contact with dust.
    (8) Soil samples shall be collected and analyzed for lead 
concentrations in the following locations:
    (i) Exterior play areas where bare soil is present; and
    (ii) The rest of the yard (i.e., non-play areas) where bare soil is 
present.
    (iii) Dripline/foundation areas where bare soil is present.
    (9) Any paint, dust, or soil sampling or testing shall be conducted 
using documented methodologies that incorporate adequate quality control 
procedures.
    (10) Any collected paint chip, dust, or soil samples shall be 
analyzed according to paragraph (f) of this section to determine if they 
contain detectable levels of lead that can be quantified numerically.
    (11) The certified risk assessor shall prepare a risk assessment 
report which shall include the following information:
    (i) Date of assessment.
    (ii) Address of each building.
    (iii) Date of construction of buildings.
    (iv) Apartment number (if applicable).
    (v) Name, address, and telephone number of each owner of each 
building.
    (vi) Name, signature, and certification of the certified risk 
assessor conducting the assessment.
    (vii) Name, address, and telephone number of the certified firm 
employing each certified risk assessor if applicable.
    (viii) Name, address, and telephone number of each recognized 
laboratory conducting analysis of collected samples.
    (ix) Results of the visual inspection.
    (x) Testing method and sampling procedure for paint analysis 
employed.

[[Page 121]]

    (xi) Specific locations of each painted component tested for the 
presence of lead.
    (xii) All data collected from on-site testing, including quality 
control data and, if used, the serial number of any XRF device.
    (xiii) All results of laboratory analysis on collected paint, soil, 
and dust samples.
    (xiv) Any other sampling results.
    (xv) Any background information collected pursuant to paragraph 
(d)(3) of this section.
    (xvi) To the extent that they are used as part of the lead-based 
paint hazard determination, the results of any previous inspections or 
analyses for the presence of lead-based paint, or other assessments of 
lead-based paint-related hazards.
    (xvii) A description of the location, type, and severity of 
identified lead-based paint hazards and any other potential lead 
hazards.
    (xviii) A description of interim controls and/or abatement options 
for each identified lead-based paint hazard and a suggested 
prioritization for addressing each hazard. If the use of an encapsulant 
or enclosure is recommended, the report shall recommend a maintenance 
and monitoring schedule for the encapsulant or enclosure.
    (e) Abatement. (1) An abatement shall be conducted only by an 
individual certified by EPA, and if conducted, shall be conducted 
according to the procedures in this paragraph.
    (2) A certified supervisor is required for each abatement project 
and shall be onsite during all work site preparation and during the 
post-abatement cleanup of work areas. At all other times when abatement 
activities are being conducted, the certified supervisor shall be onsite 
or available by telephone, pager or answering service, and able to be 
present at the work site in no more than 2 hours.
    (3) The certified supervisor and the certified firm employing that 
supervisor shall ensure that all abatement activities are conducted 
according to the requirements of this section and all other Federal, 
State and local requirements.
    (4) A certified firm must notify EPA of lead-based paint abatement 
activities as follows:
    (i) Except as provided in paragraph (e)(4)(ii) of this section, EPA 
must be notified prior to conducting lead-based paint abatement 
activities. The original notification must be received by EPA at least 5 
business days before the start date of any lead-based paint abatement 
activities.
    (ii) Notification for lead-based paint abatement activities required 
in response to an elevated blood lead level (EBL) determination, or 
Federal, State, Tribal, or local emergency abatement order should be 
received by EPA as early as possible before, but must be received no 
later than the start date of the lead-based paint abatement activities. 
Should the start date and/or location provided to EPA change, an updated 
notification must be received by EPA on or before the start date 
provided to EPA. Documentation showing evidence of an EBL determination 
or a copy of the Federal/State/Tribal/local emergency abatement order 
must be included in the written notification to take advantage of this 
abbreviated notification period.
    (iii) Except as provided in paragraph (e)(4)(ii) of this section, 
updated notification must be provided to EPA for lead-based paint 
abatement activities that will begin on a date other than the start date 
specified in the original notification, as follows:
    (A) For lead-based paint abatement activities beginning prior to the 
start date provided to EPA an updated notification must be received by 
EPA at least 5 business days before the new start date included in the 
notification.
    (B) For lead-based paint abatement activities beginning after the 
start date provided to EPA an updated notification must be received by 
EPA on or before the start date provided to EPA.
    (iv) Except as provided in paragraph (e)(4)(ii) of this section, 
updated notification must be provided to EPA for any change in location 
of lead-based paint abatement activities at least 5 business days prior 
to the start date provided to EPA.
    (v) Updated notification must be provided to EPA when lead-based 
paint abatement activities are canceled, or

[[Page 122]]

when there are other significant changes including, but not limited to, 
when the square footage or acreage to be abated changes by more than 
20%. This updated notification must be received by EPA on or before the 
start date provided to EPA, or if work has already begun, within 24 
hours of the change.
    (vi) The following must be included in each notification:
    (A) Notification type (original, updated, cancellation).
    (B) Date when lead-based paint abatement activities will start.
    (C) Date when lead-based paint abatement activities will end 
(approximation using best professional judgement).
    (D) Firm's name, EPA certification number, address, telephone 
number.
    (E) Type of building (e.g., single family dwelling, multi-family 
dwelling, child-occupied facilities) on/in which abatement work will be 
performed.
    (F) Property name (if applicable).
    (G) Property address including apartment or unit number(s) (if 
applicable) for abatement work.
    (H) Documentation showing evidence of an EBL determination or a copy 
of the Federal/State/Tribal/local emergency abatement order, if using 
the abbreviated time period as described in paragraph (e)(4)(ii) of this 
section.
    (I) Name and EPA certification number of the project supervisor.
    (J) Approximate square footage/acreage to be abated.
    (K) Brief description of abatement activities to be performed.
    (L) Name, title, and signature of the representative of the 
certified firm who prepared the notification.
    (vii) Notification must be accomplished using any of the following 
methods: Written notification, or electronically using the Agency's 
Central Data Exchange (CDX). Written notification can be accomplished 
using either the sample form titled ``Notification of Lead-Based Paint 
Abatement Activities'' or similar form containing the information 
required in paragraph (e)(4)(vi) of this section. All written 
notifications must be delivered by U.S. Postal Service, fax, commercial 
delivery service, or hand delivery (persons submitting notification by 
U.S. Postal Service are reminded that they should allow 3 additional 
business days for delivery in order to ensure that EPA receives the 
notification by the required date). Instructions and sample forms can be 
obtained from the NLIC at 1-800-424-LEAD(5323), or on the Internet at 
http://www.epa.gov/lead.
    (viii) Lead-based paint abatement activities shall not begin on a 
date, or at a location other than that specified in either an original 
or updated notification, in the event of changes to the original 
notification.
    (ix) No firm or individual shall engage in lead-based paint 
abatement activities, as defined in Sec. 745.223, prior to notifying EPA 
of such activities according to the requirements of this paragraph.
    (5) A written occupant protection plan shall be developed for all 
abatement projects and shall be prepared according to the following 
procedures:
    (i) The occupant protection plan shall be unique to each residential 
dwelling or child-occupied facility and be developed prior to the 
abatement. The occupant protection plan shall describe the measures and 
management procedures that will be taken during the abatement to protect 
the building occupants from exposure to any lead-based paint hazards.
    (ii) A certified supervisor or project designer shall prepare the 
occupant protection plan.
    (6) The work practices listed below shall be restricted during an 
abatement as follows:
    (i) Open-flame burning or torching of lead-based paint is 
prohibited;
    (ii) Machine sanding or grinding or abrasive blasting or 
sandblasting of lead-based paint is prohibited unless used with High 
Efficiency Particulate Air (HEPA) exhaust control which removes 
particles of 0.3 microns or larger from the air at 99.97 percent or 
greater efficiency;
    (iii) Dry scraping of lead-based paint is permitted only in 
conjunction with heat guns or around electrical outlets or when treating 
defective paint spots totaling no more than 2 square feet in any one 
room, hallway or stairwell or totaling no more than 20 square feet on 
exterior surfaces; and

[[Page 123]]

    (iv) Operating a heat gun on lead-based paint is permitted only at 
temperatures below 1100 degrees Fahrenheit.
    (7) If conducted, soil abatement shall be conducted in one of the 
following ways:
    (i) If the soil is removed:
    (A) The soil shall be replaced by soil with a lead concentration as 
close to local background as practicable, but no greater than 400 ppm.
    (B) The soil that is removed shall not be used as top soil at 
another residential property or child-occupied facility.
    (ii) If soil is not removed, the soil shall be permanently covered, 
as defined in Sec. 745.223.
    (8) The following post-abatement clearance procedures shall be 
performed only by a certified inspector or risk assessor:
    (i) Following an abatement, a visual inspection shall be performed 
to determine if deteriorated painted surfaces and/or visible amounts of 
dust, debris or residue are still present. If deteriorated painted 
surfaces or visible amounts of dust, debris or residue are present, 
these conditions must be eliminated prior to the continuation of the 
clearance procedures.
    (ii) Following the visual inspection and any post-abatement cleanup 
required by paragraph (e)(8)(i) of this section, clearance sampling for 
lead in dust shall be conducted. Clearance sampling may be conducted by 
employing single-surface sampling or composite sampling techniques.
    (iii) Dust samples for clearance purposes shall be taken using 
documented methodologies that incorporate adequate quality control 
procedures.
    (iv) Dust samples for clearance purposes shall be taken a minimum of 
1 hour after completion of final post-abatement cleanup activities.
    (v) The following post-abatement clearance activities shall be 
conducted as appropriate based upon the extent or manner of abatement 
activities conducted in or to the residential dwelling or child-occupied 
facility:
    (A) After conducting an abatement with containment between abated 
and unabated areas, one dust sample shall be taken from one interior 
window sill and from one window trough (if present) and one dust sample 
shall be taken from the floors of each of no less than four rooms, 
hallways or stairwells within the containment area. In addition, one 
dust sample shall be taken from the floor outside the containment area. 
If there are less than four rooms, hallways or stairwells within the 
containment area, then all rooms, hallways or stairwells shall be 
sampled.
    (B) After conducting an abatement with no containment, two dust 
samples shall be taken from each of no less than four rooms, hallways or 
stairwells in the residential dwelling or child-occupied facility. One 
dust sample shall be taken from one interior window sill and window 
trough (if present) and one dust sample shall be taken from the floor of 
each room, hallway or stairwell selected. If there are less than four 
rooms, hallways or stairwells within the residential dwelling or child-
occupied facility then all rooms, hallways or stairwells shall be 
sampled.
    (C) Following an exterior paint abatement, a visible inspection 
shall be conducted. All horizontal surfaces in the outdoor living area 
closest to the abated surface shall be found to be cleaned of visible 
dust and debris. In addition, a visual inspection shall be conducted to 
determine the presence of paint chips on the dripline or next to the 
foundation below any exterior surface abated. If paint chips are 
present, they must be removed from the site and properly disposed of, 
according to all applicable Federal, State and local requirements.
    (vi) The rooms, hallways or stairwells selected for sampling shall 
be selected according to documented methodologies.
    (vii) The certified inspector or risk assessor shall compare the 
residual lead level (as determined by the laboratory analysis) from each 
single surface dust sample with clearance levels in paragraph 
(e)(8)(viii) of this section for lead in dust on floors, interior window 
sills, and window troughs or from each composite dust sample with the 
applicable clearance levels for lead in dust on floors, interior window 
sills, and window troughs divided by half the number of subsamples in 
the composite sample. If the residual lead level in a

[[Page 124]]

single surface dust sample equals or exceeds the applicable clearance 
level or if the residual lead level in a composite dust sample equals or 
exceeds the applicable clearance level divided by half the number of 
subsamples in the composite sample, the components represented by the 
failed sample shall be recleaned and retested.
    (viii) The clearance levels for lead in dust are 40 mg/ft\2\ for 
floors, 250 mg/ft\2\ for interior window sills, and 400 mg/ft\2\ for 
window troughs.
    (9) In a multi-family dwelling with similarly constructed and 
maintained residential dwellings, random sampling for the purposes of 
clearance may be conducted provided:
    (i) The certified individuals who abate or clean the residential 
dwellings do not know which residential dwelling will be selected for 
the random sample.
    (ii) A sufficient number of residential dwellings are selected for 
dust sampling to provide a 95 percent level of confidence that no more 
than 5 percent or 50 of the residential dwellings (whichever is smaller) 
in the randomly sampled population exceed the appropriate clearance 
levels.
    (iii) The randomly selected residential dwellings shall be sampled 
and evaluated for clearance according to the procedures found in 
paragraph (e)(8) of this section.
    (10) An abatement report shall be prepared by a certified supervisor 
or project designer. The abatement report shall include the following 
information:
    (i) Start and completion dates of abatement.
    (ii) The name and address of each certified firm conducting the 
abatement and the name of each supervisor assigned to the abatement 
project.
    (iii) The occupant protection plan prepared pursuant to paragraph 
(e)(5) of this section.
    (iv) The name, address, and signature of each certified risk 
assessor or inspector conducting clearance sampling and the date of 
clearance testing.
    (v) The results of clearance testing and all soil analyses (if 
applicable) and the name of each recognized laboratory that conducted 
the analyses.
    (vi) A detailed written description of the abatement, including 
abatement methods used, locations of rooms and/or components where 
abatement occurred, reason for selecting particular abatement methods 
for each component, and any suggested monitoring of encapsulants or 
enclosures.
    (f) Collection and laboratory analysis of samples. Any paint chip, 
dust, or soil samples collected pursuant to the work practice standards 
contained in this section shall be:
    (1) Collected by persons certified by EPA as an inspector or risk 
assessor; and
    (2) Analyzed by a laboratory recognized by EPA pursuant to section 
405(b) of TSCA as being capable of performing analyses for lead 
compounds in paint chip, dust, and soil samples.
    (g) Composite dust sampling. Composite dust sampling may only be 
conducted in the situations specified in paragraphs (c) through (e) of 
this section. If such sampling is conducted, the following conditions 
shall apply:
    (1) Composite dust samples shall consist of at least two subsamples;
    (2) Every component that is being tested shall be included in the 
sampling; and
    (3) Composite dust samples shall not consist of subsamples from more 
than one type of component.
    (h) Determinations. (1) Lead-based paint is present:
    (i) On any surface that is tested and found to contain lead equal to 
or in excess of 1.0 milligrams per square centimeter or equal to or in 
excess of 0.5% by weight; and
    (ii) On any surface like a surface tested in the same room 
equivalent that has a similar painting history and that is found to be 
lead-based paint.
    (2) A paint-lead hazard is present:
    (i) On any friction surface that is subject to abrasion and where 
the lead dust levels on the nearest horizontal surface underneath the 
friction surface (e.g., the window sill or floor) are equal to or 
greater than the dust hazard levels identified in Sec. 745.227(b);
    (ii) On any chewable lead-based paint surface on which there is 
evidence of teeth marks;
    (iii) Where there is any damaged or otherwise deteriorated lead-
based paint on an impact surface that is cause by

[[Page 125]]

impact from a related building component (such as a door knob that 
knocks into a wall or a door that knocks against its door frame; and
    (iv) If there is any other deteriorated lead-based paint in any 
residential building or child-occupied facility or on the exterior of 
any residential building or child-occupied facility.
    (3) A dust-lead hazard is present in a residential dwelling or child 
occupied facility:
    (i) In a residential dwelling on floors and interior window sills 
when the weighted arithmetic mean lead loading for all single surface or 
composite samples of floors and interior window sills are equal to or 
greater than 40 mg/ft\2\ for floors and 250 mg/ft\2\ for interior window 
sills, respectively;
    (ii) On floors or interior window sills in an unsampled residential 
dwelling in a multi-family dwelling, if a dust-lead hazard is present on 
floors or interior window sills, respectively, in at least one sampled 
residential unit on the property; and
    (iii) On floors or interior window sills in an unsampled common area 
in a multi-family dwelling, if a dust-lead hazard is present on floors 
or interior window sills, respectively, in at least one sampled common 
area in the same common area group on the property.
    (4) A soil-lead hazard is present:
    (i) In a play area when the soil-lead concentration from a composite 
play area sample of bare soil is equal to or greater than 400 parts per 
million; or
    (ii) In the rest of the yard when the arithmetic mean lead 
concentration from a composite sample (or arithmetic mean of composite 
samples) of bare soil from the rest of the yard (i.e., non-play areas) 
for each residential building on a property is equal to or greater than 
1,200 parts per million.
    (i) Recordkeeping. All reports or plans required in this section 
shall be maintained by the certified firm or individual who prepared the 
report for no fewer than 3 years. The certified firm or individual also 
shall provide copies of these reports to the building owner who 
contracted for its services.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 42852, Aug. 6, 1999; 66 
FR 1239, Jan. 5, 2001; 69 FR 18496, Apr. 8, 2004]



Sec. 745.228  Accreditation of training programs: public and commercial
buildings, bridges and superstructures. [Reserved]



Sec. 745.229  Certification of individuals and firms engaged in
lead-based paint activities: public and commercial buildings, bridges
and superstructures.         
[Reserved]



Sec. 745.230  Work practice standards for conducting lead-based paint
activities: public and commercial buildings, bridges and superstructures.
[Reserved]



Sec. 745.233  Lead-based paint activities requirements.

    Lead-based paint activities, as defined in this part, shall only be 
conducted according to the procedures and work practice standards 
contained in Sec. 745.227 of this subpart. No individual or firm may 
offer to perform or perform any lead-based paint activity as defined in 
this part, unless certified to perform that activity according to the 
procedures in Sec. 745.226.



Sec. 745.235  Enforcement.

    (a) Failure or refusal to comply with any requirement of 
Sec. 745.225, Sec. 745.226, Sec. 745.227, or Sec. 745.233 is a 
prohibited act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
    (b) Failure or refusal to establish, maintain, provide, copy, or 
permit access to records or reports as required by Sec. 745.225, 
Sec. 745.226, or Sec. 745.227 is a prohibited act under sections 15 and 
409 of TSCA (15 U.S.C. 2614, 2689).
    (c) Failure or refusal to permit entry or inspection as required by 
Sec. 745.237 and section 11 of TSCA (15 U.S.C. 2610) is a prohibited act 
under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
    (d) In addition to the above, any individual or firm that performs 
any of the following acts shall be deemed to have committed a prohibited 
act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689). These 
include the following:
    (i) Obtaining certification through fraudulent representation;
    (ii) Failing to obtain certification from EPA and performing work 
requiring certification at a job site; or
    (iii) Fraudulently obtaining certification and engaging in any lead-
based paint activities requiring certification.

[[Page 126]]

    (e) Violators are subject to civil and criminal sanctions pursuant 
to section 16 of TSCA (15 U.S.C. 2615) for each violation.



Sec. 745.237  Inspections.

    EPA may conduct reasonable inspections pursuant to the provisions of 
section 11 of TSCA (15 U.S.C. 2610) to ensure compliance with this 
subpart.



Sec. 745.238  Fees for accreditation and certification of lead-based
paint activities.

    (a) Purpose. To establish and impose fees for certified individuals 
and firms engaged in lead-based paint activities and persons operating 
accredited training programs under section 402(a) of the Toxic 
Substances Control Act (TSCA).
    (b) Persons who must pay fees. Fees in accordance with paragraph (c) 
of this section must be paid by:
    (1) Training programs. (i) All non-exempt training programs applying 
to EPA for the accreditation and re-accreditation of training programs 
in one or more of the following disciplines: inspector, risk assessor, 
supervisor, project designer, abatement worker.
    (ii) Exemptions. No fee shall be imposed on any training program 
operated by a State, federally recognized Indian Tribe, local 
government, or nonprofit organization. This exemption does not apply to 
the certification of firms or individuals.
    (2) Firms and individuals. All firms and individuals seeking 
certification and re-certification from EPA to engage in lead-based 
paint activities in one or more of the following disciplines: inspector, 
risk assessor, supervisor, project designer, abatement worker.
    (c) Fee amounts--(1) Certification and accreditation fees. Initial 
and renewal certification and accreditation fees are specified in the 
following table:

------------------------------------------------------------------------
                                                       Re-accreditation
                                                        (every 4 years,
        Training Program             Accreditation        see 40 CFR
                                                       745.225(f)(1) for
                                                           details)
------------------------------------------------------------------------
Initial Course
Inspector  .....................  $870..............  $620
Risk assessor  .................  $870..............  $620
Supervisor  ....................  $870..............  $620
Worker  ........................  $870..............  $620
Project Designer  ..............  $870..............  $620
------------------------------------------------------------------------
Refresher Course
Inspector  .....................  $690..............  $580
Risk assessor  .................  $690..............  $580
Supervisor  ....................  $690..............  $580
Worker  ........................  $690..............  $580
Project Designer  ..............  $690..............  $580
------------------------------------------------------------------------
Lead-based Paint Activities--     Certification       Re-certification
 Individual                                            (every 3 years,
                                                       see 40 CFR
                                                       745.226(e)(1) for
                                                       details)
------------------------------------------------------------------------
Inspector                         $410                $410
Risk assessor...................  $410..............  $410
Supervisor......................  $410..............  $410
Worker..........................  $310..............  $310
Project designer................  $410..............  $410
Tribal certification (each        $10...............  $10
 discipline).
------------------------------------------------------------------------
Lead-based Paint Activities--     Certification       Re-certification
 Firm                                                  (every 3 years,
                                                       see 40 CFR
                                                       745.226(f)(7) for
                                                       details)
------------------------------------------------------------------------
Firm                              $550                $550
Combined Renovation and Lead-     $550                $550
 based Paint Activities Firm
 Application
Combined Renovation and Lead-     $20                 $20
 based Paint Activities Tribal
 Firm Application
Tribal Firm                       $20                 $20
------------------------------------------------------------------------


[[Page 127]]

    (2) Certification examination fee. Individuals required to take a 
certification exam in accordance with Sec. 745.226 will be assessed a 
fee of $70 for each exam attempt.
    (3) Lost identification card or certificate. A $15 fee shall be 
charged for replacement of an identification card or certificate. (See 
replacement procedure in paragraph (e) of this section.)
    (4) Accreditation amendment fees. No fee will be charged for 
accreditation amendments.
    (d) Application/payment procedure--(1) Certification and re-
certification--(i) Individuals. Submit a completed application (titled 
``Application for Individuals to Conduct Lead-based Paint Activities''), 
the materials described at Sec. 745.226, and the application fee(s) 
described in paragraph (c) of this section.
    (ii) Firms. Submit a completed application (titled ``Application for 
Firms ''), the materials described at Sec. 745.226, and the application 
fee(s) described in paragraph (c) of this section.
    (2) Accreditation and re-accreditation. Submit a completed 
application (titled ``Accreditation Application for Training 
Programs''), the materials described at Sec. 745.225, and the 
application fee described in paragraph (c) of this section.
    (3) Application forms. Application forms and instructions can be 
obtained from the National Lead Information Center at: 1-800-424-LEAD.
    (e) Identification card replacement and certificate replacement. (1) 
Parties seeking identification card or certificate replacement shall 
complete the applicable portions of the appropriate application in 
accordance with the instructions provided. The appropriate applications 
are:
    (i) Individuals. ``Application for Individuals to Conduct Lead-based 
Paint Activities.''
    (ii) Firms. ``Application for Firms.''
    (iii) Training programs. ``Accreditation Application for Training 
Programs.''
    (2) Submit application and payment in the amount specified in 
paragraph (c)(3) of this section in accordance with the instructions 
provided with the application package.
    (f) Adjustment of fees. (1) EPA will collect fees reflecting the 
costs associated with the administration and enforcement of subpart L of 
this part with the exception of costs associated with the accreditation 
of training programs operated by a State, federally recognized Indian 
Tribe, local government, and nonprofit organization. In order to do 
this, EPA will periodically adjust the fees to reflect changed economic 
conditions.
    (2) The fees will be evaluated based on the cost to administer and 
enforce the program, and the number of applicants. New fee schedules 
will be published in the Federal Register.
    (g) Failure to remit a fee. (1) EPA will not provide certification, 
re-certification, accreditation, or re-accreditation for any individual, 
firm, or training program which does not remit fees described in 
paragraph (c) of this section in accordance with the procedures 
specified in paragraph (d) of this section.
    (2) EPA will not replace identification cards or certificates for 
any individual, firm, or training program which does not remit fees 
described in paragraph (c) of this section in accordance with the 
procedures specified in paragraph (e) of this section.

[64 FR 31098, June 9, 1999, as amended at 74 FR 11870, Mar. 20, 2009; 76 
FR 47945, Aug. 5, 2011; 81 FR 7996, Feb. 17, 2016]



Sec. 745.239  Effective dates.

    This subpart L shall apply in any State or Indian Country that does 
not have an authorized program under subpart Q, effective August 31, 
1998. In such States or Indian Country:
    (a) Training programs shall not provide, offer or claim to provide 
training or refresher training for certification without accreditation 
from EPA pursuant to Sec. 745.225 on or after March 1, 1999.
    (b) No individual or firm shall perform, offer, or claim to perform 
lead-based paint activities, as defined in this subpart, without 
certification from EPA to conduct such activities pursuant to 
Sec. 745.226 on or after March 1, 2000.
    (c) All lead-based paint activities shall be performed pursuant to 
the work practice standards contained in Sec. 745.227 on or after March 
1, 2000.

[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 42852, Aug. 6, 1999]

[[Page 128]]

Subparts M-P [Reserved]



               Subpart Q_State and Indian Tribal Programs

    Source: 61 FR 45825, Aug. 29, 1996, unless otherwise noted.



Sec. 745.320  Scope and purpose.

    (a) This subpart establishes the requirements that State or Tribal 
programs must meet for authorization by the Administrator to administer 
and enforce the standards, regulations, or other requirements 
established under TSCA section 402 and/or section 406 and establishes 
the procedures EPA will follow in approving, revising, and withdrawing 
approval of State or Tribal programs.
    (b) For State or Tribal lead-based paint training and certification 
programs, a State or Indian Tribe may seek authorization to administer 
and enforce Secs. 745.225, 745.226, and 745.227. The provisions of 
Secs. 745.220, 745.223, 745.233, 745.235, 745.237, and 745.239 shall be 
applicable for the purposes of such program authorization.
    (c) A State or Indian Tribe may seek authorization to administer and 
enforce all of the provisions of subpart E of this part, just the pre-
renovation education provisions of subpart E of this part, or just the 
training, certification, accreditation, and work practice provisions of 
subpart E of this part. The provisions of Secs. 745.324 and 745.326 
apply for the purposes of such program authorizations.
    (d) A State or Indian Tribe applying for program authorization may 
seek either interim approval or final approval of the compliance and 
enforcement portion of the State or Tribal lead-based paint program 
pursuant to the procedures at Sec. 745.327(a).
    (e) State or Tribal submissions for program authorization shall 
comply with the procedures set out in this subpart.
    (f) Any State or Tribal program approved by the Administrator under 
this subpart shall at all times comply with the requirements of this 
subpart.
    (g) In many cases States will lack authority to regulate activities 
in Indian Country. This lack of authority does not impair a State's 
ability to obtain full program authorization in accordance with this 
subpart. EPA will administer the program in Indian Country if neither 
the State nor Indian Tribe has been granted program authorization by 
EPA.

[61 FR 45825, Aug. 29, 1996, as amended at 73 FR 21767, Apr. 22, 2008]



Sec. 745.323  Definitions.

    The definitions in subpart A apply to this subpart. In addition, the 
definitions in Sec. 745.223 and the following definitions apply:
    Indian Country means (1) all land within the limits of any American 
Indian reservation under the jurisdiction of the U.S. government, 
notwithstanding the issuance of any patent, and including rights-of-way 
running throughout the reservation; (2) all dependent Indian communities 
within the borders of the United States whether within the original or 
subsequently acquired territory thereof, and whether within or outside 
the limits of a State; and (3) all Indian allotments, the Indian titles 
which have not been extinguished, including rights-of-way running 
through the same.
    Indian Tribe means any Indian Tribe, band, nation, or community 
recognized by the Secretary of the Interior and exercising substantial 
governmental duties and powers.



Sec. 745.324  Authorization of State or Tribal programs.

    (a) Application content and procedures. (1) Any State or Indian 
Tribe that seeks authorization from EPA to administer and enforce the 
provisions of subpart E or subpart L of this part must submit an 
application to the Administrator in accordance with this paragraph.
    (2) Before developing an application for authorization, a State or 
Indian Tribe shall disseminate a public notice of intent to seek such 
authorization and provide an opportunity for a public hearing.
    (3) A State or Tribal application shall include:
    (i) A transmittal letter from the State Governor or Tribal 
Chairperson (or equivalent official) requesting program approval.

[[Page 129]]

    (ii) A summary of the State or Tribal program. This summary will be 
used to provide notice to residents of the State or Tribe.
    (iii) A description of the State or Tribal program in accordance 
with paragraph (b) of this section.
    (iv) An Attorney General's or Tribal Counsel's (or equivalent) 
statement in accordance with paragraph (c) of this section.
    (v) Copies of all applicable State or Tribal statutes, regulations, 
standards, and other materials that provide the State or Indian Tribe 
with the authority to administer and enforce a lead-based paint program.
    (4) After submitting an application, the Agency will publish a 
Federal Register notice that contains an announcement of the receipt of 
the State or Tribal application, the summary of the program as provided 
by the State or Tribe, and a request for public comments to be mailed to 
the appropriate EPA Regional Office. This comment period shall last for 
no less than 45 days. EPA will consider these comments during its review 
of the State or Tribal application.
    (5) Within 60 days of submission of a State or Tribal application, 
EPA will, if requested, conduct a public hearing in each State or Indian 
Country seeking program authorization and will consider all comments 
submitted at that hearing during the review of the State or Tribal 
application.
    (b) Program description. A State or Indian Tribe seeking to 
administer and enforce a program under this subpart must submit a 
description of the program. The description of the State or Tribal 
program must include:
    (1)(i) The name of the State or Tribal agency that is or will be 
responsible for administering and enforcing the program, the name of the 
official in that agency designated as the point of contact with EPA, and 
addresses and phone numbers where this official can be contacted.
    (ii) Where more than one agency is or will be responsible for 
administering and enforcing the program, the State or Indian Tribe must 
designate a primary agency to oversee and coordinate administration and 
enforcement of the program and serve as the primary contact with EPA.
    (iii) In the event that more than one agency is or will be 
responsible for administering and enforcing the program, the application 
must also include a description of the functions to be performed by each 
agency. The desciption shall explain and how the program will be 
coordinated by the primary agency to ensure consistency and effective 
administration of the within the State or Indian Tribe.
    (2) To demonstrate that the State or Tribal program is at least as 
protective as the Federal program, fulfilling the criteria in paragraph 
(e)(2)(i) of this section, the State or Tribal application must include:
    (i) A description of the program that demonstrates that the program 
contains all of the elements specified in Sec. 745.325, Sec. 745.326, or 
both; and
    (ii) An analysis of the State or Tribal program that compares the 
program to the Federal program in subpart E or subpart L of this part, 
or both. This analysis must demonstrate how the program is, in the 
State's or Indian Tribe's assessment, at least as protective as the 
elements in the Federal program at subpart E or subpart L of this part, 
or both. EPA will use this analysis to evaluate the protectiveness of 
the State or Tribal program in making its determination pursuant to 
paragraph (e)(2)(i) of this section.
    (3) To demonstrate that the State or Tribal program provides 
adequate enforcement, fulfilling the criteria in paragraph (e)(2)(ii) of 
this section, the State or Tribal application must include a description 
of the State or Tribal lead-based paint compliance and enforcement 
program that demonstrates that the program contains all of the elements 
specified at Sec. 745.327. This description shall include copies of all 
policies, certifications, plans, reports, and other materials that 
demonstrate that the State or Tribal program contains all of the 
elements specified at Sec. 745.327.
    (4)(i) The program description for an Indian Tribe shall also 
include a map, legal description, or other information sufficient to 
identify the geographical extent of the territory over which the Indian 
Tribe exercises jurisdiction.

[[Page 130]]

    (ii) The program description for an Indian Tribe shall also include 
a demonstration that the Indian Tribe:
    (A) Is recognized by the Secretary of the Interior.
    (B) has an existing government exercising substantial governmental 
duties and powers.
    (C) has adequate civil regulatory jurisdiction (as shown in the 
Tribal legal certification in paragraph (c)(2) of this section) over the 
subject matter and entities regulated.
    (D) is reasonably expected to be capable of administering the 
Federal program for which it is seeking authorization.
    (iii) If the Administrator has previously determined that an Indian 
Tribe has met the prerequisites in paragraphs (b)(4)(ii)(A) and (B) of 
this section for another EPA program, the Indian Tribe need provide only 
that information unique to the lead-based paint program required by 
paragraphs (b)(4)(ii)(C) and (D) of this section.
    (c) Attorney General's statement. (1) A State or Indian Tribe must 
submit a written statement signed by the Attorney General or Tribal 
Counsel (or equivalent) certifying that the laws and regulations of the 
State or Indian Tribe provide adequate legal authority to administer and 
enforce the State or Tribal program. This statement shall include 
citations to the specific statutes and regulations providing that legal 
authority.
    (2) The Tribal legal certification (the equivalent to the Attorney 
General's statement) may also be submitted and signed by an independent 
attorney retained by the Indian Tribe for representation in matters 
before EPA or the courts pertaining to the Indian Tribe's program. The 
certification shall include an assertion that the attorney has the 
authority to represent the Indian Tribe with respect to the Indian 
Tribe's authorization application.
    (3) If a State application seeks approval of its program to operate 
in Indian Country, the required legal certification shall include an 
analysis of the applicant's authority to implement its provisions in 
Indian Country. The applicant shall include a map delineating the area 
over which it seeks to operate the program.
    (d) Program certification. (1) At the time of submitting an 
application, a State may also certify to the Administrator that the 
State program meets the requirements contained in paragraphs (e)(2)(i) 
and (e)(2)(ii) of this section.
    (2) If this certification is contained in a State's application, the 
program shall be deemed to be authorized by EPA until such time as the 
Administrator disapproves the program application or withdraws the 
program authorization. A program shall not be deemed authorized pursuant 
to this subpart to the extent that jurisdiction is asserted over Indian 
Country, including non-member fee lands within an Indian reservation.
    (3) If the application does not contain such certification, the 
State program will be authorized only after the Administrator authorizes 
the program in accordance with paragraph (e) of this section.
    (4) This certification shall take the form of a letter from the 
Governor or the Attorney General to the Administrator. The certification 
shall reference the program analysis in paragraph (b)(3) of this section 
as the basis for concluding that the State program is at least as 
protective as the Federal program, and provides adequate enforcement.
    (e) EPA approval. (1) EPA will fully review and consider all 
portions of a State or Tribal application.
    (2) Within 180 days of receipt of a complete State or Tribal 
application, the Administrator shall either authorize the program or 
disapprove the application. The Administrator shall authorize the 
program, after notice and the opportunity for public comment and a 
public hearing, only if the Administrator finds that:
    (i) The State or Tribal program is at least as protective of human 
health and the environment as the corresponding Federal program under 
subpart E or subpart L of this part, or both; and
    (ii) The State or Tribal program provides adequate enforcement.
    (3) EPA shall notify in writing the State or Indian Tribe of the 
Administrator's decision to authorize the State

[[Page 131]]

or Tribal program or disapprove the State's or Indian Tribe's 
application.
    (4) If the State or Indian Tribe applies for authorization of State 
or Tribal programs under both subpart E and subpart L, EPA may, as 
appropriate, authorize one program and disapprove the other.
    (f) EPA administration and enforcement. (1) If a State or Indian 
Tribe does not have an authorized program to administer and enforce 
subpart L of this part in effect by August 31, 1998, the Administrator 
shall, by such date, establish and enforce the provisions of subpart L 
of this part as the Federal program for that State or Indian Country.
    (2) If a State or Indian Tribe does not have an authorized program 
to administer and enforce the pre-renovation education requirements of 
subpart E of this part by August 31, 1998, the Administrator will, by 
such date, enforce those provisions of subpart E of this part as the 
Federal program for that State or Indian Country. If a State or Indian 
Tribe does not have an authorized program to administer and enforce the 
training, certification and accreditation requirements and work practice 
standards of subpart E of this part by April 22, 2009, the Administrator 
will, by such date, enforce those provisions of subpart E of this part 
as the Federal program for that State or Indian Country.
    (3) Upon authorization of a State or Tribal program, pursuant to 
paragraph (d) or (e) of this section, it shall be an unlawful act under 
sections 15 and 409 of TSCA for any person to fail or refuse to comply 
with any requirements of such program.
    (g) Oversight. EPA shall periodically evaluate the adequacy of a 
State's or Indian Tribe's implementation and enforcement of its 
authorized programs.
    (h) Reports. Beginning 12 months after the date of program 
authorization, the primary agency for each State or Indian Tribe that 
has an authorized program shall submit a written report to the EPA 
Regional Administrator for the Region in which the State or Indian Tribe 
is located. This report shall be submitted at least once every 12 months 
for the first 3 years after program authorization. If these reports 
demonstrate successful program implementation, the Agency will 
automatically extend the reporting interval to every 2 years. If the 
subsequent reports demonstrate problems with implementation, EPA will 
require a return to annual reporting until the reports demonstrate 
successful program implementation, at which time the Agency will extend 
the reporting interval to every 2 years.
    The report shall include the following information:
    (1) Any significant changes in the content or administration of the 
State or Tribal program implemented since the previous reporting period; 
and
    (2) All information regarding the lead-based paint enforcement and 
compliance activities listed at Sec. 745.327(d) ``Summary on Progress 
and Performance.''
    (i) Withdrawal of authorization. (1) If EPA concludes that a State 
or Indian Tribe is not administering and enforcing an authorized program 
in compliance with the standards, regulations, and other requirements of 
sections 401 through 412 of TSCA and this subpart, the Administrator 
shall notify the primary agency for the State or Indian Tribe in writing 
and indicate EPA's intent to withdraw authorization of the program.
    (2) The Notice of Intent to Withdraw shall:
    (i) Identify the program aspects that EPA believes are inadequate 
and provide a factual basis for such findings.
    (ii) Include copies of relevant documents.
    (iii) Provide an opportunity for the State or Indian Tribe to 
respond either in writing or at a meeting with appropriate EPA 
officials.
    (3) EPA may request that an informal conference be held between 
representatives of the State or Indian Tribe and EPA officials.
    (4) Prior to issuance of a withdrawal, a State or Indian Tribe may 
request that EPA hold a public hearing. At this hearing, EPA, the State 
or Indian Tribe, and the public may present facts bearing on whether the 
State's or Indian Tribe's authorization should be withdrawn.
    (5) If EPA finds that deficiencies warranting withdrawal did not 
exist or

[[Page 132]]

were corrected by the State or Indian Tribe, EPA may rescind its Notice 
of Intent to Withdraw authorization.
    (6) Where EPA finds that deficiencies in the State or Tribal program 
exist that warrant withdrawal, an agreement to correct the deficiencies 
shall be jointly prepared by the State or Indian Tribe and EPA. The 
agreement shall describe the deficiencies found in the program, specify 
the steps the State or Indian Tribe has taken or will take to remedy the 
deficiencies, and establish a schedule, no longer than 180 days, for 
each remedial action to be initiated.
    (7) If the State or Indian Tribe does not respond within 60 days of 
issuance of the Notice of Intent to Withdraw or an agreement is not 
reached within 180 days after EPA determines that a State or Indian 
Tribe is not in compliance with the Federal program, the Agency shall 
issue an order withdrawing the State's or Indian Tribe's authorization.
    (8) By the date of such order, the Administrator will establish and 
enforce the provisions of subpart E or subpart L of this part, or both, 
as the Federal program for that State or Indian Country.

[61 FR 45825, Aug. 29, 1996, as amended at 73 FR 21767, Apr. 22, 2008]



Sec. 745.325  Lead-based paint activities: State and Tribal program
requirements.

    (a) Program elements. To receive authorization from EPA, a State or 
Tribal program must contain at least the following program elements for 
lead-based paint activities:
    (1) Procedures and requirements for the accreditation of lead-based 
paint activities training programs.
    (2) Procedures and requirements for the certification of individuals 
engaged in lead-based paint activities.
    (3) Work practice standards for the conduct of lead-based paint 
activities.
    (4) Requirements that all lead-based paint activities be conducted 
by appropriately certified contractors.
    (5) Development of the appropriate infrastructure or government 
capacity to effectively carry out a State or Tribal program.
    (b) Accreditation of training programs. The State or Indian Tribe 
must have either:
    (1) Procedures and requirements for the accreditation of training 
programs that establish:
    (i) Requirements for the accreditation of training programs, 
including but not limited to:
    (A) Training curriculum requirements.
    (B) Training hour requirements.
    (C) Hands-on training requirements.
    (D) Trainee competency and proficiency requirements.
    (E) Requirements for training program quality control.
    (ii) Procedures for the re-accreditation of training programs.
    (iii) Procedures for the oversight of training programs.
    (iv) Procedures for the suspension, revocation, or modification of 
training program accreditations; or
    (2) Procedures or regulations, for the purposes of certification, 
for the acceptance of training offered by an accredited training 
provider in a State or Tribe authorized by EPA.
    (c) Certification of individuals. The State or Indian Tribe must 
have requirements for the certification of individuals that:
    (1) Ensure that certified individuals:
    (i) Are trained by an accredited training program; and
    (ii) Possess appropriate education or experience qualifications for 
certification.
    (2) Establish procedures for re-certification.
    (3) Require the conduct of lead-based paint activities in accordance 
with work practice standards established by the State or Indian Tribe.
    (4) Establish procedures for the suspension, revocation, or 
modification of certifications.
    (5) Establish requirements and procedures for the administration of 
a third-party certification exam.
    (d) Work practice standards for the conduct of lead-based paint 
activities. The State or Indian Tribe must have requirements or 
standards that ensure that lead-based paint activities are conducted 
reliably, effectively, and safely. At a minimum the State's or Indian 
Tribe's work practice standards

[[Page 133]]

for conducting inspections, risk assessments, and abatements must 
contain the requirements specified in paragraphs (d)(1), (d)(2), and 
(d)(3) of this section.
    (1) The work practice standards for the inspection for the presence 
of lead-based paint must require that:
    (i) Inspections are conducted only by individuals certified by the 
appropriate State or Tribal authority to conduct inspections.
    (ii) Inspections are conducted in a way that identifies the presence 
of lead-based paint on painted surfaces within the interior or on the 
exterior of a residential dwelling or child-occupied facility.
    (iii) Inspections are conducted in a way that uses documented 
methodologies that incorporate adequate quality control procedures.
    (iv) A report is developed that clearly documents the results of the 
inspection.
    (v) Records are retained by the certified inspector or the firm.
    (2) The work practice standards for risk assessment must require 
that:
    (i) Risk assessments are conducted only by individuals certified by 
the appropriate State or Tribal authority to conduct risk assessments.
    (ii) Risk assessments are conducted in a way that identifies and 
reports the presence of lead-based paint hazards.
    (iii) Risk assessments consist of, at least:
    (A) An assessment, including a visual inspection, of the physical 
characteristics of the residential dwelling or child-occupied facility;
    (B) Environmental sampling for lead in paint, dust, and soil;
    (C) Environmental sampling requirements for lead in paint, dust, and 
soil that allow for comparison to the standards for lead-based paint 
hazards established or revised by the State or Indian Tribe pursuant to 
paragraph (e) of this section; and
    (D) A determination of the presence of lead-based paint hazards made 
by comparing the results of visual inspection and environmental sampling 
to the standards for lead-based paint hazards established or revised by 
the State or Indian Tribe pursuant to paragraph (e) of this section.
    (iv) The program elements required in paragraph (d)(2)(iii)(C) and 
(d)(2)(iii)(D) of this section shall be adopted in accordance with the 
schedule for the demonstration required in paragraph (e) of this 
section.
    (v) The risk assessor develops a report that clearly presents the 
results of the assessment and recommendations for the control or 
elimination of all identified hazards.
    (vi) The certified risk assessor or the firm retains the appropriate 
records.
    (3) The work practice standards for abatement must require that:
    (i) Abatements are conducted only by individuals certified by the 
appropriate State or Tribal authority to conduct or supervise 
abatements.
    (ii) Abatements permanently eliminate lead-based paint hazards and 
are conducted in a way that does not increase the hazards of lead-based 
paint to the occupants of the dwelling or child-occupied facility.
    (iii) Abatements include post-abatement lead in dust clearance 
sampling and conformance with clearance levels established or adopted by 
the State or Indian Tribe.
    (iv) The abatement contractor develops a report that describes areas 
of the residential dwelling or child-occupied facility abated and the 
techniques employed.
    (v) The certified abatement contractor or the firm retains 
appropriate records.
    (e) The State or Indian Tribe must demonstrate that it has standards 
for identifying lead-based paint hazards and clearance standards for 
dust, that are at least as protective as the standards in Sec. 745.227 
as amended on February 5, 2001. A State or Indian Tribe with such a 
section 402 program approved before February 5, 2003 shall make this 
demonstration no later than the first report submitted pursuant to 
Sec. 745.324(h) on or after February 5, 2003. A State or Indian Tribe 
with such a program submitted but not approved before February 5, 2003 
may make this demonstration by amending its application or in its first 
report submitted pursuant to Sec. 745.324(h). A State or Indian Tribe 
submitting its program on

[[Page 134]]

or after February 5, 2003 shall make this demonstration in its 
application.

[61 FR 45825, Aug. 29, 1996, as amended at 66 FR 1240, Jan. 5, 2001]



Sec. 745.326  Renovation: State and Tribal program requirements.

    (a) Program elements. To receive authorization from EPA, a State or 
Tribal program must contain the following program elements:
    (1) For pre-renovation education programs, procedures and 
requirements for the distribution of lead hazard information to owners 
and occupants of target housing and child-occupied facilities before 
renovations for compensation.
    (2) For renovation training, certification, accreditation, and work 
practice standards programs:
    (i) Procedures and requirements for the accreditation of renovation 
and dust sampling technician training programs. A State and Tribal 
program is not required to include procedures and requirements for the 
dust sampling technician training discipline if the State or Tribal 
program requires dust sampling to be performed by a certified lead-based 
paint inspector or risk assessor.
    (ii) Procedures and requirements for accredited initial and 
refresher training for renovators and dust sampling technicians and on-
the-job training for other individuals who perform renovations.
    (iii) Procedures and requirements for the certification of 
individuals and/or firms.
    (iv) Requirements that all renovations be conducted by appropriately 
certified individuals and/or firms.
    (v) Work practice standards for the conduct of renovations.
    (3) For all renovation programs, development of the appropriate 
infrastructure or government capacity to effectively carry out a State 
or Tribal program.
    (b) Pre-renovation education. To be considered at least as 
protective as the Federal program, the State or Tribal program must:
    (1) Establish clear standards for identifying renovation activities 
that trigger the information distribution requirements.
    (2) Establish procedures for distributing the lead hazard 
information to owners and occupants of housing and child-occupied 
facilities prior to renovation activities.
    (3) Require that the information to be distributed include either 
the pamphlet titled Renovate Right: Important Lead Hazard Information 
for Families, Child Care Providers and Schools, developed by EPA under 
section 406(a) of TSCA, or an alternate pamphlet or package of lead 
hazard information that has been submitted by the State or Tribe, 
reviewed by EPA, and approved by EPA for that State or Tribe. Such 
information must contain renovation-specific information similar to that 
in Renovate Right: Important Lead Hazard Information for Families, Child 
Care Providers and Schools, must meet the content requirements 
prescribed by section 406(a) of TSCA, and must be in a format that is 
readable to the diverse audience of housing and child-occupied facility 
owners and occupants in that State or Tribe.
    (i) A State or Tribe with a pre-renovation education program 
approved before June 23, 2008, must demonstrate that it meets the 
requirements of this section no later than the first report that it 
submits pursuant to Sec. 745.324(h) on or after April 22, 2009.
    (ii) A State or Tribe with an application for approval of a pre-
renovation education program submitted but not approved before June 23, 
2008, must demonstrate that it meets the requirements of this section 
either by amending its application or in the first report that it 
submits pursuant to Sec. 745.324(h) of this part on or after April 22, 
2009.
    (iii) A State or Indian Tribe submitting its application for 
approval of a pre-renovation education program on or after June 23, 
2008, must demonstrate in its application that it meets the requirements 
of this section.
    (c) Accreditation of training programs. To be considered at least as 
protective as the Federal program, the State or Tribal program must meet 
the requirements of either paragraph (c)(1) or (c)(2) of this section:
    (1) The State or Tribal program must establish accreditation 
procedures and requirements, including:

[[Page 135]]

    (i) Procedures and requirements for the accreditation of training 
programs, including, but not limited to:
    (A) Training curriculum requirements.
    (B) Training hour requirements.
    (C) Hands-on training requirements.
    (D) Trainee competency and proficiency requirements.
    (E) Requirements for training program quality control.
    (ii) Procedures and requirements for the re-accreditation of 
training programs.
    (iii) Procedures for the oversight of training programs.
    (iv) Procedures and standards for the suspension, revocation, or 
modification of training program accreditations; or
    (2) The State or Tribal program must establish procedures and 
requirements for the acceptance of renovation training offered by 
training providers accredited by EPA or a State or Tribal program 
authorized by EPA under this subpart.
    (d) Certification of individuals and/or renovation firms. To be 
considered at least as protective as the Federal program, the State or 
Tribal program must:
    (1) Establish procedures and requirements that ensure that 
individuals who perform or direct renovations are properly trained. 
These procedures and requirements must include:
    (i) A requirement that renovations be performed and directed by at 
least one individual who has been trained by an accredited training 
program.
    (ii) Procedures and requirements for accredited refresher training 
for these individuals.
    (iii) Procedures and requirements for individuals who have received 
accredited training to provide on-the-job training for those individuals 
who perform renovations but do not receive accredited training. A State 
and Tribal program is not required to include procedures and 
requirements for on-the-job training for renovation workers if the State 
or Tribal program requires accredited initial and refresher training for 
all persons who perform renovations.
    (2) Establish procedures and requirements for the formal 
certification and re-certification of renovation firms.
    (3) Establish procedures for the suspension, revocation, or 
modification of certifications.
    (e) Work practice standards for renovations. To be considered at 
least as protective as the Federal program, the State or Tribal program 
must establish standards that ensure that renovations are conducted 
reliably, effectively, and safely. At a minimum, the State or Tribal 
program must contain the following requirements:
    (1) Renovations must be conducted only by certified renovation 
firms, using trained individuals.
    (2) Renovations are conducted using lead-safe work practices that 
are at least as protective to occupants as the requirements in 
Sec. 745.85.
    (3) Certified individuals and/or renovation firms must retain 
appropriate records.
    (f) Revisions to renovation program requirements. When EPA publishes 
in the Federal Register revisions to the renovation program requirements 
contained in subparts E and L of this part:
    (1) A State or Tribe with a renovation program approved before the 
effective date of the revisions to the renovation program requirements 
in subparts E and L of this part must demonstrate that it meets the 
requirements of this section no later than the first report that it 
submits pursuant to Sec. 745.324(h) but no later than 2 years after the 
effective date of the revisions.
    (2) A State or Tribe with an application for approval of a 
renovation program submitted but not approved before the effective date 
of the revisions to the renovation program requirements in subparts E 
and L of this part must demonstrate that it meets the requirements of 
this section either by amending its application or in the first report 
that it submits pursuant to Sec. 745.324(h) of this part but no later 
than 2 years after the effective date of the revisions.
    (3) A State or Tribe submitting its application for approval of a 
renovation program on or after the effective date of the revisions must 
demonstrate

[[Page 136]]

in its application that it meets the requirements of the new renovation 
program requirements in subparts E and L of this part.

[73 FR 21768, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76 
FR 47945, Aug. 5, 2011]



Sec. 745.327  State or Indian Tribal lead-based paint compliance and
enforcement programs.

    (a) Approval of compliance and enforcement programs. A State or 
Indian Tribe seeking authorization of a lead-based paint program can 
apply for and receive either interim or final approval of the compliance 
and enforcement program portion of its lead-based paint program. Indian 
Tribes are not required to exercise criminal enforcement jurisdiction as 
a condition for program authorization.
    (1) Interim approval. Interim approval of the compliance and 
enforcement program portion of the State or Tribal lead-based paint 
program may be granted by EPA only once, and subject to a specific 
expiration date.
    (i) To be considered adequate for purposes of obtaining interim 
approval for the compliance and enforcement program portion of a State 
or Tribal lead-based paint program, a State or Indian Tribe must, in its 
application described at Sec. 745.324(a):
    (A) Demonstrate it has the legal authority and ability to 
immediately implement the elements in paragraph (b) of this section. 
This demonstration shall include a statement that the State or Indian 
Tribe, during the interim approval period, shall carry out a level of 
compliance monitoring and enforcement necessary to ensure that the State 
or Indian Tribe addresses any significant risks posed by noncompliance 
with lead-based paint activity requirements.
    (B) Present a plan with time frames identified for implementing in 
the field each element in paragraph (c) of this section. All elements of 
paragraph (c) of this section must be fully implemented no later than 3 
years from the date of EPA's interim approval of the compliance and 
enforcement program portion of a State or Tribal lead-based paint 
program. A statement of resources must be included in the State or 
Tribal plan which identifies what resources the State or Indian Tribe 
intends to devote to the administration of its lead-based paint 
compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (ii) Any interim approval granted by EPA for the compliance and 
enforcement program portion of a State or Tribal lead-based paint 
program will expire no later than 3 years from the date of EPA's interim 
approval. One hundred and eighty days prior to this expiration date, a 
State or Indian Tribe shall apply to EPA for final approval of the 
compliance and enforcement program portion of a State or Tribal lead-
based paint program. Final approval shall be given to any State or 
Indian Tribe which has in place all of the elements of paragraphs (b), 
(c), and (d) of this section. If a State or Indian Tribe does not 
receive final approval for the compliance and enforcement program 
portion of a State or Tribal lead-based paint program by the date 3 
years after the date of EPA's interim approval, the Administrator shall, 
by such date, initiate the process to withdraw the State or Indian 
Tribe's authorization pursuant to Sec. 745.324(i).
    (2) Final approval. Final approval of the compliance and enforcement 
program portion of a State or Tribal lead-based paint program can be 
granted by EPA either through the application process described at 
Sec. 745.324(a), or, for States or Indian Tribes which previously 
received interim approval as described in paragraph (a)(1) of this 
section, through a separate application addressing only the compliance 
and enforcement program portion of a State or Tribal lead-based paint 
program.
    (i) For the compliance and enforcement program to be considered 
adequate for final approval through the application described at 
Sec. 745.324(a), a State or Indian Tribe must, in its application:
    (A) Demonstrate it has the legal authority and ability to 
immediately implement the elements in paragraphs (b) and (c) of this 
section.

