[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2023 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 40

Protection of Environment


________________________

Parts 723 to 789

                         Revised as of July 1, 2023

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2023
                    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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                            Table of Contents



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

  Title 40:
          Chapter I--Environmental Protection Agency 
          (Continued)                                                3
  Finding Aids:
      Table of CFR Titles and Chapters........................     437
      Alphabetical List of Agencies Appearing in the CFR......     457
      List of CFR Sections Affected...........................     467

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

                     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, 2023), 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 dropped in 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.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.

[[Page vii]]

    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 
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free). E-mail, [email protected].
    The Office of the Federal Register also offers a free service on the 
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law numbers, Federal Register finding aids, and related information. 
Connect to NARA's website at www.archives.gov/federal-register.
    The eCFR 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, 2023







[[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 82-84, parts 85-96, parts 97-99, 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, 2023.

    Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. OMB control numbers for title 40 appear in Sec.  9.1 of 
this chapter.

    Chapters IV-IX--Regulations issued by the Environmental Protection 
Agency and Department of Justice, Council on Environmental Quality, 
Chemical Safety and Hazard Investigation Board, Environmental Protection 
Agency and Department of Defense; Uniform National Discharge Standards 
for Vessels of the Armed Forces, Gulf Coast Ecosystem Restoration 
Council, and the Federal Permitting Improvement Steering Council appear 
in volume thirty-seven.

    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

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         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..........          76
747             Metalworking fluids.........................         143
749             Water treatment chemicals...................         148
750             Procedures for rulemaking under section 6 of 
                    the Toxic Substances Control Act........         151
751             Regulation of certain chemical substances 
                    and mixtures under section 6 of the 
                    Toxic Substances Control Act............         157
761             Polychlorinated biphenyls (PCBs) 
                    manufacturing, processing, distribution 
                    in commerce, and use prohibitions.......         164
763             Asbestos....................................         295
766             Dibenzo-para-dioxins/dibenzofurans..........         390
767-769

[Reserved]

770             Formaldehyde standards for composite wood 
                    products................................         400
771-789

[Reserved]

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                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 Sec. Sec.  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 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.
    (xiii) Safety Data Sheet (Sec.  720.45(i)).
    (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

[[Page 9]]

the first exemption holder under the provisions of paragraph (h)(2) of 
this section.
    (g) Review period. (1) EPA will review the notice submitted under 
paragraph (e) of this section to determine whether manufacture of the 
new chemical substance is eligible for the exemption. The review period 
will end 30 days after receipt of the notice by the TSCA Document 
Control Officer. To provide additional time to address any unresolved 
issues concerning an exemption application, the exemption applicant may, 
at any time during the review period, request a suspension of the review 
period pursuant to the provisions of Sec.  720.75(b) of this chapter.
    (2) Upon expiration of the 30-day review period, if EPA has taken no 
action, the manufacturer may consider its exemption approved and begin 
to manufacture the new chemical substance under the terms described in 
its notice and in this section.
    (h) Notice of ineligibility--(1) During the review period. If the 
EPA determines during the review period that manufacture of the new 
chemical substance does not meet the terms of this section or that there 
are issues concerning toxicity or exposure that require further review 
which cannot be accomplished within the 30-day review period, EPA will 
notify the manufacturer by telephone that the substance is not eligible. 
This telephone notification will subsequently be confirmed by certified 
letter that identifies the reasons for the ineligibility determination. 
The manufacturer may not begin manufacture of the new chemical substance 
without complying with section 5(a)(1) of the Act or submitting a new 
notice under paragraph (e) of this section that satisfies EPA's 
concerns.
    (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

[[Page 10]]

not resume manufacture, processing, distribution in commerce, and use of 
the new chemical substance until it submits a notice under section 
5(a)(1) of the Act and part 720 of this chapter and the notice review 
period has ended.
    (vi) If the Assistant Administrator determines that manufacture of 
the new chemical substance does not meet the terms of this section and 
that the manufacturer acted with due diligence and in good faith to meet 
the terms of this section, the manufacturer may continue manufacture, 
processing, distribution in commerce, and use of the new chemical 
substance if:
    (A) It was actually manufacturing, processing, distributing in 
commerce, or using the chemical substance at the time it received the 
notification specified in paragraph (h)(2)(i)(A) of this section.
    (B) It submits a notice on the new chemical substance under section 
5(a)(1) of the Act and part 720 of this chapter within 15 days of 
receipt of the written notification under paragraph (h)(2)(iii) of this 
section. Such manufacture, processing, distribution in commerce, and use 
may continue unless EPA takes action under section 5(e) or 5(f) of the 
Act.
    (3) Action under this paragraph does not preclude action under 
sections 7, 15, 16, or 17 of the Act.
    (i) Additional information. If the manufacturer of a new chemical 
substance under the terms of this exemption obtains test data or other 
information indicating that the new chemical substance may not qualify 
under terms of this section, the manufacturer must submit these data or 
information to EPA within 15 working days of receipt 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 Sec. Sec.  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; 87 FR 39769, July 5, 
2022]

    Effective Date Note: At 88 FR 37173, June 7, 2023, Sec.  723.50 was 
amended by revising paragraph (l), effective Aug. 7, 2023. For the 
convenience of the user, the revised text is set forth as follows:



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.

                                * * * * *

    (l) Confidentiality. Claims of confidentiality must be made in 
accordance with the procedures described in 40 CFR part 703.

                                * * * * *



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) through (h) of this section.
    (iii) Comply with all recordkeeping requirements under paragraph (j) 
of this section.

[[Page 14]]

    (iv) Remit the applicable fee specified in Sec.  700.45(c) of this 
chapter.
    (b) Definitions--(1) Act means the Toxic Substances Control Act (15 
U.S.C. 2601 et seq.).
    (2) An article is a manufactured item--
    (i) Which is formed to a specific shape or design during 
manufacture;
    (ii) Which has end use function(s) dependent in whole or in part 
upon its shape or design during end use; and
    (iii) Which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article and that may occur as 
described in Sec.  710.2 of this chapter except that fluids and 
particles are not considered articles regardless of shape or design.
    (3) The 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, or 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

[[Page 15]]

the manufacture of an instant photographic or peel-apart film article.
    (c) Exemption category. The exemption category includes new chemical 
substances used in or for the manufacture or processing of instant 
photographic or peel-apart film articles which are manufactured and 
processed under the terms of this section.
    (d) Applicability. This exemption applies only to manufacturers of 
instant photographic or peel-apart film articles who:
    (1) Manufacture the new chemical substances used in or for the 
manufacture or processing of the instant photographic or peel-apart film 
articles.
    (2) Limit manufacture and processing of a new chemical substance to 
the site(s) listed in the exemption notice for that new chemical 
substance submitted under paragraph (i) of this section.
    (3) Comply with the requirements of paragraphs (e), (f), (g), (h), 
and (j) of this section.
    (4) Do not distribute in commerce or use a peel-apart film article 
containing a new chemical substance until submission of a premanufacture 
notice under section 5(a)(1)(A) of the Act (15 U.S.C. 2604) and until 
the review period for the notice has ended without EPA action to prevent 
distribution or use.
    (e) Conditions of manufacture and processing in the special 
production area. All manufacturing, processing, and use operations 
involving the new chemical substance must be performed in a special 
production area under the conditions set forth in this paragraph until 
the new chemical substance has been incorporated into a wet mixture, 
photographic article, or instant photographic or peel-apart film 
article.
    (1) Exposure limits. In the special production area, the ambient air 
concentration of the new chemical substance during manufacture, 
processing, and use cannot exceed an 8-hour time weighted average (TWA) 
of 10 ppm for gases and vapors and 50 [micro]g/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 [micro]g/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 (e)(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

[[Page 16]]

chemical substance being monitored. If chemical-specific monitoring 
methods are not available, nonspecific methods may be used if the 
concentration of the new chemical substance is assumed to be the total 
concentration of chemical substances monitored.
    (iii) Monitoring frequency. (A) When suitable air sampling and 
analytical procedures are available, monitoring must be done in each 
special production area during the first three 8-hour work shifts 
involving the manufacture or processing of each new chemical substance. 
Thereafter, monitoring must be done in each special production area for 
at least one 8-hour period per month, during a production run in which 
the new chemical substance is manufactured or processed. Samples must be 
of such frequency and pattern as to represent with reasonable accuracy 
the mean level and maximum 30-minute level of employee exposure during 
an 8-hour work shift. In monitoring for an 8-hour work shift or the 
equivalent, samples must be collected periodically or continuously for 
the duration of the 8-hour work shift. Samples must be taken during a 
period which is likely to represent the maximum employee exposure.
    (B) If the manufacturer demonstrates compliance with the exposure 
limits for 3 consecutive months, further monitoring of the identical 
process must be performed only every 6 months thereafter, unless there 
is a significant change in the process, process design, or equipment. If 
there is such a change, the manufacturer must begin monitoring again 
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
    (iv) Location of monitoring. Air samples must be taken so as to 
ensure that the samples adequately represent the ambient air 
concentration of a new chemical substance present in each worker's 
breathing zone.
    (4) Engineering controls and exposure safeguards. Engineering 
controls such as, but not limited to, isolation, enclosure, local 
exhaust ventilation, and dust collection must be used to ensure 
compliance with the exposure limits prescribed in paragraph (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

[[Page 17]]

substances are manufactured and processed under controlled conditions. 
Each sign must clearly restrict entry into the special production area 
to qualified personnel who are properly trained and equipped with 
appropriate personal exposure safeguards.
    (8) Removal for storage or transportation. A new chemical substance 
that is not incorporated into a wet mixture, photographic article, or 
instant photographic or peel-apart film article may be removed from the 
special production area for purposes of storage between operational 
steps or for purposes of transportation to another special production 
area. Such storage or transportation must be conducted in a manner that 
limits worker and environmental exposure through the use of engineering 
controls, training, hygiene, work practices, and personal protective 
devices appropriate to the chemical substance in question.
    (9) Labeling. (i) Any new chemical substance removed from a special 
production area or stored or transported between operational steps must 
be clearly labeled. The label must show the identity of the new chemical 
substance or an appropriate identification code, a statement of any 
known hazards associated with it, a list of special handling 
instructions, first aid information, spill control directions, and where 
applicable, the appropriate U.S. Department of Transportation notations.
    (ii) No label is required if the new chemical substance has been 
incorporated into a photographic article, or if it is contained in a 
sealed reaction vessel or pipeline, or if it has been incorporated into 
an instant photographic or peel-apart film article.
    (10) Areas immediately adjacent to the special production area. The 
ambient air concentration of the new chemical substance in areas 
immediately adjacent to the special production area must not exceed the 
exposure limit established in paragraph (e)(2)(ii) of this section for 
waiver of respirator protection within the special production area. 
Periodic monitoring in accordance with paragraph (e)(3) of this section 
must be performed in immediately adjacent areas where it is reasonable 
to expect a risk of inhalation exposure.
    (f) Conditions of processing outside the special production area. A 
wet mixture may be incorporated into a photographic article or an 
instant photographic or peel-apart film article outside the special 
production area under the conditions listed in this paragraph:
    (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 impervious 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 chemical substances during 
these operations using

[[Page 18]]

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 chemical substance must be appropriately pretreated before release 
to a Publicly Owned Treatment Works (POTW) or other receiving body of 
water. In the case of release to a POTW, the pretreatment must prevent 
structural damage to, obstruction of, or interference with the operation 
of the POTW. The treatment of direct release to a receiving body of 
water must be appropriate for the new chemical substance's physical-
chemical properties and potential toxicity.
    (3) Release to air. All process emissions released to the air which 
contain the new chemical substance must be vented through control 
devices appropriate for the new chemical substance's physical-chemical 
properties and potential toxicity.
    (i) Exemption notice. An exemption notices must be submitted to EPA 
when manufacture of the new chemical substance begins.
    (1) Contents of exemption notice. The exemption notice must include 
the following information:
    (i) Manufacturer and sites. The notice must identify the 
manufacturer and the sites and locations where the new chemical 
substance and the instant photographic or peel-apart film articles will 
be manufactured and processed.
    (ii) Chemical identification. The notice must identify the new 
chemical substance as follows:
    (A) Class 1 substances. For chemical substances whose composition 
can be represented by a definite structural diagram (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 identify 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 chemical 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

[[Page 19]]

during manufacture of the new chemical substance.
    (vi) Production volume. The notice must include an estimate of the 
anticipated maximum annual production volume.
    (vii) Test data. The notice must include all information and test 
data on the new chemical substance's health and environmental effects 
that are known to or reasonably ascertainable by the manufacturer.
    (viii) Identity of the article. The notice must identify and 
describe the instant photographic film article(s) or peel-apart film 
article(s) that will contain the new chemical substance.
    (ix) Release to water. The notice must include a description of the 
methods used to control and treat wastewater or discharge released to a 
POTW or other receiving body of water. The notice must also identify the 
POTW or receiving body of water.
    (x) Certification. The manufacturer must certify in the notice that 
it is familiar with the terms of the exemption and that the manufacture, 
processing, distribution, use, and disposal of the new chemical 
substance will comply with those terms.
    (xi) Fee payment ID number. The manufacturer or processor must 
include a payment identity number on the front page of the notice.
    (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

[[Page 20]]

records within 15 working days of receipt of this request.
    (k) Confidentiality. If the manufacturer submits information under 
paragraph (i) or (j) of this section which it claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to the Agency by bracketing, 
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or 
some other appropriate designation. Any information so identified will 
be treated in accordance with the procedures in part 2 of this chapter. 
Any information not claimed confidential at the time of submission will 
be made available to the public without further notice to the submitter.
    (l) Amendment and repeal. (1) EPA may amend or repeal any term of 
this exemption if it determines that the manufacture, processing, 
distribution, use, and disposal of new chemical substances under the 
terms of the exemption may present an unreasonable risk of injury to 
health or the environment. EPA also may amend this exemption to enlarge 
the exemption category or to reduce the restrictions or conditions of 
the exemption.
    (2) As required by section 5(h)(4) of the Act, EPA will amend or 
repeal the substantive terms of an exemption granted under this part 
only by the formal rulemaking procedures described in section 6(c)(2) 
and (3) of the Act (15 U.S.C. 2605(c)).
    (m) Prohibition of use of the exemption. The Director of the Office 
of Pollution Prevention and Toxics may prohibit the manufacture, 
processing, distribution, use, or disposal of any new chemical substance 
under the terms of this exemption if he or she determines that the 
manufacture, processing, distribution in commerce, use, or disposal of 
the new chemical substance may present an unreasonable risk of injury to 
health or the environment.
    (n) Enforcement. (1) A failure to comply with any provision of this 
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this part is a 
violation of this regulation and therefore a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture of a new chemical 
substance in violation of this exemption or act to seize any chemical 
substances manufactured in violation of the exemption under the 
authority of section 17 of the Act (15 U.S.C. 2616).

[83 FR 52719, Oct. 17, 2018]



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.

[[Page 21]]

    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 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.

[[Page 22]]

    Polymer molecule means a molecule which contains a sequence of at 
least 3 monomer units which are covalently bound to at least one other 
monomer unit or other reactant.
    Reactant means a chemical substance that is used intentionally in 
the manufacture of a polymer to become chemically a part of the polymer 
composition.
    Reactive functional group means an atom or associated group of atoms 
in a chemical substance that is intended or can reasonably be 
anticipated to undergo further chemical reaction.
    Reasonably anticipated means that a knowledgeable person would 
expect a given physical or chemical composition or characteristic to 
occur based on such factors as the nature of the precursors used to 
manufacture the polymer, the type of reaction, the type of manufacturing 
process, the products produced in polymerization, the intended uses of 
the substance, or associated use conditions.
    (c) Applicability. This section applies to manufacturers of new 
chemical substances that otherwise must submit a premanufacture notice 
to EPA under Sec.  720.22 of this chapter. New substances are eligible 
for exemption under this section if they meet the definition of 
``polymer'' in paragraph (b) of this section, and the criteria in 
paragraph (e) of this section, and if they are not excluded from the 
exemption under paragraph (d) of this section.
    (d) Polymers that cannot be manufactured under this section--(1) 
Cationic polymers. A polymer cannot be manufactured under this section 
if the polymer is a cationic polymer as defined under paragraph (b) of 
this section or if the polymer is reasonably anticipated to become a 
cationic polymer in a natural aquatic environment (e.g., rivers, lakes) 
unless:
    (i) The polymer is a solid material that is not soluble or 
dispersible in water and will be used only in the solid phase (e.g., 
polymers that will be used as ion exchange beads), or
    (ii) The combined (total) functional group equivalent weight of 
cationic groups in the polymer is equal to or greater than 5,000.
    (2) Elemental limitations. (i) A polymer manufactured under this 
section must contain as an integral part of its composition at least two 
of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and 
sulfur.
    (ii) A polymer cannot be manufactured under this section if it 
contains as an integral part of its composition, except as impurities, 
any elements other than the following:
    (A) The elements listed in paragraph (d)(2)(i) of this section.
    (B) Sodium, magnesium, aluminum, potassium, calcium, chlorine, 
bromine, and iodine as the monatomic counterions Na = , 
Mg = 2, Al = 3, K = , 
Ca = 2, Cl-, Br-, or I-.
    (C) Fluorine, chlorine, bromine, and iodine covalently bound to 
carbon.
    (D) Less than 0.20 weight percent of any combination of the atomic 
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, 
copper, zinc, tin, and zirconium.
    (3) Polymers which degrade, decompose, or depolymerize. A polymer 
cannot be manufactured under this section if the polymer is designed or 
is reasonably anticipated to substantially degrade, decompose, or 
depolymerize, including those polymers that could substantially 
decompose after manufacture and use, even though they are not actually 
intended to do so. For the purposes of this section, degradation, 
decomposition, or depolymerization mean those types of chemical change 
that convert a polymeric substance into simpler, smaller substances, 
through processes including but not limited to oxidation, hydrolysis, 
attack by solvents, heat, light, or microbial action.
    (4) Polymers manufactured or imported from monomers and reactants 
not on the TSCA Chemical Substance Inventory. A polymer cannot be 
manufactured under this section if the polymer being manufactured or 
imported is prepared from monomers and/or other reactants (that are 
either charged to the reaction vessel or incorporated in the polymer at 
levels of greater than 2 weight percent) that are not already included 
on the TSCA Chemical Substance Inventory 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

[[Page 23]]

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.
    (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

[[Page 24]]

 
  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...............
  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

[[Page 25]]

 
  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
  1-Butanol................................  71-36-3**
  Cyclohexanol.............................  108-93-0
  Cyclohexanol, 4,4'-(1-                     80-04-6
   methylethylidene)bis-.
  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

[[Page 26]]

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 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.
    (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

[[Page 27]]

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 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; 87 FR 39769, July 5, 2022]

    Effective Date Note: At 88 FR 37173, June 7, 2023, Sec.  723.250 was 
amended by revising paragraphs (f) introductory text and (n), effective 
Aug. 7, 2023. For the convenience of the user, the revised text is set 
forth as follows:



Sec.  723.250  Polymers.

                                * * * * *

    (f) Exemption report for polymers manufactured under the terms of 
this section. For substances exempt under paragraphs (e)(1) through (3) 
of this section a report of manufacture or import must be submitted by 
January 31 of the year subsequent to initial manufacture. The report and 
accompanying claims must be submitted via CDX (https://cdx.epa.gov/), 
using the TSCA Section 5 Notices and Supports--ePMN application. See 
Sec.  720.40(a)(2)(ii) of this subchapter for information on how to 
access e-PMN software. The notice must include:

                                * * * * *

    (n) Confidentiality. Claims of confidentiality must be made in 
accordance with the procedures described in 40 CFR part 703.



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.

[[Page 28]]

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.
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.

[[Page 29]]

725.1079 Arsenic detecting strain of E. coli with extra-chromosomal 
          elements, including an intergeneric screening marker 
          (generic).
725.1080 Trichoderma reesei (generic).
725.1081 Trichoderma reesei modified (generic).

    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 Sec. Sec.  725.424 and 725.428), test marketing 
activities (see Sec.  725.300), and research and development activities 
described in paragraph (c) of this section.
    (c) Any manufacturer, importer, or processor required to file a MCAN 
for research and development (R&D) activities may instead file a TSCA 
Experimental Release Application (TERA) for a specific test (see Sec.  
725.250). A TERA is not required for certain R&D activities; however a 
TERA exemption does not extend beyond the research and development 
stage, to general commercial use of the microorganism, for which 
compliance with MCAN requirements is required. The TERA exemptions are 
for R&D activities subject to other Federal agencies or programs (see 
Sec.  725.232), certain kinds of contained R&D activities (see Sec.  
725.234), and R&D activities using certain listed microorganisms (see 
Sec.  725.238).
    (d) New microorganisms will be added to the Inventory established 
under section 8 of TSCA once a MCAN has been received, the MCAN review 
period has expired, and EPA receives a Notice of Commencement (NOC) 
indicating that manufacture or importation has actually begun. New 
microorganisms approved for use under a TERA will not be added to the 
Inventory until a MCAN has been received, the MCAN review period has 
expired, and EPA has received an NOC.



Sec.  725.3  Definitions.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as 
definitions contained in Sec. Sec.  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.

[[Page 30]]

    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.
    (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

[[Page 31]]

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'') 
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.
    Submerged standard industrial fermentation means a fermentation 
system that meets all of the following conditions:
    (1) Enzyme production is conducted under conditions of submerged 
fermentation (i.e., growth of the microorganism occurs beneath the 
surface of the liquid growth medium).
    (2) Any fermentation of solid plant material or insoluble 
substrates, to which T. reesei fermentation broth is added after the 
submerged standard industrial fermentation operations used for enzyme 
production is completed, may be initiated only after the inactivation of 
the microorganism as delineated in 40 CFR 725.422(d).
    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

[[Page 32]]

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.

[62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020]



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 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

[[Page 33]]

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 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

[[Page 34]]

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 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

[[Page 35]]

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 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,

[[Page 36]]

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.
    (i) Fees. Persons submitting MCANs and exemption requests to EPA 
under this part are subject to the applicable fees and conditions 
specified in Sec. Sec.  700.40, 700.45(c), and 700.49 of this chapter.

[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 78 
FR 72828, Dec. 4, 2013; 83 FR 52723, Oct. 17, 2018]



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 Sec. Sec.  
725.150 through 725.160.
    (b) Requirements specific to TERAs are described in Sec. Sec.  
725.250 through 725.260.
    (c) Requirements specific to test marketing exemptions (TMEs) are 
described in Sec. Sec.  725.350 and 725.355.
    (d) Requirements specific to Tier I and Tier II exemptions for 
certain general commercial uses are described in Sec. Sec.  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,

[[Page 37]]

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) The submitter does not remit the fees required by Sec.  
700.45(c) of this chapter.
    (10) The submitter does not include an identifying number and a 
payment identity number.
    (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:

[[Page 38]]

    (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; 83 
FR 52723, Oct. 17, 2018]



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]



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,

[[Page 39]]

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:
    (1) Will notify the submitter that EPA is extending the review 
period for a specified length of time and state the reasons for the 
extension.
    (2) For MCANs, EPA may issue a notice for publication in the Federal 
Register which states that EPA is extending the review period and gives 
the reasons for the extension.
    (c) The total period of the extension may be for a period of up to 
the same length of time as specified for each type of submission in 
Sec.  725.50. If the initial extension is for less than the total time 
allowed, EPA may make additional extensions. However, the sum of the 
extensions may not exceed the total allowed.
    (d) The following are examples of situations in which EPA may find 
that good cause exists for extending the review period:
    (1) EPA has reviewed the submission and is seeking additional 
information.

[[Page 40]]

    (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 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.

[[Page 41]]

    (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 Sec. Sec.  725.155 and 725.160.
    (ii) Exemption from TERA reporting under subpart E. Information 
requirements are set forth in Sec. Sec.  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 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

[[Page 42]]

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.''
    (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.

[[Page 43]]

    (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.

    Effective Date Note: At 88 FR 37173, June 7, 2023, Sec.  725.80 was 
revised, effective Aug. 7, 2023. For the convenience of the user, the 
revised text is set forth as follows:



Sec.  725.80  General provisions for confidentiality claims.

    Claims of confidentiality must be made in accordance with the 
procedures described in 40 CFR part 703, except as modified in this 
paragraph. In general, references to ``chemical'' or ``chemical 
identity'' in part 703 are equivalent to ``microorganism'' or 
``microorganism identity'' for the purposes of this part.
    (a) In place of Sec.  703.5(b)(3)(v) of this subchapter, the 
following question must be answered: Has EPA, another Federal agency, or 
court made any confidentiality determination regarding information 
associated with this microorganism? If yes, please provide the 
circumstances associated with the prior determination, whether the 
information was found to be entitled to confidential treatment, the 
entity that made the decision, and the date of the determination.
    (b) In place of Sec.  703.5(b)(4) of this subchapter, the following 
questions apply:
    (1) Has the identity of the microorganism been kept confidential to 
the extent that competitors do not know it is being manufactured or 
imported into US commerce? If not, explain why the microorganism 
identity should still be afforded confidential status (e.g., the 
microorganism is publicly known only as being distributed in commerce 
for research and development purposes, but no other information about 
the current commercial distribution of the microorganism in the United 
States is publicly available).
    (2) Does the microorganism leave the site of production or testing 
in a form which is accessible to the public or to competitors? If yes, 
please explain what measures have been taken to guard against the 
discovery of its identity. Further, what is the cost to a competitor, in 
time and money, to develop appropriate use conditions? What factors 
facilitate or impede product analysis?



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

[[Page 44]]

confidentiality with respect to the specific identity is denied in 
accordance with Sec.  725.92(c), EPA will deny a claim asserted under 
paragraph (a) of this section.
    (3) Development of generic name. Any person who asserts a claim of 
confidentiality for portions of the specific microorganism identity 
under this paragraph must provide one of the following items at the time 
the submission is filed:
    (i) The generic name which was accepted by EPA in the prenotice 
consultation conducted under paragraph (a)(4) of this section.
    (ii) One generic name that is only as generic as necessary to 
protect the confidential identity of the particular microorganism. The 
name should reveal the specific identity to the maximum extent possible. 
The generic name will be subject to EPA review and approval.
    (4) Determination by EPA. (i) Any person who intends to assert a 
claim of confidentiality for the specific identity of a new 
microorganism may seek a determination by EPA of an appropriate generic 
name for the microorganism before filing a submission. For this purpose, 
the person should submit to EPA:
    (A) The specific identity of the microorganism.
    (B) A proposed generic name(s) which is only as generic as necessary 
to protect the confidential identity of the new microorganism. The 
name(s) should reveal the specific identity of the microorganism to the 
maximum extent possible.
    (ii) Within 30 days, EPA will inform the submitter either that one 
of the proposed generic names is adequate or that none is adequate and 
further consultation is necessary.
    (5) Use of generic name. If a submitter claims microorganism 
identity as confidential under paragraph (a) of this section, and if the 
submitter complies with paragraph (a)(2) of this section, EPA will issue 
for publication in the 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.

[[Page 45]]

    (ii) Agree that EPA may disclose to a person with a bona fide intent 
to manufacture or import the microorganism the fact that the particular 
microorganism is included on the confidential Inventory for purposes of 
notification under section 5(a)(1)(A) of the Act.
    (iii) Have available and agree to furnish to EPA upon request the 
taxonomic designations and supplemental information required by Sec.  
725.12.
    (iv) Provide a detailed written substantiation of the claim, in 
accordance with the requirements of Sec.  725.94(b).
    (4) Denial of claim. If the submitter does not meet the requirements 
of paragraph (b) of this section, EPA will deny the claim of 
confidentiality.
    (5) Acceptance of claim. (i) EPA will publish a generic name on the 
public Inventory if:
    (A) The submitter asserts a claim of confidentiality in accordance 
with this paragraph.
    (B) No claim for confidentiality of the microorganism identity as 
part of a health and safety study has been denied in accordance with 
part 2 of this title or Sec.  725.92.
    (ii) Publication of a generic name on the public Inventory does not 
create a category for purposes of the Inventory. Any person who has a 
bona fide intent to manufacture or import a microorganism which is 
described by a generic name on the public Inventory may submit an 
inquiry to EPA under Sec.  725.15(b) to determine whether the particular 
microorganism is included on the confidential Inventory.
    (iii) Upon receipt of a request described in Sec.  725.15(b), EPA 
may require the submitter who originally asserted confidentiality for a 
microorganism to submit to EPA the information listed in paragraph 
(b)(3)(iii) of this section.
    (iv) Failure to submit any of the information required under 
paragraph (b)(3)(iii) of this section within 10 calendar days of receipt 
of a request by EPA under paragraph (b) of this section will constitute 
a waiver of the original submitter's confidentiality 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.

    Effective Date Note: At 88 FR 37173, June 7, 2023, Sec.  725.85 was 
removed, effective Aug. 7, 2023.



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

[[Page 46]]

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



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

    (a) Information other than specific microorganism identity. Except 
as provided in paragraph (b) of this section, EPA will deny any claim of 
confidentiality with respect to information included in a health and 
safety study of a microorganism, unless the information would disclose 
confidential business information concerning:
    (1) Processes used in the manufacture or processing of a 
microorganism.
    (2) Information which is not in any way related to the effects of a 
microorganism on health or the environment, such as, the name of the 
submitting company, cost or other financial data, product development or 
marketing plans, and advertising plans, for which the person submits a 
claim of confidentiality in accordance with Sec.  725.80.
    (b) Microorganism identity--(1) Claims applicable to the period 
prior to commencement of manufacture or import for general commercial 
use. A claim of confidentiality for the period prior to commencement of 
manufacture or import 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.

    Effective Date Note: At 88 FR 37174, June 7, 2023, Sec.  725.92 was 
removed, effective Aug. 7, 2023.



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.

[[Page 47]]

    (ii) If the submitter does not provide written substantiation as 
required in paragraph (a)(1)(i) of this section, the submission will be 
considered incomplete and the review period will not begin in accordance 
with Sec.  725.33.
    (2) TERA requirements. Any person who submits a TERA, should 
strictly limit confidentiality claims to that information which is 
confidential and proprietary to the business. If any information in such 
a submission is claimed as confidential business information, the 
submitter must have available for each of those claims, and agree to 
furnish to EPA upon request, written answers to the questions in 
paragraphs (d) and (e) of this section.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. (1) If a submitter 
claimed portions of the microorganism identity confidential in the MCAN 
and wants the identity to be listed on the confidential Inventory, the 
claim must be reasserted and substantiated at the time the Notice of 
Commencement (NOC) is submitted under Sec.  725.190. Otherwise, EPA will 
list the specific microorganism identity on the public Inventory.
    (2) The submitter must substantiate the claim for confidentiality of 
the microorganism identity by answering all of the questions in 
paragraphs (c), (d), and (e) in this section. In addition, the following 
questions must be answered:
    (i) What harmful effects to the company's or institution's 
competitive position, if any, would result if EPA publishes on the 
Inventory the identity of the microorganism? How could a competitor use 
such information given the fact that the identity of the microorganism 
otherwise would appear on the TSCA Inventory with no link between the 
microorganism and the company or institution? How substantial would the 
harmful effects of disclosure be? What is the causal relationship 
between the disclosure and the harmful effects?
    (ii) Has the identity of the microorganism been kept confidential to 
the extent that competitors do not know it 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?

[[Page 48]]

    (7) If EPA disclosed to the public the information claimed as 
confidential, how difficult would it be for the competitor to enter the 
market for the resulting product? Consider such constraints as capital 
and marketing cost, specialized technical expertise, or unusual 
processes.
    (d) Microorganism identity and production method. If confidentiality 
claims are asserted for the identity of the microorganism or information 
on how the microorganism is produced, the following questions must be 
answered:
    (1) Has the microorganism or method of production been patented in 
the U.S. or elsewhere? If so, why is confidentiality necessary?
    (2) Does the microorganism leave the site of production or testing 
in a form which is accessible to the public or to competitors? What is 
the cost to a competitor, in time and money, to develop appropriate use 
conditions? What factors facilitate or impede product analysis?
    (3) For each additional type of information claimed as confidential, 
explain what harm would result from disclosure of each type of 
information if the identity of the microorganism were to remain 
confidential.
    (e) Health and safety studies of microorganisms. If confidentiality 
claims are asserted for information in a health or safety study of a 
microorganism, the following questions must be answered:
    (1) Would the disclosure of the information claimed confidential 
reveal: confidential process information, or information unrelated to 
the effects of the microorganism on health and the environment. Describe 
the causal connection between the disclosure and harm.
    (2) Does the company or institution assert that disclosure of the 
microorganism identity is not necessary to interpret any health and 
safety studies which have been submitted? If so, explain how a less 
specific identity would be sufficient to interpret the studies.

    Effective Date Note: At 88 FR 37173, June 7, 2023, Sec.  725.94 was 
removed, effective Aug. 7, 2023.



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]

    Effective Date Note: At 88 FR 37174, June 7, 2023, Sec.  725.95 was 
revised, effective Aug. 7, 2023. For the convenience of the user, the 
revised text is set forth as follows:



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 
as confidential in accordance with this section. In addition, EPA may 
add materials to the public file, subject to subpart C of this part. 
Publicly available materials are available at the docket addresses in 
Sec.  700.17(b)(1) and (2) of this subchapter and on EPA's website.



   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

[[Page 49]]

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 Sec. Sec.  725.155 
and 725.160.
    (f) EPA review procedures specific to MCANs are set forth in Sec.  
725.170.
    (g) Subparts A through C of this part apply to any MCAN submitted 
under this subpart.



Sec.  725.105  Persons who must report.

    (a) Manufacturers of new microorganisms. (1) MCAN submission is 
required for any person who intends to manufacture for commercial 
purposes in the United States a new microorganism. Exclusions are 
described in Sec.  725.110.
    (2) If a person contracts with a manufacturer to produce or process 
a new microorganism and the manufacturer produces or processes the 
microorganism exclusively for that person, and that person specifies the 
identity of the microorganism, and controls the total amount produced 
and the basic technology for the plant process, then that person must 
submit the MCAN. If it is unclear who must report, EPA should be 
contacted to determine who must submit the MCAN.
    (3) Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a MCAN.
    (b) Importers of new microorganisms. (1) MCAN submission is required 
for a person who intends to import into the United States for commercial 
purposes a new microorganism. Exclusions are described in Sec.  725.110.
    (2) When several persons are involved in an import transaction, the 
MCAN must be submitted by the principal importer. If no one person fits 
the principal importer definition in a particular transaction, the 
importer should contact EPA to determine who must submit the MCAN for 
that transaction.
    (3) Except as otherwise provided in paragraph (b)(4) of this 
section, the provisions of this subpart D apply to each person who 
submits a MCAN for a new microorganism which such person intends to 
import for a commercial purpose. In addition, each importer must comply 
with paragraph (b)(4) of this section.
    (4) EPA will hold the principal importer, or the importer that EPA 
determines must submit the MCAN when 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

[[Page 50]]

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 
Sec. Sec.  725.155 and 725.160.
    (d) Recordkeeping. Each person who submits a MCAN under this subpart 
must comply with the recordkeeping requirements of Sec.  725.65.



Sec.  725.155  Information to be included in the MCAN.

    (a) Each person who is required by this part to submit a MCAN must 
include the information specified in paragraphs (c) through (h) of this 
section, to the extent it is known to or reasonably ascertainable by 
that person. However, no person is required to include information which 
relates solely to exposure of humans or ecological populations outside 
of the United States.
    (b) Each person should also submit, in writing, all other 
information known to or reasonably ascertainable by that person that 
would permit EPA to make a reasoned evaluation of the health and 
environmental effects of the microorganism, or any microbial mixture or 
article, including information on its effects on humans, animals, 
plants, and other microorganisms, and in the environment. The 
information to be submitted under this subpart includes the information 
listed in paragraphs (c) through (h) of this section relating to the 
manufacture, processing, distribution in commerce, use, and disposal of 
the new microorganism.
    (c) Submitter identification. (1) The name and headquarters address 
of the submitter.
    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (d) Microorganism identity information. Persons must submit 
sufficient information to allow the microorganism to be accurately and 
unambiguously identified for listing purposes as required by Sec.  
725.12.
    (1) Description of the recipient microorganism and the new 
microorganism. (i) 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

[[Page 51]]

of the introduced genetic material, including genetic maps of the 
introduced sequences.
    (3) Phenotypic and ecological characteristics. (i) Habitat, 
geographical distribution, and source of the recipient microorganism.
    (ii) Survival and dissemination under relevant environmental 
conditions including a description of methods for detecting the new or 
recipient microorganism(s) in the environment and the sensitivity limit 
of detection for these techniques.
    (iii) A description of anticipated biological interactions with and 
effects on target organisms and other organisms such as competitors, 
prey, hosts, symbionts, parasites, and pathogens; a description of host 
range; a description of pathogenicity, infectivity, toxicity, virulence, 
or action as a vector of pathogens; and capacity for genetic transfer 
under laboratory and relevant environmental conditions.
    (iv) A description of anticipated involvement in biogeochemical or 
biological cycling processes, involvement in rate limiting steps in 
mineral or nutrient cycling, or involvement in inorganic compounds 
cycling (such as possible sequestration or transformation of heavy 
metals).
    (e) Byproducts. A description of the byproducts resulting from the 
manufacture, processing, use, and disposal of the new microorganism.
    (f) Total production volume. The estimated maximum amount of the new 
microorganism intended to be manufactured or imported during the first 
year of production and the estimated maximum amount to be manufactured 
or imported during any consecutive 12-month period during the first 3 
years of production. This estimate may be by weight or volume and should 
include an estimation of viability (i.e., viable cells per unit volume 
or colony forming units per unit dry weight).
    (g) Use information. A description of intended categories of use by 
function and application, the estimated percent of production volume 
devoted to each category of use, and the percent of the new 
microorganism in the formulation for each commercial or consumer use.
    (h) Worker exposure and environmental release. (1) For sites 
controlled by the submitter:
    (i) The identity of sites where the new microorganism will be 
manufactured, processed, or used. For purposes of this section, the site 
for a person who imports a new microorganism is the site of the 
operating unit within the person's organization which is directly 
responsible for importing the new microorganism and which controls the 
import transaction. The import 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

[[Page 52]]

which worker exposure to and/or environmental release of the new 
microorganism will occur, the number of workers exposed and the duration 
of exposure; procedures for transport of the new microorganism and for 
disposal, including procedures for inactivation of the new 
microorganism; and control measures which limit worker exposure and 
environmental release.



Sec.  725.160  Submission of health and environmental effects data.

    (a) Test data on the new microorganism in the possession or control 
of the submitter. (1) Except as provided in Sec.  725.25(h), and in 
addition to the information required by Sec.  725.155(d)(3), each MCAN 
must contain all test data in the submitter's possession or control 
which are related to the effects on health or the environment of any 
manufacture, processing, distribution in commerce, use, or disposal of 
the new microorganism or any microbial mixture or article containing the 
new microorganism, or any combination of such activities. This includes 
test data concerning the new microorganism in a pure culture or 
formulated form as used or as intended to be used in one of the 
activities listed above.
    (2) A full report or standard literature citation must be submitted 
for the following types of test data:
    (i) Health effects data.
    (ii) Ecological effects data.
    (iii) Physical and chemical properties data.
    (iv) Environmental fate characteristics.
    (v) Monitoring data and other test data related to human exposure to 
or environmental release of the new microorganism.
    (3)(i) If the data do not appear in the open scientific literature, 
the submitter must provide a full report. A full report includes the 
experimental methods and materials, results, discussion and data 
analysis, conclusions, references, and the name and address of the 
laboratory that developed the data.
    (ii) If the data appear in the open scientific literature, the 
submitter need only provide a standard literature citation. A standard 
literature citation includes author, title, periodical name, date of 
publication, volume, and page numbers.
    (4)(i) If a study, report, or test is incomplete when a person 
submits a MCAN, the submitter must identify the nature and purpose of 
the study; name and address of the laboratory developing the data; 
progress to date; types of data collected, significant preliminary 
results; and anticipated completion date.
    (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.

[[Page 53]]

    (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 Sec. Sec.  725.28 through 725.60. In addition, the 
following procedures apply to EPA review of MCANs submitted under this 
subpart:
    (a) Length of the review period. The MCAN review period specified in 
section 5(a) of the Act runs for 90 days from the date the Document 
Control Officer for the Office of Pollution Prevention and Toxics 
receives a complete MCAN, or the date EPA determines the MCAN is 
complete under Sec.  725.33, unless the Agency extends the period under 
section 5(c) of the Act and Sec.  725.56.
    (b) Notice of expiration of MCAN review period. (1) EPA will notify 
the submitter that the MCAN review period has expired or that EPA has 
completed its review of the MCAN. Expiration of the review period does 
not constitute EPA approval or certification of the new microorganism, 
and does not mean that EPA may not take regulatory action against the 
microorganism in the future.
    (2) After expiration of the MCAN review period, in the absence of 
regulatory action by EPA under section 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

[[Page 54]]

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]

    Effective Date Note: At 88 FR 37174, June 7, 2023, Sec.  725.190 was 
amended by revising paragraph (c) and adding paragraphs (e) and (f), 
effective Aug. 7, 2023. For the convenience of the user, the added and 
revised text is set forth as follows:



Sec.  725.190  Notice of commencement of manufacture or import.

                                * * * * *

    (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 claims any 
information on the form as confidential, the claim must be asserted and 
substantiated in accordance with the requirements described in part 703 
of this subchapter and Sec.  725.80, as indicated in EPA Form 7710-56. 
If the submitter wants the microorganism identity to be listed on the 
confidential portion of the TSCA Inventory, the microorganism identity 
must be claimed as confidential and also follow the certification, 
substantiation, and generic name requirements described in part 703 of 
this subchapter and paragraphs (e) and (f) of this section.

                                * * * * *

    (e) Requirements for assertion. Any person who asserts a 
confidentiality claim for microorganism identity must:
    (1) Comply with the requirements of paragraph (f) of this section 
regarding submission of a generic name.
    (2) 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 TSCA Inventory for 
purposes of notification under section 5(a)(1)(A) of the Act.
    (3) Have available and agree to furnish to EPA upon request the 
taxonomic designations and supplemental information required by Sec.  
725.12.
    (4) Make claims of confidentiality in accordance with the procedures 
described in 40 CFR part 703.
    (f) Generic name. If a submitter asserts a claim of confidentiality 
for microorganism identity in a notice of commencement, they must 
provide a generic name.
    (1) Generic names must:
    (i) Be structurally descriptive (e.g., not a trade name); and
    (ii) Be consistent with guidance on the determination of 
structurally descriptive generic names, developed in accordance with 
section 14(c)(4)(A) of the Act (e.g., Guidance for Creating Generic 
Names for Confidential Chemical Substance Identity Reporting under 
TSCA). Generic names for microorganisms may only mask the portion of 
microorganism identity that the submitter believes is proprietary 
(considering that the identity of a microorganism to be listed on the 
TSCA Inventory must include taxonomic designations (genus, species, and 
strain), key phenotypic traits, key genotypic traits and modifications, 
genetic material that has been introduced or modified, any vector 
constructs used, cellular location of introduced or modified genes, 
number and type of genes introduced or modified, and method of 
construction or modification). Taxonomic designation (in most cases down 
to strain) must be included in the generic name except where the 
submitter claims the taxonomic designation confidential, in which case 
the person making such claim must provide an explanation of why such 
masking is necessary to protect proprietary information. Additionally, 
the generic microorganism identity must include a statement regarding 
the function and stability of the genetic construct. This includes an 
indication of whether the introduced or modified genes are present on 
the chromosome or extrachromosomal.
    (2) Generic names will be reviewed by EPA at the time of submission.
    (i) If EPA concludes that a proposed generic name meets the criteria 
in paragraph (f)(1) of this section, EPA will include that generic name 
in the public TSCA Inventory listing for that substance.
    (ii) If the proposed generic name does not meet the criteria in 
paragraph (f)(1) of this section, EPA will notify the submitter 
concerning the deficiency via CDX, as described in Sec.  703.5(h) of 
this subchapter. EPA will provide ten business days to correct the 
deficiency and provide an alternative generic name that would be 
acceptable to EPA. If the alternative generic name proposed by EPA is 
acceptable to the submitter (or if the submitter does not respond within 
the ten-day period), EPA will place that alternative

[[Page 55]]

generic name on the public TSCA Inventory. If the alternative generic 
name proposed by EPA is not acceptable to the submitter, the submitter 
must submit a revised generic name that meets the criteria in paragraph 
(f)(1) of this section and an explanation of how EPA's proposed generic 
name reveals confidential information. If EPA concludes that the revised 
generic name also does not meet the criteria in paragraph (f)(1) of this 
section, EPA will hold the notice of commencement for a period of up to 
10 business days. Reporting requirements will not be considered to have 
been met and the microorganism will not be added to the TSCA Inventory 
during this period. If the submission remains deficient after this 10-
day period, EPA will proceed with CBI review of the microorganism 
identity claim and will likely deny the claim.



      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 Sec. Sec.  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 Sec. Sec.  725.255 
and 725.260.
    (f) EPA review procedures specific for TERAs are set forth in 
Sec. Sec.  725.270 and 725.288.
    (g) Subparts A through C of this part apply to any submission under 
this subpart.



Sec.  725.205  Persons who may report under this subpart.

    (a) Commercial research and development activities involving new 
microorganisms or significant new uses of microorganisms are subject to 
reporting under this part unless they qualify for an exemption under 
this part.
    (b) Commercial purposes for research and development means that the 
activities are conducted with the purpose of obtaining an immediate or 
eventual commercial advantage for the researcher and would include:
    (1) All research and development activities which are funded 
directly, in whole or in part, by a commercial entity regardless of who 
is actually conducting the research. Indications that the research and 
development activities are funded directly, in whole or in part, may 
include, but are not limited to:
    (i) Situations in which a commercial entity contracts directly with 
a university or researcher; or
    (ii) Situations in which a commercial entity gives a conditional 
grant where the commercial entity holds patent 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

[[Page 56]]

conditions for the exemptions described in Sec. Sec.  725.232, 725.234, 
or 725.238 is exempt from TERA reporting under this subpart.
    (d) A microorganism is not exempt from reporting under subpart D of 
this part if any amount of the microorganism, including as part of a 
mixture, is processed, distributed in commerce, or used, for any 
commercial purpose other than research and development.
    (e) Quantities of the inactivated microorganism, or mixtures or 
articles containing the inactivated microorganism, remaining after 
completion of research and development activities may be disposed of as 
a waste in accordance with applicable Federal, State, and local 
regulations.
    (f) A person who manufactures, imports, or processes a microorganism 
solely for research and development is not required to comply with the 
requirements of this section if:
    (1) The person is manufacturing a microbial pesticide identified in 
Sec.  172.45(c), or
    (2) The person is manufacturing a microbial pesticide for which an 
Experimental Use Permit is required, pursuant to Sec.  172.3; or
    (3) The person is manufacturing a microbial pesticide for which a 
notification or an Experimental Use Permit is not required to be 
submitted.



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

    This part does not apply to any research and development activity 
that meets all of the following conditions.
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec.  725.3.
    (c)(1) The person receives research funds from another Federal 
agency, and the funds are awarded on the condition that the research 
will be conducted in accordance with the relevant portions of the NIH 
Guidelines, or
    (2) A Federal agency or program otherwise imposes the legally 
binding requirement that the research is to be conducted in accordance 
with relevant portions of the NIH Guidelines.



Sec.  725.234  Activities conducted inside a structure.

    A person who manufactures, imports, or processes a microorganism is 
not subject to the reporting requirements under subpart D of this part 
if all of the following conditions are met:
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) The microorganism is used by, or directly under the supervision 
of, a technically qualified individual, as defined in Sec.  725.3. The 
technically qualified individual must maintain documentation of the 
procedures selected to 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

[[Page 57]]

containment/inactivation controls selected under paragraph (d)(1) of 
this section must be made upon EPA order. Failure to comply with EPA's 
order shall result in automatic loss of eligibility for an exemption 
under this section.
    (e) The manufacturer, importer, or processor notifies all persons in 
its employ or to whom it directly distributes the microorganism, who are 
engaged in experimentation, research, or analysis on the microorganism, 
including the manufacture, processing, use, transport, storage, and 
disposal of the microorganism associated with research and development 
activities, of any risk to health, identified under Sec.  725.235(a), 
which may be associated with the microorganism. The notification must be 
made in accordance with Sec.  725.235(b).



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

    (a) Determination of risks. To determine whether notification under 
Sec.  725.234(e) is required, the manufacturer, importer, or processor 
must do one of the following:
    (1) For research conducted in accordance with the NIH Guidelines, 
the manufacturer, importer, or processor must meet the conditions laid 
out at IV-B-4-d of the NIH Guidelines; or
    (2) For all other research conducted in accordance with Sec.  
725.234, the manufacturer, importer, or processor must review and 
evaluate the following information to determine whether there is reason 
to believe there is any risk to health which may be associated with the 
microorganism:
    (i) Information in its possession or control concerning any 
significant adverse reaction of persons exposed to the microorganism 
which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer, importer, or 
processor by a supplier or any other person concerning a health risk 
believed to be associated with the microorganism.
    (iii) Health and environmental effects data in its possession or 
control concerning the microorganism.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under TSCA section 4, 5, or 6 of the Act that applies to 
the microorganism and of which the manufacturer, importer, or processor 
has knowledge.
    (b) Notification to employees and others. (1) The manufacturer, 
importer, or processor must notify the persons identified in Sec.  
725.234(e) by means of a container labeling system, conspicuous 
placement of notices in areas where exposure may occur, written 
notification to each person potentially exposed, or any other method of 
notification which adequately informs persons of health 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

[[Page 58]]

initiation of the experiment, documentation of the exemption, along with 
standard laboratory records, shall satisfy the recordkeeping requirement 
specified in Sec.  725.234(d)(3).
    (ii) Documentation of how the following requirements are satisfied 
under the NIH Guidelines:
    (A) Copies or citations to information reviewed and evaluated to 
determine the need to make any notification of risk.
    (B) Documentation of the nature and method of notification of risk, 
including copies of any labels or written notices used.
    (C) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the microorganism, the amount distributed, 
and copies of the notifications required.
    (2) For all other research conducted in accordance with Sec.  
725.234, a person who manufacturers, imports, or processes a 
microorganism under this section, must maintain the following records:
    (i) Records describing selection and use of containment and/or 
inactivation controls required by Sec.  725.234(d)(3) and certification 
by an authorized official required by Sec.  725.234(d)(2) for each 
microorganism.
    (ii) Copies or citations to information reviewed and evaluated under 
paragraph (a) of this section to determine the need to make any 
notification of risk.
    (iii) Documentation of the nature and method of notification under 
paragraph (b)(1) of this section, including copies of any labels or 
written notices used.
    (iv) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the microorganism, the amount distributed, 
and copies of the notifications required under paragraph (b)(2) of this 
section.



Sec.  725.238  Activities conducted outside a structure.

    (a) Exemption. (1) Research and development activities involving 
intentional testing in the environment of certain microorganisms listed 
in Sec.  725.239 may be conducted without prior review by EPA if all of 
the conditions of this section and Sec.  725.239 are met.
    (2) The research and development activity involving a microorganism 
listed in Sec.  725.239 must be conducted by, or directly under the 
supervision of, a technically qualified individual, as defined in Sec.  
725.3.
    (b) Certification. To be eligible for the exemption under this 
section, a manufacturer or importer must submit to EPA prior to 
initiation of the activity a document signed by an authorized official 
containing the following information:
    (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:

[[Page 59]]

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



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 
Sec. Sec.  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

[[Page 60]]

terms of the TERA approval, as well as the conditions described in the 
TERA.
    (f) Recordkeeping. Persons submitting a TERA must comply with the 
recordkeeping requirements of Sec.  725.65. In addition, the following 
requirements apply to TERAs:
    (1) Each person submitting a TERA under this part must retain 
documentation of information contained in the TERA for a period of 3 
years from the date that the results of the study are submitted to the 
Agency.
    (2) Summaries of all data, conclusions, and reports resulting from 
the conduct of the research and development activity under the TERA must 
be submitted to the EPA address identified in Sec.  725.25(c) within 1 
year of the termination of the activity.



Sec.  725.255  Information to be included in the TERA.

    (a) To review a TERA, EPA must have sufficient information to permit 
a reasoned evaluation of the health and environmental effects of the 
planned test in the environment. The person seeking EPA approval must 
submit all information known to or reasonably ascertainable by the 
submitter on the microorganism(s) and the research and development 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will be useful for EPA's 
risk assessment. The TERA must be in writing and must include at least 
the information described in the following paragraphs.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TERA, must include the submitter 
identification and microorganism identity information required for MCANs 
in Sec.  725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TERA must submit phenotypic and 
ecological characteristics information required in Sec.  725.155(d)(3) 
as it relates directly to the conditions of the proposed research and 
development activity.
    (e) Persons applying for a TERA must also submit the following 
information about the proposed research and development activity:
    (1) A detailed description of the proposed research and development 
activity. (i) The objectives and significance of the activity and a 
rationale for testing the microorganisms in the environment.
    (ii) Number of microorganisms released (including viability per 
volume if applicable) and the method(s) of application or release.
    (iii) Characteristics of the test site(s), including location, 
geographical, physical, chemical, and biological features, proximity to 
human habitation or activity, and description 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.

[[Page 61]]



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 Sec. Sec.  725.28 through 725.60. In addition, the 
following procedures apply to EPA review of applications submitted under 
this subpart:
    (a) Length of the review period. (1) The review period for the TERA 
will be 60 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete TERA, or 
the date EPA determines the TERA is complete under Sec.  725.33, unless 
EPA finds good cause for an extension under Sec.  725.56.
    (2) A submitter shall not proceed with the research and development 
activity described in the TERA unless and until EPA provides written 
approval of the TERA. A submitter may receive early approval if a review 
is completed in less than 60 days.
    (b) EPA decision regarding proposed TERA activity. (1) A decision 
concerning a TERA under this subpart will be made by the Administrator, 
or a designee.
    (2) If EPA determines that the proposed research and development 
activity for the microorganism does not present an unreasonable risk of 
injury to health or the environment, EPA will notify the submitter that 
the TERA is approved and that the submitter can proceed with the 
proposed research and development activity described in the TERA.
    (3) EPA may include requirements and conditions in its approval of 
the TERA that would be stated in the TERA approval under paragraph (c) 
of this section.
    (4) If EPA concludes that it cannot determine that the proposed 
research and development activity described in the TERA will not present 
an unreasonable risk of injury to health or the environment, EPA will 
deny the TERA and will provide reasons for the denial in writing.
    (c) TERA approval. (1) A TERA approval issued by EPA under this 
section is legally binding on the TERA submitter.
    (2) When EPA approves a TERA, the submitter must conduct the 
research and development activity only as described in the TERA and in 
accordance with any requirements and conditions prescribed by EPA in its 
approval of the TERA.
    (3) Any person who fails to conduct the research and development 
activity 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

[[Page 62]]

which must be followed by the submitter.
    (ii) If EPA determines that it can no longer conclude that the 
activity will not present an unreasonable risk of injury to health or 
the environment, it will notify the submitter in writing that EPA is 
revoking its approval and state its reasons. In that event, the 
submitter must terminate the research and development activity within 48 
hours of receipt of the notice in accordance with directions provided by 
EPA in the notice.
    (b) Evidence of unreasonable risk. (1) If, after approval of a TERA 
under this subpart, EPA determines that the proposed research and 
development activity will present an unreasonable risk of injury to 
health or the environment, EPA will notify the submitter in writing and 
state its reasons.
    (2) In the notice, EPA may prescribe additional safeguards to 
address or reduce the risk, or may instruct the submitter to suspend the 
research and development activities.
    (3) Within 48 hours, the submitter must implement the instructions 
contained in the notice. The submitter may then submit additional 
information or arguments concerning the matters raised by EPA and 
whether EPA should modify or revoke the approval of the TERA in 
accordance with paragraph (a)(2) of this section.
    (4) EPA will consider the information and arguments in accordance 
with paragraph (a)(3) of this section.
    (5) Following consideration of the information and arguments under 
paragraph (a)(3) of this section, if EPA notifies the submitter that the 
R&D activity must be suspended or terminted, the submitter may resume 
the activity only upon written notice from EPA that EPA has approved 
resumption of the activity. In approving resumption of an activity, EPA 
may prescribe additional conditions which must be followed by the 
submitter.
    (c) Modifications. If, after approval of a TERA under this subpart, 
the submitter concludes that it is necessary to alter the conduct of the 
research and development activity in a manner which would result in the 
activity being different from that described in the TERA agreement and 
any conditions EPA prescribed in its approval, the submitter must inform 
the EPA contact for the TERA and may not modify the activity without the 
approval of EPA.



                 Subpart F_Exemptions for Test Marketing



Sec.  725.300  Scope and purpose.

    (a) This subpart describes exemptions from the reporting 
requirements under subpart D of this part for test marketing activities 
involving microorganisms.
    (b) In lieu of complying with subpart D of this part, persons 
described in Sec.  725.305 may submit an application for a test 
marketing exemption (TME).
    (c) Submission requirements specific for TME applications are 
described at Sec.  725.350.
    (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:

[[Page 63]]

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



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

    (a) To review a TME application, EPA must have sufficient 
information to permit a reasoned evaluation of the health and 
environmental effects of the planned test marketing activity. The person 
seeking EPA approval must submit all information known to or reasonably 
ascertainable by the person on the microorganism and the test marketing 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will demonstrate that the 
microorganism will not present an unreasonable risk of injury to health 
or the environment as a result of the test marketing. The TME 
application must be in writing and must include at least the information 
described in paragraphs (b), (c), (d), and (e) of this section.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TME must submit the submitter 
identification and microorganism identity information required for MCANs 
in Sec.  725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TME must submit phenotypic and ecological 
characteristics information required in Sec.  725.155(d)(3) as it 
relates directly to the conditions of the proposed test marketing 
activity.
    (e) Persons applying for a TME must also submit the following 
information about the proposed test marketing activity:
    (1) Proposed test marketing activity. (i) The maximum quantity of 
the microorganism which the applicant will manufacture or import for 
test marketing.
    (ii) The maximum number of persons who may be provided the 
microorganism during test marketing.
    (iii) The maximum number of persons who may be exposed to the 
microorganism as a result of test marketing, including information 
regarding duration and route of such exposures.
    (iv) A description of the test marketing activity, including its 
duration and how it can be distinguished from full-scale commercial 
production and research and development activities.
    (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 Sec. Sec.  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.