[[Page 137]]

    (B) Submit a statement of resources which identifies what resources 
the State or Indian Tribe intends to devote to the administration of its 
lead-based paint compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (ii) For States or Indian Tribes which previously received interim 
approval as described in paragraph (a)(1) of this section, in order for 
the State or Tribal compliance and enforcement program to be considered 
adequate for final approval through a separate application addressing 
only the compliance and enforcement program portion of a State or Tribal 
lead-based paint program, a State or Indian Tribe must, in its 
application:
    (A) Demonstrate that it has the legal authority and ability to 
immediately implement the elements in paragraphs (b) and (c) of this 
section.
    (B) Submit a statement which identifies the resources the State or 
Indian Tribe intends to devote to the administration of its lead-based 
paint compliance and enforcement program.
    (C) Agree to submit to EPA the Summary on Progress and Performance 
of lead-based paint compliance and enforcement activities as described 
at paragraph (d) of this section.
    (D) To the extent not previously submitted through the application 
described at Sec. 745.324(a), submit copies of all applicable State or 
Tribal statutes, regulations, standards, and other material that provide 
the State or Indian Tribe with authority to administer and enforce the 
lead-based paint compliance and enforcement program, and copies of the 
policies, certifications, plans, reports, and any other documents that 
demonstrate that the program meets the requirements established in 
paragraphs (b) and (c) of this section.
    (b) Standards, regulations, and authority. The standards, 
regulations, and authority described in paragraphs (b)(1) through (b)(4) 
of this section are part of the required elements for the compliance and 
enforcement portion of a State or Tribal lead-based paint program.
    (1) Lead-based paint activities or renovation requirements. State or 
Tribal lead-based paint compliance and enforcement programs will be 
considered adequate if the State or Indian Tribe demonstrates, in its 
application at Sec. 745.324(b)(2), that it has established a lead-based 
paint program that contains all of the elements specified in 
Sec. 745.325 or Sec. 745.326, or both, as applicable.
    (2) Authority to enter. State or Tribal officials must be able to 
enter, through consent, warrant, or other authority, premises or 
facilities where lead-based paint violations may occur for purposes of 
conducting inspections.
    (i) State or Tribal officials must be able to enter premises or 
facilities where those engaged in training for lead-based paint 
activities or renovations conduct business.
    (ii) For the purposes of enforcing a renovation program, State or 
Tribal officials must be able to enter a firm's place of business or 
work site.
    (iii) State or Tribal officials must have authority to take samples 
and review records as part of the lead-based paint inspection process.
    (3) Flexible remedies. A State or Tribal lead-based paint compliance 
and enforcement program must provide for a diverse and flexible array of 
enforcement statutory and regulatory authorities and remedies. At a 
minimum, these authorities and remedies, which must also be reflected in 
an enforcement response policy, must include the following:
    (i) The authority to issue warning letters, Notices of 
Noncompliance, Notices of Violation, or the equivalent;
    (ii) The authority to assess administrative or civil fines, 
including a maximum penalty authority for any violation in an amount no 
less than $5,000 per violation per day;
    (iii) The authority to assess the maximum penalties or fines for 
each instance of violation and, if the violation is continuous, the 
authority to assess penalties or fines up to the maximum amount for each 
day of violation, with all penalties assessed or collected being 
appropriate for the violation after consideration of factors as the 
State or

[[Page 138]]

Tribe determine to be relevant, including the size or viability of the 
business, enforcement history, risks to human health or the environment 
posed by the violation, and other similar factors;
    (iv) The authority to commence an administrative proceeding or to 
sue in courts of competent jurisdiction to recover penalties;
    (v) The authority to suspend, revoke, or modify the accreditation of 
any training provider or the certification of any individual or firm;
    (vi) The authority to commence an administrative proceeding or to 
sue in courts of competent jurisdiction to enjoin any threatened or 
continuing violation of any program requirement, without the necessity 
of a prior suspension or revocation of a trainer's accreditation or a 
firm's or individual's certification;
    (vii) The authority to apply criminal sanctions, including 
recovering fines; and
    (viii) The authority to enforce its authorized program using a 
burden of proof standard, including the degree of knowledge or intent of 
the respondent that is no greater than it is for EPA under TSCA.
    (4) Adequate resources. An application must include a statement that 
identifies the resources that will be devoted by the State or Indian 
Tribe to the administration of the State or Tribal lead-based paint 
compliance and enforcement program. This statement must address fiscal 
and personnel resources that will be devoted to the program.
    (c) Performance elements. The performance elements described in 
paragraphs (c)(1) through (c)(7) of this section are part of the 
required elements for the compliance and enforcement program portion of 
a State or Tribal lead-based paint program.
    (1) Training. A State or Tribal lead-based paint compliance and 
enforcement program must implement a process for training enforcement 
and inspection personnel and ensure that enforcement personnel and 
inspectors are well trained. Enforcement personnel must understand case 
development procedures and the maintenance of proper case files. 
Inspectors must successfully demonstrate knowledge of the requirements 
of the particular discipline (e.g., abatement supervisor, and/or 
abatement worker, and/or lead-based paint inspector, and/or risk 
assessor, and/or project designer) for which they have compliance 
monitoring and enforcement responsibilities. Inspectors must also be 
trained in violation discovery, methods of obtaining consent, evidence 
gathering, preservation of evidence and chain-of-custody, and sampling 
procedures. A State or Tribal lead-based paint compliance and 
enforcement program must also implement a process for the continuing 
education of enforcement and inspection personnel.
    (2) Compliance assistance. A State or Tribal lead-based paint 
compliance and enforcement program must provide compliance assistance to 
the public and the regulated community to facilitate awareness and 
understanding of and compliance with State or Tribal requirements 
governing the conduct of lead-based paint activities or renovations. The 
type and nature of this assistance can be defined by the State or Indian 
Tribe to achieve this goal.
    (3) Sampling techniques. A State or Tribal lead-based paint 
compliance and enforcement program must have the technological 
capability to ensure compliance with the lead-based paint program 
requirements. A State or Tribal application for approval of a lead-based 
paint program must show that the State or Indian Tribe is 
technologically capable of conducting a lead-based paint compliance and 
enforcement program. The State or Tribal program must have access to the 
facilities and equipment necessary to perform sampling and laboratory 
analysis as needed. This laboratory facility must be a recognized 
laboratory as defined at Sec. 745.223, or the State or Tribal program 
must implement a quality assurance program that ensures appropriate 
quality of laboratory personnel and protects the integrity of analytical 
data.
    (4) Tracking tips and complaints. A State or Tribal lead-based paint 
compliance and enforcement program must demonstrate the ability to 
process and react to tips and complaints or other information indicating 
a violation.
    (5) Targeting inspections. A State or Tribal lead-based paint 
compliance and

[[Page 139]]

enforcement program must demonstrate the ability to target inspections 
to ensure compliance with the lead-based paint program requirements. 
Such targeting must include a method for obtaining and using 
notifications of commencement of abatement activities.
    (6) Follow up to inspection reports. A State or Tribal lead-based 
paint compliance and enforcement program must demonstrate the ability to 
reasonably, and in a timely manner, process and follow-up on inspection 
reports and other information generated through enforcement-related 
activities associated with a lead-based paint program. The State or 
Tribal program must be in a position to ensure correction of violations 
and, as appropriate, effectively develop and issue enforcement remedies/
responses to follow up on the identification of violations.
    (7) Compliance monitoring and enforcement. A State or Tribal lead-
based paint compliance and enforcement program must demonstrate, in its 
application for approval, that it is in a position to implement a 
compliance monitoring and enforcement program. Such a compliance 
monitoring and enforcement program must ensure correction of violations, 
and encompass either planned and/or responsive lead-based paint 
compliance inspections and development/issuance of State or Tribal 
enforcement responses which are appropriate to the violations.
    (d) Summary on Progress and Performance. The Summary on Progress and 
Performance described below is part of the required elements for the 
compliance and enforcement program portion of a State or Tribal lead-
based paint program. A State or Tribal lead-based paint compliance and 
enforcement program must submit to the appropriate EPA Regional 
Administrator a report which summarizes the results of implementing the 
State or Tribal lead-based paint compliance and enforcement program, 
including a summary of the scope of the regulated community within the 
State or Indian Tribe (which would include the number of individuals and 
firms certified in lead-based paint activities and the number of 
training programs accredited), the inspections conducted, enforcement 
actions taken, compliance assistance provided, and the level of 
resources committed by the State or Indian Tribe to these activities. 
The report shall be submitted according to the requirements at 
Sec. 745.324(h).
    (e) Memorandum of Agreement. An Indian Tribe that obtains program 
approval must establish a Memorandum of Agreement with the Regional 
Administrator. The Memorandum of Agreement shall be executed by the 
Indian Tribe's counterpart to the State Director (e.g., the Director of 
Tribal Environmental Office, Program or Agency). The Memorandum of 
Agreement must include provisions for the timely and appropriate 
referral to the Regional Administrator for those criminal enforcement 
matters where that Indian Tribe does not have the authority (e.g., those 
addressing criminal violations by non-Indians or violations meriting 
penalties over $5,000). The Agreement must also identify any enforcement 
agreements that may exist between the Indian Tribe and any State.
    (f) Electronic reporting under State or Indian Tribe programs. 
States and tribes that choose to receive electronic documents under the 
authorized state or Indian tribe lead-based paint program, must ensure 
that the requirements of 40 CFR part 3--(Electronic reporting) are 
satisfied in their lead-based paint program.

[61 FR 45825, Aug. 29, 1996, as amended at 70 FR 59889, Oct. 13, 2005; 
73 FR 21769, Apr. 22, 2008; 76 FR 47946, Aug. 5, 2011]



Sec. 745.339  Effective date.

    States and Indian Tribes may seek authorization to administer and 
enforce subpart L of this part pursuant to this subpart at any time. 
States and Indian Tribes may seek authorization to administer and 
enforce the pre-renovation education provisions of subpart E of this 
part pursuant to this subpart at any time. States and Indian Tribes may 
seek authorization to administer and enforce all of subpart E of this 
part pursuant to this subpart effective June 23, 2008.

[73 FR 21769, Apr. 22, 2008]

[[Page 140]]



PART 747_METALWORKING FLUIDS--Table of Contents



Subpart A [Reserved]

   Subpart B_Specific Use Requirements for Certain Chemical Substances

Sec.
747.115  Mixed mono and diamides of an organic acid.
747.195  Triethanolamine salt of a substituted organic acid.
747.200  Triethanolamine salt of tricarboxylic acid.

    Authority: 15 U.S.C. 2604 and 2605.

Subpart A [Reserved]



   Subpart B_Specific Use Requirements for Certain Chemical Substances



Sec. 747.115  Mixed mono and diamides of an organic acid.

    This section identifies activities with respect to a chemical 
substance which are prohibited and requires that warnings and 
instructions accompany the substance when distributed in commerce.
    (a) Chemical substance subject to this section. The following 
chemical substance, referred to by its premanufacture notice number and 
generic chemical name, is subject to this section: P-84-529, mixed mono 
and diamides of an organic acid.
    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development have the same meaning as 
in Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (-NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.
    (4) Process or distribute in commerce solely for export means to 
process or distribute in commerce solely for export from the United 
States under the following restrictions on domestic activity:
    (i) Processing must be performed at sites under the control of the 
processor.
    (ii) Distribution in commerce is limited to purposes of export.
    (iii) The processor or distributor may not use the substance except 
in small quantities solely for research and development.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-529, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) Any person using as a metalworking fluid a product containing P-
84-529 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-529 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-529 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as mixed mono and diamides of an 
organic acid, contained in the product (insert distributor's other 
identifier for product containing P-84-529) has been regulated by the 
Environmental Protection Agency, at 40 CFR 747.115, as published in the 
Federal Register of September 20, 1984. A copy of the regulation is 
enclosed. The regulation prohibits the addition of any nitrosating 
agent, including nitrites, to the mixed mono and diamides of an organic 
acid, when the substance is or could be used in metalworking fluids. The 
addition of nitrites or other nitrosating agents to this substance leads 
to formation of a substance known to cause cancer in laboratory animals. 
The mixed mono and diamides of an organic acid has been specifically 
designed to be used without nitrites. Consult the enclosed regulation 
for further information.

    (ii) A copy of this Sec. 747.115.

[[Page 141]]

    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-529 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrites leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (iii) The first work of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area. The type size of the remainder of the warning statement 
shall be no smaller than six point type. All required label text shall 
be of sufficient prominence, and shall be placed with such 
conspicuousness relative to other label text and graphic material, to 
insure that the warning statement is read and understood by the ordinary 
individual under customary conditions of purchase and use.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by the generic chemical name in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-84-529, no 
processor, distributor, or user of P-84-529 will be in violation of this 
section unless that person has received a letter specified in paragraph 
(d)(1) of this section or a container with the label specified in 
paragraph (d)(2) of this section.
    (f) Exemptions. A person identified in paragraphs (c) and (d) of 
this section is not subject to the requirements of those paragraphs if:
    (1) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only in small quantities solely for 
research and development and in accordance with section 5(h)(3) of the 
Act.
    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export and, when distributing in commerce, lables the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act [15 U.S.C. 2614].
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act [15 U.S.C. 2614].
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act [15 
U.S.C. 2614].
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act [15 U.S.C. 2615] for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section; act to 
seize any chemical substance processed, distributed in commerce, or used 
in violation of this section; or take other actions under the authority 
of sections 7 and 17 of the Act [15 U.S.C. 2605 and 2616].

[49 FR 36855, Sept. 20, 1984]



Sec. 747.195  Triethanolamine salt of a substituted organic acid.

    This section identifies activities with respect to a chemical 
substance which are prohibited and requires that warnings and 
instructions accompany the

[[Page 142]]

substance when distributed in commerce.
    (a) Chemical substance subject to this section. The following 
chemical substance, referred to by its premanufacture notice number and 
generic chemical name, is subject to this section: P-84-310, 
triethanolamine salt of a substituted organic acid.
    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development, have the same meaning as 
in Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.
    (4) Process or distribute in commerce solely for export means to 
process or distribute in commerce solely for export from the United 
States under the following restrictions on domestic activity:
    (i) Processing must be performed at sites under the control of the 
processor.
    (ii) Distribution in commerce is limited to purposes of export.
    (iii) The processor or distributor may not use the substance except 
in small quantities solely for research and development.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-310, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) A person using as a metalworking fluid a product containing P-
84-310 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-310 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-310 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements: A substance, 
identified generically as a triethanolamine salt of a substituted 
organic acid, contained in the product (insert distributor's trade name 
or other identifier for product containing P-84-310) has been regulated 
by the Environmental Protection Agency, at 40 CFR 747.195, as published 
in the Federal Register of June 14, 1984. A copy of the regulation is 
enclosed. The regulation prohibits the addition of any nitrosating 
agent, including nitrites, to the triethanolamine salt of a substituted 
organic acid, when the substance is or could be used in metalworking 
fluids. The addition of nitrites or other nitrosating agents to this 
substance leads to formation of a substance known to cause cancer in 
laboratory animals. The triethanolamine salt of a substituted organic 
acid has been specifically designed to be used without nitrites. Consult 
the enclosed regulation for further information.
    (ii) A copy of this Sec. 747.195.
    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-310 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrites leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (iii) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area.

[[Page 143]]

The type size of the remainder of the warning statement shall be no 
smaller than six point type. All required label text shall be of 
sufficient prominence, and shall be placed with such conspicuousness 
relative to other label text and graphic material, to insure that the 
warning statement is read and understood by the ordinary individual 
under customary conditions of purchase and use.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by the generic chemical name in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-84-310, no 
processor, distributor, or user of P-84-310 will be in violation of this 
section unless that person has received a letter specified in paragraph 
(d)(1) of this section or a container with the label specified in 
paragraph (d)(2) of this section.
    (f) Exemptions. A person identified in paragraphs (c) and (d) of 
this section is not subject to the requirements of those paragraphs if:
    (1) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only in small quantities solely for 
research and development and in accordance with section 5(h)(3) of the 
Act.
    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export, and when distributing in commerce, labels the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).

[49 FR 24668, June 14, 1984]



Sec. 747.200  Triethanolamine salt of tricarboxylic acid.

    This section identifies activities with respect to two chemical 
substances which are prohibited and requires that warnings and 
instructions accompany the substances when distributed in commerce.
    (a) Chemical substances subject to this section. The following 
chemical substances, referred to by their premanufacture notice numbers 
and generic chemical names, are subject to this section:

    P-83-1005, triethanolamine salt of tricarboxylic acid; and
    P-83-1062, tricarboxylic acid.

    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, byproducts, chemical substance, 
commerce, imported, impurity, Inventory, manufacture or import for 
commercial purposes, manufacture solely for export, manufacturer, new 
chemical substance, person, process, processor, and small quantities 
solely for research and development have the same meaning as in 
Sec. 720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling or lubricating.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a secondary or tertiary amine to 
form the corresponding nitrosamine.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one

[[Page 144]]

of its components P-83-1005 is prohibited from adding any nitrosating 
agent to the metalworking fluid or product.
    (2) Any person using as metalworking fluid a product containing P-
83-1005 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-83-1005 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must sent to each 
recipient of P-83-1005 and confirm receipt prior to the first shipment 
to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as triethanolamine salt, of 
tricarboxylic acid, contained in the product (insert distributor's trade 
name or other identifier for product containing P-83-1005) has been 
regulated by the Environmental Protection Agency, at 40 CFR 747.200, as 
published in the Federal Register of January 23, 1984. A copy of the 
regulation is enclosed. The regulation prohibits the addition of any 
nitrosating agent, including nitrites, to the triethanolamine salt of 
tricarboxylic acid, when the substance is or could be used in 
metalworking fluids. The addition of nitrites or other nitrosating 
agents to this substance leads to formation of a substance known to 
cause cancer in laboratory animals. The triethanolamine salt of the 
tricarboxylic acid, has been specifically designed to be used without 
nitrites. Consult the enclosed regulation for further information.

    (ii) A copy of this rule.
    (2) Any person who distributes in commerce a metalworking fluid 
containing P-83-1005 must affix to each container containing the fluid a 
label that includes, in letters no smaller than ten point type, the 
following statement:

    WARNING! Do Not Add Nitrites to This Metalworking Fluid under 
Penalty of Federal Law. Addition of nitrite leads to formation of a 
substance known to cause cancer. This product is designed to be used 
without nitrites.

    (3) Any person who distributes in commerce P-83-1062 in any form in 
which it could be combined with water and triethanolamine to produce P-
83-1005 must send to each recipient of P-83-1062, and confirm receipt 
prior to the first shipment to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as tricarboxylic acid, contained 
in the product (insert distributor's trade name or other identifier for 
product containing P-83-1062) has been regulated by the Environmental 
Protection Agency (40 CFR 747.200 published in the Federal Register of 
January 23, 1984. A copy of the regulation is enclosed. Combining 
tricarboxylic acid with water and the triethanolamine produces a 
substance, identified generically as the triethanolamine salt of the 
tricarboxylic acid. The regulation prohibits the addition of nitrosating 
agents, including nitrites, to the triethanolamine salt of tricarboxylic 
acid, when that substance is or could be used in metalworking fluids. 
The addition of nitrites or other nitrosating agents to that substance 
leads to formation of a substance known to cause cancer in laboratory 
animals. Consult the enclosed regulation for further information.

    (ii) A copy of this rule.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by one of the generic names in paragraph 
(a) of this section makes an inquiry under Sec. 710.7(g) of this chapter 
or Sec. 720.25(b) of this chapter as to whether the specific substance 
is on the Inventory and EPA informs the manufacturer or importer that 
the substance is on the Inventory, EPA will also inform the manufacturer 
or importer whether the substance is subject to this section.
    (2) Except for manufacturers and importers of P-83-1005 and P-83-
1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will 
be in violation of this section unless that person has received a letter 
specified in paragraph (d)(1) or (3) of this section or a container with 
the label specified in paragraph (d)(2) of this section.
    (f) Exemptions and exclusions. The chemical substances identified in 
paragraph (a) of this section are not subject to the requirements of 
paragraphs (c) and (d) of this section, if:
    (1) The substance is manufactured, imported, processed, distributed 
in commerce, and used only in small quantities solely for research and 
development, and if the substance is manufactured, imported, processed, 
distributed in commerce, and used in

[[Page 145]]

accordance with section 5(h)(3) of the Act.
    (2) The substance is manufactured, imported, processed, distributed 
in commerce, or used only as an impurity.
    (3) The substance is imported, processed, distributed in commerce, 
or used only as part of an article.
    (4) The substance is manufactured solely for export.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of a section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C 2615) for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section, act to 
seize any chemical substance, processed, distributed in commerce, or 
used in violation of this section or take other actions under the 
authority of section 7 or 17 of the Act (15 U.S.C. 2605 or 2616).

[49 FR 2772, Jan. 23, 1984]



PART 749_WATER TREATMENT CHEMICALS--Table of Contents



Subparts A-C [Reserved]

             Subpart D_Air Conditioning and Cooling Systems

Sec.
749.68  Hexavalent chromium-based water treatment chemicals in cooling 
          systems.

    Authority: 15 U.S.C. 2605 and 2607.

Subparts A-C [Reserved]



             Subpart D_Air Conditioning and Cooling Systems



Sec. 749.68  Hexavalent chromium-based water treatment chemicals in
cooling systems.

    (a) Chemicals subject to this section. Hexavalent chromium-based 
water treatment chemicals that contain hexavalent chromium, usually in 
the form of sodium dichromate (CAS No. 10588-01-9), are subject to this 
section. Other examples of hexavalent chromium compounds that can be 
used to treat water are: Chromic acid (CAS No. 7738-94-5), chromium 
trioxide (CAS No. 1333-83-0), dichromic acid (CAS No.13530-68-2), 
potassium chromate (CAS No. 7789-00-6), potassium dichromate (CAS No. 
7778-50-9), sodium chromate (CAS No. 7775-11-3), zinc chromate (CAS No. 
13530-65-9), zinc chromate hydroxide (CAS No. 153936-94-6), zinc 
dichromate (CAS No. 14018-95-2), and zinc potassium chromate (CAS No. 
11103-86-9).
    (b) Purpose. The purpose of this section is to impose certain 
requirements on activities involving hexavalent chromium-based water 
treatment chemicals to prevent unreasonable risks associated with human 
exposure to air emissions of hexavalent chromium from comfort cooling 
towers.
    (c) Applicability. This section is applicable to use of hexavalent 
chromium-based water treatment chemicals in comfort cooling towers and 
to distribution in commerce of hexavalent chromium-based water treatment 
chemicals for use in cooling systems.
    (d) Definitions. Definitions in section 3 of the Toxic Substances 
Control Act, 15 U.S.C. 2602, apply to this section unless otherwise 
specified in this paragraph. In addition, the following definitions 
apply:
    (1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et 
seq.
    (2) Chilled water loop means any closed cooling water system that 
transfers heat from air handling units or refrigeration equipment to a 
refrigeration machine, or chiller.
    (3) Closed cooling water system means any configuration of equipment 
in which heat is transferred by circulating water that is contained 
within the equipment and not discharged to

[[Page 146]]

the air; chilled water loops are included.
    (4) Comfort cooling towers means cooling towers that are dedicated 
exlusively to and are an integral part of heating, ventilation, and air 
conditioning or refrigeration systems.
    (5) Container means any bag, barrel, bottle, box, can, cylinder, 
drum, or the like that holds hexavalent chromium-based water treatment 
chemicals for use in cooling systems.
    (6) Cooling tower means an open water recirculating device that uses 
fans or natural draft to draw or force ambient air through the device to 
cool warm water by direct contact.
    (7) Cooling system means any cooling tower or closed cooling water 
system.
    (8) Distributor means any person who distributes in commerce water 
treatment chemicals for use in cooling systems.
    (9) EPA means the Environmental Protection Agency.
    (10) Hexavalent chromium means the oxidation state of chromium with 
an oxidation number of + 6; a coordination number of 4 and tetrahedral 
geometry.
    (11) Hexavalent chromium-based water treatment chemicals means any 
chemical containing hexavalent chromium which can be used to treat 
water, either alone or in combination with other chemicals, where the 
mixture can be used to treat water.
    (12) Industrial cooling tower means any cooling tower used to remove 
heat from industrial processes, chemical reactions, or plants producing 
electrical power.
    (13) Label means any written, printed, or graphic material displayed 
on or affixed to containers of hexavalent chromium-based water treatment 
chemicals that are to be used in cooling systems.
    (14) Person means any natural person, firm, company, corporation, 
joint venture, partnership, sole proprietorship, association, or any 
other business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    (15) Shipment means the act or process of shipping goods by any form 
of conveyance.
    (16) Water treatment chemicals means any combination of chemical 
substances used to treat water in cooling systems and can include 
corrosion inhibitors, antiscalants, dispersants, and any other chemical 
substances except biocides.
    (e) Prohibition of distribution in commerce and commercial use. (1) 
All persons are prohibited from distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers.
    (2) All persons are prohibited from commercial use of hexavalent 
chromium-based water treatment chemicals in comfort cooling towers.
    (3) Distribution in commerce of hexavalent chromium-based water 
treatment chemicals for use in, and commercial use of hexavalent 
chromium-based water treatment chemicals in, industrial cooling towers 
and closed cooling water systems are not prohibited.
    (f) Effective dates. (1) The prohibition described in paragraph 
(e)(1) of this section against distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers is effective February 20, 1990.
    (2) The prohibition described in paragraph (e)(2) of this section 
against using hexavalent chromium-based water treatment chemicals in 
comfort cooling towers is effective May 18, 1990.
    (g) Labeling. (1) Each person who distributes in commerce hexavalent 
chromium-based water treatment chemicals for use in cooling systems 
after February 20, 1990, shall affix a label or keep affixed an existing 
label in accordance with this paragraph, to each container of the 
chemicals. The label shall consist of the following language:

    WARNING: This product contains hexavalent chromium. Inhalation of 
hexavalent chromium air emissions increases the risk of lung cancer. 
Federal Law prohibits use of this substance in comfort cooling towers, 
which are towers that are open water recirculation devices and that are 
dedicated exclusively to, and are an integral part of, heating, 
ventilation, and air conditioning or refrigeration systems.

    (2) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no

[[Page 147]]

smaller than 10-point type for a label less than or equal to 10 square 
inches in area, 12-point type for a label above 10 but less than or 
equal to 15 square inches in area, 14-point type for a label above 15 
but less than or equal to 30 square inches in area, or 18-point type for 
a label above 30 square inches in area. The type size of the remainder 
of the warning statement shall be no smaller than 6-point type. All 
required label text shall be in English and of sufficient prominence and 
shall be placed with such conspicuousness, relative to other label text 
and graphic material, to ensure that the warning statement is read and 
understood by the ordinary individual under customary conditions of 
purchase and use.
    (h) Recordkeeping. (1) Each person who distributes in commerce any 
hexavalent chromium-based water treatment chemicals for use in cooling 
systems after February 20, 1990, shall retain in one location at the 
headquarters of the distributor documentation showing:
    (i) The name, address, contact, and telephone number of the cooling 
system owners/operators to whom the chemicals were shipped.
    (ii) The chemicals included in the shipment, the amount of each 
chemical shipped, and the location(s) at which the chemicals will be 
used.
    (2) The information described in paragraph (h)(1) of this section 
shall be retained for 2 years from the date of shipment.
    (i) Reporting. (1) Each person who distributes in commerce any 
hexavalent chromium-based water treatment chemicals for use in cooling 
systems shall report to the Regional Administrator of the EPA Region in 
which the distibutor headquarters is located. The report shall be 
postmarked not later than February 20, 1990, or 30 days after the person 
first begins the distribution in commerce of hexavalent chromium-based 
water treatment chemicals, whichever is later, and shall include:
    (i) For the headquarters, the distributor name, address, telephone 
number, and the name of a contact.
    (ii) For the shipment offices through which hexavalent chromium-
based water treatment chemicals are sold for use in cooling systems, the 
distributor name, address, telephone number, and the name of a contact.
    (2) The report identified in paragraph (i)(1) of this section shall 
be updated as changes occur in the distributor headquarters or shipment 
office information. The updated report shall be submitted to the 
Regional Administrator and postmarked no later than 10 calendar days 
after the change occurs.
    (3) A person may assert a claim of confidentiality for any 
information submitted to EPA in connection with this rule. Any claim of 
confidentiality must accompany the information when submitted to EPA. 
Persons claiming information as confidential should do so by circling, 
bracketing, or underlining it and marking it with ``CONFIDENTIAL.'' EPA 
will disclose information subject to a claim of confidentiality only to 
the extent permitted by section 14 of TSCA and 40 CFR part 2, subpart B. 
If a person does not assert a claim of confidentiality for information 
at the time it is submitted to EPA, EPA may make the information public 
without further notice to that person.
    (j) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (k) Inspections. EPA will conduct inspections under section 11 of 
the Act (15 U.S.C. 2610) to ensure compliance with this section.

[55 FR 240, Jan. 3, 1990, as amended at 59 FR 42773, Aug. 19, 1994]

[[Page 148]]



PART 750_PROCEDURES FOR RULEMAKING UNDER SECTION 6 OF THE TOXIC SUBSTANCES
CONTROL ACT--Table of Contents



Subpart A  [Reserved]

     Subpart B_Interim Procedural Rules for Manufacturing Exemptions

Sec.
750.10  Applicability.
750.11  Filing of petitions for exemption.
750.12  Consolidation of rulemakings.
750.13  Notice of proposed rulemaking.
750.14  Confidentiality.
750.15  Final rule.

 Subpart C_Interim Procedural Rules for Processing and Distribution in 
                           Commerce Exemptions

750.30  Applicability.
750.31  Filing of petitions for exemption.
750.32  Consolidation of rulemaking.
750.33  Notice of proposed rulemaking.
750.34  Confidentiality.
750.35  Final rule.

    Authority: 15 U.S.C. 2605.

Subpart A  [Reserved]



     Subpart B_Interim Procedural Rules for Manufacturing Exemptions

    Source: 43 FR 50905, Nov. 1, 1978, unless otherwise noted.



Sec. 750.10  Applicability.

    Sections 750.10-750.15 apply to all rulemakings under authority of 
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 
2605(e)(3)(B) with respect to petitions filed pursuant to 
Sec. 750.11(a).

[81 FR 93636, Dec. 21, 2016]



Sec. 750.11  Filing of petitions for exemption.

    (a) Who may file. Any person seeking an exemption from the PCB 
manufacturing ban imposed by section 6(e)(3)(A) of TSCA may file a 
petition for exemption. Petitions must be submitted on an individual 
basis for each manufacturer or individual affected by the 1979 
manufacturing ban.
    (b) Where to file. All petitions pertaining to:
    (1) PCB use, which includes storage for use or reuse, manufacture, 
processing related to manufacture and use, and distribution in commerce 
related to use or processing for use, must be submitted to: OPPT 
Document Control Officer (7407T), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) PCB disposal, which includes cleanup, storage for disposal, 
processing related to disposal, distribution in commerce related to 
disposal or processing for disposal, and decontamination, must be 
submitted to: Document Control Officer, Office of Resource Conservation 
and Recovery (5305P), Environmental Protection Agency, 1200 
Pennsylvania, NW., Washington, DC 20460-0001.
    (c) Content of petition. Each petition shall contain the following:
    (1) Name, address and telephone number of petitioner.
    (2) Description of PCB ban exemption requested, including items to 
be manufactured and nature of manufacturing process--such as smelting.
    (3) Location(s) of manufacturing sites requiring exemption.
    (4) Length of time requested for exemption (maximum length of 
exemption is 1 year).
    (5) Amount of PCB chemical substance or PCB mixture (by pounds and/
or volume) to be manufactured or used during requested exemption period 
and the manner of release of PCB's into the environment associated with 
such manufacture or use.
    (6) The basis for the petitioner's contention that under section 
6(e)(3)(B)(i) of TSCA ``an unreasonable risk of injury to health or 
environment would not result'' from the granting of his petition for 
exemption.
    (7) The basis for the petitioner's contention that he meets the 
criterion of section 6(e)(3)(B)(ii) of TSCA concerning substitutes for 
PCB's.
    (8) Quantification of the reasonably ascertainable economic 
consequences of denial of the petition for exemption from the 1979 
manufacturing ban and an explanation of the manner of computation.
    (d) Request for further information. The Agency reserves the right 
to request further information as to each petition

[[Page 149]]

prior to or after publication of the notice of proposed rulemaking 
required by Sec. 750.13.
    (e) Renewal requests. (1) Any petitioner who has been granted an 
exemption under section 6(e)(3)(B) of TSCA, on or after May 25, 1994, 
and who seeks to renew that exemption without changing its terms, must 
submit a letter by certified mail to EPA requesting that the exemption 
be granted for the following year.
    (i) This letter must contain a certification by the petitioner that 
the type of activities, the procedures for handling the PCBs, the amount 
of PCBs handled, and any other aspect of the exemption have not changed 
from the original exemption petition request.
    (ii) This letter must be received by EPA at least 6 months prior to 
the expiration of the existing exemption.
    (iii) If a petitioner fails to make a submission or the submission 
is not timely under this section, the exemption will expire 1 year from 
the effective date of granting that exemption.
    (iv) EPA will address a timely submission of a renewal request by 
rulemaking and either grant or deny the request.
    (2) Any petitioner who has been granted an exemption on or after May 
25, 1994, and who seeks to increase the amount of PCBs handled or to 
change the type of activities, the procedures for handling the PCBs, and 
any other aspect of their existing exemption must submit a new exemption 
petition to EPA. The existing exemption activity may continue until the 
new submission is addressed by rulemaking, provided the activity 
conforms to the terms of the current exemption approved by EPA, and the 
petitioner complies with the conditions of paragraph (e)(1) of this 
section.
    (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) 
exemption in a rule prior to May 25, 1994, and who seeks to increase the 
amount of PCBs handled or to change the type of activities, the 
procedures for handling the PCBs, and any other aspect of their existing 
exemption must submit a new exemption petition to EPA. The existing 
exemption activity may continue until the new submission is addressed by 
rulemaking, provided the activity conforms to the terms of the original 
exemption approved by EPA.

[43 FR 50905, Nov. 1, 1978, as amended at 53 FR 12524, Apr. 15, 1988; 59 
FR 16998, Apr. 11, 1994; 72 FR 57238, Oct. 9, 2007; 74 FR 30232, June 
25, 2009]



Sec. 750.12  Consolidation of rulemakings.

    All petitions received pursuant to Sec. 750.11(a) will be 
consolidated into one rulemaking with one informal hearing held on all 
petitions.



Sec. 750.13  Notice of proposed rulemaking.

    Rulemaking for PCB exemptions filed pursuant to Sec. 750.11(a) shall 
begin with the publication of a notice of proposed rulemaking in the 
Federal Register. The notice shall state in summary form the required 
information described in Sec. 750.11(c). Due to time constraints, the 
notice need not indicate what action EPA proposes to take on the 
exemption petitions.

[81 FR 93636, Dec. 21, 2016]



Sec. 750.14  Confidentiality.

    The Agency encourages the submission of nonconfidential information 
by petitioners and commenters. The Agency does not wish to have 
unnecessary restrictions on access to the rulemaking record. However, if 
a petitioner or commenter believes that he can only state his position 
through the use of information claimed to be confidential, he may submit 
it. Such information must be separately submitted for the rulemaking 
record and marked ``confidential'' by the submitter. For the information 
claimed to be confidential, the Agency will list only the date and the 
name and address of the petitioner or commenter in the public file, 
noting that the petitioner or commenter has requested confidential 
treatment. The information claimed to be confidential will be placed in 
a confidential file. A petitioner must also file a nonconfidential 
petition with a nonconfidential summary of the confidential information 
to be placed in the public file. Similarly, a commenter must supply a 
nonconfidential summary of the information claimed to be confidential to 
be placed in the public file. Any information not marked as confidential 
will be

[[Page 150]]

placed in the public file. Information marked confidential will be 
treated in accordance with the procedures in part 2, subpart B of this 
title.

[43 FR 50905, Nov. 1, 1978. Redesignated at 81 FR 93636, Dec. 21, 2016]



Sec. 750.15  Final rule.

    (a) [Reserved]
    (b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B) 
submitted pursuant to Sec. 750.11.
    (c) In determining whether to grant an exemption to the PCB ban, the 
Agency shall apply the two standards enunciated in TSCA section 
6(e)(3)(B).

[81 FR 93636, Dec. 21, 2016]



 Subpart C_Interim Procedural Rules for Processing and Distribution in 
                           Commerce Exemptions

    Source: 44 FR 31560, Mar. 31, 1979, unless otherwise noted.



Sec. 750.30  Applicability.

    Sections 750.30 through 750.35 apply to all rulemakings under 
authority of section 6(e)(3)(B) of the Toxic Substances Control Act 
(TSCA), 15 U.S.C. 2605(e)(3)(B) with respect to petitions for PCB 
processing and distribution in commerce exemptions filed pursuant to 
Sec. 750.31(a).

[81 FR 93636, Dec. 21, 2016]



Sec. 750.31  Filing of petitions for exemption.

    (a) Who may file. Any person seeking an exemption from the PCB 
processing and distribution in commerce prohibitions imposed by section 
6(e)(3)(A)(ii) of TSCA may file a petition for exemption. Petitions must 
be submitted on an individual basis for each processor, distributor, 
seller or individual affected by the 1979 processing and distribution in 
commerce prohibitions, except as described in paragraphs (a) (1) through 
(9) of this section.
    (1) Processing and distribution in commerce of PCB-contaminated 
transformer dielectric fluid. Persons who process or distribute in 
commerce dielectric fluid containing 50 ppm or greater PCB (but less 
than 500 ppm PCB) for use in PCB-Contaminated Transformers may submit a 
single consolidated petition on behalf of any number of petitioners. The 
name and address of each petitioner must be stated in the petition.
    (2) Contaminated substances and mixtures--processing. Persons who 
process the same chemical substance or the same mixture containing 50 
ppm or greater PCB as an impurity or contaminant may submit a 
consolidated petition if the chemical substance or mixture is processed 
for the same use by each person represented by the petition. For 
example, persons who process a PCB-contaminated pigment into printing 
inks may combine their petitions into one petition. The name and address 
of each petitioner must be stated in the petition.
    (3) Contaminated substances and mixtures--distribution in commerce. 
Persons who distribute in commerce the same chemical substance or the 
same mixture containing 50 ppm or greater PCB as an impurity or 
contaminant may submit a consolidated petition if the chemical substance 
or mixture is distributed in commerce for a common use. Such a petition 
is not required to name each person who distributes in commerce the 
chemical substance or mixture.
    (4) PCB capacitor distribution for purposes of repair. Persons who 
distribute in commerce PCB capacitors for servicing (repair) of PCB 
Equipment may submit a single consolidated petition on behalf of any 
number of petitioners engaged in such distribution in commerce for 
purposes of repair. The name of each petitioner need not be stated in 
the petition.
    (5) Small quantities for research and development. Persons who 
process or distribute in commerce small quantities of PCBs for research 
and development may submit a single consolidated petition. The name and 
address of each petitioner must be stated in the petition.
    (6) Microscopy. Persons who process or distribute in commerce PCBs 
for use as a mounting medium in microscopy may submit a single 
consolidated petition on behalf of any number of petitioners. The name 
and address of each petitioner must be stated in the petition.

[[Page 151]]

    (7) Processing of PCB Articles into PCB Equipment. A person who 
processes (incorporates) PCB Articles (such as small PCB Capacitors) 
into PCB Equipment may submit a petition on behalf of himself and all 
persons who further process or distribute in commerce PCB Equipment 
built by the petitioner. For example, a builder of motors who places 
small PCB Capacitors in the motors may submit a petition on behalf of 
all persons who process or incorporate motors built by the petitioner 
into other pieces of PCB Equipment and all those who sell the equipment. 
Such a petition is not required to identify the persons who distribute 
in commerce or further process the PCB Equipment. A separate petition 
must be filed, however, by each processor of PCB Articles into PCB 
Equipment.
    (8) Processing of PCB Equipment into other PCB Equipment. A person 
who processes (incorporates) PCB Equipment into other PCB Equipment may 
submit a petition on behalf of himself and all persons who further 
process or distribute in commerce PCB Equipment built by the petitioner. 
Such a petition is not required to identify the persons who distribute 
in commerce or further process the PCB Equipment. If a petition has been 
filed under paragraph (a)(7) of this section by the builder of the 
original PCB Equipment, no other petition is required.
    (9) Distribution of PCB Equipment. Distributors in commerce of PCB 
Equipment may submit a consolidated petition on behalf of persons who 
distribute in commerce PCB Equipment of one type (such as air 
conditioners). The petition is not required to name the persons who 
distribute in commerce the affected PCB Equipment.
    (b) Where to file. All petitions pertaining to:
    (1) PCB use, which includes storage for use or reuse, manufacture, 
processing related to manufacture and use, and distribution in commerce 
related to use or processing for use, must be submitted to: OPPT 
Document Control Officer (7407T), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) PCB disposal, which includes cleanup, storage for disposal, 
processing related to disposal, distribution in commerce related to 
disposal or processing for disposal, and decontamination, must be 
submitted to: Document Control Officer, Office of Resource Conservation 
and Recovery (5305P), Environmental Protection Agency, 1200 Pennsylvania 
Avenue, NW., Washington, DC 20460-0001.
    (c) Content of petition. Each petition must contain the following:
    (1) Name, address and telephone number of petitioner. See also 
paragraphs (a) (1) through (9) of this section for additional 
identification requirements applicable to certain consolidated 
petitions.
    (2) Description of PCB processing or distribution in commerce 
exemption requested, including a description of the chemical substances, 
mixtures or items to be processed or distributed in commerce and, if 
processing is involved, the nature of the processing.
    (3) For processing petitions, location(s) of sites requiring 
exemption.
    (4) Length of time requested for exemption (maximum length of 
exemption is one year).
    (5) Estimated amount of PCBs (by pound and/or volume) to be 
processed, distributed in commerce, or used during requested exemption 
period and the manner of release of PCBs into the environment associated 
with such processing, distribution in commerce, or use. Where the PCB 
concentration is less than 500 ppm, both the total liquid volume and the 
total PCB volume must be provided.
    (6) The basis for the petitioner's contention that under section 
6(e)(3)(B)(i) of TSCA ``an unreasonable risk of injury to health or 
environment would not result'' from the granting of the petition for 
exemption.
    (7) The basis for the petitioner's contention that under section 
6(e)(3)(B)(ii) ``good faith efforts have been made to develop a chemical 
substance which does not present an unreasonable risk of injury to 
health or the environment and which may be substituted for'' the PCB.
    (8) Quantification of the reasonably ascertainable economic 
consequences of denying the petition for exemption and an explanation of 
the manner of computation.

[[Page 152]]

    (9) In addition to the information in paragraphs (c)(1) through 
(c)(8) of this section, certain petitions must contain additional 
information as follows:
    (i) Persons who process or distribute in commerce dielectric fluids 
containing 50 ppm or greater PCB for use in PCB Transformers, railroad 
transformers, or PCB electromagnets must also state the expected number 
of PCB Transformers, railroad transformers, or PCB electromagnets to be 
serviced under the exemption. In addition, a person must identify all 
the facilities which he owns or operates where he services PCB 
transformers, railroad transformers, or PCB electromagnets.
    (ii) Persons filing petitions under paragraph (a)(1) of this section 
(Processing and Distribution in Commerce of PCB-Contaminated Transformer 
Dielectric Fluid) must also provide the expected number of PCB-
Contaminated Transformers to be serviced under the requested exemption 
and the expected method of disposal of waste dielectric fluid. In 
addition, a person must identify all the facilities which he owns or 
operates where he services PCB-Contaminated Transformers. This 
information, as well as the information required by paragraphs (c)(1), 
(c)(3), and (c)(5) of this section, must be provided for each person 
represented by the petition. All other information may be provided on a 
group basis.
    (iii) Persons filing petitions under paragraphs (a)(2) (Contaminated 
Substances and Mixtures-Processing) and (a)(3) (Contaminated Substances 
and Mixtures-Distribution in Commerce) must also provide a justification 
for the class grouping selected and a description of the uses and the 
human and environmental exposure associated with each use of the PCB-
contaminated chemical substance or mixture for which an exemption is 
sought. Information may be provided on a group basis, except that the 
information required by paragraphs (c)(1), (c)(3) and (c)(5) of this 
section, must be provided for each person represented by a petition 
under paragraph (a)(2) of this section.
    (iv) Persons filing petitions under paragraph (a)(4) of this section 
(PCB Capacitor Distribution for Purposes of Repair) must also provide an 
estimate of the expected total number of PCB Capacitors to be 
distributed in commerce under the requested exemption. All information 
may be provided on a group basis.
    (v) Persons filing petitions under paragraphs (a) (7) and (8) of 
this section (Processing of PCB Articles into PCB Equipment and 
Processing of PCB Equipment into Other PCB Equipment) must provide a 
description of each type of PCB Equipment (including the amount of PCBs 
by poundage and/or volume in the PCB Equipment) to be processed and/or 
distributed in commerce under the exemption, the number of each type of 
equipment expected to be processed and/or distributed in commerce, and 
the approximate number of distributors or further processors covered by 
the petition. All information may be provided on a group basis. However, 
in the case of a petition under paragraph (a)(7) of this section, the 
processor of PCB Articles into PCB Equipment must be identified in the 
petition. In the case of a petition under paragraph (a)(8) of this 
section, the processor of PCB Equipment who files the petition must be 
identified.
    (vi) Persons filing petitions under paragraph (a)(9) of this section 
(Distribution of PCB Equipment) must provide a description of each type 
of PCB Equipment (including the amount of PCBs by poundage and/or volume 
in the PCB Equipment) to be distributed in commerce under the exemption, 
the number of each type of equipment to be distributed in commerce, and 
the approximate number of distributors covered by the petition. All 
information may be provided on a group basis.
    (vii) Persons filing petitions under paragraphs (a) (5) and (6) of 
this section must provide the information required by paragraphs (c) (1) 
through (8) of this section for each petitioner named in the petition.
    (d) EPA reserves the right to request further information as to each 
petition where necessary to determine whether the petition meets the 
statutory tests of section 6(e)(3)(B) of TSCA prior to or after 
publication of the notice of proposed rulemaking required by Sec. 750.33 
of these rules.

[[Page 153]]

    (e) Renewal requests. (1) Any petitioner who has been granted an 
exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on 
or after May 25, 1994, and who seeks to renew that exemption without 
changing its terms, must submit a letter by certified mail to EPA 
requesting that the exemption be granted for the following year.
    (i) This letter must contain a certification by the petitioner that 
the type of activities, the procedures for handling the PCBs, the amount 
of PCBs handled, and any other aspect of the exemption have not changed 
from the original exemption petition request.
    (ii) This letter must be received by EPA at least 6 months prior to 
the expiration of the existing exemption.
    (iii) If a petitioner fails to make a submission or the submission 
is not timely under this section, the exemption will expire 1 year from 
the effective date of granting that exemption.
    (iv) EPA will address a timely submission of a renewal request by 
rulemaking and either grant or deny the request.
    (2) Any petitioner who has been granted an exemption on or after May 
25, 1994, and who seeks to increase the amount of PCBs handled or to 
change the type of activities, the procedures for handling the PCBs, and 
any other aspect of their existing exemption must submit a new exemption 
petition to EPA. The existing exemption activity may continue until the 
new submission is addressed by rulemaking, provided the activity 
conforms to the terms of the current exemption approved by EPA, and the 
petitioner complies with the conditions of paragraph (e)(1) of this 
section.
    (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) 
exemption in a rule prior to May 25, 1994, and who seeks to increase the 
amount of PCBs handled or to change the type of activities, the 
procedures for handling the PCBs, and any other aspect of their existing 
exemption must submit a new exemption petition to EPA. The existing 
exemption activity may continue until the new submission is addressed by 
rulemaking, provided the activity conforms to the terms of the original 
exemption approved by EPA.

[44 FR 31560, Mar. 31, 1979, as amended at 53 FR 12524, Apr. 15, 1988; 
59 FR 16998, Apr. 11, 1994; 63 FR 35436, June 29, 1998; 72 FR 57238, 
Oct. 9, 2007; 74 FR 30232, June 25, 2009]



Sec. 750.32  Consolidation of rulemaking.

    All petitions received pursuant to Sec. 750.31(a) will be 
consolidated into one rulemaking with one informal hearing held on all 
petitions.



Sec. 750.33  Notice of proposed rulemaking.

    Rulemaking for PCB exemptions filed pursuant to Sec. 750.31(a) shall 
begin with the publication of a notice of proposed rulemaking in the 
Federal Register. The notice shall state in summary form the required 
information described in Sec. 750.31(c).

[81 FR 93636, Dec. 21, 2016]



Sec. 750.34  Confidentiality.

    EPA encourages the submission of non-confidential information by 
petitioners and commentors. EPA does not wish to have unnecessary 
restrictions on access to the rulemaking record. However, if a 
petitioner or commentor believes that he can only state his position 
through the use of information claimed to be confidential, he may submit 
it. Such information must be separately submitted for the rulemaking 
record and marked ``confidential'' by the submitter. For the information 
claimed to be confidential, EPA will list only the date and the name and 
address of the petitioner or commentor in the public file, noting that 
the petitioner or commentor has requested confidential treatment. The 
information claimed to be confidential will be placed in a confidential 
file. A petitioner must also file a non-confidential petition with a 
non-confidential summary of the confidential information to be placed in 
the public file. Similarly, a commentor must supply a non-confidential 
summary of the information claimed to be confidential to be placed in 
the public file. Any information not marked as confidential will be 
placed in the public file. Information marked confidential will be 
treated in

[[Page 154]]

accordance with the procedures in part 2, subpart B of this title.

[44 FR 31560, Mar. 31, 1979. Redesignated at 81 FR 93636, Dec. 21, 2016]



Sec. 750.35  Final rule.

    (a) [Reserved]
    (b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B) 
submitted pursuant to Sec. 750.31.
    (c) In determining whether to grant an exemption to the PCB ban, EPA 
will apply the two standards enunciated in TSCA section 6(e)(3)(B).

[81 FR 93636, Dec. 21, 2016]



PART 761_POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING,
DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS--Table of Contents



                            Subpart A_General

Sec.
761.1  Applicability.
761.2  PCB concentration assumptions for use.
761.3  Definitions.
761.19  References.

 Subpart B_Manufacturing, Processing, Distribution in Commerce, and Use 
                          of PCBs and PCB Items

761.20  Prohibitions and exceptions.
761.30  Authorizations.
761.35  Storage for reuse.

                 Subpart C_Marking of PCBs and PCB Items

761.40  Marking requirements.
761.45  Marking formats.

                     Subpart D_Storage and Disposal

761.50  Applicability.
761.60  Disposal requirements.
761.61  PCB remediation waste.
761.62  Disposal of PCB bulk product waste.
761.63  PCB household waste storage and disposal.
761.64  Disposal of wastes generated as a result of research and 
          development activities authorized under Sec. 761.30(j) and 
          chemical analysis of PCBs.
761.65  Storage for disposal.
761.70  Incineration.
761.71  High efficiency boilers.
761.72  Scrap metal recovery ovens and smelters.
761.75  Chemical waste landfills.
761.77  Coordinated approval.
761.79  Decontamination standards and procedures.

                          Subpart E_Exemptions

761.80  Manufacturing, processing and distribution in commerce 
          exemptions.

         Subpart F_Transboundary Shipments of PCBs for Disposal

761.91  Applicability.
761.93  Import for disposal.
761.97  Export for disposal.
761.99  Other transboundary shipments.

                   Subpart G_PCB Spill Cleanup Policy

761.120  Scope.
761.123  Definitions.
761.125  Requirements for PCB spill cleanup.
761.130  Sampling requirements.
761.135  Effect of compliance with this policy and enforcement.

Subparts H-I [Reserved]

                  Subpart J_General Records and Reports

761.180  Records and monitoring.
761.185  Certification program and retention of records by importers and 
          persons generating PCBs in excluded manufacturing processes.
761.187  Reporting importers and by persons generating PCBs in excluded 
          manufacturing processes.
761.193  Maintenance of monitoring records by persons who import, 
          manufacture, process, distribute in commerce, or use chemicals 
          containing inadvertently generated PCBs.

            Subpart K_PCB Waste Disposal Records and Reports

761.202  EPA identification numbers.
761.205  Notification of PCB waste activity (EPA Form 7710-53).
761.207  The manifest--general requirements.
761.208  Obtaining manifests.
761.209  Number of copies of a manifest.
761.210  Use of the manifest--Generator requirements.
761.211  Manifest system--Transporter requirements.
761.212  Transporter compliance with the manifest.
761.213  Use of manifest--Commercial storage and disposal facility 
          requirements.
761.214  Retention of manifest records.
761.215  Manifest discrepancies.
761.216  Unmanifested waste report.
761.217  Exception reporting.
761.218  Certificate of disposal.
761.219  One-year exception reporting.

[[Page 155]]

Subpart L [Reserved]

Subpart M_Determining a PCB Concentration for Purposes of Abandonment or 
  Disposal of Natural Gas Pipeline: Selecting Sample Sites, Collecting 
        Surface Samples, and Analyzing Standard PCB Wipe Samples

761.240  Scope and definitions.
761.243  Standard wipe sample method and size.
761.247  Sample site selection for pipe segment removal.
761.250  Sample site selection for pipeline section abandonment.
761.253  Chemical analysis.
761.257  Determining the regulatory status of sampled pipe.

  Subpart N_Cleanup Site Characterization Sampling for PCB Remediation 
                 Waste in Accordance with  761.61(a)(2)

761.260  Applicability.
761.265  Sampling bulk PCB remediation waste and porous surfaces.
761.267  Sampling non-porous surfaces.
761.269  Sampling liquid PCB remediation waste.
761.272  Chemical extraction and analysis of samples.
761.274  Reporting PCB concentrations in samples.

Subpart O_Sampling To Verify Completion of Self-Implementing Cleanup and 
 On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces in 
                     Accordance with  761.61(a)(6)

761.280  Application and scope.
761.283  Determination of the number of samples to collect and sample 
          collection locations.
761.286  Sample size and procedure for collecting a sample.
761.289  Compositing samples.
761.292  Chemical extraction and analysis of individual samples and 
          composite samples.
761.295  Reporting and recordkeeping of the PCB concentrations in 
          samples.
761.298  Decisions based on PCB concentration measurements resulting 
          from sampling.

Subpart P_Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse, 
and On-Site or Off-Site Disposal Under  761.61(a)(6) and Determination 
                          Under  761.79(b)(3)

761.300  Applicability.
761.302  Proportion of the total surface area to sample.
761.304  Determining sample location.
761.306  Sampling 1 meter square surfaces by random selection of halves.
761.308  Sample selection by random number generation on any two-
          dimensional square grid.
761.310  Collecting the sample.
761.312  Compositing of samples.
761.314  Chemical analysis of standard wipe test samples.
761.316  Interpreting PCB concentration measurements resulting from this 
          sampling scheme.

Subpart Q_Self-Implementing Alternative Extraction and Chemical Analysis 
         Procedures for Non-liquid PCB Remediation Waste Samples

761.320  Applicability.
761.323  Sample preparation.
761.326  Conducting the comparison study.

  Subpart R_Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for 
   Purposes of Characterization for PCB Disposal in Accordance With  
    761.62, and Sampling PCB Remediation Waste Destined for Off-Site 
                  Disposal, in Accordance With  761.61

761.340  Applicability.
761.345  Form of the waste to be sampled.
761.346  Three levels of sampling.
761.347  First level sampling--waste from existing piles.
761.348  Contemporaneous sampling.
761.350  Subsampling from composite samples.
761.353  Second level of sample selection.
761.355  Third level of sample selection.
761.356  Conducting a leach test.
761.357  Reporting the results of the procedure used to simulate 
          leachate generation.
761.358  Determining the PCB concentration of samples of waste.
761.359  Reporting the PCB concentrations in samples.

   Subpart S_Double Wash/Rinse Method for Decontaminating Non-Porous 
                                Surfaces

761.360  Background.
761.363  Applicability.
761.366  Cleanup equipment.
761.369  Pre-cleaning the surface.
761.372  Specific requirements for relatively clean surfaces.
761.375  Specific requirements for surfaces coated or covered with dust, 
          dirt, grime, grease, or another absorbent material.

[[Page 156]]

761.378  Decontamination, reuse, and disposal of solvents, cleaners, and 
          equipment.

   Subpart T_Comparison Study for Validating a New Performance-Based 
              Decontamination Solvent Under  761.79(d)(4)

761.380  Background.
761.383  Applicability.
761.386  Required experimental conditions for the validation study and 
          subsequent use during decontamination.
761.389  Testing parameter requirements.
761.392  Preparing validation study samples.
761.395  A validation study.
761.398  Reporting and recordkeeping.