[[Page 64]]

    (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 
Sec. Sec.  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.
    (k) Trichoderma reesei strain QM6a and its derivatives used only in 
submerged standard industrial fermentation operations as defined at 40 
CFR 725.3.
    (l) Bacillus amyloliquefaciens subsp. amyloliquefaciens.

[62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020]



Sec.  725.421  Introduced genetic material.

    For a new microorganism to qualify for either exemption under this 
subpart, introduced genetic material must meet all of the criteria 
listed in this section.
    (a) Limited in size. The introduced genetic material must consist 
only of the following:
    (1) The structural gene(s) of interest.
    (2) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (3) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (4) The nucleotide sequences needed for vector transfer.
    (5) The nucleotide sequences needed for vector maintenance.
    (b) Well-characterized. For introduced genetic material, well-
characterized means that the following have been determined:
    (1) The function of all of the products expressed from the 
structural gene(s).
    (2) The function of sequences that participate in the regulation of 
expression of the structural gene(s).
    (3) The presence or absence of associated nucleotide sequences and 
their associated functions, where associated nucleotide sequences are 
those sequences needed to move genetic material including linkers, 
homopolymers, adaptors, transposons, insertion sequences, and 
restriction enzyme sites.
    (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

[[Page 65]]

elongation factor 2, leading to inhibition of protein synthesis in 
target respiratory, heart, kidney, and nerve tissues. Indirectly 
contributes to toxic effects in humans means a sequence whose encoded 
polypeptide is not directly toxic to target cells, yet still adversely 
affects humans. An example of a sequence which indirectly contributes to 
toxic effects is the sequence which encodes the portion of the botulinum 
toxin, listed in paragraph (d)(3) of this section, capable of blocking 
the release of acetylcholine from gangliosides. Botulinum toxin affects 
neuromuscular junctions by its blockage of acetylcholine release, 
leading to irreversible relaxation of muscles and respiratory arrest.
    (B) It binds a toxin or toxin precursor to target human cells.
    (C) It facilitates intracellular transport of a toxin in target 
human cells.
    (ii) While these toxins are listed (with synonyms in parentheses) in 
paragraphs (d)(2) through (d)(7) of this section according to the source 
organism, it is use of the nucleotide sequences that encode the toxins 
that is being restricted and not the use of the source organisms. The 
source organisms are listed to provide specificity in identification of 
sequences whose use is restricted. Although similar or identical 
sequences may be isolated from organisms other than those listed below 
in paragraphs (d)(2) through (d)(7) of this section, these comparable 
toxin sequences, regardless of the organism from which they are derived, 
must not be included in the introduced genetic material.
    (2) Sequences for protein synthesis inhibitor.

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

    (3) Sequences for neurotoxins.

 
              Sequence Source                        Toxin Name
 
Clostridium botulinum                       Neurotoxins A, B, C1, D, E,
                                             F, G (Botulinum toxins,
                                             botulinal toxins)
Clostridium tetani                          Tetanus toxin
                                             (tetanospasmin)
Proteus mirabilis                           Neurotoxin
Staphylococcus aureus                       Alpha toxin (alpha lysin)
Yersinia pestis                             Murine toxin
 
  Snake toxins                              ............................
Bungarus caeruleus                          Caeruleotoxin
Bungarus multicinctus                       Beta-bungarotoxin
                                             (phospholipase)
Crotalus spp.                               Crotoxin (phospholipase)
Dendroaspis viridis                         Neurotoxin
Naja naja varieties                         Neurotoxin
Notechia scutatus                           Notexin (phospholipase)
Oxyuranus scutellatus                       Taipoxin
 
  Invertebrate toxins
Chironex fleckeri                           Neurotoxin
Androctnus australis                        Neurotoxin
Centruroides sculpturatus                   Neurotoxin
 

    (4) Sequences for oxygen labile cytolysins.

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

    (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.

[[Page 66]]



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

    (7) Sequences that are general cytotoxins.

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



Sec.  725.422  Physical containment and control technologies.

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



Sec.  725.424  Requirements for the Tier I exemption.

    (a) Conditions of exemption. The manufacture or import of a new 
microorganism for commercial purposes is not subject to review under 
this part if all of the following conditions are met for all activities 
involving the new microorganism:
    (1) The recipient microorganism is listed in and meets any 
requirements specified in Sec.  725.420.
    (2) The introduced genetic material meets the criteria under Sec.  
725.421.
    (3) The physical containment and control technologies of any 
facility in which the microorganism will be manufactured, processed, or 
used meet the criteria under Sec.  725.422.
    (4) The manufacturer or importer submits a certification described 
in paragraph (b) of this section to EPA at least 10 days before 
commencing initial manufacture or import of a new microorganism derived 
from a recipient microorganism listed in Sec.  725.420.
    (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.

[[Page 67]]

    (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 Sec. Sec.  
725.420, 725.421, and 725.422.



Sec.  725.428  Requirements for the Tier II exemption.

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



Sec.  725.450  Procedural requirements for the Tier II exemption.

    General requirements for all submissions under this part are 
contained in Sec.  725.25. In addition, the following requirements apply 
to requests submitted under this subpart:
    (a) Prenotice consultation. EPA strongly suggests that for a Tier II 
exemption, the submitter contact the Agency for a prenotice consultation 
regarding eligibility for the exemption.
    (b) When to submit the Tier II exemption request. Each person who is 
eligible to submit a Tier II exemption request under this subpart must 
submit the request at least 45 calendar days before the person intends 
to commence manufacture or import.
    (c) Contents of the Tier II exemption request. Each person who 
submits a request under this subpart must provide the information 
described in Sec. Sec.  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.

[[Page 68]]

    (2) The name, address, and office telephone number (including area 
code) of the principal technical contact representing the submitter.
    (b) Microorganism identity information. (1) Identification (genus, 
species, and strain) of the recipient microorganism. Genus, species 
designation should be substantiated by a letter from a culture 
collection or a brief summary of the results of tests conducted for 
taxonomic identification.
    (2) Type of genetic modification and the function of the introduced 
genetic material.
    (3) Site of insertion.
    (4) Certification of compliance with the introduced genetic material 
criteria described in Sec.  725.421.
    (c) Production volume. Production volume, including total liters per 
year, and the maximum cell concentration achieved during the production 
process.
    (d) Process and containment information. (1) A description of the 
process including the following:
    (i) Identity and location of the manufacturing site(s).
    (ii) Process flow diagram illustrating the production process, 
including downstream separations, and indicating the containment 
envelope around the appropriate equipment.
    (iii) Identities and quantities of feedstocks.
    (iv) Sources and quantities of potential releases to both the 
workplace and environment, and a description of engineering controls, 
inactivation procedures, and other measures which will reduce worker 
exposure and environmental releases.
    (v) A description of procedures which will be undertaken to prevent 
fugitive emissions, i.e. leak detection and repair program.
    (vi) A description of procedures/safeguards to prevent and mitigate 
accidental releases to the workplace and the environment.
    (2) Certification of those elements of the containment criteria 
described in Sec.  725.422 with which the manufacturer is in compliance, 
including stating by number the elements with which the manufacturer is 
in full compliance.
    (e) The site of waste disposal and the type of permits for disposal, 
the permit numbers and the institutions issuing the permits.
    (f) The certification statement required in Sec.  725.25(b). 
Certification of submission of test data is not required for the Tier II 
exemption.



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

    General procedures for review of all submissions under this part are 
contained in Sec. Sec.  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.

[[Page 69]]

    (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.
    (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 Sec. Sec.  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

[[Page 70]]

in the specific section in subpart M of this part.
    (b) The manufacturer, importer, or processor described in paragraph 
(a) of this section must submit a MCAN under subpart D of this part, if 
such person has knowledge at the time of commercial distribution of the 
microorganism identified in the specific section in subpart M of this 
part that a recipient intends to engage in a designated significant new 
use of that microorganism without submitting a MCAN under this part.
    (c) A person who processes a microorganism identified in a specific 
section in subpart M of this part for a significant new use of that 
microorganism is not required to submit a MCAN if that person can 
document each of the following:
    (1) That the person does not know the specific microorganism 
identity of the microorganism being processed, and
    (2) That the person is processing the microorganism without 
knowledge that the microorganism is identified in subpart M of this 
part.
    (d)(1) If at any time after commencing distribution in commerce of a 
microorganism identified in a specific section in subpart M of this 
part, a person who manufactures, imports, or processes a microorganism 
described in subpart M of this part and distributes it in commerce has 
knowledge that a recipient of the microorganism is engaging in a 
significant new use of that microorganism designated in that section 
without submitting a MCAN under this part, the person is required to 
cease supplying the microorganism to that recipient and to submit a MCAN 
for that microorganism and significant new use, unless the person is 
able to document each of the following:
    (i) That the person has notified the recipient and EPA enforcement 
authorities (at the address in paragraph (d)(1)(iii) of this section), 
in writing within 15 working days of the time the person develops 
knowledge that the recipient is engaging in a significant new use, that 
the recipient is engaging in a significant new use without submitting a 
MCAN.
    (ii) That, within 15 working days of notifying the recipient as 
described in paragraph (d)(1)(i) of this section, the person received 
from the recipient, in writing, a statement of assurance that the 
recipient is aware of the terms of the applicable section in subpart M 
of this part and will not engage in the significant new use.
    (iii) That the person has promptly provided EPA enforcement 
authorities with a copy of the recipient's statement of assurance 
described in paragraph (d)(1)(ii) of this section. The copy must be sent 
to the Director, Office of Compliance (2221A), Environmental Protection 
Agency, 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.

[[Page 71]]



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 Sec. Sec.  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, Sec. Sec.  725.105 and 725.910 apply and Sec.  725.920 
continues to apply. EPA will provide the MCAN submitter with written 
notification of compliance only if one of the following occurs:
    (1) EPA is unable to make the finding that the activities described 
in the MCAN will or may present an unreasonable risk of injury to health 
or the environment under reasonably foreseeable circumstances, or
    (2) EPA and the person negotiate a consent order under section 5(e) 
of the Act, such order to take effect on the effective date of the 
section in subpart M of this part which identifies the microorganism.
    (b) The person is operating under the terms of a consent order 
issued under section 5(e) of the Act applicable to that person. If a 
provision of such section 5(e) order is inconsistent with a specific 
significant new use identified in subpart M of this part, abiding by the 
provision of the section 5(e) order exempts the person from submitting a 
MCAN for that specific significant new use.



Sec.  725.920  Exports and imports.

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

[[Page 72]]



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 pertains to the microorganism for which the request 
is being submitted.
    (7) The data and information described in Sec. Sec.  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.

[[Page 73]]

    (2) If EPA determines that significant new use notifications 
requirements are not needed for a microorganism that is subject to a 
final order issued under section 5(e) of the Act, EPA will issue a 
notice in the Federal Register explaining why the significant new use 
requirements are not needed.
    (b) Designation of requirements. (1) The significant new use 
notification and other specific requirements will be based on and be 
consistent with the provisions included in the final order issued for 
the microorganism under section 5(e) of the Act. EPA may also designate 
additional activities as significant new uses which will be subject to 
notification.
    (2) Significant new use requirements and other specific requirements 
designated under this section will be listed in subpart M of this part. 
For each microorganism, subpart M of this part will identify:
    (i) The microorganism name.
    (ii) The activities designated as significant new uses.
    (iii) Other specific requirements applicable to the microorganism, 
including recordkeeping requirements or any other requirements included 
in the final section 5(e) order.
    (c) Procedures for issuing significant new use rules--(1) Possible 
processes. EPA will issue significant new use rules (SNURs) under this 
section by one of the following three processes: direct final 
rulemaking, interim final rulemaking, or notice and comment rulemaking. 
EPA will use the direct final rulemaking process to issue significant 
new use rules unless it determines that, in a particular case, one of 
the other processes is more appropriate.
    (2) Notice in the Federal Register. Federal Register documents 
issued to propose or establish significant new uses under this section 
will contain the following:
    (i) The microorganism identity or, if its specific identity is 
claimed confidential, an appropriate generic microorganism name and an 
accession number assigned by EPA.
    (ii) The MCAN number.
    (iii) A summary of EPA's findings under section 5(e)(1)(A) of the 
Act for the final order issued under section 5(e).
    (iv) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (v) Any modification of subpart L of this part applicable to the 
specific microorganism and significant new uses.
    (vi) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (3) Direct final rulemaking. (i) EPA will use direct final 
rulemaking to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. EPA will issue a final rule in the Federal Register 
following its decision to develop a significant new use rule under this 
section for a specific new microorganism.
    (ii) The Federal Register document will state that, unless written 
notice is 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

[[Page 74]]

final rule adding the microorganism to subpart M of this part and 
designating the significant new uses subject to notification.
    (4) Interim final rulemaking. (i) EPA will use the interim final 
rulemaking procedure to issue a significant new use rule, when specific 
requirements will be based on and be consistent with the provisions 
included in the final order issued for the microorganism under section 
5(e) of the Act. The Agency will issue an interim final rule in the 
Federal Register following its decision to develop a significant new use 
rule for a specific new microorganism. The document will state EPA's 
reasons for using the interim final rulemaking procedure.
    (A) The significant new use rule will take effect on the date of 
publication.
    (B) Persons will be given 30 days from the date of publication to 
submit comments.
    (ii) Interim final rules issued under this section shall cease to be 
in effect 180 days after publication unless, within the 180-day period, 
EPA issues a final rule in the Federal Register responding to any 
written comments received during the 30-day comment period specified in 
paragraph (c)(4)(i)(B) of this section and promulgating final 
significant new use notification requirements and other requirements for 
the microorganism.
    (5) Notice and comment rulemaking. (i) EPA will use a notice and 
comment procedure to issue a significant new use rule, when EPA is 
designating additional activities which are not provisions included in 
the final order issued for the microorganism under section 5(e) of the 
Act as significant new uses which will be subject to notification. EPA 
will issue a proposal in the Federal Register following its decision to 
develop a significant new use rule under this section for a specific new 
microorganism. Persons will be given 30 days to comment on whether EPA 
should establish notification requirements for the microorganism under 
this part.
    (ii) If EPA, having considered any timely comments, decides to 
establish notification requirements under this section, EPA will issue a 
final rule adding the microorganism to subpart M of this part and 
designating the significant new uses subject to notification.
    (d) Schedule for issuing significant new use rules. (1) Unless EPA 
determines that a significant new use rule should not be issued under 
this section, EPA will issue a proposed rule, a direct final rule, or an 
interim final rule within 180 days of receipt of a valid notice of 
commencement under Sec.  725.190.
    (2) If EPA receives adverse or critical significant comments 
following publication of a proposed or interim final rule, EPA will 
either withdraw the rule or issue a final rule addressing the comments 
received.



Sec.  725.984  Modification or revocation of certain notification
requirements.

    (a) Criteria for modification or revocation. EPA may at any time 
modify or revoke significant new use notification requirements for a 
microorganism which has been added to subpart M of this part using the 
procedures of Sec.  725.980. Such action may be taken under this section 
if EPA makes one of the following determinations, unless other 
information shows that the requirements should be retained:
    (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

[[Page 75]]

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, 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]



Sec.  725.1079  Arsenic detecting strain of E. coli with extra-chromosomal
elements, including an intergeneric screening marker (generic).

    (a) Microorganism and significant new uses subject to reporting. (1) 
The genetically-modified microorganism identified generically as arsenic 
detecting strain of E. coli with extra-chromosomal elements, including 
an intergeneric screening marker (MCAN J-18-41) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) It is a significant new use to manufacture (excluding import) 
the microorganism in the United States for any use.
    (ii) It is a significant new use to use the microorganism other than 
to detect arsenic in small water samples.

[[Page 76]]

    (b) Specific requirements. The provisions of subpart L of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
725.950(b)(2) through (4) are applicable to manufacturers and processors 
of this microorganism.
    (2) Modification or revocation of certain notification requirements. 
The provisions of Sec.  725.984 apply to this section.

[86 FR 24336, May 6, 2021]



Sec.  725.1080  Trichoderma reesei (generic).

    (a) Microorganism and significant new uses subject to reporting. (1) 
The genetically modified microorganism identified as Trichoderma reesei 
strain 3CH-3 (MCAN J-19-1) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2)(i) The significant new use is any manufacturing, processing, or 
use of the microorganism other than in a fermentation system that meets 
all of the following conditions:
    (A) Enzyme production occurs by submerged fermentation (i.e., for 
enzyme production, growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (B) Any further fermentation, such as saccharification (i.e., 
addition of Trichoderma reesei fermentation broth to solid plant 
material or insoluble substrate after the standard industrial 
fermentation is completed), is initiated only after the inactivation of 
the microorganism as delineated in Sec.  725.422(d).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) though (c) and (i) of this chapter, are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 of this chapter apply to this section.

[86 FR 22875, Apr. 30, 2021]



Sec.  725.1081  Trichoderma reesei modified (generic).

    (a) Microorganism and significant new uses subject to reporting. (1) 
The genetically modified microorganism generically identified as 
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2)(i) It is a significant new use to manufacture, process, or use 
the microorganism other than in a fermentation system that meets all of 
the following conditions:
    (A) Enzyme production occurs by submerged fermentation (i.e., for 
enzyme production, growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (B) Any fermentation of solid plant material or insoluble substrate 
to which Trichoderma reesei fermentation broth is added after the 
standard industrial fermentation is completed is initiated only after 
the inactivation of the microorganism as delineated in Sec.  725.422(d).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart L of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
725.950(b)(2) through (4) are applicable to manufacturers and processors 
of this microorganism.
    (2) Modification or revocation of certain notification requirements. 
The provisions of Sec.  725.984 apply to this section.

[87 FR 73955, Dec. 2, 2022]



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.

[[Page 77]]

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.
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).

[[Page 78]]

    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.
    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 [micro]g/ft\2\,

[[Page 79]]

a composite sample (three subsamples) containing 100 [micro]g/ft\2\, and 
a composite sample (4 subsamples) containing 110 [micro]g/ft\2\ is 100 
[micro]g/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 10 [micro]g/ft\2\ 
on floors or 100 [micro]g/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 
([micro]g/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.

[66 FR 1237, Jan. 5, 2001, as amended at 84 FR 32648, July 9, 2019]



                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

[[Page 80]]

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 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-

[[Page 81]]

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 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 Sec. Sec.  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

[[Page 82]]

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 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

[[Page 83]]

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 
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]

[[Page 84]]



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 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:

[[Page 85]]

    (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 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

[[Page 86]]

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 
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

[[Page 87]]

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.
    (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

[[Page 88]]

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.
    (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

[[Page 89]]

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-
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

[[Page 90]]

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).
    (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]

[[Page 91]]



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 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.

[[Page 92]]

    (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 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

[[Page 93]]

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 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

[[Page 94]]

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 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.

[[Page 95]]

    (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.
    (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

[[Page 96]]

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


    (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,

[[Page 97]]

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



Sec.  745.102  Effective dates.

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



Sec.  745.103  Definitions.

    The following definitions apply to this subpart.
    The Act means the Residential Lead-Based Paint Hazard Reduction Act 
of 1992, 42 U.S.C. 4852d.
    Agent means any party who enters into a contract with a seller or 
lessor, including any party who enters into a contract with a 
representative of the seller or lessor, for the purpose of selling or 
leasing target housing. This term does not apply to purchasers or any 
purchaser's representative who receives all compensation from the 
purchaser.
    Available means in the possession of or reasonably obtainable by the 
seller or lessor at the time of the disclosure.
    Common area means a portion of a building generally accessible to 
all residents/users including, but not limited to, hallways, stairways, 
laundry and recreational rooms, playgrounds, community centers, and 
boundary fences.
    Contract for the purchase and sale of residential real property 
means any contract or agreement in which one party agrees to purchase an 
interest in real property on which there is situated one or more 
residential dwellings used or occupied, or intended to be used or 
occupied, in whole or in part, as the home or residence of one or more 
persons.
    EPA means the Environmental Protection Agency.
    Evaluation means a risk assessment and/or inspection.
    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

[[Page 98]]

from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible 
surfaces, friction surfaces, or impact surfaces that would result in 
adverse human health effects as established by the appropriate Federal 
agency.
    Lessee means any entity that enters into an agreement to lease, 
rent, or sublease target housing, including but not limited to 
individuals, partnerships, corporations, trusts, government agencies, 
housing agencies, Indian tribes, and nonprofit organizations.
    Lessor means any entity that offers target housing for lease, rent, 
or sublease, including but not limited to individuals, partnerships, 
corporations, trusts, government agencies, housing agencies, Indian 
tribes, and nonprofit organizations.
    Owner means any entity that has legal title to target housing, 
including but not limited to individuals, partnerships, corporations, 
trusts, government agencies, housing agencies, Indian tribes, and 
nonprofit organizations, except where a mortgagee holds legal title to 
property serving as collateral for a mortgage loan, in which case the 
owner would be the mortgagor.
    Purchaser means an entity that enters into an agreement to purchase 
an interest in target housing, including but not limited to individuals, 
partnerships, corporations, trusts, government agencies, housing 
agencies, Indian tribes, and nonprofit organizations.
    Reduction means measures designed to reduce or eliminate human 
exposure to lead-based paint hazards through methods including interim 
controls and abatement.
    Residential dwelling means:
    (1) A single-family dwelling, including attached structures such as 
porches and stoops; or
    (2) A single-family dwelling unit in a structure that contains more 
than one separate residential dwelling unit, and in which each such unit 
is used or occupied, or intended to be used or occupied, in whole or in 
part, as the residence of one or more persons.
    Risk assessment means an on-site investigation to determine and 
report the existence, nature, severity, and location of lead-based paint 
hazards in residential dwellings, including:
    (1) Information gathering regarding the age and history of the 
housing and occupancy by children under age 6;
    (2) Visual inspection;
    (3) Limited wipe sampling or other environmental sampling 
techniques;
    (4) Other activity as may be appropriate; and
    (5) Provision of a report explaining the results of the 
investigation.
    Secretary means the Secretary of Housing and Urban Development.
    Seller means any entity that transfers legal title to target 
housing, in whole or in part, in return for consideration, including but 
not limited to individuals, partnerships, corporations, trusts, 
government agencies, housing agencies, Indian tribes, and nonprofit 
organizations. The term ``seller'' also includes:
    (1) An entity that transfers shares in a cooperatively owned 
project, in return for consideration; and
    (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

[[Page 99]]

the seller or lessor to conduct any evaluation or reduction activities.
    (1) The seller or lessor shall provide the purchaser or lessee with 
an EPA-approved lead hazard information pamphlet. Such pamphlets include 
the EPA document entitled Protect Your Family From Lead in Your Home 
(EPA 747-K-94-001) or an equivalent pamphlet that has been approved for 
use in that State by EPA.
    (2) The seller or lessor shall disclose to the purchaser or lessee 
the presence of any known lead-based paint and/or lead-based paint 
hazards in the target housing being sold or leased. The seller or lessor 
shall also disclose any additional information available concerning the 
known lead-based paint and/or lead-based paint hazards, such as the 
basis for the determination that lead-based paint and/or lead-based 
paint hazards exist, the location of the lead-based paint and/or lead-
based paint hazards, and the condition of the painted surfaces.
    (3) The seller or lessor shall disclose to each agent the presence 
of any known lead-based paint and/or lead-based paint hazards in the 
target housing being sold or leased and the existence of any available 
records or reports pertaining to lead-based paint and/or lead-based 
paint hazards. The seller or lessor shall also disclose any additional 
information available concerning the known lead-based paint and/or lead-
based paint hazards, such as the basis for the determination that lead-
based paint and/or lead-based paint hazards exist, the location of the 
lead-based paint and/or lead-based paint hazards, and the condition of 
the painted surfaces.
    (4) The seller or lessor shall provide the purchaser or lessee with 
any records or reports available to the seller or lessor pertaining to 
lead-based paint and/or lead-based paint hazards in the target housing 
being sold or leased. This requirement includes records or reports 
regarding common areas. This requirement also includes records or 
reports regarding other residential dwellings in multifamily target 
housing, provided that such information is part of an evaluation or 
reduction of lead-based paint and/or lead-based paint hazards in the 
target housing as a whole.
    (b) If any of the disclosure activities identified in paragraph (a) 
of this section occurs after the purchaser or lessee has provided an 
offer to purchase or lease the housing, the seller or lessor shall 
complete the required disclosure activities prior to accepting the 
purchaser's or lessee's offer and allow the purchaser or lessee an 
opportunity to review the information and possibly amend the offer.



Sec.  745.110  Opportunity to conduct an evaluation.

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


[[Page 100]]


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

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

    (2) A statement by the lessor disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being 
leased or indicating no knowledge of the presence of lead-based paint 
and/or lead-based paint hazards. The lessor shall also disclose any 
additional information available concerning the known lead-based paint 
and/or lead-based paint hazards, such as the basis for the determination 
that lead-based paint and/or lead-based paint hazards exist, the 
location of the lead-based paint and/or lead-based paint hazards, and 
the condition of the painted surfaces.
    (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

[[Page 101]]

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



Sec.  745.118  Enforcement.

    (a) Any person who knowingly fails to comply with any provision of 
this subpart shall be subject to civil monetary penalties in accordance 
with the provisions of 42 U.S.C. 3545 and 24 CFR part 30.
    (b) The Secretary is authorized to take such action as may be 
necessary to enjoin any violation of this subpart in the appropriate 
Federal district court.
    (c) Any person who knowingly violates the provisions of this subpart 
shall be jointly and severally liable to the purchaser or lessee in an 
amount equal to 3 times the amount of damages incurred by such 
individual.
    (d) In any civil action brought for damages pursuant to 42 U.S.C. 
4852d(b)(3), the appropriate court may award court costs to the party 
commencing such action, together with reasonable attorney fees and any 
expert witness fees, if that party prevails.
    (e) Failure or refusal to comply with Sec.  745.107 (disclosure 
requirements for sellers and lessors), Sec.  745.110 (opportunity to 
conduct an evaluation), Sec.  745.113 (certification and acknowledgment 
of disclosure), or Sec.  745.115 (agent responsibilities) is a violation 
of 42 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]

[[Page 102]]



                  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.
    (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

[[Page 103]]

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 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 amount of lead in dust 
on a surface following completion of an abatement activity. To achieve 
clearance when dust sampling is required, values below these levels must 
be achieved.
    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

[[Page 104]]

other heating units, shelves, shelf supports, stair treads, stair 
risers, stair stringers, newel posts, railing caps, balustrades, windows 
and trim (including sashes, window heads, jambs, sills or stools and 
troughs), built in cabinets, columns, beams, bathroom vanities, counter 
tops, and air conditioners; and exterior components such as: painted 
roofing, chimneys, flashing, gutters and downspouts, ceilings, soffits, 
fascias, rake boards, cornerboards, bulkheads, doors and door trim, 
fences, floors, joists, lattice work, railings and railing caps, siding, 
handrails, stair risers and treads, stair stringers, columns, 
balustrades, window sills or stools and troughs, casings, sashes and 
wells, and air conditioners.
    Containment means a process to protect workers and the environment 
by controlling exposures to the lead-contaminated dust and debris 
created during an abatement.
    Course agenda means an outline of the key topics to be covered 
during a training course, including the time allotted to teach each 
topic.
    Course test means an evaluation of the overall effectiveness of the 
training which shall test the trainees' knowledge and retention of the 
topics covered during the course.
    Course test blue print means written documentation identifying the 
proportion of course test questions devoted to each major topic in the 
course curriculum.
    Deteriorated paint means paint that is cracking, flaking, chipping, 
peeling, or otherwise separating from the substrate of a building 
component.
    Discipline means one of the specific types or categories of lead-
based paint activities identified in this subpart for which individuals 
may receive training from accredited programs and become certified by 
EPA. For example, ``abatement worker'' is a discipline.
    Distinct painting history means the application history, as 
indicated by its visual appearance or a record of application, over 
time, of paint or other surface coatings to a component or room.
    Documented methodologies are methods or protocols used to sample for 
the presence of lead in paint, dust, and soil.
    Elevated blood lead level (EBL) means an excessive absorption of 
lead that is a confirmed concentration of lead in whole blood of 20 
[micro]g/dl (micrograms of lead per deciliter of whole blood) for a 
single venous test or of 15-19 [micro]g/dl in two consecutive tests 
taken 3 to 4 months apart.
    Encapsulant means a substance that forms a barrier between lead-
based paint and the environment using a liquid-applied coating (with or 
without reinforcement materials) or an adhesively bonded covering 
material.
    Encapsulation means the application of an encapsulant.
    Enclosure means the use of rigid, durable construction materials 
that are mechanically fastened to the substrate in order to act as a 
barrier between lead-based paint and the environment.
    Guest instructor means an individual designated by the training 
program manager or principal instructor to provide instruction specific 
to the lecture, hands-on activities, or work practice components of a 
course.
    Hands-on skills assessment means an evaluation which tests the 
trainees' ability to satisfactorily perform the work practices and 
procedures identified in Sec.  745.225(d), as well as any other skill 
taught in a training course.
    Hazardous waste means any waste as defined in 40 CFR 261.3.
    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-

[[Page 105]]

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.
    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

[[Page 106]]

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.
    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; 86 FR 994, Jan. 7, 
2021]



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:

[[Page 107]]

    (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.
    (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

[[Page 108]]

    (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 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

[[Page 109]]

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 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

[[Page 110]]

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:
    (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

[[Page 111]]

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.
    (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.

[[Page 112]]

    (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.
    (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.

[[Page 113]]

    (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 
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,

[[Page 114]]

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) 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

[[Page 115]]

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 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.

[[Page 116]]

    (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 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.

[[Page 117]]

    (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.
    (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.

[[Page 118]]

    (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.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) In order to take the certification examination for a particular 
discipline an individual must:
    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the education and/or experience requirements in 
paragraph (b)(1)(iii) of this section.
    (4) The course completion certificate shall serve as interim 
certification for an individual until the next available opportunity to 
take the certification exam. Such interim certification shall expire 6 
months after issuance.
    (5) After passing the appropriate certification exam and submitting 
an application demonstrating that he/she meets the appropriate training, 
education, and/or experience prerequisites described in paragraph (b)(1) 
of this section, an individual shall be issued a certificate by EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (6) An individual may take the certification exam no more than three 
times within 6 months of receiving a course completion certificate.
    (7) If an individual does not pass the certification exam and 
receive a certificate within 6 months of receiving his/her course 
completion certificate, the individual must retake the appropriate 
course from an accredited training program before reapplying for 
certification from EPA.
    (c) Abatement worker and project designer. (1) To become certified 
by EPA as an abatement worker or project designer, pursuant to paragraph 
(a)(1)(i) of this section, an individual must:

[[Page 119]]

    (i) Successfully complete an accredited course in the appropriate 
discipline and receive a course completion certificate from an 
accredited training program.
    (ii) Meet or exceed the following additional experience and/or 
education requirements:
    (A) Abatement workers. (1) No additional experience and/or education 
requirements.
    (2) [Reserved]
    (B) Project designers. (1) Successful completion of an accredited 
training course for supervisors.
    (2) Bachelor's degree in engineering, architecture, or a related 
profession, and 1 year of experience in building construction and design 
or a related field; or
    (3) Four years of experience in building construction and design or 
a related field.
    (2) The following documents shall be recognized by EPA as evidence 
of meeting the requirements listed in this paragraph:
    (i) Official academic transcripts or diploma, as evidence of meeting 
the education requirements.
    (ii) Resumes, letters of reference, or documentation of work 
experience, as evidence of meeting the work experience requirements.
    (iii) Course completion certificates from lead-specific or other 
related training courses, issued by accredited training programs, as 
evidence of meeting the training requirements.
    (3) The course completion certificate shall serve as an interim 
certification until certification from EPA is received, but shall be 
valid for no more than 6 months from the date of completion.
    (4) After successfully completing the appropriate training courses 
and meeting any other qualifications described in paragraph (c)(1) of 
this section, an individual shall be issued a certificate from EPA. To 
maintain certification, an individual must be re-certified as described 
in paragraph (e) of this section.
    (d) Certification based on prior training. (1) Any individual who 
received training in a lead-based paint activity between October 1, 
1990, and March 1, 1999 shall be eligible for certification by EPA under 
the alternative procedures contained in this paragraph. Individuals who 
have received lead-based paint activities training at an EPA-authorized 
State or Tribal accredited training program shall also be eligible for 
certification by EPA under the following alternative procedures:
    (i) Applicants for certification as an inspector, risk assessor, or 
supervisor shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets or exceeds the education 
and/or experience requirements in paragraph (b)(1)(iii) of this section.
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (D) Pass a certification exam administered by EPA for the 
appropriate discipline.
    (ii) Applicants for certification as an abatement worker or project 
designer shall:
    (A) Demonstrate that the applicant has successfully completed 
training or on-the-job training in the conduct of a lead-based paint 
activity.
    (B) Demonstrate that the applicant meets the education and/or 
experience requirements in paragraphs (c)(1) of this section; and
    (C) Successfully complete an accredited refresher training course 
for the appropriate discipline.
    (2) Individuals shall have until 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

[[Page 120]]

    (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.
    (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

[[Page 121]]

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

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

[[Page 122]]

with the appropriate requirements below.
    (3) Documented methodologies that are appropriate for this section 
are found in the following: The U.S. Department of Housing and Urban 
Development (HUD) Guidelines for the Evaluation and Control of Lead-
Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-
Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil; the EPA 
Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA 
report number 7474-R-95-001); Regulations, guidance, methods or 
protocols issued by States and Indian Tribes that have been authorized 
by EPA; and other equivalent methods and quidelines.
    (4) Clearance levels are appropriate for the purposes of this 
section may be found in the EPA Guidance on Residential Lead-Based 
Paint, Lead-Contaminated Dust, and Lead Contaminiated Soil or other 
equivalent guidelines.
    (b) Inspection. (1) An inspection shall be conducted only by a 
person certified by EPA as an inspector or risk assessor and, if 
conducted, must be conducted according to the procedures in this 
paragraph.
    (2) When conducting an inspection, the following locations shall be 
selected according to documented methodologies and tested for the 
presence of lead-based paint:
    (i) In a residential dwelling and child-occupied facility, each 
component with a distinct painting history and each exterior component 
with a distinct painting history shall be tested for lead-based paint, 
except those components that the inspector or risk assessor determines 
to have been replaced after 1978, or to not contain lead-based paint; 
and
    (ii) In a multi-family dwelling or child-occupied facility, each 
component with a distinct painting history in every common area, except 
those components that the inspector or risk assessor determines to have 
been replaced after 1978, or to not contain lead-based paint.
    (3) Paint shall be sampled in the following manner:
    (i) The analysis of paint to determine the presence of lead shall be 
conducted using documented methodologies which incorporate adequate 
quality control procedures; and/or
    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) The certified inspector or risk assessor shall prepare an 
inspection report which shall include the following information:
    (i) Date of each inspection.
    (ii) Address of building.
    (iii) Date of construction.
    (iv) Apartment numbers (if applicable).
    (v) Name, address, and telephone number of the owner or owners of 
each residential dwelling or child-occupied facility.
    (vi) Name, signature, and certification number of each certified 
inspector and/or risk assessor conducting testing.
    (vii) Name, address, and telephone number of the certified firm 
employing each inspector and/or risk assessor, if applicable.
    (viii) Each testing method and device and/or sampling procedure 
employed for paint analysis, including quality control data and, if 
used, the serial number of any x-ray fluorescence (XRF) device.
    (ix) Specific locations of each painted component tested for the 
presence of lead-based paint.
    (x) The results of the inspection expressed in terms appropriate to 
the sampling method used.
    (c) Lead hazard screen. (1) A lead hazard screen shall be conducted 
only by a person certified by EPA as a risk assessor.
    (2) If conducted, a lead hazard screen shall be conducted as 
follows:
    (i) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (ii) A visual inspection of the residential dwelling or child-
occupied facility shall be conducted to:
    (A) Determine if any deteriorated paint is present, and

[[Page 123]]

    (B) Locate at least two dust sampling locations.
    (iii) If deteriorated paint is present, each surface with 
deteriorated paint, which is determined, using documented methodologies, 
to be in poor condition and to have a distinct painting history, shall 
be tested for the presence of lead.
    (iv) In residential dwellings, two composite dust samples shall be 
collected, one from the floors and the other from the windows, in rooms, 
hallways or stairwells where one or more children, age 6 and under, are 
most likely to come in contact with dust.
    (v) In multi-family dwellings and child-occupied facilities, in 
addition to the floor and window samples required in paragraph 
(c)(1)(iii) of this section, the risk assessor shall also collect 
composite dust samples from common areas where one or more children, age 
6 and under, are most likely to come into contact with dust.
    (3) Dust samples shall be collected and analyzed in the following 
manner:
    (i) All dust samples shall be taken using documented methodologies 
that incorporate adequate quality control procedures.
    (ii) All collected dust samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (4) Paint shall be sampled in the following manner:
    (i) The analysis of paint to determine the presence of lead shall be 
conducted using documented methodologies which incorporate adequate 
quality control procedures; and/or
    (ii) All collected paint chip samples shall be analyzed according to 
paragraph (f) of this section to determine if they contain detectable 
levels of lead that can be quantified numerically.
    (5) The risk assessor shall prepare a lead hazard screen report, 
which shall include the following information:
    (i) The information required in a risk assessment report as 
specified in paragraph (d) of this section, including paragraphs 
(d)(11)(i) through (d)(11)(xiv), and excluding paragraphs (d)(11)(xv) 
through (d)(11)(xviii) of this section. Additionally, any background 
information collected pursuant to paragraph (c)(2)(i) of this section 
shall be included in the risk assessment report; and
    (ii) Recommendations, if warranted, for a follow-up risk assessment, 
and as appropriate, any further actions.
    (d) Risk assessment. (1) A risk assessment shall be conducted only 
by a person certified by EPA as a risk assessor and, if conducted, must 
be conducted according to the procedures in this paragraph.
    (2) A visual inspection for risk assessment of the residential 
dwelling or child-occupied facility shall be undertaken to locate the 
existence of deteriorated paint, assess the extent and causes of the 
deterioration, and other potential lead-based paint hazards.
    (3) Background information regarding the physical characteristics of 
the residential dwelling or child-occupied facility and occupant use 
patterns that may cause lead-based paint exposure to one or more 
children age 6 years and under shall be collected.
    (4) 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

[[Page 124]]

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.
    (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.

[[Page 125]]

    (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 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

[[Page 126]]

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
    (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

[[Page 127]]

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 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 10 [micro]g/ft\2\ 
for floors, 100 [micro]g/ft\2\ for interior window sills, and 400 
[micro]g/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/

[[Page 128]]

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 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 10 [micro]g/ft\2\ for floors and 100 [micro]g/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; 84 FR 32648, July 9, 
2019; 86 FR 994, Jan. 7, 2021]

[[Page 129]]



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



Sec.  745.237  Inspections.

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



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

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

[[Page 130]]



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

    (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.''

[[Page 131]]

    (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]

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 Sec. Sec.  745.225, 745.226, and 745.227. The provisions of 
Sec. Sec.  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 Sec. Sec.  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

[[Page 132]]

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.
    (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

[[Page 133]]

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.
    (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.

[[Page 134]]

    (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 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

[[Page 135]]

State or Indian Tribe that has an authorized program shall submit a 
written report to the EPA Regional Administrator for the Region in which 
the State or Indian Tribe is located. This report shall be submitted at 
least once every 12 months for the first 3 years after program 
authorization. If these reports demonstrate successful program 
implementation, the Agency will automatically extend the reporting 
interval to every 2 years. If the subsequent reports demonstrate 
problems with implementation, EPA will require a return to annual 
reporting until the reports demonstrate successful program 
implementation, at which time the Agency will extend the reporting 
interval to every 2 years. The report shall include the following 
information:
    (1) Any significant changes in the content or administration of the 
State or Tribal program implemented since the previous reporting period; 
and
    (2) All information regarding the lead-based paint enforcement and 
compliance activities listed at Sec.  745.327(d) ``Summary on Progress 
and Performance.''
    (i) Withdrawal of authorization. (1) If EPA concludes that a State 
or Indian Tribe is not administering and enforcing an authorized program 
in compliance with the standards, regulations, and other requirements of 
sections 401 through 412 of TSCA and this subpart, the Administrator 
shall notify the primary agency for the State or Indian Tribe in writing 
and indicate EPA's intent to withdraw authorization of the program.
    (2) The Notice of Intent to Withdraw shall:
    (i) Identify the program aspects that EPA believes are inadequate 
and provide a factual basis for such findings.
    (ii) Include copies of relevant documents.
    (iii) Provide an opportunity for the State or Indian Tribe to 
respond either in writing or at a meeting with appropriate EPA 
officials.
    (3) EPA may request that an informal conference be held between 
representatives of the State or Indian Tribe and EPA officials.
    (4) Prior to issuance of a withdrawal, a State or Indian Tribe may 
request that EPA hold a public hearing. At this hearing, EPA, the State 
or Indian Tribe, and the public may present facts bearing on whether the 
State's or Indian Tribe's authorization should be withdrawn.
    (5) If EPA finds that deficiencies warranting withdrawal did not 
exist or were corrected by the State or Indian Tribe, EPA may rescind 
its Notice of Intent to Withdraw authorization.
    (6) Where EPA finds that deficiencies in the State or Tribal program 
exist that warrant withdrawal, an agreement to correct the deficiencies 
shall be jointly prepared by the State or Indian Tribe and EPA. The 
agreement shall describe the deficiencies found in the program, specify 
the steps the State or Indian Tribe has taken or will take to remedy the 
deficiencies, and establish a schedule, no longer than 180 days, for 
each remedial action to be initiated.
    (7) If the State or Indian Tribe does not respond within 60 days of 
issuance of the Notice of Intent to Withdraw or an agreement is not 
reached within 180 days after EPA determines that a State or Indian 
Tribe is not in compliance with the Federal program, the Agency shall 
issue an order withdrawing the State's or Indian Tribe's authorization.
    (8) By the date of such order, the Administrator 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.

[[Page 136]]

    (4) Requirements that all lead-based paint activities be conducted 
by appropriately certified contractors.
    (5) Development of the appropriate infrastructure or government 
capacity to effectively carry out a State or Tribal program.
    (b) Accreditation of training programs. The State or Indian Tribe 
must have either:
    (1) Procedures and requirements for the accreditation of training 
programs that establish:
    (i) Requirements for the accreditation of training programs, 
including but not limited to:
    (A) Training curriculum requirements.
    (B) Training hour requirements.
    (C) Hands-on training requirements.
    (D) Trainee competency and proficiency requirements.
    (E) Requirements for training program quality control.
    (ii) Procedures for the re-accreditation of training programs.
    (iii) Procedures for the oversight of training programs.
    (iv) Procedures for the suspension, revocation, or modification of 
training program accreditations; or
    (2) Procedures or regulations, for the purposes of certification, 
for the acceptance of training offered by an accredited training 
provider in a State or Tribe authorized by EPA.
    (c) Certification of individuals. The State or Indian Tribe must 
have requirements for the certification of individuals that:
    (1) Ensure that certified individuals:
    (i) Are trained by an accredited training program; and
    (ii) Possess appropriate education or experience qualifications for 
certification.
    (2) Establish procedures for re-certification.
    (3) Require the conduct of lead-based paint activities in accordance 
with work practice standards established by the State or Indian Tribe.
    (4) Establish procedures for the suspension, revocation, or 
modification of certifications.
    (5) Establish requirements and procedures for the administration of 
a third-party certification exam.
    (d) Work practice standards for the conduct of lead-based paint 
activities. The State or Indian Tribe must have requirements or 
standards that ensure that lead-based paint activities are conducted 
reliably, effectively, and safely. At a minimum the State's or Indian 
Tribe's work practice standards for conducting inspections, risk 
assessments, and abatements must contain the requirements specified in 
paragraphs (d)(1), (d)(2), and (d)(3) of this section.
    (1) The work practice standards for the inspection for the presence 
of lead-based paint must require that:
    (i) Inspections are conducted only by individuals certified by the 
appropriate State or Tribal authority to conduct inspections.
    (ii) Inspections are conducted in a way that identifies the presence 
of lead-based paint on painted surfaces within the interior or on the 
exterior of a residential dwelling or child-occupied facility.
    (iii) Inspections are conducted in a way that uses documented 
methodologies that incorporate adequate quality control procedures.
    (iv) A report is developed that clearly documents the results of the 
inspection.
    (v) Records are retained by the certified inspector or the firm.
    (2) The work practice standards for risk assessment must require 
that:
    (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

[[Page 137]]

    (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) Revisions to lead-based paint activities program requirements. 
When EPA publishes in the Federal Register revisions to the lead-based 
paint activities program requirements contained in subpart L of this 
part:
    (1) A State or Tribe with a lead-based paint activities program 
approved before the effective date of the revisions to the lead-based 
paint activities program requirements in subpart L of this part must 
demonstrate that it meets the requirements of this section in a report 
that it submits pursuant to Sec.  745.324(h) but no later than two years 
after the effective date of the revisions.
    (2) A State or Tribe with an application for approval of a lead-
based paint activities program submitted but not approved before the 
effective date of the revisions to the lead-based paint activities 
program requirements in subpart L of this part must demonstrate that it 
meets the requirements of this section either by amending its 
application or in a report that it submits pursuant to Sec.  745.324(h) 
but no later than two years after the effective date of the revisions.
    (3) A State or Tribe submitting its application for approval of a 
lead-based paint activities program on or after the effective date of 
the revisions must demonstrate in its application that it meets the 
requirements of the new lead-based paint activities program requirements 
in subpart L of this part.

[61 FR 45825, Aug. 29, 1996, as amended at 66 FR 1240, Jan. 5, 2001; 84 
FR 32648, July 9, 2019]



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

[[Page 138]]

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:
    (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:

[[Page 139]]

    (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 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

[[Page 140]]

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

[[Page 141]]

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 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.

[[Page 142]]

    (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 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

[[Page 143]]

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]



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:

[[Page 144]]

    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development have the same meaning as 
in Sec.  720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (-NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.
    (4) Process or distribute in commerce solely for export means to 
process or distribute in commerce solely for export from the United 
States under the following restrictions on domestic activity:
    (i) Processing must be performed at sites under the control of the 
processor.
    (ii) Distribution in commerce is limited to purposes of export.
    (iii) The processor or distributor may not use the substance except 
in small quantities solely for research and development.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-529, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) Any person using as a metalworking fluid a product containing P-
84-529 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-529 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-529 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements:

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

    (ii) A copy of this Sec.  747.115.
    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-529 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

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

    (iii) The first work of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area. The type size of the remainder of the warning statement 
shall be no smaller than six point type. All required label text shall 
be of sufficient prominence, and shall be placed with such 
conspicuousness relative to other label text and 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

[[Page 145]]

whether the specific substance is on the Inventory and EPA informs the 
manufacturer or importer that the substance is on the Inventory, EPA 
will also inform the manufacturer or importer whether the substance is 
subject to this section.
    (2) Except for manufacturers and importers of P-84-529, no 
processor, distributor, or user of P-84-529 will be in violation of this 
section unless that person has received a letter specified in paragraph 
(d)(1) of this section or a container with the label specified in 
paragraph (d)(2) of this section.
    (f) Exemptions. A person identified in paragraphs (c) and (d) of 
this section is not subject to the requirements of those paragraphs if:
    (1) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only in small quantities solely for 
research and development and in accordance with section 5(h)(3) of the 
Act.
    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export and, when distributing in commerce, lables the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act [15 U.S.C. 2614].
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act [15 U.S.C. 2614].
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act [15 
U.S.C. 2614].
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act [15 U.S.C. 2615] for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section; act to 
seize any chemical substance processed, distributed in commerce, or used 
in violation of this section; or take other actions under the authority 
of sections 7 and 17 of the Act [15 U.S.C. 2605 and 2616].

[49 FR 36855, Sept. 20, 1984]



Sec.  747.195  Triethanolamine salt of a substituted organic acid.

    This section identifies activities with respect to a chemical 
substance which are prohibited and requires that warnings and 
instructions accompany the substance when distributed in commerce.
    (a) Chemical substance subject to this section. The following 
chemical substance, referred to by its premanufacture notice number and 
generic chemical name, is subject to this section: P-84-310, 
triethanolamine salt of a substituted organic acid.
    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, chemical substance, commerce, importer, 
impurity, Inventory, manufacturer, person, process, processor, and small 
quantities solely for research and development, have the same meaning as 
in Sec.  720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling, lubricating, or rust inhibition.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a primary, secondary, or tertiary 
amine to form the corresponding nitrosamine.
    (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.

[[Page 146]]

    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-84-310, is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) A person using as a metalworking fluid a product containing P-
84-310 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-84-310 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must send to each 
recipient of P-84-310 and confirm receipt in writing prior to the first 
shipment to that person:
    (i) A letter that includes the following statements: A substance, 
identified generically as a triethanolamine salt of a substituted 
organic acid, contained in the product (insert distributor's trade name 
or other identifier for product containing P-84-310) has been regulated 
by the Environmental Protection Agency, at 40 CFR 747.195, as published 
in the Federal Register of June 14, 1984. A copy of the regulation is 
enclosed. The regulation prohibits the addition of any nitrosating 
agent, including nitrites, to the triethanolamine salt of a substituted 
organic acid, when the substance is or could be used in metalworking 
fluids. The addition of nitrites or other nitrosating agents to this 
substance leads to formation of a substance known to cause cancer in 
laboratory animals. The triethanolamine salt of a substituted organic 
acid has been specifically designed to be used without nitrites. Consult 
the enclosed regulation for further information.
    (ii) A copy of this Sec.  747.195.
    (2)(i) Any person who distributes in commerce a metalworking fluid 
containing P-84-310 must affix a label to each container containing the 
fluid.
    (ii) The label shall contain a warning statement which shall consist 
only of the following language:

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

    (iii) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than six point 
type for a label five square inches or less in area, ten point type for 
a label above five but below ten square inches in area, twelve point 
type for a label above ten but below fifteen square inches in area, 
fourteen point type for a label above fifteen but below thirty square 
inches in area, or eighteen point type for a label over thirty square 
inches in area. The type size of the remainder of the warning statement 
shall be no smaller than six point type. All required label text shall 
be of sufficient prominence, and shall be placed with such 
conspicuousness relative to other label text and graphic material, to 
insure that the warning statement is read and understood by the ordinary 
individual under customary conditions of purchase and use.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by the generic chemical name in paragraph 
(a) of this section makes an inquiry under Sec.  710.7(g) of this 
chapter or Sec.  720.25(b) of this chapter as to whether the specific 
substance is on the Inventory and EPA informs the manufacturer or 
importer that the substance is on the Inventory, EPA will also inform 
the manufacturer or importer whether the substance is subject to this 
section.
    (2) Except for manufacturers and importers of P-84-310, no 
processor, distributor, or user of P-84-310 will be in violation of this 
section unless that 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.

[[Page 147]]

    (2) The person manufactures, imports, processes, distributes in 
commerce, or uses the substance only as an impurity.
    (3) The person imports, processes, distributes in commerce, or uses 
the substance only as part of an article.
    (4) The person processes or distributes the substance in commerce 
solely for export, and when distributing in commerce, labels the 
substance in accordance with section 12(a)(1)(B) of the Act.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).

[49 FR 24668, June 14, 1984]



Sec.  747.200  Triethanolamine salt of tricarboxylic acid.

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

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

    (b) Definitions. Definitions in section 3 of the Act, 15 U.S.C. 
2602, apply to this section unless otherwise specified in this 
paragraph. In addition, the following definitions apply:
    (1) The terms Act, article, byproducts, chemical substance, 
commerce, imported, impurity, Inventory, manufacture or import for 
commercial purposes, manufacture solely for export, manufacturer, new 
chemical substance, person, process, processor, and small quantities 
solely for research and development have the same meaning as in Sec.  
720.3 of this chapter.
    (2) Metalworking fluid means a liquid of any viscosity or color 
containing intentionally added water used in metal machining operations 
for the purpose of cooling or lubricating.
    (3) Nitrosating agent means any substance that has the potential to 
transfer a nitrosyl group (--NO) to a secondary or tertiary amine to 
form the corresponding nitrosamine.
    (c) Use limitations. (1) Any person producing a metalworking fluid, 
or a product which could be used in or as a metalworking fluid, which 
includes as one of its components P-83-1005 is prohibited from adding 
any nitrosating agent to the metalworking fluid or product.
    (2) Any person using as metalworking fluid a product containing P-
83-1005 is prohibited from adding any nitrosating agent to the product.
    (d) Warnings and instructions. (1) Any person who distributes in 
commerce P-83-1005 in a metalworking fluid, or in any form in which it 
could be used as a component of a metalworking fluid, must sent to each 
recipient of P-83-1005 and confirm receipt prior to the first shipment 
to that person:
    (i) A letter that includes the following statements:

    A substance, identified generically as triethanolamine salt, of 
tricarboxylic acid, contained in the product (insert distributor's trade 
name or other identifier for product containing P-83-1005) has been 
regulated by the Environmental Protection Agency, at 40 CFR 747.200, as 
published in the Federal Register of January 23, 1984. A copy of the 
regulation is enclosed. The regulation prohibits the addition of any 
nitrosating agent, including nitrites, to the triethanolamine salt of 
tricarboxylic acid, when the substance is or could be used in 
metalworking fluids. The addition of nitrites or other nitrosating 
agents to this substance leads to formation 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

[[Page 148]]

than ten point type, the following statement:

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

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

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

    (ii) A copy of this rule.
    (e) Liability and determining whether a chemical substance is 
subject to this section. (1) If a manufacturer or importer of a chemical 
substance which is described by one of the generic names in paragraph 
(a) of this section makes an inquiry under Sec.  710.7(g) of this 
chapter or Sec.  720.25(b) of this chapter as to whether the specific 
substance is on the Inventory and EPA informs the manufacturer or 
importer that the substance is on the Inventory, EPA will also inform 
the manufacturer or importer whether the substance is subject to this 
section.
    (2) Except for manufacturers and importers of P-83-1005 and P-83-
1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will 
be in violation of this section unless that person has received a letter 
specified in paragraph (d)(1) or (3) of this section or a container with 
the label specified in paragraph (d)(2) of this section.
    (f) Exemptions and exclusions. The chemical substances identified in 
paragraph (a) of this section are not subject to the requirements of 
paragraphs (c) and (d) of this section, if:
    (1) The substance is manufactured, imported, processed, distributed 
in commerce, and used only in small quantities solely for research and 
development, and if the substance is manufactured, imported, processed, 
distributed in commerce, and used in accordance with section 5(h)(3) of 
the Act.
    (2) The substance is manufactured, imported, processed, distributed 
in commerce, or used only as an impurity.
    (3) The substance is imported, processed, distributed in commerce, 
or used only as part of an article.
    (4) The substance is manufactured solely for export.
    (g) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to permit access to or copying of records, as 
required under section 11 of the Act, is a violation of a section 15 of 
the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection, as required 
under section 11 of the Act, is a violation of section 15 of the Act (15 
U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C 2615) for each violation.
    (5) EPA may seek to enjoin the processing, distribution in commerce, 
or use of a chemical substance in violation of this section, act to 
seize any 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]

[[Page 149]]

             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 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.

[[Page 150]]

    (14) Person means any natural person, firm, company, corporation, 
joint venture, partnership, sole proprietorship, association, or any 
other business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    (15) Shipment means the act or process of shipping goods by any form 
of conveyance.
    (16) Water treatment chemicals means any combination of chemical 
substances used to treat water in cooling systems and can include 
corrosion inhibitors, antiscalants, dispersants, and any other chemical 
substances except biocides.
    (e) Prohibition of distribution in commerce and commercial use. (1) 
All persons are prohibited from distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers.
    (2) All persons are prohibited from commercial use of hexavalent 
chromium-based water treatment chemicals in comfort cooling towers.
    (3) Distribution in commerce of hexavalent chromium-based water 
treatment chemicals for use in, and commercial use of hexavalent 
chromium-based water treatment chemicals in, industrial cooling towers 
and closed cooling water systems are not prohibited.
    (f) Effective dates. (1) The prohibition described in paragraph 
(e)(1) of this section against distributing in commerce hexavalent 
chromium-based water treatment chemicals for use in comfort cooling 
towers is effective February 20, 1990.
    (2) The prohibition described in paragraph (e)(2) of this section 
against using hexavalent chromium-based water treatment chemicals in 
comfort cooling towers is effective May 18, 1990.
    (g) Labeling. (1) Each person who distributes in commerce hexavalent 
chromium-based water treatment chemicals for use in cooling systems 
after February 20, 1990, shall affix a label or keep affixed an existing 
label in accordance with this paragraph, to each container of the 
chemicals. The label shall consist of the following language:

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

    (2) The first word of the warning statement shall be capitalized, 
and the type size for the first word shall be no smaller than 10-point 
type for a label less than or equal to 10 square inches in area, 12-
point type for a label above 10 but less than or equal to 15 square 
inches in area, 14-point type for a label above 15 but less than or 
equal to 30 square inches in area, or 18-point type for a label above 30 
square inches in area. The type size of the remainder of the warning 
statement shall be no smaller than 6-point type. All required label text 
shall be in English and of sufficient prominence and shall be placed 
with such conspicuousness, relative to other label text and graphic 
material, to ensure that the warning statement is read and understood by 
the ordinary individual under customary conditions of purchase and use.
    (h) Recordkeeping. (1) Each person who distributes in commerce any 
hexavalent chromium-based water treatment chemicals for use in cooling 
systems after February 20, 1990, shall retain in one location at the 
headquarters of the distributor documentation showing:
    (i) The name, address, contact, and telephone number of the cooling 
system owners/operators to whom the chemicals were shipped.
    (ii) The chemicals included in the shipment, the amount of each 
chemical shipped, and the location(s) at which the chemicals will be 
used.
    (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

[[Page 151]]

than February 20, 1990, or 30 days after the person first begins the 
distribution in commerce of hexavalent chromium-based water treatment 
chemicals, whichever is later, and shall include:
    (i) For the headquarters, the distributor name, address, telephone 
number, and the name of a contact.
    (ii) For the shipment offices through which hexavalent chromium-
based water treatment chemicals are sold for use in cooling systems, the 
distributor name, address, telephone number, and the name of a contact.
    (2) The report identified in paragraph (i)(1) of this section shall 
be updated as changes occur in the distributor headquarters or shipment 
office information. The updated report shall be submitted to the 
Regional Administrator and postmarked no later than 10 calendar days 
after the change occurs.
    (3) A person may assert a claim of confidentiality for any 
information submitted to EPA in connection with this rule. Any claim of 
confidentiality must accompany the information when submitted to EPA. 
Persons claiming information as confidential should do so by circling, 
bracketing, or underlining it and marking it with ``CONFIDENTIAL.'' EPA 
will disclose information subject to a claim of confidentiality only to 
the extent permitted by section 14 of TSCA and 40 CFR part 2, subpart B. 
If a person does not assert a claim of confidentiality for information 
at the time it is submitted to EPA, EPA may make the information public 
without further notice to that person.
    (j) Enforcement. (1) Failure to comply with any provision of this 
section is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (k) Inspections. EPA will conduct inspections under section 11 of 
the Act (15 U.S.C. 2610) to ensure compliance with this section.