    Authority: 15 U.S.C. 2605, 2607, 2611, 2614, and 2616.



                            Subpart A_General



Sec. 761.1  Applicability.

    (a) This part establishes prohibitions of, and requirements for, the 
manufacture, processing, distribution in commerce, use, disposal, 
storage, and marking of PCBs and PCB Items.
    (b)(1) This part applies to all persons who manufacture, process, 
distribute in commerce, use, or dispose of PCBs or PCB Items. Substances 
that are regulated by this part include, but are not limited to: 
dielectric fluids; solvents; oils; waste oils; heat transfer fluids; 
hydraulic fluids; paints or coatings; sludges; slurries; sediments; 
dredge spoils; soils; materials containing PCBs as a result of spills; 
and other chemical substances or combinations of substances, including 
impurities and byproducts and any byproduct, intermediate, or impurity 
manufactured at any point in a process.
    (2) Unless otherwise noted, PCB concentrations shall be determined 
on a weight-per-weight basis (e.g., milligrams per kilogram), or for 
liquids, on a weight-per-volume basis (e.g., milligrams per liter) if 
the density of the liquid is also reported. Unless otherwise provided, 
PCBs are quantified based on the formulation of PCBs present in the 
material analyzed. For example, measure Aroclor \TM\ 1242 PCBs based on 
a comparison with Aroclor \TM\ 1242 standards. Measure individual 
congener PCBs based on a comparison with individual PCB congener 
standards.
    (3) Most provisions in this part apply only if PCBs are present in 
concentrations above a specified level. Provisions that apply to PCBs at 
concentrations of <50 ppm apply also to contaminated surfaces at PCB 
concentrations of 10 mg/100 cm\2\. Provisions that apply to PCBs at 
concentrations of $50 to 
<500 ppm apply also to contaminated surfaces at PCB concentrations of 
>10/100 cm\2\ to <100 mg/100 cm\2\. Provisions that apply to PCBs at 
concentrations of $500 ppm apply also to contaminated surfaces at PCB 
concentrations of $100 mg/100 cm\2\.
    (4) PCBs can be found in liquid, non-liquid and multi-phasic 
(combinations of liquid and non-liquid) forms. A person should use the 
following criteria to determine PCB concentrations to determine which 
provisions of this part apply to such PCBs.
    (i) Any person determining PCB concentrations for non-liquid PCBs 
must do so on a dry weight basis.
    (ii) Any person determining PCB concentrations for liquid PCBs must 
do so on a wet weight basis. Liquid PCBs containing more than 0.5 
percent by weight non-dissolved material shall be analyzed as multi-
phasic non-liquid/liquid mixtures.
    (iii) Any person determining the PCB concentration of samples 
containing PCBs and non-dissolved non-liquid materials $0.5 percent, 
must separate the non-dissolved materials into non-liquid PCBs and 
liquid PCBs. For multi-phasic non-liquid/liquid or liquid/liquid 
mixtures, the phases shall be separated before chemical analysis. 
Following phase separation, the PCB concentration in each non-liquid 
phase shall be determined on a dry weight basis and the PCB 
concentration in each liquid phase shall be determined separately on a 
wet weight basis.
    (iv) Any person disposing of multi-phasic non-liquid/liquid or 
liquid/liquid mixtures must use the PCB disposal requirements that apply 
to the individual phase with the highest PCB concentration except where 
otherwise noted. Alternatively, phases may be separated and disposed of 
using the PCB disposal requirements that apply to each separated, 
single-phase material.

[[Page 157]]

    (5) No person may avoid any provision specifying a PCB concentration 
by diluting the PCBs, unless otherwise specifically provided.
    (6) Unless otherwise specified, references to weights or volumes of 
PCBs in this part apply to the total weight or total volume of the 
material (oil, soil, debris, etc.) that contains regulated 
concentrations of PCBs, not the calculated weight or volume of only the 
PCB molecules contained in the material.
    (c) Definitions of the terms used in these regulations are in 
subpart A. The basic requirements applicable to disposal and marking of 
PCBs and PCB Items are set forth in subpart D--Disposal of PCBs and PCB 
Items and in subpart C--Marking of PCBs and PCB Items. Prohibitions 
applicable to PCB activities are set forth in subpart B--Manufacture, 
Processing, Distribution in Commerce, and Use of PCBs and PCB Items. 
Subpart B also includes authorizations from the prohibitions. Subparts C 
and D set forth the specific requirements for disposal and marking of 
PCBs and PCB Items.
    (d) Section 15 of the Toxic Substances Control Act (TSCA) states 
that failure to comply with these regulations is unlawful. Section 16 
imposes liability for civil penalties upon any person who violates these 
regulations, and the Administrator can establish appropriate remedies 
for any violations subject to any limitations included in section 16 of 
TSCA. Section 16 also subjects a person to criminal prosecution for a 
violation which is knowing or willful. In addition, section 17 
authorizes Federal district courts to enjoin activities prohibited by 
these regulations, compel the taking of actions required by these 
regulations, and issue orders to seize PCBs and PCB Items manufactured, 
processed or distributed in violation of these regulations.
    (e) These regulations do not preempt other more stringent Federal 
statutes and regulations.
    (f) Unless and until superseded by any new more stringent 
regulations issued under EPA authorities, or any permits or any 
pretreatment requirements issued by EPA, a state or local government 
that affect release of PCBs to any particular medium:
    (1) Persons who inadvertently manufacture or import PCBs generated 
as unintentional impurities in excluded manufacturing processes, as 
defined in Sec. 761.3, are exempt from the requirements of subpart B of 
this part, provided that such persons comply with subpart J of this 
part, as applicable.
    (2) Persons who process, distribute in commerce, or use products 
containing PCBs generated in excluded manufacturing processes defined in 
Sec. 761.3 are exempt from the requirements of subpart B provided that 
such persons comply with subpart J of this part, as applicable.
    (3) Persons who process, distribute in commerce, or use products 
containing recycled PCBs defined in Sec. 761.3, are exempt from the 
requirements of subpart B of this part, provided that such persons 
comply with subpart J of this part, as applicable.
    (4) Except as provided in Sec. 761.20 (d) and (e), persons who 
process, distribute in commerce, or use products containing excluded PCB 
products as defined in Sec. 761.3, are exempt from the requirements of 
subpart B of this part.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979, as amended at 49 FR 28189, July 10, 1984; 53 
FR 24220, June 27, 1988; 63 FR 35436, June 29, 1998; 64 FR 33759, June 
24, 1999]



Sec. 761.2  PCB concentration assumptions for use.

    (a)(1) Any person may assume that transformers with <3 pounds (1.36 
kilograms (kgs)) of fluid, circuit breakers, reclosers, oil-filled 
cable, and rectifiers whose PCB concentration is not established contain 
PCBs at <50 ppm.
    (2) Any person must assume that mineral oil-filled electrical 
equipment that was manufactured before July 2, 1979, and whose PCB 
concentration is not established is PCB-Contaminated Electrical 
Equipment (i.e., contains $50 ppm PCB, but <500 ppm PCB). All pole-top 
and pad-mounted distribution transformers manufactured before July 2, 
1979, must be assumed to be mineral-oil filled. Any person may assume 
that electrical equipment manufactured after July 2, 1979, is non-PCB 
(i.e., <50 ppm PCBs). If the date of manufacture

[[Page 158]]

of mineral oil-filled electrical equipment is unknown, any person must 
assume it to be PCB-Contaminated.
    (3) Any person must assume that a transformer manufactured prior to 
July 2, 1979, that contains 1.36 kg (3 pounds) or more of fluid other 
than mineral oil and whose PCB concentration is not established, is a 
PCB Transformer (i.e., $500 ppm). If the date of manufacture and the 
type of dielectric fluid are unknown, any person must assume the 
transformer to be a PCB Transformer.
    (4) Any person must assume that a capacitor manufactured prior to 
July 2, 1979, whose PCB concentration is not established contains $500 
ppm PCBs. Any person may assume that a capacitor manufactured after July 
2, 1979, is non-PCB (i.e., <50 ppm PCBs). If the date of manufacture is 
unknown, any person must assume the capacitor contains $500 ppm PCBs. 
Any person may assume that a capacitor marked at the time of manufacture 
with the statement ``No PCBs'' in accordance with Sec. 761.40(g) is non-
PCB.
    (b) PCB concentration may be established by:
    (1) Testing the equipment; or
    (2)(i) A permanent label, mark, or other documentation from the 
manufacturer of the equipment indicating its PCB concentration at the 
time of manufacture; and
    (ii) Service records or other documentation indicating the PCB 
concentration of all fluids used in servicing the equipment since it was 
first manufactured.

[63 FR 35436, June 29, 1998, as amended at 64 FR 33759, June 24, 1999]



Sec. 761.3  Definitions.

    For the purpose of this part:
    Administrator means the Administrator of the Environmental 
Protection Agency, or any employee of the Agency to whom the 
Administrator may either herein or by order delegate his authority to 
carry out his functions, or any person who shall by operation of law be 
authorized to carry out such functions.
    Agency means the United States Environmental Protection Agency.
    Air compressor system means air compressors, piping, receiver tanks, 
volume tanks and bottles, dryers, airlines, and related appurtenances.
    Annual document log means the detailed information maintained at the 
facility on the PCB waste handling at the facility.
    Annual report means the written document submitted each year by each 
disposer and commercial storer of PCB waste to the appropriate EPA 
Regional Administrator. The annual report is a brief summary of the 
information included in the annual document log.
    ASTM means American Society for Testing and Materials, 100 Barr 
Harbor Drive, West Conshohocken, PA 19428-2959.
    Byproduct means a chemical substance produced without separate 
commercial intent during the manufacturing or processing of another 
chemical substance(s) or mixture(s).
    Capacitor means a device for accumulating and holding a charge of 
electricity and consisting of conducting surfaces separated by a 
dielectric. Types of capacitors are as follows:
    (1) Small capacitor means a capacitor which contains less than 1.36 
kg (3 lbs.) of dielectric fluid. The following assumptions may be used 
if the actual weight of the dielectric fluid is unknown. A capacitor 
whose total volume is less than 1,639 cubic centimeters (100 cubic 
inches) may be considered to contain less than 1.36 kgs (3 lbs.) of 
dielectric fluid and a capacitor whose total volume is more than 3,278 
cubic centimeters (200 cubic inches) must be considered to contain more 
than 1.36 kg (3 lbs.) of dielectric fluid. A capacitor whose volume is 
between 1,639 and 3,278 cubic centimeters may be considered to contain 
less then 1.36 kg (3 lbs.) of dielectric fluid if the total weight of 
the capacitor is less than 4.08 kg (9 lbs.).
    (2) Large high voltage capacitor means a capacitor which contains 
1.36 kg (3 lbs.) or more of dielectric fluid and which operates at 2,000 
volts (a.c. or d.c.) or above.
    (3) Large low voltage capacitor means a capacitor which contains 
1.36 kg (3 lbs.) or more of dielectric fluid and which operates below 
2,000 volts (a.c. or d.c.).
    CERCLA means the Comprehensive Environmental Response, Compensation, 
and Liability Act (42 U.S.C. 9601-9657).

[[Page 159]]

    Certification means a written statement regarding a specific fact or 
representation that contains the following language:

    Under civil and criminal penalties of law for the making or 
submission of false or fraudulent statements or representations (18 
U.S.C. 1001 and 15 U.S.C. 2615), I certify that the information 
contained in or accompanying this document is true, accurate, and 
complete. As to the identified section(s) of this document for which I 
cannot personally verify truth and accuracy, I certify as the company 
official having supervisory responsibility for the persons who, acting 
under my direct instructions, made the verification that this 
information is true, accurate, and complete.

    Chemical substance, (1) except as provided in paragraph (2) of this 
definition, means any organic or inorganic substance of a particular 
molecular identity, including: Any combination of such substances 
occurring in whole or part as a result of a chemical reaction or 
occurring in nature, and any element or uncombined radical.
    (2) Such term does not include: Any mixture; any pesticide (as 
defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when 
manufactured, processed, or distributed in commerce for use as a 
pesticide; tobacco or any tobacco product; any source material, special 
nuclear material, or byproduct material (as such terms are defined in 
the Atomic Energy Act of 1954 and regulations issued under such Act); 
any article the sale of which is subject to the tax imposed by section 
4181 of the Internal Revenue Code of 1954 (determined without regard to 
any exemptions from such tax provided by section 4182 or section 4221 or 
any provisions of such Code); and any food, food additive, drug, 
cosmetic, or device (as such terms are defined in section 201 of the 
Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or 
distributed in commerce for use as a food, food additive, drug, 
cosmetic, or device.
    Chemical waste landfill means a landfill at which protection against 
risk of injury to health or the environment from migration of PCBs to 
land, water, or the atmosphere is provided from PCBs and PCB Items 
deposited therein by locating, engineering, and operating the landfill 
as specified in Sec. 761.75.
    Cleanup site means the areal extent of contamination and all 
suitable areas in very close proximity to the contamination necessary 
for implementation of a cleanup of PCB remediation waste, regardless of 
whether the site was intended for management of waste.
    Commerce means trade, traffic, transportation, or other commerce:
    (1) Between a place in a State and any place outside of such State, 
or
    (2) Which affects trade, traffic, transportation, or commerce 
described in paragraph (1) of this definition.
    Commercial storer of PCB waste means the owner or operator of each 
facility that is subject to the PCB storage unit standards of 
Sec. 761.65(b)(1) or (c)(7) or meets the alternate storage criteria of 
Sec. 761.65(b)(2), and who engages in storage activities involving 
either PCB waste generated by others or that was removed while servicing 
the equipment owned by others and brokered for disposal. The receipt of 
a fee or any other form of compensation for storage services is not 
necessary to qualify as a commercial storer of PCB waste. A generator 
who only stores its own waste is subject to the storage requirements of 
Sec. 761.65, but is not required to obtain approval as a commercial 
storer. If a facility's storage of PCB waste generated by others at no 
time exceeds a total of 500 gallons of liquid and/or non-liquid material 
containing PCBs at regulated levels, the owner or operator is a 
commercial storer but is not required to seek EPA approval as a 
commercial storer of PCB waste. Storage of one company's PCB waste by a 
related company is not considered commercial storage. A ``related 
company'' includes, but is not limited to: a parent company and its 
subsidiaries; sibling companies owned by the same parent company; 
companies owned by a common holding company; members of electric 
cooperatives; entities within the same Executive agency as defined at 5 
U.S.C. 105; and a company having a joint ownership interest in a 
facility from which PCB waste is generated (such as a jointly owned 
electric power generating station) where the PCB waste is stored by one 
of the co-owners of the facility. A ``related company'' does not include 
another voluntary member of the same trade association. Change in

[[Page 160]]

ownership or title of a generator's facility, where the generator is 
storing PCB waste, does not make the new owner of the facility a 
commercial storer of PCB waste.
    Designated facility means the off-site disposer or commercial storer 
of PCB waste designated on the manifest as the facility that will 
receive a manifested shipment of PCB waste.
    Disposal means intentionally or accidentally to discard, throw away, 
or otherwise complete or terminate the useful life of PCBs and PCB 
Items. Disposal includes spills, leaks, and other uncontrolled 
discharges of PCBs as well as actions related to containing, 
transporting, destroying, degrading, decontaminating, or confining PCBs 
and PCB Items.
    Disposer of PCB waste, as the term is used in subparts J and K of 
this part, means any person who owns or operates a facility approved by 
EPA for the disposal of PCB waste which is regulated for disposal under 
the requirements of subpart D of this part.
    Distribute in commerce and Distribution in Commerce when used to 
describe an action taken with respect to a chemical substance, mixture, 
or article containing a substance or mixture means to sell, or the sale 
of, the substance, mixture, or article in commerce; to introduce or 
deliver for introduction into commerce, or the introduction or delivery 
for introduction into commerce of the substance, mixture, or article; or 
to hold or the holding of, the substance, mixture, or article after its 
introduction into commerce.
    DOT means the United States Department of Transportation.
    Dry weight means the weight of the sample, excluding the weight of 
the water in the sample. Prior to chemical analysis the water may be 
removed by any reproducible method that is applicable to measuring PCBs 
in the sample matrix at the concentration of concern, such as air drying 
at ambient temperature, filtration, decantation, heating at low 
temperature followed by cooling in the presence of a desiccant, or other 
processes or combinations of processes which would remove water but not 
remove PCBs from the sample. Analytical procedures which calculate the 
dry weight concentration by adjusting for moisture content may also be 
used.
    EPA identification number means the 12-digit number assigned to a 
facility by EPA upon notification of PCB waste activity under 
Sec. 761.205.
    Excluded manufacturing process means a manufacturing process in 
which quantities of PCBs, as determined in accordance with the 
definition of inadvertently generated PCBs, calculated as defined, and 
from which releases to products, air, and water meet the requirements of 
paragraphs (1) through (5) of this definition, or the importation of 
products containing PCBs as unintentional impurities, which products 
meet the requirements of paragraphs (1) and (2) of this definition.
    (1) The concentration of inadvertently generated PCBs in products 
leaving any manufacturing site or imported into the United States must 
have an annual average of less than 25 ppm, with a 50 ppm maximum.
    (2) The concentration of inadvertently generated PCBs in the 
components of detergent bars leaving the manufacturing site or imported 
into the United States must be less than 5 ppm.
    (3) The release of inadvertently generated PCBs at the point at 
which emissions are vented to ambient air must be less than 10 ppm.
    (4) The amount of inadvertently generated PCBs added to water 
discharged from a manufacturing site must be less than 100 micrograms 
per resolvable gas chromatographic peak per liter of water discharged.
    (5) Disposal of any other process wastes above concentrations of 50 
ppm PCB must be in accordance with subpart D of this part.
    Excluded PCB products means PCB materials which appear at 
concentrations less than 50 ppm, including but not limited to:
    (1) Non-Aroclor inadvertently generated PCBs as a byproduct or 
impurity resulting from a chemical manufacturing process.
    (2) Products contaminated with Aroclor or other PCB materials from 
historic PCB uses (investment casting waxes are one example).
    (3) Recycled fluids and/or equipment contaminated during use 
involving the

[[Page 161]]

products described in paragraphs (1) and (2) of this definition (heat 
transfer and hydraulic fluids and equipment and other electrical 
equipment components and fluids are examples).
    (4) Used oils, provided that in the cases of paragraphs (1) through 
(4) of this definition:
    (i) The products or source of the products containing <50 ppm 
concentration PCBs were legally manufactured, processed, distributed in 
commerce, or used before October 1, 1984.
    (ii) The products or source of the products containing <50 ppm 
concentrations PCBs were legally manufactured, processed, distributed in 
commerce, or used, i.e., pursuant to authority granted by EPA 
regulation, by exemption petition, by settlement agreement, or pursuant 
to other Agency-approved programs;
    (iii) The resulting PCB concentration (i.e. below 50 ppm) is not a 
result of dilution, or leaks and spills of PCBs in concentrations over 
50 ppm.
    Facility means all contiguous land, and structures, other 
appurtenances, and improvements on the land, used for the treatment, 
storage, or disposal of PCB waste. A facility may consist of one or more 
treatment, storage, or disposal units.
    Fluorescent light ballast means a device that electrically controls 
fluorescent light fixtures and that includes a capacitor containing 0.1 
kg or less of dielectric.
    Generator of PCB waste means any person whose act or process 
produces PCBs that are regulated for disposal under subpart D of this 
part, or whose act first causes PCBs or PCB Items to become subject to 
the disposal requirements of subpart D of this part, or who has physical 
control over the PCBs when a decision is made that the use of the PCBs 
has been terminated and therefore is subject to the disposal 
requirements of subpart D of this part. Unless another provision of this 
part specifically requires a site-specific meaning, ``generator of PCB 
waste'' includes all of the sites of PCB waste generation owned or 
operated by the person who generates PCB waste.
    High occupancy area means any area where PCB remediation waste has 
been disposed of on-site and where occupancy for any individual not 
wearing dermal and respiratory protection for a calendar year is: 840 
hours or more (an average of 16.8 hours or more per week) for non-porous 
surfaces and 335 hours or more (an average of 6.7 hours or more per 
week) for bulk PCB remediation waste. Examples could include a 
residence, school, day care center, sleeping quarters, a single or 
multiple occupancy 40 hours per week work station, a school class room, 
a cafeteria in an industrial facility, a control room, and a work 
station at an assembly line.
    Importer means any person defined as an ``importer'' at 
Sec. 720.3(l) of this chapter who imports PCBs or PCB Items and is under 
the jurisdiction of the United States.
    Impurity means a chemical substance which is unintentionally present 
with another chemical substance.
    In or Near Commercial Buildings means within the interior of, on the 
roof of, attached to the exterior wall of, in the parking area serving, 
or within 30 meters of a non-industrial non-substation building. 
Commercial buildings are typically accessible to both members of the 
general public and employees, and include: (1) Public assembly 
properties, (2) educational properties, (3) institutional properties, 
(4) residential properties, (5) stores, (6) office buildings, and (7) 
transportation centers (e.g., airport terminal buildings, subway 
stations, bus stations, or train stations).
    Incinerator means an engineered device using controlled flame 
combustion to thermally degrade PCBs and PCB Items. Examples of devices 
used for incineration include rotary kilns, liquid injection 
incinerators, cement kilns, and high temperature boilers.
    Industrial building means a building directly used in manufacturing 
or technically productive enterprises. Industrial buildings are not 
generally or typically accessible to other than workers. Industrial 
buildings include buildings used directly in the production of power, 
the manufacture of products, the mining of raw materials, and the 
storage of textiles, petroleum products, wood and paper products, 
chemicals, plastics, and metals.

[[Page 162]]

    Laboratory means a facility that analyzes samples for PCBs and is 
unaffiliated with any entity whose activities involve PCBs.
    Leak or leaking means any instance in which a PCB Article, PCB 
Container, or PCB Equipment has any PCBs on any portion of its external 
surface.
    Liquid PCBs means a homogenous flowable material containing PCBs and 
no more than 0.5 percent by weight non-dissolved material.
    Low occupancy area means any area where PCB remediation waste has 
been disposed of on-site and where occupancy for any individual not 
wearing dermal and respiratory protection for a calendar year is: less 
than 840 hours (an average of 16.8 hours per week) for non-porous 
surfaces and less than 335 hours (an average of 6.7 hours per week) for 
bulk PCB remediation waste. Examples could include an electrical 
substation or a location in an industrial facility where a worker spends 
small amounts of time per week (such as an unoccupied area outside a 
building, an electrical equipment vault, or in the non-office space in a 
warehouse where occupancy is transitory).
    Manifest means the shipping document EPA form 8700-22 and any 
continuation sheet attached to EPA form 8700-22, originated and signed 
by the generator of PCB waste in accordance with the instructions 
included with the form and subpart K of this part.
    Manned Control Center means an electrical power distribution control 
room where the operating conditions of a PCB Transformer are 
continuously monitored during the normal hours of operation (of the 
facility), and, where the duty engineers, electricians, or other trained 
personnel have the capability to deenergize a PCB Transformer completely 
within 1 minute of the receipt of a signal indicating abnormal operating 
conditions such as an overtemperature condition or overpressure 
condition in a PCB Transformer.
    Manufacture means to produce, manufacture, or import into the 
customs territory of the United States.
    Manufacturing process means all of a series of unit operations 
operating at a site, resulting in the production of a product.
    Mark means the descriptive name, instructions, cautions, or other 
information applied to PCBs and PCB Items, or other objects subject to 
these regulations.
    Marked means the marking of PCB Items and PCB storage areas and 
transport vehicles by means of applying a legible mark by painting, 
fixation of an adhesive label, or by any other method that meets the 
requirements of these regulations.
    Market/Marketers means the processing or distributing in commerce, 
or the person who processes or distributes in commerce, used oil fuels 
to burners or other marketers, and may include the generator of the fuel 
if it markets the fuel directly to the burner.
    Mineral Oil PCB Transformer means any transformer originally 
designed to contain mineral oil as the dielectric fluid and which has 
been tested and found to contain 500 ppm or greater PCBs.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that such term does 
include any combination which occurs, in whole or in part, as a result 
of a chemical reaction if none of the chemical substances comprising the 
combination is a new chemical substance and if the combination could 
have been manufactured for commercial purposes without a chemical 
reaction at the time the chemical substances comprising the combination 
were combined.
    Municipal solid wastes means garbage, refuse, sludges, wastes, and 
other discarded materials resulting from residential and non-industrial 
operations and activities, such as household activities, office 
functions, and commercial housekeeping wastes.
    Natural gas pipeline system means natural gas gathering facilities, 
natural gas pipe, natural gas compressors, natural gas storage 
facilities, and natural gas pipeline appurtenances (including 
instrumentation and vessels directly in contact with transported natural 
gas such as valves, regulators, drips, filter separators, etc., but not 
including air compressors).

[[Page 163]]

    Non-liquid PCBs means materials containing PCBs that by visual 
inspection do not flow at room temperature (25 C or 77 F) or from 
which no liquid passes when a 100 g or 100 ml representative sample is 
placed in a mesh number 60  # 5 percent paint filter and 
allowed to drain at room temperature for 5 minutes.
    Non-PCB Transformer means any transformer that contains less than 50 
ppm PCB; except that any transformer that has been converted from a PCB 
Transformer or a PCB-Contaminated Transformer cannot be classified as a 
non-PCB Transformer until reclassification has occurred, in accordance 
with the requirements of Sec. 761.30(a)(2)(v).
    Non-porous surface means a smooth, unpainted solid surface that 
limits penetration of liquid containing PCBs beyond the immediate 
surface. Examples are: smooth uncorroded metal; natural gas pipe with a 
thin porous coating originally applied to inhibit corrosion; smooth 
glass; smooth glazed ceramics; impermeable polished building stone such 
as marble or granite; and high density plastics, such as polycarbonates 
and melamines, that do not absorb organic solvents.
    NTIS means the National Technical Information Service, U.S. 
Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161.
    On site means within the boundaries of a contiguous property unit.
    Open burning means the combustion of any PCB regulated for disposal, 
in a manner not approved or otherwise allowed under subpart D of this 
part, and without any of the following:
    (1) Control of combustion air to maintain adequate temperature for 
efficient combustion.
    (2) Containment of the combustion reaction in an enclosed device to 
provide sufficient residence time and mixing for complete combustion.
    (3) Control of emission of the gaseous combustion products.
    PCB and PCBs means any chemical substance that is limited to the 
biphenyl molecule that has been chlorinated to varying degrees or any 
combination of substances which contains such substance. Refer to 
Sec. 761.1(b) for applicable concentrations of PCBs. PCB and PCBs as 
contained in PCB items are defined in Sec. 761.3. For any purposes under 
this part, inadvertently generated non-Aroclor PCBs are defined as the 
total PCBs calculated following division of the quantity of 
monochlorinated biphenyls by 50 and dichlorinated biphenyls by 5.
    PCB Article means any manufactured article, other than a PCB 
Container, that contains PCBs and whose surface(s) has been in direct 
contact with PCBs. ``PCB Article'' includes capacitors, transformers, 
electric motors, pumps, pipes and any other manufactured item (1) which 
is formed to a specific shape or design during manufacture, (2) which 
has end use function(s) dependent in whole or in part upon its shape or 
design during end use, and (3) which has either no change of chemical 
composition during its end use or only those changes of composition 
which have no commercial purpose separate from that of the PCB Article.
    PCB Article Container means any package, can, bottle, bag, barrel, 
drum, tank, or other device used to contain PCB Articles or PCB 
Equipment, and whose surface(s) has not been in direct contact with 
PCBs.
    PCB bulk product waste means waste derived from manufactured 
products containing PCBs in a non-liquid state, at any concentration 
where the concentration at the time of designation for disposal was $50 
ppm PCBs. PCB bulk product waste does not include PCBs or PCB Items 
regulated for disposal under Sec. 761.60(a) through (c), Sec. 761.61, 
Sec. 761.63, or Sec. 761.64. PCB bulk product waste includes, but is not 
limited to:
    (1) Non-liquid bulk wastes or debris from the demolition of 
buildings and other man-made structures manufactured, coated, or 
serviced with PCBs. PCB bulk product waste does not include debris from 
the demolition of buildings or other man-made structures that is 
contaminated by spills from regulated PCBs which have not been disposed 
of, decontaminated, or otherwise cleaned up in accordance with subpart D 
of this part.
    (2) PCB-containing wastes from the shredding of automobiles, 
household appliances, or industrial appliances.

[[Page 164]]

    (3) Plastics (such as plastic insulation from wire or cable; radio, 
television and computer casings; vehicle parts; or furniture laminates); 
preformed or molded rubber parts and components; applied dried paints, 
varnishes, waxes or other similar coatings or sealants; caulking; 
adhesives; paper; Galbestos; sound deadening or other types of 
insulation; and felt or fabric products such as gaskets.
    (4) Fluorescent light ballasts containing PCBs in the potting 
material.
    PCB Capacitor means any capacitor that contains $500 ppm PCB. 
Concentration assumptions applicable to capacitors appear under 
Sec. 761.2.
    PCB Container means any package, can, bottle, bag, barrel, drum, 
tank, or other device that contains PCBs or PCB Articles and whose 
surface(s) has been in direct contact with PCBs.
    PCB-Contaminated means a non-liquid material containing PCBs at 
concentrations $50 ppm but <500 ppm; a liquid material containing PCBs 
at concentrations $50 ppm but <500 ppm or where insufficient liquid 
material is available for analysis, a non-porous surface having a 
surface concentration >10 mg/100 cm\2\ but <100 mg/100 cm\2\, measured 
by a standard wipe test as defined in Sec. 761.123.
    PCB-Contaminated Electrical Equipment means any electrical equipment 
including, but not limited to, transformers (including those used in 
railway locomotives and self-propelled cars), capacitors, circuit 
breakers, reclosers, voltage regulators, switches (including 
sectionalizers and motor starters), electromagnets, and cable, that 
contains PCBs at concentrations of $50 ppm and <500 ppm in the 
contaminating fluid. In the absence of liquids, electrical equipment is 
PCB-Contaminated if it has PCBs at >10 mg/100 cm\2\ and <100 mg/100 
cm\2\ as measured by a standard wipe test (as defined in Sec. 761.123) 
of a non-porous surface.
    PCB Equipment means any manufactured item, other than a PCB 
Container or a PCB Article Container, which contains a PCB Article or 
other PCB Equipment, and includes microwave ovens, electronic equipment, 
and fluorescent light ballasts and fixtures.
    PCB field screening test means a portable analytical device or kit 
which measures PCBs. PCB field screening tests usually report less than 
or greater than a specific numerical PCB concentration. These tests 
normally build in a safety factor which increases the probability of a 
false positive report and decreases the probability of a false negative 
report. PCB field screening tests do not usually provide: an identity 
record generated by an instrument; a quantitative comparison record from 
calibration standards; any identification of PCBs; and/or any indication 
or identification of interferences with the measurement of the PCBs. PCB 
field screening test technologies include, but are not limited to, total 
chlorine colorimetric tests, total chlorine x-ray fluorescence tests, 
total chlorine microcoulometric tests, and rapid immunoassay tests.
    PCB household waste means PCB waste that is generated by residents 
on the premises of a temporary or permanent residence for individuals 
(including individually owned or rented units of a multi-unit 
construction), and that is composed primarily of materials found in 
wastes generated by consumers in their homes. PCB household waste 
includes unwanted or discarded non-commercial vehicles (prior to 
shredding), household items, and appliances or appliance parts and 
wastes generated on the premises of a residence for individuals as a 
result of routine household maintenance by or on behalf of the resident. 
Bulk or commingled liquid PCB wastes at concentrations of $50 ppm, 
demolition and renovation wastes, and industrial or heavy duty equipment 
with PCBs are not household wastes.
    PCB Item means any PCB Article, PCB Article Container, PCB 
Container, PCB Equipment, or anything that deliberately or 
unintentionally contains or has as a part of it any PCB or PCBs.
    PCB/radioactive waste means PCBs regulated for disposal under 
subpart D of this part that also contain source, special nuclear, or 
byproduct material subject to regulation under the Atomic Energy Act of 
1954, as amended, or naturally-occurring or accelerator-produced 
radioactive material.
    PCB remediation waste means waste containing PCBs as a result of a 
spill, release, or other unauthorized disposal,

[[Page 165]]

at the following concentrations: Materials disposed of prior to April 
18, 1978, that are currently at concentrations $50 ppm PCBs, regardless 
of the concentration of the original spill; materials which are 
currently at any volume or concentration where the original source was 
$500 ppm PCBs beginning on April 18, 1978, or $50 ppm PCBs beginning on 
July 2, 1979; and materials which are currently at any concentration if 
the PCBs are spilled or released from a source not authorized for use 
under this part. PCB remediation waste means soil, rags, and other 
debris generated as a result of any PCB spill cleanup, including, but 
not limited to:
    (1) Environmental media containing PCBs, such as soil and gravel; 
dredged materials, such as sediments, settled sediment fines, and 
aqueous decantate from sediment.
    (2) Sewage sludge containing <50 ppm PCBs and not in use according 
to Sec. 761.20(a)(4); PCB sewage sludge; commercial or industrial sludge 
contaminated as the result of a spill of PCBs including sludges located 
in or removed from any pollution control device; aqueous decantate from 
an industrial sludge.
    (3) Buildings and other man-made structures (such as concrete 
floors, wood floors, or walls contaminated from a leaking PCB or PCB-
Contaminated Transformer), porous surfaces, and non-porous surfaces.
    PCB sewage sludge means sewage sludge as defined in 40 CFR 503.9(w) 
which contains $50 ppm PCBs, as measured on a dry weight basis.
    PCB Transformer means any transformer that contains $500 ppm PCBs. 
For PCB concentration assumptions applicable to transformers containing 
1.36 kilograms (3 lbs.) or more of fluid other than mineral oil, see 
Sec. 761.2. For provisions permitting reclassification of electrical 
equipment, including PCB Transformers, containing $500 ppm PCBs to PCB-
Contaminated Electrical Equipment, see Sec. 761.30(a) and (h).
    PCB waste(s) means those PCBs and PCB Items that are subject to the 
disposal requirements of subpart D of this part.
    Performance-based organic decontamination fluid (PODF) means 
kerosene, diesel fuel, terpene hydrocarbons, and terpene hydrocarbon/
alcohol mixtures.
    Person means any natural or judicial person including any 
individual, corporation, partnership, or association; any State or 
political subdivision thereof; any interstate body; and any department, 
agency, or instrumentality of the Federal Government.
    Porous surface means any surface that allows PCBs to penetrate or 
pass into itself including, but not limited to, paint or coating on 
metal; corroded metal; fibrous glass or glass wool; unglazed ceramics; 
ceramics with a porous glaze; porous building stone such as sandstone, 
travertine, limestone, or coral rock; low-density plastics such as 
styrofoam and low-density polyethylene; coated (varnished or painted) or 
uncoated wood; concrete or cement; plaster; plasterboard; wallboard; 
rubber; fiberboard; chipboard; asphalt; or tar paper. For purposes of 
cleaning and disposing of PCB remediation waste, porous surfaces have 
different requirements than non-porous surfaces.
    Posing an exposure risk to food or feed means being in any location 
where human food or animal feed products could be exposed to PCBs 
released from a PCB Item. A PCB Item poses an exposure risk to food or 
feed if PCBs released in any way from the PCB Item have a potential 
pathway to human food or animal feed. EPA considers human food or animal 
feed to include items regulated by the U.S. Department of Agriculture or 
the Food and Drug Administration as human food or animal feed; this 
includes direct additives. Food or feed is excluded from this definition 
if it is used or stored in private homes.
    Process means the preparation of a chemical substance or mixture, 
after its manufacture, for distribution in commerce:
    (1) In the same form or physical state as, or in a different form or 
physical state from, that in which it was received by the person so 
preparing such substance or mixture, or
    (2) As part of an article containing the chemical substance or 
mixture.
    Qualified incinerator means one of the following:

[[Page 166]]

    (1) An incinerator approved under the provisions of Sec. 761.70. Any 
level of PCB concentration can be destroyed in an incinerator approved 
under Sec. 761.70.
    (2) A high efficiency boiler which complies with the criteria of 
Sec. 761.71(a)(1), and for which the operator has given written notice 
to the appropriate EPA Regional Administrator in accordance with the 
notification requirements for the burning of mineral oil dielectric 
fluid under Sec. 761.71(a)(2).
    (3) An incinerator approved under section 3005(c) of the Resource 
Conservation and Recovery Act (42 U.S.C. 6925(c)) (RCRA).
    (4) Industrial furnaces and boilers which are identified in 40 CFR 
260.10 and 40 CFR 279.61 (a)(1) and (2) when operating at their normal 
operating temperatures (this prohibits feeding fluids, above the level 
of detection, during either startup or shutdown operations).
    Quantifiable Level/Level of Detection means 2 micrograms per gram 
from any resolvable gas chromatographic peak, i.e. 2 ppm.
    RCRA means the Resource Conservation and Recovery Act (40 U.S.C. 
6901 et seq.).
    Recycled PCBs means those PCBs which appear in the processing of 
paper products or asphalt roofing materials from PCB-contaminated raw 
materials. Processes which recycle PCBs must meet the following 
requirements:
    (1) There are no detectable concentrations of PCBs in asphalt 
roofing material products leaving the processing site.
    (2) The concentration of PCBs in paper products leaving any 
manufacturing site processing paper products, or in paper products 
imported into the United States, must have an annual average of less 
than 25 ppm with a 50 ppm maximum.
    (3) The release of PCBs at the point at which emissions are vented 
to ambient air must be less than 10 ppm.
    (4) The amount of Aroclor PCBs added to water discharged from an 
asphalt roofing processing site must at all times be less than 3 
micrograms per liter (mg/L) for total Aroclors (roughly 3 parts per 
billion (3 ppb)). Water discharges from the processing of paper products 
must at all times be less than 3 micrograms per liter (mg/L) for total 
Aroclors (roughly 3 ppb), or comply with the equivalent mass-based 
limitation.
    (5) Disposal of any other process wastes at concentrations of 50 ppm 
or greater must be in accordance with subpart D of this part.
    Research and development (R&D) for PCB disposal means demonstrations 
for commercial PCB disposal approvals, pre-demonstration tests, tests of 
major modifications to previously approved PCB disposal technologies, 
treatability studies for PCB disposal technologies which have not been 
approved, development of new disposal technologies, and research on 
chemical transformation processes including, but not limited to, 
biodegradation.
    Retrofill means to remove PCB or PCB-contaminated dielectric fluid 
and to replace it with either PCB, PCB-contaminated, or non-PCB 
dielectric fluid.
    Rupture of a PCB Transformer means a violent or non-violent break in 
the integrity of a PCB Transformer caused by an overtemperature and/or 
overpressure condition that results in the release of PCBs.
    Sale for purposes other than resale means sale of PCBs for purposes 
of disposal and for purposes of use, except where use involves sale for 
distribution in commerce. PCB Equipment which is first leased for 
purposes of use any time before July 1, 1979, will be considered sold 
for purposes other than resale.
    Sewage sludge means sewage sludge as defined in Sec. 503.9(w) of 
this chapter that contains <50 ppm (on a dry weight basis) PCBs.
    Small quantities for research and development means any quantity of 
PCBs (1) that is originally packaged in one or more hermetically sealed 
containers of a volume of no more than five (5.0) milliliters, and (2) 
that is used only for purposes of scientific experimentation or 
analysis, or chemical research on, or analysis of, PCBs, but not for 
research or analysis for the development of a PCB product.
    Soil washing means the extraction of PCBs from soil using a solvent, 
recovering the solvent from the soil, separating the PCBs from the 
recovered solvent for disposal, and then disposal or reuse of the 
solvent.

[[Page 167]]

    Standard wipe sample means a sample collected for chemical 
extraction and analysis using the standard wipe test as defined in 
Sec. 761.123. Except as designated elsewhere in part 761, the minimum 
surface area to be sampled shall be 100 cm\2\.
    Storage for disposal means temporary storage of PCBs that have been 
designated for disposal.
    SW-846 means the document having the title ``SW-846, Test Methods 
for Evaluating Solid Waste,'' which is available from either the 
National Technical Information Service (NTIS, U.S. Department of 
Commerce, 5285 Port Royal Rd., Springfield, VA 22161, telephone: (703) 
487-4650 or the U.S. Government Printing Office (U.S. GPO, 710 North 
Capitol St., NW., Washington, DC 20401, telephone: (202) 783-3238.
    Totally enclosed manner means any manner that will ensure no 
exposure of human beings or the environment to any concentration of 
PCBs.
    Transfer facility means any transportation-related facility 
including loading docks, parking areas, and other similar areas where 
shipments of PCB waste are held during the normal course of 
transportation. Transport vehicles are not transfer facilities under 
this definition, unless they are used for the storage of PCB waste, 
rather than for actual transport activities. Storage areas for PCB waste 
at transfer facilities are subject to the storage facility standards of 
Sec. 761.65, but such storage areas are exempt from the approval 
requirements of Sec. 761.65(d) and the recordkeeping requirements of 
Sec. 761.180, unless the same PCB waste is stored there for a period of 
more than 10 consecutive days between destinations.
    Transporter of PCB waste means, for the purposes of subpart K of 
this part, any person engaged in the transportation of regulated PCB 
waste by air, rail, highway, or water for purposes other than 
consolidation by a generator.
    Transport vehicle means a motor vehicle or rail car used for the 
transportation of cargo by any mode. Each cargo-carrying body (e.g., 
trailer, railroad freight car) is a separate transport vehicle.
    Treatability Study means a study in which PCB waste is subjected to 
a treatment process to determine:
    (1) Whether the waste is amenable to the treatment process;
    (2) What pretreatment (if any) is required;
    (3) The optimal process conditions needed to achieve the desired 
treatment;
    (4) The efficiency of a treatment process for the specific type of 
waste (i.e., soil, sludge, liquid, etc.); or,
    (5) The characteristics and volumes of residuals from a particular 
treatment process. A ``treatability study'' is not a mechanism to 
commercially treat or dispose of PCB waste. Treatment is a form of 
disposal under this part.
    TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et 
seq.).
    TSCA PCB Coordinated Approval means the process used to recognize 
other Federal or State waste management documents governing the storage, 
cleanup, treatment, and disposal of PCB wastes. It is the mechanism 
under TSCA for accomplishing review, coordination, and approval of PCB 
waste management activities which are conducted outside of the TSCA PCB 
approval process, but require approval under the TSCA PCB regulations at 
40 CFR part 761.
    Unit means a particular building, structure, or cell used to manage 
PCB waste (including, but not limited to, a building used for PCB waste 
storage, a landfill, an industrial boiler, or an incinerator).
    U.S. GPO means the U.S. Government Printing Office, 710 North 
Capitol St., NW., Washington, DC 20401.
    Waste Oil means used products primarily derived from petroleum, 
which include, but are not limited to, fuel oils, motor oils, gear oils, 
cutting oils, transmission fluids, hydraulic fluids, and dielectric 
fluids.
    Wet weight means reporting chemical analysis results by including 
either the

[[Page 168]]

weight, or the volume and density, of all liquids.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[49 FR 25239, June 20, 1984, as amended at 49 FR 28189, July 10, 1984; 
49 FR 29066, July 18, 1984; 49 FR 44638, Nov. 8, 1984; 50 FR 29199, July 
17, 1985; 50 FR 32176, Aug. 9, 1985; 53 FR 24220, June 27, 1988; 53 FR 
27327, July 19, 1988; 54 FR 52745, Dec. 21, 1989; 55 FR 26205, June 27, 
1990; 58 FR 32061, June 8, 1993; 61 FR 11106, Mar. 18, 1996; 63 FR 
35437, June 29, 1998; 64 FR 33759, June 24, 1999]



Sec. 761.19  References.

    The materials listed in this section are incorporated by reference 
into this part with the approval of the Director of the Federal Register 
under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other 
than that specified in this section, a document must be published in the 
Federal Register and the material must be available to the public. All 
approved materials are available for inspection at the OPPT Docket in 
the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room 
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number of the EPA/DC Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. These approved materials are also available 
for inspection at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call (202) 741-6030 or go to http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. In addition, these 
materials are available from the sources listed below.
    (a) ASTM materials. Copies of these materials may be obtained from 
ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West 
Conshohocken, PA 19428-2959, or by calling (877) 909-ASTM, or at http://
www.astm.org.
    (1) ASTM D93-09 (Approved December 15, 2009), Standard Test Methods 
for Flash Point by Pensky-Martens Closed Tester, IBR approved for 
Secs. 761.71, 761.75.
    (2) ASTM D129-64 (Reapproved 1978), Standard Test Method for Sulfur 
in Petroleum Products (General Bomb Method), IBR approved for 
Sec. 761.71.
    (3) ASTM D240-87, Standard Test Method for Heat of Combustion of 
Liquid Hydrocarbon Fuel by Bomb Calorimeter, IBR approved for 
Sec. 761.71.
    (4) ASTM D482-87, Standard Test Method for Ash from Petroleum 
Products, IBR approved for Sec. 761.71.
    (5) ASTM D524-88, Standard Test Method for Ramsbottom Carbon Residue 
of Petroleum Products, IBR approved for Sec. 761.71.
    (6) ASTM D808-87, Standard Test Method for Chlorine in New and Used 
Petroleum Products (Bomb Method), IBR approved for Sec. 761.71.
    (7) ASTM D923-86, Standard Test Method for Sampling Electrical 
Insulating Liquids, IBR approved for Sec. 761.60.
    (8) ASTM D923-89, Standard Methods of Sampling Electrical Insulating 
Liquids, IBR approved for Sec. 761.60.
    (9) ASTM D1266-87, Standard Test Method for Sulfur in Petroleum 
Products (Lamp Method), IBR approved for Sec. 761.71.
    (10) ASTM D1796-83 (Reapproved 1990), Standard Test Method for Water 
and Sediment in Fuel Oils by the Centrifuge Method (Laboratory 
Procedure), IBR approved for Sec. 761.71.
    (11) ASTM D2158-89, Standard Test Method for Residues in Liquified 
Petroleum (LP) Gases, IBR approved for Sec. 761.71.
    (12) ASTM D2709-88, Standard Test Method for Water and Sediment in 
Distillate Fuels by Centrifuge, IBR approved for Sec. 761.71.
    (13) ASTM D2784-89, Standard Test Method for Sulfur in Liquified 
Petroleum Gases (Oxy-hydrogen Burner or Lamp), IBR approved for 
Sec. 761.71.
    (14) ASTM D3178-84, Standard Test Methods for Carbon and Hydrogen in 
the Analysis Sample of Coke and Coal, IBR approved for Sec. 761.71.
    (15) ASTM D3278-89, Standard Test Methods for Flash Point of Liquids 
by Setaflash Closed-Cup Apparatus, IBR approved for Sec. 761.75.
    (16) ASTM E258-67 (Reapproved 1987), Standard Test Method for Total 
Nitrogen Inorganic Material by Modified

[[Page 169]]

KJELDAHL Method, IBR approved for Sec. 761.71.
    (b) [Reserved]

[77 FR 2463, Jan. 18, 2012]



 Subpart B_Manufacturing, Processing, Distribution in Commerce, and Use 
                          of PCBs and PCB Items



Sec. 761.20  Prohibitions and exceptions.

    Except as authorized in Sec. 761.30, the activities listed in 
paragraphs (a) and (d) of this section are prohibited pursuant to 
section 6(e)(2) of TSCA. The requirements set forth in paragraph (c) of 
this section and subpart F of this part concerning export and import of 
PCBs and PCB Items for disposal are established pursuant to section 
6(e)(1) of TSCA. Subject to any exemptions granted pursuant to section 
6(e)(3)(B) of TSCA, the activities listed in paragraphs (b) and (c) of 
this section are prohibited pursuant to section (6)(e)(3)(A) of TSCA. In 
addition, the Administrator hereby finds, under the authority of section 
12(a)(2) of TSCA, that the manufacture, processing, and distribution in 
commerce of PCBs at concentrations of 50 ppm or greater and PCB Items 
with PCB concentrations of 50 ppm or greater present an unreasonable 
risk of injury to health within the United States. This finding is based 
upon the well-documented human health and environmental hazard of PCB 
exposure, the high probability of human and environmental exposure to 
PCBs and PCB Items from manufacturing, processing, or distribution 
activities; the potential hazard of PCB exposure posed by the 
transportation of PCBs or PCB Items within the United States; and the 
evidence that contamination of the environment by PCBs is spread far 
beyond the areas where they are used. In addition, the Administrator 
hereby finds, for purposes of section 6(e)(2)(C) of TSCA, that any 
exposure of human beings or the environment to PCBs, as measured or 
detected by any scientifically acceptable analytical method, may be 
significant, depending on such factors as the quantity of PCBs involved 
in the exposure, the likelihood of exposure to humans and the 
environment, and the effect of exposure. For purposes of determining 
which PCB Items are totally enclosed, pursuant to section 6(e)(2)(C) of 
TSCA, since exposure to such Items may be significant, the Administrator 
further finds that a totally enclosed manner is a manner which results 
in no exposure to humans or the environment to PCBs. The following 
activities are considered totally enclosed: distribution in commerce of 
intact, nonleaking electrical equipment such as transformers (including 
transformers used in railway locomotives and self-propelled cars), 
capacitors, electromagnets, voltage regulators, switches (including 
sectionalizers and motor starters), circuit breakers, reclosers, and 
cable that contain PCBs at any concentration and processing and 
distribution in commerce of PCB Equipment containing an intact, 
nonleaking PCB Capacitor. See paragraph (c)(1) of this section for 
provisions allowing the distribution in commerce of PCBs and PCB Items.
    (a) No persons may use any PCB, or any PCB Item regardless of 
concentration, in any manner other than in a totally enclosed manner 
within the United States unless authorized under Sec. 761.30, except 
that:
    (1) An authorization is not required to use those PCBs or PCB Items 
which consist of excluded PCB products as defined in Sec. 761.3.
    (2) An authorization is not required to use those PCBs or PCB Items 
resulting from an excluded manufacturing process or recycled PCBs as 
defined in Sec. 761.3, provided all applicable conditions of 
Sec. 761.1(f) are met.
    (3) An authorization is not required to use those PCB Items which 
contain or whose surfaces have been in contact with excluded PCB 
products as defined in Sec. 761.3.
    (4) An authorization is not required to use sewage sludge where the 
uses are regulated at parts 257, 258, and 503 of this chapter. No person 
may blend or otherwise dilute PCBs regulated for disposal, including PCB 
sewage sludge and sewage sludge not used pursuant to parts 257, 258, and 
503 of this chapter, for purposes of use or to avoid disposal 
requirements under this part. Except as explicitly provided in subpart D 
of

[[Page 170]]

this part, no person may dispose of regulated PCB wastes including, but 
not limited to, PCB remediation waste, PCB bulk product waste, PCBs, and 
PCB industrial sludges, into treatment works, as defined in 
Sec. 503.9(aa) of this chapter.
    (b) No person may manufacture PCBs for use within the United States 
or manufacture PCBs for export from the United States without an 
exemption, except that: an exemption is not required for PCBs 
manufactured in an excluded manufacturing process as defined in 
Sec. 761.3, provided all applicable conditions of Sec. 761.1(f) are met.
    (c) No persons may process or distribute in commerce any PCB, or any 
PCB Item regardless of concentration, for use within the United States 
or for export from the United States without an exemption, except that 
an exemption is not required to process or distribute in commerce PCBs 
or PCB Items resulting from an excluded manufacturing process as defined 
in Sec. 761.3, or to process or distribute in commerce recycled PCBs as 
defined in Sec. 761.3, or to process or distribute in commerce excluded 
PCB products as defined in Sec. 761.3, provided that all applicable 
conditions of Sec. 761.1(f) are met. In addition, the activities 
described in paragraphs (c) (1) through (5) of this section may also be 
conducted without an exemption, under the conditions specified therein.
    (1) PCBs at concentrations of 50 ppm or greater, or PCB Items with 
PCB concentrations of 50 ppm or greater, sold before July 1, 1979 for 
purposes other than resale may be distributed in commerce only in a 
totally enclosed manner after that date.
    (2) Any person may process and distribute in commerce for disposal 
PCBs at concentrations of $50 ppm, or PCB Items with PCB concentrations 
of $50 ppm, if they comply with the applicable provisions of this part.
    (i) Processing activities which are primarily associated with and 
facilitate storage or transportation for disposal do not require a TSCA 
PCB storage or disposal approval.
    (ii) Processing activities which are primarily associated with and 
facilitate treatment, as defined in Sec. 260.10 of this chapter, or 
disposal require a TSCA PCB disposal approval unless they are part of an 
existing approval, are part of a self-implementing activity under 
Sec. 761.61(a) or Sec. 761.79 (b) or (c), or are otherwise specifically 
allowed under subpart D of this part.
    (iii) With the exception of provisions in Sec. 761.60 (a)(2) and 
(a)(3), in order to meet the intent of Sec. 761.1(b), processing, 
diluting, or otherwise blending of waste prior to being introduced into 
a disposal unit for purposes of meeting a PCB concentration limit shall 
be done in accordance with a TSCA PCB disposal approval or comply with 
the requirements of Sec. 761.79.
    (iv) Where the rate of delivering liquids or non-liquids into a PCB 
disposal unit is an operating parameter, this rate shall be a condition 
of the TSCA PCB disposal approval for the unit when an approval is 
required.
    (3) PCBs and PCB Items may be exported for disposal in accordance 
with the requirements of subpart F of this part.
    (4) PCBs, at concentrations of less than 50 ppm, or PCB Items, with 
concentrations of less than 50 ppm, may be processed and distributed in 
commerce for purposes of disposal.
    (5) Decontaminated materials. Any person may distribute in commerce 
equipment, structures, or other liquid or non-liquid materials that were 
contaminated with PCBs $50 ppm, including those not otherwise authorized 
for distribution in commerce under this part, provided that one of the 
following applies:
    (i) The materials were decontaminated in accordance with a TSCA PCB 
disposal approval issued under subpart D of this part, with Sec. 761.79, 
or with applicable EPA PCB spill cleanup policies in effect at the time 
of the decontamination.
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec. 761.79(b).
    (d) The use of waste oil that contains any detectable concentration 
of PCB as a sealant, coating, or dust control agent is prohibited. 
Prohibited uses include, but are not limited to, road oiling, general 
dust control, use as a pesticide or herbicide carrier, and use as a rust 
preventative on pipes.

[[Page 171]]

    (e) In addition to any applicable requirements under 40 CFR part 
279, subparts G and H, marketers and burners of used oil who market 
(process or distribute in commerce) for energy recovery, used oil 
containing any quantifiable level of PCBs are subject to the following 
requirements:
    (1) Restrictions on marketing. Used oil containing any quantifiable 
level of PCBs (2 ppm) may be marketed only to:
    (i) Qualified incinerators as defined in 40 CFR 761.3.
    (ii) Marketers who market off-specification used oil for energy 
recovery only to other marketers who have notified EPA of their used oil 
management activities, and who have an EPA identification number where 
an identification number is required by 40 CFR 279.73. This would 
include persons who market off-specification used oil who are subject to 
the requirements at 40 CFR part 279 and the notification requirements of 
40 CFR 279.73.
    (iii) Burners identified in 40 CFR 279.61(a)(1) and (2). Only 
burners in the automotive industry may burn used oil generated from 
automotive sources in used oil-fired space heaters provided the 
provisions of 40 CFR 279.23 are met. The Regional Administrator may 
grant a variance for a boiler that does not meet the 40 CFR 279.61(a)(1) 
and (2) criteria after considering the criteria listed in 40 CFR 260.32 
(a) through (f). The applicant must address the relevant criteria 
contained in 40 CFR 260.32 (a) through (f) in an application to the 
Regional Administrator.
    (2) Testing of used oil fuel. Used oil to be burned for energy 
recovery is presumed to contain quantifiable levels (2 ppm) of PCB 
unless the marketer obtains analyses (testing) or other information that 
the used oil fuel does not contain quantifiable levels of PCBs.
    (i) The person who first claims that a used oil fuel does not 
contain quantifiable level (2 ppm) PCB must obtain analyses or other 
information to support that claim.
    (ii) Testing to determine the PCB concentration in used oil may be 
conducted on individual samples, or in accordance with the testing 
procedures described in Sec. 761.60(g)(2). However, for purposes of this 
part, if any PCBs at a concentration of 50 ppm or greater have been 
added to the container or equipment, then the total container contents 
must be considered as having a PCB concentration of 50 ppm or greater 
for purposes of complying with the disposal requirements of this part.
    (iii) Other information documenting that the used oil fuel does not 
contain quantifiable levels (2 ppm) of PCBs may consist of either 
personal, special knowledge of the source and composition of the used 
oil, or a certification from the person generating the used oil claiming 
that the oil contains no detectable PCBs.
    (3) Restrictions on burning. (i) Used oil containing any 
quantifiable levels of PCB may be burned for energy recovery only in the 
combustion facilities identified in paragraph (e)(1) of this section 
when such facilities are operating at normal operating temperatures 
(this prohibits feeding these fuels during either startup or shutdown 
operations). Owners and operators of such facilities are ``burners'' of 
used oil fuels.
    (ii) Before a burner accepts from a marketer the first shipment of 
used oil fuel containing detectable PCBs (2 ppm), the burner must 
provide the marketer a one-time written and signed notice certifying 
that:
    (A) The burner has complied with any notification requirements 
applicable to ``qualified incinerators'' (Sec. 761.3) or to ``burners'' 
regulated under 40 CFR part 279, subpart G.
    (B) The burner will burn the used oil only in a combustion facility 
identified in paragraph (e)(1) of this section and identify the class of 
burner he qualifies.
    (4) Recordkeeping requirements. The following recordkeeping 
requirements are in addition to the recordkeeping requirements for 
marketers found in 40 CFR 279.72(b), 279.74(a), (b) and (c), and 279.75, 
and for burners found in 40 CFR 279.65 and 279.66.
    (i) Marketers. Marketers who first claim that the used oil fuel 
contains no detectable PCBs must include among the records required by 
40 CFR 279.72(b) and 279.74(b) and (c), copies of the analysis or other 
information documenting his claim, and he must include among the records 
required by 40 CFR 279.74(a)

[[Page 172]]

and (c) and 279.75, a copy of each certification notice received or 
prepared relating to transactions involving PCB-containing used oil.
    (ii) Burners. Burners must include among the records required by 40 
CFR 279.65 and 279.66, a copy of each certification notice required by 
paragraph (e)(3)(ii) of this section that he sends to a marketer.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020, (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 49 FR 25241, June 20, 1984; 49 FR 28190, July 10, 1984; 
49 FR 44638, Nov. 8, 1984; 53 FR 12524, Apr. 15, 1988; 53 FR 24220, June 
27, 1988; 58 FR 15435, Mar. 23, 1993; 58 FR 34205, June 23, 1993; 60 FR 
34465, July 3, 1995; 61 FR 11106, Mar. 18, 1996; 63 FR 35439, June 29, 
1998; 64 FR 33760, June 24, 1999]



Sec. 761.30  Authorizations.

    The following non-totally enclosed PCB activities are authorized 
pursuant to section 6(e)(2)(B) of TSCA:
    (a) Use in and servicing of transformers (other than railroad 
transformers). PCBs at any concentration may be used in transformers 
(other than in railroad locomotives and self-propelled railroad cars) 
and may be used for purposes of servicing including rebuilding these 
transformers for the remainder of their useful lives, subject to the 
following conditions:
    (1) Use conditions. (i) As of October 1, 1985, the use and storage 
for reuse of PCB Transformers that pose an exposure risk to food or feed 
is prohibited.
    (ii) As of October 1, 1990, the use of network PCB Transformers with 
higher secondary voltages (secondary voltages equal to or greater than 
480 volts, including 480/277 volt systems) in or near commercial 
buildings is prohibited. Network PCB Transformers with higher secondary 
voltages which are removed from service in accordance with this 
requirement must either be reclassified to PCB Contaminated or non PCB 
status, placed into storage for disposal, or disposed.
    (iii) Except as otherwise provided, as of October 1, 1985, the 
installation of PCB Transformers, which have been placed into storage 
for reuse or which have been removed from another location, in or near 
commercial buildings is prohibited.
    (A) Retrofilled mineral oil PCB Transformers may be installed for 
reclassification purposes indefinitely after October 1, 1990.
    (B) Once a retrofilled transformer has been installed for 
reclassification purposes, it must be tested 3 months after installation 
to ascertain the concentration of PCBs. If the PCB concentration is 
below 50 ppm, the transformer can be reclassified as a non-PCB 
Transformer. If the PCB concentration is between 50 and 500 ppm, the 
transformer can be reclassified as a PCB-Contaminated transformer. If 
the PCB concentration remains at 500 ppm or greater, the entire process 
must either be repeated until the transformer has been reclassified to a 
non-PCB or PCB-Contaminated transformer in accordance with paragraph 
(a)(2)(v) of this section or the transformer must be removed from 
service.
    (iv) As of October 1, 1990, all higher secondary voltage radial PCB 
Transformers, in use in or near commercial buildings, and lower 
secondary voltage network PCB Transformers not located in sidewalk 
vaults in or near commercial buildings (network transformers with 
secondary voltages below 480 volts) that have not been removed from 
service as provided in paragraph (a)(1)(iv)(B) of this section, must be 
equipped with electrical protection to avoid transformer ruptures caused 
by high current faults. As of February 25, 1991, all lower secondary 
voltage radial PCB Transformers, in use in or near commercial buildings, 
must be equipped with electrical protection to avoid transformer 
ruptures caused by high current faults.
    (A) Current-limiting fuses or other equivalent technology must be 
used to detect sustained high current faults and provide for the 
complete deenergization of the transformer (within several hundredths of 
a second in the case of higher secondary voltage radial PCB Transformers 
and within tenths of a second in the case of lower secondary voltage 
network PCB Transformers), before transformer rupture occurs. Lower 
secondary voltage radial PCB Transformers must be equipped with 
electrical protection as provided

[[Page 173]]

in paragraph (a)(1)(iv)(E) of this section. The installation, setting, 
and maintenance of current-limiting fuses or other equivalent technology 
to avoid PCB Transformer ruptures from sustained high current faults 
must be completed in accordance with good engineering practices.
    (B) All lower secondary voltage network PCB Transformers not located 
in sidewalk vaults (network transformers with secondary voltages below 
480 volts), in use in or near commercial buildings, which have not been 
protected as specified in paragraph (a)(1)(iv)(A) of this section by 
October 1, 1990, must be removed from service by October 1, 1993.
    (C) As of October 1, 1990, owners of lower secondary voltage network 
PCB Transformers, in use in or near commercial buildings which have not 
been protected as specified in paragraph (a)(1)(iv)(A) of this section 
and which are not located in sidewalk vaults, must register in writing 
those transformers with the EPA Regional Administrator in the 
appropriate region. The information required to be provided in writing 
to the Regional Administrator includes:
    (1) The specific location of the PCB Transformer(s).
    (2) The address(es) of the building(s) and the physical location of 
the PCB Transformer(s) on the building site(s).
    (3) The identification number(s) of the PCB Transformer(s).
    (D) As of October 1, 1993, all lower secondary voltage network PCB 
Transformers located in sidewalk vaults (network transformers with 
secondary voltages below 480 volts) in use near commercial buildings 
must be removed from service.
    (E) As of February 25, 1991, all lower secondary voltage radial PCB 
Transformers must be equipped with electrical protection, such as 
current-limiting fuses or other equivalent technology, to detect 
sustained high current faults and provide for the complete 
deenergization of the transformer or complete deenergization of the 
faulted phase of the transformer within several hundredths of a second. 
The installation, setting, and maintenance of current-limiting fuses or 
other equivalent technology to avoid PCB Transformer ruptures from 
sustained high current faults must be completed in accordance with good 
engineering practices.
    (v) As of October 1, 1990, all radial PCB Transformers with higher 
secondary voltages (480 volts and above, including 480/277 volt systems) 
in use in or near commercial buildings must, in addition to the 
requirements of paragraph (a)(1)(iv)(A) of this section, be equipped 
with protection to avoid transformer ruptures caused by sustained low 
current faults.
    (A) Pressure and temperature sensors (or other equivalent technology 
which has been demonstrated to be effective in early detection of 
sustained low current faults) must be used in these transformers to 
detect sustained low current faults.
    (B) Disconnect equipment must be provided to insure complete 
deenergization of the transformer in the event of a sensed abnormal 
condition (e.g., an overpressure or overtemperature condition in the 
transformer), caused by a sustained low current fault. The disconnect 
equipment must be configured to operate automatically within 30 seconds 
to 1 minute of the receipt of a signal indicating an abnormal condition 
from a sustained low current fault, or can be configured to allow for 
manual deenergization from a manned on-site control center upon the 
receipt of an audio or visual signal indicating an abnormal condition 
caused by a sustained low current fault. Manual deenergization from a 
manned on-site control center must occur within 1 minute of the receipt 
of the audio or visual signal indicating an abnormal condition caused by 
a sustained low current fault. If automatic operation is selected and a 
circuit breaker is utilized for disconnection, it must also have the 
capability to be manually opened if necessary.
    (C) The enhanced electrical protective system required for the 
detection of sustained low current faults and the complete and rapid 
deenergization of transformers must be properly installed, maintained, 
and set sensitive enough (in accordance with good engineering practices) 
to detect sustained low current faults and allow for rapid

[[Page 174]]

and total deenergization prior to PCB Transformer rupture (either 
violent or non violent rupture) and release of PCBs.
    (vi)(A) No later than December 28, 1998 all owners of PCB 
Transformers, including those in storage for reuse, must register their 
transformers with the Environmental Protection Agency, National Program 
Chemicals Division, Office of Pollution Prevention and Toxics (7404), 
1200 Pennsylvania Ave., NW., Washington, DC 20460. This registration 
requirement is subject to the limitations in paragraph (a)(1) of this 
section.
    (1) A transformer owner who assumes a transformer is a PCB-
Contaminated transformer, and discovers after December 28, 1998 that it 
is a PCB-Transformer, must register the newly-identified PCB 
Transformer, in writing, with the Environmental Protection Agency no 
later than 30 days after it is identified as such. This requirement does 
not apply to transformer owners who have previously registered with the 
EPA PCB Transformers located at the same address as the transformer that 
they assumed to be PCB-Contaminated and later determined to be a PCB 
Transformer.
    (2) A person who takes possession of a PCB Transformer after 
December 28, 1998 is not required to register or re-register the 
transformer with the EPA.
    (B) Any person submitting a registration under this section must 
include:
    (1) Company name and address.
    (2) Contact name and telephone number.
    (3) Address where these transformers are located. For mobile sources 
such as ships, provide the name of the ship.
    (4) Number of PCB Transformers and the total weight in kilograms of 
PCBs contained in the transformers.
    (5) Whether any transformers at this location contain flammable 
dielectric fluid (optional).
    (6) Signature of the owner, operator, or other authorized 
representative certifying the accuracy of the information submitted.
    (C) A transformer owner must retain a record of each PCB 
Transformer's registration (e.g., a copy of the registration and the 
return receipt signed by EPA) with the inspection and maintenance 
records required for each PCB Transformer under paragraph (a)(1)(xii)(I) 
of this section.
    (D) A transformer owner must comply with all requirements of 
paragraph (a)(1)(vi)(A) of this section to continue the PCB-
Transformer's authorization for use, or storage for reuse, pursuant to 
this section and TSCA section 6(e)(2)(B).
    (vii) As of December 1, 1985, PCB Transformers in use in or near 
commercial buildings must be registered with building owners. For PCB 
Transformers located in commercial buildings, PCB Transformer owners 
must register the transformers with the building owner of record. For 
PCB Transformers located near commercial buildings, PCB Transformer 
owners must register the transformers with all owners of buildings 
located within 30 meters of the PCB Transformer(s). Information required 
to be provided to building owners by PCB Transformer owners includes but 
is not limited to:
    (A) The specific location of the PCB Transformer(s).
    (B) The principal constituent of the dielectric fluid in the 
transformer(s) (e.g., PCBs, mineral oil, or silicone oil).
    (C) The type of transformer installation (e.g., 208/120 volt 
network, 208/120 volt radial, 208 volt radial, 480 volt network, 480/277 
volt network, 480 volt radial, 480/277 volt radial).
    (viii) As of December 1, 1985, combustible materials, including, but 
not limited to paints, solvents, plastics, paper, and sawn wood must not 
be stored within a PCB Transformer enclosure (i.e., in a transformer 
vault or in a partitioned area housing a transformer); within 5 meters 
of a transformer enclosure, or, if unenclosed (unpartitioned), within 5 
meters of a PCB Transformer.
    (ix) A visual inspection of each PCB Transformer (as defined in the 
definition of ``PCB Transformer'' under Sec. 761.3) in use or stored for 
reuse shall be performed at least once every 3 months. These inspections 
may take place any time during the 3-month periods: January-March, 
April-June, July-September, and October-December as long as there is a 
minimum of 30 days between inspections. The visual inspection must 
include investigation for any leak of dielectric fluid on or

[[Page 175]]

around the transformer. The extent of the visual inspections will depend 
on the physical constraints of each transformer installation and should 
not require an electrical shutdown of the transformer being inspected.
    (x) If a PCB Transformer is found to have a leak which results in 
any quantity of PCBs running off or about to run off the external 
surface of the transformer, then the transformer must be repaired or 
replaced to eliminate the source of the leak. In all cases any leaking 
material must be cleaned up and properly disposed of according to 
disposal requirements of subpart D of this part. Cleanup of the released 
PCBs must be initiated as soon as possible, but in no case later than 48 
hours of its discovery. Until appropriate action is completed, any 
active leak of PCBs must be contained to prevent exposure of humans or 
the environment and inspected daily to verify containment of the leak. 
Trenches, dikes, buckets, and pans are examples of proper containment 
measures.
    (xi) If a PCB Transformer is involved in a fire-related incident, 
the owner of the transformer must immediately report the incident to the 
National Response Center (toll-free 1-800-424-8802; in Washington, DC 
202-426-2675). A fire-related incident is defined as any incident 
involving a PCB Transformer which involves the generation of sufficient 
heat and/or pressure (by any source) to result in the violent or non-
violent rupture of a PCB Transformer and the release of PCBs. 
Information must be provided regarding the type of PCB Transformer 
installation involved in the fire-related incident (e.g., high or low 
secondary voltage network transformer, high or low secondary voltage 
simple radial system, expanded radial system, primary selective system, 
primary loop system, or secondary selective system or other systems) and 
the readily ascertainable cause of the fire-related incident (e.g., high 
current fault in the primary or secondary or low current fault in 
secondary). The owner of the PCB Transformer must also take measures as 
soon as practically and safely possible to contain and control any 
potential releases of PCBs and incomplete combustion products into 
water. These measures include, but are not limited to:
    (A) The blocking of all floor drains in the vicinity of the 
transformer.
    (B) The containment of water runoff.
    (C) The control and treatment (prior to release) of any water used 
in subsequent cleanup operations.
    (xii) Records of inspection and maintenance history shall be 
maintained at least 3 years after disposing of the transformer and shall 
be made available for inspection, upon request by EPA. Such records 
shall contain the following information for each PCB Transformer:
    (A) Its location.
    (B) The date of each visual inspection and the date that leak was 
discovered, if different from the inspection date.
    (C) The person performing the inspection.
    (D) The location of any leak(s).
    (E) An estimate of the amount of dielectric fluid released from any 
leak.
    (F) The date of any cleanup, containment, repair, or replacement.
    (G) A description of any cleanup, containment, or repair performed.
    (H) The results of any containment and daily inspection required for 
uncorrected active leaks.
    (I) Record of the registration of PCB Transformer(s).
    (J) Records of transfer of ownership in compliance with 
Sec. 761.180(a)(2)(ix).
    (xiii) A reduced visual inspection frequency of at least once every 
12 months applies to PCB Transformers that utilize either of the 
following risk reduction measures. These inspections may take place any 
time during the calendar year as long as there is a minimum of 180 days 
between inspections.
    (A) A PCB Transformer which has impervious, undrained, secondary 
containment capacity of at least 100 percent of the total dielectric 
fluid volume of all transformers so contained or
    (B) A PCB Transformer which has been tested and found to contain 
less than 60,000 ppm PCBs (after 3 months of in service use if the 
transformer has been serviced for purposes of reducing the PCB 
concentration).
    (xiv) An increased visual inspection frequency of at least once 
every week applies to any PCB Transformer in use

[[Page 176]]

or stored for reuse which poses an exposure risk to food or feed. The 
user of a PCB Transformer posing an exposure risk to food is responsible 
for the inspection, recordkeeping, and maintenance requirements under 
this section until the user notifies the owner that the transformer may 
pose an exposure risk to food or feed. Following such notification, it 
is the owner's ultimate responsibility to determine whether the PCB 
Transformer poses an exposure risk to food or feed.
    (xv) In the event a mineral oil transformer, assumed to contain less 
than 500 ppm of PCBs as provided in Sec. 761.2, is tested and found to 
be contaminated at 500 ppm or greater PCBs, it will be subject to all 
the requirements of this part 761. In addition, efforts must be 
initiated immediately to bring the transformer into compliance in 
accordance with the following schedule:
    (A) Report fire-related incidents, effective immediately after 
discovery.
    (B) Mark the PCB transformer within 7 days after discovery.
    (C) Mark the vault door, machinery room door, fence, hallway or 
other means of access to the PCB Transformer within 7 days after 
discovery.
    (D) Register the PCB Transformer in writing with the building owner 
within 30 days of discovery.
    (E) Install electrical protective equipment on a radial PCB 
Transformer and a non-sidewalk vault, lower secondary voltage network 
PCB Transformer in or near a commercial building within 18 months of 
discovery or by October 1, 1990, whichever is later.
    (F) Remove a non-sidewalk vault, lower secondary voltage network PCB 
Transformer in or near a commercial building, if electrical protective 
equipment is not installed, within 18 months of discovery or by October 
1, 1993, whichever is later.
    (G) Remove a lower secondary voltage network PCB Transformer located 
in a sidewalk vault in or near a commercial building, within 18 months 
of discovery or by October 1, 1993, whichever is later.
    (H) Retrofill and reclassify a radial PCB Transformer or a lower or 
higher secondary voltage network PCB Transformer, located in other than 
a sidewalk vault in or near a commercial building, within 18 months or 
by October 1, 1990, whichever is later. This is an option in lieu of 
installing electrical protective equipment on a radial or lower 
secondary voltage network PCB Transformer located in other than a 
sidewalk vault or of removing a higher secondary voltage network PCB 
Transformer or a lower secondary voltage network PCB Transformer, 
located in a sidewalk vault, from service.
    (I) Retrofill and reclassify a lower secondary voltage network PCB 
Transformer, located in a sidewalk vault, in or near a commercial 
building within 18 months or by October 1, 1993, whichever is later. 
This is an option in lieu of installing electrical protective equipment 
or removing the transformer from service.
    (J) Retrofill and reclassify a higher secondary voltage network PCB 
Transformer, located in a sidewalk vault, in or near a commercial 
building within 18 months or by October 1, 1990, whichever is later. 
This is an option in lieu of other requirements.
    (2) Servicing conditions. (i) Transformers classified as PCB-
Contaminated Electrical Equipment (as defined in the definition of 
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be 
serviced (including rebuilding) only with dielectric fluid containing 
less than 500 ppm PCB.
    (ii) Any servicing (including rebuilding) of PCB Transformers (as 
defined in the definition of ``PCB Transformer'' under Sec. 761.3) that 
requires the removal of the transformer coil from the transformer casing 
is prohibited. PCB Transformers may be serviced (including topping off) 
with dielectric fluid at any PCB concentration.
    (iii) PCBs removed during any servicing activity must be captured 
and either reused as dielectric fluid or disposed of in accordance with 
the requirements of Sec. 761.60. PCBs from PCB Transformers must not be 
mixed with or added to dielectric fluid from PCB-Contaminated Electrical 
Equipment.
    (iv) Regardless of its PCB concentration, dielectric fluids 
containing less than 500 ppm PCB that are mixed with fluids that contain 
500 ppm or greater PCB must not be used as dielectric fluid in any 
electrical equipment. The entire mixture of dielectric fluid must

[[Page 177]]

be considered to be greater than 500 ppm PCB and must be disposed of in 
an incinerator that meets the requirements in Sec. 761.70.
    (v) You may reclassify a PCB Transformer that has been tested and 
determined to have a concentration of $500 ppm PCBs to a PCB-
Contaminated transformer ($50 but <500 ppm) or to a non-PCB transformer 
(<50 ppm), and you may reclassify a PCB-Contaminated transformer that 
has been tested and determined to have a concentration of $50 ppm but 
<500 ppm to a non-PCB transformer, as follows:
    (A) Remove the free-flowing PCB dielectric fluid from the 
transformer. Flushing is not required. Either test the fluid or assume 
it contains $1,000 ppm PCBs. Retrofill the transformer with fluid 
containing known PCB levels according to the following table. Determine 
the transformer's reclassified status according to the following table 
(if following this process does not result in the reclassified status 
you desire, you may repeat the process):

----------------------------------------------------------------------------------------------------------------
                                   and you retrofill                       and test results
  If test results show the PCB      the transformer                          show the PCB          then the
   concentration (ppm) in the       with dielectric      and you . . .       concentration       transformer's
 transformer prior to retrofill   fluid containing .                          (ppm) after        reclassified
            is . . .                      . .                             retrofill is . . .    status is. . .
----------------------------------------------------------------------------------------------------------------
$1,000 (or untested)              <50 ppm PCBs        operate the         $50 but <500        PCB-contaminated
                                                       transformer
                                                       electrically
                                                       under loaded
                                                       conditions for at
                                                       least 90-
                                                       continuous days
                                                       after retrofill,
                                                       then test the
                                                       fluid for PCBs
                                 -------------------------------------------------------------------------------
                                  <50 ppm PCBs        operate the         <50                 non-PCB
                                                       transformer
                                                       electrically
                                                       under loaded
                                                       conditions for at
                                                       least 90-
                                                       continuous days
                                                       after retrofill,
                                                       then test the
                                                       fluid for PCBs
----------------------------------------------------------------------------------------------------------------
$500 but <1,000                   <50 ppm PCBs        test the fluid for  $50 but <500        PCB-contaminated
                                                       PCBs at least 90
                                                       days after
                                                       retrofill
                                 -------------------------------------------------------------------------------
                                  <50 ppm PCBs        test the fluid for  <50                 non-PCB
                                                       PCBs at least 90
                                                       days after
                                                       retrofill
----------------------------------------------------------------------------------------------------------------
$50 but <500                      $2 but <50 ppm      test the fluid for  <50                 non-PCB
                                   PCBs                PCBs at least 90
                                                       days after
                                                       retrofill
                                 -------------------------------------------------------------------------------
                                  <2 ppm PCBs         (no need to test)   (not applicable)    non-PCB
----------------------------------------------------------------------------------------------------------------

    (B) If you discover that the PCB concentration of the fluid in a 
reclassified transformer has changed, causing the reclassified status to 
change, the transformer is regulated based on the actual concentration 
of the fluid. For example, a transformer that was reclassified to non-
PCB status is regulated as a PCB-Contaminated transformer if you 
discover that the concentration of the fluid has increased to $50 but 
<500 ppm PCBs. If you discover that the PCB concentration of the fluid 
has risen to $500 ppm, the transformer is regulated as a PCB 
Transformer. Follow paragraphs (a)(1)(xv)(A) through (J) of this section 
to come into compliance with the regulations applicable to PCB 
Transformers. You also have the option of repeating the reclassification 
process.
    (C) The Director, National Program Chemicals Division, may, without 
further rulemaking, grant approval on a case-by-case basis for the use 
of alternative methods to reclassify transformers. You may request an 
approval by writing to the Director, National Program Chemicals Division 
(7404), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. Describe the equipment you

[[Page 178]]

plan to reclassify, the alternative reclassification method you plan to 
use, and test data or other evidence on the effectiveness of the method.
    (D) You must keep records of the reclassification required by 
Sec. 761.180(g).
    (vi) Any dielectric fluid containing 50 ppm or greater PCB used for 
servicing transformers must be stored in accordance with the storage for 
disposal requirements of Sec. 761.65.
    (vii) Processing and distribution in commerce of PCBs for purposes 
of servicing transformers is permitted only for persons who are granted 
an exemption under TSCA 6(e)(3)(B).
    (b) Use in and servicing of railroad transformers. PCBs may be used 
in transformers in railroad locomotives or railroad self-propelled cars 
(``railroad transformers'') and may be processed and distributed in 
commerce for purposes of servicing these transformers in a manner other 
than a totally enclosed manner subject to the following conditions:
    (1) Use restrictions. After July 1, 1986, use of railroad 
transformers that contain dielectric fluids with a PCB concentration 
>1,000 ppm is prohibited.
    (2) Servicing restrictions. (i) If the coil is removed from the 
casing of a railroad transformer (e.g., the transformer is rebuilt), 
after January 1, 1982, the railroad transformer may not be refilled with 
dielectric fluid containing a PCB concentration greater than 50 ppm;
    (ii) After January 1, 1984, railroad transformers may only be 
serviced with dielectric fluid containing less than 1000 ppm PCB, except 
as provided in paragraph (b)(2)(i) of this section;
    (iii) Dielectric fluid may be filtered through activated carbon or 
otherwise industrially processed for the purpose of reducing the PCB 
concentration in the fluid;
    (iv) Any PCB dielectric fluid that is used to service PCB railroad 
transformers must be stored in accordance with the storage for disposal 
requirements of Sec. 761.65;
    (v) After July 1, 1979, processing and distribution in commerce of 
PCBs for purposes of servicing railroad transformers is permitted only 
for persons who are granted an exemption under TSCA section 6(e)(3)(B).
    (vi) A PCB Transformer may be converted to a PCB-Contaminated 
Transformer or to a non-PCB Transformer by draining, refilling, and/or 
otherwise servicing the railroad transformer. In order to reclassify, 
the railroad transformer's dielectric fluid must contain less than 500 
ppm (for conversion to PCB-Contaminated Transformer) or less than 50 ppm 
PCB (for conversion to a non-PCB Transformer) after a minimum of three 
months of inservice use subsequent to the last servicing conducted for 
the purpose of reducing the PCB concentration in the transformer.
    (c) Use in mining equipment. After January 1, 1982, PCBs may be used 
in mining equipment only at a concentration level of <50 ppm.
    (d) Use in heat transfer systems. After July 1, 1984, PCBs may be 
used in heat transfer systems only at a concentration level of <50 ppm. 
Heat transfer systems that were in operation after July 1, 1984, with a 
concentration level of <50 ppm PCBs may be serviced to maintain a 
concentration level of <50 ppm PCBs. Heat transfer systems may only be 
serviced with fluids containing <50 ppm PCBs.
    (e) Use in hydraulic systems. After July 1, 1984, PCBs may be used 
in hydraulic systems only at a concentration level of <50 ppm. Hydraulic 
systems that were in operation after July 1, 1984, with a concentration 
level of <50 ppm PCBs may be serviced to maintain a concentration level 
of <50 ppm PCBs. Hydraulic systems may only be serviced with fluids 
containing <50 ppm PCBs.
    (f) Use in carbonless copy paper. Carbonless copy paper containing 
PCBs may be used in a manner other than a totally enclosed manner 
indefinitely.
    (g) [Reserved]
    (h) Use in and servicing of electromagnets, switches and voltage 
regulators. PCBs at any concentration may be used in electromagnets, 
switches (including sectionalizers and motor starters), and voltage 
regulators and may be used for purposes of servicing this equipment 
(including rebuilding) for the remainder of their useful lives, subject 
to the following conditions:
    (1) Use conditions. (i) After October 1, 1985, the use and storage 
for reuse of

[[Page 179]]

any electromagnet which poses an exposure risk to food or feed is 
prohibited if the electromagnet contains greater than 500 ppm PCBs.
    (ii) Use and storage for reuse of voltage regulators which contain 
1.36 kilograms (3 lbs) or more of dielectric fluid with a PCB 
concentration of $500 ppm are subject to the following provisions:
    (A) The owner of the voltage regulator must mark its location in 
accordance with Sec. 761.40.
    (B) If a voltage regulator is involved in a fire-related incident, 
the owner must immediately report the incident to the National Response 
Center (Toll-free: 1-800-424-8802; in Washington, DC: 202-426-2675). A 
fire-related incident is defined as any incident that involves the 
generation of sufficient heat and/or pressure, by any source, to result 
in the violent or non-violent rupture of the voltage regulator and the 
release of PCBs.
    (C) The owner of the voltage regulator must inspect it in accordance 
with the requirements of paragraphs (a)(1)(ix), (a)(1)(xiii), and 
(a)(1)(xiv) of this section that apply to PCB Transformers.
    (D) The owner of the voltage regulator must comply with the 
recordkeeping and reporting requirements at Sec. 761.180.
    (iii) The owner of a voltage regulator that assumes it contains <500 
ppm PCBs as provided in Sec. 761.2, and discovers by testing that it is 
contaminated at $500 ppm PCBs, must comply with paragraph (h)(1)(ii)(A) 
of this section 7 days after the discovery, and paragraphs 
(h)(1)(ii)(B), (h)(1)(ii)(C), and (h)(1)(ii)(D) of this section 
immediately upon discovery.
    (2) Servicing conditions. (i) Servicing (including rebuilding) any 
electromagnet, switch, or voltage regulator with a PCB concentration of 
500 ppm or greater which requires the removal and rework of the internal 
components is prohibited.
    (ii) Electromagnets, switches, and voltage regulators classified as 
PCB-Contaminated Electrical Equipment (as defined in the definition of 
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be 
serviced (including rebuilding) only with dielectric fluid containing 
less than 500 ppm PCB.
    (iii) PCBs removed during any servicing activity must be captured 
and either reused as dielectric fluid or disposed of in accordance with 
the requirements of Sec. 761.60. PCBs from electromagnets switches, and 
voltage regulators with a PCB concentration of at least 500 ppm must not 
be mixed with or added to dielectric fluid from PCB-Contaminated 
Electrical Equipment.
    (iv) Regardless of its PCB concentration, dielectric fluids 
containing less than 500 ppm PCB that are mixed with fluids that contain 
500 ppm or greater PCB must not be used as dielectric fluid in any 
electrical equipment. The entire mixture of dielectric fluid must be 
considered to be greater than 500 ppm PCB and must be disposed of in an 
incinerator that meets the requirements of Sec. 761.70.
    (v) You may reclassify an electromagnet, switch, or voltage 
regulator that has been tested and determined to have a concentration of 
$500 ppm PCBs to PCB-Contaminated status ($50 but <500 ppm) or to non-
PCB status (<50 ppm), and you may reclassify a PCB-Contaminated 
electromagnet, switch, or voltage regulator that has been tested and 
determined to have a concentration of $50 ppm but <500 ppm to a non-PCB 
status, as follows:
    (A) Remove the free-flowing PCB dielectric fluid from the 
electromagnet, switch, or voltage regulator. Flushing is not required. 
Either test the fluid or assume it contains $1,000 ppm PCBs. Retrofill 
the electromagnet, switch, or voltage regulator with fluid containing 
known PCB levels according to the following table. Determine the 
electromagnet, switch, or voltage regulator's reclassified status 
according to the following table (if following this process does not 
result in the reclassified status you desire, you may repeat the 
process):

[[Page 180]]



----------------------------------------------------------------------------------------------------------------
                                                                                                   then the
  If test results show the PCB     and you retrofill                       and test results     electromagnet,
   concentration (ppm) in the     the equipment with                         show the PCB     switch, or voltage
 equipment prior to retrofill is   dielectric fluid      and you . . .       concentration        regulator's
              . . .                containing . . .                           (ppm) after        reclassified
                                                                          retrofill is . . .    status is . . .
----------------------------------------------------------------------------------------------------------------
$1,000 (or untested)              <50 ppm PCBs        operate the         $50 but <500        PCB-contaminated
                                                       equipment
                                                       electrically
                                                       under loaded
                                                       conditions for at
                                                       least 90-
                                                       continuous days
                                                       after retrofill,
                                                       then test the
                                                       fluid for PCBs
                                 -------------------------------------------------------------------------------
                                  <50 ppm PCBs        operate the         <50                 non-PCB
                                                       equipment
                                                       electrically
                                                       under loaded
                                                       conditions for at
                                                       least 90-
                                                       continuous days
                                                       after retrofill,
                                                       then test the
                                                       fluid for PCBs
----------------------------------------------------------------------------------------------------------------
$500 but <1,000                   <50 ppm PCBs        test the fluid for  $50 but <500        PCB-contaminated
                                                       PCBs at least 90
                                                       days after
                                                       retrofill
                                 -------------------------------------------------------------------------------
                                  <50 ppm PCBs        test the fluid for  <50                 non-PCB
                                                       PCBs at least 90
                                                       days after
                                                       retrofill
----------------------------------------------------------------------------------------------------------------
$50 but <500                      $2 but <50 ppm      test the fluid for  <50                 non-PCB
                                   PCBs                PCBs at least 90
                                                       days after
                                                       retrofill
                                 -------------------------------------------------------------------------------
                                  <2 ppm PCBs         (no need to test)   (not applicable)    non-PCB
----------------------------------------------------------------------------------------------------------------

    (B) If you discover that the PCB concentration of the fluid in a 
reclassified electromagnet, switch, or voltage regulator has changed, 
causing the reclassified status to change, the electromagnet, switch, or 
voltage regulator is regulated based on the actual concentration of the 
fluid. For example, an electromagnet, switch, or voltage regulator that 
was reclassified to non-PCB status is regulated as a PCB-Contaminated 
electromagnet, switch, or voltage regulator if you discover that the 
concentration of the fluid has increased to $50 but <500 ppm PCBs. If 
you discover that the PCB concentration of the fluid in a voltage 
regulator has risen to $500 ppm, follow paragraph (h)(1)(iii) of this 
section to come into compliance with the regulations applicable to 
voltage regulators containing $500 ppm PCBs. You also have the option of 
repeating the reclassification process.
    (C) The Director, National Program Chemicals Division may, without 
further rulemaking, grant approval on a case-by-case basis for the use 
of alternative methods to reclassify electromagnets, switches or voltage 
regulators. You may request an approval by writing to the Director, 
National Program Chemicals Division (7404), Environmental Protection 
Agency,1200 Pennsylvania Ave., NW., Washington, DC 20460. Describe the 
equipment you plan to reclassify, the alternative reclassification 
method you plan to use, and test data or other evidence on the 
effectiveness of the method.
    (D) You must keep records of the reclassification required by 
Sec. 761.180(g).
    (vi) Any dielectric fluid containing 50 ppm or greater PCB used for 
servicing electromagnets, switches, or voltage regulators must be stored 
in accordance with the storage for disposal requirements of Sec. 761.65.
    (vii) Processing and distribution in commerce of PCBs for purposes 
of servicing electromagnets, switches or voltage regulators is permitted 
only for persons who are granted an exemption under TSCA 6(e)(3)(B).
    (i) Use and reuse of PCBs in natural gas pipeline systems; use and 
reuse of PCB-Contaminated natural gas pipe and

[[Page 181]]

appurtenances. (1)(i) PCBs are authorized for use in natural gas 
pipeline systems at concentrations <50 ppm.
    (ii) PCBs are authorized for use, at concentrations $50 ppm, in 
natural gas pipeline systems not owned or operated by a seller or 
distributor of natural gas.
    (iii)(A) PCBs are authorized for use, at concentrations $50 ppm, in 
natural gas pipeline systems owned or operated by a seller or 
distributor of natural gas, if the owner or operator:
    (1) Submits to EPA, upon request, a written description of the 
general nature and location of PCBs $50 ppm in their natural gas 
pipeline system. Each written description shall be submitted to the EPA 
Regional Administrator having jurisdiction over the segment or component 
of the system (or the Director, National Program Chemicals Division, 
Office of Pollution Prevention and Toxics, if the system is contaminated 
in more than one region).
    (2) Within 120 days after discovery of PCBs $50 ppm in natural gas 
pipeline systems, or by December 28, 1998, whichever is later, 
characterizes the extent of PCB contamination by collecting and 
analyzing samples to identify the upstream and downstream end points of 
the segment or component where PCBs $50 ppm were discovered.
    (3) Within 120 days of characterization of the extent of PCB 
contamination, or by December 28, 1998, whichever is later, samples and 
analyzes all potential sources of introduction of PCBs into the natural 
gas pipeline system for PCBs $50 ppm. Potential sources include natural 
gas compressors, natural gas scrubbers, natural gas filters, and 
interconnects where natural gas is received upstream from the most 
downstream sampling point where PCBs $50 ppm were detected; potential 
sources exclude valves, drips, or other small liquid condensate 
collection points.
    (4) Within 1 year of characterization of the extent of PCB 
contamination, reduces all demonstrated sources of PCBs $50 ppm to <50 
ppm, or removes such sources from the natural gas pipeline system; or 
implements other engineering measures or methods to reduce PCB levels to 
<50 ppm and to prevent further introduction of PCBs $50 ppm into the 
natural gas pipeline system (e.g., pigging, decontamination, in-line 
filtration).
    (5) Repeats sampling and analysis at least annually where PCBs are 
$50 ppm, until sampling results indicate the natural gas pipeline 
segment or component is <50 ppm PCB in two successive samples with a 
minimum interval between samples of 180 days.
    (6) Marks aboveground sources of PCB liquids in natural gas pipeline 
systems with the ML Mark in accordance with Sec. 761.45(a), 
where such sources have been demonstrated through historical data or 
recent sampling to contain PCBs $50 ppm.
    (B) Owners or operators of natural gas pipeline systems which do not 
include potential sources of PCB contamination as described in paragraph 
(i)(1)(iii)(A)(3) of this section containing $50 ppm PCB are not subject 
to paragraphs (i)(1)(iii)(A)(2), (i)(1)(iii)(A)(3), (i)(1)(iii)(A)(4), 
or (i)(1)(iii)(A)(6) of this section. Owners or operators of these 
systems, however, must comply with the other provisions of this section 
(e.g., sampling of any collected PCB liquids and recordkeeping).
    (C) The owner or operator of a natural gas pipeline system must 
document in writing all data collected and actions taken, or not taken, 
pursuant to the authorization in paragraph (i)(1)(iii)(A) of this 
section. They must maintain the information for 3 years after the PCB 
concentration in the component or segment is reduced to <50 ppm, and 
make it available to EPA upon request.
    (D) The Director, National Program Chemicals Division, after 
consulting with the appropriate EPA Region(s) may, based on a finding of 
no unreasonable risk, modify in writing the requirements of paragraph 
(i)(1)(iii)(A) of this section, including extending any compliance date, 
approving alternative formats for documentation, waiving one or more 
requirements for a segment or component, requiring sampling and 
analysis, and requiring implementation of engineering measures to reduce 
PCB concentrations. EPA will make such modifications based on the 
natural gas pipeline system size, configuration, and current operating

[[Page 182]]

conditions; nature, extent or source of contamination; proximity of 
contamination to end-users; or previous sampling, monitoring, remedial 
actions or documentation of activities taken regarding compliance with 
this authorization or other applicable Federal, State, or local laws and 
regulations. The Director, National Program Chemicals Division, may 
defer the authority described in this paragraph, upon request, to the 
appropriate EPA Region.
    (E) The owner or operator of a natural gas pipeline system may use 
historical data to fulfill the requirements of paragraphs 
(i)(1)(iii)(A)(1), (i)(1)(iii)(A)(2) and (i)(1)(iii)(A)(3) of this 
section. They may use documented historical actions taken to reduce PCB 
concentrations in known sources; decontaminate components or segments of 
natural gas pipeline systems; or otherwise to reduce PCB levels to 
fulfill the requirements of paragraph (i)(1)(iii)(A)(4) of this section.
    (2) Any person may reuse PCB-Contaminated natural gas pipe and 
appurtenances in a natural gas pipeline system, provided all free-
flowing liquids have been removed.
    (3) Any person may use PCB-Contaminated natural gas pipe, drained of 
all free-flowing liquids, in the transport of liquids (e.g., bulk 
hydrocarbons, chemicals, petroleum products, or coal slurry), as casing 
to provide secondary containment or protection (e.g., protection for 
electrical cable), as industrial structural material (e.g., fence posts, 
sign posts, or bridge supports), as temporary flume at construction 
sites, as equipment skids, as culverts under transportation systems in 
intermittent flow situations, for sewage service with written consent of 
the Publicly Owned Treatment Works (POTW), for steam service, as 
irrigation systems (<20 inch diameter) of less than 200 miles in length, 
and in a totally enclosed compressed air system.
    (4) Any person characterizing PCB contamination in natural gas pipe 
or natural gas pipeline systems must do so by analyzing organic liquids 
collected at existing condensate collection points in the pipe or 
pipeline system. The level of PCB contamination found at a collection 
point is assumed to extend to the next collection point downstream. Any 
person characterizing multi-phasic liquids must do so in accordance with 
Sec. 761.1(b)(4); if no liquids are present, they must use standard wipe 
samples in accordance with subpart M of this part.
    (5)(i) Any person disposing of liquids containing PCBs $50 ppm 
removed, spilled, or otherwise released from a natural gas pipeline 
system must do so in accordance with Sec. 761.61(a)(5)(iv) based on the 
PCB concentration at the time of removal from the system. Any person 
disposing of materials contaminated by spills or other releases of PCBs 
$50 ppm from a natural gas pipeline systems, must do so in accordance 
with Secs. 761.61 or 761.79, as applicable.
    (ii) Any person who markets or burns for energy recovery liquids 
containing PCBs at concentrations <50 ppm PCBs at the time of removal 
from a natural gas pipeline system must do so in accordance with the 
provisions pertaining to used oil at Sec. 761.20(e). No other use of 
liquid containing PCBs at concentrations above the quantifiable level/
level of detection removed from a natural gas pipeline system is 
authorized.
    (j) Research and development. For purposes of this section, 
authorized research and development (R&D) activities include, but are 
not limited to: the chemical analysis of PCBs, including analyses to 
determine PCB concentration; determinations of the physical properties 
of PCBs; studies of environmental transport processes; studies of 
biochemical transport processes; studies of effects of PCBs on the 
environment; and studies of the health effects of PCBs, including direct 
toxicity and toxicity of metabolic products of PCBs. Authorized R&D 
activities do not include research, development, or analysis for the 
development of any PCB product. Any person conducting R&D activities 
under this section is also responsible for determining and complying 
with all other applicable Federal, State, and local laws and 
regulations. Although the use of PCBs and PCBs in analytical reference 
samples derived from waste material is authorized in conjunction with 
PCB-disposal

[[Page 183]]

related activities, R&D for PCB disposal (as defined under Sec. 761.3) 
is addressed in Sec. 761.60(j). PCBs and PCBs in analytical reference 
samples derived from waste materials are authorized for use, in a manner 
other than a totally enclosed manner, provided that:
    (1) They obtain the PCBs and PCBs in analytical reference samples 
derived from waste materials from sources authorized under Sec. 761.80 
to manufacture, process, and distribute PCBs in commerce and the PCBs 
are packaged in compliance with the Hazardous Materials Regulations at 
49 CFR parts 171 through 180.
    (2) They store all PCB wastes resulting from R&D activities (e.g., 
spent laboratory samples, residuals, contaminated media such as 
clothing, etc.) in compliance with Sec. 761.65(b) and dispose of all PCB 
wastes in compliance with Sec. 761.64.
    (3) [Reserved]
    (4) No person may manufacture, process, or distribute in commerce 
PCBs for research and development unless they have been granted an 
exemption to do so under TSCA section 6(e)(3)(B).
    (k) Use in scientific instruments. PCBs may be used indefinitely in 
scientific instruments, for example, in oscillatory flow birefringence 
and viscoelasticity instruments for the study of the physical properties 
of polymers, as microscopy mounting fluids, as microscopy immersion oil, 
and as optical liquids in a manner other than a totally enclosed manner. 
No person may manufacture, process, or distribute in commerce PCBs for 
use in scientific instruments unless they have been granted an exemption 
to do so under TSCA section 6(e)(3)(B).
    (l) Use in capacitors. PCBs at any concentration may be used in 
capacitors, subject to the following conditions:
    (1) Use conditions. (i) After October 1, 1988, the use and storage 
for reuse of PCB Large High Voltage Capacitors and PCB Large Low Voltage 
Capacitors which pose an exposure risk to food or feed is prohibited.
    (ii) After October 1, 1988, the use of PCB Large High Voltage 
Capacitors and PCB Large Low Voltage Capacitors is prohibited unless the 
capacitor is used within a restricted-access electrical substation or in 
a contained and restricted-access indoor installation. A restricted-
access electrical substation is an outdoor, fenced or walled-in facility 
that restricts public access and is used in the transmission or 
distribution of electric power. A contained and restricted-access indoor 
installation does not have public access and has an adequate roof, 
walls, and floor to contain any release of PCBs within the indoor 
location.
    (2) [Reserved]
    (m) Use in and servicing of circuit breakers, reclosers and cable. 
PCBs at any concentration may be used in circuit breakers, reclosers, 
and cable and may be used for purposes of servicing this electrical 
equipment (including rebuilding) for the remainder of their useful 
lives, subject to the following conditions:
    (1) Servicing conditions. (i) Circuit breakers, reclosers, and cable 
may be serviced (including rebuilding) only with dielectric fluid 
containing less than 50 ppm PCB.
    (ii) Any circuit breaker, recloser or cable found to contain at 
least 50 ppm PCBs may be serviced only in accordance with the conditions 
contained in 40 CFR 761.30(h)(2).
    (2) [Reserved]
    (n)-(o) [Reserved]
    (p) Continued use of porous surfaces contaminated with PCBs 
regulated for disposal by spills of liquid PCBs. (1) Any person may use 
porous surfaces contaminated by spills of liquid PCBs at concentrations 
>10 mg/100 cm\2\ for the remainder of the useful life of the surfaces 
and subsurface material if the following conditions are met:
    (i) The source of PCB contamination is removed or contained to 
prevent further release to porous surfaces.
    (ii) If the porous surface is accessible to superficial surface 
cleaning:
    (A) The double wash rinse procedure in subpart S of this part is 
conducted on the surface to remove surface PCBs.
    (B) The treated surface is allowed to dry for 24 hours.
    (iii) After accessible surfaces have been cleaned according to 
paragraph (p)(1)(ii) of this section and for all surfaces inaccessible 
to cleanup:
    (A) The surface is completely covered to prevent release of PCBs 
with:

[[Page 184]]

    (1) Two solvent resistant and water repellent coatings of 
contrasting colors to allow for a visual indication of wear through or 
loss of outer coating integrity; or
    (2) A solid barrier fastened to the surface and covering the 
contaminated area or all accessible parts of the contaminated area. 
Examples of inaccessible areas are underneath a floor-mounted electrical 
transformer and in an impassible space between an electrical transformer 
and a vault wall.
    (B) The surface is marked with the ML Mark in a location 
easily visible to individuals present in the area; the ML 
Mark shall be placed over the encapsulated area or the barrier to the 
encapsulated area.
    (C) ML Marks shall be replaced when worn or illegible.
    (2) Removal of a porous surface contaminated with PCBs from its 
location or current use is prohibited except for removal for disposal in 
accordance with Secs. 761.61 or 761.79 for surfaces contaminated by 
spills, or Sec. 761.62 for manufactured porous surfaces.
    (q) [Reserved]
    (r) Use in and servicing of rectifiers. Any person may use PCBs at 
any concentration in rectifiers for the remainder of the PCBs' useful 
life, and may use PCBs <50 ppm in servicing (including rebuilding) 
rectifiers.
    (s) Use of PCBs in air compressor systems. (1) Any person may use 
PCBs in air compressor systems at concentrations <50 ppm.
    (2) Any person may use PCBs in air compressor systems (or components 
thereof) at concentrations $50 ppm provided that:
    (i) All free-flowing liquids containing PCBs $50 ppm are removed 
from the air compressor crankcase and the crankcase is refilled with 
non-PCB liquid.
    (ii) Other air compressor system components contaminated with PCBs 
$50 ppm, are decontaminated in accordance with Sec. 761.79 or disposed 
of in accordance with subpart D of this part.
    (iii) Air compressor piping with a nominal inside diameter of <2 
inches is decontaminated by continuous flushing for 4 hours, at no <300 
gallons per hour (Sec. 761.79 contains solvent requirements).
    (3) The requirements in paragraph (s)(2) of this section must be 
completed by August 30, 1999 or within 1 year of the date of discovery 
of PCBs at $50 ppm in the air compressor system, whichever is later. The 
EPA Regional Administrator for the EPA Region in which an air compressor 
system is located may, at his/her discretion and in writing, extend this 
timeframe.
    (t) Use of PCBs in other gas or liquid transmission systems. (1) 
PCBs are authorized for use in intact and non-leaking gas or liquid 
transmission systems at concentrations <50 ppm PCBs.
    (2) PCBs are authorized for use at concentrations $50 ppm in intact 
and non-leaking gas or liquid transmission systems not owned or operated 
by a seller or distributor of the gas or liquid transmitted in the 
system.
    (3) Any person may use PCBs at concentrations $50 ppm in intact and 
non-leaking gas or liquid transmission systems, with the written 
approval of the Director, National Program Chemicals Division, subject 
to the requirements applicable to natural gas pipeline systems at 
paragraphs (i)(1)(iii)(A), (i)(1)(iii)(C) through (i)(1)(iii)(E), and 
(i)(2) through (i)(5) of this section.
    (u) Use of decontaminated materials. (1) Any person may use 
equipment, structures, other non-liquid or liquid materials that were 
contaminated with PCBs during manufacture, use, servicing, or because of 
spills from, or proximity to, PCBs $50 ppm, including those not 
otherwise authorized for use under this part, provided:
    (i) The materials were decontaminated in accordance with:
    (A) A TSCA PCB disposal approval issued under subpart D of this 
part;
    (B) Section 761.79; or
    (C) Applicable EPA PCB spill cleanup policies (e.g., TSCA, RCRA, 
CERCLA, EPA regional) in effect at the time of the decontamination; or
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec. 761.79(b).
    (2) No person shall use or reuse materials decontaminated in 
accordance with paragraph (u)(1)(i) of this section or meeting an 
applicable decontamination standard in paragraph (u)(1)(ii) of this 
section, in direct contact with food, feed, or drinking water unless 
otherwise allowed under this section or this part.

[[Page 185]]

    (3) Any person may use water containing PCBs at concentrations 
0.5mg/L PCBs without restriction.
    (4) Any person may use water containing PCBs at concentrations <200 
mg/L (i.e., <200 ppb PCBs) for non-contact use in a closed system where 
there are no releases (e.g., as a non-contact cooling water).

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020, 2025 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982]

    Editorial Note: For Federal Register citations affecting 
Sec. 761.30, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 761.35  Storage for reuse.

    (a) The owner or operator of a PCB Article may store it for reuse in 
an area which is not designed, constructed, and operated in compliance 
with Sec. 761.65(b), for no more than 5 years after the date the Article 
was originally removed from use (e.g., disconnected electrical 
equipment) or 5 years after August 28, 1998, whichever is later, if the 
owner or operator complies with the following conditions:
    (1) Follows all use requirements at Sec. 761.30 and marking 
requirements at subpart C of this part that are applicable to the PCB 
Article.
    (2) Maintains records starting at the time the PCB Article is 
removed from use or August 28, 1998. The records must indicate:
    (i) The date the PCB Article was removed from use or August 28, 
1998, if the removal date is not known.
    (ii) The projected location and the future use of the PCB Article.
    (iii) If applicable, the date the PCB Article is scheduled for 
repair or servicing.
    (b) The owner or operator of a PCB Article may store it for reuse in 
an area that does not comply with Sec. 761.65(b) for a period longer 
than 5 years, provided that the owner or operator has received written 
approval from the EPA Regional Administrator for the Region in which the 
PCB Article is stored. An owner or operator of a PCB Article seeking 
approval to extend the 5-year period must submit a request for extension 
to the EPA Regional Administrator at least 6 months before the 5-year 
storage for reuse period expires and must include an item-by-item 
justification for the desired extension. The EPA Regional Administrator 
may include any conditions to such approval deemed necessary to protect 
health or the environment. The owner or operator of the PCB Article 
being stored for reuse must comply with the other applicable provisions 
of this part, including the record retention requirements at 
Sec. 761.180(a).
    (c) Any person may store a PCB Article for reuse indefinitely in:
    (1) A unit in compliance with Sec. 761.65(b).
    (2) A unit permitted under section 3004 of RCRA to manage hazardous 
wastes in containers.
    (3) A unit permitted by a State authorized under section 3006 of 
RCRA to manage hazardous waste.

[63 FR 35443, June 29, 1998]



                 Subpart C_Marking of PCBs and PCB Items



Sec. 761.40  Marking requirements.

    (a) Each of the following items in existence on or after July 1, 
1978 shall be marked as illustrated in Figure 1 in Sec. 761.45(a): The 
mark illustrated in Figure 1 is referred to as ML throughout 
this subpart.
    (1) PCB Containers;
    (2) PCB Transformers at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal from use if not already marked. [Marking of PCB-Contaminated 
Electrical Equipment is not required];
    (3) PCB Large High Voltage Capacitors at the time of manufacture, at 
the time of distribution in commerce if not already marked, and at the 
time of removal from use if not already marked;
    (4) Equipment containing a PCB Transformer or a PCB Large High 
Voltage Capacitor at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal of the equipment from use if not already marked;
    (5) PCB Large Low Voltage Capacitors at the time of removal from use 
(see also paragraph (k) of this section).