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



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



Subpart A [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]

[[Page 152]]



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 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

[[Page 153]]

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 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)

[[Page 154]]

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.
    (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.

[[Page 155]]

    (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.
    (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

[[Page 156]]

chemical substance or mixture for which an exemption is sought. 
Information may be provided on a group basis, except that the 
information required by paragraphs (c)(1), (c)(3) and (c)(5) of this 
section, must be provided for each person represented by a petition 
under paragraph (a)(2) of this section.
    (iv) Persons filing petitions under paragraph (a)(4) of this section 
(PCB Capacitor Distribution for Purposes of Repair) must also provide an 
estimate of the expected total number of PCB Capacitors to be 
distributed in commerce under the requested exemption. All information 
may be provided on a group basis.
    (v) Persons filing petitions under paragraphs (a) (7) and (8) of 
this section (Processing of PCB Articles into PCB Equipment and 
Processing of PCB Equipment into Other PCB Equipment) must provide a 
description of each type of PCB Equipment (including the amount of PCBs 
by poundage and/or volume in the PCB Equipment) to be processed and/or 
distributed in commerce under the exemption, the number of each type of 
equipment expected to be processed and/or distributed in commerce, and 
the approximate number of distributors or further processors covered by 
the petition. All information may be provided on a group basis. However, 
in the case of a petition under paragraph (a)(7) of this section, the 
processor of PCB Articles into PCB Equipment must be identified in the 
petition. In the case of a petition under paragraph (a)(8) of this 
section, the processor of PCB Equipment who files the petition must be 
identified.
    (vi) Persons filing petitions under paragraph (a)(9) of this section 
(Distribution of PCB Equipment) must provide a description of each type 
of PCB Equipment (including the amount of PCBs by poundage and/or volume 
in the PCB Equipment) to be distributed in commerce under the exemption, 
the number of each type of equipment to be distributed in commerce, and 
the approximate number of distributors covered by the petition. All 
information may be provided on a group basis.
    (vii) Persons filing petitions under paragraphs (a) (5) and (6) of 
this section must provide the information required by paragraphs (c) (1) 
through (8) of this section for each petitioner named in the petition.
    (d) EPA reserves the right to request further information as to each 
petition where necessary to determine whether the petition meets the 
statutory tests of section 6(e)(3)(B) of TSCA prior to or after 
publication of the notice of proposed rulemaking required by Sec.  
750.33 of these rules.
    (e) Renewal requests. (1) Any petitioner who has been granted an 
exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on 
or after May 25, 1994, and who seeks to renew that exemption without 
changing its terms, must submit a letter by certified mail to EPA 
requesting that the exemption be granted for the following year.
    (i) This letter must contain a certification by the petitioner that 
the type 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,

[[Page 157]]

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 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 751_REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER
SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT--Table of Contents



                      Subpart A_General Provisions

Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and inspections.

                      Subpart B_Methylene Chloride

751.101 General.
751.103 Definitions.
751.105 Consumer paint and coating removal.
751.107 Downstream notification.
751.109 Recordkeeping.

Subparts C-D [Reserved]

       Subpart E_Persistent, Bioaccumulative, and Toxic Chemicals

751.401 General.
751.403 Definitions.
751.405 DecaBDE.
751.407 PIP (3:1).
751.409 2,4,6-TTBP.
751.411 PCTP.
751.413 HCBD.

    Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).

[[Page 158]]


    Source: 84 FR 11435, Mar. 27, 2019, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  751.1  Purpose.

    This part sets forth requirements under section 6(a) of the Toxic 
Substances Control Act, 15 U.S.C. 2605(a), regulating the manufacture 
(including import), processing, distribution in commerce, use, or 
disposal of certain chemical substances and mixtures in order to address 
unreasonable risks to the extent necessary so that the chemical 
substance or mixture no longer presents such risk.



Sec.  751.5  Definitions.

    The definitions in section 3 of the Toxic Substances Control Act, 15 
U.S.C. 2602, apply to this part except as otherwise established in any 
subpart under this part.
    Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 
et seq.
    CASRN means Chemical Abstracts Service Registry Number.
    EPA means the U.S. Environmental Protection Agency.
    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.



Sec.  751.7  Exports and imports.

    (a) Exports. Persons who intend to export a chemical substance 
identified in any subpart under this part are subject to the export 
notification provisions of section 12(b) of the Act. The regulations 
that interpret section 12(b) appear at 40 CFR part 707, subpart D.
    (b) Imports. Persons who import a substance identified in any 
subpart under this part are subject to the import certification 
requirements under section 13 of the Act, which are codified at 19 CFR 
12.118 through 12.127. See also 19 CFR 127.28.



Sec.  751.9  Enforcement and inspections.

    (a) Enforcement. (1) Failure to comply with any provision of this 
part 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.
    (b) Inspections. EPA may conduct inspections under section 11 of the 
Act (15 U.S.C. 2610) to ensure compliance with this part.



                      Subpart B_Methylene Chloride



Sec.  751.101  General.

    This subpart sets certain restrictions on the manufacture (including 
import), processing, and distribution in commerce of methylene chloride 
(CASRN 75-09-2) for consumer paint and coating removal to prevent 
unreasonable risks of injury to health due to acute human lethality.



Sec.  751.103  Definitions.

    The definitions in subpart A of this part apply to this subpart 
unless otherwise specified in this section. In addition, the following 
definitions apply:
    Consumer paint and coating removal means paint and coating removal 
performed by any natural person who uses a paint and coating removal 
product for any personal use without receiving remuneration or other 
form of payment.
    Distribute in commerce has the same meaning as in section 3 of the 
Act, except that the term does not include retailers for purposes of 
Sec. Sec.  751.107 and 751.109.
    Paint and coating removal means application of a chemical or use of 
another method to remove, loosen, or deteriorate any paint, varnish, 
lacquer, graffiti, surface protectants, or other

[[Page 159]]

coating from a substrate, including objects, vehicles, architectural 
features, or structures.
    Retailer means a person who distributes in commerce or makes 
available a chemical substance or mixture to consumer end users, 
including e-commerce internet sales or distribution. Any distributor 
with at least one consumer end user customer is considered a retailer. A 
person who distributes in commerce or makes available a chemical 
substance or mixture solely to commercial or industrial end users or 
solely to commercial or industrial businesses is not considered a 
retailer.



Sec.  751.105  Consumer paint and coating removal.

    (a) After November 22, 2019, all persons are prohibited from 
manufacturing, processing and distributing in commerce methylene 
chloride for consumer paint and coating removal.
    (b) After November 22, 2019, all persons are prohibited from 
distributing in commerce methylene chloride, including any methylene 
chloride containing products, for paint and coating removal to 
retailers.
    (c) After November 22, 2019, all retailers are prohibited from 
distributing in commerce methylene chloride, including any methylene 
chloride containing products, for paint and coating removal.



Sec.  751.107  Downstream notification.

    Each person who manufactures, processes, or distributes in commerce 
methylene chloride for any use after August 26, 2019 must, prior to or 
concurrent with the shipment, notify companies to whom methylene 
chloride is shipped, in writing, of the restrictions described in this 
subpart. Notification must occur by inserting the following text in the 
Safety Data Sheet (SDS) provided with the methylene chloride or with any 
methylene chloride containing product:
    (a) SDS Section 1.(c): ``This chemical/product is not and cannot be 
distributed in commerce (as defined in TSCA section 3(5)) or processed 
(as defined in TSCA section 3(13)) for consumer paint or coating 
removal.''
    (b) SDS Section 15: ``This chemical/product is not and cannot be 
distributed in commerce (as defined in TSCA section 3(5)) or processed 
(as defined in TSCA section 3(13)) for consumer paint or coating 
removal.''



Sec.  751.109  Recordkeeping.

    (a) Each person who manufactures, processes, or distributes in 
commerce any methylene chloride after August 26, 2019 must retain in one 
location at the headquarters of the company, or at the facility for 
which the records were generated, documentation showing:
    (1) The name, address, contact, and telephone number of companies to 
whom methylene chloride was shipped;
    (2) A copy of the notification provided under Sec.  751.107; and
    (3) The amount of methylene chloride shipped.
    (b) The documentation in paragraph (a) of this section must be 
retained for 3 years from the date of shipment.

Subparts C-D [Reserved]



       Subpart E_Persistent, Bioaccumulative, and Toxic Chemicals

    Source: 86 FR 879, Jan. 6, 2021, unless otherwise noted.



Sec.  751.401  General.

    (a) This subpart establishes prohibitions and restrictions on the 
manufacturing, processing, and distribution in commerce of persistent, 
bioaccumulative, and toxic chemicals in accordance with TSCA section 
6(h), 15 U.S.C 2605(h).
    (b) Unless otherwise specified in this subpart, prohibitions and 
restrictions of this subpart do not apply to the following activities:
    (1) Distribution in commerce of any chemical substance, or any 
product or article that contains the chemical substance, that has 
previously been sold or supplied to an end user, i.e., any person that 
purchased or acquired the finished good for purposes other than resale. 
An example of an end user is a consumer who resells a product they no 
longer intend to use or who donates an article to charity.
    (2) Disposal of any chemical substance, or any product or article 
that contains the chemical substance, as

[[Page 160]]

well as importation, processing and distribution in commerce of any 
chemical substance or any product or article that contains the chemical 
substance for purposes of disposal.
    (3) Manufacturing, processing, distribution in commerce, and use of 
any chemical substance, or any product or article that contains the 
chemical substance, for research and development, as defined in Sec.  
751.403.



Sec.  751.403  Definitions.

    The definitions in subpart A of this part apply to this subpart 
unless otherwise specified in this section.
    2,4,6-TTBP means the chemical substance 2,4,6-tris(tert-butyl)phenol 
(CASRN 732-26-3).
    2,4,6-TTBP oil and lubricant additives means any 2,4,6-TTBP-
containing additive to a product of any viscosity intended to reduce 
friction between moving parts, whether mineral oil or synthetic base, 
including engine crankcase and gear oils and bearing greases. 2,4,6-TTBP 
oil and lubricant additive does not include hydraulic fluid and other 
oils whose primary purpose is not friction reduction.
    Article means a manufactured item:
    (1) Which is formed to a specific shape or design during 
manufacture,
    (2) Which has end use function(s) dependent in whole or in part upon 
its shape or design during end use, and
    (3) Which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article, and that result from a 
chemical reaction that occurs upon end use of other chemical substances, 
mixtures, or articles; except that fluids and particles are not 
considered articles regardless of shape or design.
    DecaBDE means the chemical substance decabromodiphenyl ether (CASRN 
1163-19-5).
    HCBD means the chemical substance hexachlorobutadiene (CASRN 87-68-
3).
    Lubricants and grease mean any product used to reduce friction, 
heat, or wear between moving or adjacent solid surfaces, or that enhance 
the lubricity of other substances.
    PCTP means the chemical substance pentachlorothiophenol (CASRN 133-
49-3).
    PIP (3:1) means the chemical substance phenol, isopropylated 
phosphate (3:1) (CASRN 68937-41-7).
    Product means the chemical substance, a mixture containing the 
chemical substance, or any object that contains the chemical substance 
or mixture containing the chemical substance that is not an article.
    Research and Development means laboratory and research use only for 
purposes of scientific experimentation or analysis, or chemical research 
on, or analysis of, the chemical substance, including methods for 
disposal, but not for research or analysis for the development of a new 
product, or refinement of an existing product that contains the chemical 
substance.

[86 FR 879, Jan. 6, 2021, as amended at 86 FR 894, 909, 922, 932, Jan. 
6, 2021]



Sec.  751.405  DecaBDE.

    (a) Prohibition--(1) General. Except as provided in paragraphs 
(a)(2) and (b) of this section, all persons are prohibited from all 
manufacturing and processing of decaBDE or decaBDE-containing products 
or articles after March 8, 2021, and all persons are prohibited from all 
distribution in commerce of decaBDE or decaBDE-containing products or 
articles after January 6, 2022.
    (2) Phase-in of Prohibitions for Specific Uses of decaBDE and 
decaBDE-containing Products or Articles. (i) After July 6, 2022, all 
persons are prohibited from all manufacturing, processing, and 
distribution in commerce decaBDE for use in curtains in the hospitality 
industry, and the curtains to which decaBDE has been added.
    (ii) After January 6, 2023, all persons are prohibited from all 
processing and distribution in commerce of decaBDE for use in wire and 
cable insulation in nuclear power generation facilities, and decaBDE-
containing wire and cable insulation.
    (iii) After January 8, 2024, all persons are prohibited from all 
manufacturing, processing, and distribution in commerce of decaBDE for 
use in parts installed in and distributed as part of new aerospace 
vehicles, and the parts to which decaBDE has been added for

[[Page 161]]

such vehicles. After the end of the aerospace vehicles service lives, 
all persons are prohibited from all importing, processing, and 
distribution in commerce of aerospace vehicles manufactured before 
January 8, 2024 that contain decaBDE in any part. After the end of the 
aerospace vehicles service lives, all persons are prohibited from all 
manufacture, processing and distribution in commerce of decaBDE for use 
in replacement parts for aerospace vehicles, and the replacement parts 
to which decaBDE has been added for such vehicles.
    (iv) After the end of the vehicles service lives or 2036, whichever 
is earlier, all persons are prohibited from all manufacture, processing 
and distribution in commerce of decaBDE for use in replacement parts for 
motor vehicles, and the replacement parts to which decaBDE has been 
added for such vehicles.
    (v) After the end of the pallets' service life, all persons are 
prohibited from all distribution in commerce of plastic shipping pallets 
that contain decaBDE and were manufactured prior March 8, 2021.
    (b) Exclusions to the Prohibition. Processing and distribution in 
commerce for recycling of decaBDE-containing plastic from products or 
articles and decaBDE-containing products or articles made from such 
recycled plastic, where no new decaBDE is added during the recycling or 
production processes is not subject to the prohibition in paragraph (a) 
of this section.
    (c) Recordkeeping. (1) After March 8, 2021, all persons who 
manufacture, process, or distribute in commerce decaBDE or decaBDE-
containing products or articles must maintain ordinary business records, 
such as invoices and bills-of-lading related to compliance with the 
prohibitions, restrictions, and other provisions of this section.
    (i) These records must be maintained for a period of three years 
from the date the record is generated.
    (ii) These records must include a statement that the decaBDE or the 
decaBDE-containing products or articles are in compliance with 40 CFR 
751.405(a).
    (iii) These records must be made available to EPA within 30 calendar 
days upon request.
    (2) The recordkeeping requirements in paragraph (c)(1) do not apply 
to the activities described in paragraphs (a)(2)(v) and (b) of this 
section.

[86 FR 894, Jan. 6, 2021]



Sec.  751.407  PIP (3:1).

    (a) Prohibitions--(1) General. Except as provided in paragraphs 
(a)(2) and (b) of this section, all persons are prohibited from all 
processing and distributing in commerce of PIP (3:1), including in PIP 
(3:1)-containing products or articles after March 8, 2021.
    (2) Phase-in Prohibitions for Specific uses of PIP (3:1) and PIP 
(3:1)-containing products and articles. (i) After January 6, 2025, all 
persons are prohibited from all processing and distributing in commerce 
of PIP (3:1) for use in adhesives and sealants, PIP (3:1)-containing 
products for use in adhesives and sealants, and PIP (3:1)-containing 
adhesives and sealants.
    (ii) After January 1, 2022, all persons are prohibited from all 
processing and distributing in commerce of PIP (3:1) for use in 
photographic printing articles and PIP (3:1)-containing photographic 
printing articles.
    (iii) After October 31, 2024, except as provided in paragraphs 
(a)(2)(ii) and (b) of this section, all persons are prohibited from all 
processing and distribution in commerce of PIP (3:1) for use in articles 
and PIP (3:1)-containing articles.
    (b) Exclusions. The following activities are not subject to the 
prohibitions in paragraph (a) of this section.
    (1) Processing and distribution in commerce of:
    (i) PIP (3:1) for use in hydraulic fluids either for the aviation 
industry or to meet military specifications for safety and performance 
where no alternative chemical is available that meets U.S. Department of 
Defense specification requirements, PIP (3:1)-containing products for 
use in such hydraulic fluids, and PIP (3:1)-containing hydraulic fluids 
either for the aviation industry or to meet military specifications for 
safety and performance where no alternative chemical is available that

[[Page 162]]

meets U.S. Department of Defense specification requirements.
    (ii) PIP (3:1) for use in lubricants and greases, PIP (3:1) 
containing products for use in lubricants and greases, and PIP (3:1)-
containing lubricants and greases.
    (iii) PIP (3:1) and PIP (3:1)-containing products for use in new and 
replacement parts for motor and aerospace vehicles, the new and 
replacement parts to which PIP (3:1) has been added for such vehicles, 
and the motor and aerospace vehicles that contain new and replacement 
parts to which PIP (3:1) has been added;
    (iv) PIP (3:1) and PIP (3:1)-containing products for use as an 
intermediate in a closed system to produce cyanoacrylate adhesives;
    (v) PIP (3:1) for use in specialized engine air filters for 
locomotive and marine applications, PIP (3:1) containing products for 
use in specialized engine air filters for locomotive and marine 
applications, and PIP (3:1)-containing specialized engine air filters 
for locomotive and marine applications;
    (vi) Plastic for recycling from products or articles containing PIP 
(3:1), where no new PIP (3:1) is added during the recycling process; and
    (vii) Finished products or articles made of plastic recycled from 
products or articles containing PIP (3:1), where no new PIP (3:1) was 
added during the production of the products or articles made of recycled 
plastic.
    (2) [Reserved]
    (c) Prohibition on releases to water. After March 8, 2021, all 
persons are prohibited from releasing PIP (3:1) to water during 
manufacturing, processing and distribution in commerce of PIP (3:1) and 
PIP (3:1) containing products, and all persons are required to follow 
all applicable regulations and best management practices for preventing 
the release of PIP (3:1) and PIP (3:1)-containing products to water 
during commercial use.
    (d) Recordkeeping. (1) After March 8, 2021, persons who manufacture, 
process, or distribute in commerce PIP (3:1) or PIP (3:1)-containing 
products or articles must maintain ordinary business records, such as 
invoices and bills-of-lading, related to compliance with the 
prohibitions, restrictions, and other provisions of this section. These 
records must be maintained for a period of three years from the date the 
record is generated.
    (2) These records must include a statement that the PIP (3:1), or 
the PIP (3:1)-containing products or articles, are in compliance with 40 
CFR 751.407(a).
    (3) These records must be made available to EPA within 30 calendar 
days upon request.
    (4) The recordkeeping requirements in paragraph (d) of this section 
do not apply to the activities described in paragraphs (b)(1)(vi) and 
(vii) of this section. The recordkeeping requirements in paragraph (d) 
of this section also do not apply to PIP (3:1)-containing articles until 
October 31, 2024.
    (e) Downstream notification. (1) Each person who manufactures PIP 
(3:1) for any use after March 8, 2021 must, prior to or concurrent with 
the shipment, notify persons to whom PIP (3:1) is shipped, in writing, 
of the restrictions described in this subpart.
    (2) Each person who processes or distributes in commerce PIP (3:1) 
or PIP (3:1)-containing products for any use after July 6, 2021 must, 
prior to or concurrent with the shipment, notify persons to whom PIP 
(3:1) is shipped, in writing, of the restrictions described in this 
subpart.
    (3) Notification must occur by inserting the text in paragraphs 
(e)(3)(i) and (e)(3)(ii) in the Safety Data Sheet (SDS) or by including 
on the label of any PIP (3:1) or PIP (3:1)-containing product the label 
language in paragraph (e)(3)(iii):
    (i) SDS Section 1(c). ``The Environmental Protection Agency 
prohibits processing and distribution of this chemical/product for any 
use other than: (1) In hydraulic fluids either for the aviation industry 
or to meet military specifications for safety and performance where no 
alternative chemical is available that meets U.S. Department of Defense 
specification requirements, (2) lubricants and greases, (3) New or 
replacement parts for motor and aerospace vehicles, (4) as an 
intermediate in the manufacture of cyanoacrylate glue, (5) In 
specialized engine air filters for locomotive and marine applications, 
(6) In adhesives

[[Page 163]]

and sealants before January 6, 2025, after which use in adhesives and 
sealants is prohibited, and (7) in other articles before October 31, 
2024, after which use in articles other than new or replacement parts 
for motor and aerospace vehicles or specialized engine air filters for 
locomotive and marine applications is prohibited. In addition, all 
persons are prohibited from releasing PIP (3:1) to water during 
manufacturing, processing, and distribution in commerce, and must follow 
all existing regulations and best practices to prevent the release of 
PIP (3:1) to water during the commercial use of PIP (3:1).''; and
    (ii) SDS Section 15. ``The Environmental Protection Agency prohibits 
processing and distribution of this chemical/product for any use other 
than: (1) In hydraulic fluids either for the aviation industry or to 
meet military specifications for safety and performance where no 
alternative chemical is available that meets U.S. Department of Defense 
specification requirements, (2) lubricants and greases, (3) new or 
replacement parts for motor and aerospace vehicles, (4) as an 
intermediate in the manufacture of cyanoacrylate glue, (5) In 
specialized engine air filters for locomotive and marine applications, 
(6) in adhesives and sealants before January 6, 2025, after which use in 
adhesives and sealants is prohibited, and (7) in other articles before 
October 31, 2024, after which use in articles other than new or 
replacement parts for motor and aerospace vehicles or specialized engine 
air filters for locomotive and marine applications is prohibited. In 
addition, all persons are prohibited from releasing PIP (3:1) to water 
during manufacturing, processing, and distribution in commerce, and must 
follow all existing regulations and best practices to prevent the 
release of PIP (3:1) to water during the commercial use of PIP (3:1).''; 
or
    (iii) Labeling. ``The Environmental Protection Agency prohibits 
processing and distribution of this chemical/product for any use other 
than: (1) In hydraulic fluids either for the aviation industry or to 
meet military specifications for safety and performance where no 
alternative chemical is available that meets U.S. Department of Defense 
specification requirements, (2) lubricants and greases, (3) new or 
replacement parts for motor and aerospace vehicles, (4) as an 
intermediate in the manufacture of cyanoacrylate glue, (5) In 
specialized engine air filters for locomotive and marine applications, 
(6) In adhesives and sealants before January 6, 2025, after which use in 
adhesives and sealants is prohibited, and (7) in other articles before 
October 31, 2024, after which use in articles other than new or 
replacement parts for motor and aerospace vehicles or specialized engine 
air filters for locomotive and marine applications is prohibited. In 
addition, all persons are prohibited from releasing PIP (3:1) to water 
during manufacturing, processing, and distribution in commerce, and must 
follow all existing regulations and best practices to prevent the 
release of PIP (3:1) to water during the commercial use of PIP (3:1).''
    (4) The downstream notification requirements in this paragraph (e) 
do not apply to the activities described in paragraphs (b)(1)(vi) and 
(vii) of this section.

[86 FR 909, Jan. 6, 2021, as amended at 86 FR 51832, Sept. 17, 2021; 87 
FR 12886, Mar. 8, 2022]



Sec.  751.409  2,4,6-TTBP.

    (a) Prohibitions. (1) After January 6, 2026, all persons are 
prohibited from all distribution in commerce of 2,4,6-TTBP, at any 
concentration above 0.3 percent by weight, in containers with a volume 
less than 35 gallons.
    (2) After January 6, 2026, all persons are prohibited from all 
processing and distribution in commerce of 2,4,6-TTBP oil and lubricant 
additives at any concentration above 0.3 percent by weight.
    (b) Recordkeeping. After January 6, 2026, distributors of 2,4,6-TTBP 
must maintain ordinary business records, such as invoices and bills-of-
lading, related to compliance with the prohibitions, restrictions, and 
other provisions of this section. These records must be maintained for a 
period of three years from the date the record is generated.



Sec.  751.411  PCTP.

    (a) Prohibition. After March 8, 2021, all persons are prohibited 
from all

[[Page 164]]

manufacturing and processing of PCTP or PCTP-containing products or 
articles, unless PCTP concentrations are at or below 1% by weight. After 
January 6, 2022, all persons are prohibited from all distribution in 
commerce of PCTP or PCTP-containing products or articles, unless PCTP 
concentrations are at or below 1% by weight.
    (b) Recordkeeping. After March 8, 2021, manufacturers, processors 
and distributors of PCTP or PCTP-containing products or articles must 
maintain ordinary business records related to compliance with the 
prohibitions, restrictions and other provisions of this section, such as 
invoices and bills-of-lading. These records must be maintained for a 
period of three years from the date the record is generated.

[86 FR 922, Jan. 6, 2021]



Sec.  751.413  HCBD.

    (a) Prohibition. After March 8, 2021, all persons are prohibited 
from all manufacturing, processing and distribution in commerce of HCBD 
and HCBD-containing products or articles, except for the following:
    (1) Unintentional production of HCBD as a byproduct in the 
production of chlorinated solvents; and
    (2) Processing and distribution in commerce of HCBD for burning as a 
waste fuel.
    (b) Recordkeeping. After March 8, 2021, manufacturers, processors 
and distributors of HCBD or HCBD-containing products or articles must 
maintain ordinary business records related to compliance with the 
prohibitions, restrictions and other provisions of this section, such as 
invoices and bills-of-lading. These records must be maintained for a 
period of three years from the date the record is generated.

[86 FR 932, Jan. 6, 2021]



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.

[[Page 165]]

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.

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.

[[Page 166]]

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.
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.

    Source: 43 FR 7156, Feb. 17, 1978, unless otherwise noted.



                            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 [micro]g/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 [micro]g/100 cm\2\. Provisions that apply to PCBs at 
concentrations of =500 ppm apply also to contaminated 
surfaces at PCB concentrations of =100 [micro]g/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

[[Page 167]]

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.
    (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

[[Page 168]]

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 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).

[[Page 169]]

    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).
    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

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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 
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.

[[Page 171]]

    (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 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.

[[Page 172]]

    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.
    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

[[Page 173]]

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

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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.
    (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 [micro]g/100 
cm\2\ but <100 [micro]g/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 [micro]g/100 cm\2\ 
and <100 [micro]g/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.

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    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, 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)

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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:
    (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 ([micro]g/L) for total Aroclors (roughly 3 parts 
per billion (3 ppb)). Water discharges from the processing of paper 
products must at all times be less than 3 micrograms per liter 
([micro]g/L) for total Aroclors (roughly 3 ppb), or comply with the 
equivalent mass-based limitation.
    (5) Disposal of any other process wastes at concentrations of 50 ppm 
or greater must be in accordance with subpart D of this part.
    Research and development (R&D) for PCB disposal means demonstrations 
for commercial PCB disposal approvals, pre-demonstration tests, tests of 
major modifications to previously approved PCB disposal technologies, 
treatability studies for PCB disposal technologies which have not been 
approved, development of new disposal technologies, and research on 
chemical transformation processes including, but not limited to, 
biodegradation.
    Retrofill means to remove PCB or PCB-contaminated dielectric fluid 
and

[[Page 177]]

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.
    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.

[[Page 178]]

    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 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 
Sec. Sec.  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.

[[Page 179]]

    (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 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.

[[Page 180]]

    (a) No persons may use any PCB, or any PCB Item regardless of 
concentration, in any manner other than in a totally enclosed manner 
within the United States unless authorized under Sec.  761.30, except 
that:
    (1) An authorization is not required to use those PCBs or PCB Items 
which consist of excluded PCB products as defined in Sec.  761.3.
    (2) An authorization is not required to use those PCBs or PCB Items 
resulting from an excluded manufacturing process or recycled PCBs as 
defined in Sec.  761.3, provided all applicable conditions of Sec.  
761.1(f) are met.
    (3) An authorization is not required to use those PCB Items which 
contain or whose surfaces have been in contact with excluded PCB 
products as defined in Sec.  761.3.
    (4) An authorization is not required to use sewage sludge where the 
uses are regulated at parts 257, 258, and 503 of this chapter. No person 
may blend or otherwise dilute PCBs regulated for disposal, including PCB 
sewage sludge and sewage sludge not used pursuant to parts 257, 258, and 
503 of this chapter, for purposes of use or to avoid disposal 
requirements under this part. Except as explicitly provided in subpart D 
of this part, no person may dispose of regulated PCB wastes including, 
but not limited to, PCB remediation waste, PCB bulk product waste, PCBs, 
and PCB industrial sludges, into treatment 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.

[[Page 181]]

    (4) PCBs, at concentrations of less than 50 ppm, or PCB Items, with 
concentrations of less than 50 ppm, may be processed and distributed in 
commerce for purposes of disposal.
    (5) Decontaminated materials. Any person may distribute in commerce 
equipment, structures, or other liquid or non-liquid materials that were 
contaminated with PCBs =50 ppm, including those not otherwise 
authorized for distribution in commerce under this part, provided that 
one of the following applies:
    (i) The materials were decontaminated in accordance with a TSCA PCB 
disposal approval issued under subpart D of this part, with Sec.  
761.79, or with applicable EPA PCB spill cleanup policies in effect at 
the time of the decontamination.
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec.  761.79(b).
    (d) The use of waste oil that contains any detectable concentration 
of PCB as a sealant, coating, or dust control agent is prohibited. 
Prohibited uses include, but are not limited to, road oiling, general 
dust control, use as a pesticide or herbicide carrier, and use as a rust 
preventative on pipes.
    (e) In addition to any applicable requirements under 40 CFR part 
279, subparts G and H, marketers and burners 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.

[[Page 182]]

    (ii) Before a burner accepts from a marketer the first shipment of 
used oil fuel containing detectable PCBs (2 ppm), the burner must 
provide the marketer a one-time written and signed notice certifying 
that:
    (A) The burner has complied with any notification requirements 
applicable to ``qualified incinerators'' (Sec.  761.3) or to ``burners'' 
regulated under 40 CFR part 279, subpart G.
    (B) The burner will burn the used oil only in a combustion facility 
identified in paragraph (e)(1) of this section and identify the class of 
burner he qualifies.
    (4) Recordkeeping requirements. The following recordkeeping 
requirements are in addition to the recordkeeping requirements for 
marketers found in 40 CFR 279.72(b), 279.74(a), (b) and (c), and 279.75, 
and for burners found in 40 CFR 279.65 and 279.66.
    (i) Marketers. Marketers who first claim that the used oil fuel 
contains no detectable PCBs must include among the records required by 
40 CFR 279.72(b) and 279.74(b) and (c), copies of the analysis or other 
information documenting his claim, and he must include among the records 
required by 40 CFR 279.74(a) and (c) and 279.75, a copy of each 
certification notice received or prepared relating to transactions 
involving PCB-containing used oil.
    (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

[[Page 183]]

network PCB Transformers not located in sidewalk vaults in or near 
commercial buildings (network transformers with secondary voltages below 
480 volts) that have not been removed from service as provided in 
paragraph (a)(1)(iv)(B) of this section, must be equipped with 
electrical protection to avoid transformer ruptures caused by high 
current faults. As of February 25, 1991, all lower secondary voltage 
radial PCB Transformers, in use in or near commercial buildings, must be 
equipped with electrical protection to avoid transformer ruptures caused 
by high current faults.
    (A) Current-limiting fuses or other equivalent technology must be 
used to detect sustained high current faults and provide for the 
complete deenergization of the transformer (within several hundredths of 
a second in the case of higher secondary voltage radial PCB Transformers 
and within tenths of a second in the case of lower secondary voltage 
network PCB Transformers), before transformer rupture occurs. Lower 
secondary voltage radial PCB Transformers must be equipped with 
electrical protection as provided in paragraph (a)(1)(iv)(E) of this 
section. The installation, setting, and maintenance of current-limiting 
fuses or other equivalent technology to 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

[[Page 184]]

must be configured to operate automatically within 30 seconds to 1 
minute of the receipt of a signal indicating an abnormal condition from 
a sustained low current fault, or can be configured to allow for manual 
deenergization from a manned on-site control center upon the receipt of 
an audio or visual signal indicating an abnormal condition caused by a 
sustained low current fault. Manual deenergization from a manned on-site 
control center must occur within 1 minute of the receipt of the audio or 
visual signal indicating an abnormal condition caused by a sustained low 
current fault. If automatic operation is selected and a circuit breaker 
is utilized for disconnection, it must also have the capability to be 
manually opened if necessary.
    (C) The enhanced electrical protective system required for the 
detection of sustained low current faults and the complete and rapid 
deenergization of transformers must be properly installed, maintained, 
and set sensitive enough (in accordance with good engineering practices) 
to detect sustained low current faults and allow for rapid and total 
deenergization prior to PCB Transformer rupture (either violent or non 
violent rupture) and release of PCBs.
    (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).

[[Page 185]]

    (B) The principal constituent of the dielectric fluid in the 
transformer(s) (e.g., PCBs, mineral oil, or silicone oil).
    (C) The type of transformer installation (e.g., 208/120 volt 
network, 208/120 volt radial, 208 volt radial, 480 volt network, 480/277 
volt network, 480 volt radial, 480/277 volt radial).
    (viii) As of December 1, 1985, combustible materials, including, but 
not limited to paints, solvents, plastics, paper, and sawn wood must not 
be stored within a PCB Transformer enclosure (i.e., in a transformer 
vault or in a partitioned area housing a transformer); within 5 meters 
of a transformer enclosure, or, if unenclosed (unpartitioned), within 5 
meters of a PCB Transformer.
    (ix) A visual inspection of each PCB Transformer (as defined in the 
definition of ``PCB Transformer'' under Sec.  761.3) in use or stored 
for reuse shall be performed at least once every 3 months. These 
inspections may take place any time during the 3-month periods: January-
March, April-June, July-September, and October-December as long as there 
is a minimum of 30 days between inspections. The visual inspection must 
include investigation for any leak of dielectric fluid on or around the 
transformer. The extent of the visual inspections will depend on 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.

[[Page 186]]

    (G) A description of any cleanup, containment, or repair performed.
    (H) The results of any containment and daily inspection required for 
uncorrected active leaks.
    (I) Record of the registration of PCB Transformer(s).
    (J) Records of transfer of ownership in compliance with Sec.  
761.180(a)(2)(ix).
    (xiii) A reduced visual inspection frequency of at least once every 
12 months applies to PCB Transformers that utilize either of the 
following risk reduction measures. These inspections may take place any 
time during the calendar year as long as there is a minimum of 180 days 
between inspections.
    (A) A PCB Transformer which has impervious, undrained, secondary 
containment capacity of at least 100 percent of the total dielectric 
fluid volume of all transformers so contained or
    (B) A PCB Transformer which has been tested and found to contain 
less than 60,000 ppm PCBs (after 3 months of in service use if the 
transformer has been serviced for purposes of reducing the PCB 
concentration).
    (xiv) An increased visual inspection frequency of at least once 
every week applies to any PCB Transformer in use or stored for reuse 
which poses an exposure risk to food or feed. The user of a PCB 
Transformer posing an exposure 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.

[[Page 187]]

    (2) Servicing conditions. (i) Transformers classified as PCB-
Contaminated Electrical Equipment (as defined in the definition of 
``PCB-Contaminated Electrical Equipment'' under Sec.  761.3) may be 
serviced (including rebuilding) only with dielectric fluid containing 
less than 500 ppm PCB.
    (ii) Any servicing (including rebuilding) of PCB Transformers (as 
defined in the definition of ``PCB Transformer'' under Sec.  761.3) that 
requires the removal of the transformer coil from the transformer casing 
is prohibited. PCB Transformers may be serviced (including topping off) 
with dielectric fluid at any PCB concentration.
    (iii) PCBs removed during any servicing activity must be captured 
and either reused as dielectric fluid or disposed of in accordance with 
the requirements of Sec.  761.60. PCBs from PCB Transformers must not be 
mixed with or added to dielectric fluid from PCB-Contaminated Electrical 
Equipment.
    (iv) Regardless of its PCB concentration, dielectric fluids 
containing less than 500 ppm PCB that are mixed with fluids that contain 
500 ppm or greater PCB must not be used as dielectric fluid in any 
electrical equipment. The entire mixture of dielectric fluid must be 
considered to be greater than 500 ppm PCB and must be disposed of in an 
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  PCB-contaminated
                                                       transformer         <500
                                                       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  PCB-contaminated
                                                       PCBs at least 90    <500
                                                       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   test the fluid for  <50                 non-PCB
                                   <50 ppm PCBs        PCBs at least 90
                                                       days after
                                                       retrofill
                                 -------------------------------------------------------------------------------
                                  <2 ppm PCBs         (no need to test)   (not applicable)    non-PCB
----------------------------------------------------------------------------------------------------------------


[[Page 188]]

    (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 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

[[Page 189]]

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 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

[[Page 190]]

<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):

----------------------------------------------------------------------------------------------------------------
                                                                                                   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  PCB-contaminated
                                                       equipment           <500
                                                       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  PCB-contaminated
                                                       PCBs at least 90    <500
                                                       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   test the fluid for  <50                 non-PCB
                                   <50 ppm 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

[[Page 191]]

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 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

[[Page 192]]

component or segment is reduced to <50 ppm, and make it available to EPA 
upon request.
    (D) The Director, National Program Chemicals Division, after 
consulting with the appropriate EPA Region(s) may, based on a finding of 
no unreasonable risk, modify in writing the requirements of paragraph 
(i)(1)(iii)(A) of this section, including extending any compliance date, 
approving alternative formats for documentation, waiving one or more 
requirements for a segment or component, requiring sampling and 
analysis, and requiring implementation of engineering measures to reduce 
PCB concentrations. EPA will make such modifications based on the 
natural gas pipeline system size, configuration, and current operating 
conditions; nature, extent or source of contamination; proximity of 
contamination to end-users; or previous sampling, monitoring, remedial 
actions or documentation of activities taken regarding compliance with 
this authorization or other applicable Federal, State, or local laws and 
regulations. The Director, National Program Chemicals Division, may 
defer the authority described in this paragraph, upon request, to the 
appropriate EPA Region.
    (E) The owner or operator of a natural gas pipeline system may use 
historical data to fulfill the requirements of paragraphs 
(i)(1)(iii)(A)(1), (i)(1)(iii)(A)(2) and (i)(1)(iii)(A)(3) of this 
section. They may use documented historical actions taken to reduce PCB 
concentrations in known sources; decontaminate components or segments of 
natural gas pipeline systems; or otherwise to reduce PCB levels to 
fulfill the requirements of paragraph (i)(1)(iii)(A)(4) of this section.
    (2) Any person may reuse PCB-Contaminated natural gas pipe and 
appurtenances in a natural gas pipeline system, provided all free-
flowing liquids have been removed.
    (3) Any person may use PCB-Contaminated natural gas pipe, drained of 
all free-flowing liquids, in the transport of liquids (e.g., bulk 
hydrocarbons, chemicals, petroleum products, or coal slurry), as casing 
to provide secondary containment or protection (e.g., protection for 
electrical cable), as industrial structural material (e.g., fence posts, 
sign posts, or bridge supports), as temporary flume at construction 
sites, as equipment skids, as culverts under transportation systems in 
intermittent flow situations, for sewage service with written consent of 
the Publicly Owned Treatment Works (POTW), for steam service, as 
irrigation systems (<20 inch diameter) of less than 200 miles in length, 
and in a totally enclosed compressed air system.
    (4) Any person characterizing PCB contamination in natural gas pipe 
or natural gas pipeline systems must do so by analyzing organic liquids 
collected at existing condensate collection points in the pipe or 
pipeline system. The level of PCB contamination found at a collection 
point is assumed to extend to the next collection point downstream. Any 
person characterizing multi-phasic liquids must do so in accordance with 
Sec.  761.1(b)(4); if no liquids are present, they must use standard 
wipe samples in accordance with subpart M of this part.
    (5)(i) Any person disposing of liquids containing PCBs 
=50 ppm removed, spilled, or otherwise released from a 
natural gas pipeline system must do so in accordance with Sec.  
761.61(a)(5)(iv) based on the PCB concentration at the time of removal 
from the system. Any person disposing of materials contaminated by 
spills or other releases of PCBs =50 ppm from a natural gas 
pipeline systems, must do so in accordance with Sec. Sec.  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

[[Page 193]]

properties of PCBs; studies of environmental transport processes; 
studies of biochemical transport processes; studies of effects of PCBs 
on the environment; and studies of the health effects of PCBs, including 
direct toxicity and toxicity of metabolic products of PCBs. Authorized 
R&D activities do not include research, development, or analysis for the 
development of any PCB product. Any person conducting R&D activities 
under this section is also responsible for determining and complying 
with all other applicable Federal, State, and local laws and 
regulations. Although the use of PCBs and PCBs in analytical reference 
samples derived from waste material is authorized in conjunction with 
PCB-disposal related activities, R&D for PCB disposal (as defined under 
Sec.  761.3) is addressed in Sec.  761.60(j). PCBs and PCBs in 
analytical reference samples derived from waste materials are authorized 
for use, in a manner other than a totally enclosed manner, provided 
that:
    (1) They obtain the PCBs and PCBs in analytical reference samples 
derived from waste materials from sources authorized under Sec.  761.80 
to manufacture, process, and distribute PCBs in commerce and the PCBs 
are packaged in compliance with the Hazardous Materials Regulations at 
49 CFR parts 171 through 180.
    (2) They store all PCB wastes resulting from R&D activities (e.g., 
spent laboratory samples, residuals, contaminated media such as 
clothing, etc.) in compliance with Sec.  761.65(b) and dispose of all 
PCB wastes in compliance with Sec.  761.64.
    (3) [Reserved]
    (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 [micro]g/100 cm\2\ for the

[[Page 194]]

remainder of the useful life of the surfaces and subsurface material if 
the following conditions are met:
    (i) The source of PCB contamination is removed or contained to 
prevent further release to porous surfaces.
    (ii) If the porous surface is accessible to superficial surface 
cleaning:
    (A) The double wash rinse procedure in subpart S of this part is 
conducted on the surface to remove surface PCBs.
    (B) The treated surface is allowed to dry for 24 hours.
    (iii) After accessible surfaces have been cleaned according to 
paragraph (p)(1)(ii) of this section and for all surfaces inaccessible 
to cleanup:
    (A) The surface is completely covered to prevent release of PCBs 
with:
    (1) Two solvent resistant and water repellent coatings of 
contrasting colors to allow for a visual indication of wear through or 
loss of outer coating integrity; or
    (2) A solid barrier fastened to the surface and covering the 
contaminated area or all accessible parts of the contaminated area. 
Examples of inaccessible areas are underneath a floor-mounted electrical 
transformer and in an impassible space between an electrical transformer 
and a vault wall.
    (B) The surface is marked with the ML Mark in a location 
easily visible to individuals present in the area; the ML 
Mark shall be placed over the encapsulated area or the barrier to the 
encapsulated area.
    (C) ML Marks shall be replaced when worn or illegible.
    (2) Removal of a porous surface contaminated with PCBs from its 
location or current use is prohibited except for removal for disposal in 
accordance with Sec. Sec.  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:

[[Page 195]]

    (i) The materials were decontaminated in accordance with:
    (A) A TSCA PCB disposal approval issued under subpart D of this 
part;
    (B) Section 761.79; or
    (C) Applicable EPA PCB spill cleanup policies (e.g., TSCA, RCRA, 
CERCLA, EPA regional) in effect at the time of the decontamination; or
    (ii) If not previously decontaminated, the materials now meet an 
applicable decontamination standard in Sec.  761.79(b).
    (2) No person shall use or reuse materials decontaminated in 
accordance with paragraph (u)(1)(i) of this section or meeting an 
applicable decontamination standard in paragraph (u)(1)(ii) of this 
section, in direct contact with food, feed, or drinking water unless 
otherwise allowed under this section or this part.
    (3) Any person may use water containing PCBs at concentrations 
<=0.5[micro]g/L PCBs without restriction.
    (4) Any person may use water containing PCBs at concentrations <200 
[micro]g/L (i.e., <200 ppb PCBs) for non-contact use in a closed system 
where there are no releases (e.g., as a non-contact cooling water).

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

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

    Editorial Note: For Federal Register citations 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.govinfo.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;

[[Page 196]]

    (2) PCB Transformers at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal from use if not already marked. [Marking of PCB-Contaminated 
Electrical Equipment is not required];
    (3) PCB Large High Voltage Capacitors at the time of manufacture, at 
the time of distribution in commerce if not already marked, and at the 
time of removal from use if not already marked;
    (4) Equipment containing a PCB Transformer or a PCB Large High 
Voltage Capacitor at the time of manufacture, at the time of 
distribution in commerce if not already marked, and at the time of 
removal of the equipment from use if not already marked;
    (5) PCB Large Low Voltage Capacitors at the time of removal from use 
(see also paragraph (k) of this section).
    (6) Electric motors using PCB coolants (See also paragraph (e) of 
this section).
    (7) Hydraulic systems using PCB hydraulic fluid (See also paragraph 
(e) of this section);
    (8) Heat transfer systems (other than PCB Transformers) using PCBs 
(See also paragraph (e) of this section);
    (9) PCB Article Containers containing articles or equipment that 
must be marked under paragraphs (a) (1) through (8) of this section;
    (10) Each storage area used to store PCBs and PCB Items for 
disposal.
    (b) As of October 1, 1978, each transport vehicle loaded with PCB 
Containers that contain more than 45 kg (99.4 lbs.) of liquid PCBs at 
concentrations of =50 ppm or with one or more PCB 
Transformers shall be marked on each end and each side with the 
ML mark as described in Sec.  761.45(a).
    (c) As of January 1, 1979, the following PCB Articles shall be 
marked with mark ML as described in Sec.  761.45(a):
    (1) All PCB Transformers not marked under paragraph (a) of this 
section [marking of PCB-Contaminated Electrical Equipment is not 
required];
    (2) All PCB Large High Voltage Capacitors not marked under paragraph 
(a) of this section
    (i) Will be marked individually with mark ML, or
    (ii) If one or more PCB Large High Voltage Capacitors are installed 
in a protected location such as on a power pole, or structure, or behind 
a fence; the pole, structure, or fence shall be marked with mark 
ML, and a record or procedure identifying the PCB Capacitors 
shall be maintained by the owner or operator at the protected location.
    (d) As of January 1, 1979, all PCB Equipment containing a PCB Small 
Capacitor shall be marked at the time of manufacture with the statement, 
``This equipment contains PCB Capacitor(s)''. The mark shall be of the 
same size as the mark ML.
    (e) As of October 1, 1979, applicable PCB Items in paragraphs 
(a)(1), (a)(6), (a)(7), and (a)(8) of this section containing PCBs in 
concentrations of 50 to 500 ppm shall be marked with the ML 
mark as described in Sec.  761.45(a).
    (f) Where mark ML is specified but the PCB Article or PCB 
Equipment is too small to accomodate the smallest permissible size of 
mark ML, mark MS as described in Sec.  761.45(b), 
may be used instead of mark ML.
    (g) Each large low voltage capacitor, each small capacitor normally 
used in alternating current circuits, and each fluorescent light ballast 
manufactured (``manufactured'', for purposes of this sentence, means 
built) between July 1, 1978 and July 1, 1998 that do not contain PCBs 
shall be marked by the manufacturer at the time of manufacture with the 
statement, ``No PCBs''. The mark shall be of similar durability and 
readability as other marking that indicate electrical information, part 
numbers, or the manufacturer's name. For purposes of this paragraph 
marking requirement only is applicable to items built domestically or 
abroad after June 30, 1978.
    (h) All marks required by this subpart must be placed in a position 
on 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

[[Page 197]]

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

[[Page 198]]

    (a) Large PCB Mark--ML. Mark ML shall be as shown in 
Figure 1, letters and striping on a white or yellow background and shall 
be sufficiently durable to equal or exceed the life (including storage 
for disposal) of the PCB Article, PCB Equipment, or PCB Container. The 
size of the mark shall be at least 15.25 cm (6 inches) on each side. If 
the PCB Article or PCB Equipment is too small to accommodate this size, 
the mark may be reduced in size proportionately down to a minimum of 5 
cm (2 inches) on each side.
    (b) Small PCB Mark--Ms. Mark Ms shall be as shown in 
Figure 2, letters and striping on a white or yellow background, and 
shall be sufficiently durable to equal or exceed the life (including 
storage for disposal) of the PCB Article, PCB Equipment, or PCB 
Container. The mark shall be a rectangle 2.5 by 5 cm (1 inch by 2 
inches). If the PCB Article or PCB Equipment is too small to accommodate 
this size, the mark may be reduced in size proportionately down to a 
minimum of 1 by 2 cm (.4 by .8 inches).
[GRAPHIC] [TIFF OMITTED] TC01AP92.000


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



                     Subpart D_Storage and Disposal



Sec.  761.50  Applicability.

    (a) General PCB disposal requirements. Any person storing or 
disposing of PCB waste must do so in accordance with subpart D of this 
part. The following prohibitions and conditions apply to all PCB waste 
storage and disposal:
    (1) No person may open burn PCBs. Combustion of PCBs approved under 
Sec.  761.60 (a) or (e), or otherwise allowed under part 761, is not 
open burning.
    (2) No person may process liquid PCBs into non-liquid forms to 
circumvent the high temperature incineration requirements of Sec.  
761.60(a).
    (3) No person may discharge water containing PCBs to a treatment 
works (as defined Sec.  503.9(aa) of this chapter) or to navigable 
waters unless the PCB concentration is <3 [micro]g/L (approximately 3 
ppb), or unless the discharge is in accordance with a PCB discharge 
limit included in a permit issued under

[[Page 199]]

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 [micro]g/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, 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

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after April 18, 1978, but prior to July 2, 1979, where the concentration 
of the spill or release was =500 ppm; or placed in a land 
disposal facility, spilled, or otherwise released into the environment 
on or after July 2, 1979, where the concentration of the spill or 
release was =50 ppm, must dispose of it in accordance with 
either of the following:
    (A) In accordance with the PCB Spill Cleanup Policy (Policy) at 
subpart G of this part, for those PCB remediation wastes that meet the 
criteria of the Policy. Consult the Policy for a description of the 
spills it covers and its notification and timing requirements.
    (B) In accordance with Sec.  761.61. Complete compliance with Sec.  
761.61 does not create a presumption against enforcement action for 
penalties for any unauthorized PCB disposal.
    (iii) The owner or operator of a site containing PCB remediation 
waste has the burden of proving the date that the waste was placed in a 
land disposal facility, spilled, or otherwise released into the 
environment, and the concentration of the original spill.
    (4) PCB bulk product waste--(i) General. Any person disposing of PCB 
bulk product waste must do so in accordance with Sec.  761.62. PCB bulk 
product waste, as that term is defined in Sec.  761.3, is waste that was 
=50 ppm when originally removed from service, even if its 
current PCB concentration is <50 ppm. PCB bulk product waste is 
regulated for disposal based on the risk from the waste once disposed 
of. For waste which is land disposed, the waste is regulated based on 
how readily the waste is released from disposal to the environment, in 
particular by leaching out from the land disposal unit.
    (ii) Metal surfaces in contact with PCBs. Any person disposing of 
metal surfaces in contact with PCBs (e.g., painted metal) may use 
thermal decontamination procedures in accordance with Sec.  761.79(c)(6) 
(see Sec.  761.62(a)(6)).
    (5) PCB household waste. Any person storing or disposing of PCB 
household waste, as that term is defined in Sec.  761.3, must do so in 
accordance with Sec.  761.63.
    (6) PCB research and development waste. Any person disposing of PCB 
wastes generated during and as a result of research and development for 
use under Sec.  761.30(j), or for disposal under Sec.  761.60(j), must 
do so in accordance with Sec.  761.64.
    (7) PCB/Radioactive waste. (i) Any person storing PCB/radioactive 
waste =50 ppm PCBs must do so taking into account both its 
PCB concentration and its radioactive properties, except as provided in 
Sec.  761.65(a)(1), (b)(1)(ii), and (c)(6)(i).
    (ii) Any person disposing of PCB/radioactive waste must do so taking 
into account both its PCB concentration and its radioactive properties. 
If, taking into account only the properties of the PCBs in the waste 
(and not the radioactive properties of the waste), the waste meets the 
requirements for disposal in a facility permitted, licensed, or 
registered by a State as a municipal or non-municipal non-hazardous 
waste landfill (e.g., PCB bulk product waste under Sec.  761.62(b)(1)), 
then the person may dispose of the PCB/radioactive waste, without regard 
to the PCB component of the waste, on the basis of its radioactive 
properties in accordance with all applicable requirements for the 
radioactive component of the waste.
    (8) Porous surfaces. In most cases a person must dispose of porous 
surfaces as materials where PCBs have penetrated far beneath the 
surface, rather than a simple surface contamination. Any person 
disposing of porous surfaces on which PCBs have been spilled and meeting 
the definition of PCB remediation waste at Sec.  761.3 must do so in 
accordance with Sec.  761.61. Any person disposing of porous surfaces 
which are part of manufactured non-liquid products containing PCBs and 
meeting the definition of PCB bulk product waste at Sec.  761.3 must do 
so in accordance with Sec.  761.62. Any person may decontaminate 
concrete surfaces upon which PCBs have been spilled in accordance with 
Sec.  761.79(b)(4), if the decontamination procedure is commenced within 
72 hours of the initial spill of PCBs to the concrete or portion thereof 
being decontaminated. Any person may decontaminate porous non-liquid 
PCBs in contact with non-porous surfaces, such 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).

[[Page 201]]

    (c) Storage for disposal. Any person who holds PCB waste must store 
it in accordance with Sec.  761.65.
    (d) Performance specifications for disposal technologies--(1) 
Incinerators. Any person using an incinerator to dispose of PCBs must 
use an incinerator that meets the criteria set forth in Sec.  761.70.
    (2) High efficiency boilers. Any person using a high efficiency 
boiler to dispose of PCBs must use a boiler that meets the criteria set 
forth in Sec.  761.71.
    (3) Scrap metal recovery ovens and smelters. Any person using scrap 
metal recovery ovens and smelters to dispose of PCBs must use a device 
that meets the criteria set forth in Sec.  761.72.
    (4) Chemical waste landfills. Any person using a chemical waste 
landfill to dispose of PCBs must use a chemical waste landfill that 
meets the criteria set forth in Sec.  761.75.
    (e) TSCA PCB Coordinated Approval. Any person seeking a TSCA PCB 
Coordinated Approval must follow the procedures set forth in Sec.  
761.77.

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



Sec.  761.60  Disposal requirements.