[[Page 186]]

    (6) Electric motors using PCB coolants (See also paragraph (e) of 
this section).
    (7) Hydraulic systems using PCB hydraulic fluid (See also paragraph 
(e) of this section);
    (8) Heat transfer systems (other than PCB Transformers) using PCBs 
(See also paragraph (e) of this section);
    (9) PCB Article Containers containing articles or equipment that 
must be marked under paragraphs (a) (1) through (8) of this section;
    (10) Each storage area used to store PCBs and PCB Items for 
disposal.
    (b) As of October 1, 1978, each transport vehicle loaded with PCB 
Containers that contain more than 45 kg (99.4 lbs.) of liquid PCBs at 
concentrations of $50 ppm or with one or more PCB Transformers shall be 
marked on each end and each side with the ML mark as 
described in Sec. 761.45(a).
    (c) As of January 1, 1979, the following PCB Articles shall be 
marked with mark ML as described in Sec. 761.45(a):
    (1) All PCB Transformers not marked under paragraph (a) of this 
section [marking of PCB-Contaminated Electrical Equipment is not 
required];
    (2) All PCB Large High Voltage Capacitors not marked under paragraph 
(a) of this section
    (i) Will be marked individually with mark ML, or
    (ii) If one or more PCB Large High Voltage Capacitors are installed 
in a protected location such as on a power pole, or structure, or behind 
a fence; the pole, structure, or fence shall be marked with mark 
ML, and a record or procedure identifying the PCB Capacitors 
shall be maintained by the owner or operator at the protected location.
    (d) As of January 1, 1979, all PCB Equipment containing a PCB Small 
Capacitor shall be marked at the time of manufacture with the statement, 
``This equipment contains PCB Capacitor(s)''. The mark shall be of the 
same size as the mark ML.
    (e) As of October 1, 1979, applicable PCB Items in paragraphs 
(a)(1), (a)(6), (a)(7), and (a)(8) of this section containing PCBs in 
concentrations of 50 to 500 ppm shall be marked with the ML 
mark as described in Sec. 761.45(a).
    (f) Where mark ML is specified but the PCB Article or PCB 
Equipment is too small to accomodate the smallest permissible size of 
mark ML, mark MS as described in Sec. 761.45(b), 
may be used instead of mark ML.
    (g) Each large low voltage capacitor, each small capacitor normally 
used in alternating current circuits, and each fluorescent light ballast 
manufactured (``manufactured'', for purposes of this sentence, means 
built) between July 1, 1978 and July 1, 1998 that do not contain PCBs 
shall be marked by the manufacturer at the time of manufacture with the 
statement, ``No PCBs''. The mark shall be of similar durability and 
readability as other marking that indicate electrical information, part 
numbers, or the manufacturer's name. For purposes of this paragraph 
marking requirement only is applicable to items built domestically or 
abroad after June 30, 1978.
    (h) All marks required by this subpart must be placed in a position 
on the exterior of the PCB Items, storage units, or transport vehicles 
so that the marks can be easily read by any persons inspecting or 
servicing the marked PCB Items, storage units, or transport vehicles.
    (i) Any chemical substance or mixture that is manufactured after the 
effective date of this rule and that contains less than 500 ppm PCB 
(0.05% on a dry weight basis), including PCB that is a byproduct or 
impurity, must be marked in accordance with any requirements contained 
in the exemption granted by EPA to permit such manufacture and is not 
subject to any other requirement in this subpart unless so specified in 
the exemption. This paragraph applies only to containers of chemical 
substances or mixtures. PCB articles and equipment into which the 
chemical substances or mixtures are processed, are subject to the 
marking requirements contained elsewhere in this subpart.
    (j) PCB Transformer locations shall be marked as follows:
    (1) Except as provided in paragraph (j)(2) of this section, as of 
December 1, 1985, the vault door, machinery room door, fence, hallway, 
or means of access, other than grates and manhole covers, to a PCB 
Transformer must be

[[Page 187]]

marked with the mark ML as required by paragraph (a) of this 
section.
    (2) A mark other than the ML mark may be used provided 
all of the following conditions are met:
    (i) The program using such an alternative mark was initiated prior 
to August 15, 1985, and can be substantiated with documentation.
    (ii) Prior to August 15, 1985, coordination between the transformer 
owner and the primary fire department occurred, and the primary fire 
department knows, accepts, and recognizes what the alternative mark 
means, and that this can be substantiated with documentation.
    (iii) The EPA Regional Administrator in the appropriate region is 
informed in writing of the use of the alternative mark by October 3, 
1988 and is provided with documentation that the program began before 
August 15, 1985, and documentation that demonstrates that prior to that 
date the primary fire department knew, accepted and recognized the 
meaning of the mark, and included this information in firefighting 
training.
    (iv) The Regional Administrator will either approve or disapprove in 
writing the use of an alternative mark within 30 days of receipt of the 
documentation of a program.
    (3) Any mark placed in accordance with the requirements of this 
section must be placed in the locations described in paragraph (j)(1) of 
this section and in a manner that can be easily read by emergency 
response personnel fighting a fire involving this equipment.
    (k) As of April 26, 1999 the following PCB Items shall be marked 
with the ML mark as described in Sec. 761.45(a):
    (1) All PCB Large Low Voltage Capacitors not marked under paragraph 
(a) of this section shall be marked individually, or if one or more PCB 
Large Low Voltage Capacitors are installed in a protected location such 
as on a power pole, or structure, or behind a fence, then the owner or 
operator shall mark the pole, structure, or fence with the ML 
mark, and maintain a record or procedure identifying the PCB Capacitors 
at the protected location. PCB Large Low Voltage Capacitors in 
inaccessible locations inside equipment need not be marked individually, 
provided the owner or operator marks the equipment in accordance with 
paragraph (k)(2) of this section, and marks the individual capacitors at 
the time of removal from use in accordance with paragraph (a) of this 
section.
    (2) All equipment not marked under paragraph (a) of this section 
containing a PCB Transformer or a PCB Large High or Low Voltage 
Capacitor.
    (l)(1) All voltage regulators which contain 1.36 kilograms (3 lbs.) 
or more of dielectric fluid with a PCB concentration of $500 ppm must be 
marked individually with the ML mark as described in 
Sec. 761.45(a).
    (2) Locations of voltage regulators which contain 1.36 kilograms (3 
lbs.) or more of dielectric fluid with a PCB concentration of $500 ppm 
shall be marked as follows: The vault door, machinery room door, fence, 
hallway, or means of access, other than grates or manhole covers, must 
be marked with the ML mark as described in Sec. 761.45(a).

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 47 FR 37359, Aug. 25, 1982; 50 FR 29201, July 17, 1985; 
50 FR 32176, Aug. 9, 1985; 53 FR 12524, Apr. 15, 1988; 53 FR 27329, July 
19, 1988; 63 FR 35443, June 29, 1998; 64 FR 33760, June 24, 1999]



Sec. 761.45  Marking formats.

    The following formats shall be used for marking:
    (a) Large PCB Mark--ML. Mark ML shall be as shown in 
Figure 1, letters and striping on a white or yellow background and shall 
be sufficiently durable to equal or exceed the life (including storage 
for disposal) of the PCB Article, PCB Equipment, or PCB Container. The 
size of the mark shall be at least 15.25 cm (6 inches) on each side. If 
the PCB Article or PCB Equipment is too small to accommodate this size, 
the mark may be reduced in size proportionately down to a minimum of 5 
cm (2 inches) on each side.
    (b) Small PCB Mark--Ms. Mark Ms shall be as shown in 
Figure 2, letters and striping on a white or yellow background, and 
shall be sufficiently durable to equal or exceed the life (including 
storage for disposal) of the PCB Article, PCB Equipment, or PCB 
Container. The mark shall be a rectangle 2.5 by 5 cm (1 inch by 2 
inches). If the

[[Page 188]]

PCB Article or PCB Equipment is too small to accommodate this size, the 
mark may be reduced in size proportionately down to a minimum of 1 by 2 
cm (.4 by .8 inches).
[GRAPHIC] [TIFF OMITTED] TC01AP92.000


[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982]



                     Subpart D_Storage and Disposal



Sec. 761.50  Applicability.

    (a) General PCB disposal requirements. Any person storing or 
disposing of PCB waste must do so in accordance with subpart D of this 
part. The following prohibitions and conditions apply to all PCB waste 
storage and disposal:
    (1) No person may open burn PCBs. Combustion of PCBs approved under 
Sec. 761.60 (a) or (e), or otherwise allowed under part 761, is not open 
burning.
    (2) No person may process liquid PCBs into non-liquid forms to 
circumvent the high temperature incineration requirements of 
Sec. 761.60(a).
    (3) No person may discharge water containing PCBs to a treatment 
works (as defined Sec. 503.9(aa) of this chapter) or to navigable waters 
unless the PCB concentration is <3 mg/L (approximately 3 ppb), or unless 
the discharge is in accordance with a PCB discharge limit included in a 
permit issued under section 307(b) or 402 of the Clean Water Act.
    (4) Spills and other uncontrolled discharges of PCBs at 
concentrations of $50 ppm constitute the disposal of PCBs.
    (5) Any person land disposing of non-liquid PCBs may avoid 
otherwise-applicable sampling requirements by presuming that the PCBs 
disposed of are $500 ppm (or $100 mg/100 cm\2\ if no free-flowing 
liquids are present).
    (6) Any person storing or disposing of PCBs is also responsible for 
determining and complying with all other applicable Federal, State, and 
local laws and regulations.
    (b) PCB waste--(1) PCB liquids. Any person removing PCB liquids from 
use (i.e., not PCB remediation waste) must dispose of them in accordance 
with Sec. 761.60(a), or decontaminate them in accordance with 
Sec. 761.79.
    (2) PCB Items. Any person removing from use a PCB Item containing an 
intact and non-leaking PCB Article must dispose of it in accordance with 
Sec. 761.60(b), or decontaminate it in accordance with Sec. 761.79. PCB 
Items where the PCB Articles are no longer intact and non-leaking are 
regulated for disposal as PCB bulk product waste under Sec. 761.62(a) or 
(c).
    (i) Fluorescent light ballasts containing PCBs only in an intact and 
non-leaking PCB Small Capacitor are regulated for disposal under 
Sec. 761.60(b)(2)(ii).
    (ii) Fluorescent light ballasts containing PCBs in the potting 
material are regulated for disposal as PCB bulk product waste under 
Sec. 761.62.
    (3) PCB remediation waste. PCB remediation waste, including PCB 
sewage sludge, is regulated for cleanup and disposal in accordance with 
Sec. 761.61.
    (i) Any person responsible for PCB waste at as-found concentrations 
$50 ppm that was either placed in a land disposal facility, spilled, or 
otherwise released into the environment prior to April 18, 1978, 
regardless of the concentration of the spill or release; or placed in a 
land disposal facility,

[[Page 189]]

spilled, or otherwise released into the environment on or after April 
18, 1978, but prior to July 2, 1979, where the concentration of the 
spill or release was $50 ppm but <500 ppm, must dispose of the waste as 
follows:
    (A) Sites containing these wastes are presumed not to present an 
unreasonable risk of injury to health or the environment from exposure 
to PCBs at the site. However, the EPA Regional Administrator may inform 
the owner or operator of the site that there is reason to believe that 
spills, leaks, or other uncontrolled releases or discharges, such as 
leaching, from the site constitute ongoing disposal that may present an 
unreasonable risk of injury to health or the environment from exposure 
to PCBs at the site, and may require the owner or operator to generate 
data necessary to characterize the risk. If after reviewing any such 
data, the EPA Regional Administrator makes a finding, that an 
unreasonable risk exists, then he or she may direct the owner or 
operator of the site to dispose of the PCB remediation waste in 
accordance with Sec. 761.61 such that an unreasonable risk of injury no 
longer exists.
    (B) Unless directed by the EPA Regional Administrator to dispose of 
PCB waste in accordance with paragraph (b)(3)(i)(A) of this section, any 
person responsible for PCB waste at as-found concentrations $50 ppm that 
was either placed in a land disposal facility, spilled, or otherwise 
released into the environment prior to April 18, 1978, regardless of the 
concentration of the spill or release; or placed in a land disposal 
facility, spilled, or otherwise released into the environment on or 
after April 18, 1978, but prior to July 2, 1979, where the concentration 
of the spill or release was $50 ppm but <500 ppm, who unilaterally 
decides to dispose of that waste (for example, to obtain insurance or to 
sell the property), is not required to clean up in accordance with 
Sec. 761.61. Disposal of the PCB remediation waste must comply with 
Sec. 761.61. However, cleanup of those wastes that is not in complete 
compliance with Sec. 761.61 will not afford the responsible party with 
relief from the applicable PCB regulations for that waste.
    (ii) Any person responsible for PCB waste at as-found concentrations 
$50 ppm that was either placed in a land disposal facility, spilled, or 
otherwise released into the environment on or after April 18, 1978, but 
prior to July 2, 1979, where the concentration of the spill or release 
was $500 ppm; or placed in a land disposal facility, spilled, or 
otherwise released into the environment on or after July 2, 1979, where 
the concentration of the spill or release was $50 ppm, must dispose of 
it in accordance with either of the following:
    (A) In accordance with the PCB Spill Cleanup Policy (Policy) at 
subpart G of this part, for those PCB remediation wastes that meet the 
criteria of the Policy. Consult the Policy for a description of the 
spills it covers and its notification and timing requirements.
    (B) In accordance with Sec. 761.61. Complete compliance with 
Sec. 761.61 does not create a presumption against enforcement action for 
penalties for any unauthorized PCB disposal.
    (iii) The owner or operator of a site containing PCB remediation 
waste has the burden of proving the date that the waste was placed in a 
land disposal facility, spilled, or otherwise released into the 
environment, and the concentration of the original spill.
    (4) PCB bulk product waste--(i) General. Any person disposing of PCB 
bulk product waste must do so in accordance with Sec. 761.62. PCB bulk 
product waste, as that term is defined in Sec. 761.3, is waste that was 
$50 ppm when originally removed from service, even if its current PCB 
concentration is <50 ppm. PCB bulk product waste is regulated for 
disposal based on the risk from the waste once disposed of. For waste 
which is land disposed, the waste is regulated based on how readily the 
waste is released from disposal to the environment, in particular by 
leaching out from the land disposal unit.
    (ii) Metal surfaces in contact with PCBs. Any person disposing of 
metal surfaces in contact with PCBs (e.g., painted metal) may use 
thermal decontamination procedures in accordance with Sec. 761.79(c)(6) 
(see Sec. 761.62(a)(6)).
    (5) PCB household waste. Any person storing or disposing of PCB 
household waste, as that term is defined in Sec. 761.3, must do so in 
accordance with Sec. 761.63.

[[Page 190]]

    (6) PCB research and development waste. Any person disposing of PCB 
wastes generated during and as a result of research and development for 
use under Sec. 761.30(j), or for disposal under Sec. 761.60(j), must do 
so in accordance with Sec. 761.64.
    (7) PCB/Radioactive waste. (i) Any person storing PCB/radioactive 
waste $50 ppm PCBs must do so taking into account both its PCB 
concentration and its radioactive properties, except as provided in 
Sec. 761.65(a)(1), (b)(1)(ii), and (c)(6)(i).
    (ii) Any person disposing of PCB/radioactive waste must do so taking 
into account both its PCB concentration and its radioactive properties. 
If, taking into account only the properties of the PCBs in the waste 
(and not the radioactive properties of the waste), the waste meets the 
requirements for disposal in a facility permitted, licensed, or 
registered by a State as a municipal or non-municipal non-hazardous 
waste landfill (e.g., PCB bulk product waste under Sec. 761.62(b)(1)), 
then the person may dispose of the PCB/radioactive waste, without regard 
to the PCB component of the waste, on the basis of its radioactive 
properties in accordance with all applicable requirements for the 
radioactive component of the waste.
    (8) Porous surfaces. In most cases a person must dispose of porous 
surfaces as materials where PCBs have penetrated far beneath the 
surface, rather than a simple surface contamination. Any person 
disposing of porous surfaces on which PCBs have been spilled and meeting 
the definition of PCB remediation waste at Sec. 761.3 must do so in 
accordance with Sec. 761.61. Any person disposing of porous surfaces 
which are part of manufactured non-liquid products containing PCBs and 
meeting the definition of PCB bulk product waste at Sec. 761.3 must do 
so in accordance with Sec. 761.62. Any person may decontaminate concrete 
surfaces upon which PCBs have been spilled in accordance with 
Sec. 761.79(b)(4), if the decontamination procedure is commenced within 
72 hours of the initial spill of PCBs to the concrete or portion thereof 
being decontaminated. Any person may decontaminate porous non-liquid 
PCBs in contact with non-porous surfaces, such as underground metal fuel 
tanks coated with fire retardant resin or pitch, for purposes of 
unrestricted use or disposal in a smelter in accordance with 
Sec. 761.79(b)(3).
    (c) Storage for disposal. Any person who holds PCB waste must store 
it in accordance with Sec. 761.65.
    (d) Performance specifications for disposal technologies--(1) 
Incinerators. Any person using an incinerator to dispose of PCBs must 
use an incinerator that meets the criteria set forth in Sec. 761.70.
    (2) High efficiency boilers. Any person using a high efficiency 
boiler to dispose of PCBs must use a boiler that meets the criteria set 
forth in Sec. 761.71.
    (3) Scrap metal recovery ovens and smelters. Any person using scrap 
metal recovery ovens and smelters to dispose of PCBs must use a device 
that meets the criteria set forth in Sec. 761.72.
    (4) Chemical waste landfills. Any person using a chemical waste 
landfill to dispose of PCBs must use a chemical waste landfill that 
meets the criteria set forth in Sec. 761.75.
    (e) TSCA PCB Coordinated Approval. Any person seeking a TSCA PCB 
Coordinated Approval must follow the procedures set forth in 
Sec. 761.77.

[63 FR 35444, June 29, 1998, as amended at 64 FR 33760, June 24, 1999]



Sec. 761.60  Disposal requirements.

    (a) PCB liquids. PCB liquids at concentrations $50 ppm must be 
disposed of in an incinerator which complies with Sec. 761.70, except 
that PCB liquids at concentrations $50 ppm and <500 ppm may be disposed 
of as follows:
    (1) For mineral oil dielectric fluid, in a high efficiency boiler 
according to Sec. 761.71(a).
    (2) For liquids other than mineral oil dielectric fluid, in a high 
efficiency boiler according to Sec. 761.71(b).
    (3) For liquids from incidental sources, such as precipitation, 
condensation, leachate or load separation and are associated with PCB 
Articles or non-liquid PCB wastes, in a chemical waste landfill which 
complies with Sec. 761.75 if:
    (i) [Reserved]
    (ii) Information is provided to or obtained by the owner or operator 
of the chemical waste landfill that shows that the liquids do not exceed 
500 ppm PCB

[[Page 191]]

and are not an ignitable waste as described in Sec. 761.75(b)(8)(iii).
    (b) PCB Articles. This paragraph does not authorize disposal that is 
otherwise prohibited in Sec. 761.20 or elsewhere in this part.
    (1) Transformers. (i) PCB Transformers shall be disposed of in 
accordance with either of the following:
    (A) In an incinerator that complies with Sec. 761.70; or
    (B) In a chemical waste landfill approved under Sec. 761.75; 
provided that all free-flowing liquid is removed from the transformer, 
the transformer is filled with a solvent, the transformer is allowed to 
stand for at least 18 continuous hours, and then the solvent is 
thoroughly removed. Any person disposing of PCB liquids that are removed 
from the transformer (including the dielectric fluid and all solvents 
used as a flush), shall do so in an incinerator that complies with 
Sec. 761.70 of this part, or shall decontaminate them in accordance with 
Sec. 761.79. Solvents may include kerosene, xylene, toluene, and other 
solvents in which PCBs are readily soluble. Any person disposing of 
these PCB liquids must ensure that the solvent flushing procedure is 
conducted in accordance with applicable safety and health standards as 
required by Federal or State regulations.
    (ii) [Reserved]
    (2) PCB Capacitors. (i) The disposal of any capacitor shall comply 
with all requirements of this subpart unless it is known from label or 
nameplate information, manufacturer's literature (including documented 
communications with the manufacturer), or chemical analysis that the 
capacitor does not contain PCBs.
    (ii) Any person may dispose of PCB Small Capacitors as municipal 
solid waste, unless that person is subject to the requirements of 
paragraph (b)(2)(iv) of this section.
    (iii) Any PCB Large High or Low Voltage Capacitor which contains 500 
ppm or greater PCBs, owned by any person, shall be disposed of in 
accordance with either of the following:
    (A) Disposal in an incinerator that complies with Sec. 761.70; or
    (B) Until March 1, 1981, disposal in a chemical waste landfill that 
complies with Sec. 761.75.
    (iv) Any person who manufactures or at any time manufactured PCB 
Capacitors or PCB Equipment, and acquired the PCB Capacitor in the 
course of such manufacturing, shall place the PCB Small Capacitors in a 
container meeting the DOT packaging requirements at 49 CFR parts 171 
through 180 and dispose of them in accordance with either of the 
following:
    (A) Disposal in an incinerator which complies with Sec. 761.70; or
    (B) Until March 1, 1981, disposal in a chemical waste landfill which 
complies with Sec. 761.75.
    (v) Notwithstanding the restrictions imposed by paragraph 
(b)(2)(iii)(B) or (b)(2)(iv)(B) of this section, PCB capacitors may be 
disposed of in PCB chemical waste landfills that comply with Sec. 761.75 
subsequent to March 1, 1981, if EPA publishes a notice in the Federal 
Register declaring that those landfills are available for such disposal 
and explaining the reasons for the extension or reopening. An extension 
or reopening for disposal of PCB capacitors that is granted under this 
subsection shall be subject to such terms and conditions as the 
Assistant Administrator may prescribe and shall be in effect for such 
period as the Assistant Administrator may prescribe. EPA may permit 
disposal of PCB capacitors in EPA-approved chemical waste landfills 
after March 1, 1981, if in its opinion,
    (A) Adequate incineration capability for PCB capacitors is not 
available, or
    (B) The incineration of PCB capacitors will significantly interfere 
with the incineration of liquid PCBs, or
    (C) There is other good cause shown.

As part of this evaluation, the Assistant Administrator will consider 
the impact of his action on the incentives to construct or expand PCB 
incinerators.
    (vi) Any person disposing of large PCB capacitors or small PCB 
capacitors described in paragraph (b)(2)(iv) of this section in a 
chemical waste landfill approved under Sec. 761.75, shall first place 
them in a container meeting the DOT packaging requirements at 49 CFR 
parts 171 through 180. In all cases, the person must fill the 
interstitial space in the container with sufficient absorbent material 
(such as soil) to absorb

[[Page 192]]

any liquid PCBs remaining in the capacitors.
    (3) PCB hydraulic machines. (i) Any person disposing of PCB 
hydraulic machines containing PCBs at concentrations of $50 ppm, such as 
die casting machines, shall do so by one of the following methods:
    (A) In accordance with Sec. 761.79.
    (B) In a facility which is permitted, licensed, or registered by a 
State to manage municipal solid waste subject to part 258 of this 
chapter or non-municipal non-hazardous waste subject to Secs. 257.5 
through 257.30 of this chapter, as applicable (excluding thermal 
treatment units).
    (C) In a scrap metal recovery oven or smelter operating in 
compliance with Sec. 761.72.
    (D) In a disposal facility approved under this part.
    (ii) All free-flowing liquid must be removed from each machine and 
the liquid must be disposed of in accordance with the provisions of 
paragraph (a) of this section. If the PCB liquid contains $1,000 ppm 
PCB, then the hydraulic machine must be decontaminated in accordance 
with Sec. 761.79 or flushed prior to disposal with a solvent listed at 
paragraph (b)(1)(i)(B) of this section which contains <50 ppm PCB. The 
solvent must be disposed of in accordance with paragraph (a) of this 
section or Sec. 761.79.
    (4) PCB-Contaminated Electrical Equipment. Any person disposing of 
PCB-Contaminated Electrical Equipment, except capacitors, shall do so in 
accordance with paragraph (b)(6)(ii)(A) of this section. Any person 
disposing of Large Capacitors that contain $50 ppm but <500 ppm PCBs 
shall do so in a disposal facility approved under this part.
    (5) Natural gas pipeline systems containing PCBs. The owner or 
operator of natural gas pipeline systems containing $50 ppm PCBs, when 
no longer in use, shall dispose of the system either by abandonment in 
place of the pipe under paragraph (b)(5)(i) of this section or removal 
with subsequent action under paragraph (b)(5)(ii) of this section. Any 
person determining the PCB concentrations in natural gas pipeline 
systems shall do so in accordance with paragraph (b)(5)(iii) of this 
section.
    (i) Abandonment. Natural gas pipe containing $50 ppm PCBs may be 
abandoned in place under one or more of the following provisions:
    (A) Natural gas pipe having a nominal inside diameter of 4 inches, 
and containing PCBs at any concentration but no free-flowing liquids, 
may be abandoned in the place it was used to transport natural gas if 
each end is sealed closed and the pipe is either:
    (1) Included in a public service notification program, such as a 
``one-call'' system under 49 CFR 192.614(a) and (b).
    (2) Filled to 50 percent or more of the volume of the pipe with 
grout (such as a hardening slurry consisting of cement, bentonite, or 
clay) or high density polyurethane foam.
    (B) PCB-Contaminated natural gas pipe of any diameter, where the PCB 
concentration was determined after the last transmission of gas through 
the pipe or at the time of abandonment, that contains no free-flowing 
liquids may be abandoned in the place it was used to transport natural 
gas if each end is sealed closed.
    (C) Natural gas pipe of any diameter which contains PCBs at any 
concentration but no free-flowing liquids, may be abandoned in the place 
it was used to transport natural gas, if each end is sealed closed, and 
either:
    (1) The interior surface is decontaminated with one or more washes 
of a solvent in accordance with the use and disposal requirements of 
Sec. 761.79(d). This decontamination process must result in a recovery 
of 95 percent of the solvent volume introduced into the system, and the 
PCB concentration of the recovered wash must be <50 ppm (see 
Sec. 761.79(a)(1) for requirements on use and disposal of 
decontaminating fluids).
    (2) The pipe is filled to 50 percent or more of the volume of the 
pipe with grout (such as a hardening slurry-like cement, bentonite, or 
clay) or high density polyurethane foam (except that only cement shall 
be used as grout under rivers or streams) and each end is sealed closed.
    (D) Natural gas pipe of any diameter which contains PCBs at any 
concentration may be abandoned in place after decontamination in 
accordance with

[[Page 193]]

Sec. 761.79(c)(3), (c)(4) or (h) or a PCB disposal approval issued under 
Sec. 761.60(e) or Sec. 761.61(c).
    (ii) Removal with subsequent action. Natural gas pipeline systems 
may be disposed of under one of the following provisions:
    (A) The following classifications of natural gas pipe containing no 
free-flowing liquids may be disposed of in a facility permitted, 
licensed, or registered by a State to manage municipal solid waste 
subject to part 258 of this chapter or non-municipal non-hazardous waste 
subject to Secs. 257.5 through 257.30 of this chapter, as applicable 
(excluding thermal treatment units); a scrap metal recovery oven or 
smelter operating in compliance with the requirements of Sec. 761.72; or 
a disposal facility approved under this part:
    (1) PCB-Contaminated natural gas pipe of any diameter where the PCB 
concentration was determined after the last transmission of gas through 
the pipe or during removal from the location it was used to transport 
natural gas.
    (2) Natural gas pipe containing PCBs at any concentration and having 
a nominal inside diameter 4 inches.
    (B) Any component of a natural gas pipeline system may be disposed 
of under one of the following provisions:
    (1) In an incinerator operating in compliance with Sec. 761.70.
    (2) In a chemical waste landfill operating in compliance with 
Sec. 761.75, provided that all free-flowing liquid PCBs have been 
thoroughly drained.
    (3) As a PCB remediation waste in compliance with Sec. 761.61.
    (4) In accordance with Sec. 761.79.
    (iii) Characterization of natural gas pipeline systems by PCB 
concentration in condensate. (A) Any person disposing of a natural gas 
pipeline system under paragraphs (b)(5)(i)(B) or (b)(5)(ii)(A)(1) of 
this section must characterize it for PCB contamination by analyzing 
organic liquids collected at existing condensate collection points in 
the natural gas pipeline system. The level of PCB contamination found at 
a collection point is assumed to extend to the next collection point 
downstream. If no organic liquids are present, drain free-flowing 
liquids and collect standard wipe samples according to subpart M of this 
part. Collect condensate within 72 hours of the final transmission of 
natural gas through the part of the system to be abandoned or removed. 
Collect wipe samples after the last transmission of gas through the pipe 
or during removal from the location it was used to transport natural 
gas.
    (B) PCB concentration of the organic phase of multi-phasic liquids 
shall be determined in accordance with Sec. 761.1(b)(4).
    (iv) Disposal of pipeline liquids. (A) Any person disposing of 
liquids containing PCBs $50 ppm removed, spilled, or otherwise released 
from a natural gas pipeline system must do so in accordance with 
Sec. 761.61(a)(5)(iv) based on the PCB concentration at the time of 
removal from the system. Any person disposing of material contaminated 
by spills or other releases of PCBs $50 ppm from a natural gas pipeline 
system, must do so in accordance with Sec. 761.61 or Sec. 761.79, as 
applicable.
    (B) Any person who markets or burns for energy recovery liquid 
containing PCBs at concentrations <50 ppm PCBs at the time of removal 
from a natural gas pipeline system must do so in accordance with the 
provisions pertaining to used oil at Sec. 761.20(e). No other use of 
liquid containing PCBs at concentrations above the quantifiable level/
level of detection removed from a natural gas pipeline system is 
authorized.
    (6) Other PCB Articles. (i) PCB articles with concentrations at 500 
ppm or greater must be disposed of:
    (A) In an incinerator that complies with Sec. 761.70; or
    (B) In a chemical waste landfill that complies with Sec. 761.75, 
provided that all free-flowing liquid PCBs have been thoroughly drained 
from any articles before the articles are placed in the chemical waste 
landfill and that the drained liquids are disposed of in an incinerator 
that complies with Sec. 761.70.
    (ii)(A) Except as specifically provided in paragraphs (b)(1) through 
(b)(5) of this section, any person disposing of a PCB-Contaminated 
Article must do so by removing all free-flowing liquid from the article, 
disposing of the liquid in accordance with paragraph (a) of this 
section, and disposing of the PCB-Contaminated Article with no free-

[[Page 194]]

flowing liquid by one of the following methods:
    (1) In accordance with Sec. 761.79.
    (2) In a facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Secs. 257.5 through 257.30 of 
this chapter, as applicable (excluding thermal treatment units).
    (3) In a scrap metal recovery oven or smelter operating in 
compliance with Sec. 761.72.
    (4) In a disposal facility approved under this part.
    (B) Storage for disposal of PCB-Contaminated Articles from which all 
free-flowing liquids have been removed is not regulated under subpart D 
of this part.
    (C) Requirements in subparts J and K of this part do not apply to 
PCB-Contaminated Articles from which all free-flowing liquids have been 
removed.
    (iii) Fluorescent light ballasts containing PCBs in their potting 
material must be disposed of in a TSCA-approved disposal facility, as 
bulk product waste under Sec. 761.62, as household waste under 
Sec. 761.63 (where applicable), or in accordance with the 
decontamination provisions of Sec. 761.79.
    (7) Storage of PCB Articles. Except for a PCB Article described in 
paragraph (b)(2)(ii) of this section and hydraulic machines that comply 
with the municipal solid waste disposal provisions described in 
paragraph (b)(3) of this section, any PCB Article, with PCB 
concentrations at 50 ppm or greater, shall be stored in accordance with 
Sec. 761.65 prior to disposal.
    (8) Persons disposing of PCB Articles must wear or use protective 
clothing or equipment to protect against dermal contact with or 
inhalation of PCBs or materials containing PCBs.
    (c) PCB Containers. (1) Unless decontaminated in compliance with 
Sec. 761.79 or as provided in paragraph (c)(2) of this section, a PCB 
container with PCB concentrations at 500 ppm or greater shall be 
disposed of:
    (i) In an incinerator which complies with Sec. 761.70, or
    (ii) In a chemical waste landfill that complies with Sec. 761.75; 
provided that if there are PCBs in a liquid state, the PCB Container 
shall first be drained and the PCB liquid disposed of in accordance with 
paragraph (a) of this section.
    (2) Any PCB Container used to contain only PCBs at a concentration 
less than 500 ppm shall be disposed of as municipal solid wastes; 
provided that if the PCBs are in a liquid state, the PCB Container shall 
first be drained and the PCB liquid shall be disposed of in accordance 
with paragraph (a) of this section.
    (3) Prior to disposal, a PCB container with PCB concentrations at 50 
ppm or greater shall be stored in a unit which complies with 
Sec. 761.65.
    (d) [Reserved]
    (e) Any person who is required to incinerate any PCBs and PCB items 
under this subpart and who can demonstrate that an alternative method of 
destroying PCBs and PCB items exists and that this alternative method 
can achieve a level of performance equivalent to an incinerator approved 
under Sec. 761.70 or a high efficiency boiler operating in compliance 
with Sec. 761.71, must submit a written request to the Regional 
Administrator or the Director, Office of Resource Conservation and 
Recovery, for a waiver from the incineration requirements of Sec. 761.70 
or Sec. 761.71. Requests for approval of alternate methods that will be 
operated in more than one Region must be submitted to the Director, 
Office of Resource Conservation and Recovery, except for research and 
development activities involving less than 500 pounds of PCB material 
(see paragraph (i)(2) of this section). Requests for approval of 
alternate methods that will be operated in only one Region must be 
submitted to the appropriate EPA Regional Administrator. The applicant 
must show that his or her method of destroying PCBs will not present an 
unreasonable risk of injury to health or the environment. On the basis 
of such information and any available information, EPA may, in its 
discretion, approve the use of the alternate method if it finds that the 
alternate disposal method provides PCB destruction equivalent to 
disposal in a Sec. 761.60 incinerator or a Sec. 761.61 high efficiency 
boiler and will not present an unreasonable risk of injury to health or 
the

[[Page 195]]

environment. Any approval must be stated in writing and may include such 
conditions and provisions as EPA deems appropriate. The person to whom 
such waiver is issued must comply with all limitations contained in such 
determination. No person may use the alternate method of destroying PCBs 
or PCB items prior to obtaining permission from the appropriate EPA 
official.
    (f)(1) Each operator of a chemical waste landfill, incinerator, or 
alternative to incineration approved under paragraph (e) of this section 
shall give the following written notices to the state and local 
governments within whose jurisdiction the disposal facility is located:
    (i) Notice at least thirty (30) days before a facility is first used 
for disposal of PCBs required by these regulations; and
    (ii) At the request of any state or local government, annual notice 
of the quantities and general description of PCBs disposed of during the 
year. This annual notice shall be given no more than thirty (30) days 
after the end of the year covered.
    (iii) The Regional Administrator may reduce the notice period 
required by paragraph (f)(1)(i) of this section from thirty days to a 
period of no less than five days in order to expedite interim approval 
of the chemical waste landfill located in Sedgwick County, Kansas.
    (2) [Reserved]
    (g) Testing procedures. (1) Owners or users of mineral oil 
dielectric fluid electrical equipment may use the following procedures 
to determine the concentration of PCBs in the dielectric fluid:
    (i) Dielectric fluid removed from mineral oil dielectric fluid 
electrical equipment may be collected in a common container, provided 
that no other chemical substances or mixtures are added to the 
container. This common container option does not permit dilution of the 
collected oil. Mineral oil that is assumed or known to contain at least 
50 ppm PCBs must not be mixed with mineral oil that is known or assumed 
to contain less than 50 ppm PCBs to reduce the concentration of PCBs in 
the common container. If dielectric fluid from untested, oil-filled 
circuit breakers, reclosers, or cable is collected in a common container 
with dielectric fluid from other oil-filled electrical equipment, the 
entire contents of the container must be treated as PCBs at a 
concentration of at least 50 ppm, unless all of the fluid from the other 
oil-filled electrical equipment has been tested and shown to contain 
less than 50 ppm PCBs.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration, except that if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this subparagraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including EPA Method 608, ``Organochlorine 
Pesticides and PCBs'' at 40 CFR part 136, Appendix A;'' EPA Method 8082, 
``Polychlorinated Biphenyls (PCBs) by Capillary Column Gas 
Chromatography'' of SW-846, ``OSW Test Methods for Evaluating Solid 
Waste,'' which is available from NTIS; and ASTM Standard D-4059, 
``Standard Test Method for Analysis of Polychlorinated Biphenyls in 
Insulating Liquids by Gas Chromatography,'' which is available from 
ASTM.
    (2) Owners or users of waste oil may use the following procedures to 
determine the PCB concentration of waste oil:

[[Page 196]]

    (i) Waste oil from more than one source may be collected in a common 
container, provided that no other chemical substances or mixtures, such 
as non-waste oils, are added to the container.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration. Except, That if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this paragraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including those indicated in paragraph (g)(1)(iii) 
of this section.
    (h) Requirements for export and import of PCBs and PCB Items for 
disposal are found in subpart F of this part.
    (i) Approval authority for disposal methods. (1) The officials 
designated in paragraph (e) of this section and Sec. 761.70(a) and (b) 
to receive requests for approval of PCB disposal activities are the 
primary approval authorities for these activities. Notwithstanding, EPA 
may, at its discretion, assign the authority to review and approve any 
aspect of a disposal system to the Office of Land and Emergency 
Management or to a Regional Administrator.
    (2) Except for activity authorized under paragraph (j) of this 
section, research and development (R&D) for PCB disposal using a total 
of <500 pounds of PCB material (regardless of PCB concentration) will be 
reviewed and approved by the EPA Regional Administrator for the Region 
where the R&D will be conducted, and R&D for PCB disposal using 500 
pounds or more of PCB material (regardless of PCB concentration) will be 
reviewed and approved by the EPA.
    (j) Self-implementing requirements for research and development 
(R&D) for PCB disposal. (1) Any person may conduct R&D for PCB disposal 
without prior written approval from EPA if they meet the following 
conditions:
    (i) File a notification and obtain an EPA identification number 
pursuant to subpart K of this part.
    (ii) Notify in writing the EPA Regional Administrator, the State 
environmental protection agency, and local environmental protection 
agency, having jurisdiction where the R&D for PCB disposal activity will 
occur at least 30 days prior to the commencement of any R&D for PCB 
disposal activity conducted under this section. Each written 
notification shall include the EPA identification number of the site 
where the R&D for PCB disposal activities will be conducted, the 
quantity of PCBs to be treated, the type of R&D technology to be used, 
the general physical and chemical properties of material being treated, 
and an estimate of the duration of the PCB activity. The EPA Regional 
Administrator, the State environmental protection agency, and the local 
environmental protection agency may waive notification in writing prior 
to commencement of the research.
    (iii) The amount of material containing PCBs treated annually by the 
facility during R&D for PCB disposal activities does not exceed 500 
gallons or 70 cubic feet of liquid or non-liquid PCBs and does not 
exceed a maximum concentration of 10,000 ppm PCBs.
    (iv) No more than 1 kilogram total of pure PCBs per year is disposed 
of in all R&D for PCB disposal activities at a facility.
    (v) Each R&D for PCB disposal activity under this section lasts no 
more than 1 calendar year.
    (vi) Store all PCB wastes (treated and untreated PCB materials, 
testing

[[Page 197]]

samples, spent laboratory samples, residuals, untreated samples, 
contaminated media or instrumentation, clothing, etc.) in compliance 
with Sec. 761.65(b) and dispose of them according to the undiluted PCB 
concentration prior to treatment. However, PCB materials not treated in 
the R&D for PCB disposal activity may be returned either to the physical 
location where the samples were collected or a location where other 
regulated PCBs from the physical location where the samples were 
collected are being stored for disposal.
    (vii) Use manifests pursuant to subpart K of this part for all R&D 
PCB wastes being transported from the R&D facility to an approved PCB 
storage or disposal facility. However, Secs. 761.207 through 761.219 do 
not apply if the residuals or treated samples are returned either to the 
physical location where the samples were collected or a location where 
other regulated PCBs from the physical location where the samples were 
collected are being stored for disposal.
    (viii) Package and ship all PCB wastes pursuant to DOT requirements 
under 49 CFR parts 171 through 180.
    (ix) Comply with the recordkeeping requirements of Sec. 761.180.
    (2) Do not exceed material limitations set out in paragraphs (j)(1) 
(iii) and (iv) of this section and the time limitation set out in 
paragraph (j)(1)(v) of this section without prior written approval from 
EPA. Requests for approval to exceed the material limitations for PCBs 
in R&D for PCB disposal activities as specified in this section must be 
submitted in writing to the EPA Regional Administrator for the Region in 
which the facility conducting R&D for PCB disposal activities is 
located. Each request shall specify the quantity or concentration 
requested or additional time needed for disposal and include a 
justification for each increase. For extensions to the duration of the 
R&D for PCB disposal activity, the request shall also include a report 
on the accomplishments and progress of the previously authorized R&D for 
PCB disposal activity for which the extension is sought. The EPA 
Regional Administrator may grant a waiver in writing for an increase in 
the volume of PCB material, the maximum concentration of PCBs, the total 
amount of pure PCBs, or the duration of the R&D activity. Approvals will 
state all requirements applicable to the R&D for PCB disposal activity.
    (3) The EPA Regional Administrator for the Region in which an R&D 
for PCB disposal activity is conducted may determine, at any time, that 
an R&D PCB disposal approval is required under paragraphs (e) and (i)(2) 
of this section or Sec. 761.70(d) to ensure that any R&D for PCB 
disposal activity does not present an unreasonable risk of injury to 
health or the environment.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979]

    Editorial Note: For Federal Register citations affecting 
Sec. 761.60, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 761.61  PCB remediation waste.

    This section provides cleanup and disposal options for PCB 
remediation waste. Any person cleaning up and disposing of PCBs managed 
under this section shall do so based on the concentration at which the 
PCBs are found. This section does not prohibit any person from 
implementing temporary emergency measures to prevent, treat, or contain 
further releases or mitigate migration to the environment of PCBs or PCB 
remediation waste.
    (a) Self-implementing on-site cleanup and disposal of PCB 
remediation waste. EPA designed the self-implementing procedure for a 
general, moderately-sized site where there should be low residual 
environmental impact from remedial activities. The procedure may be less 
practical for larger or environmentally diverse sites. For these other 
sites, the self-implementing procedure still applies, but an EPA 
Regional Administrator may authorize more practical procedures through 
paragraph (c) of this section. Any person may conduct self-implementing 
cleanup and disposal of PCB remediation waste in accordance with the 
following requirements without prior written approval from EPA.

[[Page 198]]

    (1) Applicability. (i) The self-implementing procedures may not be 
used to clean up:
    (A) Surface or ground waters.
    (B) Sediments in marine and freshwater ecosystems.
    (C) Sewers or sewage treatment systems.
    (D) Any private or public drinking water sources or distribution 
systems.
    (E) Grazing lands.
    (F) Vegetable gardens.
    (ii) The self-implementing cleanup provisions shall not be binding 
upon cleanups conducted under other authorities, including but not 
limited to, actions conducted under section 104 or section 106 of 
CERCLA, or section 3004(u) and (v) or section 3008(h) of RCRA.
    (2) Site characterization. Any person conducting self-implementing 
cleanup of PCB remediation waste must characterize the site adequately 
to be able to provide the information required by paragraph (a)(3) of 
this section. Subpart N of this part provides a method for collecting 
new site characterization data or for assessing the sufficiency of 
existing site characterization data.
    (3) Notification and certification. (i) At least 30 days prior to 
the date that the cleanup of a site begins, the person in charge of the 
cleanup or the owner of the property where the PCB remediation waste is 
located shall notify, in writing, the EPA Regional Administrator, the 
Director of the State or Tribal environmental protection agency, and the 
Director of the county or local environmental protection agency where 
the cleanup will be conducted. The notice shall include:
    (A) The nature of the contamination, including kinds of materials 
contaminated.
    (B) A summary of the procedures used to sample contaminated and 
adjacent areas and a table or cleanup site map showing PCB 
concentrations measured in all pre-cleanup characterization samples. The 
summary must include sample collection and analysis dates. The EPA 
Regional Administrator may require more detailed information including, 
but not limited to, additional characterization sampling or all sample 
identification numbers from all previous characterization activities at 
the cleanup site.
    (C) The location and extent of the identified contaminated area, 
including topographic maps with sample collection sites cross referenced 
to the sample identification numbers in the data summary from paragraph 
(a)(3)(i)(B) of this section.
    (D) A cleanup plan for the site, including schedule, disposal 
technology, and approach. This plan should contain options and 
contingencies to be used if unanticipated higher concentrations or wider 
distributions of PCB remediation waste are found or other obstacles 
force changes in the cleanup approach.
    (E) A written certification, signed by the owner of the property 
where the cleanup site is located and the party conducting the cleanup, 
that all sampling plans, sample collection procedures, sample 
preparation procedures, extraction procedures, and instrumental/chemical 
analysis procedures used to assess or characterize the PCB contamination 
at the cleanup site, are on file at the location designated in the 
certificate, and are available for EPA inspection. Persons using 
alternate methods for chemical extraction and chemical analysis for site 
characterization must include in the certificate a statement that such a 
method will be used and that a comparison study which meets or exceeds 
the requirements of subpart Q of this part, and for which records are on 
file, has been completed prior to verification sampling.
    (ii) Within 30 calendar days of receiving the notification, the EPA 
Regional Administrator will respond in writing approving of the self-
implementing cleanup, disapproving of the self-implementing cleanup, or 
requiring additional information. If the EPA Regional Administrator does 
not respond within 30 calendar days of receiving the notice, the person 
submitting the notification may assume that it is complete and 
acceptable and proceed with the cleanup according to the information the 
person provided to the EPA Regional Administrator. Once cleanup is 
underway, the person conducting the cleanup must provide any proposed 
changes from the notification to the

[[Page 199]]

EPA Regional Administrator in writing no less than 14 calendar days 
prior to the proposed implementation of the change. The EPA Regional 
Administrator will determine in his or her discretion whether to accept 
the change, and will respond to the change notification verbally within 
7 calendar days and in writing within 14 calendar days of receiving it. 
If the EPA Regional Administrator does not respond verbally within 7 
calendar days and in writing within 14 calendar days of receiving the 
change notice, the person who submitted it may deem it complete and 
acceptable and proceed with the cleanup according to the information in 
the change notice provided to the EPA Regional Administrator.
    (iii) Any person conducting a cleanup activity may obtain a waiver 
of the 30-day notification requirement, if they receive a separate 
waiver, in writing, from each of the agencies they are required to 
notify under this section. The person must retain the original written 
waiver as required in paragraph (a)(9) of this section.
    (4) Cleanup levels. For purposes of cleaning, decontaminating, or 
removing PCB remediation waste under this section, there are four 
general waste categories: bulk PCB remediation waste, non-porous 
surfaces, porous surfaces, and liquids. Cleanup levels are based on the 
kind of material and the potential exposure to PCBs left after cleanup 
is completed.
    (i) Bulk PCB remediation waste. Bulk PCB remediation waste includes, 
but is not limited to, the following non-liquid PCB remediation waste: 
soil, sediments, dredged materials, muds, PCB sewage sludge, and 
industrial sludge.
    (A) High occupancy areas. The cleanup level for bulk PCB remediation 
waste in high occupancy areas is 1 ppm without further conditions. High 
occupancy areas where bulk PCB remediation waste remains at 
concentrations >1 ppm and 10 ppm shall be covered with a cap meeting 
the requirements of paragraphs (a)(7) and (a)(8) of this section.
    (B) Low occupancy areas. (1) The cleanup level for bulk PCB 
remediation waste in low occupancy areas is 25 ppm unless otherwise 
specified in this paragraph.
    (2) Bulk PCB remediation wastes may remain at a cleanup site at 
concentrations >25 ppm and 50 ppm if the site is secured by a fence and 
marked with a sign including the ML mark.
    (3) Bulk PCB remediation wastes may remain at a cleanup site at 
concentrations >25 ppm and 100 ppm if the site is covered with a cap 
meeting the requirements of paragraphs (a)(7) and (a)(8) of this 
section.
    (ii) Non-porous surfaces. In high occupancy areas, the surface PCB 
cleanup standard is 10 mg/100 cm\2\ of surface area. In low occupancy 
areas, the surface cleanup standard is <100 mg/100 cm\2\ of surface 
area. Select sampling locations in accordance with subpart P of this 
part or a sampling plan approved under paragraph (c) of this section.
    (iii) Porous surfaces. In both high and low occupancy areas, any 
person disposing of porous surfaces must do so based on the levels in 
paragraph (a)(4)(i) of this section. Porous surfaces may be cleaned up 
for use in accordance with Sec. 761.79(b)(4) or Sec. 761.30(p).
    (iv) Liquids. In both high and low occupancy areas, cleanup levels 
are the concentrations specified in Sec. 761.79(b)(1) and (b)(2).
    (v) Change in the land use for a cleanup site. Where there is an 
actual or proposed change in use of an area cleaned up to the levels of 
a low occupancy area, and the exposure of people or animal life in or at 
that area could reasonably be expected to increase, resulting in a 
change in status from a low occupancy area to a high occupancy area, the 
owner of the area shall clean up the area in accordance with the high 
occupancy area cleanup levels in paragraphs (a)(4)(i) through (a)(4)(iv) 
of this section.
    (vi) The EPA Regional Administrator, as part of his or her response 
to a notification submitted in accordance with Sec. 761.61(a)(3) of this 
part, may require cleanup of the site, or portions of it, to more 
stringent cleanup levels than are otherwise required in this section, 
based on the proximity to areas such as residential dwellings, 
hospitals, schools, nursing homes, playgrounds, parks, day care centers, 
endangered species habitats, estuaries, wetlands,

[[Page 200]]

national parks, national wildlife refuges, commercial fisheries, and 
sport fisheries.
    (5) Site cleanup. In addition to the options set out in this 
paragraph, PCB disposal technologies approved under Secs. 761.60 and 
761.70 are acceptable for on-site self-implementing PCB remediation 
waste disposal within the confines of the operating conditions of the 
respective approvals.
    (i) Bulk PCB remediation waste. Any person cleaning up bulk PCB 
remediation waste shall do so to the levels in paragraph (a)(4)(i) of 
this section.
    (A) Any person cleaning up bulk PCB remediation waste on-site using 
a soil washing process may do so without EPA approval, subject to all of 
the following:
    (1) A non-chlorinated solvent is used.
    (2) The process occurs at ambient temperature.
    (3) The process is not exothermic.
    (4) The process uses no external heat.
    (5) The process has secondary containment to prevent any solvent 
from being released to the underlying or surrounding soils or surface 
waters.
    (6) Solvent disposal, recovery, and/or reuse is in accordance with 
relevant provisions of approvals issued according to paragraphs (b)(1) 
or (c) of this section or applicable paragraphs of Sec. 761.79.
    (B) Bulk PCB remediation waste may be sent off-site for 
decontamination or disposal in accordance with this paragraph, provided 
the waste is either dewatered on-site or transported off-site in 
containers meeting the requirements of the DOT Hazardous Materials 
Regulations (HMR) at 49 CFR parts 171 through 180.
    (1) Removed water shall be disposed of according to paragraph (b)(1) 
of this section.
    (2) Any person disposing off-site of dewatered bulk PCB remediation 
waste shall do so as follows:
    (i) Unless sampled and analyzed for disposal according to the 
procedures set out in Secs. 761.283, 761.286, and 761.292, the bulk PCB 
remediation waste shall be assumed to contain $50 ppm PCBs.
    (ii) Bulk PCB remediation wastes with a PCB concentration of <50 ppm 
shall be disposed of in accordance with paragraph (a)(5)(v)(A) of this 
section.
    (iii) Bulk PCB remediation wastes with a PCB concentration $50 ppm 
shall be disposed of in a hazardous waste landfill permitted by EPA 
under section 3004 of RCRA, or by a State authorized under section 3006 
of RCRA, or a PCB disposal facility approved under this part.
    (iv) The generator must provide written notice, including the 
quantity to be shipped and highest concentration of PCBs (using 
extraction EPA Method 3500B/3540C or Method 3500B/3550B followed by 
chemical analysis using EPA Method 8082 in SW-846 or methods validated 
under subpart Q of this part) at least 15 days before the first shipment 
of bulk PCB remediation waste from each cleanup site by the generator, 
to each off-site facility where the waste is destined for an area not 
subject to a TSCA PCB Disposal Approval.
    (3) Any person may decontaminate bulk PCB remediation waste in 
accordance with Sec. 761.79 and return the waste to the cleanup site for 
disposal as long as the cleanup standards of paragraph (a)(4) of this 
section are met.
    (ii) Non-porous surfaces. PCB remediation waste non-porous surfaces 
shall be cleaned on-site or off-site for disposal on-site, disposal off-
site, or use, as follows:
    (A) For on-site disposal, non-porous surfaces shall be cleaned on-
site or off-site to the levels in paragraph (a)(4)(ii) of this section 
using:
    (1) Procedures approved under Sec. 761.79.
    (2) Technologies approved under Sec. 761.60(e).
    (3) Procedures or technologies approved under paragraph (c) of this 
section.
    (B) For off-site disposal, non-porous surfaces:
    (1) Having surface concentrations <100 mg/100 cm\2\ shall be 
disposed of in accordance with paragraph (a)(5)(i)(B)(2)(ii) of this 
section. Metal surfaces may be thermally decontaminated in accordance 
with Sec. 761.79(c)(6)(i).
    (2) Having surface concentrations $100 mg/100 cm\2\ shall be 
disposed of in accordance with paragraph (a)(5)(i)(B)(2)(iii) of this 
section. Metal

[[Page 201]]

surfaces may be thermally decontaminated in accordance with 
Sec. 761.79(c)(6)(ii).
    (C) For use, non-porous surfaces shall be decontaminated on-site or 
off-site to the standards specified in Sec. 761.79(b)(3) or in 
accordance with Sec. 761.79(c).
    (iii) Porous surfaces. Porous surfaces shall be disposed on-site or 
off-site as bulk PCB remediation waste according to paragraph (a)(5)(i) 
of this section or decontaminated for use according to 
Sec. 761.79(b)(4), as applicable.
    (iv) Liquids. Any person disposing of liquid PCB remediation waste 
shall either:
    (A) Decontaminate the waste to the levels specified in 
Sec. 761.79(b)(1) or (b)(2).
    (B) Dispose of the waste in accordance with paragraph (b) of this 
section or an approval issued under paragraph (c) of this section.
    (v) Cleanup wastes. Any person generating the following wastes 
during and from the cleanup of PCB remediation waste shall dispose of or 
reuse them using one of the following methods:
    (A) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
cleanup activities shall be either decontaminated in accordance with 
Sec. 761.79(b) or (c), or disposed of in one of the following 
facilities, without regard to the requirements of subparts J and K of 
this part:
    (1) A facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter.
    (2) A facility permitted, licensed, or registered by a State to 
manage non-municipal non-hazardous waste subject to Secs. 257.5 through 
257.30 of this chapter, as applicable.
    (3) A hazardous waste landfill permitted by EPA under section 3004 
of RCRA, or by a State authorized under section 3006 of RCRA.
    (4) A PCB disposal facility approved under this part.
    (B) Cleaning solvents, abrasives, and equipment may be reused after 
decontamination in accordance with Sec. 761.79.
    (6) Cleanup verification--(i) Sampling and analysis. Any person 
collecting and analyzing samples to verify the cleanup and on-site 
disposal of bulk PCB remediation wastes and porous surfaces must do so 
in accordance with subpart O of this part. Any person collecting and 
analyzing samples from non-porous surfaces must do so in accordance with 
subpart P of this part. Any person collecting and analyzing samples from 
liquids must do so in accordance with Sec. 761.269. Any person 
conducting interim sampling during PCB remediation waste cleanup to 
determine when to sample to verify that cleanup is complete, may use PCB 
field screening tests.
    (ii) Verification. (A) Where sample analysis results in a 
measurement of PCBs less than or equal to the levels specified in 
paragraph (a)(4) of this section, self-implementing cleanup is complete.
    (B) Where sample analysis results in a measurement of PCBs greater 
than the levels specified in paragraph (a)(4) of this section, self-
implementing cleanup of the sampled PCB remediation waste is not 
complete. The owner or operator of the site must either dispose of the 
sampled PCB remediation waste, or reclean the waste represented by the 
sample and reinitiate sampling and analysis in accordance with paragraph 
(a)(6)(i) of this section.
    (7) Cap requirements. A cap means, when referring to on-site cleanup 
and disposal of PCB remediation waste, a uniform placement of concrete, 
asphalt, or similar material of minimum thickness spread over the area 
where remediation waste was removed or left in place in order to prevent 
or minimize human exposure, infiltration of water, and erosion. Any 
person designing and constructing a cap must do so in accordance with 
Sec. 264.310(a) of this chapter, and ensure that it complies with the 
permeability, sieve, liquid limit, and plasticity index parameters in 
Sec. 761.75(b)(1)(ii) through (b)(1)(v). A cap of compacted soil shall 
have a minimum thickness of 25 cm (10 inches). A concrete or asphalt cap 
shall have a minimum thickness of 15 cm (6 inches). A cap must be of 
sufficient strength to maintain its effectiveness and integrity during 
the use of the cap surface

[[Page 202]]

which is exposed to the environment. A cap shall not be contaminated at 
a level $1 ppm PCB per Aroclor \TM\ (or equivalent) or per congener. 
Repairs shall begin within 72 hours of discovery for any breaches which 
would impair the integrity of the cap.
    (8) Deed restrictions for caps, fences and low occupancy areas. When 
a cleanup activity conducted under this section includes the use of a 
fence or a cap, the owner of the site must maintain the fence or cap, in 
perpetuity. In addition, whenever a cap, or the procedures and 
requirements for a low occupancy area, is used, the owner of the site 
must meet the following conditions:
    (i) Within 60 days of completion of a cleanup activity under this 
section, the owner of the property shall:
    (A) Record, in accordance with State law, a notation on the deed to 
the property, or on some other instrument which is normally examined 
during a title search, that will in perpetuity notify any potential 
purchaser of the property:
    (1) That the land has been used for PCB remediation waste disposal 
and is restricted to use as a low occupancy area as defined in 
Sec. 761.3.
    (2) Of the existence of the fence or cap and the requirement to 
maintain the fence or cap.
    (3) The applicable cleanup levels left at the site, inside the 
fence, and/or under the cap.
    (B) Submit a certification, signed by the owner, that he/she has 
recorded the notation specified in paragraph (a)(8)(i)(A) of this 
section to the EPA Regional Administrator.
    (ii) The owner of a site being cleaned up under this section may 
remove a fence or cap after conducting additional cleanup activities and 
achieving cleanup levels, specified in paragraph (a)(4) of this section, 
which do not require a cap or fence. The owner may remove the notice on 
the deed no earlier than 30 days after achieving the cleanup levels 
specified in this section which do not require a fence or cap.
    (9) Recordkeeping. For paragraphs (a)(3), (a)(4), and (a)(5) of this 
section, recordkeeping is required in accordance with 
Sec. 761.125(c)(5).
    (b) Performance-based disposal. (1) Any person disposing of liquid 
PCB remediation waste shall do so according to Sec. 761.60(a) or (e), or 
decontaminate it in accordance with Sec. 761.79.
    (2) Any person disposing of non-liquid PCB remediation waste shall 
do so by one of the following methods:
    (i) Dispose of it in a high temperature incinerator approved under 
Sec. 761.70(b), an alternate disposal method approved under 
Sec. 761.60(e), a chemical waste landfill approved under Sec. 761.75, or 
in a facility with a coordinated approval issued under Sec. 761.77.
    (ii) Decontaminate it in accordance with Sec. 761.79.
    (3) Any person may manage or dispose of material containing <50 ppm 
PCBs that has been dredged or excavated from waters of the United 
States:
    (i) In accordance with a permit that has been issued under section 
404 of the Clean Water Act, or the equivalent of such a permit as 
provided for in regulations of the U.S. Army Corps of Engineers at 33 
CFR part 320.
    (ii) In accordance with a permit issued by the U.S. Army Corps of 
Engineers under section 103 of the Marine Protection, Research, and 
Sanctuaries Act, or the equivalent of such a permit as provided for in 
regulations of the U.S. Army Corps of Engineers at 33 CFR part 320.
    (c) Risk-based disposal approval. (1) Any person wishing to sample, 
cleanup, or dispose of PCB remediation waste in a manner other than 
prescribed in paragraphs (a) or (b) of this section, or store PCB 
remediation waste in a manner other than prescribed in Sec. 761.65, must 
apply in writing to the Regional Administrator in the Region where the 
sampling, cleanup, disposal, or storage site is located, for sampling, 
cleanup, disposal, or storage occurring in a single EPA Region; or to 
the Director, Office of Resource Conservation and Recovery, for 
sampling, cleanup, disposal, or storage occurring in more than one EPA 
Region. Each application must include information described in the 
notification required by paragraph (a)(3) of this section. EPA may 
request other information that it believes necessary to evaluate the 
application. No person may conduct cleanup activities under

[[Page 203]]

this paragraph prior to obtaining written approval by EPA.
    (2) EPA will issue a written decision on each application for a 
risk-based method for PCB remediation wastes. EPA will approve such an 
application if it finds that the method will not pose an unreasonable 
risk of injury to health or the environment.