    (a) PCB liquids. PCB liquids at concentrations =50 ppm 
must be disposed of in an incinerator which complies with Sec.  761.70, 
except that PCB liquids at concentrations =50 ppm and <500 
ppm may be disposed of as follows:
    (1) For mineral oil dielectric fluid, in a high efficiency boiler 
according to Sec.  761.71(a).
    (2) For liquids other than mineral oil dielectric fluid, in a high 
efficiency boiler according to Sec.  761.71(b).
    (3) For liquids from incidental sources, such as precipitation, 
condensation, leachate or load separation and are associated with PCB 
Articles or non-liquid PCB wastes, in a chemical waste landfill which 
complies with Sec.  761.75 if:
    (i) [Reserved]
    (ii) Information is provided to or obtained by the owner or operator 
of the chemical waste landfill that shows that the liquids do not exceed 
500 ppm PCB and are not an ignitable waste as described in Sec.  
761.75(b)(8)(iii).
    (b) PCB Articles. This paragraph does not authorize disposal that is 
otherwise prohibited in Sec.  761.20 or elsewhere in this part.
    (1) Transformers. (i) PCB Transformers shall be disposed of in 
accordance with either of the following:
    (A) In an incinerator that complies with Sec.  761.70; or
    (B) In a chemical waste landfill approved under Sec.  761.75; 
provided that all free-flowing liquid is removed from the transformer, 
the transformer is filled with a solvent, the transformer is allowed to 
stand for at least 18 continuous hours, and then the solvent is 
thoroughly removed. Any person disposing of PCB liquids that are removed 
from the transformer (including the dielectric fluid and all solvents 
used as a flush), shall do so in an incinerator that complies with Sec.  
761.70 of this part, or shall decontaminate them in accordance with 
Sec.  761.79. Solvents may include kerosene, xylene, toluene, and other 
solvents in which PCBs are readily soluble. Any person disposing of 
these PCB liquids must ensure that the solvent flushing procedure is 
conducted in accordance with applicable safety and health standards as 
required by Federal or State regulations.
    (ii) [Reserved]
    (2) PCB Capacitors. (i) The disposal of any capacitor shall comply 
with all requirements of this subpart unless it is known from label or 
nameplate information, manufacturer's literature (including documented 
communications with the manufacturer), or chemical analysis that the 
capacitor does not contain PCBs.
    (ii) Any person may dispose of PCB Small Capacitors as municipal 
solid waste, unless that person is subject to the requirements of 
paragraph (b)(2)(iv) of this section.
    (iii) Any PCB Large High or Low Voltage Capacitor which contains 500 
ppm or greater PCBs, owned by any person, shall be disposed of in 
accordance with either of the following:
    (A) Disposal in an incinerator that complies with Sec.  761.70; or
    (B) Until March 1, 1981, disposal in a chemical waste landfill that 
complies with Sec.  761.75.
    (iv) Any person who manufactures or at any time manufactured PCB 
Capacitors or PCB Equipment, and acquired the PCB Capacitor in the 
course of

[[Page 202]]

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 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 Sec. Sec.  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:

[[Page 203]]

    (A) Natural gas pipe having a nominal inside diameter of <=4 inches, 
and containing PCBs at any concentration but no free-flowing liquids, 
may be abandoned in the place it was used to transport natural gas if 
each end is sealed closed and the pipe is either:
    (1) Included in a public service notification program, such as a 
``one-call'' system under 49 CFR 192.614(a) and (b).
    (2) Filled to 50 percent or more of the volume of the pipe with 
grout (such as a hardening slurry consisting of cement, bentonite, or 
clay) or high density polyurethane foam.
    (B) PCB-Contaminated natural gas pipe of any diameter, where the PCB 
concentration was determined after the last transmission of gas through 
the pipe or at the time of abandonment, that contains no free-flowing 
liquids may be abandoned in the place it was used to transport natural 
gas if each end is sealed closed.
    (C) Natural gas pipe of any diameter which contains PCBs at any 
concentration but no free-flowing liquids, may be abandoned in the place 
it was used to transport natural gas, if each end is sealed closed, and 
either:
    (1) The interior surface is decontaminated with one or more washes 
of a solvent in accordance with the use and disposal requirements of 
Sec.  761.79(d). This decontamination process must result in a recovery 
of 95 percent of the solvent volume introduced into the system, and the 
PCB concentration of the recovered wash must be <50 ppm (see Sec.  
761.79(a)(1) for requirements on use and disposal of decontaminating 
fluids).
    (2) The pipe is filled to 50 percent or more of the volume of the 
pipe with grout (such as a hardening slurry-like cement, bentonite, or 
clay) or high density polyurethane foam (except that only cement shall 
be used as grout under rivers or streams) and each end is sealed closed.
    (D) Natural gas pipe of any diameter which contains PCBs at any 
concentration may be abandoned in place after decontamination in 
accordance with Sec.  761.79(c)(3), (c)(4) or (h) or a PCB disposal 
approval issued under Sec.  761.60(e) or Sec.  761.61(c).
    (ii) Removal with subsequent action. Natural gas pipeline systems 
may be disposed of under one of the following provisions:
    (A) The following classifications of natural gas pipe containing no 
free-flowing liquids may be disposed of in a facility permitted, 
licensed, or registered by a State to manage municipal solid waste 
subject to part 258 of this chapter or non-municipal non-hazardous waste 
subject to Sec. Sec.  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

[[Page 204]]

wipe samples after the last transmission of gas through the pipe or 
during removal from the location it was used to transport natural gas.
    (B) PCB concentration of the organic phase of multi-phasic liquids 
shall be determined in accordance with Sec.  761.1(b)(4).
    (iv) Disposal of pipeline liquids. (A) Any person disposing of 
liquids containing PCBs =50 ppm removed, spilled, or 
otherwise released from a natural gas pipeline system must do so in 
accordance with Sec.  761.61(a)(5)(iv) based on the PCB concentration at 
the time of removal from the system. Any person disposing of material 
contaminated by spills or other releases of PCBs =50 ppm from 
a natural gas pipeline system, must do so in accordance with Sec.  
761.61 or Sec.  761.79, as applicable.
    (B) Any person who markets or burns for energy recovery liquid 
containing PCBs at concentrations <50 ppm PCBs at the time of removal 
from a natural gas pipeline system must do so in accordance with the 
provisions pertaining to used oil at Sec.  761.20(e). No other use of 
liquid containing PCBs at concentrations above the quantifiable level/
level of detection removed from a natural gas pipeline system is 
authorized.
    (6) Other PCB Articles. (i) PCB articles with concentrations at 500 
ppm or greater must be disposed of:
    (A) In an incinerator that complies with Sec.  761.70; or
    (B) In a chemical waste landfill that complies with Sec.  761.75, 
provided that all free-flowing liquid PCBs have been thoroughly drained 
from any articles before the articles are placed in the chemical waste 
landfill and that the drained liquids are disposed of in an incinerator 
that complies with Sec.  761.70.
    (ii)(A) Except as specifically provided in paragraphs (b)(1) through 
(b)(5) of this section, any person disposing of a PCB-Contaminated 
Article must do so by removing all free-flowing liquid from the article, 
disposing of the liquid in accordance with paragraph (a) of this 
section, and disposing of the PCB-Contaminated Article with no free-
flowing liquid by one of the following methods:
    (1) In accordance with Sec.  761.79.
    (2) In a facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Sec. Sec.  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

[[Page 205]]

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 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

[[Page 206]]

collected in a common container with dielectric fluid from other oil-
filled electrical equipment, the entire contents of the container must 
be treated as PCBs at a concentration of at least 50 ppm, unless all of 
the fluid from the other oil-filled electrical equipment has been tested 
and shown to contain less than 50 ppm PCBs.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration, except that if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this subparagraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including EPA Method 608, ``Organochlorine 
Pesticides and PCBs'' at 40 CFR part 136, Appendix A;'' EPA Method 8082, 
``Polychlorinated Biphenyls (PCBs) by Capillary Column Gas 
Chromatography'' of SW-846, ``OSW Test Methods for Evaluating Solid 
Waste,'' which is available from NTIS; and ASTM Standard D-4059, 
``Standard Test Method for Analysis of Polychlorinated Biphenyls in 
Insulating Liquids by Gas Chromatography,'' which is available from 
ASTM.
    (2) Owners or users of waste oil may use the following procedures to 
determine the PCB concentration of waste oil:
    (i) Waste oil from more than one source may be collected in a common 
container, provided that no other chemical substances or mixtures, such 
as non-waste oils, are added to the container.
    (ii) For purposes of complying with the marking and disposal 
requirements, representative samples may be taken from either the common 
containers or the individual electrical equipment to determine the PCB 
concentration. Except, That if any PCBs at a concentration of 500 ppm or 
greater have been added to the container or equipment then the total 
container contents must be considered as having a PCB concentration of 
500 ppm or greater for purposes of complying with the disposal 
requirements of this subpart. For purposes of this paragraph, 
representative samples of mineral oil dielectric fluid are either 
samples taken in accordance with ASTM D 923-86 or ASTM D 923-89 or 
samples taken from a container that has been thoroughly mixed in a 
manner such that any PCBs in the container are uniformly distributed 
throughout the liquid in the container.
    (iii) Unless otherwise specified in this part, any person conducting 
the chemical analysis of PCBs shall do so using gas chromatography. Any 
gas chromatographic method that is appropriate for the material being 
analyzed may be used, including those indicated in paragraph (g)(1)(iii) 
of this section.
    (h) Requirements for export and import of PCBs and PCB Items for 
disposal are found in subpart F of this part.
    (i) Approval authority for disposal methods. (1) The officials 
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

[[Page 207]]

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 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, Sec. Sec.  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,

[[Page 208]]

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.govinfo.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.
    (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.

[[Page 209]]

    (C) The location and extent of the identified contaminated area, 
including topographic maps with sample collection sites cross referenced 
to the sample identification numbers in the data summary from paragraph 
(a)(3)(i)(B) of this section.
    (D) A cleanup plan for the site, including schedule, disposal 
technology, and approach. This plan should contain options and 
contingencies to be used if unanticipated higher concentrations or wider 
distributions of PCB remediation waste are found or other obstacles 
force changes in the cleanup approach.
    (E) A written certification, signed by the owner of the property 
where the cleanup site is located and the party conducting the cleanup, 
that all sampling plans, sample collection procedures, sample 
preparation procedures, extraction procedures, and instrumental/chemical 
analysis procedures used to assess or characterize the PCB contamination 
at the cleanup site, are on file at the location designated in the 
certificate, and are available for EPA inspection. Persons using 
alternate methods for chemical extraction and chemical analysis for site 
characterization must include in the certificate a statement that such a 
method will be used and that a comparison study which meets or exceeds 
the requirements of subpart Q of this part, and for which records are on 
file, has been completed prior to verification sampling.
    (ii) Within 30 calendar days of receiving the notification, the EPA 
Regional Administrator will respond in writing approving of the self-
implementing cleanup, disapproving of the self-implementing cleanup, or 
requiring additional information. If the EPA Regional Administrator does 
not respond within 30 calendar days of receiving the notice, the person 
submitting the notification may assume that it is complete and 
acceptable and proceed with the cleanup according to the information the 
person provided to the EPA Regional Administrator. Once cleanup is 
underway, the person conducting the cleanup must provide any proposed 
changes from the notification to the EPA Regional Administrator in 
writing no less than 14 calendar days prior to the proposed 
implementation of the change. The EPA Regional Administrator will 
determine in his or her discretion whether to accept the change, and 
will respond to the change notification verbally within 7 calendar days 
and in writing within 14 calendar days of receiving it. If the EPA 
Regional Administrator does not respond verbally within 7 calendar days 
and in writing within 14 calendar days of receiving the change notice, 
the person who submitted it may deem it complete and acceptable and 
proceed with the cleanup according to the information in the change 
notice provided to the EPA Regional Administrator.
    (iii) Any person conducting a cleanup activity may obtain a waiver 
of the 30-day notification requirement, if they receive a separate 
waiver, in writing, from each of the agencies they are required to 
notify under this section. The person must retain the original written 
waiver as required in paragraph (a)(9) of this section.
    (4) Cleanup levels. For purposes of cleaning, decontaminating, or 
removing PCB remediation waste under this section, there are four 
general waste categories: bulk PCB remediation waste, non-porous 
surfaces, porous surfaces, and liquids. Cleanup levels are based on the 
kind of material and the potential exposure to PCBs left after cleanup 
is completed.
    (i) Bulk PCB remediation waste. Bulk PCB remediation waste includes, 
but is not limited to, the following non-liquid PCB remediation waste: 
soil, sediments, dredged materials, muds, PCB sewage sludge, and 
industrial sludge.
    (A) High occupancy areas. The cleanup level for bulk PCB remediation 
waste in high occupancy areas is <=1 ppm without further conditions. 
High occupancy areas where bulk PCB remediation waste remains at 
concentrations 1 ppm and <=10 ppm shall be covered with a cap 
meeting the requirements of 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

[[Page 210]]

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 [micro]g/100 cm\2\ of surface area. In low 
occupancy areas, the surface cleanup standard is <100 [micro]g/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, 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 Sec. Sec.  761.60 
and 761.70 are acceptable for on-site self-implementing PCB remediation 
waste disposal within the confines of the operating conditions of the 
respective approvals.
    (i) Bulk PCB remediation waste. Any person cleaning up bulk PCB 
remediation waste shall do so to the levels in paragraph (a)(4)(i) of 
this section.
    (A) Any person cleaning up bulk PCB remediation waste on-site using 
a soil washing process may do so without EPA approval, subject to all of 
the following:
    (1) A non-chlorinated solvent is used.
    (2) The process occurs at ambient temperature.
    (3) The process is not exothermic.
    (4) The process uses no external heat.
    (5) The process has secondary containment to prevent any solvent 
from being released to the underlying or surrounding soils or surface 
waters.
    (6) Solvent disposal, recovery, and/or reuse is in accordance with 
relevant provisions of approvals issued according to paragraphs (b)(1) 
or (c) of this section or applicable paragraphs of Sec.  761.79.
    (B) Bulk PCB remediation waste may be sent off-site for 
decontamination or disposal in accordance with this paragraph, provided 
the waste is either dewatered on-site or transported off-site in 
containers meeting the requirements of the DOT Hazardous Materials 
Regulations (HMR) at 49 CFR parts 171 through 180.
    (1) Removed water shall be disposed of according to paragraph (b)(1) 
of this section.
    (2) Any person disposing off-site of dewatered bulk PCB remediation 
waste shall do so as follows:
    (i) Unless sampled and analyzed for disposal according to the 
procedures set out in Sec. Sec.  761.283, 761.286, and 761.292, 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

[[Page 211]]

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 [micro]g/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 [micro]g/100 cm\2\ 
shall be disposed of in accordance with paragraph (a)(5)(i)(B)(2)(iii) 
of this section. Metal surfaces may be thermally decontaminated in 
accordance with Sec.  761.79(c)(6)(ii).
    (C) For use, non-porous surfaces shall be decontaminated on-site or 
off-site to the standards specified in Sec.  761.79(b)(3) or in 
accordance with Sec.  761.79(c).
    (iii) Porous surfaces. Porous surfaces shall be disposed on-site or 
off-site as bulk PCB remediation waste according to paragraph (a)(5)(i) 
of this section or decontaminated for use according to Sec.  
761.79(b)(4), as applicable.
    (iv) Liquids. Any person disposing of liquid PCB remediation waste 
shall either:
    (A) Decontaminate the waste to the levels specified in Sec.  
761.79(b)(1) or (b)(2).
    (B) Dispose of the waste in accordance with paragraph (b) of this 
section or an approval issued under paragraph (c) of this section.
    (v) Cleanup wastes. Any person generating the following wastes 
during and from the cleanup of PCB remediation waste shall dispose of or 
reuse them using one of the following methods:
    (A) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
cleanup activities shall be either decontaminated in accordance with 
Sec.  761.79(b) or (c), or disposed of in one of the following 
facilities, without regard to the requirements of subparts J and K of 
this part:
    (1) A facility permitted, licensed, or registered by a State to 
manage municipal solid waste subject to part 258 of this chapter.
    (2) A facility permitted, licensed, or registered by a State to 
manage non-municipal non-hazardous waste subject to Sec. Sec.  257.5 
through 257.30 of this chapter, as applicable.
    (3) A hazardous waste landfill permitted by EPA under section 3004 
of RCRA, or by a State authorized under section 3006 of RCRA.
    (4) A PCB disposal facility approved under this part.
    (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

[[Page 212]]

O of this part. Any person collecting and analyzing samples from non-
porous surfaces must do so in accordance with subpart P of this part. 
Any person collecting and analyzing samples from liquids must do so in 
accordance with Sec.  761.269. Any person conducting interim sampling 
during PCB remediation waste cleanup to determine when to sample to 
verify that cleanup is complete, may use PCB field screening tests.
    (ii) Verification. (A) Where sample analysis results in a 
measurement of PCBs less than or equal to the levels specified in 
paragraph (a)(4) of this section, self-implementing cleanup is complete.
    (B) Where sample analysis results in a measurement of PCBs greater 
than the levels specified in paragraph (a)(4) of this section, self-
implementing cleanup of the sampled PCB remediation waste is not 
complete. The owner or operator of the site must either dispose of the 
sampled PCB remediation waste, or reclean the waste represented by the 
sample and reinitiate sampling and analysis in accordance with paragraph 
(a)(6)(i) of this section.
    (7) Cap requirements. A cap means, when referring to on-site cleanup 
and disposal of PCB remediation waste, a uniform placement of concrete, 
asphalt, or similar material of minimum thickness spread over the area 
where remediation waste was removed or left in place in order to prevent 
or minimize human exposure, infiltration of water, and erosion. Any 
person designing and constructing a cap must do so in accordance with 
Sec.  264.310(a) of this chapter, and ensure that it complies with the 
permeability, sieve, liquid limit, and plasticity index parameters in 
Sec.  761.75(b)(1)(ii) through (b)(1)(v). A cap of compacted soil shall 
have a minimum thickness of 25 cm (10 inches). A concrete or asphalt cap 
shall have a minimum thickness of 15 cm (6 inches). A cap must be of 
sufficient strength to maintain its effectiveness and integrity during 
the use of the cap surface which is exposed to the environment. A cap 
shall not be contaminated at a level =1 ppm PCB per 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.

[[Page 213]]

    (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 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;

[[Page 214]]

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 
[micro]g/L of water measured using a procedure used to simulate leachate 
generation.
    (2) Any person may dispose of PCB bulk product waste other than 
those materials meeting the conditions of paragraph (b)(1) of this 
section, (e.g., paper or felt gaskets contaminated by liquid PCBs in a 
facility that is permitted, licensed, or registered by a State to manage 
municipal solid waste subject to part 258 of this chapter or non-
municipal non-hazardous waste subject to Sec. Sec.  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 
[micro]g/L PCBs.
    (ii) Any person disposing off-site of PCB bulk product waste 
regulated under paragraph (b)(2) of this section at a waste management 
facility not having a commercial PCB storage or disposal approval must 
provide written notice to the facility a minimum of 15 days in advance 
of the first shipment from the same disposal waste stream and with each 
shipment thereafter. The notice shall state that the PCB bulk product 
waste may include components containing PCBs at =50 ppm based 
on analysis of the waste in the shipment or application of a general 
knowledge of the waste stream (or similar material) which is known to 
contain PCBs at those levels, and that the PCB bulk product waste is 
known or presumed to leach =10 [micro]g/L PCBs.
    (5) Any person disposing of PCB bulk product waste must maintain a 
written record of all sampling and analysis of PCBs or notifications 
made under this paragraph for 3 years from the date of the waste's 
generation. The records must be made available to EPA upon request.
    (6) Requirements in subparts C, J, and K of this part do not apply 
to waste disposed of under paragraph (b) of this section.
    (c) Risk-based disposal approval. (1) Any person wishing to sample 
or dispose of PCB bulk product waste in a manner other than prescribed 
in paragraphs (a) or (b) of this section, or store PCB bulk product 
waste in a manner other than prescribed in Sec.  761.65, must apply in 
writing to the 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

[[Page 215]]

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 Sec. Sec.  761.30, 761.60, 761.61, 761.62, and 
761.79. For determining the presence of PCBs in samples, chemical 
analysis includes: sample preparation, sample extraction, extract 
cleanup, extract concentration, addition of PCB standards, and 
instrumental analysis.
    (a) Portions of samples of a size designated in a chemical 
extraction and analysis method for PCBs and extracted for purposes of 
determining the presence of PCBs or concentration of PCBs are 
unregulated for PCB disposal under this part.
    (b) All other wastes generated during these activities are regulated 
for disposal based on their concentration at the time of disposal as 
follows:
    (1) Liquid wastes, including rinse solvents, must be disposed of 
according to Sec.  761.61(a)(5)(iv).
    (2) Non-liquid wastes must be disposed of in the same manner as non-
liquid cleaning materials and personal protective equipment waste 
according to Sec.  761.61(a)(5)(v)(A).

[63 FR 35452, June 29, 1998]



Sec.  761.65  Storage for disposal.

    This section applies to the storage for disposal of PCBs at 
concentrations of 50 ppm or greater and PCB Items with PCB 
concentrations of 50 ppm or greater.
    (a)(1) Storage limitations. Any PCB waste shall be disposed of as 
required by subpart D of this part within 1-year from the date it was 
determined to be PCB waste and the decision was made to dispose of it. 
This date is the date of removal from service for disposal and the point 
at which the 1-year time frame for disposal begins. PCB/radioactive 
waste removed from service for disposal is exempt from the 1-year time 
limit provided that the provisions at paragraphs (a)(2)(ii) and 
(a)(2)(iii) of this section are followed and the waste is managed in 
accordance with all other applicable Federal, State, and local laws and 
regulations for the management of radioactive material.
    (2) One-year extension. Any person storing PCB waste that is subject 
to the 1-year time limit for storage and disposal in paragraph (a)(1) of 
this section may provide written notification to the EPA Regional 
Administrator for the Region in which the PCB waste is stored that their 
continuing attempts to dispose of or secure disposal for their waste 
within the 1-year time 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

[[Page 216]]

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.
    (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.

[[Page 217]]

    (v) Not located at a site that is below the 100-year flood water 
elevation.
    (2) No person may store PCBs and PCB Items designated for disposal 
in a storage unit other than one approved pursuant to paragraph (d) of 
this section or meeting the design requirements of paragraph (b) of this 
section, unless the unit meets one of the following conditions:
    (i) Is permitted by EPA under section 3004 of RCRA to manage 
hazardous waste in containers, and spills of PCBs are cleaned up in 
accordance with subpart G of this part.
    (ii) Qualifies for interim status under section 3005 of RCRA to 
manage hazardous waste in containers, meets the requirements for 
containment at Sec.  264.175 of this chapter, and spills of PCBs are 
cleaned up in accordance with subpart G of this part.
    (iii) Is permitted by a State authorized under section 3006 of RCRA 
to manage hazardous waste in containers, and spills of PCBs are cleaned 
up in accordance with subpart G of this part.
    (iv) Is approved or otherwise regulated pursuant to a State PCB 
waste management program no less stringent in protection of health or 
the environment than the applicable TSCA requirements found in this 
part.
    (v) Is subject to a TSCA Coordinated Approval, which includes 
provisions for storage of PCBs, issued pursuant to Sec.  761.77.
    (vi) Has a TSCA PCB waste management approval, which includes 
provisions for storage, issued pursuant to Sec.  761.61(c) or Sec.  
761.62(c).
    (c)(1) The following PCB Items may be stored temporarily in an area 
that does not comply with the requirements of paragraph (b) of this 
section for up to thirty days from the date of their removal from 
service, provided that a notation is attached to the PCB Item or a PCB 
Container (containing the item) indicating the date the item was removed 
from service:
    (i) Non-leaking PCB Articles and PCB Equipment;
    (ii) Leaking PCB Articles and PCB Equipment if the PCB Items are 
placed in a non-leaking PCB Container that contains sufficient sorbent 
materials to absorb any liquid PCBs remaining in the PCB Items;
    (iii) PCB Containers containing non-liquid PCBs such as contaminated 
soil, rags, and debris; and
    (iv) PCB containers containing liquid PCBs at concentrations of 
=50 ppm, provided a Spill Prevention, Control and 
Countermeasure Plan has been prepared for the temporary storage area in 
accordance with part 112 of this chapter and the liquid PCB waste is in 
packaging authorized in the DOT Hazardous Materials Regulations at 49 
CFR parts 171 through 180 or stationary bulk storage tanks (including 
rolling stock such as, but not limited to, tanker trucks, as specified 
by DOT).
    (2) Non-leaking and structurally undamaged PCB Large High Voltage 
Capacitors and PCB-Contaminated Electrical Equipment that have not been 
drained of free flowing dielectric fluid may be stored on pallets next 
to a storage facility that meets the requirements of paragraph (b) of 
this section. PCB-Contaminated Electrical Equipment that has been 
drained of free flowing dielectric fluid is not subject to the storage 
provisions of Sec.  761.65. Storage under this subparagraph will be 
permitted only when the storage facility has immediately available 
unfilled storage space equal to 10 percent of the volume of capacitors 
and equipment stored outside the facility. The capacitors and equipment 
temporarily stored outside the facility shall be checked for leaks 
weekly.
    (3) Any storage area subject to the requirements of paragraph (b) or 
paragraph (c)(1) of this section shall be marked as required in subpart 
C Sec.  761.40(a)(10).
    (4) No item of movable equipment that is used for handling PCBs and 
PCB Items in the storage units and that comes in direct contact with 
PCBs shall be removed from the storage unit area unless it has been 
decontaminated as specified in Sec.  761.79.
    (5) All PCB Items in storage shall be checked for leaks at least 
once every 30 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

[[Page 218]]

up and the materials and residues containing PCBs shall be disposed of 
in accordance with Sec.  761.61. Records of inspections, maintenance, 
cleanup and disposal must be maintained in accordance with Sec.  
761.180(a) and (b).
    (6) Except as provided in paragraphs (c)(6)(i) and (c)(6)(ii) of 
this section, any container used for the storage of liquid or non-liquid 
PCB waste shall be in accordance with the requirements set forth in the 
DOT Hazardous Materials Regulations (HMR) at 49 CFR parts 171 through 
180. PCB waste not subject to the HMR (i.e., PCB wastes at 
concentrations of <20 ppm or <1 pound of PCBs regardless of 
concentration) must be packaged in accordance with Packaging Group III, 
unless other hazards associated with the PCB waste cause it to require 
packaging in accordance with Packaging Groups I or II. For purposes of 
describing PCB waste not subject to DOT's HMR on a manifest, one may use 
the term ``Non-DOT Regulated PCBs.''
    (i) Containers other than those meeting HMR performance standards 
may be used for storage of PCB/radioactive waste provided the following 
requirements are met:
    (A) Containers used for storage of liquid PCB/radioactive wastes 
must be non-leaking.
    (B) Containers used for storage of non-liquid PCB/ radioactive 
wastes must be designed to prevent the buildup of liquids if such 
containers are stored in an area meeting the containment requirements of 
paragraph (b)(1)(ii) of this section, as well as all other applicable 
State or Federal regulations or requirements for control of radioactive 
materials.
    (C) Containers used to store both liquid and non-liquid PCB/
radioactive wastes must meet all regulations and requirements pertaining 
to nuclear criticality safety. Acceptable container materials currently 
include polyethylene and stainless steel provided that the container 
material is chemically compatible with the wastes being stored. Other 
containers may be used to store both liquid and non-liquid PCB/
radioactive wastes if the users are able to demonstrate, to the 
appropriate Regional Administrator and other appropriate regulatory 
authorities (i.e., Nuclear Regulatory Commission, Department of Energy 
or the Department of Transportation), that the use of such containers is 
protective of health and the environment as well as public health and 
safety.
    (ii) The following DOT specification containers that conform to the 
requirements of 49 CFR, chapter I, subchapter C in effect on September 
30, 1991, may be used for storage and transportation activities that are 
not subject to DOT regulation, and may be used on a transitional basis 
as permitted at 49 CFR 171.14. For liquid PCBs: Specification 5 
container without removable head, Specification 5B container without 
removable head, Specification 6D overpack with Specification 2S or 2SL 
polyethylene containers, or Specification 17E container. For non-liquid 
PCBs: Specification 5 container, Specification 5B container, or 
Specification 17C container.
    (7) Stationary storage containers for liquid PCBs can be larger than 
the containers specified in paragraph (c)(6) of this section provided 
that:
    (i) The containers are designed, constructed, and operated in 
compliance with Occupational Safety and Health Standards, 29 CFR 
1910.106, Flammable and combustible liquids. Before using these 
containers for storing PCBs, the design of the containers must be 
reviewed to determine the effect on the structural safety of the 
containers that will result from placing liquids with the specific 
gravity of PCBs into the containers (see 29 CFR 1910.106(b)(1)(i)(f)).
    (ii) The owners or operators of any facility using containers 
described in paragraph (c)(7)(i) of this section, shall prepare and 
implement a Spill Prevention Control and Countermeasure (SPCC) Plan as 
described in part 112 of this title. In complying with 40 CFR part 112, 
the owner or operator shall read ``oil(s)'' as ``PCB(s)'' whenever it 
appears. The exemptions for storage capacity, 40 CFR 112.1(d)(2), and 
the amendment of SPCC plans by the Regional Administrator, 40 CFR 112.4, 
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.

[[Page 219]]

    (8) PCB Items shall be dated on the item when they are removed from 
service for disposal. The storage shall be managed so that the PCB Items 
can be located by this date. Storage containers provided in paragraph 
(c)(7) of this section, shall have a record that includes for each batch 
of PCBs the quantity of the batch and date the batch was added to the 
container. The record shall also include the date, quantity, and 
disposition of any batch of PCBs removed from the container.
    (9) Bulk PCB remediation waste or PCB bulk product waste may be 
stored at the clean-up site or site of generation for 180 days subject 
to the following conditions:
    (i) The waste is placed in a pile designed and operated to control 
dispersal of the waste by wind, where necessary, by means other than 
wetting.
    (ii) The waste must not generate leachate through decomposition or 
other reactions.
    (iii) The storage site must have:
    (A) A liner that is designed, constructed, and installed to prevent 
any migration of wastes off or through the liner into the adjacent 
subsurface soil, ground water or surface water at any time during the 
active life (including the closure period) of the storage site. The 
liner may be constructed of materials that may allow waste to migrate 
into the liner. The liner must be:
    (1) Constructed of materials that have appropriate chemical 
properties and sufficient strength and thickness to prevent failure due 
to pressure gradients (including static head and external hydrogeologic 
forces), physical contact with the waste or leachate to which they are 
exposed, climatic conditions, the stress of installation, and the stress 
of daily operation.
    (2) Placed upon a foundation or base capable of providing support to 
the liner and resistance to pressure gradients above and below the liner 
to prevent failure of the liner due to settlement, compression, or 
uplift.
    (3) Installed to cover all surrounding earth likely to be in contact 
with the waste.
    (B) A cover that meets the requirements of paragraph (c)(9)(iii)(A) 
of this section, is installed to cover all of the stored waste likely to 
be contacted with precipitation, and is secured so as not to be 
functionally disabled by winds expected under normal seasonal 
meteorological conditions at the storage site.
    (C) A run-on control system designed, constructed, operated, and 
maintained such that:
    (1) It prevents flow onto the stored waste during peak discharge 
from at least a 25-year storm.
    (2) It collects and controls at least the water volume resulting 
from a 24-hour, 25-year storm. Collection and holding facilities (e.g., 
tanks or basins) must be emptied or otherwise managed expeditiously 
after storms to maintain design capacity of the system.
    (iv) The provisions of this paragraph may be modified under Sec.  
761.61(c).
    (10) Owners or operators of storage facilities shall establish and 
maintain records as provided in Sec.  761.180.
    (d) Approval of commercial storers of PCB waste. (1) All commercial 
storers of PCB waste shall have interim approval to operate commercial 
facilities for the storage of PCB waste until August 2, 1990. Commercial 
storers of PCB waste are prohibited from storing any PCB waste at their 
facilities after August 2, 1990 unless they have submitted by August 2, 
1990 a complete application for a final storage approval under paragraph 
(d)(2) of this section. The period of interim approval shall continue 
until 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.

[[Page 220]]

    (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:
    (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.

[[Page 221]]

    (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 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

[[Page 222]]

take to close the PCB waste storage facility in a manner that eliminates 
the potential for post-closure releases of PCBs which may present an 
unreasonable risk to human health or the environment. An acceptable 
closure plan must include, at a minimum, all of the following:
    (i) A description of how the PCB storage areas of the facility will 
be closed in a manner that eliminates the potential for post-closure 
releases of PCBs into the environment.
    (ii) An identification of the maximum extent of storage operations 
that will be open during the active life of the facility, including an 
identification of the extent of PCB storage operations at the facility 
relative to other wastes that will be handled at the facility.
    (iii) An estimate of the maximum inventory of PCB wastes that could 
be handled at one time at the facility over its active life, and a 
detailed description of the methods or arrangements to be used during 
closure for removing, transporting, storing, or disposing of the 
facility's inventory of PCB waste, including an identification of any 
off-site facilities that will be used.
    (iv) A detailed description of the steps needed to remove or 
decontaminate PCB waste residues and contaminated containment system 
components, equipment, structures, and soils during closure in 
accordance with the levels specified in the PCB Spills Cleanup Policy in 
subpart G of this part, including a description of the methods for 
sampling and testing of surrounding soils, and the criteria for 
determining the extent of removal or decontamination.
    (v) A detailed description of other activities necessary during the 
closure period to ensure that any post-closure releases of PCBs will not 
present unreasonable risks to human health or the environment. This 
includes activities such as ground-water monitoring, run-on and run-off 
control, and facility security.
    (vi) A schedule for closure of each area of the facility where PCB 
waste is stored or handled, including the total time required to close 
each area of PCB waste storage or handling, and the time required for 
any intervening closure activities.
    (vii) An estimate of the expected year of closure of the PCB waste 
storage areas, if a trust fund is opted for as the financial mechanism.
    (2) A written closure plan determined to be acceptable by 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

[[Page 223]]

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 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

[[Page 224]]

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 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

[[Page 225]]

any reference to hazardous waste management facilities, shall be deemed 
to be in compliance with the requirement to submit a trust agreement 
under this subpart.
    (2) The ``surety bond guaranteeing payment into a closure trust 
fund,'' as specified in Sec.  264.143(b) of this chapter, including the 
use of the surety bond instrument specified at Sec.  264.151(b) of this 
chapter and the standby trust specified at Sec.  264.143(b)(3) of this 
chapter. The use of the surety bonds, surety bond instruments, and 
standby trust agreements specified in Sec. Sec.  264.143(b) and 
264.151(b) of this chapter shall be deemed to be in compliance with this 
subpart.
    (3)(i) The ``surety bond guaranteeing performance of closure,'' as 
specified at Sec.  264.143(c) of this chapter, except for paragraph 
(c)(5) of Sec.  264.143 of this chapter. The submission and use of the 
surety bond instrument specified at Sec.  264.151(c) of this chapter and 
the standby trust specified at Sec.  264.143(c)(3) of this chapter shall 
be deemed to be in compliance with the requirements under this subpart 
relating to the use of surety bonds and standby trust funds.
    (ii) For the purposes of this paragraph, and under the terms of the 
bond, the surety shall become liable on the bond obligation when the 
owner or operator fails to perform as guaranteed by the bond. Liability 
is established by a final administrative determination pursuant to 
section 16 of TSCA that the owner or operator has failed to perform 
final closure in accordance with the closure plan and other approval or 
regulatory requirements when required to do so.
    (4)(i) The ``closure letter of credit'' specified in Sec.  
264.143(d) of this chapter, except for paragraph (d)(8). The submission 
and use of the irrevocable letter of credit instrument specified in 
Sec.  264.151(d) of this chapter and the standby trust specified in 
Sec.  264.143(d)(3) of this chapter shall be deemed to be in compliance 
with the requirements of this subpart relating to the use of letters of 
credit and standby trust funds.
    (ii) For the purposes of this paragraph, the Regional Administrator 
(or the 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

[[Page 226]]

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 Sec. Sec.  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 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 Sec. Sec.  761.210 through 761.213, 
retain a copy of each manifest, as required under Sec. Sec.  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

[[Page 227]]

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

[[Page 228]]

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 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

[[Page 229]]

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.
    (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

[[Page 230]]

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.
    (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

[[Page 231]]

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:
    (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

[[Page 232]]

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 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 Sec. Sec.  
761.62(a)(6) and 761.79(c)(6), from which all free-flowing liquids have 
been removed:
    (a) In a scrap metal recovery oven:
    (1) The oven shall have at least two enclosed (i.e., negative draft, 
no fugitive emissions) interconnected chambers.
    (2) The equipment with all free-flowing liquid removed shall first 
be placed in the primary chamber at room temperature.
    (3) The primary chamber shall operate at a temperature between 537 
[deg]C and 650 [deg]C for a minimum of 2\1/2\ hours and reach a minimum 
temperature of 650 [deg]C (1,202 [deg]F) once during each heating cycle 
or batch treatment of unheated, liquid-free equipment.
    (4) Heated gases from the primary chamber must feed directly into 
the secondary chamber (i.e., afterburner) which must operate at a 
minimum temperature of 1,200 [deg]C (2,192 [deg]F) with at least a 3 
percent excess oxygen and a retention time of 2.0 seconds with a minimum 
combustion efficiency of 99.9 percent according to the definition in 
Sec.  761.70(a)(2).
    (5) Heating of the primary chamber shall not commence until the 
secondary chamber has reached a temperature of 1,200 100 [deg]C (2,192 [deg] 180 
[deg]F).
    (6) Continuous emissions monitors and recorders for carbon dioxide, 
carbon monoxide, and excess oxygen in the secondary chamber and 
continuous temperature recorders in the primary and secondary chambers 
shall be installed and operated while the primary and secondary chambers 
are in operation to assure that the two chambers are within the 
operating parameters in paragraphs (a)(3) through (a)(5) of this 
section.
    (7) Emissions from the secondary chamber must be vented through an 
exhaust gas stack in accordance with either:
    (i) State or local air regulations or permits, or
    (ii) The standards in paragraph (a)(8) of this section.
    (8) Exhaust gas stack emissions shall be for: particulates <0.015 
grains/dry

[[Page 233]]

standard cubic foot, sulfur dioxide <35 parts per million by volume 
(ppmv), nitrogen oxide <150 ppmv, carbon monoxide <35 ppmv, and hydrogen 
chloride <35 ppmv.
    (9) A measurement of the temperature in the secondary chamber at the 
time the primary chamber starts heating must be taken, recorded and 
retained at the facility for 3 years from the date each charge is 
introduced into the primary chamber.
    (b) By smelting:
    (1) The operating temperature of the hearth must be at least 1,000 
[deg]C at the time it is charged with any PCB-Contaminated non-porous 
surface.
    (2) Each charge containing a PCB-Contaminated item must be added 
into molten metal or a hearth at =1,000 [deg]C.
    (3) Successive charges may not be introduced into the hearth in less 
than 15-minute intervals.
    (4) The smelter must operate in compliance with any applicable 
emissions standards in part 60 of this chapter.
    (5) The smelter must have an operational device which accurately 
measures directly or indirectly, the temperature in the hearth.
    (6) Take, record and retain at the disposal facility for 3 years 
from the date each charge is introduced, a reading of the temperature in 
the hearth at the time it is charged with a non-porous surface item.
    (c)(1) Scrap metal recovery ovens and smelters must either have a 
final permit under RCRA (part 266, subpart H of this chapter and Sec.  
270.66 of this chapter) or be operating under a valid State air 
emissions permit which includes a standard for PCBs.
    (2) Scrap metal recovery ovens and smelters disposing of PCBs must 
provide notification as disposers of PCBs, are not required to submit 
annual reports, and shall otherwise comply with all applicable 
provisions of subparts J and K of this part, as well as other applicable 
Federal, State, and local laws and regulations.
    (3) In lieu of the requirements in paragraph (c)(1) of this section, 
upon written request by the owner or operator of a scrap metal recovery 
oven or smelter, the EPA Regional Administrator, for the Region where 
the oven or smelter is located, may make a finding in writing, based on 
a site-specific risk assessment, that the oven or smelter does not pose 
an unreasonable risk of injury to health or the environment because it 
is operating in compliance with the parameters and conditions listed in 
paragraph (a) or (b) of this section even though the oven or smelter 
does not have a RCRA or State air permit as required by paragraph (c)(1) 
of this section. The written request shall include a site-specific risk 
assessment.
    (d) PCB liquids, other liquid waste qualifying as waste oils which 
may be used as provided for at Sec.  761.20(e), or PCB remediation 
waste, other than PCB-Contaminated articles, may not be disposed of in a 
scrap metal recovery oven or smelter unless approved or otherwise 
allowed under subpart D of this part.

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



Sec.  761.75  Chemical waste landfills.

    This section applies to facilities used to dispose of PCBs in 
accordance with the part.
    (a) General. A chemical waste landfill used for the disposal of PCBs 
and PCB Items shall be approved by the Agency Regional Administrator 
pursuant to paragraph (c) of this section. The landfill shall meet all 
of the requirements specified in paragraph (b) of this section, unless a 
waiver from these requirements is obtained pursuant to paragraph (c)(4) 
of this section. In addition, the landfill shall meet any other 
requirements that may be prescribed pursuant to paragraph (c)(3) of this 
section.
    (b) Technical requirements. Requirements for chemical waste 
landfills used for the disposal of PCBs and PCB Items are as follows:
    (1) Soils. The landfill site shall be located in thick, relatively 
impermeable formations such as large-area clay pans. Where this is not 
possible, the soil shall have a high clay and silt content with the 
following parameters:
    (i) In-place soil thickness, 4 feet or compacted soil liner 
thickness, 3 feet;
    (ii) Permeability (cm/sec), equal to or less than 1 x 
10-7;
    (iii) Percent soil passing No. 200 Sieve, 30;

[[Page 234]]

    (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.
    (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.

[[Page 235]]

    (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 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 [deg]C (140 [deg]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).

[[Page 236]]

    (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;
    (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

[[Page 237]]

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]



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

[[Page 238]]

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 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 Sec. Sec.  761.65(a), (c), and (d)(2), as 
appropriate.

[[Page 239]]

    (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 (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 [micro]g/L (i.e., <200 ppb PCBs) for non-contact 
use in a closed system where there are no releases;
    (ii) For water discharged to a treatment works (as defined in Sec.  
503.9(aa) of this chapter) or to navigable waters, <3 [micro]g/L 
(approximately <3 ppb) or a PCB discharge limit included in a permit 
issued under section 307(b) or 402 of the Clean Water Act; or
    (iii) Less than or equal to 0.5 [micro]g/L (i.e., approximately 
<=0.5 ppb PCBs) for unrestricted use.
    (2) The decontamination standard for organic liquids and non-aqueous 
inorganic liquids containing PCBs is <2 milligrams per kilogram (i.e., 
<2 ppm PCBs).

[[Page 240]]

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

[[Page 241]]

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 [deg]C.
    (iv) Approved PODFs include:
    (A) Kerosene.
    (B) Diesel fuel.
    (C) Terpene hydrocarbons.
    (D) Mixtures of terpene hydrocarbons and terpene alcohols.
    (v) Drain the PODF from the surfaces.
    (vi) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (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 [deg]C.
    (viii) Drain the PODF from the surfaces.
    (ix) Dispose of the drained PODF in accordance with paragraph (g) of 
this section.
    (5) Any person decontaminating piping and air lines in an air 
compressor system must do so as follows:
    (i) Before decontamination proceeds, disconnect or bypass the air 
compressors and air dryers from the piping and air lines and 
decontaminate the air compressors and air dryers separately in 
accordance with paragraphs (b), (c)(1) through (c)(4), or (c)(6) of this 
section. Dispose of filter media and desiccant in the air dyers based on 
their existing PCB concentration.
    (ii) Test the connecting line and appurtenances of the system to 
assure that there is no leakage. Test by introducing air into the closed 
system at from 90 to 100 pounds per square inch (psi). Only if there is 
a pressure drop of <5 psi in 30 minutes may decontamination take place.
    (iii) When there is no leakage, fill the piping and air lines with 
clean (containing <2 ppm PCBs) solvent. Solvents include PODF, aqueous 
potassium hydroxide at a pH between 9 and 12, or water containing 5 
percent sodium hydroxide by weight.
    (iv) Circulate the solvent to achieve turbulent flow through the 
piping and air lines in the air compressor system until the total volume 
of solvent circulated equals 10 times the total volume of the particular 
article being decontaminated, then drain the solvent. Calculate the 
total volume of solvent circulated by multiplying the pump rate by the 
time of pumping. Turbulent flow means a Reynolds number range from 
20,000 to 43,000. Refill the system with clean solvent and repeat the 
circulation and drain process.
    (6) Any person using thermal processes to decontaminate metal 
surfaces in contact with PCBs, as required by Sec.  761.62(a)(6), must 
use one of the following options:
    (i) Surfaces in contact with liquid and non-liquid PCBs at 
concentrations <500 ppm may be decontaminated in a scrap metal recovery 
oven or smelter for purposes of disposal in accordance with Sec.  
761.72.
    (ii) Surfaces in contact with liquid or non-liquid PCBs at 
concentrations =500 ppm may be smelted in a smelter operating 
in accordance with Sec.  761.72(b), but must first be decontaminated in 
accordance with Sec.  761.72(a) or to a surface concentration of <100 
[micro]g/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

[[Page 242]]

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 
Sec. Sec.  761.269 and 761.272. For non-porous surfaces and concrete 
described in paragraphs (b)(3) and (b)(4) of this section, sample in 
accordance with subpart P of this part. A written record of such 
sampling must be established and maintained for 3 years from the date of 
any decontamination under this section. The record must show sampling 
locations and analytical results and must be retained at the site of the 
decontamination or a copy of the record must be made available to EPA in 
a timely manner, if requested. In addition, recordkeeping is required in 
accordance with Sec.  761.180(a) for all wastes generated by a 
decontamination process and regulated for disposal under this subpart.
    (2) Confirmatory sampling is not required for self-implementing 
decontamination procedures under paragraph (c) of this section. Any 
person using these procedures must retain a written record documenting 
compliance with the procedures for 3 years after completion of the 
decontamination procedures (e.g., video recordings, photographs).
    (g) Decontamination waste and residues. Decontamination waste and 
residues shall be disposed of at their existing PCB concentration unless 
otherwise specified.
    (1) Distillation bottoms or residues and filter media are regulated 
for disposal as PCB remediation waste.
    (2) PCBs physically separated from regulated waste during 
decontamination (such as by chopping, shredding, scraping, abrading or 
oil/water separation, as opposed to solvent rinsing and soaking), other 
than wastes described in paragraph (g)(1) of this section, are regulated 
for disposal at their original concentration.
    (3) Hydrocarbon solvent used or reused for decontamination under 
this section that contains <50 ppm PCB must be burned and marketed in 
accordance with the requirements for used oil in Sec.  761.20(e), 
disposed of in accordance with Sec.  761.60(a) or (e), or decontaminated 
pursuant to this section.
    (4) Chlorinated solvent at any PCB concentration used for 
decontamination under this section shall be disposed of in an 
incinerator operating in compliance with Sec.  761.70, or decontaminated 
pursuant to this section.
    (5) Solvents =50 ppm other than those described in 
paragraphs (g)(3) and (g)(4) of this section shall be disposed of in 
accordance with Sec.  761.60(a) or decontaminated pursuant to this 
section.
    (6) Non-liquid cleaning materials and personal protective equipment 
waste at any concentration, including non-porous surfaces and other non-
liquid materials such as rags, gloves, booties, other disposable 
personal protective equipment, and similar materials resulting from 
decontamination shall be disposed of in accordance with Sec.  
761.61(a)(5)(v).
    (h) Alternative decontamination or sampling approval. (1) Any person 
wishing to decontaminate material described in paragraph (a) of this 
section in a manner other than prescribed in paragraph (b) of this 
section must apply in writing to the 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

[[Page 243]]

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.
    (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

[[Page 244]]

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 
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

[[Page 245]]

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 Sec. Sec.  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.
    (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-

[[Page 246]]

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., 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 [micro]g 
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]

[[Page 247]]



                   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 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

[[Page 248]]

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 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

[[Page 249]]

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 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

[[Page 250]]

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 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

[[Page 251]]

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 (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.

[[Page 252]]

    (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 [micro]g/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, 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

[[Page 253]]

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 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 ([micro]g)/100 
square centimeters (cm\2\) (as measured by standard wipe tests).
    (ii) At the option of the responsible party, soil contaminated by 
the spill will be cleaned either to 25 ppm PCBs by weight, or to 50 ppm 
PCBs by weight provided that a label or notice is visibly placed in the 
area. Upon demonstration by the responsible party that cleanup to 25 ppm 
or 50 ppm will

[[Page 254]]

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 [micro]g/100 cm\2\ (as measured by standard wipe 
tests).
    (ii) Low-contact, indoor, impervious solid surfaces will be 
decontaminated to 10 [micro]g/100 cm\2\.
    (iii) At the option of the responsible party, low-contact, indoor, 
nonimpervious surfaces will be cleaned either to 10 [micro]g/100 cm\2\ 
or to 100 [micro]g/100 cm\2\ and encapsulated. The Regional 
Administrator, however, retains the authority to disallow the 
encapsulation option for a particular spill situation upon finding that 
the uncertainties associated with that option pose special concerns at 
that site. That is, the Regional Administrator would not permit 
encapsulation if he/she determined that if the encapsulation failed the 
failure would create an imminent hazard at the site.
    (iv) Low-contact, outdoor surfaces (both impervious and 
nonimpervious) shall be cleaned to 100 [micro]g/100 cm\2\.
    (v) Soil contaminated by the spill will be cleaned to 25 ppm PCBs by 
weight.
    (4) Requirements for decontaminating spills in nonrestricted access 
areas. Spills which occur in nonrestricted access locations, as defined 
under Sec.  761.123, shall be decontaminated in accordance with 
paragraphs (c)(4) (i) through (v) of this section. Conformance to the 
cleanup standards at paragraphs (c)(4) (i) through (v) of this section 
shall be verified by postcleanup sampling as specified under Sec.  
761.130.
    (i) Furnishings, toys, and other easily replaceable household items 
shall be disposed of in accordance with the provisions of subpart D of 
this part and replaced by the responsible party.
    (ii) Indoor solid surfaces and high-contact outdoor solid surfaces, 
defined as high contact residential/commercial surfaces under Sec.  
761.123, shall be cleaned to 10 [micro]g/100 cm\2\ (as measured by 
standard wipe tests).
    (iii) Indoor vault areas and low-contact, outdoor, impervious solid 
surfaces shall be decontaminated to 10 [micro]g/100 cm\2\.
    (iv) At the option of the responsible party, low-contact, outdoor, 
nonimpervious solid surfaces shall be either cleaned to 10 [micro]g/100 
cm\2\ or cleaned to 100 [micro]g/100 cm\2\ and encapsulated. The 
Regional Administrator, however, retains the authority to disallow the 
encapsulation option for a particular spill situation upon finding that 
the uncertainties associated with that option pose special concerns at 
that site. That is, the Regional Administrator would not permit 
encapsulation if he/she determined that if the encapsulation failed the 
failure would create an imminent hazard at the site.
    (v) Soil contaminated by the spill will be decontaminated to 10 ppm 
PCBs by weight provided that soil is excavated to a minimum depth of 10 
inches. The excavated soil will be replaced with clean soil, i.e., 
containing less than 1 ppm PCBs, and the spill site will be restored 
(e.g., replacement of turf).
    (5) Records. The responsible party shall document the cleanup with 
records of decontamination. The records must be maintained for a period 
of 5 years. The records and certification shall consist of the 
following:
    (i) Identification of the source of the spill, e.g., type of 
equipment.
    (ii) Estimated or actual date and time of the spill occurrence.
    (iii) The date and time cleanup was completed or terminated (if 
cleanup was delayed by emergency or adverse

[[Page 255]]

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.
    (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]

[[Page 256]]



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 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

[[Page 257]]

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 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

[[Page 258]]

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

[[Page 259]]

    (E) Disposers of PCB waste shall include the confirmed date of 
disposal for items in paragraphs (b)(2)(ii)(A) through (b)(2)(ii)(D) of 
this section.
    (iii) For any PCB waste disposed at a facility that generated the 
PCB waste or any PCB waste that was not manifested to the facility, the 
information required under paragraph (b)(2)(ii)(A) through (b)(2)(ii)(E) 
of this section.
    (3) The owner or operator of a PCB disposal facility (including an 
owner or operator who disposes of his/her own waste and does not receive 
or generate manifests) or a commercial storage facility shall submit an 
annual report, which briefly summarizes the records and annual document 
log required to be maintained and prepared under paragraphs (b)(1) and 
(b)(2) of this section to the EPA Regional Administrator of the Region 
in which the facility is located by July 15 of each year, beginning with 
July 15, 1991. The first annual report submitted on July 15, 1991, shall 
be for the period starting February 5, 1990, and ending December 31, 
1990. The annual report shall contain no confidential business 
information. The annual report shall consist of the information listed 
in paragraphs (b)(3)(i) through (b)(3)(vi) of this section.
    (i) The name, address, and EPA identification number of the facility 
covered by the annual report for the calendar year.
    (ii) A list of the numbers of all signed manifests of PCB waste 
initiated or received by the facility during that year.
    (iii) The total weight in kilograms of bulk PCB waste, PCB waste in 
PCB Transformers, PCB waste in PCB Large High or Low Voltage Capacitors, 
PCB waste in PCB Article Containers, and PCB waste in PCB Containers in 
storage at the facility at the beginning of the calendar year, received 
or generated at the facility, transferred to another facility, or 
disposed of at the facility during the calendar year. The information 
must be provided for each of these categories, as appropriate.
    (iv) The total number of PCB Transformers, the total number of PCB 
Large High or Low Voltage Capacitors, the total number of PCB Article 
Containers, and the total number of PCB Containers in storage at the 
facility at the beginning of the calendar year, received or generated at 
the facility, transferred to another facility, or disposed of at the 
facility during the calendar year. The information must be provided for 
each of these categories, as appropriate.
    (v) The total weight in kilograms of each of the following PCB 
categories: bulk PCB waste, PCB waste in PCB Transformers, PCB waste in 
PCB Large High or Low Voltage Capacitors, PCB waste in PCB Article 
Containers, and PCB waste in PCB Containers remaining in storage for 
disposal at the facility at the end of the calendar year.
    (vi) The total number of PCB Transformers, the total number of PCB 
Large High or Low Voltage Capacitors, the total number of PCB Article 
Containers, and the total number of PCB Containers remaining in storage 
for disposal at the facility at the end of the calendar year.
    (vii) The requirement to submit annual reports to the Regional 
Administrator continues until the submission of the annual report for 
the calendar year during which the facility ceases PCB storage or 
disposal operations. Storage operations have not ceased until all PCB 
waste, including any PCB waste generated during closure, has been 
removed from the facility.
    (4) Whenever a commercial storer of PCB waste accepts PCBs or PCB 
Items at his storage facility and transfers the PCB waste off-site to 
another facility for storage or disposal, the commercial storer of PCB 
waste shall initiate a manifest under subpart K of this part for the 
transfer of PCBs or PCB Items to the next storage or disposal facility.
    Note: Any requirements for weights in kilograms of PCBs may be 
calculated values if the internal volume of PCBs in containers and 
transformers is known and included in the reports, together with any 
assumptions on the density of the PCBs contained in the containers or 
tranformers. If the internal volume of PCBs is not known, a best 
estimate may be used.
    (5) For purposes of this paragraph, PCB Voltage Regulators shall be 
recorded and reported as PCB Transformers.

[[Page 260]]

    (c) Incineration facilities. Each owner or operator of a PCB 
incinerator facility shall collect and maintain for a period of 5 years 
from the date of collection the following information, in addition to 
the information required in paragraph (b) of this section:
    (1) When PCBs are being incinerated, the following continuous and 
short-interval data:
    (i) Rate and quantity of PCBs fed to the combustion system as 
required in Sec.  761.70(a)(3);
    (ii) Temperature of the combustion process as required in Sec.  
761.70(a)(4); and
    (iii) Stack emission product to include O2, CO, and 
CO2 as required in Sec.  761.70(a)(7).
    (2) When PCBs are being incinerated, data and records on the 
monitoring of stack emissions as required in Sec.  761.70(a)(6).
    (3) Total weight in kilograms of any solid residues generated by the 
incineration of PCBs and PCB Items during the calendar year, the total 
weight in kilograms of any solid residues disposed of by the facility in 
chemical waste landfills, and the total weight in kilograms of any solid 
residues remaining on the facility site.
    (4) When PCBs and PCB Items are being incinerated, additional 
periodic data shall be collected and maintained as specified by the 
Regional Administrator pursuant to Sec.  761.70(d)(4).
    (5) Upon any suspension of the operation of any incinerator pursuant 
to Sec.  761.70(a)(8), the owner or operator of such an incinerator 
shall prepare a document. The document shall, at a minimum, include the 
date and time of the suspension and an explanation of the circumstances 
causing the suspension of operation. The document shall be sent to the 
appropriate Regional Administrator within 30 days of any such 
suspension.
    (d) Chemical waste landfill facilities. Each owner or operator of a 
PCB chemical waste landfill facility shall collect and maintain until at 
least 20 years after the chemical waste landfill is no longer used for 
the disposal of PCBs the following information in addition to the 
information required in paragraph (b) of this section:
    (1) Any water analysis obtained in compliance with Sec.  
761.75(b)(6)(iii); and
    (2) Any operations records including burial coordinates of wastes 
obtained in compliance with Sec.  761.75(b)(8)(ii).
    (e) High efficiency boiler facilities. Each owner or operator of a 
high efficiency boiler used for the disposal of liquids between 50 and 
500 ppm PCB shall collect and maintain for a period of 5 years the 
following information, in addition to the information required in 
paragraph (b) of this section:
    (1) For each month PCBs are burned in the boiler the carbon monoxide 
and excess oxygen data required in Sec.  761.71(a)(1)(viii) and Sec.  
761.71(b)(1)(viii);
    (2) The quantity of PCBs burned each month as required in Sec.  
761.71(a)(1)(vii) and Sec.  761.71(b)(1)(vii); and
    (3) For each month PCBs (other than mineral oil dielectric fluid) 
are burned, chemical analysis data of the waste as required in Sec.  
761.71(b)(2)(vi).
    (f) Retention of special records by storage and disposal facilities. 
In addition to the information required to be maintained under 
paragraphs (b), (c), (d) and (e) of this section, each owner or operator 
of a PCB storage or disposal facility (including high efficiency boiler 
operations) shall collect and maintain for the time period specified in 
paragraph (b) of this section the following data:
    (1) All documents, correspondence, and data that have been provided 
to the owner or operator of the facility by any State or local 
government agency and that pertain to the storage or disposal of PCBs 
and PCB Items at the facility.
    (2) All documents, correspondence, and data that have been provided 
by the owner or operator of the facility to any State or local 
government agency and that pertain to the storage or disposal of PCBs 
and PCB Items at the facility.
    (3) Any applications and related correspondence sent by the owner or 
operator of the facility to any local, State, or Federal authorities in 
regard to waste water discharge permits, solid waste permits, building 
permits, or other permits or authorizations such as those required by 
Sec. Sec.  761.70(d) and 761.75(c).
    (g) Reclassification records. If you reclassify electrical equipment 
using the procedures in Sec.  761.30(a)(2)(v) or Sec.  761.30(h)(2)(v), 
you must keep records

[[Page 261]]

showing that you followed the required reclassification procedures. 
Where these procedures require testing, the records must include copies 
of pre- and post-reclassification PCB concentration measurements from a 
laboratory using quality control and quality assurance procedures. You 
must make these records available promptly to EPA or to any party 
possessing the equipment through sale, loan, lease, or for servicing. 
You must retain the records for at least 3 years after you sell or 
dispose of the equipment.

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

[44 FR 31542, May 31, 1979. Redesignated at 47 FR 19527, May 6, 1982, 
and further redesignated at 47 FR 37360, Aug. 25, 1982; 49 FR 28191, 
July 10, 1984; 53 FR 12524, Apr. 15, 1988; 54 FR 52750, Dec. 21, 1989; 
55 FR 26205, June 27, 1990; 58 FR 34205, June 23, 1993; 63 FR 35461, 
June 29, 1998; 66 FR 17619, Apr. 2, 2001; 77 FR 54830, Sept. 6, 2012]



Sec.  761.185  Certification program and retention of records by 
importers and persons generating PCBs in excluded manufacturing processes.

    (a) In addition to meeting the basic requirements of Sec.  761.1(f) 
and the definition of excluded manufacturing processes at Sec.  761.3, 
manufacturers with processes inadvertently generating PCBs and importers 
of products containing inadvertently generated PCBs must report to EPA 
any excluded manufacturing process or imports for which the 
concentration of PCBs in products leaving the manufacturing site or 
imported is greater than 2 micrograms per gram (2 [micro]g/g, roughly 2 
ppm) for any resolvable gas chromatographic peak. Such reports must be 
filed by October 1, 1984 or, if no processes or imports require reports 
at the time, within 90 days of having processes or imports for which 
such reports are required.
    (b) Manufacturers required to report by paragraph (a) of this 
section must transmit a letter notifying EPA of the number, the type, 
and the location of excluded manufacturing processes in which PCBs are 
generated when the PCB level in products leaving any manufacturing site 
is greater than 2 [micro]g/g for any resolvable gas chromatographic 
peak. Importers required to report by paragraph (a) of this section must 
transmit a letter notifying EPA of the concentration of PCBs in imported 
products when the PCB concentration of products being imported is 
greater than 2 [micro]g/g for any resolvable gas chromatographic peak. 
Persons must also certify the following:
    (1) Their compliance with all applicable requirements of Sec.  
761.1(f), including any applicable requirements for air and water 
releases and process waste disposal.
    (2) Whether determinations of compliance are based on actual 
monitoring of PCB levels or on theoretical assessments.
    (3) That such determinations of compliance are being maintained.
    (4) If the determination of compliance is based on a theoretical 
assessment, the letter must also notify EPA of the estimated PCB 
concentration levels generated and released.
    (c) Any person who reports pursuant to paragraph (a) of this 
section:
    (1) Must have performed either a theoretical analysis or actual 
monitoring of PCB concentrations.
    (2) Must maintain for a period of three years after ceasing process 
operations or importation, or for seven years, whichever is shorter, 
records containing the following information:
    (i) Theoretical analysis. Manufacturers records must include: the 
reaction or reactions believed to be generating PCBs; the levels of PCBs 
generated; and the levels of PCBs released. Importers records must 
include: the reaction or reactions believed to be generating PCBs and 
the levels of PCBs generated; the basis for all estimations of PCB 
concentrations; and the name and qualifications of the person or persons 
performing the theoretical analysis; or
    (ii) Actual monitoring. (A) The method of analysis.
    (B) The results of the analysis, including data from the Quality 
Assurance Plan.
    (C) Description of the sample matrix.
    (D) The name of the analyst or analysts.
    (E) The date and time of the analysis.
    (F) Numbers for the lots from which the samples are taken.
    (d) The certification required by paragraph (b) of this section must 
be

[[Page 262]]

signed by a responsible corporate officer. This certification must be 
maintained by each facility or importer for a period of three years 
after ceasing process operation or importation, or for seven years, 
whichever is shorter, and must be made available to EPA upon request. 
For the purpose of this section, a responsible corporate officer means:
    (1) A president, secretary, treasurer, or vice-president of the 
corporation in charge of a principal business function, or any other 
person who performs similar policy or decision-making functions for the 
corporation.
    (2) The manager of one or more manufacturing, production, or 
operating facilities employing more than 250 persons or having gross 
annual sales or expenditures exceeding $25,000,000 (in second quarter 
1980 dollars), if authority to sign documents has been assigned or 
delegated to the manager in accordance with corporate procedures.
    (e) Any person signing a document under paragraph (d) of this 
section shall also make the following certification:

    I certify under penalty of law that this document and all 
attachments were prepared under my direction or supervision in 
accordance with a system designed to assure that qualified personnel 
properly gather and evaluate information. Based on my inquiry of the 
person or persons directly responsible for gathering information, the 
information is, to the best of my knowledge and belief, true, accurate, 
and complete. I am aware that there are significant penalties for 
falsifying information, including the possibility of fines and 
imprisonment for knowing violations.

Dated:__________________________________________________________________
Signature:______________________________________________________________

    (f) This report must be submitted to the Document Control Office 
(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, ATTN: PCB Notification. This report must be 
submitted by October 1, 1984 or within 90 days of starting up processes 
or commencing importation of PCBs.
    (g) This certification process must be repeated whenever process 
conditions are significantly modified to make the previous certification 
no longer valid.

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

[49 FR 28191, July 10, 1984; 49 FR 33019, Aug. 20, 1984, as amended at 
53 FR 12524, Apr. 15, 1988; 58 FR 34205, June 23, 1993; 59 FR 33697, 
June 30, 1994; 60 FR 34465, July 3, 1995; 71 FR 33642, June 12, 2006]



Sec.  761.187  Reporting importers and by persons generating PCBs in
excluded manufacturing processes.

    In addition to meeting the basic requirements of Sec.  761.1(f) and 
the definition of excluded manufacturing process at Sec.  761.3, PCB-
generating manufacturing processes or importers of PCB-containing 
products shall be considered ``excluded manufacturing processes'' only 
when the following conditions are met:
    (a) Data are reported to the EPA by the owner/operator or importer 
concerning the total quantity of PCBs in product from excluded 
manufacturing processes leaving any manufacturing site in any calendar 
year when such quantity exceeds 0.0025 percent of that site's rated 
capacity for such manufacturing processes as of October 1, 1984; or the 
total quantity of PCBs imported in any calendar year when such quantity 
exceeds 0.0025 percent of the average total quantity of such product 
containing PCBs imported by such importer during the years 1978, 1979, 
1980, 1981 and 1982.
    (b) Data are reported to the EPA by the owner/operator concerning 
the total quantity of inadvertently generated PCBs released to the air 
from excluded manufacturing processes at any manufacturing site in any 
calendar year when such quantity exceeds 10 pounds.
    (c) Data are reported to the EPA by the owner/operator concerning 
the total quantity of inadvertently generated PCBs released to water 
from excluded manufacturing processes from any manufacturing site in any 
calendar year when such quantity exceeds 10 pounds.
    (d) These reports must be submitted to the Document Control Office 
(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), 
Environmental Protection Agency, 1200 Pennsylvania

[[Page 263]]

Ave., NW., Washington, DC 20460-0001, ATTN: PCB Notification.

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

[49 FR 28192, July 10, 1984, as amended at 53 FR 12524, Apr. 15, 1988; 
58 FR 34205, June 23, 1993; 59 FR 33697, June 30, 1994; 60 FR 34465, 
July 3, 1995; 71 FR 33642, June 12, 2006]



Sec.  761.193  Maintenance of monitoring records by persons who import,
manufacture, process, distribute in commerce, or use chemicals containing 
inadvertently generated PCBs.

    (a) Persons who import, manufacture, process, distribute in 
commerce, or use chemicals containing PCBs present as a result of 
inadvertent generation or recycling who perform any actual monitoring of 
PCB concentrations must maintain records of any such monitoring for a 
period of three years after a process ceases operation or importing 
ceases, or for seven years, whichever is shorter.
    (b) Monitoring records maintained pursuant to paragraph (a) of this 
section must contain:
    (1) The method of analysis.
    (2) The results of the analysis, including data from the Quality 
Assurance Plan.
    (3) Description of the sample matrix.
    (4) The name of the analyst or analysts.
    (5) The date and time of the analysis.
    (6) Numbers for the lots from which the samples are taken.

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

[49 FR 28193, July 10, 1984, as amended at 58 FR 34205, June 23, 1993]



            Subpart K_PCB Waste Disposal Records and Reports

    Source: 54 FR 52752, Dec. 21, 1989, unless otherwise noted.



Sec.  761.202  EPA identification numbers.

    (a) General. Any generator, commercial storer, transporter, or 
disposer of PCB waste who is required to have an EPA identification 
number under this subpart must notify EPA of his/her PCB waste handling 
activities, using the notification procedures and form described in 
Sec.  761.205. EPA will confirm the EPA identification number of 
facilities already assigned one, and will assign an EPA identification 
number to facilities that do not have one.
    (b) Prohibitions. After June 4, 1990:
    (1) A generator of PCB waste shall not:
    (i) Process, store, dispose of, transport, or offer for 
transportation PCB waste without having received an EPA identification 
number from the Agency. A generator of PCB waste who is exempted from 
notification under Sec.  761.205(c)(1) or who notifies EPA in a timely 
manner under Sec.  761.205(c)(2)(i), but has not yet received a unique 
identification number, shall be regarded as having received from EPA the 
identification number ``40 CFR PART 761.''
    (ii) Offer the PCB waste to transporters, disposers, or commercial 
storers of PCB waste who have not received an EPA identification number.
    (2) A transporter of PCB waste shall not:
    (i) Transport PCB waste without having received an EPA 
identification number from EPA.
    (ii) Deliver PCB waste to transporters, disposers, or commercial 
storers of PCB waste that have not received an EPA identification 
number.
    (3) A commercial storer of PCB waste shall not accept any PCB waste 
for storage without having received an EPA identification number from 
EPA.
    (4) A disposer of PCB waste shall not accept any PCB waste for 
disposal without having received an EPA identification number from EPA. 
A disposer of PCB waste who owns more than one disposal facility or 
mobile treatment unit shall not accept waste unless the disposer has 
received an EPA identification number for each facility or mobile unit.
    (c) PCB waste handled prior to effective date of this subpart. 
Generators (other than generators exempt from notification under Sec.  
761.205(c)(1)), commercial storers, transporters, and disposers of PCB 
waste who are required to have EPA identification numbers under this 
subpart, and who were engaged in PCB waste handling activities on or 
prior to February 5, 1990, are not subject to the prohibitions of 
paragraph (b) of this section if they have applied for an EPA

[[Page 264]]

identification number in accordance with the applicable notification 
procedures of Sec.  761.205. Such persons shall use the EPA 
identification number ``40 CFR PART 761,'' or a number assigned to the 
persons by EPA or a State under RCRA, until EPA issues to such persons a 
specific identification number under Sec.  761.205(a), (b), or (c).
    (d) PCB waste first handled after effective date of this subpart. 
Generators (other than generators exempt from notification under Sec.  
761.205(c)(1)), commercial storers, transporters, and disposers of PCB 
waste who are required to have EPA identification numbers under this 
subpart, and who first engage in PCB waste activities after February 5, 
1990, are subject to the prohibitions in paragraph (b) of this section.



Sec.  761.205  Notification of PCB waste activity (EPA Form 7710-53).

    (a)(1) All commercial storers, transporters, and disposers of PCB 
waste who were engaged in PCB waste handling activities on or prior to 
February 5, 1990 shall notify EPA of their PCB waste activities by 
filing EPA Form 7710-53 with EPA by no later than April 4, 1990. Upon 
receiving the notification form, EPA will assign an EPA identification 
number to each entity that notifies.
    (2) All generators (other than generators exempt from notification 
under paragraph (c)(1) of this section), commercial storers, 
transporters, and disposers of PCB waste who first engage in PCB waste 
handling activities after February 5, 1990, shall notify EPA of their 
PCB waste activities by filing EPA Form 7710-53 with EPA prior to 
engaging in PCB waste handling activities.
    (3) Any person required to notify EPA under this section shall file 
with EPA Form 7710-53. Copies of EPA Form 7710-53 are available on EPA's 
Web site at http://www.epa.gov/pcb, or from the Program Management, 
Communications, and Analysis Office, Office of Resource Conservation and 
Recovery (5305P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001. Descriptive information and 
instructions for filling in the form are included in paragraphs 
(a)(4)(i) through (vii) of this section.
    (4) All of the following information shall be provided to EPA on 
Form 7710-53:
    (i) The name of the facility, and the name of the owner or operator 
of the facility.
    (ii) EPA identification number, if any, previously issued to the 
facility.
    (iii) The facility's mailing address.
    (iv) The location of the facility.
    (v) The facility's installation contact and telephone number.
    (vi) The type of PCB waste activity engaged in at the facility.
    (vii) Signature of the signer of the certification statement, typed 
or printed name and official title of signer, and date signed.
    (viii) EPA has determined that the information in paragraphs 
(a)(4)(i) through (a)(4)(vii) of this section shall not be treated as 
confidential business information. This information will be disclosed to 
the public without further notice to the submitter unless the submitter 
provides a written justification (submitted with the notification form) 
which demonstrates extraordinary reasons why the information should be 
entitled to confidential treatment.
    (b) Generators (other than those generators exempt from notification 
under paragraph (c)(1) of this section), commercial storers, 
transporters, and disposers of PCB waste who have previously notified 
EPA or a State of hazardous waste activities under RCRA shall notify EPA 
of their PCB waste activities under this part by filing EPA Form 7710-53 
with EPA by no later than April 4, 1990. The notification shall include 
the EPA identification number previously issued by EPA or the State and 
upon receipt of the notification, EPA shall verify and authorize the use 
of the previously issued identification number for PCB waste activities.
    (c)(1) Generators of PCB waste need not notify EPA and receive 
unique EPA identification numbers under this section, unless their PCB 
waste activities are described in paragraph (c)(2) of this section. 
Generators exempted from notifying EPA under this paragraph shall use 
the generic identification number ``40 CFR PART 761'' on the manifests, 
records, and reports which they shall prepare under this subpart,

[[Page 265]]

unless such generators elect to use a unique EPA identification number 
previously assigned to them under RCRA by EPA or a State.
    (2) Generators of PCB waste who use, own, service, or process PCBs 
or PCB Items shall notify EPA of their PCB waste activities only if they 
own or operate PCB storage facilities subject to the storage 
requirements of Sec.  761.65 (b) or (c)(7). Such generators shall notify 
EPA in the following manner:
    (i) Generators storing PCB waste subject to the storage requirements 
of Sec.  761.65 (b) or (c)(7) shall notify EPA by filing EPA Form 7710-
53 with EPA by no later than April 4, 1990.
    (ii) Generators who desire to commence storage of PCB waste after 
February 5, 1990 shall notify EPA and receive an EPA identification 
number before they may commence storage of PCBs at their facilities 
established under Sec.  761.65 (b) or (c)(7).
    (iii) A separate notification shall be submitted to EPA for each PCB 
storage facility owned or operated by generators of PCB waste. Upon 
receiving these notifications, EPA will assign generators unique EPA 
identification numbers for each storage facility notifying EPA under 
this section.
    (d) Persons required to notify under this section shall file EPA 
Form 7710-53 with EPA by mailing the form to the following address: 
Document Control Officer, Office of Resource Conservation and Recovery 
(5305P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (e) The requirements under this section to notify EPA and obtain EPA 
identification numbers shall in no case excuse compliance by any person 
subject to the 1-year limit on storage prior to disposal under Sec.  
761.65(a).
    (f) When a facility has previously notified EPA of its PCB waste 
handling activities using EPA Form 7710-53 and those activities change, 
the facility must resubmit EPA Form 7710-53 to reflect those changes no 
later than 30 days from when a change is made. Examples of when a PCB 
waste handler must renotify the Agency include, but are not limited to 
the following: the company changes location of the facility; or the 
company had notified solely as engaging in a certain type of PCB waste 
handling activity and now wishes to engage in another PCB waste activity 
(e.g., previously only commercially stored PCB waste and now wishes to 
transport PCB waste).

[54 FR 52752, Dec. 21, 1989, as amended at 58 FR 15809, Mar. 24, 1993; 
58 FR 34205, June 23, 1993; 59 FR 33697, June 30, 1994; 63 FR 35461, 
June 29, 1998; 72 FR 57241, Oct. 9, 2007; 74 FR 30234, June 25, 2009]



Sec.  761.207  The manifest--general requirements.

    (a) A generator who transports, or offers for transport PCB waste 
for commercial off-site storage or off-site disposal, and commercial 
storage or disposal facility who offers for transport a rejected load of 
PCB waste, must prepare a manifest on EPA Form 8700-22, and, if 
necessary, a continuation sheet, according to the instructions included 
in the appendix of 40 CFR Part 262. The generator shall specify:
    (1) For each bulk load of PCBs, the identity of the PCB waste, the 
earliest date of removal from service for disposal, and the weight in 
kilograms of the PCB waste. (Item 14--Special Handling Instructions box)
    (2) For each PCB Article Container or PCB Container, the unique 
identifying number, type of PCB waste (e.g., soil, debris, small 
capacitors), earliest date of removal from service for disposal, and 
weight in kilograms of the PCB waste contained. (Item 14--Special 
Handling Instructions box)
    (3) For each PCB Article not in a PCB Container or PCB Article 
Container, the serial number if available, or other identification if 
there is no serial number, the date of removal from service for 
disposal, and weight in kilograms of the PCB waste in each PCB Article. 
(Item 14--Special Handling Instructions box)

    Note 1 to paragraph (a): EPA Form 8700-22A is not required as the 
PCB manifest continuation sheet. In practice, form 8700-22A does not 
have adequate space to list required PCB-specific information for 
several PCB articles. However, if form 8700-22A fits the needs of the 
user community, the form is permissible.
    Note 2 to paragraph (a): PCB waste handlers should use the Part 262 
appendix instructions as a guide, but should defer to the Part 761 
manifest regulations whenever there

[[Page 266]]

is any difference between the Part 761 requirements and the instructions 
in the appendix to Part 262. The differences should be minimal.
    Note 3 to paragraph (a): PCBs are not regulated under RCRA, thus do 
not have a RCRA waste code. EPA does not require boxes 13 and 31 on 
forms 8700-22 and 8700-22A (if used), respectively, to be completed for 
shipments only containing PCB waste. However, some States track PCB 
wastes as State-regulated hazardous wastes, and assign State hazardous 
waste codes to these wastes. In such a case, the user should follow the 
State instructions for completing the waste code fields.

    (b) A generator must designate on the manifest one facility which is 
approved to handle the PCB waste described on the manifest.
    (c) A generator may also designate on the manifest one alternate 
facility which is approved to handle his PCB waste in the event an 
emergency prevents delivery of the waste to the primary designated 
facility.
    (d) If the transporter is unable to deliver the PCB waste to the 
designated facility or the alternate facility, the generator must either 
designate another facility or instruct the transporter to return the PCB 
waste.
    (e) The requirements of this section apply only to PCB wastes as 
defined in Sec.  761.3. This includes PCB wastes with PCB concentrations 
below 50 ppm where the PCB concentration below 50 ppm was the result of 
dilution; these PCB wastes are required under Sec.  761.1(b) to be 
managed as if they contained PCB concentrations of 50 ppm and above. An 
example of such a PCB waste is spill cleanup material containing <50 ppm 
PCBs when the spill involved material containing PCBs at a concentration 
of =50 ppm. However, there is no manifest requirement for 
material currently below 50 ppm which derives from pre-April 18, 1978, 
spills of any concentration, pre-July 2, 1979, spills of <500 ppm PCBs, 
or materials decontaminated in accordance with Sec.  761.79.
    (f) The requirements of this subpart do not apply to the transport 
of PCB wastes on a public or private right-of-way within or along the 
border of contiguous property under the control of the same person, even 
if such contiguous property is divided by a public or private right-of-
way.

[77 FR 54830, Sept. 6, 2012, as amended at 80 FR 37995, July 2, 2015]



Sec.  761.208  Obtaining manifests.

    (a)(1) A generator may use manifests printed by any source so long 
as the source of the printed form has received approval from EPA to 
print the manifest under 40 CFR 262.21 (c) and (e). A registered source 
may be a:
    (i) State agency;
    (ii) Commercial printer;
    (iii) PCB waste generator, transporter or, designated facility; or
    (iv) PCB waste broker or other preparer who prepares or arranges 
shipments of PCB waste for transportation.
    (2) A generator must determine whether the generator state or the 
consignment state for a shipment regulates PCB waste as a State-
regulated hazardous waste. Generators also must determine whether the 
consignment state or generator state requires the generator to submit 
any copies of the manifest to these states. In cases where the generator 
must supply copies to either the generator's state or the consignment 
state, the generator is responsible for supplying legible photocopies of 
the manifest to these states.
    (b) [Reserved]

[77 FR 54831, Sept. 6, 2012]



Sec.  761.209  Number of copies of a manifest.

    The manifest consists of at least the number of copies which will 
provide the generator, each transporter, and the owner or operator of 
the designated facility with one copy each for their records and another 
copy to be returned to the generator.

[77 FR 54831, Sept. 6, 2012]



Sec.  761.210  Use of the manifest--Generator requirements.

    (a) The generator must:
    (1) Sign the manifest certification by hand; and
    (2) Obtain the handwritten signature of the initial transporter and 
date of acceptance on the manifest; and
    (3) Retain one copy, in accordance with Sec.  761.214(a)(1).

[[Page 267]]

    (b) The generator must give the transporter the remaining copies of 
the manifest.
    (c) For shipments of PCB waste within the United States solely by 
water (bulk shipments only), the generator must send three copies of the 
manifest dated and signed in accordance with this section to the owner 
or operator of the designated facility. Copies of the manifest are not 
required for each transporter.
    (d) For rail shipments of PCB waste within the United States which 
originate at the site of generation, the generator must send at least 
three copies of the manifest dated and signed in accordance with this 
section to:
    (1) The next non-rail transporter, if any; or
    (2) The designated facility if transported solely by rail.
    (e) For rejected shipments of PCB waste that are returned to the 
generator by the designated facility (following the procedures of Sec.  
761.215(f)), the generator must:
    (1) Sign either:
    (i) Item 20 of the new manifest if a new manifest is used for the 
returned shipment; or
    (ii) Item 18c of the original manifest if the original manifest is 
used for the returned shipment;
    (2) Provide the transporter a copy of the manifest;
    (3) Within 30 days of delivery of the rejected shipment, send a copy 
of the manifest to the designated facility that returned the shipment to 
the generator; and
    (4) Retain at the generator's site a copy of each manifest for at 
least three years from the date of delivery.

[77 FR 54831, Sept. 6, 2012]



Sec.  761.211  Manifest system--Transporter requirements.

    (a)(1) A transporter shall not accept PCB waste from a generator 
unless it is accompanied by a manifest signed by the generator in 
accordance with Sec.  761.210(a)(1), except that a manifest is not 
required if any one of the following conditions exists:
    (i) The shipment of PCB waste consists solely of PCB wastes with PCB 
concentrations below 50 ppm, unless the PCB concentration below 50 ppm 
was the result of dilution, in which case Sec.  761.1(b) requires that 
the waste be managed as if it contained PCBs at the concentration prior 
to dilution.
    (ii) The PCB waste is accepted by the transporter for transport only 
to a storage or disposal facility owned or operated by the generator of 
the PCB waste.
    (2) [Reserved]
    (b) Before transporting the PCB waste, the transporter must sign and 
date the manifest acknowledging acceptance of the PCB waste from the 
generator. The transporter must return a signed copy to the generator 
before leaving the generator's property.
    (c) The transporter shall ensure that the manifest accompanies the 
PCB waste.
    (d) A transporter who delivers PCB waste to another transporter or 
to the designated facility must:
    (1) Obtain the date of delivery and the handwritten signature of 
that transporter or of the owner or operator of the designated facility 
on the manifest; and
    (2) Retain one copy of the manifest in accordance with Sec.  
761.214; and
    (3) Give the remaining copies of the manifest to the accepting 
transporter or designated facility.
    (e) The requirements of paragraphs (c), (d) and (f) of this section 
do not apply to water (bulk shipment) transporters if:
    (1) The PCB waste is delivered by water (bulk shipment) to the 
designated facility; and
    (2) A shipping paper containing all the information required on the 
manifest (excluding EPA identification number, generator certification, 
and signatures) accompanies the PCB waste; and
    (3) The delivering transporter obtains the date of delivery and 
handwritten signature of the owner or operator of the designated 
facility on either the manifest or the shipping paper; and
    (4) The person delivering the PCB waste to the initial water (bulk 
shipment) transporter obtains the date of delivery and signature of the 
water (bulk shipment) transporter on the manifest and forwards it to the 
designated facility; and

[[Page 268]]

    (5) A copy of the shipping paper or manifest is retained by each 
water (bulk shipment) transporter in accordance with Sec.  761.214.
    (f) For shipments involving rail transportation, the requirements of 
paragraphs (c), (d) and (e) do not apply and the following requirements 
do apply:
    (1) When accepting PCB waste from a non-rail transporter, the 
initial rail transporter must:
    (i) Sign and date the manifest acknowledging acceptance of the PCB 
waste;
    (ii) Return a signed copy of the manifest to the non-rail 
transporter;
    (iii) Forward at least three copies of the manifest to:
    (A) The next non-rail transporter, if any; or,
    (B) The designated facility, if the shipment is delivered to that 
facility by rail;
    (iv) Retain one copy of the manifest and rail shipping paper in 
accordance with Sec.  761.214.
    (2) Rail transporters must ensure that a shipping paper containing 
all the information required on the manifest (excluding the EPA 
identification numbers, generator certification, and signatures) 
accompanies the PCB waste at all times.
    Note: Intermediate rail transporters are not required to sign either 
the manifest or shipping paper.
    (3) When delivering PCB waste to the designated facility, a rail 
transporter must:
    (i) Obtain the date of delivery and handwritten signature of the 
owner or operator of the designated facility on the manifest or the 
shipping paper (if the manifest has not been received by the facility); 
and
    (ii) Retain a copy of the manifest or signed shipping paper in 
accordance with Sec.  761.214.
    (4) When delivering PCB waste to a non-rail transporter a rail 
transporter must:
    (i) Obtain the date of delivery and the handwritten signature of the 
next non-rail transporter on the manifest; and
    (ii) Retain a copy of the manifest in accordance with Sec.  761.214.
    (5) Before accepting PCB waste from a rail transporter, a non-rail 
transporter must sign and date the manifest and provide a copy to the 
rail transporter.

[77 FR 54832, Sept. 6, 2012]



Sec.  761.212  Transporter compliance with the manifest.

    (a) The transporter must deliver the entire quantity of PCB waste 
which he has accepted from a generator or a transporter to:
    (1) The designated facility listed on the manifest; or
    (2) The alternate designated facility, if the PCB waste cannot be 
delivered to the designated facility because an emergency prevents 
delivery; or
    (3) The next designated transporter.
    (b)(1) If the PCB waste cannot be delivered in accordance with 
paragraph (a) of this section because of an emergency condition other 
than rejection of the waste by the designated facility, then the 
transporter must contact the generator for further directions and must 
revise the manifest according to the generator's instructions.
    (2) If PCB waste is rejected by the designated facility while the 
transporter is on the facility's premises, then the transporter must 
obtain the following:
    (i) For a partial load rejection, a copy of the original manifest 
that includes the facility's date and signature, and the Manifest 
Tracking Number of the new manifest that will accompany the shipment, 
and a description of the partial rejection in the discrepancy block of 
the original manifest. The transporter must retain a copy of this 
manifest in accordance with Sec.  761.214, and give the remaining copies 
of the original manifest to the rejecting designated facility. If the 
transporter is forwarding the rejected part of the shipment to an 
alternate facility or returning it to the generator, the transporter 
must obtain a new manifest to accompany the shipment, and the new 
manifest must include all of the information required in 40 CFR 
761.215(e)(1) through (6) or (f)(1) through (6).
    (ii) For a full load rejection that will be taken back by the 
transporter, a copy of the original manifest that includes the rejecting 
facility's signature and date attesting to the rejection, the

[[Page 269]]

description of the rejection in the discrepancy block of the manifest, 
and the name, address, phone number, and Identification Number for the 
alternate facility or generator to whom the shipment must be delivered. 
The transporter must retain a copy of the manifest in accordance with 
Sec.  761.214, and give a copy of the manifest containing this 
information to the rejecting designated facility. If the original 
manifest is not used, then the transporter must obtain a new manifest 
for the shipment and comply with 40 CFR 761.215(e)(1) through (6).
    (iii) No provision of this section shall be construed to affect or 
limit the applicability of any requirement applicable to transporters of 
PCB waste under regulations issued by the Department of Transportation 
(DOT) and set forth at 49 CFR Part 171.

[77 FR 54832, Sept. 6, 2012]



Sec.  761.213  Use of manifest--Commercial storage and disposal facility
requirements.

    (a)(1) If a commercial storage or disposal facility receives PCB 
waste accompanied by a manifest, the owner, operator or his/her agent 
must sign and date the manifest as indicated in paragraph (a)(2) of this 
section to certify that the PCB waste covered by the manifest was 
received, that the PCB waste was received except as noted in the 
discrepancy space of the manifest, or that the PCB waste was rejected as 
noted in the manifest discrepancy space.
    (2) If a commercial storage or disposal facility receives an off-
site shipment of PCB waste accompanied by a manifest, the owner or 
operator, or his agent, shall:
    (i) Sign and date, by hand, each copy of the manifest;
    (ii) Note any discrepancies (as defined in Sec.  761.215(a)) on each 
copy of the manifest;
    (iii) Immediately give the transporter at least one copy of the 
manifest;
    (iv) Within 30 days of delivery, send a copy of the manifest to the 
generator; and
    (v) Retain at the facility a copy of each manifest for at least 
three years from the date of delivery.
    (b) If a commercial storage or disposal facility receives, from a 
rail or water (bulk shipment) transporter, PCB waste which is 
accompanied by a shipping paper containing all the information required 
on the manifest (excluding the EPA identification numbers, generator's 
certification, and signatures), the owner or operator, or his agent, 
must:
    (1) Sign and date each copy of the manifest or shipping paper (if 
the manifest has not been received) to certify that the PCB waste 
covered by the manifest or shipping paper was received;
    (2) Note any significant discrepancies (as defined in Sec.  
761.215(a)) in the manifest or shipping paper (if the manifest has not 
been received) on each copy of the manifest or shipping paper.

    Note to paragraph (b)(2): The Agency does not intend that the owner 
or operator of a facility whose procedures include waste analysis must 
perform that analysis before signing the shipping paper and giving it to 
the transporter. Section 761.215(a), however, requires reporting an 
unreconciled discrepancy discovered during later analysis.

    (3) Immediately give the rail or water (bulk shipment) transporter 
at least one copy of the manifest or shipping paper (if the manifest has 
not been received);
    (4) Within 30 days after the delivery, send a copy of the signed and 
dated manifest or a signed and dated copy of the shipping paper (if the 
manifest has not been received within 30 days after delivery) to the 
generator; and

    Note to paragraph (b)(4): Section 761.210(c) requires the generator 
to send three copies of the manifest to the facility when PCB waste is 
sent by rail or water (bulk shipment).]

    (5) Retain at the facility a copy of the manifest and shipping paper 
(if signed in lieu of the manifest at the time of delivery) for at least 
three years from the date of delivery.
    (c) Whenever an off-site shipment of PCB waste is initiated from a 
commercial storage or disposal facility, the owner or operator of the 
commercial storage or disposal facility shall comply with the manifest 
requirements

[[Page 270]]

that apply to generators of PCB waste (Sec.  761.207).

[77 FR 54833, Sept. 6, 2012]



Sec.  761.214  Retention of manifest records.

    (a)(1) A generator must keep a copy of each manifest signed in 
accordance with Sec.  761.210(a) for three years or until he receives a 
signed copy from the designated facility which received the PCB waste. 
This signed copy must be retained as a record for at least three years 
from the date the waste was accepted by the initial transporter. A 
generator subject to annual document requirements under Sec.  761.180 
shall retain copies of each manifest for the period required by Sec.  
761.180(a).
    (2) A transporter of PCB waste must keep a copy of the manifest 
signed by the generator, himself, and the next designated transporter or 
the owner or operator of the designated facility for a period of three 
years from the date the PCB waste was accepted by the initial 
transporter.
    (b) For shipments delivered to the designated facility by water 
(bulk shipment), each water (bulk shipment) transporter must retain a 
copy of the shipping paper containing all the information required in 
Sec.  761.211(e)(2) for a period of three years from the date the PCB 
waste was accepted by the initial transporter.
    (c) For shipments of PCB waste by rail within the United States:
    (1) The initial rail transporter must keep a copy of the manifest 
and shipping paper with all the information required in Sec.  
761.211(f)(2) for a period of three years from the date the PCB waste 
was accepted by the initial transporter; and
    (2) The final rail transporter must keep a copy of the signed 
manifest (or the shipping paper if signed by the designated facility in 
lieu of the manifest) for a period of three years from the date the PCB 
waste was accepted by the initial transporter.

    Note to paragraph (c): Intermediate rail transporters are not 
required to keep records pursuant to these regulations.

    (d) A generator must keep a copy of each Exception Report for a 
period of at least three years from the due date of the report.
    (e) The periods of retention referred to in this Section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity or as requested by the 
Administrator.

[77 FR 54833, Sept. 6, 2012]



Sec.  761.215  Manifest discrepancies.

    (a) Manifest discrepancies are:
    (1) Significant differences (as defined by paragraph (b) of this 
section) between the quantity or type of PCB waste designated on the 
manifest or shipping paper, and the quantity and type of PCB waste a 
facility actually receives; or
    (2) Rejected wastes, which may be a full or partial shipment of PCB 
waste that the designated facility cannot accept.
    (b) Significant differences in quantity are: For bulk waste, 
variations greater than 10 percent in weight or variations greater than 
10 percent in weight of PCB waste in containers; for batch waste, any 
variation in piece count, such as a discrepancy of one PCB Transformer 
or PCB Container or PCB Article Container in a truckload. Significant 
differences in type are obvious differences which can be discovered by 
inspection or waste analysis, such as the substitution of solids for 
liquids or the substitution of high concentration PCBs (above 500 ppm) 
with lower concentration materials.
    (c) Upon discovering a significant difference in quantity or type, 
the owner or operator must attempt to reconcile the discrepancy with the 
waste generator or transporter (e.g., with telephone conversations). If 
the discrepancy is not resolved within 15 days after receiving the 
waste, the owner or operator must immediately submit to the Regional 
Administrator a letter describing the discrepancy and attempts to 
reconcile it, and a copy of the manifest or shipping paper at issue.
    (d)(1) Upon rejecting the PCB waste, the facility must consult with 
the generator prior to forwarding the waste to another facility that can 
manage the waste. If it is impossible to locate an alternative facility 
that can receive the waste, the facility may return the

[[Page 271]]

rejected waste to the generator. The facility must send the waste to the 
alternative facility or to the generator within 60 days of the rejection 
identification.
    (2) While the facility is making arrangements for forwarding 
rejected wastes to another facility under this section, it must ensure 
that either the delivering transporter retains custody of the waste, or, 
the facility must provide for secure, temporary custody of the waste, 
pending delivery of the waste to the first transporter designated on the 
manifest prepared under paragraph (e) or (f) of this section.
    (e) Except as provided in paragraph (e)(7) of this section, for full 
or partial load rejections that are to be sent off-site to an alternate 
facility, the facility is required to prepare a new manifest in 
accordance with Sec.  761.207(a) and the following instructions:
    (1) Write the generator's U.S. EPA ID number in Item 1 of the new 
manifest. Write the generator's name and mailing address in Item 5 of 
the new manifest. If the mailing address is different from the 
generator's site address, then write the generator's site address in the 
designated space for Item 5.
    (2) Write the name of the alternate designated facility and the 
facility's U.S. EPA ID number in the designated facility block (Item 8) 
of the new manifest.
    (3) Copy the manifest tracking number found in Item 4 of the old 
manifest to the Special Handling and Additional Information Block of the 
new manifest, and indicate that the shipment is a rejected waste from 
the previous shipment.
    (4) Copy the manifest tracking number found in Item 4 of the new 
manifest to the manifest reference number line in the Discrepancy Block 
of the old manifest (Item 18a).
    (5) Write the DOT description for the rejected load in Item 9 (U.S. 
DOT Description) of the new manifest and write the container types, 
quantity, and volume(s) of waste.
    (6) Sign the Generator's/Offeror's Certification to certify, as the 
offeror of the shipment, that the waste has been properly packaged, 
marked and labeled and is in proper condition for transportation, and 
mail a signed copy of the manifest to the generator identified in Item 5 
of the new manifest.
    (7) For full load rejections that are made while the transporter 
remains present at the facility, the facility may forward the rejected 
shipment to the alternate facility by completing Item 18b of the 
original manifest and supplying the information on the next destination 
facility in the Alternate Facility space. The facility must retain a 
copy of this manifest for its records, and then give the remaining 
copies of the manifest to the transporter to accompany the shipment. If 
the original manifest is not used, then the facility must use a new 
manifest and comply with paragraphs (e)(1), (2), (3), (4), (5), and (6) 
of this section.
    (f) Except as provided in paragraph (f)(7) of this section, for 
rejected wastes that must be sent back to the generator, the facility is 
required to prepare a new manifest in accordance with Sec.  761.207(a) 
and the following instructions:
    (1) Write the facility's U.S. EPA ID number in Item 1 of the new 
manifest. Write the facility's name and mailing address in Item 5 of the 
new manifest. If the mailing address is different from the facility's 
site address, then write the facility's site address in the designated 
space for Item 5 of the new manifest.
    (2) Write the name of the initial generator and the generator's U.S. 
EPA ID number in the designated facility block (Item 8) of the new 
manifest.
    (3) Copy the manifest tracking number found in Item 4 of the old 
manifest to the Special Handling and Additional Information Block of the 
new manifest, and indicate that the shipment is a rejected waste from 
the previous shipment.
    (4) Copy the manifest tracking number found in Item 4 of the new 
manifest to the manifest reference number line in the Discrepancy Block 
of the old manifest (Item 18a).
    (5) Write the DOT description for the rejected load in Item 9 (U.S. 
DOT Description) of the new manifest and write the container types, 
quantity, and volume(s) of waste.
    (6) Sign the Generator's/Offeror's Certification to certify, as 
offeror of the shipment, that the waste has been

[[Page 272]]

properly packaged, marked and labeled and is in proper condition for 
transportation.
    (7) For full load rejections that are made while the transporter 
remains at the facility, the facility may return the shipment to the 
generator with the original manifest by completing Item 18a and 18b of 
the manifest and supplying the generator's information in the Alternate 
Facility space. The facility must retain a copy for its records and then 
give the remaining copies of the manifest to the transporter to 
accompany the shipment. If the original manifest is not used, then the 
facility must use a new manifest and comply with paragraphs (f)(1), (2), 
(3), (4), (5), (6), and (8) of this section.
    (8) For full or partial load rejections that are returned to the 
generator, the facility must also comply with the exception reporting 
requirements in Sec.  761.217(a).
    (g) If a facility rejects a waste after it has signed, dated, and 
returned a copy of the manifest to the delivering transporter or to the 
generator, the facility must amend its copy of the manifest to indicate 
the rejected wastes in the discrepancy space of the amended manifest. 
The facility must also copy the manifest tracking number from Item 4 of 
the new manifest to the Discrepancy space of the amended manifest, and 
must re-sign and date the manifest to certify to the information as 
amended. The facility must retain the amended manifest for at least 
three years from the date of amendment, and must within 30 days, send a 
copy of the amended manifest to the transporter and generator that 
received copies prior to their being amended.

[77 FR 54833, Sept. 6, 2012]



Sec.  761.216  Unmanifested waste report.

    (a) If a facility accepts for storage or disposal any PCB waste from 
an off-site source without an accompanying manifest, or without an 
accompanying shipping paper as described by Sec.  761.211(e), and the 
owner or operator of the commercial storage or disposal facility cannot 
contact the generator of the PCB waste, then he shall notify the 
Regional Administrator of the EPA region in which his facility is 
located of the unmanifested PCB waste so that the Regional Administrator 
can determine whether further actions are required before the owner or 
operator may store or dispose of the unmanifested PCB waste, and 
additionally the owner or operator must prepare and submit a letter to 
the Regional Administrator within 15 days after receiving the waste. The 
unmanifested waste report must contain the following information:
    (1) The EPA identification number, name and address of the facility;
    (2) The date the facility received the waste;
    (3) The EPA identification number, name and address of the generator 
and the transporter, if available;
    (4) A description and the quantity of each unmanifested PCB waste 
the facility received;
    (5) The method of storage or disposal for each PCB waste;
    (6) Signature of the owner or operator of the facility or his 
authorized representative; and,
    (7) A brief explanation of why the waste was unmanifested, if known.
    (8) The disposition made of the unmanifested waste by the commercial 
storage or disposal facility, including:
    (i) If the waste was stored or disposed by that facility, was the 
generator identified and was a manifest subsequently supplied.
    (ii) If the waste was sent back to the generator, why and when.
    (b) [Reserved]

[77 FR 54834, Sept. 6, 2012]



Sec.  761.217  Exception reporting.

    (a)(1) A generator of PCB waste, who does not receive a copy of the 
manifest with the handwritten signature of the owner or operator of the 
designated facility within 35 days of the date the waste was accepted by 
the initial transporter, shall immediately contact the transporter and/
or the owner or operator of the designated facility to determine the 
status of the PCB waste.
    (2) A generator of PCB waste subject to the manifesting requirements 
shall submit an Exception Report to the EPA Regional Administrator for 
the Region in which the generator is located if the generator has not 
received a copy of the manifest with the hand

[[Page 273]]

written signature of the owner or operator of the designated facility 
within 45 days of the date the waste was accepted by the initial 
transporter. The exception report shall be submitted to EPA no later 
than 45 days from the date on which the generator should have received 
the manifest. The Exception Report shall include the following:
    (i) A legible copy of the manifest for which the generator does not 
have confirmation of delivery;
    (ii) A cover letter signed by the generator or his authorized 
representative explaining the efforts taken to locate the PCB waste and 
the results of those efforts.
    (b) For rejected shipments of PCB waste that are forwarded to an 
alternate facility by a designated facility using a new manifest 
(following the procedures of Sec.  761.215(e)(1) through (6)), the 
generator must comply with the requirements of paragraph (a) of this 
section, as applicable, for the shipment forwarding the material from 
the designated facility to the alternate facility instead of for the 
shipment from the generator to the designated facility. For purposes of 
paragraph (a) of this section for a shipment forwarding such waste to an 
alternate facility by a designated facility:
    (1) The copy of the manifest received by the generator must have the 
handwritten signature of the owner or operator of the alternate facility 
in place of the signature of the owner or operator of the designated 
facility, and
    (2) The 35- and 45-day timeframes begin the date the waste was 
accepted by the initial transporter forwarding the PCB waste shipment 
from the designated facility to the alternate facility.

[77 FR 54835, Sept. 6, 2012]



Sec.  761.218  Certificate of disposal.

    (a) For each shipment of manifested PCB waste that the owner or 
operator of a disposal facility accepts by signing the manifest, the 
owner or operator of the disposal facility shall prepare a Certificate 
of Disposal for the PCBs and PCB Items disposed of at the facility, 
which shall include:
    (1) The identity of the disposal facility, by name, address, and EPA 
identification number.
    (2) The identity of the PCB waste affected by the Certificate of 
Disposal including reference to the manifest number for the shipment.
    (3) A statement certifying the fact of disposal of the identified 
PCB waste, including the date(s) of disposal, and identifying the 
disposal process used.
    (4) A certification as defined in Sec.  761.3.
    (b) The owner or operator of the disposal facility shall send the 
Certificate of Disposal to the generator identified on the manifest 
which accompanied the shipment of PCB waste within 30 days of the date 
that disposal of each item of PCB waste identified on the manifest was 
completed unless the generator and the disposer contractually agree to 
another time frame.
    (c) The disposal facility shall keep a copy of each Certificate of 
Disposal among the records that it retains under Sec.  761.180(b).
    (d)(1) Generators of PCB waste shall keep a copy of each Certificate 
of Disposal that they receive from disposers of PCB waste among the 
records they retain under Sec.  761.180(a).
    (2) Commercial storers of PCB waste shall keep a copy of each 
Certificate of Disposal that they receive from disposers of PCB waste 
among the records they retain under Sec.  761.180(b).

[54 FR 52752, Dec. 21, 1984, as amended at 63 FR 35462, June 29, 1998]



Sec.  761.219  One-year exception reporting.

    (a) A disposer of PCB waste shall submit a One-year Exception Report 
to the EPA Regional Administrator for the Region in which the disposal 
facility is located no later than 45 days from the end of the 1-year 
storage for disposal date when the following occurs:
    (1) The disposal facility receives PCBs or PCB Items on a date more 
than 9 months from the date the PCBs or PCB Items were removed from 
service for disposal, as indicated on the manifest or continuation 
sheet; and
    (2) Because of contractual commitments or other factors affecting 
the facility's disposal capacity, the disposer of PCB waste could not 
dispose of the affected PCBs or PCB Items within 1

[[Page 274]]

year of the date of removal from service for disposal.
    (b) A generator or commercial storer of PCB waste who manifests PCBs 
or PCB Items to a disposer of PCB waste shall submit a One-year 
Exception Report to the EPA Regional Administrator for the Region in 
which the generator or commercial storer is located no later than 45 
days from the date the following occurs:
    (1) The generator or commercial storer transferred the PCBs or PCB 
Items to the disposer of PCB waste on a date within 9 months from the 
date of removal from service for disposal of the affected PCBs or PCB 
Items, as indicated on the manifest or continuation sheet; and
    (2) The generator or commercial storer either has not received 
within 13 months from the date of removal from service for disposal a 
Certificate of Disposal confirming the disposal of the affected PCBs or 
PCB Items, or the generator or commercial storer receives a Certificate 
of Disposal confirming disposal of the affected PCBs or PCB Items on a 
date more than 1 year after the date of removal from service.
    (c) The One-year Exception Report shall include:
    (1) A legible copy of any manifest or other written communication 
relevant to the transfer and disposal of the affected PCBs or PCB Items.
    (2) A cover letter signed by the submitter or an authorized 
representative explaining:
    (i) The date(s) when the PCBs or PCB Items were removed from service 
for disposal.
    (ii) The date(s) when the PCBs or PCB Items were received by the 
submitter of the report, if applicable.
    (iii) The date(s) when the affected PCBs or PCB Items were 
transferred to a designated disposal facility.
    (iv) The identity of the transporters, commercial storers, or 
disposers known to be involved with the transaction.
    (v) The reason, if known, for the delay in bringing about the 
disposal of the affected PCBs or PCB Items within 1 year from the date 
of removal from service for disposal.
    (d) PCB/radioactive waste that is exempt from the 1-year storage for 
disposal time limit pursuant to Sec.  761.65(a)(1) is also exempt from 
the exception reporting requirements of paragraphs (a), (b), and (c) of 
this section.

[77 FR 54835, Sept. 6, 2012]

Subpart L [Reserved]



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

    Source: 63 FR 35462, June 29, 1998, unless otherwise noted.



Sec.  761.240  Scope and definitions.

    (a) Use these procedures to select surface sampling sites for 
natural gas pipe to determine its PCB surface concentration for 
abandonment-in-place or removal and disposal off-site in accordance with 
Sec.  761.60(b)(5).
    (b) ``Pipe segment'' means a length of natural gas pipe that has 
been removed from the pipeline system to be disposed of or reused, and 
that is usually approximately 12.2 meters (40 feet) or shorter in 
length. Pipe segments are usually linear.
    (c) ``Pipeline section'' means a length of natural gas pipe that has 
been cut or otherwise separated from the active pipeline, usually for 
purposes of abandonment, and that is usually longer than 12.2 meters in 
length. Pipeline sections may be branched.



Sec.  761.243  Standard wipe sample method and size.

    (a) Collect a surface sample from a natural gas pipe segment or 
pipeline section using a standard wipe test as defined in Sec.  761.123. 
Detailed guidance for the entire wipe sampling process appears in the 
document entitled, ``Wipe Sampling and Double Wash/Rinse Cleanup as 
Recommended by the Environmental Protection Agency PCB Spill Cleanup 
Policy,'' dated June 23, 1987 and revised on April 18, 1991. This 
document is available on EPA's Web site at http://www.epa.gov/pcb, or 
from

[[Page 275]]

the Program Management, Communications, and Analysis Office, Office of 
Resource Conservation and Recovery (5305P), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (b) Collect a surface sample from a minimum surface area of 100 
cm\2\ at each sampling site selected. The EPA Regional Administrator may 
approve, in writing, requests to collect a sample from smaller surface 
areas, when <100 cm\2\ of surface eligible for sampling is present; 
e.g., when sampling a small diameter pipe, a small valve, or a small 
regulator. When smaller surfaces are sampled, convert the measurement to 
the equivalent measurement for 100 cm\2\ for purposes of comparison to 
standards based on 100 cm\2\.

[63 FR 35462, June 29, 1998, as amended at 72 FR 57241, Oct. 9, 2007; 74 
FR 30235, June 25, 2009]



Sec.  761.247  Sample site selection for pipe segment removal.

    (a) General. (1) Select the pipe segments to be sampled by following 
the directions in paragraph (b) of this section.
    (2) Locate the proper position along the length of the pipe segment 
that you have selected for sampling, by following the directions in 
paragraph (c) of this section.
    (3) Select the proper sampling position around the circumference of 
the pipe segment that you have selected for sampling, by following the 
directions in paragraph (d) of this section.
    (4) Prior to removing pipe from the ground or lifting the pipe from 
its location during former operations, mark the top side of the pipe.
    (5) Do not sample if there are free-flowing liquids in the pipe 
segment. Free-flowing liquids must be removed prior to sampling.
    (b) Selecting pipe segments to sample. Select the pipe segment(s) 
that you will sample from a length of pipe or group of pipe segments, as 
follows:
    (1) Do not sample a pipe segment that is longer than 12.2 meters (40 
feet). If a segment is longer than 12.2 meters in length, cut the 
segment so that all resulting segments are 12.2 meters or less in 
length.
    (2) Determine which pipe segments to sample as follows:
    (i) When a length of pipe having seven or fewer segments is removed 
for purposes of disposal, sample each pipe segment.
    (ii) When removing a length of pipe having multiple contiguous 
segments less than 3 miles in total length, take samples from a total of 
seven segments.
    (A) Sample the first and last segments removed.
    (B) Select the five additional segments according to one of the two 
following procedures:
    (1) Assign all segments a unique sequential number. Then select five 
numbers using a random number table or random number generator. If the 
random number generator or random number table produces either the first 
pipe segment, the last pipe segment, or any previously selected segment, 
select another random number until there are seven different numbers, 
each corresponding to a different pipe segment.
    (2) Divide the total number of segments by six. Round the resulting 
quotient off to the nearest whole number. The resulting number is the 
interval between the segments you will sample. For example, cut a 2.9 
mile length of pipeline into 383 segments of approximately 40 feet each. 
Sample the first (number 1) and last (number 383) segments. To determine 
which additional five segments to sample, divide the total number of 
segments, 383, by 6. Round up the resulting number in this example, 
63.8, to the next whole number, 64. Add 64 to the number of each 
preceding pipe segment five separate times to select five additional 
pipe segments for sampling. In this example, the first pipe segment has 
the number 1, add 64 to 1 to select segment 65. Next, add 64 to 65 to 
select segment 129. Continue in this fashion to select all seven 
segments: 1, 65, 129, 193, 257, 321, and 383.
    (iii) When removing a length of pipe having multiple contiguous 
segments more than 3 miles in total length for purposes of disposal, 
take samples of each segment that is \1/2\ mile distant from the segment 
previously sampled. Sample a minimum of seven segments.

[[Page 276]]

    (c) Selecting the sampling position--length. Select the sampling 
position along the length of the pipe segment, as follows:
    (1) Take samples at the end upstream of the former gas flow of each 
segment removed.
    (2) If the pipe segment is cut with a torch or other high 
temperature heat source, take the sample at least 15 cm (6 inches) 
inside the cut end of the pipe segment.
    (3) If the pipe segment is cut with a saw or other mechanical 
device, take the sample at least 2 cm (1 inch) inside the end of the 
pipe segment.
    (4) If the sample site location selected in the procedure at 
paragraph (c)(2) or (c)(3) of this section is a porous surface (for 
example, there is significant corrosion so that the wipe material will 
be shredded), then move the sample site further inside the pipe segment 
(away from the end of the pipe or pipe segment) until there is no such 
porous surface. For purposes of this subpart, natural gas pipe with a 
thin porous corrosion preventive coating is a non-porous surface.
    (5) If there is not a non-porous surface accessible by paragraphs 
(c)(2) and (c)(3) of this section, use one of the following three 
options:
    (i) Sample the downstream end of the pipe segment using the same 
sample site location procedure as for the upstream end.
    (ii) Select another pipe segment using the random selection 
procedure described in paragraph (b) of this section.
    (iii) If there is no other pipe segment in the population to be 
sampled and both ends of a pipe segment have porous surfaces at all 
possible sample collection sites, then assume that the pipe segment 
contains =50 ppm PCB but <500 ppm PCB.
    (d) Selecting the sample position--circumference. Based on the mark 
on the top of the pipe segment made prior to removing pipe from the 
ground or lifting the pipe from its location during former operations, 
sample the inside center of the bottom of the pipe being sampled. Make 
sure the sample is centered on the bottom of the pipe segment; that is, 
sample an equal area on both sides of the middle of the bottom of the 
pipe segment for the entire length of the sample.

[63 FR 35462, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec.  761.250  Sample site selection for pipeline section abandonment.

    This procedure is for the sample site selection for a pipeline 
section to be abandoned, in accordance with Sec.  761.60(b)(5)(i)(B).
    (a) General. (1) Select sample collection sites in the pipeline 
section(s) by following the directions in paragraph (b) of this section.
    (2) Select the proper sampling position along the pipe by following 
the directions in Sec.  761.247 (c) and (d).
    (3) Assure, by visual inspection, the absence of free-flowing 
liquids in the pipe by affirming no liquids at all liquid collection 
points and all ends of the pipeline section to be abandoned.
    (b) Selection sample collection sites. At a minimum, sample all ends 
of all pipeline sections to be abandoned in place.
    (1) If the pipeline section to be abandoned is between the pressure 
side of one compressor station and the suction side of the next 
compressor station downstream of the former gas flow, at a minimum, 
sample all ends of the abandoned pipe.
    (2) If the pipeline section to be abandoned is longer than the 
distance between the pressure side of one compressor station and the 
suction side of the next compressor station downstream of the former gas 
flow, divide the pipeline section, for purposes of sampling, into 
smaller pipeline sections no longer than the distance from the pressure 
side of one compressor station to the suction side of the next 
compressor station downstream of the former gas flow. Consider each of 
the smaller sections to be a separate abandonment and sample each one, 
at a minimum, at all ends.
    (3) Use the following procedure to locate representative sample 
collection sites in pipeline sections at points other than the suction 
and pressure side of compressor stations, or the ends of the pipeline 
section to be abandoned.
    (i) First, assign a unique identifying sequential number to each 
kilometer or fraction of a kilometer length of pipe within the entire 
pipeline section.

[[Page 277]]

    (ii) Use a random number table or a random number generator to 
select each representative sample collection site from a complete list 
of the sequential identification numbers.
    (iii) Samples may be collected by removing any covering soil, 
cutting the pipe to gain access to the sampling location, and collecting 
the surface sample with the pipe in place, rather than completely 
removing the pipeline sections to collect the surface sample.

[63 FR 35462, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec.  761.253  Chemical analysis.

    (a) Extract PCBs from the standard wipe sample collection medium and 
clean-up the extracted PCBs in accordance with either Method 3500B/3540C 
or Method 3500B/3550B from EPA's SW-846, Test Methods for Evaluating 
Solid Waste, or a method validated under subpart Q of this part. Use 
Method 8082 from SW-846, or a method validated under subpart Q of this 
part, to analyze these extracts for PCBs.
    (b) Report all PCB sample concentrations in [micro]g/100 cm\2\ (16 
square inches) of surface sampled. If sampling an area smaller than 100 
cm\2\, report converted sample concentrations in accordance with Sec.  
761.243(b).



Sec.  761.257  Determining the regulatory status of sampled pipe.

    (a) For purposes of removal for disposal of a pipe segment that has 
been sampled, the sample results for that segment determines its PCB 
surface concentration. Determine the PCB surface concentration of a 
segment which was not sampled as follows:
    (1) If the unsampled pipe segment is between two pipe segments which 
have been sampled, assume that the unsampled segment has the same PCB 
surface concentration as the nearest sampled pipe segment.
    (2) If an unsampled pipe segment is equidistant between two pipe 
segments which have been sampled, assume the PCB surface concentration 
of the unsampled segment to be the arithmetic mean of the PCB surface 
concentrations measured in the two equidistant, sampled, pipe segments.
    (b) For purposes of abandonment of a pipeline section, assume that 
the PCB surface concentration for an entire pipeline section is the 
arithmetic mean of the PCB surface concentrations measured at the ends 
of the pipeline section. If additional representative samples were taken 
in a pipeline section, assume that the PCB surface concentration for the 
entire pipeline section is the arithmetic mean of the concentrations 
measured in all representative samples taken.
    (c) For purposes of removal for disposal under Sec.  
761.60(b)(5)(ii)(A)(1) or abandonment under Sec.  761.60(b)(5)(i)(B), if 
the surface PCB concentration of a pipe segment, determined by direct 
measurement or in accordance with paragraph (a) of this section, or of a 
pipeline section as determined in accordance with paragraph (b) of this 
section, is 10 [micro]g/100 cm\2\, but <100 [micro]g/100 
cm\2\, then that segment or section is PCB-Contaminated.



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

    Source: 63 FR 35464, June 29, 1998, unless otherwise noted.



Sec.  761.260  Applicability.

    This subpart provides a method for collecting new data for 
characterizing a PCB remediation waste cleanup site or for assessing the 
sufficiency of existing site characterization data, as required by Sec.  
761.61(a)(2).



Sec.  761.265  Sampling bulk PCB remediation waste and porous surfaces.

    (a) Use a grid interval of 3 meters and the procedures in Sec. Sec.  
761.283 and 761.286 to sample bulk PCB remediation waste that is not in 
a container and porous surfaces.
    (b) Use the following procedures to sample bulk PCB remediation 
waste that is in a single container.
    (1) Use a core sampler to collect a minimum of one core sample for 
the entire depth of the waste at the center of the container. Collect a 
minimum of 50 cm\3\ of waste for analysis.
    (2) If more than one core sample is taken, thoroughly mix all 
samples into a composite sample. Take a subsample

[[Page 278]]

of a minimum of 50 cm\3\ from the mixed composite for analysis.
    (c) Use the following procedures to sample bulk PCB remediation 
waste that is in more than one container.
    (1) Segregate the containers by type (for example, a 55-gallon drum 
and a roll-off container are types of containers).
    (2) For fewer than three containers of the same type, sample all 
containers.
    (3) For more than three containers of the same type, list the 
containers and assign each container an unique sequential number. Use a 
random number generator or table to select a minimum of 10 percent of 
the containers from the list, or select three containers, whichever is 
the larger.
    (4) Sample the selected container(s) according to paragraph (b) of 
this section.



Sec.  761.267  Sampling non-porous surfaces.

    (a) Sample large, nearly flat, non-porous surfaces by dividing the 
surface into roughly square portions approximately 2 meters on each 
side. Follow the procedures in Sec.  761.302(a).
    (b) It is not necessary to sample small or irregularly shaped 
surfaces.



Sec.  761.269  Sampling liquid PCB remediation waste.

    (a) If the liquid is single phase, collect and analyze one sample. 
There are no required procedures for collecting a sample.
    (b) If the liquid is multi-phasic, separate the phases, and collect 
and analyze a sample from each liquid phase. There are no required 
procedures for collecting a sample from each single phase liquid.
    (c) If the liquid has a non-liquid phase which is 0.5 
percent by total weight of the waste, separate the non-liquid phase from 
the liquid phase and sample it separately as a non-liquid in accordance 
with Sec.  761.265.



Sec.  761.272  Chemical extraction and analysis of samples.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB remediation waste. Use Method 
8082 from SW-846, or a method validated under subpart Q of this part, to 
analyze these extracts for PCBs.