[63 FR 35448, June 29, 1998, as amended at 64 FR 33761, June 24, 1999; 
72 FR 57239, Oct. 9, 2007; 74 FR 30232, June 25, 2009]



Sec. 761.62  Disposal of PCB bulk product waste.

    PCB bulk product waste shall be disposed of in accordance with 
paragraph (a), (b), or (c) of this section. Under some of these 
provisions, it may not be necessary to determine the PCB concentration 
or leaching characteristics of the PCB bulk product waste. When it is 
necessary to analyze the waste to make either of these determinations, 
use the applicable procedures in subpart R of this part to sample the 
waste for analysis, unless EPA approves another sampling plan under 
paragraph (c) of this section.
    (a) Performance-based disposal. Any person disposing of PCB bulk 
product waste may do so as follows:
    (1) In an incinerator approved under Sec. 761.70.
    (2) In a chemical waste landfill approved under Sec. 761.75.
    (3) In a hazardous waste landfill permitted by EPA under section 
3004 of RCRA, or by a State authorized under section 3006 of RCRA.
    (4) Under an alternate disposal approval under Sec. 761.60(e).
    (5) In accordance with the decontamination provisions of 
Sec. 761.79.
    (6) For metal surfaces in contact with PCBs, in accordance with the 
thermal decontamination provisions of Sec. 761.79(c)(6).
    (7) In accordance with a TSCA PCB Coordinated Approval issued under 
Sec. 761.77.
    (b) Disposal in solid waste landfills. (1) Any person may dispose of 
the following PCB bulk product waste in a facility permitted, licensed, 
or registered by a State as a municipal or non-municipal non-hazardous 
waste landfill:
    (i) Plastics (such as plastic insulation from wire or cable; radio, 
television and computer casings; vehicle parts; or furniture laminates); 
preformed or molded rubber parts and components; applied dried paints, 
varnishes, waxes or other similar coatings or sealants; caulking; 
Galbestos; non-liquid building demolition debris; or non-liquid PCB bulk 
product waste from the shredding of automobiles or household appliances 
from which PCB small capacitors have been removed (shredder fluff).
    (ii) Other PCB bulk product waste, sampled in accordance with the 
protocols set out in subpart R of this part, that leaches PCBs at <10 
mg/L of water measured using a procedure used to simulate leachate 
generation.
    (2) Any person may dispose of PCB bulk product waste other than 
those materials meeting the conditions of paragraph (b)(1) of this 
section, (e.g., paper or felt gaskets contaminated by liquid PCBs in a 
facility that is permitted, licensed, or registered by a State to manage 
municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Secs. 257.5 through 257.30 of 
this chapter, as applicable, if:
    (i) The PCB bulk product waste is segregated from organic liquids 
disposed of in the landfill unit.
    (ii) Leachate is collected from the landfill unit and monitored for 
PCBs.
    (3) Any release of PCBs (including but not limited to leachate) from 
the landfill unit shall be cleaned up in accordance with Sec. 761.61.
    (4)(i) Any person disposing off-site of PCB bulk product waste 
regulated under paragraph (b)(1) of this section at a waste management 
facility not having a commercial PCB storage or disposal approval must 
provide written notice to the facility a minimum of 15 days in advance 
of the first shipment from the same disposal waste stream. The notice 
shall state that the PCB bulk product waste may include components 
containing PCBs at $50 ppm based on analysis of the waste in the 
shipment or application of a general knowledge of the waste stream (or 
similar material) which is known to contain PCBs at those levels, and 
that the PCB bulk product waste is known or presumed to leach <10 mg/L 
PCBs.

[[Page 204]]

    (ii) Any person disposing off-site of PCB bulk product waste 
regulated under paragraph (b)(2) of this section at a waste management 
facility not having a commercial PCB storage or disposal approval must 
provide written notice to the facility a minimum of 15 days in advance 
of the first shipment from the same disposal waste stream and with each 
shipment thereafter. The notice shall state that the PCB bulk product 
waste may include components containing PCBs at $50 ppm based on 
analysis of the waste in the shipment or application of a general 
knowledge of the waste stream (or similar material) which is known to 
contain PCBs at those levels, and that the PCB bulk product waste is 
known or presumed to leach $10 mg/L PCBs.
    (5) Any person disposing of PCB bulk product waste must maintain a 
written record of all sampling and analysis of PCBs or notifications 
made under this paragraph for 3 years from the date of the waste's 
generation. The records must be made available to EPA upon request.
    (6) Requirements in subparts C, J, and K of this part do not apply 
to waste disposed of under paragraph (b) of this section.
    (c) Risk-based disposal approval. (1) Any person wishing to sample 
or dispose of PCB bulk product waste in a manner other than prescribed 
in paragraphs (a) or (b) of this section, or store PCB bulk product 
waste in a manner other than prescribed in Sec. 761.65, must apply in 
writing to the Regional Administrator in the Region where the sampling, 
disposal, or storage site is located, for sampling, disposal, or storage 
occurring in a single EPA Region; or to the Director, Office of Resource 
Conservation and Recovery, for sampling, disposal, or storage occurring 
in more than one EPA Region. Each application must contain information 
indicating that, based on technical, environmental, or waste-specific 
characteristics or considerations, the proposed sampling, disposal, or 
storage methods or locations will not pose an unreasonable risk or 
injury to health or the environment. EPA may request other information 
that it believes necessary to evaluate the application. No person may 
conduct sampling, disposal, or storage activities under this paragraph 
prior to obtaining written approval by EPA.
    (2) EPA will issue a written decision on each application for a 
risk-based sampling, disposal, or storage method for PCB bulk product 
wastes. EPA will approve such an application if it finds that the method 
will not pose an unreasonable risk of injury to health or the 
environment.
    (d) Disposal as daily landfill cover or roadbed. Bulk product waste 
described in paragraph (b)(1) of this section may be disposed of:
    (1) As daily landfill cover as long as the daily cover remains in 
the landfill and is not released or dispersed by wind or other action; 
or
    (2) Under asphalt as part of a road bed.

[63 FR 35451, June 29, 1998, as amended at 64 FR 33761, June 24, 1999; 
72 FR 57239, Oct. 9, 2007; 74 FR 30232, June 25, 2009]



Sec. 761.63  PCB household waste storage and disposal.

    PCB household waste, as defined at Sec. 761.3, managed in a facility 
permitted, licensed, or registered by a State to manage municipal or 
industrial solid waste, or in a facility with an approval to dispose of 
PCB bulk product waste under Sec. 761.62(c), is not subject to any other 
requirements of part 761 of this chapter. PCB household waste stored in 
a unit regulated for storage of PCB waste must not be commingled with 
PCB waste.

[63 FR 35452, June 29, 1998]



Sec. 761.64  Disposal of wastes generated as a result of research and
development activities authorized under Sec. 761.30(j) and chemical
analysis of PCBs.

    This section provides disposal requirements for wastes generated 
during and as a result of research and development authorized under 
Sec. 761.30(j). This section also provides disposal requirements for 
wastes generated during the chemical analysis of samples containing PCBs 
under part 761, including Secs. 761.30, 761.60, 761.61, 761.62, and 
761.79. For determining the presence of PCBs in samples, chemical 
analysis includes: sample preparation, sample extraction, extract 
cleanup, extract concentration,

[[Page 205]]

addition of PCB standards, and instrumental analysis.
    (a) Portions of samples of a size designated in a chemical 
extraction and analysis method for PCBs and extracted for purposes of 
determining the presence of PCBs or concentration of PCBs are 
unregulated for PCB disposal under this part.
    (b) All other wastes generated during these activities are regulated 
for disposal based on their concentration at the time of disposal as 
follows:
    (1) Liquid wastes, including rinse solvents, must be disposed of 
according to Sec. 761.61(a)(5)(iv).
    (2) Non-liquid wastes must be disposed of in the same manner as non-
liquid cleaning materials and personal protective equipment waste 
according to Sec. 761.61(a)(5)(v)(A).

[63 FR 35452, June 29, 1998]



Sec. 761.65  Storage for disposal.

    This section applies to the storage for disposal of PCBs at 
concentrations of 50 ppm or greater and PCB Items with PCB 
concentrations of 50 ppm or greater.
    (a)(1) Storage limitations. Any PCB waste shall be disposed of as 
required by subpart D of this part within 1-year from the date it was 
determined to be PCB waste and the decision was made to dispose of it. 
This date is the date of removal from service for disposal and the point 
at which the 1-year time frame for disposal begins. PCB/radioactive 
waste removed from service for disposal is exempt from the 1-year time 
limit provided that the provisions at paragraphs (a)(2)(ii) and 
(a)(2)(iii) of this section are followed and the waste is managed in 
accordance with all other applicable Federal, State, and local laws and 
regulations for the management of radioactive material.
    (2) One-year extension. Any person storing PCB waste that is subject 
to the 1-year time limit for storage and disposal in paragraph (a)(1) of 
this section may provide written notification to the EPA Regional 
Administrator for the Region in which the PCB waste is stored that their 
continuing attempts to dispose of or secure disposal for their waste 
within the 1-year time limit have been unsuccessful. Upon receipt of the 
notice by the EPA Regional Administrator, the time for disposal is 
automatically extended for 1 additional year (2 years total) if the 
following conditions are met:
    (i) The notification is received by the EPA Regional Administrator 
at least 30 days before the initial 1-year time limit expires and the 
notice identifies the storer, the types, volumes, and locations of the 
waste and the reasons for failure to meet the initial 1-year time limit.
    (ii) A written record documenting all continuing attempts to secure 
disposal is maintained until the waste is disposed of.
    (iii) The written record required by paragraph (a)(2)(ii) of this 
section is available for inspection or submission if requested by EPA.
    (iv) Continuing attempts to secure disposal were initiated within 
270 days after the time the waste was first subject to the 1-year time 
limit requirement, as specified in paragraph (a)(1) of this section. 
Failure to initiate and continue attempts to secure disposal throughout 
the total time the waste is in storage shall automatically disqualify 
the notifier from receiving an automatic extension under this section.
    (3) Additional extensions. Upon written request, the EPA Regional 
Administrator for the Region in which the wastes are stored or the 
appropriate official at EPA Headquarters, may grant additional 
extensions beyond the 1-year extension authorized in paragraph (a)(2) of 
this section. At the time of the request, the requestor must supply 
specific justification for the additional extension and indicate what 
measures the requestor is taking to secure disposal of the waste or 
indicate why disposal could not be conducted during the period of the 
prior extension. The EPA Regional Administrator or the appropriate 
official at EPA Headquarters may require, as a condition to granting any 
extension under this section, specific actions including, but not 
limited to, marking, inspection, recordkeeping, or financial assurance 
to ensure that the waste does not pose an unreasonable risk of injury to 
health or the environment.

[[Page 206]]

    (4) Storage at an approved facility. Increased time for storage may 
be granted as a condition of any TSCA PCB storage or disposal approval, 
by the EPA Regional Administrator for the Region in which the PCBs or 
PCB Items are to be stored or disposed of, or by the appropriate 
official at EPA Headquarters, if EPA determines that there is a 
demonstrated need or justification for additional time, that the owner 
or operator of the facility is pursuing relevant treatment or disposal 
options, and that no unreasonable risk of injury to health or the 
environment will result from the increased storage time. In making this 
determination, EPA will consider such factors as absence of any approved 
treatment technology and insufficient time to complete the treatment or 
destruction process. EPA may require as a condition of the approval that 
the owner or operator submit periodic progress reports.
    (b) Except as provided in paragraphs (b)(2), (c)(1), (c)(7), (c)(9), 
and (c)(10) of this section, after July 1, 1978, owners or operators of 
any facilities used for the storage of PCBs and PCB Items designated for 
disposal shall comply with the following storage unit requirements:
    (1) The facilities shall meet the following criteria:
    (i) Adequate roof and walls to prevent rain water from reaching the 
stored PCBs and PCB Items;
    (ii) An adequate floor that has continuous curbing with a minimum 6 
inch high curb. The floor and curbing must provide a containment volume 
equal to at least two times the internal volume of the largest PCB 
Article or PCB Container or 25 percent of the total internal volume of 
all PCB Articles or PCB Containers stored there, whichever is greater. 
PCB/radioactive wastes are not required to be stored in an area with a 
minimum 6 inch high curbing. However, the floor and curbing must still 
provide a containment volume equal to at least two times the internal 
volume of the largest PCB Container or 25 percent of the total internal 
volume of all PCB Containers stored there, whichever is greater.
    (iii) No drain valves, floor drains, expansion joints, sewer lines, 
or other openings that would permit liquids to flow from the curbed 
area;
    (iv) Floors and curbing constructed of Portland cement, concrete, or 
a continuous, smooth, non-porous surface as defined at Sec. 761.3, which 
prevents or minimizes penetration of PCBs.
    (v) Not located at a site that is below the 100-year flood water 
elevation.
    (2) No person may store PCBs and PCB Items designated for disposal 
in a storage unit other than one approved pursuant to paragraph (d) of 
this section or meeting the design requirements of paragraph (b) of this 
section, unless the unit meets one of the following conditions:
    (i) Is permitted by EPA under section 3004 of RCRA to manage 
hazardous waste in containers, and spills of PCBs are cleaned up in 
accordance with subpart G of this part.
    (ii) Qualifies for interim status under section 3005 of RCRA to 
manage hazardous waste in containers, meets the requirements for 
containment at Sec. 264.175 of this chapter, and spills of PCBs are 
cleaned up in accordance with subpart G of this part.
    (iii) Is permitted by a State authorized under section 3006 of RCRA 
to manage hazardous waste in containers, and spills of PCBs are cleaned 
up in accordance with subpart G of this part.
    (iv) Is approved or otherwise regulated pursuant to a State PCB 
waste management program no less stringent in protection of health or 
the environment than the applicable TSCA requirements found in this 
part.
    (v) Is subject to a TSCA Coordinated Approval, which includes 
provisions for storage of PCBs, issued pursuant to Sec. 761.77.
    (vi) Has a TSCA PCB waste management approval, which includes 
provisions for storage, issued pursuant to Sec. 761.61(c) or 
Sec. 761.62(c).
    (c)(1) The following PCB Items may be stored temporarily in an area 
that does not comply with the requirements of paragraph (b) of this 
section for up to thirty days from the date of their removal from 
service, provided that a notation is attached to the PCB Item or a PCB 
Container (containing the item) indicating the date the item was removed 
from service:

[[Page 207]]

    (i) Non-leaking PCB Articles and PCB Equipment;
    (ii) Leaking PCB Articles and PCB Equipment if the PCB Items are 
placed in a non-leaking PCB Container that contains sufficient sorbent 
materials to absorb any liquid PCBs remaining in the PCB Items;
    (iii) PCB Containers containing non-liquid PCBs such as contaminated 
soil, rags, and debris; and
    (iv) PCB containers containing liquid PCBs at concentrations of $50 
ppm, provided a Spill Prevention, Control and Countermeasure Plan has 
been prepared for the temporary storage area in accordance with part 112 
of this chapter and the liquid PCB waste is in packaging authorized in 
the DOT Hazardous Materials Regulations at 49 CFR parts 171 through 180 
or stationary bulk storage tanks (including rolling stock such as, but 
not limited to, tanker trucks, as specified by DOT).
    (2) Non-leaking and structurally undamaged PCB Large High Voltage 
Capacitors and PCB-Contaminated Electrical Equipment that have not been 
drained of free flowing dielectric fluid may be stored on pallets next 
to a storage facility that meets the requirements of paragraph (b) of 
this section. PCB-Contaminated Electrical Equipment that has been 
drained of free flowing dielectric fluid is not subject to the storage 
provisions of Sec. 761.65. Storage under this subparagraph will be 
permitted only when the storage facility has immediately available 
unfilled storage space equal to 10 percent of the volume of capacitors 
and equipment stored outside the facility. The capacitors and equipment 
temporarily stored outside the facility shall be checked for leaks 
weekly.
    (3) Any storage area subject to the requirements of paragraph (b) or 
paragraph (c)(1) of this section shall be marked as required in subpart 
C Sec. 761.40(a)(10).
    (4) No item of movable equipment that is used for handling PCBs and 
PCB Items in the storage units and that comes in direct contact with 
PCBs shall be removed from the storage unit area unless it has been 
decontaminated as specified in Sec. 761.79.
    (5) All PCB Items in storage shall be checked for leaks at least 
once every 30 days. Any leaking PCB Items and their contents shall be 
transferred immediately to properly marked non-leaking containers. Any 
spilled or leaked materials shall be immediately cleaned up and the 
materials and residues containing PCBs shall be disposed of in 
accordance with Sec. 761.61. Records of inspections, maintenance, 
cleanup and disposal must be maintained in accordance with 
Sec. 761.180(a) and (b).
    (6) Except as provided in paragraphs (c)(6)(i) and (c)(6)(ii) of 
this section, any container used for the storage of liquid or non-liquid 
PCB waste shall be in accordance with the requirements set forth in the 
DOT Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 
180. PCB waste not subject to the HMR (i.e., PCB wastes at 
concentrations of <20 ppm or <1 pound of PCBs regardless of 
concentration) must be packaged in accordance with Packaging Group III, 
unless other hazards associated with the PCB waste cause it to require 
packaging in accordance with Packaging Groups I or II. For purposes of 
describing PCB waste not subject to DOT's HMR on a manifest, one may use 
the term ``Non-DOT Regulated PCBs.''
    (i) Containers other than those meeting HMR performance standards 
may be used for storage of PCB/radioactive waste provided the following 
requirements are met:
    (A) Containers used for storage of liquid PCB/radioactive wastes 
must be non-leaking.
    (B) Containers used for storage of non-liquid PCB/ radioactive 
wastes must be designed to prevent the buildup of liquids if such 
containers are stored in an area meeting the containment requirements of 
paragraph (b)(1)(ii) of this section, as well as all other applicable 
State or Federal regulations or requirements for control of radioactive 
materials.
    (C) Containers used to store both liquid and non-liquid PCB/
radioactive wastes must meet all regulations and requirements pertaining 
to nuclear criticality safety. Acceptable container materials currently 
include polyethylene and stainless steel provided that the container 
material is chemically compatible with the wastes being stored. Other 
containers may be used

[[Page 208]]

to store both liquid and non-liquid PCB/radioactive wastes if the users 
are able to demonstrate, to the appropriate Regional Administrator and 
other appropriate regulatory authorities (i.e., Nuclear Regulatory 
Commission, Department of Energy or the Department of Transportation), 
that the use of such containers is protective of health and the 
environment as well as public health and safety.
    (ii) The following DOT specification containers that conform to the 
requirements of 49 CFR, chapter I, subchapter C in effect on September 
30, 1991, may be used for storage and transportation activities that are 
not subject to DOT regulation, and may be used on a transitional basis 
as permitted at 49 CFR 171.14. For liquid PCBs: Specification 5 
container without removable head, Specification 5B container without 
removable head, Specification 6D overpack with Specification 2S or 2SL 
polyethylene containers, or Specification 17E container. For non-liquid 
PCBs: Specification 5 container, Specification 5B container, or 
Specification 17C container.
    (7) Stationary storage containers for liquid PCBs can be larger than 
the containers specified in paragraph (c)(6) of this section provided 
that:
    (i) The containers are designed, constructed, and operated in 
compliance with Occupational Safety and Health Standards, 29 CFR 
1910.106, Flammable and combustible liquids. Before using these 
containers for storing PCBs, the design of the containers must be 
reviewed to determine the effect on the structural safety of the 
containers that will result from placing liquids with the specific 
gravity of PCBs into the containers (see 29 CFR 1910.106(b)(1)(i)(f)).
    (ii) The owners or operators of any facility using containers 
described in paragraph (c)(7)(i) of this section, shall prepare and 
implement a Spill Prevention Control and Countermeasure (SPCC) Plan as 
described in part 112 of this title. In complying with 40 CFR part 112, 
the owner or operator shall read ``oil(s)'' as ``PCB(s)'' whenever it 
appears. The exemptions for storage capacity, 40 CFR 112.1(d)(2), and 
the amendment of SPCC plans by the Regional Administrator, 40 CFR 112.4, 
shall not apply unless some fraction of the liquids stored in the 
container are oils as defined by section 311 of the Clean Water Act.
    (8) PCB Items shall be dated on the item when they are removed from 
service for disposal. The storage shall be managed so that the PCB Items 
can be located by this date. Storage containers provided in paragraph 
(c)(7) of this section, shall have a record that includes for each batch 
of PCBs the quantity of the batch and date the batch was added to the 
container. The record shall also include the date, quantity, and 
disposition of any batch of PCBs removed from the container.
    (9) Bulk PCB remediation waste or PCB bulk product waste may be 
stored at the clean-up site or site of generation for 180 days subject 
to the following conditions:
    (i) The waste is placed in a pile designed and operated to control 
dispersal of the waste by wind, where necessary, by means other than 
wetting.
    (ii) The waste must not generate leachate through decomposition or 
other reactions.
    (iii) The storage site must have:
    (A) A liner that is designed, constructed, and installed to prevent 
any migration of wastes off or through the liner into the adjacent 
subsurface soil, ground water or surface water at any time during the 
active life (including the closure period) of the storage site. The 
liner may be constructed of materials that may allow waste to migrate 
into the liner. The liner must be:
    (1) Constructed of materials that have appropriate chemical 
properties and sufficient strength and thickness to prevent failure due 
to pressure gradients (including static head and external hydrogeologic 
forces), physical contact with the waste or leachate to which they are 
exposed, climatic conditions, the stress of installation, and the stress 
of daily operation.
    (2) Placed upon a foundation or base capable of providing support to 
the liner and resistance to pressure gradients above and below the liner 
to prevent failure of the liner due to settlement, compression, or 
uplift.
    (3) Installed to cover all surrounding earth likely to be in contact 
with the waste.

[[Page 209]]

    (B) A cover that meets the requirements of paragraph (c)(9)(iii)(A) 
of this section, is installed to cover all of the stored waste likely to 
be contacted with precipitation, and is secured so as not to be 
functionally disabled by winds expected under normal seasonal 
meteorological conditions at the storage site.
    (C) A run-on control system designed, constructed, operated, and 
maintained such that:
    (1) It prevents flow onto the stored waste during peak discharge 
from at least a 25-year storm.
    (2) It collects and controls at least the water volume resulting 
from a 24-hour, 25-year storm. Collection and holding facilities (e.g., 
tanks or basins) must be emptied or otherwise managed expeditiously 
after storms to maintain design capacity of the system.
    (iv) The provisions of this paragraph may be modified under 
Sec. 761.61(c).
    (10) Owners or operators of storage facilities shall establish and 
maintain records as provided in Sec. 761.180.
    (d) Approval of commercial storers of PCB waste. (1) All commercial 
storers of PCB waste shall have interim approval to operate commercial 
facilities for the storage of PCB waste until August 2, 1990. Commercial 
storers of PCB waste are prohibited from storing any PCB waste at their 
facilities after August 2, 1990 unless they have submitted by August 2, 
1990 a complete application for a final storage approval under paragraph 
(d)(2) of this section. The period of interim approval shall continue 
until EPA makes a final decision on the storage application at which 
time such interim approval shall terminate.
    (2) The Regional Administrator for the region in which the storage 
facility is located (or the appropriate official at EPA Headquarters, if 
the commercial storage area is ancillary to a disposal facility for 
which an official at EPA Headquarters has approval authority)shall grant 
written, final approval to engage in the commercial storage of PCB waste 
upon a determination that the criteria in paragraph (d)(2)(i) through 
(d)(2)(vii) of this section have been met by the applicant:
    (i) The applicant, its principals, and its key employees responsible 
for the establishment or operation of the commercial storage facility 
are qualified to engage in the business of commercial storage of PCB 
waste.
    (ii) The facility possesses the capacity to handle the quantity of 
PCB waste which the owner or operator of the facility has estimated will 
be the maximum quantity of PCB waste that will be handled at any one 
time at the facility.
    (iii) The owner or operator of the unit has certified compliance 
with the storage facility standards in paragraphs (b) and (c)(7) of this 
section.
    (iv) The owner or operator has developed a written closure plan for 
the facility that is deemed acceptable by the Regional Administrator (or 
the appropriate official at EPA Headquarters, if the commercial storage 
area is ancillary to a disposal facility permitted by an official at EPA 
Headquarters) under the closure plan standards of paragraph (e) of this 
section.
    (v) The owner or operator has included in the application for final 
approval a demonstration of financial responsibility for closure that 
meets the financial responsibility standards of paragraph (g) of this 
section.
    (vi) The operation of the storage facility will not pose an 
unreasonable risk of injury to health or the environment.
    (vii) The environmental compliance history of the applicant, its 
principals, and its key employees may be deemed to constitute a 
sufficient basis for denial of approval whenever in the judgment of the 
appropriate EPA official that history of environmental civil violations 
or criminal convictions evidences a pattern or practice of noncompliance 
that demonstrates the applicant's unwillingness or inability to achieve 
and maintain compliance with the regulations.
    (3) Applicants for storage approvals shall submit a written 
application that includes any relevant information bearing upon the 
qualifications of the facility's principals and key employees to engage 
in the business of commercial storage of PCB wastes. This information 
shall include, but is not limited to:

[[Page 210]]

    (i) The identification of the owner and the operator of the 
facility, including all general partners of a partnership, any limited 
partner of a partnership, any stockholder of a corporation or any 
participant in any other type of business organization or entity who 
owns or controls, directly or indirectly, more than 5 percent of each 
partnership, corporation, or other business organization and all 
officials of the facility who have direct management responsibility for 
the facility.
    (ii) The identification of the person responsible for the overall 
operations of the facility (i.e., a plant manager, superintendent, or a 
person of similar responsibility) and the supervisory employees who are 
or will be responsible for the operation of the facility.
    (iii) Information concerning the technical qualifications and 
experience of the persons responsible for the overall operation of the 
facility and the employees responsible for handling PCB waste or other 
wastes.
    (iv) Information concerning any past State or Federal environmental 
violations involving the same business or another business with which 
the principals or supervisory employees were affiliated directly that 
occurred within 5 years preceding the date of submission and which 
relate directly to violations that resulted in either a civil penalty 
(irrespective of whether the matter was disposed of by an adjudication 
or by a without prejudice settlement) or judgment of conviction whether 
entered after trial or a plea, either of guilt or nolo contendere or 
civil injunctive relief and involved storage, disposal, transport, or 
other waste handling activities.
    (v) A list of all companies currently owned or operated in the past 
by the principals or key employees identified in paragraphs (d)(3)(i) 
and (d)(3)(ii) of this section that are or were directly or indirectly 
involved with waste handling activities.
    (vi) The owner's or operator's estimate of maximum PCB waste 
quantity to be handled at the facility.
    (vii) A written statement certifying compliance with paragraph (b) 
or (c) of this section and containing a certification as defined in 
Sec. 761.3.
    (viii) A written closure plan for the facility, as described in 
paragraph (e) of this section.
    (ix) The current closure cost estimate for the facility, as 
described in paragraph (f) of this section.
    (x) A demonstration of financial responsibility to close the 
facility, as described in paragraph (g) of this section.
    (4) The written approval issued by EPA shall include, but not be 
limited to, the following:
    (i) The determination that the applicant has satisfied the 
requirements set forth in paragraph (d)(2) of this section, and a brief 
statement setting forth the basis for the determination.
    (ii) Incorporation of the closure plan submitted by the facility 
owner or operator and approved by EPA.
    (iii) A condition imposing a maximum PCB storage capacity which the 
facility shall not exceed during its PCB waste storage operations. The 
maximum storage capacity imposed under this condition shall not be 
greater than the estimated maximum inventory of PCB waste included in 
the owner's or operator's application for final approval.
    (iv) Such other conditions as deemed necessary by EPA to ensure that 
the operations of the PCB storage facility will not pose an unreasonable 
risk of injury to health or the environment.
    (5) Storage areas at transfer facilities are exempt from the 
requirement to obtain approval as a commercial storer of PCB waste under 
this paragraph, unless the same PCB waste is stored at these facilities 
for a period of time greater than 10 consecutive days between 
destinations.
    (6) Storage areas at RCRA-permitted facilities may be exempt from 
the separate TSCA storage approval requirements in this paragraph (d) 
upon a showing to the Regional Administrator's satisfaction that the 
facility's existing RCRA closure plan is substantially equivalent to 
this rule's closure plan standards, and that such facility's closure 
cost estimate and financial assurance demonstration account for maximum 
PCB waste inventories, and the requirements of paragraph (d)(3)(i) 
through (d)(3)(v) and (d)(3)(vii) of this section are met. A pay-in 
period of longer than 3 years after approval of

[[Page 211]]

the storage facility pursuant to this rule, will be acceptable to EPA if 
that pay-in period has already been established for a valid RCRA 
facility or previously approved TSCA facility.
    (7) Storage areas ancillary to TSCA-approved disposal facilities may 
be exempt from a separate facility approval provided all of the 
following conditions are met:
    (i) The current disposal approval contains an expiration date.
    (ii) The current disposal approval's closure and financial 
responsibility conditions specifically extend to storage areas ancillary 
to disposal.
    (iii) The current disposal approval's closure and financial 
responsibility conditions provide for annual adjustments for inflation, 
and for modification when changes in operation would affect closure 
costs.
    (iv) The current disposal approval contains conditions on closure 
and financial responsibility that are at least as stringent as those in 
paragraphs (e) and (g) of this section. However, the provision for a 3-
year closure trust pay-in period, as specified in paragraph (g)(1)(i) of 
this section, would be waived in a case in which an approved TSCA 
facility or RCRA facility that covers PCB storage has a longer pay-in 
period for the trust.
    (v) The current disposal approval satisfies the requirements of 
paragraph (d)(3)(i) through (d)(3)(v) of this section.
    (8) The approval of any existing TSCA-approved disposal facility 
ancillary to a commercial storage facility that is deficient in any of 
the conditions of paragraph (d)(7)(i) through (d)(7)(v) of this section 
shall be called in by the Regional Administrator (or the appropriated 
official at EPA Headquarters, if approval was granted by an official at 
EPA Headquarters). The approval shall be modified to meet the 
requirements of paragraph (d)(7) of this section within 180 days of the 
effective date of this final rule, or a separate application for 
approval of the storage facility may be submitted to the Regional 
Administrator or the Director, Office of Resource Conservation and 
Recovery, in the cases where an official at EPA Headquarters issued the 
approval.
    (e) Closure. (1) A commercial storer of PCB waste shall have a 
written closure plan that identifies the steps that the owner or 
operator of the facility shall take to close the PCB waste storage 
facility in a manner that eliminates the potential for post-closure 
releases of PCBs which may present an unreasonable risk to human health 
or the environment. An acceptable closure plan must include, at a 
minimum, all of the following:
    (i) A description of how the PCB storage areas of the facility will 
be closed in a manner that eliminates the potential for post-closure 
releases of PCBs into the environment.
    (ii) An identification of the maximum extent of storage operations 
that will be open during the active life of the facility, including an 
identification of the extent of PCB storage operations at the facility 
relative to other wastes that will be handled at the facility.
    (iii) An estimate of the maximum inventory of PCB wastes that could 
be handled at one time at the facility over its active life, and a 
detailed description of the methods or arrangements to be used during 
closure for removing, transporting, storing, or disposing of the 
facility's inventory of PCB waste, including an identification of any 
off-site facilities that will be used.
    (iv) A detailed description of the steps needed to remove or 
decontaminate PCB waste residues and contaminated containment system 
components, equipment, structures, and soils during closure in 
accordance with the levels specified in the PCB Spills Cleanup Policy in 
subpart G of this part, including a description of the methods for 
sampling and testing of surrounding soils, and the criteria for 
determining the extent of removal or decontamination.
    (v) A detailed description of other activities necessary during the 
closure period to ensure that any post-closure releases of PCBs will not 
present unreasonable risks to human health or the environment. This 
includes activities such as ground-water monitoring, run-on and run-off 
control, and facility security.
    (vi) A schedule for closure of each area of the facility where PCB 
waste is stored or handled, including the total

[[Page 212]]

time required to close each area of PCB waste storage or handling, and 
the time required for any intervening closure activities.
    (vii) An estimate of the expected year of closure of the PCB waste 
storage areas, if a trust fund is opted for as the financial mechanism.
    (2) A written closure plan determined to be acceptable by EPA under 
this section shall become a condition of any approval granted under 
paragraph (d) of this section.
    (3) A separate and new closure plan need not be submitted in cases 
where a facility is currently covered by a TSCA approval or a RCRA 
permit, upon a showing to the satisfaction of the Regional Administrator 
(or the appropriate official at EPA Headquarters, if the commercial 
storage area is ancillary to a disposal facility for which an official 
at EPA Headquarters has approval authority) that the existing closure 
plan is substantially equivalent to closure plans required under 
paragraphs (d) through (g) of this section, and that the plan adequately 
accounts for PCB waste inventories.
    (4) The commercial storer of PCB waste shall submit a written 
request to the Regional Administrator (or the Director, Office of 
Resource Conservation and Recovery, if an official at EPA Headquarters 
approved the closure plan) for a modification to its storage approval to 
amend its closure plan, whenever:
    (i) Changes in ownership, operating plans, or facility design affect 
the existing closure plan.
    (ii) There is a change in the expected date of closure, if 
applicable.
    (iii) In conducting closure activities, unexpected events require a 
modification of the approved closure plan.
    (5) The Regional Administrator or the Director, appropriate official 
at EPA Headquarters, if an official at EPA Headquarters approved the 
closure plan, may modify the existing closure plan under the conditions 
described in paragraph (e)(4) of this section.
    (6) Commercial storers of PCB waste shall comply with the following 
closure schedule:
    (i) The commercial storer shall notify in writing the Regional 
Administrator or the Director, Office of Resource Conservation and 
Recovery, if an official at EPA Headquarters approved the closure plan, 
at least 60 days prior to the date on which final closure of its PCB 
storage facility is expected to begin.
    (ii) The date when a commercial storer of PCB waste ``expects to 
begin closure'' shall be no later than 30 days after the date on which 
the storage facility received its final quantities of PCB waste. For 
good cause shown, EPA may extend the date for commencement of closure 
for an additional 30-day period.
    (iii) Within 90 days after receiving the final quantity of PCB waste 
for storage, a commercial storer of PCB waste shall remove all PCB waste 
in storage at the facility from the facility in accordance with the 
approved closure plan. For good cause shown, EPA may approve a 
reasonable extension to the period for removal of the PCB waste.
    (iv) A commercial storer of PCB waste shall complete closure 
activities in accordance with the approved closure plan and within 180 
days after receiving the final quantity of PCB waste for storage at the 
facility. For good cause shown, EPA may approve a reasonable extension 
to the closure period.
    (7) During the closure period, all contaminated system component 
equipment, structures, and soils shall be disposed of in accordance with 
the disposal requirements of subpart D of this part, or, if applicable, 
decontaminated in accordance with the levels specified in the PCB Spills 
Cleanup Policy at subpart G of this part. When PCB waste is removed from 
the storage facility during closure, the owner or operator becomes a 
generator of PCB waste subject to the generator requirements of subpart 
J of this part.
    (8) Within 60 days of completion of closure of each facility for the 
storage of PCB waste, the commercial storer of PCB waste shall submit to 
the Regional Administrator (or the Director, Office of Resource 
Conservation and Recovery, if an official at EPA Headquarters approved 
the closure plan), by registered mail, a certification that the PCB 
storage facility has been closed in accordance with the approved

[[Page 213]]

closure plan. The certification shall be signed by the owner or operator 
and by an independent registered professional engineer.
    (f) Closure cost estimate. (1) A commercial storer of PCB wastes 
shall have a detailed estimate, in current dollars, of the cost of 
closing the facility in accordance with its approved closure plan. The 
closure cost estimate shall be in writing, be certified by the person 
preparing it (using the certification defined in Sec. 761.3) and comply 
with all of the following criteria:
    (i) The closure cost estimate shall equal the cost of final closure 
at the point in the PCB storage facility's active life when the extent 
and manner of PCB storage operations would make closure the most 
expensive, as indicated by the facility's closure plan.
    (ii) The closure cost estimate shall be based on the costs to the 
owner or operator of hiring a third party to close the facility, and the 
third party shall not be either a corporate parent or subsidiary of the 
owner or operator, or member in joint ownership of the facility.
    (iii) The owner or operator shall include in the estimate the 
current market costs for off-site commercial disposal of the facility's 
maximum estimated inventory of PCB wastes, except that on-site disposal 
costs may be used if on-site disposal capacity will exist at the 
facility at all times over the life of the PCB storage facility.
    (iv) The closure cost estimate may not incorporate any salvage value 
that may be realized with the sale of wastes, facility structures or 
equipment, land, or other assets associated with the facility at the 
time of closure.
    (2) During the active life of the PCB storage facility, the 
commercial storer of PCB waste shall adjust annually for inflation the 
closure cost estimate within 60 days prior to the anniversary date of 
the establishment of the financial instruments used to demonstrate 
financial responsibility for closure, except that owners or operators 
who use the financial test or corporate guarantee shall adjust their 
closure cost estimates for inflation within 30 days after the close of 
the storer's fiscal year. The adjustment may be made by recalculating 
the maximum costs of closure in current dollars, or by using an 
inflation factor derived from the most recent Implicit Price Deflator 
for Gross National Product published by the U.S. Department of Commerce 
in its Survey of Current Business. The Implicit Price Deflator for Gross 
National Product is included in a monthly publication titled Economic 
Indicators, which is available from the Superintendent of Documents, 
Government Printing Office, Washington, DC 20402. The inflation factor 
used in the latter method is the result of dividing the latest published 
annual Deflator by the Deflator for the previous year. The adjustment to 
the closure cost estimate is then made by multiplying the most recent 
closure cost estimate by the latest inflation factor.
    (3) Where EPA approves a modification to the facility's closure 
plan, and that modification increases the cost of closure, the owner or 
operator shall revise the closure cost estimate no later than 30 days 
after the modification is approved. Any such revision shall also be 
adjusted for inflation in accordance with paragraph (f)(2) of this 
section.
    (4) The owner or operator of the facility shall keep at the facility 
during its operating life the most recent closure cost estimate, 
including any adjustments resulting from inflation or from modifications 
to the closure plan.
    (g) Financial assurance for closure. A commercial storer of PCB 
waste shall establish financial assurance for closure of each PCB 
storage facility that he owns or operates. In establishing financial 
assurance for closure, the commercial storer of PCB waste may choose 
from the following financial assurance mechanisms or any combination of 
mechanisms:
    (1) The ``closure trust fund,'' as specified in Sec. 264.143(a) of 
this chapter, except for paragraph (a)(3) of Sec. 264.143. For purposes 
of this paragraph, the following provisions also apply:
    (i) Payments into the trust fund shall be made annually by the owner 
or operator over the remaining operating life of the facility as 
estimated in the closure plan, or over 3 years, whichever period is 
shorter. This period of time is hereafter referred to as the ``pay-in 
period.'' For an existing facility, the first

[[Page 214]]

payment must be made within 30 calendar days after EPA has notified the 
facility of its conditional approval. Interim approval to operate is 
canceled and the application is denied if EPA does not receive 
verification that the payment was made in that 30-day period.
    (ii) For a new facility, the first payment into the closure trust 
fund shall be made before EPA grants final approval of the application 
and before the facility may accept the initial shipment of PCB waste for 
commercial storage. A receipt from the trustee shall be submitted by the 
owner or operator to the Regional Administrator (or the Director, Office 
of Resource Conservation and Recovery, if the commercial storage area is 
ancillary to a disposal facility approved by an official at EPA 
Headquarters) before this initial delivery of PCB waste. The first 
payment shall be at least equal to the current closure cost estimate, 
divided by the number of years in the pay-in period, except as provided 
in paragraph (g)(7) of this section for multiple mechanisms. Subsequent 
payments shall be made no later than 30 days after each anniversary date 
of the first payment. The amount of each subsequent payment shall be 
determined by subtracting the current value of the trust fund from the 
current closure cost estimate, and dividing this difference by the 
number of years remaining in the pay-in period.
    (iii) If an owner or operator of a facility existing on the 
effective date of this paragraph establishes a trust fund to meet the 
financial assurance requirements of this paragraph, and the value of the 
trust fund is less than the current closure cost estimate when a final 
approval is granted for the facility, the amount of the current closure 
cost estimate still to be paid into the trust fund shall be paid in over 
the pay-in period as defined in paragraph (g)(1)(i) of this section. 
Payments shall continue to be made no later than 30 days after each 
anniversary date of the first payment made into the trust fund. The 
amount of each payment shall be determined by subtracting the current 
value of the trust fund from the current closure cost estimate, and 
dividing this difference by the number of years remaining in the pay-in 
period.
    (iv) The submission of a trust agreement with the wording specified 
in Sec. 264.151(a)(1) of this chapter, including any reference to 
hazardous waste management facilities, shall be deemed to be in 
compliance with the requirement to submit a trust agreement under this 
subpart.
    (2) The ``surety bond guaranteeing payment into a closure trust 
fund,'' as specified in Sec. 264.143(b) of this chapter, including the 
use of the surety bond instrument specified at Sec. 264.151(b) of this 
chapter and the standby trust specified at Sec. 264.143(b)(3) of this 
chapter. The use of the surety bonds, surety bond instruments, and 
standby trust agreements specified in Secs. 264.143(b) and 264.151(b) of 
this chapter shall be deemed to be in compliance with this subpart.
    (3)(i) The ``surety bond guaranteeing performance of closure,'' as 
specified at Sec. 264.143(c) of this chapter, except for paragraph 
(c)(5) of Sec. 264.143 of this chapter. The submission and use of the 
surety bond instrument specified at Sec. 264.151(c) of this chapter and 
the standby trust specified at Sec. 264.143(c)(3) of this chapter shall 
be deemed to be in compliance with the requirements under this subpart 
relating to the use of surety bonds and standby trust funds.
    (ii) For the purposes of this paragraph, and under the terms of the 
bond, the surety shall become liable on the bond obligation when the 
owner or operator fails to perform as guaranteed by the bond. Liability 
is established by a final administrative determination pursuant to 
section 16 of TSCA that the owner or operator has failed to perform 
final closure in accordance with the closure plan and other approval or 
regulatory requirements when required to do so.
    (4)(i) The ``closure letter of credit'' specified in Sec. 264.143(d) 
of this chapter, except for paragraph (d)(8). The submission and use of 
the irrevocable letter of credit instrument specified in Sec. 264.151(d) 
of this chapter and the standby trust specified in Sec. 264.143(d)(3) of 
this chapter shall be deemed to be in compliance with the requirements 
of this subpart relating to the use of letters of credit and standby 
trust funds.

[[Page 215]]

    (ii) For the purposes of this paragraph, the Regional Administrator 
(or the appropriate official at EPA Headquarters, if the commercial 
storage area is ancillary to a disposal facility for which an official 
at EPA Headquarters has approval authority) may draw on the letter of 
credit following a final administrative determination pursuant to 
section 16 of TSCA that the owner or operator has failed to perform 
final closure in accordance with the closure plan and other approval or 
regulatory requirements when required to do so.
    (5) ``Closure insurance,'' as specified in Sec. 264.143(e) of this 
chapter, utilizing the certificate of insurance for closure specified at 
Sec. 264.151(e) of this chapter. The use of closure insurance as 
specified in Sec. 264.143(e) of this chapter and the submission and use 
of the certificate of insurance specified in Sec. 264.151(e) of this 
chapter shall be deemed to be in compliance with the requirements of 
this subpart relating to the use of closure insurance.
    (6) The ``financial test and corporate guarantee for closure,'' as 
described in Sec. 264.143(f) of this chapter, including a letter signed 
by the owner's or operator's chief financial officer as specified at 
Sec. 264.151(f) of this chapter and, if applicable, the written 
corporate guarantee specified at Sec. 264.151(h) of this chapter. The 
use of the financial test and corporate guarantee specified in 
Sec. 264.143(f) of this chapter, the submission and use of the letter 
specified in Sec. 264.151(f) of this chapter, and the submission and use 
of the written corporate guarantee specified at Sec. 264.151(h) of this 
chapter shall be deemed to be in compliance with the requirements of 
this subpart relating to the use of financial tests and corporate 
guarantees.
    (7) The corporate guarantee as specified in Sec. 264.143(f)(10) of 
this chapter.
    (8) The use of multiple financial mechanisms, as specified in 
Sec. 264.143(g) of this chapter is permitted.
    (9) A modification to a facility storing PCB waste that increases 
the maximum storage capacity indicated in the permit requires that a new 
financial assurance mechanism be established or an existing one be 
amended. When such a modification occurs, the Director of the Federal or 
State issuing authority must be notified in writing no later than 30 
days from the completion of the modification. The new or revised 
financial assurance mechanism must be established and activated no later 
than 30 days after the Director of the Federal or State issuing 
authority is notified of the completion of the modification, but prior 
to the use of the modified portion of the facility.
    (h) Release of owner or operator. Within 60 days after receiving 
certifications from the owner or operator and an independent registered 
professional engineer that final closure has been completed in 
accordance with the approved closure plan, EPA will notify the owner or 
operator in writing that the owner or operator is no longer required by 
this section to maintain financial assurance for final closure of the 
facility, unless EPA has reason to believe that final closure has not 
been completed in accordance with the approved closure plan. EPA shall 
provide the owner or operator with a detailed written statement stating 
the reasons why EPA shall provide the owner or operator with a detailed 
written statement stating the reasons why he believed closure was not 
conducted in accordance with the approved closure plan.
    (i) Laboratories and samples. (1) A laboratory is conditionally 
exempt from the notification and approval requirements for a commercial 
storer under Sec. 761.65 (d) through (h) when it stores samples held for 
disposal in a facility that complies with the standards in Sec. 761.65 
(b)(1)(i) through (b)(1)(iv).
    (2) A laboratory sample is exempt from the manifesting requirements 
in Secs. 761.210 through 761.213 when:
    (i) The sample is being transported to a laboratory for the purpose 
of testing.
    (ii) The sample is being transported back to the sample collector 
after testing.
    (iii) The sample is being stored by the sample collector before 
transport to a laboratory for testing.
    (iv) The sample is being stored in a laboratory before testing.
    (v) The sample is being stored in a laboratory after testing but 
before it is returned to the sample collector.
    (vi) The sample is being stored temporarily in the laboratory after 
testing

[[Page 216]]

for a specific purpose (for example, until conclusion of a court case or 
enforcement action where further testing of the sample may be 
necessary).
    (3) In order to qualify for the exemption in paragraph (i)(2)(i) and 
(i)(2)(ii) of this section, a sample collector shipping samples to a 
laboratory and a laboratory returning samples to a sample collector 
must:
    (i) Comply with applicable U.S. Department of Transportation (DOT) 
or U.S. Postal Service (USPS) shipping requirements, found respectively 
in 49 CFR 173.345 and U.S. Postal Regulations 652.2 and 652.3.
    (ii) Assure that the following information accompanies the sample:
    (A) The sample collector's name, mailing address, and telephone 
number.
    (B) The laboratory's name, mailing address, and telephone number.
    (C) The quantity of the sample.
    (D) The date of shipment.
    (E) A description of the sample.
    (iii) Package the sample so that it does not leak, spill, or 
vaporize from its packaging.
    (4) When the concentration of the PCB sample has been determined, 
and its use is terminated, the sample must be properly disposed. A 
laboratory must either manifest the PCB waste to a disposer or 
commercial storer, as required under Secs. 761.210 through 761.213, 
retain a copy of each manifest, as required under Secs. 761.213 and 
761.214, and follow up on exception reporting, as required under 
Sec. 761.217, or return the sample to the sample collector who must then 
properly dispose of the sample. If the laboratory returns the sample to 
the sample collector, the laboratory must comply with the shipping 
requirements set forth in paragraphs (i)(3)(i) through (i)(3)(iii) of 
this section.
    (j) Changes in ownership or operational control of a commercial 
storage facility. The date of transfer of interim status or final 
approval shall be the date the EPA Regional Administrator (or 
appropriate official at EPA Headquarters) provides written approval of 
the transfer. EPA will provide a final written decision within 90 days 
of receipt of the complete new or amended application. The Agency will 
approve the transfer if the following conditions are met:
    (1) The transferee has established financial assurance for closure 
pursuant to paragraph (g) of this section using a mechanism effective as 
of the date of final approval so that there will be no lapse in 
financial assurance for the transferred facility.
    (2) The transferor or transferee has resolved any deficiencies 
(e.g., technical operations, closure plans, cost estimates, etc.) the 
Agency has identified in the transferor's application.
    (k) States and the Federal Government. States and the Federal 
Government are exempt from the requirements of paragraphs (f) and (g) of 
this section.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 47 FR 37359, Aug. 8, 1982; 49 FR 28191, July 10, 1984; 53 
FR 12524, Apr. 15, 1988; 54 FR 52746, Dec. 21, 1989; 55 FR 695, Jan. 8, 
1990; 55 FR 26205, June 27, 1990; 58 FR 15809, Mar. 24, 1993; 58 FR 
34205, June 23, 1993; 58 FR 59374, Nov. 9, 1993; 63 FR 35439, 35452, 
June 29, 1998; 72 FR 57239, 57240 Oct. 9, 2007; 74 FR 30232, June 25, 
2009; 77 FR 54830, Sept. 6, 2012]



Sec. 761.70  Incineration.

    This section applies to facilities used to incinerate PCBs required 
to be incinerated by this part.
    (a) Liquid PCBs. An incinerator used for incinerating PCBs shall be 
approved by EPA pursuant to paragraph (d) of this section. Requests for 
approval of incinerators to be used in more than one region must be 
submitted to the Director, Office of Resource Conservation and Recovery, 
except for research and development involving less than 500 pounds of 
PCB material (see Sec. 761.60(i)(2)). Requests for approval of 
incinerators to be used in only one region must be submitted to the 
appropriate Regional Administrator. The incinerator shall meet all of 
the requirements specified in paragraphs (a)(1) through (9) of this 
section, unless a waiver from these requirements is obtained pursuant to 
paragraph (d)(5) of this section, In addition, the incinerator shall 
meet any other requirements which may be prescribed pursuant to 
paragraph (d)(4) of this section.

[[Page 217]]

    (1) Combustion criteria shall be either of the following:
    (i) Maintenance of the introduced liquids for a 2-second dwell time 
at 1200 C ( # 100 C) and 3 percent excess oxygen in the 
stack gas; or
    (ii) Maintenance of the introduced liquids for a 1\1/2\ second dwell 
time at 1600 C( # 100 C) and 2 percent excess oxygen in the 
stack gas.
    (2) Combustion efficiency shall be at least 99.9 percent computed as 
follows:

Combustion efficiency = [Cco2/(Cco2 + Cco)]100

where

Cco2 = Concentration of carbon dioxide.
Cco = Concentration of carbon monoxide.