Sec.  761.274  Reporting PCB concentrations in samples.

    (a) Report all sample concentrations for non-liquid PCBs on a dry 
weight basis as micrograms of PCBs per gram of sample (ppm by weight). 
Report surface sampling results as [micro]g/100 cm\2\. Divide 100 cm\2\ 
by the surface area and multiply this quotient by the total number of 
micrograms of PCBs on the surface to obtain the equivalent measurement 
of micrograms per 100 cm\2\.
    (b) Report all sample concentrations for liquid PCBs on a wet weight 
basis as micrograms of PCBs per gram of sample (ppm by weight).



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

    Source: 63 FR 35465, June 29, 1998, unless otherwise noted.



Sec.  761.280  Application and scope.

    Follow the procedures in this subpart when sampling to verify 
completion of the cleanup for self-implementing, on-site disposal of 
bulk PCB remediation waste and porous surfaces consistent with the 
levels of Sec.  761.61(a)(4)(i) and (iii). The objective of this subpart 
is not to search for new contamination. Confirmation of compliance with 
the cleanup levels in Sec.  761.61(a)(4) is only verifiable for the area 
sampled in accordance with this subpart. Do not make conclusions or 
extrapolations about PCB concentrations outside of the area which has 
been cleaned up and verified based on the results of this verification 
sampling.

[[Page 279]]



Sec.  761.283  Determination of the number of samples to collect and 
sample collection locations.

    This section addresses how to determine the number of samples to 
collect and sample collection locations for bulk PCB remediation waste 
and porous surfaces destined to remain at a cleanup site after cleanup.
    (a) Minimum number of samples. (1) At each separate cleanup site at 
a PCB remediation waste location, take a minimum of three samples for 
each type of bulk PCB remediation waste or porous surface at the cleanup 
site, regardless of the amount of each type of waste that is present. 
There is no upper limit to the number of samples required or allowed.
    (2) This is an example of how to calculate the minimum number of 
required samples at a PCB remediation waste location. There are three 
distinct cleanup sites at this example location: a loading dock, a 
transformer storage lot, and a disposal pit. The minimum number of 
samples to take appears in parentheses after each type of waste for each 
cleanup site. The PCB remediation wastes present at the loading dock are 
concrete (three samples) and clay soil (three samples). The non-liquid 
PCB remediation wastes present at the transformer storage lot are oily 
soil (three samples), clay soil (three samples) and gravel (three 
samples). The PCB remediation wastes present at the disposal pit are 
sandy soil (three samples), clay soil (three samples), oily soil (three 
samples), industrial sludge (three samples), and gravel (three samples).
    (b) Selection of sample locations--general. (1)(i) Use a square-
based grid system to overlay the entire area to be sampled. Orient the 
grid axes on a magnetic north-south line centered in the area and an 
east-west axis perpendicular to the magnetic north-south axis also 
centered in the area.
    (ii) If the site is recleaned based on the results of cleanup 
verification conducted in accordance with Sec.  761.61(a)(6), follow the 
procedures in paragraph (b) of this section for locating sampling points 
after the recleaning, but reorient the grid axes established in 
paragraph (b)(1)(i) of this section by moving the origin one meter in 
the direction of magnetic north and one meter in the direction east of 
magnetic north.
    (2) Mark out a series of sampling points 1.5 meters apart oriented 
to the grid axes. The sampling points shall proceed in every direction 
to the extent sufficient to result in a two-dimensional grid completely 
overlaying the sampling area.
    (3) Collect a sample at each point if the grid falls in the cleanup 
area. Analyze all samples either individually or according to the 
compositing schemes provided in the procedures at Sec.  761.289. So long 
as every sample collected at a grid point is analyzed as either an 
individual sample or as part of a composite sample, there are no other 
restrictions on how many samples are analyzed.
    (c) Selection of sample locations--small cleanup sites. When a 
cleanup site is sufficiently small or irregularly shaped that a square 
grid with a grid interval of 1.5 meters will not result in a minimum of 
three sampling points for each type of bulk PCB remediation waste or 
porous surface at the cleanup site, there are two options.
    (1) Use a smaller square grid interval and the procedures in 
paragraph (b) of this section.
    (2) Use the following coordinate-based random sampling scheme. If 
the site is recleaned based on the results of cleanup verification 
conducted in accordance with Sec.  761.61(a)(6), follow the procedures 
in this section for locating sampling points after the recleaning, but 
select three new pairs of sampling coordinates.
    (i) Beginning in the southwest corner (lower left when facing 
magnetic north) of the area to be sampled, measure in centimeters (or 
inches) the maximum magnetic north-south dimension of the area to be 
sampled. Next, beginning in the southwest corner, measure in centimeters 
(or inches) the maximum magnetic east-west dimension of the area to be 
sampled. Designate the north-south and east-west dimensions (describing 
the west and south boundaries, respectively, of the area to be sampled), 
as the reference axes of a square-based grid system.
    (ii) Use a random number table or random number generator to select 
a pair of coordinates that will locate the sample within the area to be 
sampled.

[[Page 280]]

The first coordinate in the pair is the measurement on the north-south 
axis. The second coordinate in the pair is the measurement on the east-
west axis. Collect the sample at the intersection of an east-west line 
drawn through the measured spot on the north-south axis, and a north-
south line drawn through the measured spot on the east-west axis. If the 
cleanup site is irregularly shaped and this intersection falls outside 
the cleanup site, select a new pair of sampling coordinates. Continue to 
select pairs of sampling coordinates until three are selected for each 
type of bulk PCB remediation waste or porous surface at the cleanup 
site.
    (d) Area of inference. Analytical results for an individual sample 
point apply to the sample point and to an area of inference extending to 
four imaginary lines parallel to the grid axes and one half grid 
interval distant from the sample point in four different directions. The 
area of inference forms a square around the sample point. The sides of 
the square are parallel to the grid axes and one grid interval in 
length. The sample point is in the center of the square area of 
inference. The area of inference from a composite sample is the total of 
the areas of the individual samples included in the composite.



Sec.  761.286  Sample size and procedure for collecting a sample.

    At each selected sampling location for bulk PCB remediation waste or 
porous surfaces, collect at least 20 milliliters of waste, or a portion 
of sufficient weight for the chemical analyst to measure the 
concentration of PCBs and still have sufficient analytical detection 
sensitivity to reproducibly measure PCBs at the levels designated in 
Sec.  761.61(a)(4). Use a core sampler having a diameter =2 
cm and <=3 cm. Collect waste to a maximum depth of 7.5 cms.



Sec.  761.289  Compositing samples.

    Compositing is a method of combining several samples of a specific 
type of bulk PCB remediation waste or porous surface from nearby 
locations for a single chemical analysis. There are two procedures for 
compositing bulk PCB remediation waste samples. These procedures are 
based on the method for selecting sampling site locations in Sec.  
761.283(b) and (c). The single chemical analysis of a composite sample 
results in an averaging of the concentrations of its component samples. 
The area of inference of a composite is determined by the area of 
inference of each of its component samples as described in Sec.  
761.283(d). Compositing is not mandatory. However, if compositing is 
used, it must be performed in accordance with the following procedures.
    (a) Compositing in the field or in a laboratory. Compositing may 
occur either in the field or in a laboratory. Prepare composite samples 
using equal volumes of each constituent or component sample. Composited 
samples must be from the same type of bulk PCB remediation waste or 
porous surface (see the example at Sec.  761.283(a)(2)). Mix composite 
samples thoroughly. From each well-mixed composite sample, take a 
portion of sufficient weight for the chemical analyst to measure the 
concentration of PCBs and still have sufficient analytical detection 
sensitivity to reproducibly measure PCBs at the levels designated in 
Sec.  761.61(a)(4).
    (b)(1) Compositing from samples collected at grid points in 
accordance with Sec.  761.283(b). There are two kinds of composite 
sampling procedures depending on the original source of contamination of 
the site.
    (i) The first procedure is for sites with multiple point sources of 
contamination (such as an old electrical equipment storage area, a scrap 
yard, or repair shop) or for unknown sources of contamination. Under 
this compositing scheme, composite a maximum of nine samples for each 
type of bulk PCB remediation waste or porous surface at the cleanup 
site. The maximum dimensions of the area enclosing a nine grid point 
composite is two grid intervals bounded by three collinear grid points 
(3.0 meters or approximately 10 feet long). Take all samples in the 
composite at the same depth. Assure that composite sample areas and 
individually analyzed samples completely overlay the cleanup site.
    (ii) The second procedure is for a single point source of 
contamination, such as discharge into a large containment

[[Page 281]]

area (e.g., pit, waste lagoon, or evaporation pond), or a leak onto soil 
from a single drum or tank. Single point source contamination may be 
from a one-time or continuous contamination. Composites come from two 
stages: an initial compositing area centered in the area to be sampled, 
and subsequent compositing areas forming concentric square zones around 
the initial compositing area. The center of the initial compositing area 
and each of the subsequent compositing areas is the origin of the grid 
axes.
    (A) Definition of the initial compositing area. The initial 
compositing area is based on a square that contains nine grid points, is 
centered on the grid origin, and has sides two grid intervals long. The 
initial compositing area has the same center as this square and sides 
one half a grid interval more distant from the center than the square. 
The initial compositing area has sides three grid intervals long.
    (B) Definition of subsequent compositing areas. Subsequent composite 
sampling areas are in concentric square zones one grid interval wide 
around the initial compositing area and around each successive 
subsequent compositing area. The inner boundary of the first subsequent 
compositing area is the outer boundary of the initial compositing area. 
The outer boundary of the first subsequent compositing area is centered 
on the grid origin, has sides one grid interval more distant from the 
grid origin than the inner boundary, and is two grid intervals longer on 
a side than the inner boundary. The inner boundary of each further 
subsequent compositing area is the outer boundary of the previous 
subsequent compositing area. The outer boundary of each further 
subsequent compositing area is centered on the grid origin, has sides 
one grid interval more distant from the grid origin than the inner 
boundary, and is two grid intervals longer on a side than the inner 
boundary.
    (C) Taking composite samples from the initial and subsequent 
compositing areas. (1) Select composite sampling areas from the initial 
compositing area and subsequent compositing areas such that all grid 
points in the initial compositing area and subsequent compositing areas 
are part of a composite or individual sample.
    (2) A person may include in a single composite sample a maximum of 
all nine grid points in the initial compositing area. The maximum number 
of grid points in a composite sample taken from a subsequent compositing 
area is eight. These eight grid points must be adjacent to one another 
in the subsequent compositing area, but need not be collinear.
    (2) Compositing from samples taken at grid points or pairs of 
coordinates in accordance with Sec.  761.283(c). Samples collected at 
small sites are based on selecting pairs of coordinates or using the 
sample site selection procedure for grid sampling with a smaller grid 
interval.
    (i) Samples collected from a grid having a smaller grid interval. 
Use the procedure in paragraph (b)(1)(i) of this section to composite 
samples and determine the area of inference for composite samples.
    (ii) Samples collected from pairs of coordinates. All three samples 
must be composited. The area of inference for the composite is the 
entire area sampled.



Sec.  761.292  Chemical extraction and analysis of individual samples
and composite samples.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB remediation waste. Use Method 
8082 from SW-846, or a method validated under subpart Q of this part, to 
analyze these extracts for PCBs.



Sec.  761.295  Reporting and recordkeeping of the PCB concentrations
in samples.

    (a) Report all sample concentrations for bulk PCB remediation waste 
and porous surfaces on a dry weight basis and as micrograms of PCBs per 
gram of sample (ppm by weight).
    (b) Record and keep on file for 3 years the PCB concentration for 
each sample or composite sample.

[[Page 282]]



Sec.  761.298  Decisions based on PCB concentration measurements resulting
from sampling.

    (a) For grid samples which are chemically analyzed individually, the 
PCB concentration applies to the area of inference as described in Sec.  
761.283(d).
    (b) For grid samples analyzed as part of a composite sample, the PCB 
concentration applies to the area of inference of the composite sample 
as described in Sec.  761.283(d) (i.e., the area of inference is the 
total of the areas of the individual samples included in the composite).
    (c) For coordinate pair samples analyzed as part of a composite 
sample, in accordance with Sec. Sec.  761.283(c)(2) and 
761.289(b)(2)(ii), the PCB concentration applies to the entire cleanup 
site.



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

    Source: 63 FR 35467, June 29, 1998, unless otherwise noted.



Sec.  761.300  Applicability.

    This subpart provides sample site selection procedures for large, 
nearly flat non-porous surfaces, and for small or irregularly shaped 
non-porous surfaces. This subpart also provides procedures for analyzing 
the samples and interpreting the results of the sampling. Any person 
verifying completion of self-implementing cleanup and on-site disposal 
of non-porous surfaces under Sec.  761.61(a)(6), or verifying that 
decontamination standards under Sec.  761.79(b)(3) are met, must use 
these procedures.



Sec.  761.302  Proportion of the total surface area to sample.

    (a) Large nearly flat surfaces. Divide the entire surface into 
approximately 1 meter square portions and mark the portions so that they 
are clearly identified. Determine the sample location in each portion as 
directed in Sec.  761.304.
    (1) For large nearly flat surfaces contaminated by a single source 
of PCBs with a uniform concentration, assign each 1 meter square surface 
a unique sequential number.
    (i) For three or fewer 1 meter square areas, sample all of the 
areas.
    (ii) For four or more 1 meter square areas, use a random number 
generator or table to select a minimum of 10 percent of the areas from 
the list, or to select three areas, whichever is more.
    (2) For other large nearly flat surfaces, sample all of the one 
meter square areas.
    (b) Small or irregularly shaped surfaces. For small surfaces having 
irregular contours, such as hand tools, natural gas pipeline valves, and 
most exterior surfaces of machine tools, sample the entire surface. Any 
person may select sampling locations for small, nearly flat surfaces in 
accordance with Sec.  761.308 with the exception that the maximum area 
in Sec.  761.308(a) is <1 meter square.
    (c) Preparation of surfaces. Drain all free-flowing liquids from 
surfaces and brush off dust or loose grit.



Sec.  761.304  Determining sample location.

    (a) For 1 square meter non-porous surface areas having the same size 
and shape, it is permissible to sample the same 10 cm by 10 cm location 
or position in each identical 1 square meter area. This location or 
position is determined in accordance with Sec.  761.306 or Sec.  
761.308.
    (b) If some 1 square meter surfaces for a larger non-porous surface 
area have different sizes and shapes, separately select the 10 cm by 10 
cm sampling position for each different 1 square meter surface in 
accordance with Sec.  761.308.
    (c) If non-porous surfaces have been cleaned and the cleaned 
surfaces do not meet the applicable standards or levels, surfaces may be 
recleaned and resampled. When resampling surfaces previously sampled to 
verify cleanup levels, use the sampling procedures in Sec. Sec.  761.306 
through 761.316 to resample the surfaces. If any sample site selected 
coincides with a previous sampling site, restart the sample selection 
process until all resampling sites are different from any previous 
sampling sites.

[[Page 283]]



Sec.  761.306  Sampling 1 meter square surfaces by random selection 
of halves.

    (a) Divide each 1 meter square portion where it is necessary to 
collect a surface wipe test sample into two equal (or as nearly equal as 
possible) halves. For example, divide the area into top and bottom 
halves or left and right halves. Choose the top/bottom or left/right 
division that produces halves having as close to the shape of a circle 
as possible. For example, a square is closer to the shape of a circle 
than is a rectangle and a rectangle having a length to width ratio of 
2:1 is closer to the shape of a circle than a rectangle having a length 
to width ratio of 3:1.
    (b) Assign a unique identifier to each half and then select one of 
the halves for further sampling with a random number generator or other 
device (i.e., by flipping a coin).
    (c) Continue selecting progressively smaller halves by dividing the 
previously selected half, in accordance with paragraphs (a) and (b) of 
this section, until the final selected half is larger than or equal to 
100 cm\2\ and smaller than 200 cm\2\.
    (d) Perform a standard PCB wipe test on the final selected halves 
from each 1 meter square portion.
    (e) The following is an example of applying sampling by halves. 
Assume that the area to sample is a 1 meter square surface area (a 
square that has sides 1 meter long). Assign each half to one face of a 
coin. After flipping the coin, the half assigned to the face of the coin 
that is showing is the half selected.
    (1) Selecting the first half:
    (i) For a square shape the top/bottom halves have the same shape as 
the left/right halves when compared to a circle, i.e., regardless of 
which way the surface is divided, each half is 1 half meter wide by 1 
meter long. Therefore, divide the area either top/bottom or left/right. 
For selecting the first half, this example will select from left/right 
halves.
    (ii) A coin flip selects the left half. The dimensions of this 
selected surface area are 1 meter high and \1/2\ meter wide.
    (2) Selecting the second half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/4\ meter wide and 
1 meter high). Halves selected from top/bottom would be square (\1/2\ 
meter on a side). Therefore, select the next halves top/bottom, because 
the shape of the top/bottom halves (square) is closer to the shape of a 
circle than the shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the top half. The dimensions of this 
selected surface area are \1/2\ meter high and \1/2\ meter wide.
    (3) Selecting the third half:
    (i) Just as for the selection of the first half, which divided the 
original square area, both the left/right and the top/bottom halves have 
the same shape when compared to a circle (both are rectangles having the 
same dimensions). Therefore, choose either left/right or top/bottom 
halves. This example will select from left/right halves.
    (ii) A coin flip selects the right half. The dimensions of this 
selected surface are \1/4\ meter by \1/2\ meter.
    (4) Selecting the fourth half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/8\ meter wide and 
\1/2\ meter high. Halves selected from top/bottom would be square (\1/4\ 
meter on a side). Therefore, select the next halves top/bottom, because 
the shape of the top/bottom halves (square) are closer to the shape of a 
circle than the shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the bottom half. The dimensions of this 
selected surface area are \1/4\ meter high and \1/4\ meter wide.
    (5) Selecting the fifth half:
    (i) Just as for the selection of the first and third halves, both 
the left/right and the top/bottom halves have the same shape when 
compared to a circle (both are rectangles having the same dimensions). 
Therefore, choose either left/right or top/bottom halves. This example 
will select from left/right halves.
    (ii) A coin flip selects the right half. The dimensions of the 
selected surface are \1/8\ meter by \1/4\ meter.
    (6) Selecting the sixth half:
    (i) If the next selection of halves was left/right, the halves would 
be rectangles four times as long as they are wide (\1/16\ meter wide and 
\1/4\ meter high.

[[Page 284]]

Halves selected from top/bottom would be square (\1/8\ meter on a side). 
Therefore, select the next halves top/bottom, because the shape of the 
top/bottom halves (square) are closer to the shape of a circle than the 
shape of the left/right halves (long narrow rectangles).
    (ii) A coin flip selects the top half. The dimensions of this 
selected surface are \1/8\ meter high and \1/8\ meter wide or 12.5 cm by 
12.5 cm.
    (7) Collect a standard wipe test sample in the sixth half. Since the 
dimensions of half of the sixth half would be 12.5 cm by 6.25 cm, the 
area (approximately 78 cm\2\) would be less than the required 100 cm\2\ 
minimum area for the standard wipe test. Therefore, no further sampling 
by halves is necessary. Take the standard wipe test samples of the 
entire selected sixth half.



Sec.  761.308  Sample selection by random number generation on any
two-dimensional square grid.

    (a) Divide the surface area of the non-porous surface into 
rectangular or square areas having a maximum area of 1 square meter and 
a minimum dimension of 10 centimeters.
    (b) Measure the length and width, in centimeters, of each area 
created in paragraph (a) of this section. Round off the number of 
centimeters in the length and the width measurements to the nearest 
centimeter.
    (c) For each 1 square meter area created in accordance with 
paragraph (a) of this section, select two random numbers: one each for 
the length and width borders measured in paragraph (b) of this section. 
An eligible random number can be from zero up to the total width, minus 
10 centimeters.
    (d) Locate the 10 centimeter by 10 centimeter sample.
    (1) Orient the 1 square meter surface area so that, when you are 
facing the area, the length is left to right and the width is top to 
bottom. The origin, or reference point for measuring selected random 
numbers of centimeters to the sampling area, is on the lower left corner 
when facing the surface.
    (2) Mark the random number selected for the length distance, in 
centimeters, from the origin to the right (at the bottom of the area 
away from the origin).
    (3) From the marked length distance on the bottom of the area, move 
perpendicularly up from the bottom of the area into the area for the 
distance randomly selected for the width.
    (4) Use the point determined in paragraph (d)(3) of this section as 
the lower left corner of the 10 centimeter by 10 centimeter sample.



Sec.  761.310  Collecting the sample.

    Use the standard wipe test as defined in Sec.  761.123 to sample one 
10 centimeter by 10 centimeter square (100 cm\2\) area to represent 
surface area PCB concentrations of each square meter or fraction of a 
square meter of a nearly flat, non-porous surface. For small surfaces, 
use the same procedure as for the standard wipe test, only sample the 
entire area, rather than 10 centimeter by 10 centimeter squares.



Sec.  761.312  Compositing of samples.

    For a surface originally contaminated by a single source of PCBs 
with a uniform concentration, it is permissible to composite surface 
wipe test samples and to use the composite measurement to represent the 
PCB concentration of the entire surface. Composite samples consist of 
more than one sample gauze extracted and chemically analyzed together 
resulting in a single measurement. The composite measurement represents 
an arithmetic mean of the composited samples.
    (a) Compositing samples from surfaces to be used or reused. For 
small or irregularly shaped surfaces or large nearly flat surfaces, if 
the surfaces are contaminated by a single source of PCBs with a uniform 
concentration, composite a maximum of three adjacent samples.
    (b) Compositing samples from surfaces to be disposed of off-site or 
on-site. (1) For small or irregularly shaped surfaces, composite a 
maximum of three adjacent samples.
    (2) For large nearly flat surfaces, composite a maximum of 10 
adjacent samples.

[[Page 285]]



Sec.  761.314  Chemical analysis of standard wipe test samples.

    Perform the chemical analysis of standard wipe test samples in 
accordance with Sec.  761.272. Report sample results in micrograms per 
100 cm\2\.



Sec.  761.316  Interpreting PCB concentration measurements resulting
from this sampling scheme.

    (a) For an individual sample taken from an approximately 1 meter 
square portion of the entire surface area and not composited with other 
samples, the status of the portion is based on the surface concentration 
measured in that sample. If the sample surface concentration is not 
equal to or lower than the cleanup level, by inference the entire 1 
meter area, and not just the immediate area where the sample was taken, 
is not equal to or lower than the cleanup level.
    (b) For areas represented by the measurement results from 
compositing more than one 10 centimeter by 10 centimeter sample, the 
measurement for the composite is the measurement for the entire area. 
For example, when there is a composite of 10 standard wipe test samples 
representing 9.5 square meters of surface area and the result of the 
analysis of the composite is 20 [micro]g/100 cm\2\, then the entire 9.5 
square meters has a PCB surface concentration of 20 [micro]g/100 cm\2\, 
not just the area in the 10 cm by 10 cm sampled areas.
    (c) For small surfaces having irregular contours, where the entire 
surface was sampled, measure the surface area. Divide 100 cm\2\ by the 
surface area and multiply this quotient by the total number of 
micrograms of PCBs on the surface to obtain the equivalent measurement 
of micrograms per 100 cm\2\.



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

    Source: 63 FR 35468, June 29, 1998, unless otherwise noted.



Sec.  761.320  Applicability.

    This subpart describes self-implementing comparison testing 
requirements for chemical extraction and chemical analysis methods used 
as an alternative to the methods required in Sec.  761.272 or Sec.  
761.292. Any person conducting comparison testing under this subpart 
must comply with the requirements of Sec.  761.80(i), including 
notification. Use alternative methods only after successful completion 
of these comparison testing requirements and after documentation of the 
results of the testing.



Sec.  761.323  Sample preparation.

    (a) The comparison study requires analysis of a minimum of 10 
samples weighing at least 300 grams each. Samples of PCB remediation 
waste used in the comparison study must meet the following three 
requirements.
    (1) The samples must either be taken from the PCB remediation waste 
at the cleanup site, or must be the same kind of material as that waste. 
For example, if the waste at the cleanup site is sandy soil, you must 
use the same kind of sandy soil in the comparison study. Do not use 
unrelated materials such as clay soil or dredged sediments in place of 
sandy soil.
    (2) PCB remediation waste may contain interferences which confound 
or hamper sample extraction and chemical analysis. These interferences 
may be from chemicals or other attributes preexisting in the waste 
material, resulting from the PCB contamination source, or resulting from 
treatment to remove or destroy PCBs. Comparison study samples must also 
contain these interfering materials to demonstrate successful analysis 
in their presence. For example, a PCB remediation waste may have been 
co-disposed with chlorobenzene solvents or chlorinated pesticides. These 
chlorinated compounds would have to be present in the comparison study 
compounds at the same levels found, or at the highest levels expected to 
be found, in the PCB remediation waste. As another example, for PCB 
remediation waste which had been solvent washed with liquid amines to

[[Page 286]]

remove PCBs, comparison study samples would have to contain 
concentrations of these amines at the same levels found, or at the 
highest levels expected to be found, in the PCB remediation waste.
    (b) Prior to initiating the comparison study, confirm the following 
PCB concentrations in the comparison study samples using the methods 
specified in Sec.  761.292. All samples of non-liquid PCB remediation 
waste must have PCB concentrations between 0.1 and 150 ppm.
    (1) A minimum of three comparison study samples must have PCB 
concentrations above the cleanup level specified for the site in Sec.  
761.61(a)(4) and a minimum of three comparison study samples must have 
PCB concentrations below the specified cleanup level.
    (2) At least one comparison study sample must have a PCB 
concentration =90 percent and <=100 percent of the cleanup 
level.
    (3) At least one comparison study sample must have a PCB 
concentration =100 percent and <=110 percent of the cleanup 
level.
    (c) If the comparison study samples do not have the concentrations 
or concentration ranges required by paragraph (b) of this section, for 
purposes of use in this chemical extraction and chemical analysis 
comparison study, a person may adjust PCB concentrations by dilution. 
Any excess material resulting from the preparation of these samples, 
which is not used as an analytical sample, is regulated as the PCB 
concentration in the component having the highest PCB concentration of 
the component materials in the sample.



Sec.  761.326  Conducting the comparison study.

    Extract or analyze the comparison study samples using the 
alternative method. For an alternative extraction method or alternative 
analytical method to be comparable to the methods required in Sec.  
761.292, all of the following conditions must be met.
    (a) All samples having PCB concentrations greater than or equal to 
the level of concern, as measured by the methods required in Sec.  
761.292, are found to be greater than or equal to the level of concern 
as measured by the alternative method (no false negatives).
    (b) Only one sample which contains PCBs at a level less than the 
level of concern, as measured by the methods required in Sec.  761.292, 
is found to have a PCB concentration greater than the level of concern 
as measured by the alternative method (false positive); and all other 
samples which contain PCBs at levels less than the level of concern, as 
measured by the methods required in Sec.  761.292, are found by the 
alternative method to have PCBs less than the level of concern (there 
are no additional false positives).



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

    Source: 63 FR 35469, June 29, 1998, unless otherwise noted.



Sec.  761.340  Applicability.

    Use the procedures specified in this subpart to sample the following 
types of waste when it is necessary to analyze the waste to determine 
PCB concentration or leaching characteristics for storage or disposal.
    (a) Existing accumulations of non-liquid, non-metal PCB bulk product 
waste.
    (b) Non-liquid, non-metal PCB bulk product waste from processes that 
continuously generate new waste.
    (c) Non-liquid PCB remediation waste from processes that 
continuously generate new waste, that will be sent off-site for 
disposal.



Sec.  761.345  Form of the waste to be sampled.

    PCB bulk product waste and PCB remediation waste destined for off-
site disposal must be in the form of either flattened or roughly conical 
piles. This subpart also contains a procedure for contemporaneous 
sampling of waste as it is being generated.

[[Page 287]]



Sec.  761.346  Three levels of sampling.

    To select a sample of the waste and prepare it for chemical 
extraction and analysis, there are three required levels of random 
sampling.
    (a) First, select a single 19-liter (5 gallon) portion from a 
composite accumulated either contemporaneously with the generation of 
the waste or by sampling an existing pile of waste. Collection 
procedures for the first level of sampling from existing piles of waste 
are in Sec.  761.347. Collection procedures for the first level of 
sampling from a contemporaneous generation of waste are in Sec.  
761.348. Compositing requirements and requirements for the subsampling 
of composite samples to result in a single 19-liter sample are in Sec.  
761.350. Send the 19-liter sample to the laboratory for the second and 
third levels of sampling, including particle size reduction for leach 
testing and drying as required by Sec.  761.1(b)(4).
    (b) Second, at the laboratory, select one quarter of the 19-liter 
sample. Procedures the laboratory must use for this second level of 
sample selection appear in Sec.  761.353.
    (c) Third, select a 100 gram subsample from the second level 
subsample. Procedures the laboratory must use for this third level of 
sample selection appear in Sec.  761.355.



Sec.  761.347  First level sampling--waste from existing piles.

    (a) General. Sample piles that are either specifically configured 
for sampling (see paragraph (b) of this section) or that are of conical 
shape (see paragraph (c) of this section). If sampling from either of 
these shapes is not possible, conduct contemporaneous sampling, in 
accordance with the procedures in Sec.  761.348, or obtain the approval 
of the Regional Administrator for an alternate sampling plan in 
accordance with Sec.  761.62(c).
    (b) Specifically configured piles. A specifically configured pile is 
a single flattened pile in the shape of a square or rectangle having no 
restrictions on length or width but restricted to 30 cm (1 foot) in 
depth. A square shaped pile facilitates sampling site selection for the 
first level sample. Select eight 19-liter samples from the pile and 
composite them into one 19-liter sample as follows:
    (1) Divide the pile into quarters.
    (2) Divide each of the quarter sections into quarters (i.e., into 
sixteenths of the original pile).
    (3) Select two sixteenths from each of the four quarters, according 
to one of the two following options:
    (i) Randomly select the two sixteenths from one quarter and sample 
the sixteenths occupying the same positions in each of the other three 
quarters.
    (ii) Randomly select two sixteenths from each of the four quarters 
(i.e., perform a random selection four different times).
    (4) At this point the eight selected sixteenths undergo further 
division and sample selection. Divide each of the eight selected 
sixteenths into four equal parts. Using a random number generator or 
random number table, select one of the four equal parts from each of the 
eight equal areas. If each of the four equal parts has a volume 
76 liters when projected downwards 30 cm, continue to divide 
each selected area into four equal parts, and select one of the parts, 
until each selected area has a volume of <76 liters but =19 
liters. When projected to a depth of 30 cm, a square having a 25 cm side 
or a circle having a diameter of approximately 28.5 cm equals a volume 
of approximately 19 liters. The volume of 76 liters is equal to the 
volume enclosed by a square having a side of 50 cm (or other shape 
having an area of 250 cm\2\) projected to a depth of 30 cm.
    (5) Take one sample of approximately 19 unsorted liters of waste 
from each of the eight selected areas. Place each sample into a separate 
19-liter container, allowing only sufficient space at the top of the 
container to secure the lid.
    (6) Composite the eight 19-liter samples in accordance with Sec.  
761.350.
    (c) Conical-shaped piles. If it is necessary to sample a pile which 
is too large to be spread on the site to a uniform thickness of 1 foot 
or 30 cm, or if there are too many piles to spread out in the space 
available, use the following procedure to sample the piles. This 
procedure assumes that the shape of the piles is analogous to a cone; 
that

[[Page 288]]

is, having a circular base with PCB bulk product waste or PCB 
remediation waste destined for off-site disposal stacked up uniformly to 
a peak that is a point centered above the center of the circular base. 
Collect eight 19-liter samples as follows:
    (1) Collecting samples from more than one pile. If the PCB bulk 
product waste or PCB remediation waste consists of more than one pile or 
container, assign each pile or container an integer number and then 
generate seven random integer numbers to select the piles from which you 
will collect samples. It is possible that this random selection 
procedure will result in selecting the same pile number more than once, 
even if seven or more piles are present. If so, sample the pile once and 
restart the sampling collection process to collect additional samples. 
Do not collect multiple samples from the same location in the pile.
    (2) Collecting samples from a single pile. If only one pile or 
container is present, collect all eight samples from the same pile.
    (3) Setting up the sample site selection system from a pile. Locate 
a sample in a pile by the use of three parameters: a particular radial 
direction, ``r,'' from the peak at the center of the pile to the outer 
edge at the base of the pile; a point, ``s,'' along that radial 
direction between the peak of the pile and the outer edge of the base of 
the pile; and a depth, ``t'', beneath point ``s.'' The top of the sample 
material will be below depth t, at point s, on radius r. Use a rod, 
dowel, stake, or broom handle as a marker. Nail or otherwise fasten to 
the top of the marker two pieces of string or cord of sufficient length 
and strength to reach from the top of the marker at the top of the pile 
to the farthest peripheral edge at the bottom of the pile, when the 
marker is positioned at the top or apex of the pile. Pound or push the 
marker into the top center (apex) of the pile, downward toward the 
center of the base. Insert the marker for at least 30 cm or one foot 
until the marker is rigidly standing on its own, even when the cord is 
pulled tight to the bottom peripheral edge of the pile. Ensure that the 
marker protrudes from the top of the pile sufficiently to allow the 
strings to move easily around the pile when they are pulled tight. 
Select the three parameters and the sampling location as follows:
    (i) Determine the radial component (r) of the location for each 
sample.
    (A) Tie to a stake or otherwise fasten one of the strings at ``b,'' 
the bottom of the pile, as a reference point for finding r.
    (B) Measure the circumference ``c,'' the distance around the bottom 
of the pile. Determine r from b in one of two ways:
    (1) Multiply c by a randomly generated fraction or percentage of 
one.
    (2) Select a random number between one and the total number of 
centimeters in c.
    (C) Locate r by starting at b, the place where the fixed string 
meets the base of the pile, and travel clockwise around the edge of the 
pile at the base for the distance you selected in paragraph (c)(3)(i)(B) 
of this section.
    (D) Fasten the second string at the selected distance. The second 
string marks the first parameter r.
    (ii) Determine the second parameter s of the location for each 
sample.
    (A) Measure the distance, l, along the string, positioned in 
paragraph (c)(3)(i)(D) of this section, from the top to the bottom of 
the pile at the selected radial distance r. Determine the distance s 
from l in one of two ways:
    (1) Multiply l by a randomly generated fraction or percentage of 
one.
    (2) Select a random number between one and the total number of 
centimeters in l.
    (B) Mark, for example by placing a piece of tape on the string 
positioned according to paragraph (c)(3)(i)(D) of this section, the 
distance s, up from the bottom of the pile on the string at r.
    (iii) Determine the third and final parameter t of the location for 
each sample.
    (A) Mark and number 1 cm intervals from one end of a rigid device, 
for example a rod, dowel, stake, or broom handle, for measuring the 
distance from the top of the pile to the bottom at the point s selected 
in paragraph (c)(3)(ii)(B) of this section. The marked and numbered 
device shall be of sufficient strength to be forced down through the 
maximum depth of the pile

[[Page 289]]

and sufficient length to measure the depth of the waste in the pile at 
any point.
    (B) Take the measuring device, constructed according to paragraph 
(c)(3)(iii)(A) of this section, and at position s, push the end of the 
device marked with zero straight down into the pile until it reaches the 
bottom of the pile or ground level. The vertical distance ``v'' is the 
number of centimeters from the surface of the pile at point s on the 
string to the bottom of the pile or ground level. Read the distance v on 
the measuring device at the surface of the pile. From the distance v, 
determine t, in one of two ways:
    (1) Randomly generate a fraction of one and multiply the fraction 
times v.
    (2) Select a random number between zero and the total number of 
centimeters of the vertical distance v.
    (iv) Dig a hole straight down into the pile for t centimeters 
(inches) from the surface of the pile at s.
    (v) At depth t, directly under the s mark on the string, outline the 
top of the sample container and collect (shovel) all waste under the 
outline in the following order of preference in paragraphs (c)(3)(v)(A) 
through (c)(3)(v)(C) of this section. It is possible that some of the 
eight sampling locations will not provide 19 liters of sample.
    (A) For a depth of 30 cm.
    (B) Until the container is full.
    (C) Until the ground level is reached.
    (d) Compositing the samples. Composite the eight 19-liter samples 
and subsample in accordance with Sec.  761.350. Send the subsample to a 
laboratory for further sampling as described in Sec. Sec.  761.353 and 
761.355 and for chemical extraction and analysis. If there is 
insufficient sample for a 19-liter sample from the composite sample 
composed of the eight iterations of sample site selection, according to 
the procedures in paragraphs (c)(3)(i) through (c)(3)(v) of this 
section, select additional sample sites, collect additional samples and 
composite the additional waste in the samples until a minimum of 19 
liters is in the composite.

[63 FR 35469, June 29, 1998, as amended at 64 FR 33762, June 24, 1999]



Sec.  761.348  Contemporaneous sampling.

    Contemporaneous sampling is possible when there is active generation 
of waste and it is possible to sample the waste stream as it is 
generated. Collect eight 19-liter samples as follows.
    (a) Collect each sample by filling a 19-liter (5 gallon) container 
at a location where the PCB bulk product waste is released from the 
waste generator onto a pile or into a receptacle container before the 
waste reaches the pile or receptacle container.
    (b) Determine a sample collection start time using a random number 
generator or a random number table to select a number between 1 and 60. 
Collect the first sample at the randomly selected time in minutes after 
start up of the waste output, or if the waste is currently being 
generated, after the random time is selected. For example, if the 
randomly selected time is 35, begin collection 35 minutes after the 
start up of waste generation. Similarly, if waste output is ongoing and 
the random start determination occurred at 8:35 a.m., collect the first 
sample at 9:10 a.m. (35 minutes after the random start determination).
    (c) Collect seven more samples, one every 60 minutes after the 
initial sample is collected. If the waste output process stops, stop the 
60-minute interval time clock. When the process restarts, restart the 
60-minute interval time clock and complete the incomplete 60-minute 
interval.
    (d) Composite the eight 19-liter samples and subsample in accordance 
with Sec.  761.350.



Sec.  761.350  Subsampling from composite samples.

    (a) Preparing the composite. Composite the samples (eight from a 
flattened pile; eight or more from a conical pile; eight from waste that 
is continuously generated) and select a 19-liter subsample for shipment 
to the chemical extraction and analysis laboratory for further 
subsampling. There are two options for the preparation of the composite:
    (1) Option one. Place all of the contents of all 19-liter samples 
that you collected into a 209 liter (55 gallon) drum or similar sized, 
cylinder-shaped

[[Page 290]]

container. Completely close the container, and roll it 10 or more 
complete revolutions to mix the contents.
    (2) Option two. Add the 19-liter samples one at a time to a 209 
liter (55 gallon) drum. Between the addition of each 19-liter sample, 
stir the composite using a broom handle or similar long, narrow, sturdy 
rod that reaches the bottom of the container. Stir the mixture for a 
minimum of 10 complete revolutions of the stirring instrument around the 
container at a distance approximately half way between the outside and 
center of the container.
    (b) Selecting a 19-liter subsample from the composite. Once the 
composite is mixed, pour the mixture of waste out on a plastic sheet and 
either divide it into 19-liter size piles or make one large pile.
    (1) From 19-liter sized piles, use a random number generator or 
random number table to select one of the piles.
    (2) From one large pile, flatten the pile to a depth of 30 cm and 
divide it into 4 quarters of equal size. Use a random number generator 
or random number table to select one quarter of the pile. Further divide 
the selected quarter pile into 19-liter portions and use a random number 
generator or random number table to select one 19-liter portion. A 
square having a 25 cm side or a circle having a diameter of 
approximately 28.5 cm when projected downwards 30 cm equals 
approximately 19 liters.
    (c) Transferring the sample to the analytical laboratory. Place the 
selected 19-liter subsample in a container, approved for shipment of the 
sample, to the chemical extraction and analysis laboratory, for the next 
step in sample selection in accordance with Sec.  761.353.



Sec.  761.353  Second level of sample selection.

    The second level of sample selection reduces the size of the 19-
liter subsample that was collected according to either Sec.  761.347 or 
Sec.  761.348 and subsampled according to Sec.  761.350. The purpose of 
the sample size reduction is to limit the amount of time required to 
manually cut up larger particles of the waste to pass through a 9.5 
millimeter (mm) screen.
    (a) Selecting a portion of the subsample for particle size 
reduction. At the chemical extraction and analysis laboratory, pour the 
19-liter subsample onto a plastic sheet or into a pan and divide the 
subsample into quarters. Use a random number generator or random number 
table to select one of these quarters.
    (b) Reduction of the particle size by the use of a 9.5 mm screen. 
Collect the contents of the selected quarter of waste resulting from 
conducting the procedures in paragraph (a) of this section and shake the 
waste in a 9.5 mm screen. Separate the waste material which passes 
through the screen from the waste material which does not pass through 
the screen. Manually cut or otherwise reduce the size of all parts of 
the waste portion which did not pass through the 9.5 mm screen, such 
that each part of the waste shall pass through the 9.5 mm screen by 
shaking.
    (c) Drying the reduced particle size waste. Dry all of the waste 
portion resulting from conducting the procedures in paragraph (b) of 
this section, from 10 to 15 hours in a drying oven at 100 [deg]C. Allow 
the dried waste to cool to room temperature.
    (d) Mixing the dried waste. Place all of the waste resulting from 
conducting the procedures in paragraph (c) of this section in a 19-liter 
pail or similarly sized, cylinder-shaped container. Mix the dried 
material according to one of the two following options:
    (1) First mixing option. Completely close the container and roll the 
container a minimum of 10 complete revolutions to mix the contents.
    (2) Second mixing option. Use a sturdy stirring rod, such as a broom 
handle or other device that reaches the bottom of the container, to stir 
the waste for a minimum of 10 complete revolutions around the container 
at a distance approximately half way between the outside and the center 
of the container.



Sec.  761.355  Third level of sample selection.

    The third level of sample selection further reduces the size of the 
subsample to 100 grams which is suitable for the chemical extraction and 
analysis procedure.

[[Page 291]]

    (a) Divide the subsample resulting from conducting the procedures in 
Sec.  761.353 of this part into 100 gram portions.
    (b) Use a random number generator or random number table to select 
one 100 gram size portion as a sample for a procedure used to simulate 
leachate generation.
    (c) Dry the 100 gram sample, selected after conducting the procedure 
in paragraph (b) of this section, for 10 to 15 hours in a drying oven at 
100 [deg]C and cool it to the analytical laboratory room temperature 
before analysis using a procedure used to simulate leachate generation. 
This sample was dried previously in the larger quantity sample at the 
second level of sampling (Sec.  761.353(c)) and is dried a second time 
here (in the third level of sample selection). This dried and cooled 
sample must weigh at least 50 grams.
    (d) If the dried and cooled sample weighs <50 grams, select 
additional 100 gram portions of sample one at a time by repeating the 
directions in paragraph (b) and (c) of this section, and add each 
additional 100 gram portion of sample to the first 100 gram portion 
until at least 50 grams of dried material is in the sample to be 
analyzed using a procedure used to simulate leachate generation.



Sec.  761.356  Conducting a leach test.

    No method is specified as a procedure used to simulate leachate 
generation.



Sec.  761.357  Reporting the results of the procedure used to simulate
leachate generation.

    Report the results of the procedure used to simulate leachate 
generation as micrograms PCBs per liter of extract from a 100 gram 
sample of dry bulk product waste. Divide 100 grams by the grams in the 
sample and multiply this quotient by the number of micrograms PCBs per 
liter of extract to obtain the equivalent measurement from a 100 gram 
sample.



Sec.  761.358  Determining the PCB concentration of samples of waste.

    Use either Method 3500B/3540C or Method 3500B/3550B from EPA's SW-
846, Test Methods for Evaluating Solid Waste, or a method validated 
under subpart Q of this part, for chemical extraction of PCBs from 
individual and composite samples of PCB bulk product waste. Use Method 
8082 from SW-846, or a method validated under subpart Q of this part, to 
analyze these extracts for PCBs.



Sec.  761.359  Reporting the PCB concentrations in samples.

    Report all sample concentrations as ppm by weight on a dry weight 
basis.



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

    Source: 63 FR 35472, June 29, 1998, unless otherwise noted.



Sec.  761.360  Background.

    The double wash/rinse procedure is used to quickly and effectively 
remove PCBs on surfaces. It is important to select and use the proper 
cleanup equipment, to conduct the procedure correctly so as not to 
redistribute PCBs, and to comply with disposal requirements for all 
cleanup materials.



Sec.  761.363  Applicability.

    The double wash/rinse procedure includes two washing steps and two 
rinsing steps. The two washing and rinsing steps are slightly different 
depending on whether a contaminated surface was relatively clean before 
the spill (see Sec.  761.372), or whether the surface was coated or 
covered with dust, dirt, grime, grease or another absorbent material 
(see Sec.  761.375).



Sec.  761.366  Cleanup equipment.

    (a) Use scrubbers and absorbent pads that are not dissolved by the 
solvents or cleaners used, and that do not shred, crumble, or leave 
visible fragments on the surface. Scrubbers and absorbent pads used to 
wash contaminated surfaces must not be reused. Scrubbers and absorbent 
pads for rinsing must not contain =2 ppm PCBs. Scrubbers and 
absorbent pads used in the second rinse of contaminated surfaces may be 
reused to wash contaminated surfaces.

[[Page 292]]

    (b) Capture and contain all solvents and cleaners for reuse, 
decontamination, or disposal. Clean organic solvents contain <2 ppm 
PCBs. Clean water contains <3 ppb PCBs.



Sec.  761.369  Pre-cleaning the surface.

    If visible PCB-containing liquid is present on the surface to be 
cleaned, thoroughly wipe or mop the entire surface with absorbent paper 
or cloth until no liquid is visible on the surface.



Sec.  761.372  Specific requirements for relatively clean surfaces.

    For surfaces that do not appear dusty or grimy before a spill, such 
as glass, automobile surfaces, newly-poured concrete, and desk tops, use 
the double wash/rinse procedures in this section.
    (a) First wash. Cover the entire surface with organic solvent in 
which PCBs are soluble to at least 5 percent by weight. Contain and 
collect any runoff solvent for disposal. Scrub rough surfaces with a 
scrub brush or disposable scrubbing pad and solvent such that each 900 
cm\2\ (1 square foot) of the surface is always very wet for 1 minute. 
Wipe smooth surfaces with a solvent-soaked, disposable absorbent pad 
such that each 900 cm\2\ (1 square foot) is wiped for 1 minute. Any 
surface <1 square foot shall also be wiped for 1 minute. Wipe, mop, and/
or sorb the solvent onto absorbent material until no visible traces of 
the solvent remain.
    (b) First rinse. Wet the surface with clean rinse solvent such that 
the entire surfaces is very wet for 1 minute. Drain and contain the 
solvent from the surface. Wipe the residual solvent off the drained 
surface using a clean, disposable absorbent pad until no liquid is 
visible on the surface.
    (c) Second wash. Repeat the procedures in paragraph (a) of this 
section. The rinse solvent from the first rinse (paragraph (b) of this 
section) may be used.
    (d) Second rinse. Repeat the procedures in paragraph (b) of this 
section.



Sec.  761.375  Specific requirements for surfaces coated or covered 
with dust, dirt, grime, grease, or another absorbent material.

    (a) First wash. Cover the entire surface with concentrated or 
industrial strength detergent or non-ionic surfactant solution. Contain 
and collect all cleaning solutions for proper disposal. Scrub rough 
surfaces with a scrub brush or scrubbing pad, adding cleaning solution 
such that the surface is always very wet, such that each 900 cm\2\ (1 
square foot) is washed for 1 minute. Wipe smooth surfaces with a 
cleaning solution-soaked disposable absorbent pad such that each 900 
cm\2\ (1 square foot) is wiped for 1 minute. Wash any surface <1 square 
foot for 1 minute. Mop up or absorb the residual cleaner solution and 
suds with a clean, disposable, absorbent pad until the surface appears 
dry. This cleaning should remove any residual dirt, dust, grime, or 
other absorbent materials left on the surface during the first wash.
    (b) First rinse. Rinse off the wash solution with 1 gallon of clean 
water per square foot and capture the rinse water. Mop up the wet 
surface with a clean, disposable, absorbent pad until the surface 
appears dry.
    (c) Second wash. Follow the procedure in Sec.  761.372(a).
    (d) Second rinse. Follow the procedure in Sec.  761.372(b).



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

    (a) Decontamination. Decontaminate solvents and non-porous surfaces 
on equipment in accordance with the standards and procedures in Sec.  
761.79(b) and (c).
    (b) Reuse. A solvent may be reused so long as its PCB concentration 
is <50 ppm. Decontaminated equipment may be reused in accordance with 
Sec.  761.30(u). Store solvents and equipment for reuse in accordance 
with Sec.  761.35.
    (c) Disposal. Dispose of all solvents, cleaners, and absorbent 
materials in accordance with Sec.  761.79(g). Dispose of equipment in 
accordance with Sec.  761.61(a)(5)(v)(A), or decontaminate in accordance 
with Sec.  761.79(b) or (c). Store for disposal equipment, solvents, 
cleaners, and absorbent materials in accordance with Sec.  761.65.

[[Page 293]]



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

    Source: 63 FR 35473, June 29, 1998, unless otherwise noted.



Sec.  761.380  Background.

    This subpart provides self-implementing criteria for validating the 
conditions for use in performance-based decontamination of solvents 
other than those listed in Sec.  761.79(c)(3) and (c)(4). Any person may 
use this subpart for validating either a chemical formulation or a 
product with a trade name whether or not the constituents of the product 
are proprietary.



Sec.  761.383  Applicability.

    Use the self-implementing decontamination procedure only on smooth, 
non-porous surfaces that were once in contact with liquid PCBs. 
Decontamination procedures under this subpart shall exactly parallel 
Sec.  761.79(c)(3) and (c)(4), except that the procedures described in 
Sec.  761.79(c)(3)(iii) and (c)(3)(iv) and (c)(4)(iii), (c)(4)(iv) and 
(c)(4)(vii) may be revised to contain parameters validated in accordance 
with this subpart.



Sec.  761.386  Required experimental conditions for the validation study
and subsequent use during decontamination.

    The following experimental conditions apply for any solvent:
    (a) Temperature and pressure. Conduct the validation study and 
perform decontamination at room temperature (from =15 [deg]C 
to <=30 [deg]C) and at atmospheric pressure.
    (b) Agitation. Limit the movement in the solvent to the short-term 
movement from placing the contaminated surface into the soak solvent and 
from removing the surface from the soak solvent.
    (c) Time of soak. Soak the surface for a minimum of 1 hour.
    (d) Surface conditions for the validation study. Prior to beginning 
the validation study, ensure that there are no free-flowing liquids on 
surfaces and that surfaces are dry (i.e., there are no liquids visible 
without magnification). Also ensure that surfaces are virtually free 
from non-liquid residues, corrosion, and other defects which would 
prevent the solvent from freely circulating over the surface.
    (e) Confirmatory sampling for the validation study. Select surface 
sample locations using representative sampling or a census. Sample a 
minimum area of 100 cm\2\ on each individual surface in the validation 
study. Measure surface concentrations using the standard wipe test, as 
defined in Sec.  761.123, from which a standard wipe sample is generated 
for chemical analysis. Guidance for wipe sampling appears in the 
document entitled ``Wipe Sampling and Double Wash/Rinse Cleanup as 
Recommended by the Environmental Protection Agency PCB Spill Cleanup 
Policy,'' available on EPA's Web site at http://www.epa.gov/pcb, or from 
the Program Management, Communications, and Analysis Office, Office of 
Resource Conservation and Recovery (5305P), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (f) Concentration of PCBs. The method validated may be used only to 
decontaminate surfaces containing PCBs at concentrations on which the 
validation study was performed and lower concentrations.

[63 FR 35473, June 29, 1998, as amended at 72 FR 57241, Oct. 9, 2007; 74 
FR 30235, June 25, 2009]



Sec.  761.389  Testing parameter requirements.

    There are no restrictions on the variable testing parameters 
described in this section which may be used in the validation study. The 
conditions demonstrated in the validation study for these variables 
shall become the required conditions for decontamination using the 
solvent being validated and shall replace the comparable conditions in 
Sec.  761.79(b)(3) through (b)(6). There are limited potential options 
for varying a single requirement in this section. If you change one of 
these variable requirements, change it only in the way listed in this 
section and do not change any other validated conditions. If you desire 
to change more than one of the requirements in this section, you must 
conduct a new study

[[Page 294]]

to validate the decontamination under the desired conditions.
    (a) The study apparatus is not standardized. Critical components of 
the study are the PCB material (for example MODEF or some other spiking 
solution), the volume of the soaking solvent, and the area of the 
contaminated surface. The EPA study used beakers and shallow dishes as 
the experimental vessels to contain the surface and solvent during the 
soaking process. In order to minimize surface-to-volume ratios, it is 
convenient to utilize flat contaminated surfaces and shallow solvent 
containers. During the validation study, use the same ratio of 
contaminated surface area to soak solvent volume as would be used during 
actual decontamination. It is also permissible to use a smaller surface 
area to soaking solvent volume than used in the validation study, so 
long as all other required parameters are used as validated in the 
confirmation required in Sec.  761.386 (a) through (f), and paragraphs 
(a) through (c) of this section. Do not use a larger surface-area-to-
solvent-volumes ratio or different kind of solvent based on the results 
of the validation study.
    (b) Except for the minimum soak time of 1 hour (as required in Sec.  
761.386(c)), the length of soak time is not otherwise restricted in the 
validation study. The soak time used in the validation study, however, 
is a use requirement for subsequent decontamination using the solvent 
being validated. It is permissible to use longer soak times for 
decontamination than the soak time used in the validation study, if all 
other parameters required in Sec.  761.386, and paragraphs (a) and (c) 
of this section are used.
    (c) There is no restriction on the kind of material containing PCBs 
to use to create the surface contamination for the validation study. 
There is also no restriction on the level of starting PCB surface 
concentration. It is permissible to use lower concentrations of PCB than 
the concentration used in the validation study, if all other parameters 
required in Sec.  761.386 (a) through (f), and paragraphs (a) through 
(c) of this section are used.



Sec.  761.392  Preparing validation study samples.

    (a)(1) To validate a procedure to decontaminate a surface 
contaminated with a spill from liquid of a known concentration, 
contaminate (spike) the surface to be used in the validation study as 
follows:
    (i) Use a spiking solution made of PCBs mixed with a solvent to 
contaminate clean surfaces. Clean surfaces are surfaces having PCB 
surface concentrations <1 [micro]g/100 cm\2\ before intentionally 
contaminating the surface.
    (ii) Prior to contaminating a surface for the validation study, mark 
the surface sampling area to assure that it is completely covered with 
the spiking solution.
    (iii) Deliver the spiking solution onto the surface, covering all of 
the sampling area. Contain any liquids which spill or flow off the 
surface. Allow the spiking solution to drip drain off into a container 
and then evaporate the spiking solution off the contaminated surface 
prior to beginning the validation study. Contaminate a minimum of eight 
surfaces for a complete validation study.
    (iv) As a quality control step, test at least one contaminated 
surface to determine the PCB concentration to verify that there are 
measurable surface levels of PCBs resulting from the contamination 
before soaking the surface in the decontamination solvent. The surface 
levels of PCBs on the contaminated surfaces must be =20 
[micro]g/100 cm\2\.
    (2) To validate a procedure to decontaminate a specified surface 
concentrations of PCBs as measured by a standard wipe sample, 
contaminate a minimum of 10 surfaces. Contaminate all the surfaces 
identically following the procedures in paragraph (a)(1) of this section 
and measure the PCB surface concentrations of at least three of the 
surfaces using a standard wipe test to establish a surface concentration 
to be included in the standard operating procedure. The surface levels 
of PCBs on the contaminated surfaces must be =20 [micro]g/100 
cm\2\.
    (b) [Reserved]

[[Page 295]]



Sec.  761.395  A validation study.

    (a) Decontaminate the following prepared sample surfaces using the 
selected testing parameters and experimental conditions. Take a standard 
wipe sample of the decontaminated surface.
    (1) At least one uncontaminated surface. The surface levels of PCBs 
on the uncontaminated surface must be <1 [micro]g/100 cm\2\.
    (2) At least seven contaminated surfaces.
    (b)(1) Use SW-846, Test Methods for Evaluating Solid Waste methods 
for sample extraction and chemical analysis as follows: Use Method 
3500B/3540C or Method 3500B/3550B for the extraction and cleanup of the 
extract and Method 8082 for the chemical analysis, or methods validated 
under subpart Q of this part.
    (2) Report all validation study surface sample concentrations on the 
basis of micrograms of PCBs per 100 cm\2\ of surface sampled.
    (c) Following completion of the validation study, measurements from 
the contaminated surfaces must have an arithmetic mean of <=10 [micro]g/
100 cm\2\. If the arithmetic mean is 10 [micro]g/100 cm\2\, 
then the validation study failed and the solvent may not be used for 
decontamination under Sec.  761.79(d)(4) according to the parameters 
tested.



Sec.  761.398  Reporting and recordkeeping.

    (a) Submit validation study results to the Director, Office of 
Resource Conservation and Recovery (5301P), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, prior to 
the first use of a new solvent for alternate decontamination under Sec.  
761.79(d)(4). The use of a new solvent is not TSCA Confidential Business 
Information (CBI). From time to time, EPA will confirm the use of 
validated new decontamination solvents and publish the new solvents and 
validated decontamination procedures in the Federal Register.
    (b) Any person may begin to use solvent validated in accordance with 
this subpart at the time results are submitted to EPA.
    (c) Record all testing parameters and experimental conditions from 
the successful validation study into a standard operating procedure 
(SOP) for reference whenever the decontamination procedure is used. 
Include in the SOP the identity of the soaking solvent, the length of 
time of the soak, and the ratio of the soak solvent to contaminated 
surface area during the soaking process. Also include in the SOP the 
maximum concentration of PCBs in the spilled material and the identity 
of the spilled material, and/or the measured maximum surface 
concentration of the contaminated surface used in the validation study. 
Record and keep the results of the validation study as an appendix to 
the SOP. Include in this appendix, the solvent used to make the spiking 
solution, the PCB concentration of the spiking solution used to 
contaminate the surfaces in the validation study, and all of the 
validation study testing parameters and experimental conditions.

[63 FR 35473, June 29, 1998, as amended at 72 FR 57241, Oct. 9, 2007; 74 
FR 30235, June 25, 2009]



PART 763_ASBESTOS--Table of Contents



Subparts A-D [Reserved]

           Subpart E_Asbestos-Containing Materials in Schools

Sec.
763.80 Scope and purpose.
763.83 Definitions.
763.84 General local education agency responsibilities.
763.85 Inspection and reinspections.
763.86 Sampling.
763.87 Analysis.
763.88 Assessment.
763.90 Response actions.
763.91 Operations and maintenance.
763.92 Training and periodic surveillance.
763.93 Management plans.
763.94 Recordkeeping.
763.95 Warning labels.
763.97 Compliance and enforcement.
763.98 Waiver; delegation to State.
763.99 Exclusions.

Appendix A to Subpart E of Part 763--Interim Transmission Electron 
          Microscopy Analytical Methods--Mandatory and Nonmandatory--and 
          Mandatory Section To Determine Completion of Response Actions
Appendix B to Subpart E of Part 763 [Reserved]

[[Page 296]]

Appendix C to Subpart E of Part 763--Asbestos Model Accreditation Plan
Appendix D to Subpart E of Part 763--Transport and Disposal of Asbestos 
          Waste
Appendix E to Subpart E of Part 763--Interim Method of the Determination 
          of Asbestos In Bulk Insulation Samples

Subpart F [Reserved]

                  Subpart G_Asbestos Worker Protection

763.120 What is the purpose of this subpart?
763.121 Does this subpart apply to me?
763.122 What does this subpart require me to do?
763.123 May a State implement its own asbestos worker protection plan?

Subpart H [Reserved]

 Subpart I_Prohibition of the Manufacture, Importation, Processing, and 
   Distribution in Commerce of Certain Asbestos-Containing Products; 
                          Labeling Requirements

763.160 Scope.
763.163 Definitions.
763.165 Manufacture and importation prohibitions.
763.167 Processing prohibitions.
763.169 Distribution in commerce prohibitions.
763.171 Labeling requirements.
763.173 Exemptions.
763.175 Enforcement.
763.176 Inspections.
763.178 Recordkeeping.
763.179 Confidential business information claims.

    Authority: 15 U.S.C. 2605, 2607(c), 2643, and 2646.

Subparts A-D [Reserved]



           Subpart E_Asbestos-Containing Materials in Schools

    Source: 52 FR 41846, Oct. 30, 1987, unless otherwise noted.



Sec.  763.80  Scope and purpose.

    (a) This rule requires local education agencies to identify friable 
and nonfriable asbestos-containing material (ACM) in public and private 
elementary and secondary schools by visually inspecting school buildings 
for such materials, sampling such materials if they are not assumed to 
be ACM, and having samples analyzed by appropriate techniques referred 
to in this rule. The rule requires local education agencies to submit 
management plans to the Governor of their State by October 12, 1988, 
begin to implement the plans by July 9, 1989, and complete 
implementation of the plans in a timely fashion. In addition, local 
education agencies are required to use persons who have been accredited 
to conduct inspections, reinspections, develop management plans, or 
perform response actions. The rule also includes recordkeeping 
requirements. Local education agencies may contractually delegate their 
duties under this rule, but they remain responsible for the proper 
performance of those duties. Local education agencies are encouraged to 
consult with EPA Regional Asbestos Coordinators, or if applicable, a 
State's lead agency designated by the State Governor, for assistance in 
complying with this rule.
    (b) Local education agencies must provide for the transportation and 
disposal of asbestos in accordance with EPA's ``Asbestos Waste 
Management Guidance.'' For convenience, applicable sections of this 
guidance are reprinted as appendix D of this subpart. There are 
regulations in place, however, that affect transportation and disposal 
of asbestos waste generated by this rule. The transportation of asbestos 
waste is covered by the Department of Transportation (49 CFR part 173, 
subpart J) and disposal is covered by the National Emissions Standards 
for Hazardous Air Pollutants (NESHAP) (40 CFR part 61, subpart M).



Sec.  763.83  Definitions.

    For purposes of this subpart:
    Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601, 
et seq.
    Accessible when referring to ACM means that the material is subject 
to disturbance by school building occupants or custodial or maintenance 
personnel in the course of their normal activities.
    Accredited or accreditation when referring to a person or laboratory 
means that such person or laboratory is accredited in accordance with 
section 206 of Title II of the Act.
    Air erosion means the passage of air over friable ACBM which may 
result in the release of asbestos fibers.

[[Page 297]]

    Asbestos means the asbestiform varieties of: Chrysotile 
(serpentine); crocidolite (riebeckite); amosite (cum- 
mingtonitegrunerite); anthophyllite; tremolite; and actinolite.
    Asbestos-containing material (ACM) when referring to school 
buildings means any material or product which contains more than 1 
percent asbestos.
    Asbestos-containing building material (ACBM) means surfacing ACM, 
thermal system insulation ACM, or miscellaneous ACM that is found in or 
on interior structural members or other parts of a school building.
    Asbestos debris means pieces of ACBM that can be identified by 
color, texture, or composition, or means dust, if the dust is determined 
by an accredited inspector to be ACM.
    Damaged friable miscellaneous ACM means friable miscellaneous ACM 
which has deteriorated or sustained physical injury such that the 
internal structure (cohesion) of the material is inadequate or, if 
applicable, which has delaminated such that its bond to the substrate 
(adhesion) is inadequate or which for any other reason lacks fiber 
cohesion or adhesion qualities. Such damage or deterioration may be 
illustrated by the separation of ACM into layers; separation of ACM from 
the substrate; flaking, blistering, or crumbling of the ACM surface; 
water damage; significant or repeated water stains, scrapes, gouges, 
mars or other signs of physical injury on the ACM. Asbestos debris 
originating from the ACBM in question may also indicate damage.
    Damaged friable surfacing ACM means friable surfacing ACM which has 
deteriorated or sustained physical injury such that the internal 
structure (cohesion) of the material is inadequate or which has 
delaminated such that its bond to the substrate (adhesion) is 
inadequate, or which, for any other reason, lacks fiber cohesion or 
adhesion qualities. Such damage or deterioration may be illustrated by 
the separation of ACM into layers; separation of ACM from the substrate; 
flaking, blistering, or crumbling of the ACM surface; water damage; 
significant or repeated water stains, scrapes, gouges, mars or other 
signs of physical injury on the ACM. Asbestos debris originating from 
the ACBM in question may also indicate damage.
    Damaged or significantly damaged thermal system insulation ACM means 
thermal system insulation ACM on pipes, boilers, tanks, ducts, and other 
thermal system insulation equipment where the insulation has lost its 
structural integrity, or its covering, in whole or in part, is crushed, 
water-stained, gouged, punctured, missing, or not intact such that it is 
not able to contain fibers. Damage may be further illustrated by 
occasional punctures, gouges or other signs of physical injury to ACM; 
occasional water damage on the protective coverings/jackets; or exposed 
ACM ends or joints. Asbestos debris originating from the ACBM in 
question may also indicate damage.
    Encapsulation means the treatment of ACBM with a material that 
surrounds or embeds asbestos fibers in an adhesive matrix to prevent the 
release of fibers, as the encapsulant creates a membrane over the 
surface (bridging encapsulant) or penetrates the material and binds its 
components together (penetrating encapsulant).
    Enclosure means an airtight, impermeable, permanent barrier around 
ACBM to prevent the release of asbestos fibers into the air.
    Fiber release episode means any uncontrolled or unintentional 
disturbance of ACBM resulting in visible emission.
    Friable when referring to material in a school building means that 
the material, when dry, may be crumbled, pulverized, or reduced to 
powder by hand pressure, and includes previously nonfriable material 
after such previously nonfriable material becomes damaged to the extent 
that when dry it may be crumbled, pulverized, or reduced to powder by 
hand pressure.
    Functional space means a room, group of rooms, or homogeneous area 
(including crawl spaces or the space between a dropped ceiling and the 
floor or roof deck above), such as classroom(s), a cafeteria, gymnasium, 
hallway(s), designated by a person accredited to prepare management 
plans, design abatement projects, or conduct response actions.
    High-efficiency particulate air (HEPA) refers to a filtering system 
capable of

[[Page 298]]

trapping and retaining at least 99.97 percent of all monodispersed 
particles 0.3 [micro]m in diameter or larger.
    Homogeneous area means an area of surfacing material, thermal system 
insulation material, or miscellaneous material that is uniform in color 
and texture.
    Local education agency means:
    (1) Any local educational agency as defined in section 198 of the 
Elementary and Secondary Education Act of 1965 (20 U.S.C. 3381).
    (2) The owner of any nonpublic, nonprofit elementary, or secondary 
school building.
    (3) The governing authority of any school operated under the defense 
dependent's education system provided for under the Defense Dependents' 
Education Act of 1978 (20 U.S.C. 921, et seq.).
    Miscellaneous ACM means miscellaneous material that is ACM in a 
school building.
    Miscellaneous material means interior building material on 
structural components, structural members or fixtures, such as floor and 
ceiling tiles, and does not include surfacing material or thermal system 
insulation.
    Nonfriable means material in a school building which when dry may 
not be crumbled, pulverized, or reduced to powder by hand pressure.
    Operations and maintenance program means a program of work practices 
to maintain friable ACBM in good condition, ensure clean up of asbestos 
fibers previously released, and prevent further release by minimizing 
and controlling friable ACBM disturbance or damage.
    Potential damage means circumstances in which:
    (1) Friable ACBM is in an area regularly used by building occupants, 
including maintenance personnel, in the course of their normal 
activities.
    (2) There are indications that there is a reasonable likelihood that 
the material or its covering will become damaged, deteriorated, or 
delaminated due to factors such as changes in building use, changes in 
operations and maintenance practices, changes in occupancy, or recurrent 
damage.
    Potential significant damage means circumstances in which:
    (1) Friable ACBM is in an area regularly used by building occupants, 
including maintenance personnel, in the course of their normal 
activities.
    (2) There are indications that there is a reasonable likelihood that 
the material or its covering will become significantly damaged, 
deteriorated, or delaminated due to factors such as changes in building 
use, changes in operations and maintenance practices, changes in 
occupancy, or recurrent damage.
    (3) The material is subject to major or continuing disturbance, due 
to factors including, but not limited to, accessibility or, under 
certain circumstances, vibration or air erosion.
    Preventive measures means actions taken to reduce disturbance of 
ACBM or otherwise eliminate the reasonable likelihood of the material's 
becoming damaged or significantly damaged.
    Removal means the taking out or the stripping of substantially all 
ACBM from a damaged area, a functional space, or a homogeneous area in a 
school building.
    Repair means returning damaged ACBM to an undamaged condition or to 
an intact state so as to prevent fiber release.
    Response action means a method, including removal, encapsulation, 
enclosure, repair, operations and maintenance, that protects human 
health and the environment from friable ACBM.
    Routine maintenance area means an area, such as a boiler room or 
mechanical room, that is not normally frequented by students and in 
which maintenance employees or contract workers regularly conduct 
maintenance activities.
    School means any elementary or secondary school as defined in 
section 198 of the Elementary and Secondary Education Act of 1965 (20 
U.S.C. 2854).
    School building means:
    (1) Any structure suitable for use as a classroom, including a 
school facility such as a laboratory, library, school eating facility, 
or facility used for the preparation of food.
    (2) Any gymnasium or other facility which is specially designed for 
athletic or recreational activities for an academic course in physical 
education.

[[Page 299]]

    (3) Any other facility used for the instruction or housing of 
students or for the administration of educational or research programs.
    (4) Any maintenance, storage, or utility facility, including any 
hallway, essential to the operation of any facility described in this 
definition of ``school building'' under paragraphs (1), (2), or (3).
    (5) Any portico or covered exterior hallway or walkway.
    (6) Any exterior portion of a mechanical system used to condition 
interior space.
    Significantly damaged friable miscellaneous ACM means damaged 
friable miscellaneous ACM where the damage is extensive and severe.
    Significantly damaged friable surfacing ACM means damaged friable 
surfacing ACM in a functional space where the damage is extensive and 
severe.
    State means a State, the District of Columbia, the Commonwealth of 
Puerto Rico, Guam, American Samoa, the Northern Marianas, the Trust 
Territory of the Pacific Islands, and the Virgin Islands.
    Surfacing ACM means surfacing material that is ACM.
    Surfacing material means material in a school building that is 
sprayed-on, troweled-on, or otherwise applied to surfaces, such as 
acoustical plaster on ceilings and fireproofing materials on structural 
members, or other materials on surfaces for acoustical, fireproofing, or 
other purposes.
    Thermal system insulation means material in a school building 
applied to pipes, fittings, boilers, breeching, tanks, ducts, or other 
interior structural components to prevent heat loss or gain, or water 
condensation, or for other purposes.
    Thermal system insulation ACM means thermal system insulation that 
is ACM.
    Vibration means the periodic motion of friable ACBM which may result 
in the release of asbestos fibers.



Sec.  763.84  General local education agency responsibilities.

    Each local education agency shall:
    (a) Ensure that the activities of any persons who perform 
inspections, reinspections, and periodic surveillance, develop and 
update management plans, and develop and implement response actions, 
including operations and maintenance, are carried out in accordance with 
subpart E of this part.
    (b) Ensure that all custodial and maintenance employees are properly 
trained as required by this subpart E and other applicable Federal and/
or State regulations (e.g., the Occupational Safety and Health 
Administration asbestos standard for construction, the EPA worker 
protection rule, or applicable State regulations).
    (c) Ensure that workers and building occupants, or their legal 
guardians, are informed at least once each school year about 
inspections, response actions, and post-response action activities, 
including periodic reinspection and surveillance activities that are 
planned or in progress.
    (d) Ensure that short-term workers (e.g., telephone repair workers, 
utility workers, or exterminators) who may come in contact with asbestos 
in a school are provided information regarding the locations of ACBM and 
suspected ACBM assumed to be ACM.
    (e) Ensure that warning labels are posted in accordance with Sec.  
763.95.
    (f) Ensure that management plans are available for inspection and 
notification of such availability has been provided as specified in the 
management plan under Sec.  763.93(g).
    (g)(1) Designate a person to ensure that requirements under this 
section are properly implemented.
    (2) Ensure that the designated person receives adequate training to 
perform duties assigned under this section. Such training shall provide, 
as necessary, basic knowledge of:
    (i) Health effects of asbestos.
    (ii) Detection, identification, and assessment of ACM.
    (iii) Options for controlling ACBM.
    (iv) Asbestos management programs.
    (v) Relevant Federal and State regulations concerning asbestos, 
including those in this subpart E and those of the Occupational Safety 
and Health Administration, U.S. Department of Labor, the U.S. Department 
of Transportation and the U.S. Environmental Protection Agency.

[[Page 300]]

    (h) Consider whether any conflict of interest may arise from the 
interrelationship among accredited personnel and whether that should 
influence the selection of accredited personnel to perform activities 
under this subpart.



Sec.  763.85  Inspection and reinspections.

    (a) Inspection. (1) Except as provided in paragraph (a)(2) of this 
section, before October 12, 1988, local education agencies shall inspect 
each school building that they lease, own, or otherwise use as a school 
building to identify all locations of friable and nonfriable ACBM.
    (2) Any building leased or acquired on or after October 12, 1988, 
that is to be used as a school building shall be inspected as described 
under paragraphs (a) (3) and (4) of this section prior to use as a 
school building. In the event that emergency use of an uninspected 
building as a school building is necessitated, such buildings shall be 
inspected within 30 days after commencement of such use.
    (3) Each inspection shall be made by an accredited inspector.
    (4) For each area of a school building, except as excluded under 
Sec.  763.99, each person performing an inspection shall:
    (i) Visually inspect the area to identify the locations of all 
suspected ACBM.
    (ii) Touch all suspected ACBM to determine whether they are friable.
    (iii) Identify all homogeneous areas of friable suspected ACBM and 
all homogeneous areas of nonfriable suspected ACBM.
    (iv) Assume that some or all of the homogeneous areas are ACM, and, 
for each homogeneous area that is not assumed to be ACM, collect and 
submit for analysis bulk samples under Sec. Sec.  763.86 and 763.87.
    (v) Assess, under Sec.  763.88, friable material in areas where 
samples are collected, friable material in areas that are assumed to be 
ACBM, and friable ACBM identified during a previous inspection.
    (vi) Record the following and submit to the person designated under 
Sec.  763.84 a copy of such record for inclusion in the management plan 
within 30 days of the inspection:
    (A) An inspection report with the date of the inspection signed by 
each accredited person making the inspection, State of accreditation, 
and if applicable, his or her accreditation number.
    (B) An inventory of the locations of the homogeneous areas where 
samples are collected, exact location where each bulk sample is 
collected, dates that samples are collected, homogeneous areas where 
friable suspected ACBM is assumed to be ACM, and homogeneous areas where 
nonfriable suspected ACBM is assumed to be ACM.
    (C) A description of the manner used to determine sampling 
locations, the name and signature of each accredited inspector who 
collected the samples, State of accreditation, and, if applicable, his 
or her accreditation number.
    (D) A list of whether the homogeneous areas identified under 
paragraph (a)(4)(vi)(B) of this section, are surfacing material, thermal 
system insulation, or miscellaneous material.
    (E) Assessments made of friable material, the name and signature of 
each accredited inspector making the assessment, State of accreditation, 
and if applicable, his or her accreditation number.
    (b) Reinspection. (1) At least once every 3 years after a management 
plan is in effect, each local education agency shall conduct a 
reinspection of all friable and nonfriable known or assumed ACBM in each 
school building that they lease, own, or otherwise use as a school 
building.
    (2) Each inspection shall be made by an accredited inspector.
    (3) For each area of a school building, each person performing a 
reinspection shall:
    (i) Visually reinspect, and reassess, under Sec.  763.88, the 
condition of all friable known or assumed ACBM.
    (ii) Visually inspect material that was previously considered 
nonfriable ACBM and touch the material to determine whether it has 
become friable since the last inspection or reinspection.
    (iii) Identify any homogeneous areas with material that has become 
friable since the last inspection or reinspection.

[[Page 301]]

    (iv) For each homogeneous area of newly friable material that is 
already assumed to be ACBM, bulk samples may be collected and submitted 
for analysis in accordance with Sec. Sec.  763.86 and 763.87.
    (v) Assess, under Sec.  763.88, the condition of the newly friable 
material in areas where samples are collected, and newly friable 
materials in areas that are assumed to be ACBM.
    (vi) Reassess, under Sec.  763.88, the condition of friable known or 
assumed ACBM previously identified.
    (vii) Record the following and submit to the person designated under 
Sec.  763.84 a copy of such record for inclusion in the management plan 
within 30 days of the reinspection:
    (A) The date of the reinspection, the name and signature of the 
person making the reinspection, State of accreditation, and if 
applicable, his or her accreditation number, and any changes in the 
condition of known or assumed ACBM.
    (B) The exact locations where samples are collected during the 
reinspection, a description of the manner used to determine sampling 
locations, the name and signature of each accredited inspector who 
collected the samples, State of accreditation, and, if applicable, his 
or her accreditation number.
    (C) Any assessments or reassessments made of friable material, the 
name and signature of the accredited inspector making the assessments, 
State of accreditation, and if applicable, his or her accreditation 
number.
    (c) General. Thermal system insulation that has retained its 
structural integrity and that has an undamaged protective jacket or wrap 
that prevents fiber release shall be treated as nonfriable and therefore 
is subject only to periodic surveillance and preventive measures as 
necessary.



Sec.  763.86  Sampling.

    (a) Surfacing material. An accredited inspector shall collect, in a 
statistically random manner that is representative of the homogeneous 
area, bulk samples from each homogeneous area of friable surfacing 
material that is not assumed to be ACM, and shall collect the samples as 
follows:
    (1) At least three bulk samples shall be collected from each 
homogeneous area that is 1,000 ft\2\ or less, except as provided in 
Sec.  763.87(c)(2).
    (2) At least five bulk samples shall be collected from each 
homogeneous area that is greater than 1,000 ft\2\ but less than or equal 
to 5,000 ft\2\, except as provided in Sec.  763.87(c)(2).
    (3) At least seven bulk samples shall be collected from each 
homogeneous area that is greater than 5,000 ft\2\, except as provided in 
Sec.  763.87(c)(2).
    (b) Thermal system insulation. (1) Except as provided in paragraphs 
(b) (2) through (4) of this section and Sec.  763.87(c), an accredited 
inspector shall collect, in a randomly distributed manner, at least 
three bulk samples from each homogeneous area of thermal system 
insulation that is not assumed to be ACM.
    (2) Collect at least one bulk sample from each homogeneous area of 
patched thermal system insulation that is not assumed to be ACM if the 
patched section is less than 6 linear or square feet.
    (3) In a manner sufficient to determine whether the material is ACM 
or not ACM, collect bulk samples from each insulated mechanical system 
that is not assumed to be ACM where cement or plaster is used on 
fittings such as tees, elbows, or valves, except as provided under Sec.  
763.87(c)(2).
    (4) Bulk samples are not required to be collected from any 
homogeneous area where the accredited inspector has determined that the 
thermal system insulation is fiberglass, foam glass, rubber, or other 
non-ACBM.
    (c) Miscellaneous material. In a manner sufficient to determine 
whether material is ACM or not ACM, an accredited inspector shall 
collect bulk samples from each homogeneous area of friable miscellaneous 
material that is not assumed to be ACM.
    (d) Nonfriable suspected ACBM. If any homogeneous area of nonfriable 
suspected ACBM is not assumed to be ACM, then an accredited inspector 
shall collect, in a manner sufficient to determine whether the material 
is ACM or not ACM, bulk samples from the homogeneous area of nonfriable 
suspected ACBM that is not assumed to be ACM.

[[Page 302]]



Sec.  763.87  Analysis.

    (a) Local education agencies shall have bulk samples, collected 
under Sec.  763.86 and submitted for analysis, analyzed for asbestos 
using laboratories accredited by the National Bureau of Standards (NBS). 
Local education agencies shall use laboratories which have received 
interim accreditation for polarized light microscopy (PLM) analysis 
under the EPA Interim Asbestos Bulk Sample Analysis Quality Assurance 
Program until the NBS PLM laboratory accreditation program for PLM is 
operational.
    (b) Bulk samples shall not be composited for analysis and shall be 
analyzed for asbestos content by PLM, using the ``Interim Method for the 
Determination of Asbestos in Bulk Insulation Samples'' found at appendix 
E to subpart E of this part.
    (c)(1) A homogeneous area is considered not to contain ACM only if 
the results of all samples required to be collected from the area show 
asbestos in amounts of 1 percent or less.
    (2) A homogeneous area shall be determined to contain ACM based on a 
finding that the results of at least one sample collected from that area 
shows that asbestos is present in an amount greater than 1 percent.
    (d) The name and address of each laboratory performing an analysis, 
the date of analysis, and the name and signature of the person 
performing the analysis shall be submitted to the person designated 
under Sec.  763.84 for inclusion into the management plan within 30 days 
of the analysis.

[52 FR 41846, Oct. 30, 1987, as amended at 60 FR 31922, June 19, 1995]



Sec.  763.88  Assessment.

    (a)(1) For each inspection and reinspection conducted under Sec.  
763.85 (a) and (c) and previous inspections specified under Sec.  
763.99, the local education agency shall have an accredited inspector 
provide a written assessment of all friable known or assumed ACBM in the 
school building.
    (2) Each accredited inspector providing a written assessment shall 
sign and date the assessment, provide his or her State of accreditation, 
and if applicable, accreditation number, and submit a copy of the 
assessment to the person designated under Sec.  763.84 for inclusion in 
the management plan within 30 days of the assessment.
    (b) The inspector shall classify and give reasons in the written 
assessment for classifying the ACBM and suspected ACBM assumed to be ACM 
in the school building into one of the following categories:
    (1) Damaged or significantly damaged thermal system insulation ACM.
    (2) Damaged friable surfacing ACM.
    (3) Significantly damaged friable surfacing ACM.
    (4) Damaged or significantly damaged friable miscellaneous ACM.
    (5) ACBM with potential for damage.
    (6) ACBM with potential for significant damage.
    (7) Any remaining friable ACBM or friable suspected ACBM.
    (c) Assessment may include the following considerations:
    (1) Location and the amount of the material, both in total quantity 
and as a percentage of the functional space.
    (2) Condition of the material, specifying:
    (i) Type of damage or significant damage (e.g., flaking, blistering, 
water damage, or other signs of physical damage).
    (ii) Severity of damage (e.g., major flaking, severely torn jackets, 
as opposed to occasional flaking, minor tears to jackets).
    (iii) Extent or spread of damage over large areas or large 
percentages of the homogeneous area.
    (3) Whether the material is accessible.
    (4) The material's potential for disturbance.
    (5) Known or suspected causes of damage or significant damage (e.g., 
air erosion, vandalism, vibration, water).
    (6) Preventive measures which might eliminate the reasonable 
likelihood of undamaged ACM from becoming significantly damaged.
    (d) The local education agency shall select a person accredited to 
develop management plans to review the results of each inspection, 
reinspection, and assessment for the school building

[[Page 303]]

and to conduct any other necessary activities in order to recommend in 
writing to the local education agency appropriate response actions. The 
accredited person shall sign and date the recommendation, provide his or 
her State of accreditation, and, if applicable, provide his or her 
accreditation number, and submit a copy of the recommendation to the 
person designated under Sec.  763.84 for inclusion in the management 
plan.



Sec.  763.90  Response actions.

    (a) The local education agency shall select and implement in a 
timely manner the appropriate response actions in this section 
consistent with the assessment conducted in Sec.  763.88. The response 
actions selected shall be sufficient to protect human health and the 
environment. The local education agency may then select, from the 
response actions which protect human health and the environment, that 
action which is the least burdensome method. Nothing in this section 
shall be construed to prohibit removal of ACBM from a school building at 
any time, should removal be the preferred response action of the local 
education agency.
    (b) If damaged or significantly damaged thermal system insulation 
ACM is present in a building, the local education agency shall:
    (1) At least repair the damaged area.
    (2) Remove the damaged material if it is not feasible, due to 
technological factors, to repair the damage.
    (3) Maintain all thermal system insulation ACM and its covering in 
an intact state and undamaged condition.
    (c)(1) If damaged friable surfacing ACM or damaged friable 
miscellaneous ACM is present in a building, the local education agency 
shall select from among the following response actions: encapsulation, 
enclosure, removal, or repair of the damaged material.
    (2) In selecting the response action from among those which meet the 
definitional standards in Sec.  763.83, the local education agency shall 
determine which of these response actions protects human health and the 
environment. For purposes of determining which of these response actions 
are the least burdensome, the local education agency may then consider 
local circumstances, including occupancy and use patterns within the 
school building, and its economic concerns, including short- and long-
term costs.
    (d) If significantly damaged friable surfacing ACM or significantly 
damaged friable miscellaneous ACM is present in a building the local 
education agency shall:
    (1) Immediately isolate the functional space and restrict access, 
unless isolation is not necessary to protect human health and the 
environment.
    (2) Remove the material in the functional space or, depending upon 
whether enclosure or encapsulation would be sufficient to protect human 
health and the environment, enclose or encapsulate.
    (e) If any friable surfacing ACM, thermal system insulation ACM, or 
friable miscellaneous ACM that has potential for damage is present in a 
building, the local education agency shall at least implement an 
operations and maintenance (O&M) program, as described under Sec.  
763.91.
    (f) If any friable surfacing ACM, thermal system insulation ACM, or 
friable miscellaneous ACM that has potential for significant damage is 
present in a building, the local education agency shall:
    (1) Implement an O&M program, as described under Sec.  763.91.
    (2) Institute preventive measures appropriate to eliminate the 
reasonable likelihood that the ACM or its covering will become 
significantly damaged, deteriorated, or delaminated.
    (3) Remove the material as soon as possible if appropriate 
preventive measures cannot be effectively implemented, or unless other 
response actions are determined to protect human health and the 
environment. Immediately isolate the area and restrict access if 
necessary to avoid an imminent and substantial endangerment to human 
health or the environment.
    (g) Response actions including removal, encapsulation, enclosure, or 
repair, other than small-scale, short-duration repairs, shall be 
designed and conducted by persons accredited to design and conduct 
response actions.

[[Page 304]]

    (h) The requirements of this subpart E in no way supersede the 
worker protection and work practice requirements under 29 CFR 1926.58 
(Occupational Safety and Health Administration (OSHA) asbestos worker 
protection standards for construction), 40 CFR part 763, subpart G (EPA 
asbestos worker protection standards for public employees), and 40 CFR 
part 61, subpart M (National Emission Standards for Hazardous Air 
Pollutants--Asbestos).
    (i) Completion of response actions. (1) At the conclusion of any 
action to remove, encapsulate, or enclose ACBM or material assumed to be 
ACBM, a person designated by the local education agency shall visually 
inspect each functional space where such action was conducted to 
determine whether the action has been properly completed.
    (2)(i) A person designated by the local education agency shall 
collect air samples using aggressive sampling as described in appendix A 
to this subpart E to monitor air for clearance after each removal, 
encapsulation, and enclosure project involving ACBM, except for projects 
that are of small-scale, short-duration.
    (ii) Local education agencies shall have air samples collected under 
this section analyzed for asbestos using laboratories accredited by the 
National Bureau of Standards to conduct such analysis using transmission 
electron microscopy (TEM) or, under circumstances permitted in this 
section, laboratories enrolled in the American Industrial Hygiene 
Association Proficiency Analytical Testing Program for phase contrast 
microscopy (PCM).
    (iii) Until the National Bureau of Standards TEM laboratory 
accreditation program is operational, local educational agencies shall 
use laboratories that use the protocol described in appendix A to 
subpart E of this part.
    (3) Except as provided in paragraphs (i)(4), and (i)(5), of this 
section, an action to remove, encapsulate, or enclose ACBM shall be 
considered complete when the average concentration of asbestos of five 
air samples collected within the affected functional space and analyzed 
by the TEM method in appendix A of this subpart E, is not statistically 
significantly different, as determined by the Z-test calculation found 
in appendix A of this subpart E, from the average asbestos concentration 
of five air samples collected at the same time outside the affected 
functional space and analyzed in the same manner, and the average 
asbestos concentration of the three field blanks described in appendix A 
of this subpart E is below the filter background level, as defined in 
appendix A of this subpart E, of 70 structures per square millimeter (70 
s/mm\2\).
    (4) An action may also be considered complete if the volume of air 
drawn for each of the five samples collected within the affected 
functional space is equal to or greater than 1,199 L of air for a 25 mm 
filter or equal to or greater than 2,799 L of air for a 37 mm filter, 
and the average concentration of asbestos as analyzed by the TEM method 
in appendix A of this subpart E, for the five air samples does not 
exceed the filter background level, as defined in appendix A, of 70 
structures per square millimeter (70 s/mm\2\). If the average 
concentration of asbestos of the five air samples within the affected 
functional space exceeds 70 s/mm\2\, or if the volume of air in each of 
the samples is less than 1,199 L of air for a 25 mm filter or less than 
2,799 L of air for a 37 mm filter, the action shall be considered 
complete only when the requirements of paragraph (i)(3) or (i)(5), of 
this section are met.
    (5) At any time, a local education agency may analyze air monitoring 
samples collected for clearance purposes by phase contrast microscopy 
(PCM) to confirm completion of removal, encapsulation, or enclosure of 
ACBM that is greater than small-scale, short-duration and less than or 
equal to 160 square feet or 260 linear feet. The action shall be 
considered complete when the results of samples collected in the 
affected functional space and analyzed by phase contrast microscopy 
using the National Institute for Occupational Safety and Health (NIOSH) 
Method 7400 entitled ``Fibers'' published in the NIOSH Manual of 
Analytical Methods, 3rd Edition, Second Supplement, August 1987, show 
that the concentration of fibers for each of the five samples is less 
than or equal to a

[[Page 305]]

limit of quantitation for PCM (0.01 fibers per cubic centimeter (0.01 f/
cm\3\) of air). The method is available at the addresses in Sec.  
700.17(b)(1) and (2) of this chapter. 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. This incorporation by reference was approved by the 
Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. The method is incorporated as it exists on the effective 
date of this rule, and a notice of any change to the method will be 
published in the Federal Register.
    (6) To determine the amount of ACBM affected under paragraph (i)(5) 
of this section, the local education agency shall add the total square 
or linear footage of ACBM within the containment barriers used to 
isolate the functional space for the action to remove, encapsulate, or 
enclose the ACBM. Contiguous portions of material subject to such action 
conducted concurrently or at approximately the same time within the same 
school building shall not be separated to qualify under paragraph 
(i)(5), of this section.

[52 FR 41846, Oct. 30, 1987, as amended at 53 FR 12525, Apr. 15, 1988; 
60 FR 31922, June 19, 1995; 60 FR 34465, July 3, 1995; 69 FR 18803, Apr. 
9, 2004; 77 FR 46292, Aug. 3, 2012]



Sec.  763.91  Operations and maintenance.

    (a) Applicability. The local education agency shall implement an 
operations, maintenance, and repair (O&M) program under this section 
whenever any friable ACBM is present or assumed to be present in a 
building that it leases, owns, or otherwise uses as a school building. 
Any material identified as nonfriable ACBM or nonfriable assumed ACBM 
must be treated as friable ACBM for purposes of this section when the 
material is about to become friable as a result of activities performed 
in the school building.
    (b) Worker protection. Local education agencies must comply with 
either the OSHA Asbestos Construction Standard at 29 CFR 1926.1101, or 
the Asbestos Worker Protection Rule at 40 CFR 763.120, whichever is 
applicable.
    (c) Cleaning--(1) Initial cleaning. Unless the building has been 
cleaned using equivalent methods within the previous 6 months, all areas 
of a school building where friable ACBM, damaged or significantly 
damaged thermal system insulation ACM, or friable suspected ACBM assumed 
to be ACM are present shall be cleaned at least once after the 
completion of the inspection required by Sec.  763.85(a) and before the 
initiation of any response action, other than O&M activities or repair, 
according to the following procedures:
    (i) HEPA-vacuum or steam-clean all carpets.
    (ii) HEPA-vacuum or wet-clean all other floors and all other 
horizontal surfaces.
    (iii) Dispose of all debris, filters, mopheads, and cloths in 
sealed, leak-tight containers.
    (2) Additional cleaning. The accredited management planner shall 
make a written recommendation to the local education agency whether 
additional cleaning is needed, and if so, the methods and frequency of 
such cleaning.
    (d) Operations and maintenance activities. The local education 
agency shall ensure that the procedures described below to protect 
building occupants shall be followed for any operations and maintenance 
activities disturbing friable ACBM:
    (1) Restrict entry into the area by persons other than those 
necessary to perform the maintenance project, either by physically 
isolating the area or by scheduling.
    (2) Post signs to prevent entry by unauthorized persons.
    (3) Shut off or temporarily modify the air-handling system and 
restrict other sources of air movement.
    (4) Use work practices or other controls, such as, wet methods, 
protective clothing, HEPA-vacuums, mini-enclosures, glove bags, as 
necessary to inhibit the spread of any released fibers.
    (5) Clean all fixtures or other components in the immediate work 
area.
    (6) Place the asbestos debris and other cleaning materials in a 
sealed, leak-tight container.
    (e) Maintenance activities other than small-scale, short-duration. 
The response action for any maintenance activities disturbing friable 
ACBM, other than

[[Page 306]]

small-scale, short-duration maintenance activities, shall be designed by 
persons accredited to design response actions and conducted by persons 
accredited to conduct response actions.
    (f) Fiber release episodes--(1) Minor fiber release episode. The 
local education agency shall ensure that the procedures described below 
are followed in the event of a minor fiber release episode (i.e., the 
falling or dislodging of 3 square or linear feet or less of friable 
ACBM): 5
    (i) Thoroughly saturate the debris using wet methods.
    (ii) Clean the area, as described in paragraph (e) of this section.
    (iii) Place the asbestos debris in a sealed, leak-tight container.
    (iv) Repair the area of damaged ACM with materials such as asbestos-
free spackling, plaster, cement, or insulation, or seal with latex paint 
or an encapsulant, or immediately have the appropriate response action 
implemented as required by Sec.  763.90.
    (2) Major fiber release episode. The local education agency shall 
ensure that the procedures described below are followed in the event of 
a major fiber release episode (i.e., the falling or dislodging of more 
than 3 square or linear feet of friable ACBM):
    (i) Restrict entry into the area and post signs to prevent entry 
into the area by persons other than those necessary to perform the 
response action.
    (ii) Shut off or temporarily modify the air-handling system to 
prevent the distribution of fibers to other areas in the building.
    (iii) The response action for any major fiber release episode must 
be designed by persons accredited to design response actions and 
conducted by persons accredited to conduct response actions.

[52 FR 41846, Oct. 30, 1987, as amended at 65 FR 69216, Nov. 15, 2000]



Sec.  763.92  Training and periodic surveillance.

    (a) Training. (1) The local education agency shall ensure, prior to 
the implementation of the O&M provisions of the management plan, that 
all members of its maintenance and custodial staff (custodians, 
electricians, heating/air conditioning engineers, plumbers, etc.) who 
may work in a building that contains ACBM receive awareness training of 
at least 2 hours, whether or not they are required to work with ACBM. 
New custodial and maintenance employees shall be trained within 60 days 
after commencement of employment. Training shall include, but not be 
limited to:
    (i) Information regarding asbestos and its various uses and forms.
    (ii) Information on the health effects associated with asbestos 
exposure.
    (iii) Locations of ACBM identified throughout each school building 
in which they work.
    (iv) Recognition of damage, deterioration, and delamination of ACBM.
    (v) Name and telephone number of the person designated to carry out 
general local education agency responsibilities under Sec.  763.84 and 
the availability and location of the management plan.
    (2) The local education agency shall ensure that all members of its 
maintenance and custodial staff who conduct any activities that will 
result in the disturbance of ACBM shall receive training described in 
paragraph (a)(1) of this section and 14 hours of additional training. 
Additional training shall include, but not be limited to:
    (i) Descriptions of the proper methods of handling ACBM.
    (ii) Information on the use of respiratory protection as contained 
in the EPA/NIOSH Guide to Respiratory Protection for the Asbestos 
Abatement Industry, September 1986 (EPA 560/OPPTS-86-001), available 
from the Director, Environmental Assistance Division (7408), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Room E-543B, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 
Telephone: (202) 554-1404, TDD: (202) 544-0551 and other personal 
protection measures.
    (iii) The provisions of this section and Sec.  763.91, appendices A, 
C, and D of this subpart E of this part, EPA regulations contained in 40 
CFR part 763, subpart G, and in 40 CFR part 61, subpart M, and OSHA 
regulations contained in 29 CFR 1926.58.
    (iv) Hands-on training in the use of respiratory protection, other 
personal

[[Page 307]]

protection measures, and good work practices.
    (3) Local education agency maintenance and custodial staff who have 
attended EPA-approved asbestos training or received equivalent training 
for O&M and periodic surveillance activities involving asbestos shall be 
considered trained for the purposes of this section.
    (b) Periodic surveillance. (1) At least once every 6 months after a 
management plan is in effect, each local education agency shall conduct 
periodic surveillance in each building that it leases, owns, or 
otherwise uses as a school building that contains ACBM or is assumed to 
contain ACBM.
    (2) Each person performing periodic surveillance shall:
    (i) Visually inspect all areas that are identified in the management 
plan as ACBM or assumed ACBM.
    (ii) Record the date of the surveillance, his or her name, and any 
changes in the condition of the materials.
    (iii) Submit to the person designated to carry out general local 
education agency responsibilities under Sec.  763.84 a copy of such 
record for inclusion in the management plan.

[52 FR 41846, Oct. 30, 1987, as amended at 60 FR 34465, July 3, 1995; 65 
FR 69216, Nov. 15, 2000]



Sec.  763.93  Management plans.

    (a)(1) On or before October 12, 1988, each local education agency 
shall develop an asbestos management plan for each school, including all 
buildings that they lease, own, or otherwise use as school buildings, 
and submit the plan to an Agency designated by the Governor of the State 
in which the local education agency is located. The plan may be 
submitted in stages that cover a portion of the school buildings under 
the authority of the local education agency.
    (2) If a building to be used as part of a school is leased or 
otherwise acquired after October 12, 1988, the local education agency 
shall include the new building in the management plan for the school 
prior to its use as a school building. The revised portions of the 
management plan shall be submitted to the Agency designated by the 
Governor.
    (3) If a local education agency begins to use a building as a school 
after October 12, 1988, the local education agency shall submit a 
management plan for the school to the Agency designated by the Governor 
prior to its use as a school.
    (b) On or before October 17, 1987, the Governor of each State shall 
notify local education agencies in the State regarding where to submit 
their management plans. States may establish administrative procedures 
for reviewing management plans. If the Governor does not disapprove a 
management plan within 90 days after receipt of the plan, the local 
education agency shall implement the plan.
    (c) Each local education agency must begin implementation of its 
management plan on or before July 9, 1989, and complete implementation 
in a timely fashion.
    (d) Each local education agency shall maintain and update its 
management plan to keep it current with ongoing operations and 
maintenance, periodic surveillance, inspection, reinspection, and 
response action activities. All provisions required to be included in 
the management plan under this section shall be retained as part of the 
management plan, as well as any information that has been revised to 
bring the plan up-to-date.
    (e) The management plan shall be developed by an accredited 
management planner and shall include:
    (1) A list of the name and address of each school building and 
whether the school building contains friable ACBM, nonfriable ACBM, and 
friable and nonfriable suspected ACBM assumed to be ACM.
    (2) For each inspection conducted before the December 14, 1987:
    (i) The date of the inspection.
    (ii) A blueprint, diagram, or written description of each school 
building that identifies clearly each location and approximate square or 
linear footage of any homogeneous or sampling area where material was 
sampled for ACM, and, if possible, the exact locations where bulk 
samples were collected, and the dates of collection.

[[Page 308]]

    (iii) A copy of the analyses of any bulk samples, dates of analyses, 
and a copy of any other laboratory reports pertaining to the analyses.
    (iv) A description of any response actions or preventive measures 
taken to reduce asbestos exposure, including if possible, the names and 
addresses of all contractors involved, start and completion dates of the 
work, and results of any air samples analyzed during and upon completion 
of the work.
    (v) A description of assessments, required to be made under Sec.  
763.88, of material that was identified before December 14, 1987, as 
friable ACBM or friable suspected ACBM assumed to be ACM, and the name 
and signature, State of accreditation, and if applicable, accreditation 
number of each accredited person making the assessments.
    (3) For each inspection and reinspection conducted under Sec.  
763.85:
    (i) The date of the inspection or reinspection and the name and 
signature, State of accreditation and, if applicable, the accreditation 
number of each accredited inspector performing the inspection or 
reinspection.
    (ii) A blueprint, diagram, or written description of each school 
building that identifies clearly each location and approximate square or 
linear footage of homogeneous areas where material was sampled for ACM, 
the exact location where each bulk sample was collected, date of 
collection, homogeneous areas where friable suspected ACBM is assumed to 
be ACM, and where nonfriable suspected ACBM is assumed to be ACM.
    (iii) A description of the manner used to determine sampling 
locations, and the name and signature of each accredited inspector 
collecting samples, the State of accreditation, and if applicable, his 
or her accreditation number.
    (iv) A copy of the analyses of any bulk samples collected and 
analyzed, the name and address of any laboratory that analyzed bulk 
samples, a statement that the laboratory meets the applicable 
requirements of Sec.  763.87(a) the date of analysis, and the name and 
signature of the person performing the analysis.
    (v) A description of assessments, required to be made under Sec.  
763.88, of all ACBM and suspected ACBM assumed to be ACM, and the name, 
signature, State of accreditation, and if applicable, accreditation 
number of each accredited person making the assessments.
    (4) The name, address, and telephone number of the person designated 
under Sec.  763.84 to ensure that the duties of the local education 
agency are carried out, and the course name, and dates and hours of 
training taken by that person to carry out the duties.
    (5) The recommendations made to the local education agency regarding 
response actions, under Sec.  763.88(d), the name, signature, State of 
accreditation of each person making the recommendations, and if 
applicable, his or her accreditation number.
    (6) A detailed description of preventive measures and response 
actions to be taken, including methods to be used, for any friable ACBM, 
the locations where such measures and action will be taken, reasons for 
selecting the response action or preventive measure, and a schedule for 
beginning and completing each preventive measure and response action.
    (7) With respect to the person or persons who inspected for ACBM and 
who will design or carry out response actions, except for operations and 
maintenance, with respect to the ACBM, one of the following statements:
    (i) If the State has adopted a contractor accreditation program 
under section 206(b) of Title II of the Act, a statement that the 
person(s) is accredited under such plan.
    (ii) A statement that the local education agency used (or will use) 
persons who have been accredited by another State which has adopted a 
contractor accreditation plan under section 206(b) of Title II of the 
Act or is accredited by an EPA-approved course under section 206(c) of 
Title II of the Act.
    (8) A detailed description in the form of a blueprint, diagram, or 
in writing of any ACBM or suspected ACBM assumed to be ACM which remains 
in the school once response actions are undertaken pursuant to Sec.  
763.90. This description shall be updated as response actions are 
completed.
    (9) A plan for reinspection under Sec.  763.85, a plan for 
operations and maintenance activities under Sec.  763.91, and a

[[Page 309]]

plan for periodic surveillance under Sec.  763.92, a description of the 
recommendation made by the management planner regarding additional 
cleaning under Sec.  763.91(c)(2) as part of an operations and 
maintenance program, and the response of the local education agency to 
that recommendation.
    (10) A description of steps taken to inform workers and building 
occupants, or their legal guardians, about inspections, reinspections, 
response actions, and post-response action activities, including 
periodic reinspection and surveillance activities that are planned or in 
progress.
    (11) An evaluation of the resources needed to complete response 
actions successfully and carry out reinspection, operations and 
maintenance activities, periodic surveillance and training.
    (12) With respect to each consultant who contributed to the 
management plan, the name of the consultant and one of the following 
statements:
    (i) If the State has adopted a contractor accreditation plan under 
section 206(b) of Title II of the Act, a statement that the consultant 
is accredited under such plan.
    (ii) A statement that the contractor is accredited by another State 
which has adopted a contractor accreditation plan under section 206(b) 
of Title II of the Act, or is accredited by an EPA-approved course 
developed under section 206(c) of Title II of the Act.
    (f) A local education agency may require each management plan to 
contain a statement signed by an accredited management plan developer 
that such person has prepared or assisted in the preparation of such 
plan or has reviewed such plan, and that such plan is in compliance with 
this subpart E. Such statement may not be signed by a person who, in 
addition to preparing or assisting in preparing the management plan, 
also implements (or will implement) the management plan.
    (g)(1) Upon submission of a management plan to the Governor for 
review, a local education agency shall keep a copy of the plan in its 
administrative office. The management plans shall be available, without 
cost or restriction, for inspection by representatives of EPA and the 
State, the public, including teachers, other school personnel and their 
representatives, and parents. The local education agency may charge a 
reasonable cost to make copies of management plans.
    (2) Each local education agency shall maintain in its administrative 
office a complete, updated copy of a management plan for each school 
under its administrative control or direction. The management plans 
shall be available, during normal business hours, without cost or 
restriction, for inspection by representatives of EPA and the State, the 
public, including teachers, other school personnel and their 
representatives, and parents. The local education agency may charge a 
reasonable cost to make copies of management plans.
    (3) Each school shall maintain in its administrative office a 
complete, updated copy of the management plan for that school. 
Management plans shall be available for inspection, without cost or 
restriction, to workers before work begins in any area of a school 
building. The school shall make management plans available for 
inspection to representatives of EPA and the State, the public, 
including parents, teachers, and other school personnel and their 
representatives within 5 working days after receiving a request for 
inspection. The school may charge a reasonable cost to make copies of 
the management plan.
    (4) Upon submission of its management plan to the Governor and at 
least once each school year, the local education agency shall notify in 
writing parent, teacher, and employee organizations of the availability 
of management plans and shall include in the management plan a 
description of the steps taken to notify such organizations, and a dated 
copy of the notification. In the absence of any such organizations for 
parents, teachers, or employees, the local education agency shall 
provide written notice to that relevant group of the availability of 
management plans and shall include in the management plan a description 
of the steps taken to notify such groups, and a dated copy of the 
notification.

[[Page 310]]

    (h) Records required under Sec.  763.94 shall be made by local 
education agencies and maintained as part of the management plan.
    (i) Each management plan must contain a true and correct statement, 
signed by the individual designated by the local education agency under 
Sec.  763.84, which certifies that the general, local education agency 
responsibilities, as stipulated by Sec.  763.84, have been met or will 
be met.



Sec.  763.94  Recordkeeping.

    (a) Records required under this section shall be maintained in a 
centralized location in the administrative office of both the school and 
the local education agency as part of the management plan. For each 
homogeneous area where all ACBM has been removed, the local education 
agency shall ensure that such records are retained for 3 years after the 
next reinspection required under Sec.  763.85(b)(1), or for an 
equivalent period.
    (b) For each preventive measure and response action taken for 
friable and nonfriable ACBM and friable and nonfriable suspected ACBM 
assumed to be ACM, the local education agency shall provide:
    (1) A detailed written description of the measure or action, 
including methods used, the location where the measure or action was 
taken, reasons for selecting the measure or action, start and completion 
dates of the work, names and addresses of all contractors involved, and 
if applicable, their State of accreditation, and accreditation numbers, 
and if ACBM is removed, the name and location of storage or disposal 
site of the ACM.
    (2) The name and signature of any person collecting any air sample 
required to be collected at the completion of certain response actions 
specified by Sec.  763.90(i), the locations where samples were 
collected, date of collection, the name and address of the laboratory 
analyzing the samples, the date of analysis, the results of the 
analysis, the method of analysis, the name and signature of the person 
performing the analysis, and a statement that the laboratory meets the 
applicable requirements of Sec.  763.90(i)(2)(ii).
    (c) For each person required to be trained under Sec.  763.92(a) (1) 
and (2), the local education agency shall provide the person's name and 
job title, the date that training was completed by that person, the 
location of the training, and the number of hours completed in such 
training.
    (d) For each time that periodic surveillance under Sec.  763.92(b) 
is performed, the local education agency shall record the name of each 
person performing the surveillance, the date of the surveillance, and 
any changes in the conditions of the materials.
    (e) For each time that cleaning under Sec.  763.91(c) is performed, 
the local education agency shall record the name of each person 
performing the cleaning, the date of such cleaning, the locations 
cleaned, and the methods used to perform such cleaning.
    (f) For each time that operations and maintenance activities under 
Sec.  763.91(d) are performed, the local education agency shall record 
the name of each person performing the activity, the start and 
completion dates of the activity, the locations where such activity 
occurred, a description of the activity including preventive measures 
used, and if ACBM is removed, the name and location of storage or 
disposal site of the ACM.
    (g) For each time that major asbestos activity under Sec.  763.91(e) 
is performed, the local education agency shall provide the name and 
signature, State of accreditation, and if applicable, the accreditation 
number of each person performing the activity, the start and completion 
dates of the activity, the locations where such activity occurred, a 
description of the activity including preventive measures used, and if 
ACBM is removed, the name and location of storage or disposal site of 
the ACM.
    (h) For each fiber release episode under Sec.  763.91(f), the local 
education agency shall provide the date and location of the episode, the 
method of repair, preventive measures or response action taken, the name 
of each person performing the work, and if ACBM is removed, the name and 
location of storage or disposal site of the ACM.

(Approved by the Office of Management and Budget under control number 
2070-0091)

[[Page 311]]



Sec.  763.95  Warning labels.

    (a) The local education agency shall attach a warning label 
immediately adjacent to any friable and nonfriable ACBM and suspected 
ACBM assumed to be ACM located in routine maintenance areas (such as 
boiler rooms) at each school building. This shall include:
    (1) Friable ACBM that was responded to by a means other than 
removal.
    (2) ACBM for which no response action was carried out.
    (b) All labels shall be prominently displayed in readily visible 
locations and shall remain posted until the ACBM that is labeled is 
removed.
    (c) The warning label shall read, in print which is readily visible 
because of large size or bright color, as follows:

CAUTION: ASBESTOS. HAZARDOUS. DO NOT DISTURB WITHOUT PROPER TRAINING AND 
EQUIPMENT.



Sec.  763.97  Compliance and enforcement.

    (a) Compliance with Title II of the Act. (1) Section 207(a) of Title 
II of the Act (15 U.S.C. 2647) makes it unlawful for any local education 
agency to:
    (i) Fail to conduct inspections pursuant to section 203(b) of Title 
II of the Act, including failure to follow procedures and failure to use 
accredited personnel and laboratories.
    (ii) Knowingly submit false information to the Governor regarding 
any inspection pursuant to regulations under section 203(i) of Title II 
of the Act.
    (iii) Fail to develop a management plan pursuant to regulations 
under section 203(i) of Title II of the Act.
    (2) Section 207(a) of Title II of the Act (15 U.S.C. 2647) also 
provides that any local education agency which violates any provision of 
section 207 shall be liable for a civil penalty of not more than $5,000 
for each day during which the violation continues. For the purposes of 
this subpart, a ``violation'' means a failure to comply with respect to 
a single school building.
    (b) Compliance with Title I of the Act. (1) Section 15(1)(D) of 
Title I of the Act (15 U.S.C. 2614) makes it unlawful for any person to 
fail or refuse to comply with any requirement of Title II or any rule 
promulgated or order issued under Title II. Therefore, any person who 
violates any requirement of this subpart is in violation of section 15 
of Title I of the Act.
    (2) Section 15(3) of Title I of the Act (15 U.S.C. 2614) makes it 
unlawful for any person to fail or refuse to establish or maintain 
records, submit reports, notices or other information, or permit access 
to or copying of records, as required by this Act or a rule thereunder.
    (3) Section 15(4) (15 U.S.C. 2614) of Title I of the Act makes it 
unlawful for any person to fail or refuse to permit entry or inspection 
as required by section 11 of Title I of the Act.
    (4) Section 16(a) of Title I of the Act (15 U.S.C. 2615) provides 
that any person who violates any provision of section 15 of Title I of 
the Act shall be liable to the United States for a civil penalty in an 
amount not to exceed $25,000 for each such violation. Each day such a 
violation continues shall, for purposes of this paragraph, constitute a 
separate violation of section 15. A local education agency is not liable 
for any civil penalty under Title I of the Act for failing or refusing 
to comply with any rule promulgated or order issued under Title II of 
the Act.
    (c) Criminal penalties. If any violation committed by any person 
(including a local education agency) is knowing or willful, criminal 
penalties may be assessed under section 16(b) of Title I of the Act.
    (d) Injunctive relief. The Agency may obtain injunctive relief under 
section 208(b) of Title II of the Act to respond to a hazard which poses 
an imminent and substantial endangerment to human health or the 
environment or section 17 (15 U.S.C. 2616) of Title I of the Act to 
restrain any violation of section 15 of Title I of the Act or to compel 
the taking of any action required by or under Title I of the Act.
    (e) Citizen complaints. Any citizen who wishes to file a complaint 
pursuant to section 207(d) of Title II of the Act should direct the 
complaint to the Governor of the State or the EPA Asbestos Ombudsman, 
1200 Pennsylvania Ave., NW., Washington, DC 20460. The citizen complaint 
should be in writing and identified as a citizen complaint pursuant to 
section 207(d) of Title II of TSCA. The EPA Asbestos Ombudsman or the 
Governor shall investigate and

[[Page 312]]

respond to the complaint within a reasonable period of time if the 
allegations provide a reasonable basis to believe that a violation of 
the Act has occurred.
    (f) Inspections. EPA may conduct inspections and review management 
plans under section 11 of Title I of the Act (15 U.S.C. 2610) to ensure 
compliance.



Sec.  763.98  Waiver; delegation to State.