    (3) The rate and quantity of PCBs which are fed to the combustion 
system shall be measured and recorded at regular intervals of no longer 
than 15 minutes.
    (4) The temperatures of the incineration process shall be 
continuously measured and recorded. The combustion temperature of the 
incineration process shall be based on either direct (pyrometer) or 
indirect (wall thermocouple-pyrometer correlation) temperature readings.
    (5) The flow of PCBs to the incinerator shall stop automatically 
whenever the combustion temperature drops below the temperatures 
specified in paragraph (a)(1) of this section.
    (6) Monitoring of stack emission products shall be conducted:
    (i) When an incinerator is first used for the disposal of PCBs under 
the provisions of this regulation;
    (ii) When an incinerator is first used for the disposal of PCBs 
after the incinerator has been modified in a manner which may affect the 
characteristics of the stack emission products; and
    (iii) At a minimum such monitoring shall be conducted for the 
following parameters:
    (a) O2; (b) CO; (c) CO2; (d) Oxides of 
Nitrogen (NOX); (e) Hydrochloric Acid (HCl); (f) Total 
Chlorinated Organic Content (RCl); (g) PCBs; and (h) Total Particulate 
Matter.
    (7) At a minimum monitoring and recording of combustion products and 
incineration operations shall be conducted for the following parameters 
whenever the incinerator is incinerating PCBs:
    (i) O2; (ii) CO; and (iii) CO2. The monitoring 
for O2 and CO shall be continuous. The monitoring for 
CO2 shall be periodic, at a frequency specified by the 
Regional Administrator or appropriate official at EPA Headquarters.
    (8) The flow of PCBs to the incinerator shall stop automatically 
when any one or more of the following conditions occur, unless a 
contingency plan is submitted by the incinerator owner or operator and 
approved by the Regional Administrator or appropriate official at EPA 
Headquarters. The contingency plan indicates what alternative measures 
the incinerator owner or operator would take if any of the following 
conditions occur:
    (i) Failure of monitoring operations specified in paragraph (a)(7) 
of this section;
    (ii) Failure of the PCB rate and quantity measuring and recording 
equipment specified in paragraph (a)(3) of this section; or
    (iii) Excess oxygen falls below the percentage specified in 
paragraph (a)(1) of this section.
    (9) Water scrubbers shall be used for HCl control during PCB 
incineration and shall meet any performance requirements specified by 
EPA. Scrubber effluent shall be monitored and shall comply with 
applicable effluent or pretreatment standards, and any other State and 
Federal laws and regulations. An alternate method of HCl control may be 
used if the alternate method has been approved by EPA. (The HCl 
neutralizing capability of cement kilns is considered to be an alternate 
method.)
    (b) Nonliquid PCBs. An incinerator used for incinerating nonliquid 
PCBs, PCB Articles, PCB Equipment, or PCB Containers shall be approved 
by EPA pursuant to paragraph (d) of this section. Requests for approval 
of incinerators to be used in more than one region must be submitted to 
the Director, Office of Resource Conservation and Recovery except for 
research and development involving less that 500 pounds of PCB material 
(see Sec. 761.60(i)(2)). Requests for approval of

[[Page 218]]

incinerators to be used in only one region must be submitted to the 
appropriate Regional Administrator. The incinerator shall meet all of 
the requirements specified in paragraphs (b)(1) and (2) of this section 
unless a waiver from these requirements is obtained pursuant to 
paragraph (d)(5) of this section. In addition, the incinerator shall 
meet any other requirements that may be prescribed pursuant to paragraph 
(d)(4) of this section.
    (1) The mass air emissions from the incinerator shall be no greater 
than 0.001g PCB/kg of the PCB introduced into the incinerator.
    (2) The incinerator shall comply with the provisions of paragraphs 
(a)(2), (3), (4), (6), (7), (8)(i) and (ii), and (9) of this section.
    (c) Maintenance of data and records. All data and records required 
by this section shall be maintained in accordance with Sec. 761.180, 
Records and monitoring.
    (d) Approval of incinerators. Prior to the incineration of PCBs and 
PCB Items the owner or operator of an incinerator shall receive the 
written approval of the Agency Regional Administrator for the region in 
which the incinerator is located, or the appropriate official at EPA 
Headquarters. Approval from the appropriate official at EPA Headquarters 
may be effective in all ten EPA regions. Such approval shall be obtained 
in the following manner:
    (1) Application. The owner or operator shall submit to the Regional 
Administrator or the Director, Office of Resource Conservation and 
Recovery an application which contains:
    (i) The location of the incinerator;
    (ii) A detailed description of the incinerator including general 
site plans and design drawings of the incinerator;
    (iii) Engineering reports or other information on the anticipated 
performance of the incinerator;
    (iv) Sampling and monitoring equipment and facilities available;
    (v) Waste volumes expected to be incinerated;
    (vi) Any local, State, or Federal permits or approvals; and
    (vii) Schedules and plans for complying with the approval 
requirements of this regulation.
    (2) Trial burn. (i) Following receipt of the application described 
in paragraph (d)(1) of this section, EPA shall determine if a trial burn 
is required and notify the person who submitted the report whether a 
trial burn of PCBs and PCB Items must be conducted. EPA may require the 
submission of any other information that EPA finds to be reasonably 
necessary to determine the need for a trial burn. Such other information 
shall be restricted to the types of information required in paragraphs 
(d)(1)(i) through (vii) of this section.
    (ii) If EPA determines that a trail burn must be held, the person 
who submitted the report described in paragraph (d)(1) of this section 
shall submit to the Regional Administrator or the Director, Office of 
Resource Conservation and Recovery a detailed plan for conducting and 
monitoring the trail burn. At a minimum, the plan must include:
    (A) Date trial burn is to be conducted;
    (B) Quantity and type of PCBs and PCB Items to be incinerated;
    (C) Parameters to be monitored and location of sampling points;
    (D) Sampling frequency and methods and schedules for sample 
analyses; and
    (E) Name, address, and qualifications of persons who will review 
analytical results and other pertinent data, and who will perform a 
technical evaluation of the effectiveness of the trial burn.
    (iii) Following receipt of the plan described in paragraph 
(d)(2)(ii) of this section, EPA will approve the plan, require additions 
or modifications to the plan, or disapprove the plan. If the plan is 
disapproved, EPA will notify the person who submitted the plan of such 
disapproval, together with the reasons why it is disapproved. That 
person may thereafter submit a new plan in accordance with paragraph 
(d)(2)(ii) of this section. If the plan is approved (with any additions 
or modifications which EPA may prescribe), EPA will notify the person 
who submitted the plan of the approval. Thereafter, the trial burn shall 
take place at a date and time to be agreed upon between EPA and the 
person who submitted the plan.

[[Page 219]]

    (3) Other information. In addition to the information contained in 
the report and plan described in paragraphs (d)(1) and (2) of this 
section, EPA may require the owner or operator to submit any other 
information that the EPA finds to be reasonably necessary to determine 
whether an incinerator shall be approved.

    Note: The Regional Administrator will have available for review and 
inspection an Agency manual containing information on sampling methods 
and analytical procedures for the parameters required in Sec. 761.70(a) 
(3), (4), (6), and (7) plus any other parameters he/she may determine to 
be appropriate. Owners or operators are encouraged to review this manual 
prior to submitting any report required in Sec. 761.70.

    (4) Contents of approval. (i) Except as provided in paragraph (d)(5) 
of this section, the Regional Administrator or the appropriate official 
at EPA Headquarters may not approve an incinerator for the disposal of 
PCBs and PCB Items unless he finds that the incinerator meets all of the 
requirements of paragraphs (a) and/or (b) of this section.
    (ii) In addition to the requirements of paragraphs (a) and/or (b) of 
this section, EPA may include in an approval any other requirements that 
EPA finds are necessary to ensure that operation of the incinerator does 
not present an unreasonable risk of injury to health or the environment 
from PCBs. Such requirements may include a fixed period of time for 
which the approval is valid.
    (5) Waivers. An owner or operator of the incinerator may submit 
evidence to the Regional Administrator or the Director, Office of 
Resource Conservation and Recovery that operation of the incinerator 
will not present an unreasonable risk of injury to health or the 
environment from PCBs, when one or more of the requirements of 
paragraphs (a) and/or (b) of this section are not met. On the basis of 
such evidence and any other available information, EPA may, in its 
discretion, find that any requirement of paragraphs (a) and (b) of this 
section is not necessary to protect against such a risk, and may waive 
the requirements in any approval for that incinerator. Any finding and 
waiver under this paragraph must be stated in writing and included as 
part of the approval.
    (6) Persons approved. An approval will designate the persons who own 
and who are authorized to operate the incinerator, and will apply only 
to such persons, except as provided in paragraph (d)(8) of this section.
    (7) Final approval. Approval of an incinerator will be in writing 
and signed by the appropriate EPA official. The approval will state all 
requirements applicable to the approved incinerator.
    (8) Transfer of property. Any person who owns or operates an 
approved incinerator must notify EPA at least 30 days before 
transferring ownership in the incinerator or the property it stands 
upon, or transferring the right to operate the incinerator. The 
transferor must also submit to EPA, at least 30 days before such 
transfer, a notarized affidavit signed by the transferee which states 
that the transferee will abide by the transferor's EPA incinerator 
approval. Within 30 days of receiving such notification and affidavit, 
EPA will issue an amended approval substituting the transferee's name 
for the transferor's name, or EPA may require the transferee to apply 
for a new incinerator approval. In the latter case, the transferee must 
abide by the transferor's EPA approval until EPA issues the new approval 
to the transferee.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 48 FR 13185, Mar. 30, 1983; 49 FR 28191, July 10, 1984; 
53 FR 12524, Apr. 15, 1988; 58 FR 15809, Mar. 24, 1993; 63 FR 35439, 
June 29, 1998; 72 FR 57240, Oct. 9, 2007; 74 FR 30233, June 25, 2009]



Sec. 761.71  High efficiency boilers.

    (a) To burn mineral oil dielectric fluid containing a PCB 
concentration of $50 ppm, but <500 ppm:
    (1) The boiler shall comply with the following criteria:
    (i) The boiler is rated at a minimum of 50 million BTU hours.
    (ii) If the boiler uses natural gas or oil as the primary fuel, the 
carbon monoxide concentration in the stack is 50 ppm and the excess 
oxygen is at least 3 percent when PCBs are being burned.

[[Page 220]]

    (iii) If the boiler uses coal as the primary fuel, the carbon 
monoxide concentration in the stack is 100 ppm and the excess oxygen is 
at least 3 percent when PCBs are being burned.
    (iv) The mineral oil dielectric fluid does not comprise more than 10 
percent (on a volume basis) of the total fuel feed rate.
    (v) The mineral oil dielectric fluid is not fed into the boiler 
unless the boiler is operating at its normal operating temperature (this 
prohibits feeding these fluids during either start up or shut down 
operations).
    (vi) The owner or operator of the boiler:
    (A) Continuously monitors and records the carbon monoxide 
concentration and excess oxygen percentage in the stack gas while 
burning mineral oil dielectric fluid; or
    (B) If the boiler will burn <30,000 gallons of mineral oil 
dielectric fluid per year, measures and records the carbon monoxide 
concentration and excess oxygen percentage in the stack gas at regular 
intervals of no longer than 60 minutes while burning mineral oil 
dielectric fluid.
    (vii) The primary fuel feed rates, mineral oil dielectric fluid feed 
rates, and total quantities of both primary fuel and mineral oil 
dielectric fluid fed to the boiler are measured and recorded at regular 
intervals of no longer than 15 minutes while burning mineral oil 
dielectric fluid.
    (viii) The carbon monoxide concentration and the excess oxygen 
percentage are checked at least once every hour that mineral oil 
dielectric fluid is burned. If either measurement falls below the levels 
specified in this section, the flow of mineral oil dielectric fluid to 
the boiler shall be stopped immediately.
    (2) Thirty days before any person burns mineral oil dielectric fluid 
in the boiler, the person gives written notice to the EPA Regional 
Administrator for the EPA Region in which the boiler is located and that 
the notice contains the following information:
    (i) The name and address of the owner or operator of the boiler and 
the address of the boiler.
    (ii) The boiler rating in units of BTU/hour.
    (iii) The carbon monoxide concentration and the excess oxygen 
percentage in the stack of the boiler when it is operated in a manner 
similar to the manner in which it will be operated when mineral oil 
dielectric fluid is burned.
    (iv) The type of equipment, apparatus, and procedures to be used to 
control the feed of mineral oil dielectric fluid to the boiler and to 
monitor and record the carbon monoxide concentration and excess oxygen 
percentage in the stack.
    (3) When burning mineral oil dielectric fluid, the boiler must 
operate at a level of output no less than the output at which the 
measurements required under paragraph (a)(2)(iii) of this section were 
taken.
    (4) Any person burning mineral oil dielectric fluid in a boiler 
obtains the following information and retains the information for 5 
years at the boiler location:
    (i) The data required to be collected under paragraphs (a)(1)(vi) 
and (vii) of this section.
    (ii) The quantity of mineral oil dielectric fluid burned in the 
boiler each month.
    (b) To burn liquids, other than mineral oil dielectric fluid, 
containing a PCB concentration of $50 ppm, but <500 ppm:
    (1) The boiler shall comply with the following criteria:
    (i) The boiler is rated at a minimum of 50 million BTU/hour.
    (ii) If the boiler uses natural gas or oil as the primary fuel, the 
carbon monoxide concentration in the stack is 50 ppm and the excess 
oxygen is at least 3 percent when PCBs are being burned.
    (iii) If the boiler uses coal as the primary fuel, the carbon 
monoxide concentration in the stack is 100 ppm and the excess oxygen is 
at least 3 percent when PCBs are being burned.
    (iv) The waste does not comprise more than 10 percent (on a volume 
basis) of the total fuel feed rate.
    (v) The waste is not fed into the boiler unless the boiler is 
operating at its normal operating temperature (this prohibits feeding 
these fluids during either start up or shut down operations).
    (vi) The owner or operator of the boiler must:

[[Page 221]]

    (A) Continuously monitor and record the carbon monoxide 
concentration and excess oxygen percentage in the stack gas while 
burning waste fluid; or
    (B) If the boiler will burn <30,000 gallons of waste fluid per year, 
measure and record the carbon monoxide concentration and excess oxygen 
percentage in the stack gas at regular intervals of no longer than 60 
minutes while burning waste fluid.
    (vii) The primary fuel feed rate, waste fluid feed rate, and total 
quantities of both primary fuel and waste fluid fed to the boiler must 
be measured and recorded at regular intervals of no longer than 15 
minutes while burning waste fluid.
    (viii) The carbon monoxide concentration and the excess oxygen 
percentage must be checked at least once every hour that the waste is 
burned. If either measurement falls below the levels specified in either 
(a)(1)(ii) or (a)(1)(iii) of this section, the flow of waste to the 
boiler shall be stopped immediately.
    (2) Prior to any person burning these liquids in the boiler, 
approval must be obtained from the EPA Regional Administrator for the 
EPA Region in which the boiler is located and any persons seeking such 
approval must submit to the EPA Regional Administrator a request 
containing at least the following information:
    (i) The name and address of the owner or operator of the boiler and 
the address of the boiler.
    (ii) The boiler rating in units of BTU/hour.
    (iii) The carbon monoxide concentration and the excess oxygen 
percentage in the stack of the boiler when it is operated in a manner 
similar to the manner in which it will be operated when low 
concentration PCB liquid is burned.
    (iv) The type of equipment, apparatus, and procedures to be used to 
control the feed of mineral oil dielectric fluid to the boiler and to 
monitor and record the carbon monoxide concentration and excess oxygen 
percentage in the stack.
    (v) The type of waste to be burned (e.g., hydraulic fluid, 
contaminated fuel oil, heat transfer fluid, etc.).
    (vi) The concentration of PCBs and of any other chlorinated 
hydrocarbon in the waste and the results of analyses using the ASTM 
International methods as follows: Carbon and hydrogen content using ASTM 
D3178-84, nitrogen content using ASTM E258-67 (Reapproved 1987), sulfur 
content using ASTM D2784-89, ASTM D1266-87, or ASTM D129-64 (Reapproved 
1978), chlorine content using ASTM D808-87, water and sediment content 
using either ASTM D2709-88 or ASTM D1796-83 (Reapproved 1990), ash 
content using ASTM D482-87, calorific value using ASTM D240-87, carbon 
residue using either ASTM D2158-89 or ASTM D524-88, and flash point 
using ASTM D93-09 (all standards incorporated by reference in 
Sec. 761.19).
    (vii) The quantity of wastes estimated to be burned in a 30-day 
period.
    (viii) An explanation of the procedures to be followed to ensure 
that burning the waste will not adversely affect the operation of the 
boiler such that combustion efficiency will decrease.
    (3) On the basis of the information in paragraph (b)(2) of this 
section and any other available information, the Regional Administrator 
may, at his/her discretion, find that the alternate disposal method will 
not present an unreasonable risk of injury to health or the environment 
and approve the use of the boiler.
    (4) When burning PCB wastes, the boiler must operate at a level of 
output no less than the output at which the measurements required under 
paragraph (b)(2)(iii) of this section were taken.
    (5) Any person burning liquids in boilers approved as provided in 
paragraph (b)(3) of this section, must obtain the following information 
and retain the information for 5 years at the boiler location:
    (i) The data required to be collected in paragraphs (b)(1)(vi) and 
(b)(1)(vii) of this section.
    (ii) The quantity of low concentration PCB liquid burned in the 
boiler each month.
    (iii) The analysis of the waste required by paragraph (b)(2)(vi) of 
this section taken once a month for each

[[Page 222]]

month during which low concentration PCB liquid is burned in the boiler.

[63 FR 35454, June 29, 1998, as amended at 77 FR 2464, Jan. 18, 2012]



Sec. 761.72  Scrap metal recovery ovens and smelters.

    Any person may dispose of residual PCBs associated with PCB-
Contaminated articles regulated for disposal under Sec. 761.60(b), metal 
surfaces in PCB remediation waste regulated under Sec. 761.61, or metal 
surfaces in PCB bulk product waste regulated under Secs. 761.62(a)(6) 
and 761.79(c)(6), from which all free-flowing liquids have been removed:
    (a) In a scrap metal recovery oven:
    (1) The oven shall have at least two enclosed (i.e., negative draft, 
no fugitive emissions) interconnected chambers.
    (2) The equipment with all free-flowing liquid removed shall first 
be placed in the primary chamber at room temperature.
    (3) The primary chamber shall operate at a temperature between 537 
C and 650 C for a minimum of 2\1/2\ hours and reach a minimum 
temperature of 650 C (1,202 F) once during each heating cycle or batch 
treatment of unheated, liquid-free equipment.
    (4) Heated gases from the primary chamber must feed directly into 
the secondary chamber (i.e., afterburner) which must operate at a 
minimum temperature of 1,200 C (2,192 F) with at least a 3 percent 
excess oxygen and a retention time of 2.0 seconds with a minimum 
combustion efficiency of 99.9 percent according to the definition in 
Sec. 761.70(a)(2).
    (5) Heating of the primary chamber shall not commence until the 
secondary chamber has reached a temperature of 1,200  # 100 
C (2,192   # 180 F).
    (6) Continuous emissions monitors and recorders for carbon dioxide, 
carbon monoxide, and excess oxygen in the secondary chamber and 
continuous temperature recorders in the primary and secondary chambers 
shall be installed and operated while the primary and secondary chambers 
are in operation to assure that the two chambers are within the 
operating parameters in paragraphs (a)(3) through (a)(5) of this 
section.
    (7) Emissions from the secondary chamber must be vented through an 
exhaust gas stack in accordance with either:
    (i) State or local air regulations or permits, or
    (ii) The standards in paragraph (a)(8) of this section.
    (8) Exhaust gas stack emissions shall be for: particulates <0.015 
grains/dry standard cubic foot, sulfur dioxide <35 parts per million by 
volume (ppmv), nitrogen oxide <150 ppmv, carbon monoxide <35 ppmv, and 
hydrogen chloride <35 ppmv.
    (9) A measurement of the temperature in the secondary chamber at the 
time the primary chamber starts heating must be taken, recorded and 
retained at the facility for 3 years from the date each charge is 
introduced into the primary chamber.
    (b) By smelting:
    (1) The operating temperature of the hearth must be at least 1,000 
C at the time it is charged with any PCB-Contaminated non-porous 
surface.
    (2) Each charge containing a PCB-Contaminated item must be added 
into molten metal or a hearth at $1,000 C.
    (3) Successive charges may not be introduced into the hearth in less 
than 15-minute intervals.
    (4) The smelter must operate in compliance with any applicable 
emissions standards in part 60 of this chapter.
    (5) The smelter must have an operational device which accurately 
measures directly or indirectly, the temperature in the hearth.
    (6) Take, record and retain at the disposal facility for 3 years 
from the date each charge is introduced, a reading of the temperature in 
the hearth at the time it is charged with a non-porous surface item.
    (c)(1) Scrap metal recovery ovens and smelters must either have a 
final permit under RCRA (part 266, subpart H of this chapter and 
Sec. 270.66 of this chapter) or be operating under a valid State air 
emissions permit which includes a standard for PCBs.
    (2) Scrap metal recovery ovens and smelters disposing of PCBs must 
provide notification as disposers of PCBs, are not required to submit 
annual reports, and shall otherwise comply with all applicable 
provisions of subparts J

[[Page 223]]

and K of this part, as well as other applicable Federal, State, and 
local laws and regulations.
    (3) In lieu of the requirements in paragraph (c)(1) of this section, 
upon written request by the owner or operator of a scrap metal recovery 
oven or smelter, the EPA Regional Administrator, for the Region where 
the oven or smelter is located, may make a finding in writing, based on 
a site-specific risk assessment, that the oven or smelter does not pose 
an unreasonable risk of injury to health or the environment because it 
is operating in compliance with the parameters and conditions listed in 
paragraph (a) or (b) of this section even though the oven or smelter 
does not have a RCRA or State air permit as required by paragraph (c)(1) 
of this section. The written request shall include a site-specific risk 
assessment.
    (d) PCB liquids, other liquid waste qualifying as waste oils which 
may be used as provided for at Sec. 761.20(e), or PCB remediation waste, 
other than PCB-Contaminated articles, may not be disposed of in a scrap 
metal recovery oven or smelter unless approved or otherwise allowed 
under subpart D of this part.

[63 FR 35455, June 29, 1998, as amended at 64 FR 33761, June 24, 1999]



Sec. 761.75  Chemical waste landfills.

    This section applies to facilities used to dispose of PCBs in 
accordance with the part.
    (a) General. A chemical waste landfill used for the disposal of PCBs 
and PCB Items shall be approved by the Agency Regional Administrator 
pursuant to paragraph (c) of this section. The landfill shall meet all 
of the requirements specified in paragraph (b) of this section, unless a 
waiver from these requirements is obtained pursuant to paragraph (c)(4) 
of this section. In addition, the landfill shall meet any other 
requirements that may be prescribed pursuant to paragraph (c)(3) of this 
section.
    (b) Technical requirements. Requirements for chemical waste 
landfills used for the disposal of PCBs and PCB Items are as follows:
    (1) Soils. The landfill site shall be located in thick, relatively 
impermeable formations such as large-area clay pans. Where this is not 
possible, the soil shall have a high clay and silt content with the 
following parameters:
    (i) In-place soil thickness, 4 feet or compacted soil liner 
thickness, 3 feet;
    (ii) Permeability (cm/sec), equal to or less than 1  x  
10-7;
    (iii) Percent soil passing No. 200 Sieve, >30;
    (iv) Liquid Limit, >30; and
    (v) Plasticity Index >15.
    (2) Synthetic membrane liners. Synthetic membrane liners shall be 
used when, in the judgment of the Regional Administrator, the hydrologic 
or geologic conditions at the landfill require such a liner in order to 
provide at least a permeability equivalent to the soils in paragraph 
(b)(1) of this section. Whenever a synthetic liner is used at a landfill 
site, special precautions shall be taken to insure that its integrity is 
maintained and that it is chemically compatible with PCBs. Adequate soil 
underlining and soil cover shall be provided to prevent excessive stress 
on the liner and to prevent rupture of the liner. The liner must have a 
minimum thickness of 30 mils.
    (3) Hydrologic conditions. The bottom of the landfill shall be above 
the historical high groundwater table as provided below. Floodplains, 
shorelands, and groundwater recharge areas shall be avoided. There shall 
be no hydraulic connection between the site and standing or flowing 
surface water. The site shall have monitoring wells and leachate 
collection. The bottom of the landfill liner system or natural in-place 
soil barrier shall be at least fifty feet from the historical high water 
table.
    (4) Flood protection. (i) If the landfill site is below the 100-year 
floodwater elevation, the operator shall provide surface water diversion 
dikes around the perimeter of the landfill site with a minimum height 
equal to two feet above the 100-year floodwater elevation.
    (ii) If the landfill site is above the 100-year floodwater 
elevation, the operators shall provide diversion structures capable of 
diverting all of the surface water runoff from a 24-hour, 25-year storm.

[[Page 224]]

    (5) Topography. The landfill site shall be located in an area of low 
to moderate relief to minimize erosion and to help prevent landslides or 
slumping.
    (6) Monitoring systems--(i) Water sampling. (A) For all sites 
receiving PCBs, the ground and surface water from the disposal site area 
shall be sampled prior to commencing operations under an approval 
provided in paragraph (c) of this section for use as baseline data.
    (B) Any surface watercourse designated by the Regional Administrator 
using the authority provided in paragraph (c)(3)(ii) of this section 
shall be sampled at least monthly when the landfill is being used for 
disposal operations.
    (C) Any surface watercourse designated by the Regional Administrator 
using the authority provided in paragraph (c)(3)(ii) of this section 
shall be sampled for a time period specified by the Regional 
Administrator on a frequency of no less than once every six months after 
final closure of the disposal area.
    (ii) Groundwater monitor wells. (A) If underlying earth materials 
are homogenous, impermeable, and uniformly sloping in one direction, 
only three sampling points shall be necessary. These three points shall 
be equally spaced on a line through the center of the disposal area and 
extending from the area of highest water table elevation to the area of 
the lowest water table elevation on the property.
    (B) All monitor wells shall be cased and the annular space between 
the monitor zone (zone of saturation) and the surface shall be 
completely backfilled with Portland cement or an equivalent material and 
plugged with Portland cement to effectively prevent percolation of 
surface water into the well bore. The well opening at the surface shall 
have a removable cap to provide access and to prevent entrance of 
rainfall or stormwater runoff. The well shall be pumped to remove the 
volume of liquid initially contained in the well before obtaining a 
sample for analysis. The discharge shall be treated to meet applicable 
State or Federal discharge standards or recycled to the chemical waste 
landfill.
    (iii) Water analysis. As a minimum, all samples shall be analyzed 
for the following parameters, and all data and records of the sampling 
and analysis shall be maintained as required in Sec. 761.180(d)(1). 
Sampling methods and analytical procedures for these parameters shall 
comply with those specified in 40 CFR part 136 as amended in 41 FR 52779 
on December 1, 1976.
    (A) PCBs.
    (B) pH.
    (C) Specific conductance.
    (D) Chlorinated organics.
    (7) Leachate collection. A leachate collection monitoring system 
shall be installed above the chemical waste landfill. Leachate 
collection systems shall be monitored monthly for quantity and 
physicochemical characteristics of leachate produced. The leachate 
should be either treated to acceptable limits for discharge in 
accordance with a State or Federal permit or disposed of by another 
State or Federally approved method. Water analysis shall be conducted as 
provided in paragraph (b)(6)(iii) of this section. Acceptable leachate 
monitoring/collection systems shall be any of the following designs, 
unless a waiver is obtained pursuant to paragraph (c)(4) of this 
section.
    (i) Simple leachate collection. This system consists of a gravity 
flow drainfield installed above the waste disposal unit liner. This 
design is recommended for use when semi-solid or leachable solid wastes 
are placed in a lined pit excavated into a relatively thick, 
unsaturated, homogenous layer of low permeability soil.
    (ii) Compound leachate collection. This system consists of a gravity 
flow drainfield installed above the waste disposal unit liner and above 
a secondary installed liner. This design is recommended for use when 
semi-liquid or leachable solid wastes are placed in a lined pit 
excavated into relatively permeable soil.
    (iii) Suction lysimeters. This system consists of a network of 
porous ceramic cups connected by hoses/tubing to a vacuum pump. The 
porous ceramic cups or suction lysimeters are installed along the sides 
and under the bottom of the waste disposal unit liner. This type of 
system works best when installed in a relatively permeable unsaturated 
soil immediately adjacent to

[[Page 225]]

the bottom and/or sides of the disposal facility.
    (8) Chemical waste landfill operations. (i) PCBs and PCB Items shall 
be placed in a landfill in a manner that will prevent damage to 
containers or articles. Other wastes placed in the landfill that are not 
chemically compatible with PCBs and PCB Items including organic solvents 
shall be segregated from the PCBs throughout the waste handling and 
disposal process.
    (ii) An operation plan shall be developed and submitted to the 
Regional Administrator for approval as required in paragraph (c) of this 
section. This plan shall include detailed explanations of the procedures 
to be used for recordkeeping, surface water handling procedures, 
excavation and backfilling, waste segregation burial coordinates, 
vehicle and equipment movement, use of roadways, leachate collection 
systems, sampling and monitoring procedures, monitoring wells, 
environmental emergency contingency plans, and security measures to 
protect against vandalism and unauthorized waste placements. EPA 
guidelines entitled ``Thermal Processing and Land Disposal of Solid 
Waste'' (39 FR 29337, Aug. 14, 1974) are a useful reference in 
preparation of this plan. If the facility is to be used to dispose of 
liquid wastes containing between 50 ppm and 500 ppm PCB, the operations 
plan must include procedures to determine that liquid PCBs to be 
disposed of at the landfill do not exceed 500 ppm PCB and measures to 
prevent the migration of PCBs from the landfill. Bulk liquids not 
exceeding 500 ppm PCBs may be disposed of provided such waste is 
pretreated and/or stabilized (e.g., chemically fixed, evaporated, mixed 
with dry inert absorbant) to reduce its liquid content or increase its 
solid content so that a non-flowing consistency is achieved to eliminate 
the presence of free liquids prior to final disposal in a landfill. PCB 
Container of liquid PCBs with a concentration between 50 and 500 ppm PCB 
may be disposed of if each container is surrounded by an amount of inert 
sorbant material capable of absorbing all of the liquid contents of the 
container.
    (iii) Ignitable wastes shall not be disposed of in chemical waste 
landfills. Liquid ignitable wastes are wastes that have a flash point 
less than 60 C (140   F) as determined by the following method or an 
equivalent method: Flash point of liquids shall be determined by a 
Pensky-Martens Closed Cup Tester, using the protocol specified in ASTM 
D93-09, or the Setaflash Closed Tester using the protocol specified in 
ASTM D3278-89 (all standards incorporated by reference in Sec. 761.19).
    (iv) Records shall be maintained for all PCB disposal operations and 
shall include information on the PCB concentration in liquid wastes and 
the three dimensional burial coordinates for PCBs and PCB Items. 
Additional records shall be developed and maintained as required in 
Sec. 761.180.
    (9) Supporting facilities. (i) A six foot woven mesh fence, wall, or 
similar device shall be placed around the site to prevent unauthorized 
persons and animals from entering.
    (ii) Roads shall be maintained to and within the site which are 
adequate to support the operation and maintenance of the site without 
causing safety or nuisance problems or hazardous conditions.
    (iii) The site shall be operated and maintained in a manner to 
prevent safety problems or hazardous conditions resulting from spilled 
liquids and windblown materials.
    (c) Approval of chemical waste landfills. Prior to the disposal of 
any PCBs and PCB Items in a chemical waste landfill, the owner or 
operator of the landfill shall receive written approval of the Agency 
Regional Administrator for the Region in which the landfill is located. 
The approval shall be obtained in the following manner:
    (1) Initial report. The owner or operator shall submit to the 
Regional Administrator an initial report which contains:
    (i) The location of the landfill;
    (ii) A detailed description of the landfill including general site 
plans and design drawings;
    (iii) An engineering report describing the manner is which the 
landfill complies with the requirements for chemical waste landfills 
specified in paragraph (b) of this section;
    (iv) Sampling and monitoring equipment and facilities available;

[[Page 226]]

    (v) Expected waste volumes of PCBs;
    (vi) General description of waste materials other than PCBs that are 
expected to be disposed of in the landfill;
    (vii) Landfill operations plan as required in paragraph (b) of this 
section;
    (viii) Any local, State, or Federal permits or approvals; and
    (ix) Any schedules or plans for complying with the approval 
requirements of these regulations.
    (2) Other information. In addition to the information contained in 
the report described in paragraph (c)(1) of this section, the Regional 
Administrator may require the owner or operator to submit any other 
information that the Regional Administrator finds to be reasonably 
necessary to determine whether a chemical waste landfill should be 
approved. Such other information shall be restricted to the types of 
information required in paragraphs (c)(1) (i) through (ix) of this 
section.
    (3) Contents of approval. (i) Except as provided in paragraph (c)(4) 
of this section the Regional Administrator may not approve a chemical 
waste landfill for the disposal of PCBs and PCB Items, unless he finds 
that the landfill meets all of the requirements of paragraph (b) of this 
section.
    (ii) In addition to the requirements of paragraph (b) of this 
section, the Regional Administrator may include in an approval any other 
requirements or provisions that the Regional Administrator finds are 
necessary to ensure that operation of the chemical waste landfill does 
not present an unreasonable risk of injury to health or the environment 
from PCBs. Such provisions may include a fixed period of time for which 
the approval is valid.

The approval may also include a stipulation that the operator of the 
chemical waste landfill report to the Regional Administrator any 
instance when PCBs are detectable during monitoring activities conducted 
pursuant to paragraph (b)(6) of this section.
    (4) Waivers. An owner or operator of a chemical waste landfill may 
submit evidence to the Regional Administrator that operation of the 
landfill will not present an unreasonable risk of injury to health or 
the environment from PCBs when one or more of the requirements of 
paragraph (b) of this section are not met. On the basis of such evidence 
and any other available information, the Regional Administrator may in 
his discretion find that one or more of the requirements of paragraph 
(b) of this section is not necessary to protect against such a risk and 
may waive the requirements in any approval for that landfill. Any 
finding and waiver under this paragraph will be stated in writing and 
included as part of the approval.
    (5) Persons approved. Any approval will designate the persons who 
own and who are authorized to operate the chemical waste landfill, and 
will apply only to such persons, except as provided by paragraph (c)(7) 
of this section.
    (6) Final approval. Approval of a chemical waste landfill will be in 
writing and will be signed by the Regional Administrator. The approval 
will state all requirements applicable to the approved landfill.
    (7) Transfer of property. Any person who owns or operates an 
approved chemical waste landfill must notify EPA at least 30 days before 
transferring ownership in the property or transferring the right to 
conduct the chemical waste landfill operation. The transferor must also 
submit to EPA, at least 30 days before such transfer, a notarized 
affidavit signed by the transferee which states that the transferee will 
abide by the transferor's EPA chemical waste landfill approval. Within 
30 days of receiving such notification and affidavit, EPA will issue an 
amended approval substituting the transferee's name for the transferor's 
name, or EPA may require the transferee to apply for a new chemical 
waste landfill approval. In the latter case, the transferee must abide 
by the transferor's EPA approval until EPA issues the new approval to 
the transferee.

(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.S.C. 2605)

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and amended at 48 FR 5730, Feb. 8, 1983; 49 FR 28191, July 10, 1984; 53 
FR 12524, Apr. 15, 1988; 53 FR 21641, June 9, 1988; 57 FR 13323, Apr. 
16, 1992; 63 FR 35456, June 29, 1998; 77 FR 2464, Jan. 18, 2012]

[[Page 227]]



Sec. 761.77  Coordinated approval.

    (a) General requirements. Notwithstanding any other provision of 
this part, the EPA Regional Administrator for the Region in which a PCB 
disposal or PCB commercial storage facility described in paragraphs (b) 
and (c) of this section is located may issue a TSCA PCB Coordinated 
Approval to the persons described in those paragraphs if the conditions 
listed in this section are met. A TSCA PCB Coordinated Approval will 
designate the persons who own and who are authorized to operate the 
facilities described in paragraphs (b) and (c) of this section and will 
apply only to such persons. All requirements, conditions, and 
limitations of any other permit or waste management document cited or 
described in paragraphs (b) and (c) of this section, as the technical or 
legal basis on which the TSCA PCB Coordinated Approval is issued, are 
conditions of the TSCA PCB Coordinated Approval.
    (1) Persons seeking a TSCA PCB Coordinated Approval shall submit a 
request for approval by certified mail, to the EPA Regional 
Administrator for the Region in which the activity will take place. 
Persons seeking a TSCA PCB Coordinated Approval for a new PCB activity 
shall submit the request for approval at the same time they seek a 
permit, approval, or other action for a PCB waste management activity 
under any other Federal or State authority.
    (i) The request for a TSCA PCB Coordinated Approval shall include a 
copy of the letter from EPA announcing or confirming the EPA 
identification number issued to the facility for conducting PCB 
activities; the name, organization, and telephone number of the person 
who is the contact point for the non-TSCA Federal or State waste 
management authority; a copy of the relevant permit or waste management 
document specified in paragraphs (b) and (c) of this section, including 
all requirements, conditions, and limitations, if the EPA Regional 
Administrator does not have a copy of the document, or a description of 
the waste management activities to be conducted if a permit or other 
relevant waste management document has not been issued; and a 
certification that the person who owns or operates the facility is aware 
of and will adhere to the TSCA PCB reporting and recordkeeping 
requirements at subparts J and K of this part.
    (ii) The EPA Regional Administrator shall review the request for 
completeness, for compliance with the requirements of paragraphs (b) and 
(c) of this section, and to ensure that the PCB activity for which 
approval is requested will not present an unreasonable risk of injury to 
health or the environment. The EPA Regional Administrator shall either:
    (A) Issue a written notice of deficiency explaining why the request 
for approval is deficient. If appropriate, the EPA Regional 
Administrator may either:
    (1) Request additional information to cure the deficiency.
    (2) Deny the request for a TSCA PCB Coordinated Approval.
    (B) Issue a letter granting or denying the TSCA PCB Coordinated 
Approval. If the EPA Regional Administrator grants the TSCA PCB 
Coordinated Approval, he or she may acknowledge the non-TSCA approval 
meets the regulatory requirements under TSCA as written, or require 
additional conditions the EPA Regional Administrator has determined are 
necessary to prevent unreasonable risk of injury to health or the 
environment.
    (C) If the EPA Regional Administrator denies a request for a 
Coordinated Approval under paragraphs (a)(1)(ii)(A) or (a)(1)(ii)(B) of 
this section, the person who requested the TSCA PCB Coordinated Approval 
may submit an application for a TSCA Disposal Approval.
    (2) The EPA Regional Administrator may issue a notice of deficiency, 
revoke the TSCA PCB Coordinated Approval, require the person to whom the 
TSCA PCB Coordinated Approval was issued to submit an application for a 
TSCA PCB approval, or bring an enforcement action under TSCA if he or 
she determines that:
    (i) Conditions of the approval relating to PCB waste management 
activities are not met.
    (ii) The PCB waste management process is being operated in a manner 
which may result in an unreasonable

[[Page 228]]

risk of injury to health or the environment.
    (iii) The non-TSCA approval expires, is revoked, is suspended, or 
otherwise ceases to be in full effect.
    (3) Any person with a TSCA PCB Coordinated Approval must notify the 
EPA Regional Administrator in writing within 5 calendar days of changes 
relating to PCB waste requirements in the non-TSCA waste management 
document which serves as the basis for a TSCA PCB Coordinated Approval. 
Changes in the ownership of a commercial storage facility which holds a 
TSCA PCB Coordinated Approval shall be handled pursuant to 
Sec. 761.65(j).
    (b) Any person who owns or operates a facility that he or she 
intends to use to landfill PCB wastes; incinerate PCB wastes; dispose of 
PCB wastes using an alternative disposal method that is equivalent to 
disposal in an incinerator approved under Sec. 761.70 or a high 
efficiency boiler operating in compliance with Sec. 761.71; or stores 
PCB wastes may apply for a TSCA PCB Coordinated Approval. The EPA 
Regional Administrator may approve the request if the EPA Regional 
Administrator determines that the activity will not pose an unreasonable 
risk of injury to health or the environment and the person:
    (1)(i) Has a waste management permit or other decision or 
enforcement document which exercises control over PCB wastes, issued by 
EPA or an authorized State Director for a State program that has been 
approved by EPA and is no less stringent in protection of health or the 
environment than the applicable TSCA requirements found in this part; or
    (ii) Has a PCB waste management permit or other decision or 
enforcement document issued by a State Director pursuant to a State PCB 
waste management program no less stringent in protection of health or 
the environment than the applicable TSCA requirements found in this 
part; or
    (iii) Is subject to a waste management permit or other decision or 
enforcement document which is applicable to the disposal of PCBs and 
which was issued through the promulgation of a regulation published in 
Title 40 of the Code of Federal Regulations.
    (2) Complies with the terms and conditions of the permit or other 
decision or enforcement document described in paragraph (b)(1) of this 
section.
    (3) Unless otherwise waived or modified in writing by the EPA 
Regional Administrator, complies with Sec. 761.75(b); Sec. 761.70(a)(1) 
through (a)(9), (b)(1) and (b)(2), and (c); or the PCB storage 
requirements at Secs. 761.65(a), (c), and (d)(2), as appropriate.
    (4) Complies with the reporting and recordkeeping requirements in 
subparts J and K of this part.
    (c) A person conducting research and development (R&D) into PCB 
disposal methods (regardless of PCB concentration), or conducting PCB 
remediation activities may apply for a TSCA PCB Coordinated Approval. 
The EPA Regional Administrator may approve the request if the EPA 
Regional Administrator determines that the activity will not pose an 
unreasonable risk of injury to health or the environment and the person:
    (1)(i) Has a permit or other decision and enforcement document 
issued or otherwise agreed to by EPA, or permit or other decision and 
enforcement document issued by an authorized State Director for a State 
program that has been approved by EPA, which exercises control over the 
management of PCB wastes, and that person is in compliance with all 
terms and conditions of that document; or
    (ii) Has a permit, which exercises control over the management of 
PCB wastes, issued by a State Director pursuant to a State PCB disposal 
program no less stringent than the requirements in this part.
    (2) Complies with the terms and conditions of that permit or other 
decision and enforcement document.
    (3) Complies with the reporting and recordkeeping requirements in 
subparts J and K of this part.

[63 FR 35456, June 29, 1998]



Sec. 761.79  Decontamination standards and procedures.

    (a) Applicability. This section establishes decontamination 
standards and procedures for removing PCBs, which are regulated for 
disposal, from water, organic liquids, non-porous surfaces

[[Page 229]]

(including scrap metal from disassembled electrical equipment), 
concrete, and non-porous surfaces covered with a porous surface, such as 
paint or coating on metal.
    (1) Decontamination in accordance with this section does not require 
a disposal approval under subpart D of this part.
    (2) Materials from which PCBs have been removed by decontamination 
in accordance with this section may be distributed in commerce in 
accordance with Sec. 761.20(c)(5).
    (3) Materials from which PCBs have been removed by decontamination 
in accordance with this section may be used or reused in accordance with 
Sec. 761.30(u).
    (4) Materials from which PCBs have been removed by decontamination 
in accordance with this section, not including decontamination waste and 
residuals under paragraph (g) of this section, are unregulated for 
disposal under subpart D of this part.
    (5) Any person decontaminating porous surfaces other than concrete 
under paragraph (b)(4) of this section and non-porous surfaces covered 
with a porous surface, such as paint or coating on metal, under 
paragraph (b)(3) or (c)(6) of this section must obtain an alternative 
decontamination approval in accordance with paragraph (h) of this 
section.
    (6) Any person engaging in decontamination under this section is 
responsible for determining and complying with all other applicable 
Federal, State, and local laws and regulations.
    (b) Decontamination standards. Chopping (including wire chopping), 
distilling, filtering, oil/water separation, spraying, soaking, wiping, 
stripping of insulation, scraping, scarification or the use of abrasives 
or solvents may be used to remove or separate PCBs, to the following 
standards, from liquids, concrete, or non-porous surfaces.
    (1) The decontamination standard for water containing PCBs is:
    (i) Less than 200 mg/L (i.e., <200 ppb PCBs) for non-contact use in 
a closed system where there are no releases;
    (ii) For water discharged to a treatment works (as defined in 
Sec. 503.9(aa) of this chapter) or to navigable waters, <3 mg/L 
(approximately <3 ppb) or a PCB discharge limit included in a permit 
issued under section 307(b) or 402 of the Clean Water Act; or
    (iii) Less than or equal to 0.5 mg/L (i.e., approximately 0.5 ppb 
PCBs) for unrestricted use.
    (2) The decontamination standard for organic liquids and non-aqueous 
inorganic liquids containing PCBs is <2 milligrams per kilogram (i.e., 
<2 ppm PCBs).
    (3) The decontamination standard for non-porous surfaces in contact 
with liquid and non-liquid PCBs is:
    (i) For unrestricted use:
    (A) For non-porous surfaces previously in contact with liquid PCBs 
at any concentration, where no free-flowing liquids are currently 
present, 10 micrograms PCBs per 100 square centimeters (10 mg/100 
cm\2\) as measured by a standard wipe test (Sec. 761.123) at locations 
selected in accordance with subpart P of this part.
    (B) For non-porous surfaces in contact with non-liquid PCBs 
(including non-porous surfaces covered with a porous surface, such as 
paint or coating on metal), cleaning to Visual Standard No. 2, Near-
White Blast Cleaned Surface Finish, of the National Association of 
Corrosion Engineers (NACE). A person shall verify compliance with 
standard No. 2 by visually inspecting all cleaned areas.
    (ii) For disposal in a smelter operating in accordance with 
Sec. 761.72(b):
    (A) For non-porous surfaces previously in contact with liquid PCBs 
at any concentration, where no free-flowing liquids are currently 
present, <100 mg/100 cm\2\ as measured by a standard wipe test 
(Sec. 761.123) at locations selected in accordance with subpart P of 
this part.
    (B) For non-porous surfaces in contact with non-liquid PCBs 
(including non-porous surfaces covered with a porous surface, such as 
paint or coating on metal), cleaning to Visual Standard No. 3, 
Commercial Blast Cleaned Surface Finish, of the National Association of 
Corrosion Engineers (NACE). A person shall verify compliance with 
standard No. 3 by visually inspecting all cleaned areas.
    (4) The decontamination standard for concrete is 10 mg/100 cm\2\ as 
measured

[[Page 230]]

by a standard wipe test (Sec. 761.123) if the decontamination procedure 
is commenced within 72 hours of the initial spill of PCBs to the 
concrete or portion thereof being decontaminated.
    (c) Self-implementing decontamination procedures. The following 
self-implementing decontamination procedures are available as an 
alternative to the measurement-based decontamination methods specified 
in paragraph (b) of this section. Any person performing self-
implementing decontamination must comply with one of the following 
procedures.
    (1) Any person decontaminating a PCB Container must do so by 
flushing the internal surfaces of the container three times with a 
solvent containing <50 ppm PCBs. Each rinse shall use a volume of the 
flushing solvent equal to approximately 10 percent of the PCB Container 
capacity.
    (2) Any person decontaminating movable equipment contaminated by 
PCBs, tools, and sampling equipment may do so by:
    (i) Swabbing surfaces that have contacted PCBs with a solvent;
    (ii) A double wash/rinse as defined in subpart S of this part; or
    (iii) Another applicable decontamination procedure in this section.
    (3) Any person decontaminating a non-porous surface in contact with 
free-flowing mineral oil dielectric fluid (MODEF) at levels 10,000 ppm 
PCBs must do so as follows:
    (i) Drain the free-flowing MODEF and allow the residual surfaces to 
drain for an additional 15 hours.
    (ii) Dispose of drained MODEF according to paragraph (g) of this 
section.
    (iii) Soak the surfaces to be decontaminated in a sufficient amount 
of clean (containing <2 ppm PCBs) performance-based organic 
decontamination fluid (PODF) such that there is a minimum of 800 ml of 
PODF for each 100 cm\2\ of contaminated or potentially contaminated 
surface for at least 15 hours at $20 C.
    (iv) Approved PODFs include:
    (A) Kerosene.
    (B) Diesel fuel.
    (C) Terpene hydrocarbons.
    (D) Mixtures of terpene hydrocarbons and terpene alcohols.
    (v) Drain the PODF from the surfaces.
    (vi) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (4) Any person decontaminating a non-porous surface in contact with 
free-flowing MODEF containing >10,000 ppm PCB in MODEF or askarel PCB 
(up to 70 percent PCB in a mixture of trichlorobenzenes and 
tetrachlorobenzenes) must do so as follows:
    (i) Drain the free-flowing MODEF or askarel and allow the residual 
surfaces to drain for an additional 15 hours.
    (ii) Dispose of drained MODEF or askarel according to paragraph (g) 
of this section.
    (iii) Soak the surfaces to be decontaminated in a sufficient amount 
of clean PODF (containing <2 ppm PCBs) such that there is a minimum of 
800 ml of PODF for each 100 cm\2\ of contaminated or potentially 
contaminated surface for at least 15 hours at $20 C.
    (iv) Approved PODFs include:
    (A) Kerosene.
    (B) Diesel fuel.
    (C) Terpene hydrocarbons.
    (D) Mixtures of terpene hydrocarbons and terpene alcohols.
    (v) Drain the PODF from the surfaces.
    (vi) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (vii) Resoak the surfaces to be decontaminated, pursuant to 
paragraph (c)(3)(iii) of this section, in a sufficient amount of clean 
PODF (containing <2 ppm PCBs) such that there is a minimum of 800 ml of 
PODF for each 100 cm\2\ of surface for at least 15 hours at $20 C.
    (viii) Drain the PODF from the surfaces.
    (ix) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (5) Any person decontaminating piping and air lines in an air 
compressor system must do so as follows:
    (i) Before decontamination proceeds, disconnect or bypass the air 
compressors and air dryers from the piping and air lines and 
decontaminate the air compressors and air dryers separately in 
accordance with paragraphs (b),

[[Page 231]]

(c)(1) through (c)(4), or (c)(6) of this section. Dispose of filter 
media and desiccant in the air dyers based on their existing PCB 
concentration.
    (ii) Test the connecting line and appurtenances of the system to 
assure that there is no leakage. Test by introducing air into the closed 
system at from 90 to 100 pounds per square inch (psi). Only if there is 
a pressure drop of <5 psi in 30 minutes may decontamination take place.
    (iii) When there is no leakage, fill the piping and air lines with 
clean (containing <2 ppm PCBs) solvent. Solvents include PODF, aqueous 
potassium hydroxide at a pH between 9 and 12, or water containing 5 
percent sodium hydroxide by weight.
    (iv) Circulate the solvent to achieve turbulent flow through the 
piping and air lines in the air compressor system until the total volume 
of solvent circulated equals 10 times the total volume of the particular 
article being decontaminated, then drain the solvent. Calculate the 
total volume of solvent circulated by multiplying the pump rate by the 
time of pumping. Turbulent flow means a Reynolds number range from 
20,000 to 43,000. Refill the system with clean solvent and repeat the 
circulation and drain process.
    (6) Any person using thermal processes to decontaminate metal 
surfaces in contact with PCBs, as required by Sec. 761.62(a)(6), must 
use one of the following options:
    (i) Surfaces in contact with liquid and non-liquid PCBs at 
concentrations <500 ppm may be decontaminated in a scrap metal recovery 
oven or smelter for purposes of disposal in accordance with Sec. 761.72.
    (ii) Surfaces in contact with liquid or non-liquid PCBs at 
concentrations $500 ppm may be smelted in a smelter operating in 
accordance with Sec. 761.72(b), but must first be decontaminated in 
accordance with Sec. 761.72(a) or to a surface concentration of <100 mg/
100 cm\2\.
    (d) Decontamination solvents. (1) Unless otherwise provided in 
paragraphs (c)(3) through (c)(5) of this section, the solubility of PCBs 
in any solvent used for purposes of decontamination under this section 
must be 5 percent or more by weight.
    (2) The solvent may be reused for decontamination so long as its PCB 
concentration is <50 ppm.
    (3) Solvent shall be disposed of under paragraph (g) of this 
section.
    (4) Other than as allowed in paragraphs (c)(3) and (c)(4) of this 
section, solvents may be tested and validated for performance-based 
decontamination of non-porous surfaces contaminated with MODEF or other 
PCB liquids, in accordance with the self-implementing procedures found 
in subpart T of this part. Specific conditions for the performance-based 
testing from this validation are determined in the validation study.
    (e) Limitation of exposure and control of releases. (1) Any person 
conducting decontamination activities under this section shall take 
necessary measures to protect against direct release of PCBs to the 
environment from the decontamination area.
    (2) Persons participating in decontamination activities shall wear 
or use protective clothing or equipment to protect against dermal 
contact or inhalation of PCBs or materials containing PCBs.
    (f) Sampling and recordkeeping. (1) Confirmatory sampling is 
required under paragraph (b) of this section. For liquids described in 
paragraphs (b)(1) and (b)(2) of this section, sample in accordance with 
Secs. 761.269 and 761.272. For non-porous surfaces and concrete 
described in paragraphs (b)(3) and (b)(4) of this section, sample in 
accordance with subpart P of this part. A written record of such 
sampling must be established and maintained for 3 years from the date of 
any decontamination under this section. The record must show sampling 
locations and analytical results and must be retained at the site of the 
decontamination or a copy of the record must be made available to EPA in 
a timely manner, if requested. In addition, recordkeeping is required in 
accordance with Sec. 761.180(a) for all wastes generated by a 
decontamination process and regulated for disposal under this subpart.
    (2) Confirmatory sampling is not required for self-implementing 
decontamination procedures under paragraph (c) of this section. Any 
person using these procedures must retain a

[[Page 232]]

written record documenting compliance with the procedures for 3 years 
after completion of the decontamination procedures (e.g., video 
recordings, photographs).
    (g) Decontamination waste and residues. Decontamination waste and 
residues shall be disposed of at their existing PCB concentration unless 
otherwise specified.
    (1) Distillation bottoms or residues and filter media are regulated 
for disposal as PCB remediation waste.
    (2) PCBs physically separated from regulated waste during 
decontamination (such as by chopping, shredding, scraping, abrading or 
oil/water separation, as opposed to solvent rinsing and soaking), other 
than wastes described in paragraph (g)(1) of this section, are regulated 
for disposal at their original concentration.
    (3) Hydrocarbon solvent used or reused for decontamination under 
this section that contains <50 ppm PCB must be burned and marketed in 
accordance with the requirements for used oil in Sec. 761.20(e), 
disposed of in accordance with Sec. 761.60(a) or (e), or decontaminated 
pursuant to this section.
    (4) Chlorinated solvent at any PCB concentration used for 
decontamination under this section shall be disposed of in an 
incinerator operating in compliance with Sec. 761.70, or decontaminated 
pursuant to this section.
    (5) Solvents $50 ppm other than those described in paragraphs (g)(3) 
and (g)(4) of this section shall be disposed of in accordance with 
Sec. 761.60(a) or decontaminated pursuant to this section.
    (6) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
decontamination shall be disposed of in accordance with 
Sec. 761.61(a)(5)(v).
    (h) Alternative decontamination or sampling approval. (1) Any person 
wishing to decontaminate material described in paragraph (a) of this 
section in a manner other than prescribed in paragraph (b) of this 
section must apply in writing to the Regional Administrator in the 
Region where the activity would take place, for decontamination activity 
occurring in a single EPA Region; or to the Director, Office of Resource 
Conservation and Recovery, for decontamination activity occurring in 
more than one EPA Region. Each application must describe the material to 
be decontaminated and the proposed decontamination method, and must 
demonstrate that the proposed method is capable of decontaminating the 
material to the applicable level set out in paragraphs (b)(1) through 
(b)(4) of this section.
    (2) Any person wishing to decontaminate material described in 
paragraph (a) of this section using a self-implementing procedure other 
than prescribed in paragraph (c) of this section must apply in writing 
to the Regional Administrator in the Region where the activity would 
take place, for decontamination activity occurring in a single EPA 
Region; or to the Director, Office of Resource Conservation and 
Recovery, for decontamination activity occurring in more than one EPA 
Region. Each application must describe the material to be decontaminated 
and the proposed self-implementing decontamination method and must 
include a proposed validation study to confirm performance of the 
method.
    (3) Any person wishing to sample decontaminated material in a manner 
other than prescribed in paragraph (f) of this section must apply in 
writing to the Regional Administrator in the Region where the activity 
would take place, for decontamination activity occurring in a single EPA 
Region; or to the Director, Office of Resource Conservation and 
Recovery, for decontamination activity occurring in more than one EPA 
Region. Each application must contain a description of the material to 
be decontaminated, the nature and PCB concentration of the contaminating 
material (if known), the decontamination method, the proposed sampling 
procedure, and a justification for how the proposed sampling is 
equivalent to or more comprehensive than the sampling procedure required 
under paragraph (f) of this section.
    (4) EPA may request additional information that it believes 
necessary to evaluate the application.

[[Page 233]]

    (5) EPA will issue a written decision on each application for risk-
based decontamination or sampling. No person may conduct decontamination 
or sampling under this paragraph prior to obtaining written approval 
from EPA. EPA will approve an application if it finds that the proposed 
decontamination or sampling method will not pose an unreasonable risk of 
injury to health or the environment.

[63 FR 35457, June 29, 1998, as amended at 64 FR 33761, June 24, 1999; 
72 FR 57240, Oct. 9, 2007; 74 FR 30233, June 25, 2009]



                          Subpart E_Exemptions



Sec. 761.80  Manufacturing, processing and distribution in commerce
exemptions.

    (a) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and distribute in commerce PCBs for use 
as a mounting medium in microscopy:
    (1) McCrone Accessories Components, Division of Walter C. McCrone 
Associates, Inc., 2820 South Michigan Avenue, Chicago, IL. 60616.
    (2) [Reserved]
    (b) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and distribute in commerce PCBs for use 
as a mounting medium in microscopy, an immersion oil in low fluorescence 
microscopy and an optical liquid:
    (1) R.P. Cargille Laboratories, Inc., 55 Commerce Road, Cedar Grove, 
N.J. 07009.
    (2) [Reserved]
    (c) The Administrator grants the following petitioner(s) an 
exemption for 1 year to export PCBs for use in small quantities for 
research and development:
    (1) Accu-Standard, New Haven, CT. 06503.
    (2) ManTech, Research Triangle Park, NC 27709.
    (d) The Administrator grants the following petitioner(s) an 
exemption for 1 year to import (manufacture) into the United States, 
small quantities of existing PCB fluids from electrical equipment for 
analysis:
    (1) Unison Transformer Services, Inc., Tarrytown, N.Y. 10591, 
provided each of the following conditions are met:
    (i) The samples must be shipped in 5.0 ml or less, hermetically 
sealed vials.
    (ii) The exemption is limited to no more than 250 total samples per 
year.
    (iii) Unison makes quarterly inspections of its laboratories to 
ensure that proper safety procedures are being followed.
    (iv) Unison annually notifies and describes to EPA its attempts to 
have samples analyzed abroad.
    (2) [Reserved]
    (e) The Administrator grants a class exemption to all research and 
development (R&D) facilities for a period of 1 year to manufacture or 
import PCBs for use solely in the manufacturer or importer's own 
research for the development of PCB disposal technologies. Each person 
that wishes to be part of the exemption must meet the following 
conditions:
    (1) A petition for an exemption from the PCB prohibition on 
manufacturing PCBs must be received by EPA 60 days prior to engaging in 
these activities.
    (2) Requests for renewal must be filed pursuant to Sec. 750.11 of 
this chapter. EPA will deem any properly filed request for the renewal 
of the exemption by any member of the class as a renewal request for the 
entire class.
    (3) The quantity of the PCBs manufactured annually must not exceed 
500 grams by total weight of pure PCBs. Any person who wishes to 
manufacture or import more than 500 grams of PCBs in 1 year must receive 
written approval from the Director, National Program Chemicals Division 
to exceed the limitations established by this provision. The Director, 
National Program Chemicals Division may grant approval without further 
rulemaking. Any increase granted will be in writing and will extend only 
for a maximum of the time remaining in a specific exemption year.
    (4) The owner or operator of the facility must notify the EPA 
Regional Administrator in writing 30 days prior to the commencement of 
R&D activities that include the manufacture or import of PCBs under the 
exemption, unless the facility has obtained a PCB R&D approval from EPA 
pursuant to Sec. 761.60(e), Sec. 761.60(i)(2), Sec. 761.70(a), or

[[Page 234]]

Sec. 761.70(b) and the approval contains a provision allowing the 
manufacture of PCBs.
    (5) Records are maintained of their PCB activities for a period of 3 
years after ceasing operations. The records must include the sources and 
the annual amounts of PCBs received if imported and the type and annual 
amount of PCBs that were manufactured.
    (6) All PCBs and materials containing PCBs, regardless of 
concentration, remaining from the disposal-related studies must be 
disposed of according to Sec. 761.60(j)(1)(vi), or decontaminated 
pursuant to Sec. 761.79, based on the original PCB concentration.
    (f) The Administrator grants the following petitioner(s) an 
exemption for 1 year to manufacture PCBs for use in small quantities for 
research and development:
    (1) California Bionuclear Corp., Sun Valley, CA 91352 (ME-13).
    (2) Foxboro Co., North Haven, CT 06473 (ME-6).
    (3) ULTRA-Scientific, Inc.,Hope, RI 02831 (ME-99.1).
    (4) Midwest Research Institute, Kansas City, MO 64110 (ME-70.1).
    (5) Pathfinder Laboratories, St. Louis, MO 63146 (A division of 
Sigma Aldridge Corporation, St. Louis, MO, 63178 (ME-76).
    (6) Radian Corp., Austin, TX 78766 (ME-81.2).
    (7) Wellington Sciences USA, College Station, TX 77840 (ME-104.1).
    (8) Accu-Standard, 25 Science Park, New Haven, CT. 06503.
    (g) The Administrator grants a class exemption to all processors and 
distributors of PCBs in small quantities for research and development 
provided that the following conditions are met:
    (1) All processors and distributors must maintain records of their 
PCB activities for a period of 5 years.
    (2) Any person or company which expects to process or distribute in 
commerce 100 grams (.22 lb) or more PCBs in 1 year must report to EPA 
identifying the sites of PCB activities and the quantity of PCBs to be 
processed or distributed in commerce.
    (h) The Administrator grants the following petitioners an exemption 
for 1 year to process and distribute in commerce PCBs for analytical 
reference samples derived from actual waste materials:
    (1) R.T. Corporation, Laramie, WY 82070.
    (2) [Reserved]
    (i) The Administrator grants a class exemption to all persons who 
manufacture, import, process, distribute in commerce, or export PCBs, or 
analytical reference samples derived from PCB waste material, provided 
the PCBs are manufactured, imported, processed, distributed in commerce, 
or exported solely for the purpose of R&D and the following conditions 
are met:
    (1) Notification in the form of a petition for an exemption from the 
PCB prohibitions on manufacture, import, processing, distribution in 
commerce, or export is received by EPA 60 days prior to engaging in 
these activities.
    (2) Requests for renewal are filed pursuant to Secs. 750.11 and 
750.31 of this chapter. EPA will deem any properly filed request for the 
renewal of the exemption by any member of the class as a renewal request 
for the entire class.
    (3) The PCBs are packaged in one or more hermetically sealed 
containers of a volume of no more than 5.0 ml each. Analytical reference 
samples derived from PCB waste material may be packaged in a container 
larger than 5.0 ml when packaged pursuant to applicable DOT performance 
standards.
    (4) The quantity of PCBs manufactured, imported, processed, 
distributed in commerce, or exported annually must not exceed 500 grams 
by total weight of pure PCBs. Any person who expects to manufacture, 
import, process, distribute in commerce, or export more than 500 grams 
of PCBs in 1 year or to exceed the 5.0 ml packaging requirement must 
obtain a written approval from the Director, National Program Chemicals 
Division and must identify the sites of PCB activities and the quantity 
of PCBs to be manufactured, imported, processed, distributed in 
commerce, or exported. Each request must include a justification. The 
Director, National Program Chemicals Division, may grant approval 
without further rulemaking. Any increase granted will be in writing and 
will extend only for a maximum of the time remaining in a specific 
exemption year.

[[Page 235]]

    (5) All treated and untreated PCB regulated material and material 
coming into contact with regulated material must be stored and disposed 
of according to subpart D of this part, or decontaminated pursuant to 
Sec. 761.79.
    (6) All PCB materials must be distributed in DOT-authorized 
packaging.
    (7) Records are maintained of their PCB activities for a period of 3 
years after ceasing operations. The records must include the sources and 
the annual amounts of PCBs received if imported, the annual amount of 
PCBs that were manufactured, the annual amount of PCBs that were 
processed and/or distributed in commerce (to include export), and the 
persons to whom the PCBs were shipped.
    (j) The Administrator grants the United States Defense Logistics 
Agency's April 23, 2013 petition for an exemption for 1 year beginning 
on October 1, 2014, to import up to 1,014,222 pounds of PCBs and PCB 
Items stored or in use in Japan as identified in its petition for 
disposal.
    (k)-(l) [Reserved]
    (m) The Administrator grants the following petitioner(s) an 
exemption for 1 year to process and export small quantities of PCBs for 
research and development:
    (1) Chem Service, Inc., West Chester, PA 19380 (PDE-41).
    (2) Foxboro Co., North Haven, CT 06473 (ME-6).
    (3) PolyScience Corp., Niles, IL 60648 (PDE-178).
    (4) ULTRA-Scientific, Inc., Hope, RI 02831 (PDE-282.1).
    (5) Supelco, Inc., Bellefonte, PA 16823-0048 (PDE-41.2).
    (6) Radian Corp., Austin, TX 78766 (PDE-182.1).
    (7) Restek Corporation, Bellefonte, PA
    (n) The 1-year exemption granted to petitioners in paragraphs (a) 
through (c)(1), (d), (f), and (m)(1) through (m)(6) of this section 
shall be renewed automatically as long as there is no increase in the 
amount of PCBs to be processed and distributed, imported (manufactured), 
or exported, nor any change in the manner of processing and 
distributing, importing (manufacturing), or exporting of PCBs. If there 
is such a change, a new exemption petition must be submitted to EPA and 
it will be addressed through an exemption rulemaking. In such a case, 
the activities granted under the existing exemption may continue until 
the new petition is addressed by rulemaking, but must conform to the 
terms of the existing exemption approved by EPA. The 1-year exemption 
granted to petitioners in paragraphs (c)(2), (h) and (m)(7) of this 
section may be extended pursuant to 40 CFR 750.11(e) or 750.31(e).
    (o) The 1-year class exemption granted to all processors and 
distributors of PCBs in small quantities for research and development in 
paragraph (g) of this section shall be renewed automatically unless 
information is submitted affecting EPA's conclusion that the class 
exemption, or the activities of any individual or company included in 
the exemption, will not pose an unreasonable risk of injury to health or 
the environment. EPA will evaluate the information, issue a proposed 
rule for public comment, and issue a final rule affecting the class 
exemption or individuals or companies included in the class exemption. 
Until EPA issues a final rule, individuals and companies included in the 
class exemption will be allowed to continue processing and distributing 
PCBs in small quantities for research and development.

[55 FR 38999, Sept. 24, 1990, as amended at 59 FR 16998, Apr. 11, 1994; 
63 FR 35460, June 29, 1998; 68 FR 4941, Jan. 31, 2003; 72 FR 53158, 
Sept. 18, 2007; 79 FR 58270, Sept. 29, 2014]



         Subpart F_Transboundary Shipments of PCBs for Disposal

    Source: 61 FR 11107, Mar. 18, 1996, unless otherwise noted.



Sec. 761.91  Applicability.

    This subpart establishes requirements under section 6 of TSCA 
applicable to the transboundary shipments of PCBs and PCB Items into and 
out of the United States for disposal. Nothing in this subpart is 
intended to obviate or otherwise alter obligations applicable to 
imported or exported PCBs and PCB Items under foreign laws, 
international agreements or arrangements, other United States statutes 
and regulations, other sections of TSCA (e.g.,

[[Page 236]]

sections 13 and 14), or laws of the various States of the United States. 
No provision of this section shall be construed to affect or limit the 
applicability of any requirement applicable to transporters of PCB waste 
under regulations issued by the U.S. Department of Transportation (DOT) 
and set forth at 49 CFR parts 171-180.



Sec. 761.93  Import for disposal.

    (a) General provisions. No person may import PCBs or PCB Items for 
disposal without an exemption issued under the authority of TSCA section 
6(e)(3).
    (b) [Reserved]

[63 FR 35460, June 29, 1998]



Sec. 761.97  Export for disposal.

    (a) General provisions. No person may export PCBs or PCB Items for 
disposal without an exemption, except that:
    (1) PCBs and PCB Items at concentrations <50 ppm (or <10 mg PCB/100 
cm\2\ if no free-flowing liquids are present) may be exported for 
disposal.
    (2) For the purposes of this section, PCBs and PCB Items of unknown 
concentrations shall be treated as if they contain $50 ppm.
    (b) [Reserved]

[61 FR 11107, Mar. 18, 1996, as amended at 63 FR 35460, June 29, 1998]



Sec. 761.99  Other transboundary shipments.

    For purposes of this subpart, the following transboundary shipments 
are not considered exports or imports:
    (a) PCB waste generated in the United States, transported outside 
the Customs Territory of the United States (including any residuals 
resulting from cleanup of spills of such wastes in transit) through 
another country or its territorial waters, or through international 
waters, and returned to the United States for disposal.
    (b) PCB waste in transit, including any residuals resulting from 
cleanup of spills during transit, through the United States (e.g., from 
Mexico to Canada, from Canada to Mexico).
    (c) PCB waste transported from any State to any other State for 
disposal, regardless of whether the waste enters or leaves the customs 
territory of the United States, provided that the PCB waste or the PCBs 
from which the waste was derived were present in the United States on 
January 1, 1979, and have remained within the United States since that 
date.

[63 FR 35461, June 29, 1998, as amended at 66 FR 17478, Mar. 30, 2001]



                   Subpart G_PCB Spill Cleanup Policy

    Source: 52 FR 10705, Apr. 2, 1987, unless otherwise noted.



Sec. 761.120  Scope.

    (a) General. This policy establishes criteria EPA will use to 
determine the adequacy of the cleanup of spills resulting from the 
release of materials containing PCBs at concentrations of 50 ppm or 
greater. The policy applies to spills which occur after May 4, 1987.
    (1) Existing spills (spills which occurred prior to May 4, 1987, are 
excluded from the scope of this policy for two reasons:
    (i) For old spills which have already been discovered, this policy 
is not intended to require additional cleanup where a party has already 
cleaned a spill in accordance with requirements imposed by EPA through 
its regional offices, nor is this policy intended to interfere with 
ongoing litigation of enforcement actions which bring into issue PCB 
spills cleanup.
    (ii) EPA recognizes that old spills which are discovered after the 
effective date of this policy will require site-by-site evaluation 
because of the likelihood that the site involves more pervasive PCB 
contamination than fresh spills and because old spills are generally 
more difficult to clean up than fresh spills (particularly on porous 
surfaces such as concrete). Therefore, spills which occurred before the 
effective date of this policy are to be decontaminated to requirements 
established at the discretion of EPA, usually through its regional 
offices.
    (2) EPA expects most PCB spills subject to the TSCA PCB regulations 
to conform to the typical spill situations considered in developing this 
policy. This policy does, however, exclude from application of the final 
numerical

[[Page 237]]

cleanup standards certain spill situations from its scope: Spills 
directly into surface waters, drinking water, sewers, grazing lands, and 
vegetable gardens. These types of spills are subject to final cleanup 
standards to be established at the discretion of the regional office. 
These spills are, however, subject to the immediate notification 
requirements and measures to minimize further environmental 
contamination.
    (3) For all other spills, EPA generally expects the decontamination 
standards of this policy to apply. Occasionally, some small percentage 
of spills covered by this policy may warrant more stringent cleanup 
requirements because of additional routes of exposure or significantly 
greater exposures than those assumed in developing the final cleanup 
standards of this policy. While the EPA regional offices have the 
authority to require additional cleanup in these circumstances, the 
Regional Administrator must first make a finding based on the specific 
facts of a spill that additional cleanup must occur to prevent 
unreasonable risk. In addition, before a final decision is made to 
require additional cleanup, the Regional Administrator must notify the 
Director, Office of Resource Conservation and Recovery of his/her 
finding and the basis for the finding.
    (4) There may also be exceptional spill situations that requires 
less stringent cleanup or a different approach to cleanup because of 
factors associated with the particular spill. These factors may mitigate 
expected exposures and risks or make cleanup to these requirements 
impracticable.
    (b) Spills that may require more stringent cleanup levels. For 
spills within the scope of this policy, EPA generally retains, under 
Sec. 761.135, the authority to require additional cleanup upon finding 
that, despite good faith efforts by the responsible party, the numerical 
decontamination levels in the policy have not been met. In addition, EPA 
foresees the possibility of exceptional spill situations in which site-
specific risk factors may warrant additional cleanup to more stringent 
numerical decontamination levels than are required by the policy. In 
these situations, the Regional Administrator has the authority to 
require cleanup to levels lower than those included in this policy upon 
finding that further cleanup must occur to prevent unreasonable risk. 
The Regional Administrator will consult with the Director, Office of 
Resource Conservation and Recovery, prior to making such a finding.
    (1) For example, site-specific characteristics, such as short depth 
to ground water, type of soil, or the presence of a shallow well, may 
pose exceptionally high potential for ground water contamination by PCBs 
remaining after cleanup to the standards specified in this policy. 
Spills that pose such a high degree of potential for ground water 
contamination have not been excluded from the policy under paragraph (d) 
of this section because the presence of such potential may not be 
readily apparent. EPA feels that automatically excluding such spills 
from the scope of the policy could result in the delay of cleanup--a 
particularly undesirable outcome if potential ground water contamination 
is, in fact, a significant concern.
    (2) In those situations, the Regional Administrator may require 
cleanup in addition to that required under Sec. 761.125(b) and (c). 
However, the Regional Administrator must first make a finding, based on 
the specific facts of a spill, that additional cleanup is necessary to 
prevent unreasonable risk. In addition, before making a final decision 
on additional cleanup, the Regional Administrator must notify the 
Director, Office of Resource Conservation and Recovery of his finding 
and the basis for the finding.
    (c) Flexibility to allow less stringent or alternative requirements. 
EPA retains the flexibility to allow less stringent or alternative 
decontamination measures based upon site-specific considerations. EPA 
will exercise this flexibility if the responsible party demonstrates 
that cleanup to the numerical decontamination levels is clearly 
unwarranted because of risk-mitigating factors, that compliance with the 
procedural requirements or numerical standards in the policy is 
impracticable at a particular site, or that site-specific 
characteristics make the costs of cleanup prohibitive. The Regional 
Administrator will notify the Director, Office

[[Page 238]]

of Resource Conservation and Recovery of any decision and the basis for 
the decision to allow less stringent cleanup. The purpose of this 
notification is to enable the Director, Office of Resource Conservation 
and Recovery to ensure consistency of spill cleanup standards under 
special circumstances across the regions.
    (d) Excluded spills. (1) Although the spill situations in paragraphs 
(d)(2) (i) through (vi) of this section are excluded from the automatic 
application of final decontamination standards under Sec. 761.125 (b) 
and (c), the general requirements under Sec. 761.125(a) do apply to 
these spills. In addition, all of these excluded situations require 
practicable, immediate actions to contain the area of contamination. 
While these situations may not always require more stringent cleanup 
measures, the Agency is excluding these scenarios because they will 
always involve significant factors that may not be adequately addressed 
by cleanup standards based upon typical spill characteristics.
    (2) For the spill situations in paragraphs (d)(2)(i) through (vi) of 
this section, the responsible party shall decontaminate the spill in 
accordance with site-specific requirements established by the EPA 
regional offices.
    (i) Spills that result in the direct contamination of surface waters 
(surface waters include, but are not limited to, ``waters of the United 
States'' as defined in part 122 of this chapter, ponds, lagoons, 
wetlands, and storage reservoirs).
    (ii) Spills that result in the direct contamination of sewers or 
sewage treatment systems.
    (iii) Spills that result in the direct contamination of any private 
or public drinking water sources or distribution systems.
    (iv) Spills which migrate to and contaminate surface waters, sewers, 
or drinking water supplies before cleanup has been completed in 
accordance with this policy.
    (v) Spills that contaminate animal grazing lands.
    (vi) Spills that contaminate vegetable gradens.
    (e) Relationship of policy to other statutes. (1) This policy does 
not affect cleanup standards or requirements for the reporting of spills 
imposed, or to be imposed, under other Federal statutory authorities, 
including but not limited to, the Clean Water Act (CWA), the Resource 
Conservation and Recovery Act (RCRA), and the Comprehensive 
Environmental Response Compensation and Liability Act of 1980 (CERCLA) 
as amended by the Superfund Amendments and Reauthorization Act (SARA). 
Where more than one requirement applies, the stricter standard must be 
met.
    (2) The Agency recognizes that the existence of this policy will 
inevitably result in attempts to apply the standards to situations 
within the scope of other statutory authorities. However, other statutes 
require the Agency to consider different or alternative factors in 
determining appropriate corrective actions. In addition, the types and 
magnitudes of exposures associated with sites requiring corrective 
action under other statutes often involve important differences from 
those expected of the typical, electrical equipment-type spills 
considered in developing this policy. Thus, cleanups under other 
statutes, such as RCRA corrective actions or remedial and response 
actions under SARA may result in different outcomes.

[52 FR 10705, Apr. 2, 1987, as amended at 72 FR 57241, Oct. 9, 2007; 74 
FR 30234, June 25, 2009]



Sec. 761.123  Definitions.

    For purposes of this policy, certain words and phrases are used to 
denote specific materials, procedures, or circumstances. The following 
definitions are provided for purposes of clarity and are not to be taken 
as exhaustive lists of situations and materials covered by the policy.
    Double wash/rinse means a minimum requirement to cleanse solid 
surfaces (both impervious and nonimpervious) two times with an 
appropriate solvent or other material in which PCBs are at least 5 
percent soluble (by weight). A volume of PCB-free fluid sufficient to 
cover the contaminated surface completely must be used in each wash/
rinse. The wash/rinse requirement does not mean the mere spreading of 
solvent or other fluid over the surface, nor does

[[Page 239]]

the requirement mean a once-over wipe with a soaked cloth. Precautions 
must be taken to contain any runoff resulting from the cleansing and to 
dispose properly of wastes generated during the cleansing.
    High-concentration PCBs means PCBs that contain 500 ppm or greater 
PCBs, or those materials which EPA requires to be assumed to contain 500 
ppm or greater PCBs in the absence of testing.
    High-contact industrial surface means a surface in an industrial 
setting which is repeatedly touched, often for relatively long periods 
of time. Manned machinery and control panels are examples of high-
contact industrial surfaces. High-contact industrial surfaces are 
generally of impervious solid material. Examples of low-contact 
industrial surfaces include ceilings, walls, floors, roofs, roadways and 
sidewalks in the industrial area, utility poles, unmanned machinery, 
concrete pads beneath electrical equipment, curbing, exterior structural 
building components, indoor vaults, and pipes.
    High-contact residential/commercial surface means a surface in a 
residential/commercial area which is repeatedly touched, often for 
relatively long periods of time. Doors, wall areas below 6 feet in 
height, uncovered flooring, windowsills, fencing, bannisters, stairs, 
automobiles, and children's play areas such as outdoor patios and 
sidewalks are examples of high-contact residential/commercial surfaces. 
Examples of low-contact residential/commercial surfaces include interior 
ceilings, interior wall areas above 6 feet in height, roofs, asphalt 
roadways, concrete roadways, wooden utility poles, unmanned machinery, 
concrete pads beneath electrical equipment, curbing, exterior structural 
building components (e.g., aluminum/vinyl siding, cinder block, asphalt 
tiles), and pipes.
    Impervious solid surfaces means solid surfaces which are nonporous 
and thus unlikely to absorb spilled PCBs within the short period of time 
required for cleanup of spills under this policy. Impervious solid 
surfaces include, but are not limited to, metals, glass, aluminum 
siding, and enameled or laminated surfaces.
    Low-concentration PCBs means PCBs that are tested and found to 
contain less than 500 ppm PCBs, or those PCB-containing materials which 
EPA requires to be assumed to be at concentrations below 500 ppm (i.e., 
untested mineral oil dielectric fluid).
    Nonimpervious solid surfaces means solid surfaces which are porous 
and are more likely to absorb spilled PCBs prior to completion of the 
cleanup requirements prescribed in this policy. Nonimpervious solid 
surfaces include, but are not limited to, wood, concrete, asphalt, and 
plasterboard.
    Nonrestricted access areas means any area other than restricted 
access, outdoor electrical substations, and other restricted access 
locations, as defined in this section. In addition to residential/
commercial areas, these areas include unrestricted access rural areas 
(areas of low density development and population where access is 
uncontrolled by either man-made barriers or naturally occurring 
barriers, such as rough terrain, mountains, or cliffs).
    Other restricted access (nonsubstation) locations means areas other 
than electrical substations that are at least 0.1 kilometer (km) from a 
residential/commercial area and limited by man-made barriers (e.g., 
fences and walls) to substantially limited by naturally occurring 
barriers such as mountains, cliffs, or rough terrain. These areas 
generally include industrial facilities and extremely remote rural 
locations. (Areas where access is restricted but are less than 0.1 km 
from a residential/commercial area are considered to be residential/
commercial areas.)
    Outdoor electrical substations means outdoor, fenced-off, and 
restricted access areas used in the transmission and/or distribution of 
electrical power Outdoor electrical substations restrict public access 
by being fenced or walled off as defined under Sec. 761.30(l)(1)(ii). 
For purposes of this TSCA policy, outdoor electrical substations are 
defined as being located at least 0.1 km from a residential/commercial 
area. Outdoor fenced-off and restricted access areas used in the 
transmission and/or distribution of electrical power which are located 
less than 0.1. km from a residential/commercial area are considered to 
be residential/commercial areas.
    PCBs means polychlorinated biphenyls as defined under Sec. 761.3. As

[[Page 240]]

specified under Sec. 761.1(b), no requirements may be avoided through 
dilution of the PCB concentration.
    Requirements and standards means:
    (1) ``Requirements'' as used in this policy refers to both the 
procedural responses and numerical decontamination levels set forth in 
this policy as constituting adequate cleanup of PCBs.
    (2) ``Standards'' refers to the numerical decontamination levels set 
forth in this policy.
    Residential/commercial areas means those areas where people live or 
reside, or where people work in other than manufacturing or farming 
industries. Residential areas include housing and the property on which 
housing is located, as well as playgrounds, roadways, sidewalks, parks, 
and other similar areas within a residential community. Commercial areas 
are typically accessible to both members of the general public and 
employees and include public assembly properties, institutional 
properties, stores, office buildings, and transportation centers.
    Responsible party means the owner of the PCB equipment, facility, or 
other source of PCBs or his/her designated agent (e.g., a facility 
manager or foreman).
    Soil means all vegetation, soils and other ground media, including 
but not limited to, sand, grass, gravel, and oyster shells. It does not 
include concrete and asphalt.
    Spill means both intentional and unintentional spills, leaks, and 
other uncontrolled discharges where the release results in any quantity 
of PCBs running off or about to run off the external surface of the 
equipment or other PCB source, as well as the contamination resulting 
from those releases. This policy applies to spills of 50 ppm or greater 
PCBs. The concentration of PCBs spilled is determined by the PCB 
concentration in the material spilled as opposed to the concentration of 
PCBs in the material onto which the PCBs were spilled. Where a spill of 
untested mineral oil occurs, the oil is presumed to contain greater than 
50 ppm, but less than 500 ppm PCBs and is subject to the relevant 
requirements of this policy.
    Spill area means the area of soil on which visible traces of the 
spill can be observed plus a buffer zone of 1 foot beyond the visible 
traces. Any surface or object (e.g., concrete sidewalk or automobile) 
within the visible traces area or on which visible traces of the spilled 
material are observed is included in the spill area. This area 
represents the minimum area assumed to be contaminated by PCBs in the 
absence of precleanup sampling data and is thus the minimum area which 
must be cleaned.
    Spill boundaries means the actual area of contamination as 
determined by postcleanup verification sampling or by precleanup 
sampling to determine actual spill boundaries. EPA can require 
additional cleanup when necessary to decontaminate all areas within the 
spill boundaries to the levels required in this policy (e.g., additional 
cleanup will be required if postcleanup sampling indicates that the area 
decontaminated by the responsible party, such as the spill area as 
defined in this section, did not encompass the actual boundaries of PCB 
contamination).
    Standard wipe test means, for spills of high-concentration PCBs on 
solid surfaces, a cleanup to numerical surface standards and sampling by 
a standard wipe test to verify that the numerical standards have been 
met. This definition constitutes the minimum requirements for an 
appropriate wipe testing protocol. A standard-size template (10 
centimeters (cm)  x  10 cm) will be used to delineate the area of 
cleanup; the wiping medium will be a gauze pad or glass wool of known 
size which has been saturated with hexane. It is important that the wipe 
be performed very quickly after the hexane is exposed to air. EPA 
strongly recommends that the gauze (or glass wool) be prepared with 
hexane in the laboratory and that the wiping medium be stored in sealed 
glass vials until it is used for the wipe test. Further, EPA requires 
the collection and testing of field blanks and replicates.

[52 FR 10705, Apr. 2, 1987; 52 FR 23397, June 19, 1987]



Sec. 761.125  Requirements for PCB spill cleanup.

    (a) General. Unless expressly limited, the reporting, disposal, and 
precleanup sampling requirements in paragraphs

[[Page 241]]

(a) (1) through (3) of this section apply to all spills of PCBs at 
concentrations of 50 ppm or greater which are subject to decontamination 
requirements under TSCA, including those spills listed under 
Sec. 761.120(b) which are excluded from the cleanup standards at 
paragraphs (b) and (c) of this section.
    (1) Reporting requirements. The reporting in paragraphs (a)(1) (i) 
through (iv) of this section is required in addition to applicable 
reporting requirements under the Clean Water Act (CWA) or the 
Comprehensive Environmental Response Compensation and Liability Act of 
1980 (CERCLA). For example, under the National Contingency Plan all 
spills involving 1 pound or more by weight of PCBs must currently be 
reported to the National Response Center (1-800-424-8802). The 
requirements in paragraphs (a)(1) (i) through (iv) of this section are 
designed to be consistent with existing reporting requirements to the 
extent possible so as to minimize reporting burdens on governments as 
well as the regulated community.
    (i) Where a spill directly contaminates surface water, sewers, or 
drinking water supplies, as discussed under Sec. 761.120(d), the 
responsible party shall notify the appropriate EPA regional office and 
obtain guidance for appropriate cleanup measures in the shortest 
possible time after discovery, but in no case later than 24 hours after 
discovery.
    (ii) Where a spill directly contaminates grazing lands or vegetable 
gardens, as discussed under Sec. 761.120(d), the responsible party shall 
notify the appropriate EPA regional office and proceed with the 
immediate requirements specified under paragraph (b) or (c) of this 
section, depending on the source of the spill, in the shortest possible 
time after discovery, but in no case later than 24 hours after 
discovery.
    (iii) Where a spill exceeds 10 pounds of PCBs by weight and is not 
addressed in paragraph (a)(1) (i) or (ii) of this section, the 
responsible party will notify the appropriate EPA regional office and 
proceed to decontaminate the spill area in accordance with this TSCA 
policy in the shortest possible time after discovery, but in no case 
later than 24 hours after discovery.
    (iv) Spills of 10 pounds or less, which are not addressed in 
paragraph (a)(1) (i) or (ii) of this section, must be cleaned up in 
accordance with this policy (in order to avoid EPA enforcement 
liability), but notification of EPA is not required.
    (2) Disposal of cleanup debris and materials. All concentrated 
soils, solvents, rags, and other materials resulting from the cleanup of 
PCBs under this policy shall be properly stored, labeled, and disposed 
of in accordance with the provisions of subpart D of this part.
    (3) Determination of spill boundaries in the absence of visible 
traces. For spills where there are insufficient visible traces yet there 
is evidence of a leak or spill, the boundaries of the spill are to be 
determined by using a statistically based sampling scheme.
    (b) Requirements for cleanup of low-concentration spills which 
involve less than 1 pound of PCBs by weight (less than 270 gallons of 
untested mineral oil)--(1) Decontamination requirements. Spills of less 
than 270 gallons of untested mineral oil, low-concentration PCBs, as 
defined under Sec. 761.123, which involve less than 1 pound of PCBs by 
weight (e.g., less than 270 gallons of untested mineral oil containing 
less than 500 ppm PCBs) shall be cleaned in the following manner:
    (i) Solid surfaces must be double washed/rinsed (as defined under 
Sec. 761.123); except that all indoor, residential surfaces other than 
vault areas must be cleaned to 10 micrograms per 100 square centimeters 
(10 mg/100 cm\2\) by standard commercial wipe tests.
    (ii) All soil within the spill area (i.e., visible traces of soil 
and a buffer of 1 lateral foot around the visible traces) must be 
excavated, and the ground be restored to its original configuration by 
back-filling with clean soil (i.e., containing less than 1 ppm PCBs).
    (iii) Requirements of paragraphs (b)(1) (i) and (ii) of this section 
must be completed within 48 hours after the responsible party was 
notified or became aware of the spill.
    (2) Effect of emergency or adverse weather. Completion of cleanup 
may be delayed beyond 48 hours in case of circumstances including but 
not limited to, civil emergency, adverse weather conditions, lack of 
access to the site,

[[Page 242]]

and emergency operating conditions. The occurrence of a spill on a 
weekend or overtime costs are not acceptable reasons to delay response. 
Completion of cleanup may be delayed only for the duration of the 
adverse conditions. If the adverse weather conditions, or time lapse due 
to other emergency, has left insufficient visible traces, the 
responsible party must use a statistically based sampling scheme to 
determine the spill boundaries as required under paragraph (a)(3) of 
this section.
    (3) Records and certification. At the completion of cleanup, the 
responsible party shall document the cleanup with records and 
certification of decontamination. The records and certification must be 
maintained for a period of 5 years. The records and certification shall 
consist of the following:
    (i) Identification of the source of the spill (e.g., type of 
equipment).
    (ii) Estimated or actual date and time of the spill occurrence.
    (iii) The date and time cleanup was completed or terminated (if 
cleanup was delayed by emergency or adverse weather: the nature and 
duration of the delay).
    (iv) A brief description of the spill location.
    (v) Precleanup sampling data used to establish the spill boundaries 
if required because of insufficient visible traces, and a brief 
description of the sampling methodology used to establish the spill 
boundaries.
    (vi) A brief description of the solid surfaces cleaned and of the 
double wash/rinse method used.
    (vii) Approximate depth of soil excavation and the amount of soil 
removed.
    (viii) A certification statement signed by the responsible party 
stating that the cleanup requirements have been met and that the 
information contained in the record is true to the best of his/her 
knowledge.
    (ix) While not required for compliance with this policy, the 
following information would be useful if maintained in the records:
    (A) Additional pre- or post-cleanup sampling.
    (B) The estimated cost of the cleanup by man-hours, dollars, or 
both.
    (c) Requirements for cleanup of high-concentration spills and low-
concentration spills involving 1 pound or more PCBs by weight (270 
gallons or more of untested mineral oil). Cleanup of low-concentration 
spills involving 1 lb or more PCBs by weight and of all spills of 
materials other than low-concentration materials shall be considered 
complete if all of the immediate requirements, cleanup standards, 
sampling, and recordkeeping requirements of paragraphs (c) (1) through 
(5) of this section are met.
    (1) Immediate requirements. The four actions in paragraphs (c)(1) 
(i) through (iv) of this section must be taken as quickly as possible 
and within no more than 24 hours (or within 48 hours for PCB 
Transformers) after the responsible party was notified or became aware 
of the spill, except that actions described in paragraphs (c)(1) (ii) 
through (iv) of this section can be delayed beyond 24 hours if 
circumstances (e.g., civil emergency, hurricane, tornado, or other 
similar adverse weather conditions, lack of access due to physical 
impossibility, or emergency operating conditions) so require for the 
duration of the adverse conditions. The occurrence of a spill on a 
weekend or overtime costs are not acceptable reasons to delay response. 
Owners of spilled PCBs who have delayed cleanup because of these types 
of circumstances must keep records documenting the fact that 
circumstances precluded rapid response.
    (i) The responsible party shall notify the EPA regional office and 
the NRC as required by Sec. 761.125(a)(1) or by other applicable 
statutes.
    (ii) The responsible party shall effectively cordon off or otherwise 
delineate and restrict an area encompassing any visible traces plus a 3-
foot buffer and place clearly visible signs advising persons to avoid 
the area to minimize the spread of contamination as well as the 
potential for human exposure.
    (iii) The responsible party shall record and document the area of 
visible contamination, noting the extent of the visible trace areas and 
the center of the visible trace area. If there are no visible traces, 
the responsible party shall record this fact and contact the regional 
office of the EPA for guidance in completing statistical sampling of

[[Page 243]]

the spill area to establish spill boundaries.
    (iv) The responsible party shall initiate cleanup of all visible 
traces of the fluid on hard surfaces and initiate removal of all visible 
traces of the spill on soil and other media, such as gravel, sand, 
oyster shells, etc.
    (v) If there has been a delay in reaching the site and there are 
insufficient visible traces of PCBs remaining at the spill site, the 
responsible party must estimate (based on the amount of material missing 
from the equipment or container) the area of the spill and immediately 
cordon off the area of suspect contamination. The responsible party must 
then utilize a statistically based sampling scheme to identify the 
boundaries of the spill area as soon as practicable.
    (vi) Although this policy requires certain immediate actions, as 
described in paragraphs (c)(1)(i) through (iv) of this section, EPA is 
not placing a time limit on completion of the cleanup effort since the 
time required for completion will vary from case to case. However, EPA 
expects that decontamination will be achieved promptly in all cases and 
will consider promptness of completion in determining whether the 
responsible party made good faith efforts to clean up in accordance with 
this policy.
    (2) Requirements for decontaminating spills in outdoor electrical 
substations. Spills which occur in outdoor electrical substations, as 
defined under Sec. 761.123, shall be decontaminated in accordance with 
paragraphs (c)(2) (i) and (ii) of this section. Conformance to the 
cleanup standards under paragraphs (c)(2) (i) and (ii) of this section 
shall be verified by post-cleanup sampling as specified under 
Sec. 761.130. At such times as outdoor electrical substations are 
converted to another use, the spill site shall be cleaned up to the 
nonrestricted access requirements under paragraph (c)(4) of this 
section.
    (i) Contaminated solid surfaces (both impervious and non-impervious) 
shall be cleaned to a PCB concentration of 100 micrograms (mg)/100 
square centimeters (cm\2\) (as measured by standard wipe tests).
    (ii) At the option of the responsible party, soil contaminated by 
the spill will be cleaned either to 25 ppm PCBs by weight, or to 50 ppm 
PCBs by weight provided that a label or notice is visibly placed in the 
area. Upon demonstration by the responsible party that cleanup to 25 ppm 
or 50 ppm will jeopardize the integrity of the electrical equipment at 
the substation, the EPA regional office may establish an alternative 
cleanup method or level and place the responsible party on a reasonably 
timely schedule for completion of cleanup.
    (3) Requirements for decontaminating spills in other restricted 
access areas. Spills which occur in restricted access locations other 
than outdoor electrical substations, as defined under Sec. 761.123, 
shall be decontaminated in accordance with paragraphs (c)(3) (i) through 
(v) of this section. Conformance to the cleanup standards in paragraphs 
(c)(3) (i) through (v) of this section shall be verified by postcleanup 
sampling as specified under Sec. 761.130. At such times as restricted 
access areas other than outdoor electrical substations are converted to 
another use, the spill site shall be cleaned up to the nonrestricted 
access area requirements of paragraph (c)(4) of this section.
    (i) High-contact solid surfaces, as defined under Sec. 761.163 shall 
be cleaned to 10 mg/100 cm\2\ (as measured by standard wipe tests).
    (ii) Low-contact, indoor, impervious solid surfaces will be 
decontaminated to 10 mg/100 cm\2\.
    (iii) At the option of the responsible party, low-contact, indoor, 
nonimpervious surfaces will be cleaned either to 10 mg/100 cm\2\ or to 
100 mg/100 cm\2\ and encapsulated. The Regional Administrator, however, 
retains the authority to disallow the encapsulation option for a 
particular spill situation upon finding that the uncertainties 
associated with that option pose special concerns at that site. That is, 
the Regional Administrator would not permit encapsulation if he/she 
determined that if the encapsulation failed the failure would create an 
imminent hazard at the site.
    (iv) Low-contact, outdoor surfaces (both impervious and 
nonimpervious) shall be cleaned to 100 mg/100 cm\2\.

[[Page 244]]

    (v) Soil contaminated by the spill will be cleaned to 25 ppm PCBs by 
weight.
    (4) Requirements for decontaminating spills in nonrestricted access 
areas. Spills which occur in nonrestricted access locations, as defined 
under Sec. 761.123, shall be decontaminated in accordance with 
paragraphs (c)(4) (i) through (v) of this section. Conformance to the 
cleanup standards at paragraphs (c)(4) (i) through (v) of this section 
shall be verified by postcleanup sampling as specified under 
Sec. 761.130.
    (i) Furnishings, toys, and other easily replaceable household items 
shall be disposed of in accordance with the provisions of subpart D of 
this part and replaced by the responsible party.
    (ii) Indoor solid surfaces and high-contact outdoor solid surfaces, 
defined as high contact residential/commercial surfaces under 
Sec. 761.123, shall be cleaned to 10 mg/100 cm\2\ (as measured by 
standard wipe tests).
    (iii) Indoor vault areas and low-contact, outdoor, impervious solid 
surfaces shall be decontaminated to 10 mg/100 cm\2\.
    (iv) At the option of the responsible party, low-contact, outdoor, 
nonimpervious solid surfaces shall be either cleaned to 10 mg/100 cm\2\ 
or cleaned to 100 mg/100 cm\2\ and encapsulated. The Regional 
Administrator, however, retains the authority to disallow the 
encapsulation option for a particular spill situation upon finding that 
the uncertainties associated with that option pose special concerns at 
that site. That is, the Regional Administrator would not permit 
encapsulation if he/she determined that if the encapsulation failed the 
failure would create an imminent hazard at the site.
    (v) Soil contaminated by the spill will be decontaminated to 10 ppm 
PCBs by weight provided that soil is excavated to a minimum depth of 10 
inches. The excavated soil will be replaced with clean soil, i.e., 
containing less than 1 ppm PCBs, and the spill site will be restored 
(e.g., replacement of turf).
    (5) Records. The responsible party shall document the cleanup with 
records of decontamination. The records must be maintained for a period 
of 5 years. The records and certification shall consist of the 
following:
    (i) Identification of the source of the spill, e.g., type of 
equipment.
    (ii) Estimated or actual date and time of the spill occurrence.
    (iii) The date and time cleanup was completed or terminated (if 
cleanup was delayed by emergency or adverse weather: the nature and 
duration of the delay).
    (iv) A brief description of the spill location and the nature of the 
materials contaminated. This information should include whether the 
spill occurred in an outdoor electrical substation, other restricted 
access location, or in a nonrestricted access area.
    (v) Precleanup sampling data used to establish the spill boundaries 
if required because of insufficient visible traces and a brief 
description of the sampling methodology used to establish the spill 
boundaries.
    (vi) A brief description of the solid surfaces cleaned.
    (vii) Approximate depth of soil excavation and the amount of soil 
removed.
    (viii) Postcleanup verification sampling data and, if not otherwise 
apparent from the documentation, a brief description of the sampling 
methodology and analytical technique used.
    (ix) While not required for compliance with this policy, information 
on the estimated cost of cleanup (by man-hours, dollars, or both) would 
be useful if maintained in the records.

[52 FR 10705, Apr. 2, 1987, as amended at 53 FR 40884, Oct. 19, 1988; 63 
FR 35461, June 29, 1998; 72 FR 57241, Oct. 9, 2007]



Sec. 761.130  Sampling requirements.

    Postcleanup sampling is required to verify the level of cleanup 
under Sec. 761.125(c) (2) through (4). The responsible party may use any 
statistically valid, reproducible, sampling scheme (either random 
samples or grid samples) provided that the requirements of paragraphs 
(a) and (b) of this section are satisfied.
    (a) The sampling area is the greater of (1) an area equal to the 
area cleaned plus an additional 1-foot boundary, or (2) an area 20 
percent larger than the original area of contamination.
    (b) The sampling scheme must ensure 95 percent confidence against 
false positives.

[[Page 245]]

    (c) The number of samples must be sufficient to ensure that areas of 
contamination of a radius of 2 feet or more within the sampling area 
will be detected, except that the minimum number of samples is 3 and the 
maximum number of samples is 40.
    (d) The sampling scheme must include calculation for expected 
variability due to analytical error.
    (e) EPA recommends the use of a sampling scheme developed by the 
Midwest Research Institute (MRI) for use in enforcement inspections: 
``Verification of PCB Spill Cleanup by Sampling and Analysis.'' Guidance 
for the use of this sampling scheme is available in the MRI report 
``Field Manual for Grid Sampling of PCB Spill Sites to Verify Cleanup.'' 
Both the MRI sampling scheme and the guidance document are available on 
EPA's PCB Web site at http://www.epa.gov/pcb, or from the Program 
Management, Communications, and Analysis Office, Office of Resource 
Conservation and Recovery (5305P), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. The major advantage of this sampling scheme 
is that it is designed to characterize the degree of contamination 
within the entire sampling area with a high degree of confidence while 
using fewer samples than any other grid or random sampling scheme. This 
sampling scheme also allows some sites to be characterized on the basis 
of composite samples.
    (f) EPA may, at its discretion, take samples from any spill site. If 
EPA's sampling indicates that the remaining concentration level exceeds 
the required level, EPA will require further cleanup. For this purpose, 
the numerical level of cleanup required for spills cleaned in accordance 
with Sec. 761.125(b) is deemed to be the equivalent of numerical cleanup 
requirements required for cleanups under Sec. 761.125(c) (2) through 
(4). Using its best engineering judgment, EPA may sample a statistically 
valid random or grid sampling technique, or both. When using engineering 
judgment or random ``grab'' samples, EPA will take into account that 
there are limits on the power of a grab sample to dispute statistically 
based sampling of the type required of the responsible party. EPA 
headquarters will provide guidance to the EPA regions on the degree of 
certainty associated with various grab sample results.

[52 FR 10705, Apr. 2, 1987, as amended at 60 FR 34465, July 3, 1995; 72 
FR 57241, Oct. 9, 2007; 74 FR 30234, June 25, 2009]



Sec. 761.135  Effect of compliance with this policy and enforcement.

    (a) Although a spill of material containing 50 ppm or greater PCBs 
is considered improper PCB disposal, this policy establishes 
requirements that EPA considers to be adequate cleanup of the spilled 
PCBs. Cleanup in accordance with this policy means compliance with the 
procedural as well as the numerical requirements of this policy. 
Compliance with this policy creates a presumption against both 
enforcement action for penalties and the need for further cleanup under 
TSCA. The Agency reserves the right, however, to initiate appropriate 
action to compel cleanup where, upon review of the records of cleanup or 
EPA sampling following cleanup, EPA finds that the decontamination 
levels in the policy have not been achieved. The Agency also reserves 
the right to seek penalties where the Agency believes that the 
responsible party has not made a good faith effort to comply with all 
provisions of this policy, such as prompt notification of EPA of a 
spill, recordkeeping, etc.
    (b) EPA's exercise of enforcement discretion does not preclude 
enforcement action under other provisions of TSCA or any other Federal 
statute. This includes, even in cases where the numerical 
decontamination levels set forth in this policy have been met, civil or 
criminal action for penalties where EPA believes the spill to have been 
the result of gross negligence or knowing violation.

Subparts H-I [Reserved]



                  Subpart J_General Records and Reports



Sec. 761.180  Records and monitoring.

    This section contains recordkeeping and reporting requirements that 
apply to PCBs, PCB Items, and PCB storage

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and disposal facilities that are subject to the requirements of the 
part.
    (a) PCBs and PCB Items in service or projected for disposal. 
Beginning February 5, 1990, each owner or operator of a facility, other 
than a commercial storer or a disposer of PCB waste, using or storing at 
any one time at least 45 kilograms (99.4 pounds) of PCBs contained in 
PCB Container(s), or one or more PCB Transformers, or 50 or more PCB 
Large High or Low Voltage Capacitors shall develop and maintain at the 
facility, or a central facility provided they are maintained at that 
facility, all annual records and the written annual document log of the 
disposition of PCBs and PCB Items. The written annual document log must 
be prepared for each facility by July 1 covering the previous calendar 
year (January through December). The annual document log shall be 
maintained for at least 3 years after the facility ceases using or 
storing PCBs and PCB Items in the quantities prescribed in this 
paragraph. Annual records (manifests and certificates of disposal) shall 
be maintained for the same period. The annual records and the annual 
document log shall be available for inspection at the facility where 
they are maintained by authorized representatives of EPA during normal 
business hours, and each owner or operator of a facility subject to 
these requirements shall know the location of these records. All records 
and annual documents required to be prepared and maintained by this 
section prior to February 5, 1990 shall continue to be maintained at the 
facility for the same time as the annual records and the annual document 
log. The annual document required for 1989 shall cover the period from 
January 1, 1989 to February 5, 1990.
    (1) The annual records shall include the following:
    (i) All signed manifests generated by the facility during the 
calendar year.
    (ii) All Certificates of Disposal that have been received by the 
facility during the calendar year.
    (iii) Records of inspections and cleanups performed in accordance 
with Sec. 761.65(c)(5).
    (2) The written annual document log shall include the following:
    (i) The name, address, and EPA identification number of the facility 
covered by the annual document log and the calendar year covered by the 
annual document log.
    (ii) The unique manifest number of every manifest generated by the 
facility during the calendar year, and from each manifest and for 
unmanifested waste that may be stored at the facility, the following 
information:
    (A) For bulk PCB waste (e.g., in a tanker or truck), its weight in 
kilograms, the first date it was removed from service for disposal, the 
date it was placed into transport for off-site storage or disposal, and 
the date of disposal, if known.
    (B) The serial number (if available) or other means of identifying 
each PCB Article (e.g., transformer or capacitor), the weight in 
kilograms of the PCB waste in each transformer or capacitor, the date it 
was removed from service for disposal, the date it was placed in 
transport for off-site storage or disposal, and the date of disposal, if 
known.
    (C) A unique number identifying each PCB Container, a description of 
the contents of each PCB Container, such as liquid, soil, cleanup 
debris, etc., including the total weight of the material in kilograms in 
each PCB Container, the first date material placed in each PCB Container 
was removed from service for disposal, and the date each PCB Container 
was placed in transport for off-site storage or disposal, and the date 
of disposal (if known).
    (D) A unique number identifying each PCB Article Container, a 
description of the contents of each PCB Article Container, such as 
pipes, capacitors, electric motors, pumps, etc., including the total 
weight in kilograms of the content of each PCB Article Container, the 
first date a PCB Article placed in each PCB Article Container was 
removed from service for disposal, and the date the PCB Article 
Container was placed in transport for off-site storage or disposal, and 
the date of disposal (if known.)
    (iii) The total number by specific type of PCB Articles and the 
total weight in kilograms of PCBs in PCB

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Articles, the total number of PCB Article Containers and total weight in 
kilograms of the contents of PCB Article Containers, the total number of 
PCB Containers and the total weight in kilograms of the contents of PCB 
Containers, and the total weight in kilograms of bulk PCB waste that was 
placed into storage for disposal or disposed during the calendar year.
    (iv) The total number of PCB Transformers and total weight in 
kilograms of PCBs contained in the transformers remaining in service at 
the end of the calendar year.
    (v) The total number of Large High or Low Voltage PCB Capacitors 
remaining in service at the end of the calendar year.
    (vi) The total weight in kilograms of any PCBs and PCB Items in PCB 
Containers, including the identification of container contents, 
remaining in service at the facility at the end of the calendar year.
    (vii) For any PCBs or PCB item received from or shipped to another 
facility owned or operated by the same generator, the information 
required under paragraph (a)(2)(ii)(A) through (a)(2)(ii)(D) of this 
section.
    (viii) [Reserved]
    (ix) Whenever a PCB Item, excluding small capacitors, with a 
concentration of $50 ppm is distributed in commerce for reuse pursuant 
to Sec. 761.20(c)(1), the name, address, and telephone number of the 
person to whom the item was transferred, date of transfer, and the 
serial number of the item or the internal identification number, if a 
serial number is not available, must be recorded in the annual document 
log. The serial number or internal identification number shall be 
permanently marked on the equipment.
    (3) [Reserved]
    (4) For purposes of this paragraph, PCB Voltage Regulators shall be 
recorded as PCB Transformers.
    (b) Disposers and commercial storers of PCB waste. Beginning 
February 5, 1990, each owner or operator of a facility (including high 
efficiency boiler operations) used for the commercial storage or 
disposal of PCBs and PCB Items shall maintain annual records on the 
disposition of all PCBs and PCB items at the facility and prepare and 
maintain a written annual document log that includes the information 
required by paragraphs (b)(2) of this section for PCBs and PCB Items 
that were handled as PCB waste at the facility. The written annual 
document log shall be prepared by July 1 for the previous calendar year 
(January through December). The written annual document log shall be 
maintained at each facility for at least 3 years after the facility is 
no longer used for the storage or disposal of PCBs and PCB Items except 
that, in the case of chemical waste landfills, the annual document log 
shall be maintained at least 20 years after the chemical waste landfill 
is no longer used for the disposal of PCBs and PCB Items. The annual 
records shall be maintained for the same period. The annual records and 
written annual document log shall be available at the facility for 
inspection by authorized representatives of the EPA. All records and 
annual documents required to be prepared and maintained by this section 
prior to February 5, 1990 shall continue to be maintained at the 
facility for the same time as the annual records and the annual document 
log. The annual document for 1989 shall cover the period from January 1, 
1989 to February 5, 1990. From the written annual document log the owner 
or operator of a facility must prepare the annual report containing the 
information required by paragraphs (b)(3)(i) through (b)(3)(vi) of this 
section for PCBs and PCB Items that were handled as PCB waste at the 
facility during the previous calendar year (January through December). 
The annual report must be submitted by July 15 of each year for the 
preceding calendar year. If the facility ceases commercial PCB storage 
or disposal operations, the owner or operator of the facility shall 
provide at least 60 days advance written notice to the Regional 
Administrator for the region in which the facility is located of the 
date the facility intends to begin closure. d
    (1) The annual records shall include the following:
    (i) All signed manifests generated or received at the facility 
during the calendar year.
    (ii) All Certificates of Disposal that have been generated or 
received by the facility during the calendar year.

[[Page 248]]

    (iii) Records of inspections and cleanups performed in accordance 
with Sec. 761.65(c)(5).
    (2) The written annual document log shall include the following:
    (i) The name, address, and EPA identification number of the storage 
or disposal facility covered by the annual document log and the calendar 
year covered by the annual document log.
    (ii) For each manifest generated or received by the facility during 
the calendar year, the unique manifest number and the name and address 
of the facility that generated the manifest and the following 
information:
    (A) For bulk PCB waste (e.g., in a tanker or truck), its weight in 
kilograms, the first date PCB waste placed in the tanker or truck was 
removed from service for disposal, the date it was received at the 
facility, the date it was placed in transport for off-site disposal (if 
applicable), and the date of disposal, (if known).
    (B) The serial number or other means of identifying each PCB 
Article, not in a PCB Container or PCB Article Container, the weight in 
kilograms of the PCB waste in the PCB Article, the date it was removed 
from service for disposal, the date it was received at the facility, the 
date it was placed in transport for off-site disposal (if applicable), 
and the date of disposal (if known).
    (C) The unique number assigned by the generator identifying each PCB 
Container, a description of the contents of each PCB Container, such as 
liquid, soil, cleanup debris, etc., including the total weight of the 
PCB waste in kilograms in each PCB Container, the first date PCB waste 
placed in each PCB Container was removed from service for disposal, the 
date it was received at the fac