    (a) General. (1) Upon request from a state Governor and after notice 
and comment and an opportunity for a public hearing in accordance with 
paragraphs (b) and (c) of this section, EPA may waive some or all of the 
requirements of this subpart E if the state has established and is 
implementing or intends to implement a program of asbestos inspection 
and management that contains requirements that are at least as stringent 
as the requirements of this subpart. In addition, if the state chooses 
to receive electronic documents, the state program must include, at a 
minimum, the requirements of 40 CFR part 3--(Electronic reporting).
    (2) A waiver from any requirement of this subpart E shall apply only 
to the specific provision for which a waiver has been granted under this 
section. All requirements of this subpart E shall apply until a waiver 
is granted under this section.
    (b) Request. Each request by a Governor to waive any requirement of 
this subpart E shall be sent with three complete copies of the request 
to the Regional Administrator for the EPA Region in which the State is 
located and shall include:
    (1) A copy of the State provisions or proposed provisions relating 
to its program of asbestos inspection and management in schools for 
which the request is made.
    (2)(i) The name of the State agency that is or will be responsible 
for administering and enforcing the requirements for which a waiver is 
requested, the names and job titles of responsible officials in that 
agency, and phone numbers where the officials can be contacted.
    (ii) In the event that more than one agency is or will be 
responsible for administering and enforcing the requirements for which a 
waiver is requested, a description of the functions to be performed by 
each agency, how the program will be coordinated by the lead agency to 
ensure consistency and effective administration in the asbestos 
inspection and management program within the State, the names and job 
titles of responsible officials in the agencies, and phone numbers where 
the officials can be contacted. The lead agency will serve as the 
central contact point for the EPA.
    (3) Detailed reasons, supporting papers, and the rationale for 
concluding that the state's asbestos inspection and management program 
provisions for which the request is made are at least as stringent as 
the requirements of subpart E of this part, and that, if the state 
chooses to receive electronic documents, the state program includes, at 
a minimum, the requirements of 40 CFR part 3--(Electronic reporting).
    (4) A discussion of any special situations, problems, and needs 
pertaining to the waiver request accompanied by an explanation of how 
the State intends to handle them.
    (5) A statement of the resources that the State intends to devote to 
the administration and enforcement of the provisions relating to the 
waiver request.
    (6) Copies of any specific or enabling State laws (enacted and 
pending enactment) and regulations (promulgated and pending 
promulgation) relating to the request, including provisions for 
assessing criminal and/or civil penalties.
    (7) Assurance from the Governor, the Attorney General, or the legal 
counsel of the lead agency that the lead agency or other cooperating 
agencies have the legal authority necessary to carry out the 
requirements relating to the request.
    (c) General notice--hearing. (1) Within 30 days after receipt of a 
request for a waiver, EPA will determine the completeness of the 
request. If EPA does not request further information within the 30-day 
period, the request will be deemed complete.
    (2) Within 30 days after EPA determines that a request is complete, 
EPA will issue for publication in the Federal Register a notice that 
announces

[[Page 313]]

receipt of the request, describes the information submitted under 
paragraph (b) of this section, and solicits written comment from 
interested members of the public. Comments must be submitted within 60 
days.
    (3) If, during the comment period, EPA receives a written objection 
to a Governor's request and a request for a public hearing detailing 
specific objections to the granting of a waiver, EPA will schedule a 
public hearing to be held in the affected State after the close of the 
comment period and will announce the public hearing date in the Federal 
Register before the date of the hearing. Each comment shall include the 
name and address of the person submitting the comment.
    (d) Criteria. EPA may waive some or all of the requirements of 
subpart E of this part if:
    (1) The State's lead agency and other cooperating agencies have the 
legal authority necessary to carry out the provisions of asbestos 
inspection and management in schools relating to the waiver request.
    (2) The State's program of asbestos inspection and management in 
schools relating to the waiver request and implementation of the program 
are or will be at least as stringent as the requirements of this subpart 
E.
    (3) The state has an enforcement mechanism to allow it to implement 
the program described in the waiver request and any electronic reporting 
requirements are at least as stringent as 40 CFR part 3--(Electronic 
reporting).
    (4) The lead agency and any cooperating agencies have or will have 
qualified personnel to carry out the provisions relating to the waiver 
request.
    (5) The State will devote adequate resources to the administration 
and enforcement of the asbestos inspection and management provisions 
relating to the waiver request.
    (6) When specified by EPA, the State gives satisfactory assurances 
that necessary steps, including specific actions it proposes to take and 
a time schedule for their accomplishment, will be taken within a 
reasonable time to conform with applicable criteria under paragraphs (d) 
(2) through (4) of this section.
    (e) Decision. EPA will issue for publication in the Federal Register 
a notice announcing its decision to grant or deny, in whole or in part, 
a Governor's request for a waiver from some or all of the requirements 
of this subpart E within 30 days after the close of the comment period 
or within 30 days following a public hearing, whichever is applicable. 
The notice will include the Agency's reasons and rationale for granting 
or denying the Governor's request. The 30-day period may be extended if 
mutually agreed upon by EPA and the State.
    (f) Modifications. When any substantial change is made in the 
administration or enforcement of a State program for which a waiver was 
granted under this section, a responsible official in the lead agency 
shall submit such changes to EPA.
    (g) Reports. The lead agency in each State that has been granted a 
waiver by EPA from any requirement of subpart E of this part shall 
submit a report to the Regional Administrator for the Region in which 
the State is located at least once every 12 months to include the 
following information:
    (1) A summary of the State's implementation and enforcement 
activities during the last reporting period relating to provisions 
waived under this section, including enforcement actions taken.
    (2) Any changes in the administration or enforcement of the State 
program implemented during the last reporting period.
    (3) Other reports as may be required by EPA to carry out effective 
oversight of any requirement of this subpart E that was waived under 
this section.
    (h) Oversight. EPA may periodically evaluate the adequacy of a 
State's implementation and enforcement of and resources devoted to 
carrying out requirements relating to the waiver. This evaluation may 
include, but is not limited to, site visits to local education agencies 
without prior notice to the State.
    (i) Informal conference. (1) EPA may request that an informal 
conference be held between appropriate State and EPA officials when EPA 
has reason to believe that a State has failed to:

[[Page 314]]

    (i) Substantially comply with the terms of any provision that was 
waived under this section.
    (ii) Meet the criteria under paragraph (d) of this section, 
including the failure to carry out enforcement activities or act on 
violations of the State program.
    (2) EPA will:
    (i) Specify to the State those aspects of the State's program 
believed to be inadequate.
    (ii) Specify to the State the facts that underlie the belief of 
inadequacy.
    (3) If EPA finds, on the basis of information submitted by the State 
at the conference, that deficiencies did not exist or were corrected by 
the State, no further action is required.
    (4) Where EPA finds that deficiencies in the State program exist, a 
plan to correct the deficiencies shall be negotiated between the State 
and EPA. The plan shall detail the deficiencies found in the State 
program, specify the steps the State has taken or will take to remedy 
the deficiencies, and establish a schedule for each remedial action to 
be initiated.
    (j) Rescission. (1) If the State fails to meet with EPA or fails to 
correct deficiencies raised at the informal conference, EPA will deliver 
to the Governor of the State and a responsible official in the lead 
agency a written notice of its intent to rescind, in whole or part, the 
waiver.
    (2) EPA will issue for publication in the Federal Register a notice 
that announces the rescission of the waiver, describes those aspects of 
the State's program determined to be inadequate, and specifies the facts 
that underlie the findings of inadequacy.

[52 FR 41846, Oct. 30, 1987, as amended at 70 FR 59889, Oct. 13, 2005]



Sec.  763.99  Exclusions.

    (a) A local education agency shall not be required to perform an 
inspection under Sec.  763.85(a) in any sampling area as defined in 40 
CFR 763.103 or homogeneous area of a school building where:
    (1) An accredited inspector has determined that, based on sampling 
records, friable ACBM was identified in that homogeneous or sampling 
area during an inspection conducted before December 14, 1987. The 
inspector shall sign and date a statement to that effect with his or her 
State of accreditation and if applicable, accreditation number and, 
within 30 days after such determination, submit a copy of the statement 
to the person designated under Sec.  763.84 for inclusion in the 
management plan. However, an accredited inspector shall assess the 
friable ACBM under Sec.  763.88.
    (2) An accredited inspector has determined that, based on sampling 
records, nonfriable ACBM was identified in that homogeneous or sampling 
area during an inspection conducted before December 14, 1987. The 
inspector shall sign and date a statement to that effect with his or her 
State of accreditation and if applicable, accreditation number and, 
within 30 days after such determination, submit a copy of the statement 
to the person designated under Sec.  763.84 for inclusion in the 
management plan. However, an accredited inspector shall identify whether 
material that was nonfriable has become friable since that previous 
inspection and shall assess the newly-friable ACBM under Sec.  763.88.
    (3) Based on sampling records and inspection records, an accredited 
inspector has determined that no ACBM is present in the homogeneous or 
sampling area and the records show that the area was sampled, before 
December 14, 1987 in substantial compliance with Sec.  763.85(a), which 
for purposes of this section means in a random manner and with a 
sufficient number of samples to reasonably ensure that the area is not 
ACBM.
    (i) The accredited inspector shall sign and date a statement, with 
his or her State of accreditation and if applicable, accreditation 
number that the homogeneous or sampling area determined not to be ACBM 
was sampled in substantial compliance with Sec.  763.85(a).
    (ii) Within 30 days after the inspector's determination, the local 
education agency shall submit a copy of the inspector's statement to the 
EPA Regional Office and shall include the statement in the management 
plan for that school.
    (4) The lead agency responsible for asbestos inspection in a State 
that has been granted a waiver from Sec.  763.85(a) has determined that, 
based on sampling records and inspection records,

[[Page 315]]

no ACBM is present in the homogeneous or sampling area and the records 
show that the area was sampled before December 14, 1987, in substantial 
compliance with Sec.  763.85(a). Such determination shall be included in 
the management plan for that school.
    (5) An accredited inspector has determined that, based on records of 
an inspection conducted before December 14, 1987, suspected ACBM 
identified in that homogeneous or sampling area is assumed to be ACM. 
The inspector shall sign and date a statement to that effect, with his 
or her State of accreditation and if applicable, accreditation number 
and, within 30 days of such determination, submit a copy of the 
statement to the person designated under Sec.  763.84 for inclusion in 
the management plan. However, an accredited inspector shall identify 
whether material that was nonfriable suspected ACBM assumed to be ACM 
has become friable since the previous inspection and shall assess the 
newly friable material and previously identified friable suspected ACBM 
assumed to be ACM under Sec.  763.88.
    (6) Based on inspection records and contractor and clearance 
records, an accredited inspector has determined that no ACBM is present 
in the homogeneous or sampling area where asbestos removal operations 
have been conducted before December 14, 1987, and shall sign and date a 
statement to that effect and include his or her State of accreditation 
and, if applicable, accreditation number. The local education agency 
shall submit a copy of the statement to the EPA Regional Office and 
shall include the statement in the management plan for that school.
    (7) An architect or project engineer responsible for the 
construction of a new school building built after October 12, 1988, or 
an accredited inspector signs a statement that no ACBM was specified as 
a building material in any construction document for the building, or, 
to the best of his or her knowledge, no ACBM was used as a building 
material in the building. The local education agency shall submit a copy 
of the signed statement of the architect, project engineer, or 
accredited inspector to the EPA Regional Office and shall include the 
statement in the management plan for that school.
    (b) The exclusion, under paragraphs (a) (1) through (4) of this 
section, from conducting the inspection under Sec.  763.85(a) shall 
apply only to homogeneous or sampling areas of a school building that 
were inspected and sampled before October 17, 1987. The local education 
agency shall conduct an inspection under Sec.  763.85(a) of all areas 
inspected before October 17, 1987, that were not sampled or were not 
assumed to be ACM.
    (c) If ACBM is subsequently found in a homogeneous or sampling area 
of a local education agency that had been identified as receiving an 
exclusion by an accredited inspector under paragraphs (a) (3), (4), (5) 
of this section, or an architect, project engineer or accredited 
inspector under paragraph (a)(7) of this section, the local education 
agency shall have 180 days following the date of identification of ACBM 
to comply with this subpart E.



Sec. Appendix A to Subpart E of Part 763--Interim Transmission Electron 
Microscopy Analytical Methods--Mandatory and Nonmandatory--and Mandatory 
           Section To Determine Completion of Response Actions

                             I. Introduction

    The following appendix contains three units. The first unit is the 
mandatory transmission electron microscopy (TEM) method which all 
laboratories must follow; it is the minimum requirement for analysis of 
air samples for asbestos by TEM. The mandatory method contains the 
essential elements of the TEM method. The second unit contains the 
complete non-mandatory method. The non-mandatory method supplements the 
mandatory method by including additional steps to improve the analysis. 
EPA recommends that the non-mandatory method be employed for analyzing 
air filters; however, the laboratory may choose to employ the mandatory 
method. The non-mandatory method contains the same minimum requirements 
as are outlined in the mandatory method. Hence, laboratories may choose 
either of the two methods for analyzing air samples by TEM.
    The final unit of this Appendix A to subpart E defines the steps 
which must be taken to determine completion of response actions. This 
unit is mandatory.

[[Page 316]]

          II. Mandatory Transmission Electron Microscopy Method

                         A. Definitions of Terms

    1. Analytical sensitivity--Airborne asbestos concentration 
represented by each fiber counted under the electron microscope. It is 
determined by the air volume collected and the proportion of the filter 
examined. This method requires that the analytical sensitivity be no 
greater than 0.005 structures/cm\3\.
    2. Asbestiform--A specific type of mineral fibrosity in which the 
fibers and fibrils possess high tensile strength and flexibility.
    3. Aspect ratio--A ratio of the length to the width of a particle. 
Minimum aspect ratio as defined by this method is equal to or greater 
than 5:1.
    4. Bundle--A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    5. Clean area--A controlled environment which is maintained and 
monitored to assure a low probability of asbestos contamination to 
materials in that space. Clean areas used in this method have HEPA 
filtered air under positive pressure and are capable of sustained 
operation with an open laboratory blank which on subsequent analysis has 
an average of less than 18 structures/mm\2\ in an area of 0.057 mm\2\ 
(nominally 10 200-mesh grid openings) and a maximum of 53 structures/
mm\2\ for any single preparation for that same area.
    6. Cluster--A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    7. ED--Electron diffraction.
    8. EDXA--Energy dispersive X-ray analysis.
    9. Fiber--A structure greater than or equal to 0.5 [micro]m in 
length with an aspect ratio (length to width) of 5:1 or greater and 
having substantially parallel sides.
    10. Grid--An open structure for mounting on the sample to aid in its 
examination in the TEM. The term is used here to denote a 200-mesh 
copper lattice approximately 3 mm in diameter.
    11. Intersection--Nonparallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater.
    12. Laboratory sample coordinator--That person responsible for the 
conduct of sample handling and the certification of the testing 
procedures.
    13. Filter background level--The concentration of structures per 
square millimeter of filter that is considered indistinguishable from 
the concentration measured on a blank (filters through which no air has 
been drawn). For this method the filter background level is defined as 
70 structures/mm\2\.
    14. Matrix--Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    15. NSD--No structure detected.
    16. Operator--A person responsible for the TEM instrumental analysis 
of the sample.
    17. PCM--Phase contrast microscopy.
    18. SAED--Selected area electron diffraction.
    19. SEM--Scanning electron microscope.
    20. STEM--Scanning transmission electron microscope.
    21. Structure--a microscopic bundle, cluster, fiber, or matrix which 
may contain asbestos.
    22. S/cm\3\--Structures per cubic centimeter.
    23. S/mm\2\--Structures per square millimeter.
    24. TEM--Transmission electron microscope.

                               B. Sampling

    1. The sampling agency must have written quality control procedures 
and documents which verify compliance.
    2. Sampling operations must be performed by qualified individuals 
completely independent of the abatement contractor to avoid possible 
conflict of interest (References 1, 2, 3, and 5 of Unit II.J.).
    3. Sampling for airborne asbestos following an abatement action must 
use commercially available cassettes.
    4. Prescreen the loaded cassette collection filters to assure that 
they do not contain concentrations of asbestos which may interfere with 
the analysis of the sample. A filter blank average of less than 18 s/
mm\2\ in an area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) 
and a single preparation with a maximum of 53 s/mm\2\ for that same area 
is acceptable for this method.
    5. Use sample collection filters which are either polycarbonate 
having a pore size less than or equal to 0.4 [micro]m or mixed cellulose 
ester having a pore size less than or equal to 0.45 [micro]m.
    6. Place these filters in series with a 5.0 [micro]m backup filter 
(to serve as a diffuser) and a support pad. See the following Figure 1:

[[Page 317]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.001

    7. Reloading of used cassettes is not permitted.
    8. Orient the cassette downward at approximately 45 degrees from the 
horizontal.
    9. Maintain a log of all pertinent sampling information.

[[Page 318]]

    10. Calibrate sampling pumps and their flow indicators over the 
range of their intended use with a recognized standard. Assemble the 
sampling system with a representative filter (not the filter which will 
be used in sampling) before and after the sampling operation.
    11. Record all calibration information.
    12. Ensure that the mechanical vibrations from the pump will be 
minimized to prevent transferral of vibration to the cassette.
    13. Ensure that a continuous smooth flow of negative pressure is 
delivered by the pump by damping out any pump action fluctuations if 
necessary.
    14. The final plastic barrier around the abatement area remains in 
place for the sampling period.
    15. After the area has passed a thorough visual inspection, use 
aggressive sampling conditions to dislodge any remaining dust. (See 
suggested protocol in Unit III.B.7.d.)
    16. Select an appropriate flow rate equal to or greater than 1 liter 
per minute (L/min) or less than 10 L/min for 25 mm cassettes. Larger 
filters may be operated at proportionally higher flow rates.
    17. A minimum of 13 samples are to be collected for each testing 
site consisting of the following:
    a. A minimum of five samples per abatement area.
    b. A minimum of five samples per ambient area positioned at 
locations representative of the air entering the abatement site.
    c. Two field blanks are to be taken by removing the cap for not more 
than 30 seconds and replacing it at the time of sampling before sampling 
is initiated at the following places:
    i. Near the entrance to each abatement area.
    ii. At one of the ambient sites. (DO NOT leave the field blanks open 
during the sampling period.)
    d. A sealed blank is to be carried with each sample set. This 
representative cassette is not to be opened in the field.
    18. Perform a leak check of the sampling system at each indoor and 
outdoor sampling site by activating the pump with the closed sampling 
cassette in line. Any flow indicates a leak which must be eliminated 
before initiating the sampling operation.
    19. The following Table I specifies volume ranges to be used:

[[Page 319]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.002

    20. Ensure that the sampler is turned upright before interrupting 
the pump flow.
    21. Check that all samples are clearly labeled and that all 
pertinent information has been enclosed before transfer of the samples 
to the laboratory.
    22. Ensure that the samples are stored in a secure and 
representative location.
    23. Do not change containers if portions of these filters are taken 
for other purposes.
    24. A summary of Sample Data Quality Objectives is shown in the 
following Table II:

[[Page 320]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.003

                           C. Sample Shipment

    Ship bulk samples to the analytical laboratory in a separate 
container from air samples.

                           D. Sample Receiving

    1. Designate one individual as sample coordinator at the laboratory. 
While that individual will normally be available to receive samples, the 
coordinator may train and supervise others in receiving procedures for 
those times when he/she is not available.
    2. Bulk samples and air samples delivered to the analytical 
laboratory in the same container shall be rejected.

                          E. Sample Preparation

    1. All sample preparation and analysis shall be performed by a 
laboratory independent of the abatement contractor.
    2. Wet-wipe the exterior of the cassettes to minimize contamination 
possibilities before taking them into the clean room facility.
    3. Perform sample preparation in a well-equipped clean facility.
    Note: The clean area is required to have the following minimum 
characteristics. The area or hood must be capable of maintaining a 
positive pressure with make-up air being HEPA-filtered. The cumulative 
analytical blank concentration must average less than 18 s/mm\2\ in an 
area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) and a single 
preparation with a maximum of 53 s/mm\2\ for that same area.
    4. Preparation areas for air samples must not only be separated from 
preparation areas for bulk samples, but they must be prepared in 
separate rooms.
    5. Direct preparation techniques are required. The object is to 
produce an intact film containing the particulates of the filter surface 
which is sufficiently clear for TEM analysis.
    a. TEM Grid Opening Area measurement must be done as follows:
    i. The filter portion being used for sample preparation must have 
the surface collapsed using an acetone vapor technique.
    ii. Measure 20 grid openings on each of 20 random 200-mesh copper 
grids by placing a grid on a glass and examining it under the PCM. Use a 
calibrated graticule to measure the average field diameters. From the 
data, calculate the field area for an average grid opening.
    iii. Measurements can also be made on the TEM at a properly 
calibrated low magnification or on an optical microscope at a 
magnification of approximately 400X by using an eyepiece fitted with a 
scale that has been calibrated against a stage micrometer. Optical 
microscopy utilizing manual or automated procedures may be used 
providing instrument calibration can be verified.
    b. TEM specimen preparation from polycarbonate (PC) filters. 
Procedures as described in Unit III.G. or other equivalent methods may 
be used.
    c. TEM specimen preparation from mixed cellulose ester (MCE) 
filters.
    i. Filter portion being used for sample preparation must have the 
surface collapsed using an acetone vapor technique or the Burdette 
procedure (Ref. 7 of Unit II.J.)
    ii. Plasma etching of the collapsed filter is required. The 
microscope slide to which the collapsed filter pieces are attached is 
placed in a plasma asher. Because plasma ashers vary greatly in their 
performance, both from unit to unit and between different positions in 
the asher chamber, it is difficult to specify the conditions that should 
be used. Insufficient etching will result in a failure to expose 
embedded filters, and too much etching may result in loss of particulate 
from the surface. As an interim measure, it is recommended that the time 
for ashing of a

[[Page 321]]

known weight of a collapsed filter be established and that the etching 
rate be calculated in terms of micrometers per second. The actual 
etching time used for the particulate asher and operating conditions 
will then be set such that a 1-2 [micro]m (10 percent) layer of 
collapsed surface will be removed.
    iii. Procedures as described in Unit III. or other equivalent 
methods may be used to prepare samples.

                              F. TEM Method

    1. An 80-120 kV TEM capable of performing electron diffraction with 
a fluorescent screen inscribed with calibrated gradations is required. 
If the TEM is equipped with EDXA it must either have a STEM attachment 
or be capable of producing a spot less than 250 nm in diameter at 
crossover. The microscope shall be calibrated routinely for 
magnification and camera constant.
    2. Determination of Camera Constant and ED Pattern Analysis. The 
camera length of the TEM in ED operating mode must be calibrated before 
ED patterns on unknown samples are observed. This can be achieved by 
using a carbon-coated grid on which a thin film of gold has been 
sputtered or evaporated. A thin film of gold is evaporated on the 
specimen TEM grid to obtain zone-axis ED patterns superimposed with a 
ring pattern from the polycrystalline gold film. In practice, it is 
desirable to optimize the thickness of the gold film so that only one or 
two sharp rings are obtained on the superimposed ED pattern. Thicker 
gold film would normally give multiple gold rings, but it will tend to 
mask weaker diffraction spots from the unknown fibrous particulate. 
Since the unknown d-spacings of most interest in asbestos analysis are 
those which lie closest to the transmitted beam, multiple gold rings are 
unnecessary on zone-axis ED patterns. An average camera constant using 
multiple gold rings can be determined. The camera constant is one-half 
the diameter of the rings times the interplanar spacing of the ring 
being measured.
    3. Magnification Calibration. The magnification calibration must be 
done at the fluorescent screen. The TEM must be calibrated at the grid 
opening magnification (if used) and also at the magnification used for 
fiber counting. This is performed with a cross grating replica (e.g., 
one containing 2,160 lines/mm). Define a field of view on the 
fluorescent screen either by markings or physical boundaries. The field 
of view must be measurable or previously inscribed with a scale or 
concentric circles (all scales should be metric). A logbook must be 
maintained, and the dates of calibration and the values obtained must be 
recorded. The frequency of calibration depends on the past history of 
the particular microscope. After any maintenance of the microscope that 
involved adjustment of the power supplied to the lenses or the high-
voltage system or the mechanical disassembly of the electron optical 
column apart from filament exchange, the magnification must be 
recalibrated. Before the TEM calibration is performed, the analyst must 
ensure that the cross grating replica is placed at the same distance 
from the objective lens as the specimens are. For instruments that 
incorporate a eucentric tilting specimen stage, all specimens and the 
cross grating replica must be placed at the eucentric position.
    4. While not required on every microscope in the laboratory, the 
laboratory must have either one microscope equipped with energy 
dispersive X-ray analysis or access to an equivalent system on a TEM in 
another laboratory.
    5. Microscope settings: 80-120 kV, grid assessment 250-1,000X, then 
15,000-20,000X screen magnification for analysis.
    6. Approximately one-half (0.5) of the predetermined sample area to 
be analyzed shall be performed on one sample grid preparation and the 
remaining half on a second sample grid preparation.
    7. Individual grid openings with greater than 5 percent openings 
(holes) or covered with greater than 25 percent particulate matter or 
obviously having nonuniform loading must not be analyzed.
    8. Reject the grid if:
    a. Less than 50 percent of the grid openings covered by the replica 
are intact.
    b. The replica is doubled or folded.
    c. The replica is too dark because of incomplete dissolution of the 
filter.
    9. Recording Rules.
    a. Any continuous grouping of particles in which an asbestos fiber 
with an aspect ratio greater than or equal to 5:1 and a length greater 
than or equal to 0.5 [micro]m is detected shall be recorded on the count 
sheet. These will be designated asbestos structures and will be 
classified as fibers, bundles, clusters, or matrices. Record as 
individual fibers any contiguous grouping having 0, 1, or 2 definable 
intersections. Groupings having more than 2 intersections are to be 
described as cluster or matrix. An intersection is a nonparallel 
touching or crossing of fibers, with the projection having an aspect 
ratio of 5:1 or greater. See the following Figure 2:

[[Page 322]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.004


[[Page 323]]


[GRAPHIC] [TIFF OMITTED] TC01AP92.005

    i. Fiber. A structure having a minimum length greater than or equal 
to 0.5 [micro]m and an aspect ratio (length to width) of 5:1 or greater 
and substantially parallel sides. Note the appearance of the end of the 
fiber, i.e., whether it is flat, rounded or dovetailed.
    ii. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    iii. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    iv. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    b. Separate categories will be maintained for fibers less than 5 
[micro]m and for fibers equal to or greater than 5 [micro]m in length.
    c. Record NSD when no structures are detected in the field.
    d. Visual identification of electron diffraction (ED) patterns is 
required for each asbestos structure counted which would cause the

[[Page 324]]

analysis to exceed the 70 s/mm\2\ concentration. (Generally this means 
the first four fibers identified as asbestos must exhibit an 
identifiable diffraction pattern for chrysotile or amphibole.)
    e. The micrograph number of the recorded diffraction patterns must 
be reported to the client and maintained in the laboratory's quality 
assurance records. In the event that examination of the pattern by a 
qualified individual indicates that the pattern has been misidentified 
visually, the client shall be contacted.
    f. Energy Dispersive X-ray Analysis (EDXA) is required of all 
amphiboles which would cause the analysis results to exceed the 70 s/
mm\2\ concentration. (Generally speaking, the first 4 amphiboles would 
require EDXA.)
    g. If the number of fibers in the nonasbestos class would cause the 
analysis to exceed the 70 s/mm\2\ concentration, the fact that they are 
not asbestos must be confirmed by EDXA or measurement of a zone axis 
diffraction pattern.
    h. Fibers classified as chrysotile must be identified by diffraction 
or X-ray analysis and recorded on a count sheet. X-ray analysis alone 
can be used only after 70 s/mm\2\ have been exceeded for a particular 
sample.
    i. Fibers classified as amphiboles must be identified by X-ray 
analysis and electron diffraction and recorded on the count sheet. (X-
ray analysis alone can be used only after 70 s/mm\2\ have been exceeded 
for a particular sample.)
    j. If a diffraction pattern was recorded on film, record the 
micrograph number on the count sheet.
    k. If an electron diffraction was attempted but no pattern was 
observed, record N on the count sheet.
    l. If an EDXA spectrum was attempted but not observed, record N on 
the count sheet.
    m. If an X-ray analysis spectrum is stored, record the file and disk 
number on the count sheet.
    10. Classification Rules.
    a. Fiber. A structure having a minimum length greater than or equal 
to 0.5 [micro]m and an aspect ratio (length to width) of 5:1 or greater 
and substantially parallel sides. Note the appearance of the end of the 
fiber, i.e., whether it is flat, rounded or dovetailed.
    b. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    c. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    d. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    11. After finishing with a grid, remove it from the microscope, and 
replace it in the appropriate grid holder. Sample grids must be stored 
for a minimum of 1 year from the date of the analysis; the sample 
cassette must be retained for a minimum of 30 days by the laboratory or 
returned at the client's request.

                      G. Sample Analytical Sequence

    1. Under the present sampling requirements a minimum of 13 samples 
is to be collected for the clearance testing of an abatement site. These 
include five abatement area samples, five ambient samples, two field 
blanks, and one sealed blank.
    2. Carry out visual inspection of work site prior to air monitoring.
    3. Collect a minimum of 5 air samples inside the work site and 5 
samples outside the work site. The indoor and outdoor samples shall be 
taken during the same time period.
    4. Remaining steps in the analytical sequence are contained in Unit 
IV of this Appendix.

                              H. Reporting

    1. The following information must be reported to the client for each 
sample analyzed:
    a. Concentration in structures per square millimeter and structures 
per cubic centimeter.
    b. Analytical sensitivity used for the analysis.
    c. Number of asbestos structures.
    d. Area analyzed.
    e. Volume of air sampled (which must be initially supplied to lab by 
client).
    f. Copy of the count sheet must be included with the report.
    g. Signature of laboratory official to indicate that the laboratory 
met specifications of the method.
    h. Report form must contain official laboratory identification 
(e.g., letterhead).
    i. Type of asbestos.

     I. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards are to be performed 
along with the sample analysis as indicators that the materials used are 
adequate and the

[[Page 325]]

operations are within acceptable limits. In this way, the quality of the 
data is defined and the results are of known value. These checks and 
tests also provide timely and specific warning of any problems which 
might develop within the sampling and analysis operations. A description 
of these quality control/quality assurance procedures is summarized in 
the following Table III:
[GRAPHIC] [TIFF OMITTED] TC01AP92.006

    1. When the samples arrive at the laboratory, check the samples and 
documentation for completeness and requirements before initiating the 
analysis.
    2. Check all laboratory reagents and supplies for acceptable 
asbestos background levels.
    3. Conduct all sample preparation in a clean room environment 
monitored by laboratory blanks. Testing with blanks must also be done 
after cleaning or servicing the room.
    4. Prepare multiple grids of each sample.

[[Page 326]]

    5. Provide laboratory blanks with each sample batch. Maintain a 
cumulative average of these results. If there are more than 53 fibers/
mm\2\ per 10 200-mesh grid openings, the system must be checked for 
possible sources of contamination.
    6. Perform a system check on the transmission electron microscope 
daily.
    7. Make periodic performance checks of magnification, electron 
diffraction and energy dispersive X-ray systems as set forth in Table 
III under Unit II.I.
    8. Ensure qualified operator performance by evaluation of replicate 
analysis and standard sample comparisons as set forth in Table III under 
Unit II.I.
    9. Validate all data entries.
    10. Recalculate a percentage of all computations and automatic data 
reduction steps as specified in Table III under Unit II.I.
    11. Record an electron diffraction pattern of one asbestos structure 
from every five samples that contain asbestos. Verify the identification 
of the pattern by measurement or comparison of the pattern with patterns 
collected from standards under the same conditions. The records must 
also demonstrate that the identification of the pattern has been 
verified by a qualified individual and that the operator who made the 
identification is maintaining at least an 80 percent correct visual 
identification based on his measured patterns.
    12. Appropriate logs or records must be maintained by the analytical 
laboratory verifying that it is in compliance with the mandatory quality 
assurance procedures.

                              J. References

    For additional background information on this method, the following 
references should be consulted.
    1. ``Guidance for Controlling Asbestos-Containing Materials in 
Buildings,'' EPA 560/5-85-024, June 1985.
    2. ``Measuring Airborne Asbestos Following an Abatement Action,'' 
USEPA, Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 
1985.
    3. Small, John and E. Steel. Asbestos Standards: Materials and 
Analytical Methods. N.B.S. Special Publication 619, 1982.
    4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. 
Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. 
Information Circular 8751, U.S. Bureau of Mines, 1977.
    5. Quality Assurance Handbook for Air Pollution Measurement System. 
Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and 
Development, 1977.
    6. Method 2A: Direct Measurement of Gas Volume through Pipes and 
Small Ducts. 40 CFR Part 60 Appendix A.
    7. Burdette, G.J., Health & Safety Exec. Research & Lab. Services 
Div., London, ``Proposed Analytical Method for Determination of Asbestos 
in Air.''
    8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI 
Assoc., ``Standard Operating Procedure for Determination of Airborne 
Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate 
Membrane Filters,'' WERL SOP 87-1, March 5, 1987.
    9. NIOSH Method 7402 for Asbestos Fibers, 12-11-86 Draft.
    10. Yamate, G., Agarwall, S.C., Gibbons, R.D., IIT Research 
Institute, ``Methodology for the Measurement of Airborne Asbestos by 
Electron Microscopy,'' Draft report, USEPA Contract 68-02-3266, July 
1984.
    11. ``Guidance to the Preparation of Quality Assurance Project 
Plans,'' USEPA, Office of Pollution Prevention and Toxics, 1984.

        III. Nonmandatory Transmission Electron Microscopy Method

                         A. Definitions of Terms

    1. Analytical sensitivity--Airborne asbestos concentration 
represented by each fiber counted under the electron microscope. It is 
determined by the air volume collected and the proportion of the filter 
examined. This method requires that the analytical sensitivity be no 
greater than 0.005 s/cm\3\.
    2. Asbestiform--A specific type of mineral fibrosity in which the 
fibers and fibrils possess high tensile strength and flexibility.
    3. Aspect ratio--A ratio of the length to the width of a particle. 
Minimum aspect ratio as defined by this method is equal to or greater 
than 5:1.
    4. Bundle--A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    5. Clean area--A controlled environment which is maintained and 
monitored to assure a low probability of asbestos contamination to 
materials in that space. Clean areas used in this method have HEPA 
filtered air under positive pressure and are capable of sustained 
operation with an open laboratory blank which on subsequent analysis has 
an average of less than 18 structures/mm\2\ in an area of 0.057 mm\2\ 
(nominally 10 200 mesh grid openings) and a maximum of 53 structures/
mm\2\ for no more than one single preparation for that same area.
    6. Cluster--A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    7. ED--Electron diffraction.
    8. EDXA--Energy dispersive X-ray analysis.
    9. Fiber--A structure greater than or equal to 0.5 [micro]m in 
length with an aspect ratio (length to width) of 5:1 or greater and 
having substantially parallel sides.

[[Page 327]]

    10. Grid--An open structure for mounting on the sample to aid in its 
examination in the TEM. The term is used here to denote a 200-mesh 
copper lattice approximately 3 mm in diameter.
    11. Intersection--Nonparallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater.
    12. Laboratory sample coordinator--That person responsible for the 
conduct of sample handling and the certification of the testing 
procedures.
    13. Filter background level--The concentration of structures per 
square millimeter of filter that is considered indistinguishable from 
the concentration measured on blanks (filters through which no air has 
been drawn). For this method the filter background level is defined as 
70 structures/mm\2\.
    14. Matrix--Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    15. NSD--No structure detected.
    16. Operator--A person responsible for the TEM instrumental analysis 
of the sample.
    17. PCM--Phase contrast microscopy.
    18. SAED--Selected area electron diffraction.
    19. SEM--Scanning electron microscope.
    20. STEM--Scanning transmission electron microscope.
    21. Structure--a microscopic bundle, cluster, fiber, or matrix which 
may contain asbestos.
    22. S/cm\3\--Structures per cubic centimeter.
    23. S/mm\2\--Structures per square millimeter.
    24. TEM--Transmission electron microscope.

                               B. Sampling

    1. Sampling operations must be performed by qualified individuals 
completely independent of the abatement contractor to avoid possible 
conflict of interest (See References 1, 2, and 5 of Unit III.L.) Special 
precautions should be taken to avoid contamination of the sample. For 
example, materials that have not been prescreened for their asbestos 
background content should not be used; also, sample handling procedures 
which do not take cross contamination possibilities into account should 
not be used.
    2. Material and supply checks for asbestos contamination should be 
made on all critical supplies, reagents, and procedures before their use 
in a monitoring study.
    3. Quality control and quality assurance steps are needed to 
identify problem areas and isolate the cause of the contamination (see 
Reference 5 of Unit III.L.). Control checks shall be permanently 
recorded to document the quality of the information produced. The 
sampling firm must have written quality control procedures and documents 
which verify compliance. Independent audits by a qualified consultant or 
firm should be performed once a year. All documentation of compliance 
should be retained indefinitely to provide a guarantee of quality. A 
summary of Sample Data Quality Objectives is shown in Table II of Unit 
II.B.
    4. Sampling materials.
    a. Sample for airborne asbestos following an abatement action using 
commercially available cassettes.
    b. Use either a cowling or a filter-retaining middle piece. 
Conductive material may reduce the potential for particulates to adhere 
to the walls of the cowl.
    c. Cassettes must be verified as ``clean'' prior to use in the 
field. If packaged filters are used for loading or preloaded cassettes 
are purchased from the manufacturer or a distributor, the manufacturer's 
name and lot number should be entered on all field data sheets provided 
to the laboratory, and are required to be listed on all reports from the 
laboratory.
    d. Assemble the cassettes in a clean facility (See definition of 
clean area under Unit III.A.).
    e. Reloading of used cassettes is not permitted.
    f. Use sample collection filters which are either polycarbonate 
having a pore size of less than or equal to 0.4 [micro]m or mixed 
cellulose ester having a pore size of less than or equal to 0.45 
[micro]m.
    g. Place these filters in series with a backup filter with a pore 
size of 5.0 [micro]m (to serve as a diffuser) and a support pad. See the 
following Figure 1:

[[Page 328]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.007

    h. When polycarbonate filters are used, position the highly 
reflective face such that the incoming particulate is received on this 
surface.
    i. Seal the cassettes to prevent leakage around the filter edges or 
between cassette part joints. A mechanical press may be useful to 
achieve a reproducible leak-free seal.

[[Page 329]]

Shrink fit gel-bands may be used for this purpose and are available from 
filter manufacturers and their authorized distributors.
    j. Use wrinkle-free loaded cassettes in the sampling operation.
    5. Pump setup.
    a. Calibrate the sampling pump over the range of flow rates and 
loads anticipated for the monitoring period with this flow measuring 
device in series. Perform this calibration using guidance from EPA 
Method 2A each time the unit is sent to the field (See Reference 6 of 
Unit III.L.).
    b. Configure the sampling system to preclude pump vibrations from 
being transmitted to the cassette by using a sampling stand separate 
from the pump station and making connections with flexible tubing.
    c. Maintain continuous smooth flow conditions by damping out any 
pump action fluctuations if necessary.
    d. Check the sampling system for leaks with the end cap still in 
place and the pump operating before initiating sample collection. Trace 
and stop the source of any flow indicated by the flowmeter under these 
conditions.
    e. Select an appropriate flow rate equal to or greater than 1 L/min 
or less than 10 L/min for 25 mm cassettes. Larger filters may be 
operated at proportionally higher flow rates.
    f. Orient the cassette downward at approximately 45 degrees from the 
horizontal.
    g. Maintain a log of all pertinent sampling information, such as 
pump identification number, calibration data, sample location, date, 
sample identification number, flow rates at the beginning, middle, and 
end, start and stop times, and other useful information or comments. Use 
of a sampling log form is recommended. See the following Figure 2:

[[Page 330]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.008

    h. Initiate a chain of custody procedure at the start of each 
sampling, if this is requested by the client.
    i. Maintain a close check of all aspects of the sampling operation 
on a regular basis.
    j. Continue sampling until at least the minimum volume is collected, 
as specified in the following Table I:

[[Page 331]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.009

    k. At the conclusion of sampling, turn the cassette upward before 
stopping the flow to minimize possible particle loss. If the sampling is 
resumed, restart the flow before reorienting the cassette downward. Note 
the condition of the filter at the conclusion of sampling.
    l. Double check to see that all information has been recorded on the 
data collection forms and that the cassette is securely closed and 
appropriately identified using a waterproof label. Protect cassettes in 
individual clean resealed polyethylene bags. Bags are to be used for 
storing cassette caps when they are removed for sampling purposes. Caps 
and plugs should only be removed or replaced using clean hands or clean 
disposable plastic gloves.
    m. Do not change containers if portions of these filters are taken 
for other purposes.

[[Page 332]]

    6. Minimum sample number per site. A minimum of 13 samples are to be 
collected for each testing consisting of the following:
    a. A minimum of five samples per abatement area.
    b. A minimum of five samples per ambient area positioned at 
locations representative of the air entering the abatement site.
    c. Two field blanks are to be taken by removing the cap for not more 
than 30 sec and replacing it at the time of sampling before sampling is 
initiated at the following places:
    i. Near the entrance to each ambient area.
    ii. At one of the ambient sites.
    (Note: Do not leave the blank open during the sampling period.)
    d. A sealed blank is to be carried with each sample set. This 
representative cassette is not to be opened in the field.
    7. Abatement area sampling.
    a. Conduct final clearance sampling only after the primary 
containment barriers have been removed; the abatement area has been 
thoroughly dried; and, it has passed visual inspection tests by 
qualified personnel. (See Reference 1 of Unit III.L.)
    b. Containment barriers over windows, doors, and air passageways 
must remain in place until the TEM clearance sampling and analysis is 
completed and results meet clearance test criteria. The final plastic 
barrier remains in place for the sampling period.
    c. Select sampling sites in the abatement area on a random basis to 
provide unbiased and representative samples.
    d. After the area has passed a thorough visual inspection, use 
aggressive sampling conditions to dislodge any remaining dust.
    i. Equipment used in aggressive sampling such as a leaf blower and/
or fan should be properly cleaned and decontaminated before use.
    ii. Air filtration units shall remain on during the air monitoring 
period.
    iii. Prior to air monitoring, floors, ceiling and walls shall be 
swept with the exhaust of a minimum one (1) horsepower leaf blower.
    iv. Stationary fans are placed in locations which will not interfere 
with air monitoring equipment. Fan air is directed toward the ceiling. 
One fan shall be used for each 10,000 ft\3\ of worksite.
    v. Monitoring of an abatement work area with high-volume pumps and 
the use of circulating fans will require electrical power. Electrical 
outlets in the abatement area may be used if available. If no such 
outlets are available, the equipment must be supplied with electricity 
by the use of extension cords and strip plug units. All electrical power 
supply equipment of this type must be approved Underwriter Laboratory 
equipment that has not been modified. All wiring must be grounded. 
Ground fault interrupters should be used. Extreme care must be taken to 
clean up any residual water and ensure that electrical equipment does 
not become wet while operational.
    vi. Low volume pumps may be carefully wrapped in 6-mil polyethylene 
to insulate the pump from the air. High volume pumps cannot be sealed in 
this manner since the heat of the motor may melt the plastic. The pump 
exhausts should be kept free.
    vii. If recleaning is necessary, removal of this equipment from the 
work area must be handled with care. It is not possible to completely 
decontaminate the pump motor and parts since these areas cannot be 
wetted. To minimize any problems in this area, all equipment such as 
fans and pumps should be carefully wet wiped prior to removal from the 
abatement area. Wrapping and sealing low volume pumps in 6-mil 
polyethylene will provide easier decontamination of this equipment. Use 
of clean water and disposable wipes should be available for this 
purpose.
    e. Pump flow rate equal to or greater than 1 L/min or less than 10 
L/min may be used for 25 mm cassettes. The larger cassette diameters may 
have comparably increased flow.
    f. Sample a volume of air sufficient to ensure the minimum 
quantitation limits. (See Table I of Unit III.B.5.j.)
    8. Ambient sampling.
    a. Position ambient samplers at locations representative of the air 
entering the abatement site. If makeup air entering the abatement site 
is drawn from another area of the building which is outside of the 
abatement area, place the pumps in the building, pumps should be placed 
out of doors located near the building and away from any obstructions 
that may influence wind patterns. If construction is in progress 
immediately outside the enclosure, it may be necessary to select another 
ambient site. Samples should be representative of any air entering the 
work site.
    b. Locate the ambient samplers at least 3 ft apart and protect them 
from adverse weather conditions.
    c. Sample same volume of air as samples taken inside the abatement 
site.

                           C. Sample Shipment

    1. Ship bulk samples in a separate container from air samples. Bulk 
samples and air samples delivered to the analytical laboratory in the 
same container shall be rejected.
    2. Select a rigid shipping container and pack the cassettes upright 
in a noncontaminating nonfibrous medium such as a bubble pack. The use 
of resealable polyethylene bags may help to prevent jostling of 
individual cassettes.
    3. Avoid using expanded polystyrene because of its static charge 
potential. Also avoid using particle-based packaging materials because 
of possible contamination.
    4. Include a shipping bill and a detailed listing of samples 
shipped, their descriptions

[[Page 333]]

and all identifying numbers or marks, sampling data, shipper's name, and 
contact information. For each sample set, designate which are the 
ambient samples, which are the abatement area samples, which are the 
field blanks, and which is the sealed blank if sequential analysis is to 
be performed.
    5. Hand-carry samples to the laboratory in an upright position if 
possible; otherwise choose that mode of transportation least likely to 
jar the samples in transit.
    6. Address the package to the laboratory sample coordinator by name 
when known and alert him or her of the package description, shipment 
mode, and anticipated arrival as part of the chain of custody and sample 
tracking procedures. This will also help the laboratory schedule timely 
analysis for the samples when they are received.

     D. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards is performed along with 
the sample analysis as indicators that the materials used are adequate 
and the operations are within acceptable limits. In this way, the 
quality of the data is defined, and the results are of known value. 
These checks and tests also provide timely and specific warning of any 
problems which might develop within the sampling and analysis 
operations. A description of these quality control/quality assurance 
procedures is summarized in the text below.
    1. Prescreen the loaded cassette collection filters to assure that 
they do not contain concentrations of asbestos which may interfere with 
the analysis of the sample. A filter blank average of less than 18 s/
mm\2\ in an area of 0.057 mm\2\ (nominally 10 200-mesh grid openings) 
and a maximum of 53 s/mm\2\ for that same area for any single 
preparation is acceptable for this method.
    2. Calibrate sampling pumps and their flow indicators over the range 
of their intended use with a recognized standard. Assemble the sampling 
system with a representative filter--not the filter which will be used 
in sampling--before and after the sampling operation.
    3. Record all calibration information with the data to be used on a 
standard sampling form.
    4. Ensure that the samples are stored in a secure and representative 
location.
    5. Ensure that mechanical calibrations from the pump will be 
minimized to prevent transferral of vibration to the cassette.
    6. Ensure that a continuous smooth flow of negative pressure is 
delivered by the pump by installing a damping chamber if necessary.
    7. Open a loaded cassette momentarily at one of the indoor sampling 
sites when sampling is initiated. This sample will serve as an indoor 
field blank.
    8. Open a loaded cassette momentarily at one of the outdoor sampling 
sites when sampling is initiated. This sample will serve as an outdoor 
field blank.
    9. Carry a sealed blank into the field with each sample series. Do 
not open this cassette in the field.
    10. Perform a leak check of the sampling system at each indoor and 
outdoor sampling site by activating the pump with the closed sampling 
cassette in line. Any flow indicates a leak which must be eliminated 
before initiating the sampling operation.
    11. Ensure that the sampler is turned upright before interrupting 
the pump flow.
    12. Check that all samples are clearly labeled and that all 
pertinent information has been enclosed before transfer of the samples 
to the laboratory.

                           E. Sample Receiving

    1. Designate one individual as sample coordinator at the laboratory. 
While that individual will normally be available to receive samples, the 
coordinator may train and supervise others in receiving procedures for 
those times when he/she is not available.
    2. Adhere to the following procedures to ensure both the continued 
chain-of-custody and the accountability of all samples passing through 
the laboratory:
    a. Note the condition of the shipping package and data written on it 
upon receipt.
    b. Retain all bills of lading or shipping slips to document the 
shipper and delivery time.
    c. Examine the chain-of-custody seal, if any, and the package for 
its integrity.
    d. If there has been a break in the seal or substantive damage to 
the package, the sample coordinator shall immediately notify the shipper 
and a responsible laboratory manager before any action is taken to 
unpack the shipment.
    e. Packages with significant damage shall be accepted only by the 
responsible laboratory manager after discussions with the client.
    3. Unwrap the shipment in a clean, uncluttered facility. The sample 
coordinator or his or her designee will record the contents, including a 
description of each item and all identifying numbers or marks. A

[[Page 334]]

Sample Receiving Form to document this information is attached for use 
when necessary. (See the following Figure 3.)
[GRAPHIC] [TIFF OMITTED] TC01AP92.010


[[Page 335]]


    Note: The person breaking the chain-of-custody seal and itemizing 
the contents assumes responsibility for the shipment and signs documents 
accordingly.
    4. Assign a laboratory number and schedule an analysis sequence.
    5. Manage all chain-of-custody samples within the laboratory such 
that their integrity can be ensured and documented.

                          F. Sample Preparation

    1. Personnel not affiliated with the Abatement Contractor shall be 
used to prepare samples and conduct TEM analysis. Wet-wipe the exterior 
of the cassettes to minimize contamination possibilities before taking 
them to the clean sample preparation facility.
    2. Perform sample preparation in a well-equipped clean facility.
    Note: The clean area is required to have the following minimum 
characteristics. The area or hood must be capable of maintaining a 
positive pressure with make-up air being HEPA filtered. The cumulative 
analytical blank concentration must average less than 18 s/mm\2\ in an 
area of 0.057 s/mm\2\ (nominally 10 200-mesh grid openings) with no more 
than one single preparation to exceed 53 s/mm\2\ for that same area.
    3. Preparation areas for air samples must be separated from 
preparation areas for bulk samples. Personnel must not prepare air 
samples if they have previously been preparing bulk samples without 
performing appropriate personal hygiene procedures, i.e., clothing 
change, showering, etc.
    4. Preparation. Direct preparation techniques are required. The 
objective is to produce an intact carbon film containing the 
particulates from the filter surface which is sufficiently clear for TEM 
analysis. Currently recommended direct preparation procedures for 
polycarbonate (PC) and mixed cellulose ester (MCE) filters are described 
in Unit III.F.7. and 8. Sample preparation is a subject requiring 
additional research. Variation on those steps which do not substantively 
change the procedure, which improve filter clearing or which reduce 
contamination problems in a laboratory are permitted.
    a. Use only TEM grids that have had grid opening areas measured 
according to directions in Unit III.J.
    b. Remove the inlet and outlet plugs prior to opening the cassette 
to minimize any pressure differential that may be present.
    c. Examples of techniques used to prepare polycarbonate filters are 
described in Unit III.F.7.
    d. Examples of techniques used to prepare mixed cellulose ester 
filters are described in Unit III.F.8.
    e. Prepare multiple grids for each sample.
    f. Store the three grids to be measured in appropriately labeled 
grid holders or polyethylene capsules.
    5. Equipment.
    a. Clean area.
    b. Tweezers. Fine-point tweezers for handling of filters and TEM 
grids.
    c. Scalpel Holder and Curved No. 10 Surgical Blades.
    d. Microscope slides.
    e. Double-coated adhesive tape.
    f. Gummed page reinforcements.
    g. Micro-pipet with disposal tips 10 to 100 [micro]L variable 
volume.
    h. Vacuum coating unit with facilities for evaporation of carbon. 
Use of a liquid nitrogen cold trap above the diffusion pump will 
minimize the possibility of contamination of the filter surface by oil 
from the pumping system. The vacuum-coating unit can also be used for 
deposition of a thin film of gold.
    i. Carbon rod electrodes. Spectrochemically pure carbon rods are 
required for use in the vacuum evaporator for carbon coating of filters.
    j. Carbon rod sharpener. This is used to sharpen carbon rods to a 
neck. The use of necked carbon rods (or equivalent) allows the carbon to 
be applied to the filters with a minimum of heating.
    k. Low-temperature plasma asher. This is used to etch the surface of 
collapsed mixed cellulose ester (MCE) filters. The asher should be 
supplied with oxygen, and should be modified as necessary to provide a 
throttle or bleed valve to control the speed of the vacuum to minimize 
disturbance of the filter. Some early models of ashers admit air too 
rapidly, which may disturb particulates on the surface of the filter 
during the etching step.
    l. Glass petri dishes, 10 cm in diameter, 1 cm high. For prevention 
of excessive evaporation of solvent when these are in use, a good seal 
must be provided between the base and the lid. The seal can be improved 
by grinding the base and lid together with an abrasive grinding 
material.
    m. Stainless steel mesh.
    n. Lens tissue.
    o. Copper 200-mesh TEM grids, 3 mm in diameter, or equivalent.
    p. Gold 200-mesh TEM grids, 3 mm in diameter, or equivalent.
    q. Condensation washer.
    r. Carbon-coated, 200-mesh TEM grids, or equivalent.
    s. Analytical balance, 0.1 mg sensitivity.
    t. Filter paper, 9 cm in diameter.
    u. Oven or slide warmer. Must be capable of maintaining a 
temperature of 65-70 [deg]C.
    v. Polyurethane foam, 6 mm thickness.
    w. Gold wire for evaporation.
    6. Reagents.
    a. General. A supply of ultra-clean, fiber-free water must be 
available for washing of all components used in the analysis. Water

[[Page 336]]

that has been distilled in glass or filtered or deionized water is 
satisfactory for this purpose. Reagents must be fiber-free.
    b. Polycarbonate preparation method--chloroform.
    c. Mixed Cellulose Ester (MCE) preparation method--acetone or the 
Burdette procedure (Ref. 7 of Unit III.L.).
    7. TEM specimen preparation from polycarbonate filters.
    a. Specimen preparation laboratory. It is most important to ensure 
that contamination of TEM specimens by extraneous asbestos fibers is 
minimized during preparation.
    b. Cleaning of sample cassettes. Upon receipt at the analytical 
laboratory and before they are taken into the clean facility or laminar 
flow hood, the sample cassettes must be cleaned of any contamination 
adhering to the outside surfaces.
    c. Preparation of the carbon evaporator. If the polycarbonate filter 
has already been carbon-coated prior to receipt, the carbon coating step 
will be omitted, unless the analyst believes the carbon film is too 
thin. If there is a need to apply more carbon, the filter will be 
treated in the same way as an uncoated filter. Carbon coating must be 
performed with a high-vacuum coating unit. Units that are based on 
evaporation of carbon filaments in a vacuum generated only by an oil 
rotary pump have not been evaluated for this application, and must not 
be used. The carbon rods should be sharpened by a carbon rod sharpener 
to necks of about 4 mm long and 1 mm in diameter. The rods are installed 
in the evaporator in such a manner that the points are approximately 10 
to 12 cm from the surface of a microscope slide held in the rotating and 
tilting device.
    d. Selection of filter area for carbon coating. Before preparation 
of the filters, a 75 mm x 50 mm microscope slide is washed and dried. 
This slide is used to support strips of filter during the carbon 
evaporation. Two parallel strips of double-sided adhesive tape are 
applied along the length of the slide. Polycarbonate filters are easily 
stretched during handling, and cutting of areas for further preparation 
must be performed with great care. The filter and the MCE backing filter 
are removed together from the cassette and placed on a cleaned glass 
microscope slide. The filter can be cut with a curved scalpel blade by 
rocking the blade from the point placed in contact with the filter. The 
process can be repeated to cut a strip approximately 3 mm wide across 
the diameter of the filter. The strip of polycarbonate filter is 
separated from the corresponding strip of backing filter and carefully 
placed so that it bridges the gap between the adhesive tape strips on 
the microscope slide. The filter strip can be held with fine-point 
tweezers and supported underneath by the scalpel blade during placement 
on the microscope slide. The analyst can place several such strips on 
the same microscope slide, taking care to rinse and wet-wipe the scalpel 
blade and tweezers before handling a new sample. The filter strips 
should be identified by etching the glass slide or marking the slide 
using a marker insoluble in water and solvents. After the filter strip 
has been cut from each filter, the residual parts of the filter must be 
returned to the cassette and held in position by reassembly of the 
cassette. The cassette will then be archived for a period of 30 days or 
returned to the client upon request.
    e. Carbon coating of filter strips. The glass slide holding the 
filter strips is placed on the rotation-tilting device, and the 
evaporator chamber is evacuated. The evaporation must be performed in 
very short bursts, separated by some seconds to allow the electrodes to 
cool. If evaporation is too rapid, the strips of polycarbonate filter 
will begin to curl, which will lead to cross-linking of the surface 
material and make it relatively insoluble in chloroform. An experienced 
analyst can judge the thickness of carbon film to be applied, and some 
test should be made first on unused filters. If the film is too thin, 
large particles will be lost from the TEM specimen, and there will be 
few complete and undamaged grid openings on the specimen. If the coating 
is too thick, the filter will tend to curl when exposed to chloroform 
vapor and the carbon film may not adhere to the support mesh. Too thick 
a carbon film will also lead to a TEM image that is lacking in contrast, 
and the ability to obtain ED patterns will be compromised. The carbon 
film should be as thin as possible and remain intact on most of the grid 
openings of the TEM specimen intact.
    f. Preparation of the Jaffe washer. The precise design of the Jaffe 
washer is not considered important, so any one of the published designs 
may be used. A washer consisting of a simple stainless steel bridge is 
recommended. Several pieces of lens tissue approximately 1.0 cm x 0.5 cm 
are placed on the stainless steel bridge, and the washer is filled with 
chloroform to a level where the meniscus contacts the underside of the 
mesh, which results in saturation of the lens tissue. See References 8 
and 10 of Unit III.L.
    g. Placing of specimens into the Jaffe washer. The TEM grids are 
first placed on a piece of lens tissue so that individual grids can be 
picked up with tweezers. Using a curved scalpel blade, the analyst 
excises three 3 mm square pieces of the carbon-coated polycarbonate 
filter from the filter strip. The three squares are selected from the 
center of the strip and from two points between the outer periphery of 
the active surface and the center. The piece of filter is placed on a 
TEM specimen grid with the shiny side of the TEM grid facing upwards, 
and the whole assembly is placed boldly onto the saturated lens tissue 
in the Jaffe washer. If carbon-coated grids are used, the filter should 
be

[[Page 337]]

placed carbon-coated side down. The three excised squares of filters are 
placed on the same piece of lens tissue. Any number of separate pieces 
of lens tissue may be placed in the same Jaffe washer. The lid is then 
placed on the Jaffe washer, and the system is allowed to stand for 
several hours, preferably overnight.
    h. Condensation washing. It has been found that many polycarbonate 
filters will not dissolve completely in the Jaffe washer, even after 
being exposed to chloroform for as long as 3 days. This problem becomes 
more serious if the surface of the filter was overheated during the 
carbon evaporation. The presence of undissolved filter medium on the TEM 
preparation leads to partial or complete obscuration of areas of the 
sample, and fibers that may be present in these areas of the specimen 
will be overlooked; this will lead to a low result. Undissolved filter 
medium also compromises the ability to obtain ED patterns. Before they 
are counted, TEM grids must be examined critically to determine whether 
they are adequately cleared of residual filter medium. It has been found 
that condensation washing of the grids after the initial Jaffe washer 
treatment, with chloroform as the solvent, clears all residual filter 
medium in a period of approximately 1 hour. In practice, the piece of 
lens tissue supporting the specimen grids is transferred to the cold 
finger of the condensation washer, and the washer is operated for about 
1 hour. If the specimens are cleared satisfactorily by the Jaffe washer 
alone, the condensation washer step may be unnecessary.
    8. TEM specimen preparation from MCE filters.
    a. This method of preparing TEM specimens from MCE filters is 
similar to that specified in NIOSH Method 7402. See References 7, 8, and 
9 of Unit III.L.
    b. Upon receipt at the analytical laboratory, the sample cassettes 
must be cleaned of any contamination adhering to the outside surfaces 
before entering the clean sample preparation area.
    c. Remove a section from any quadrant of the sample and blank 
filters.
    d. Place the section on a clean microscope slide. Affix the filter 
section to the slide with a gummed paged reinforcement or other suitable 
means. Label the slide with a water and solvent-proof marking pen.
    e. Place the slide in a petri dish which contains several paper 
filters soaked with 2 to 3 mL acetone. Cover the dish. Wait 2 to 4 
minutes for the sample filter to fuse and clear.
    f. Plasma etching of the collapsed filter is required.
    i. The microscope slide to which the collapsed filter pieces are 
attached is placed in a plasma asher. Because plasma ashers vary greatly 
in their performance, both from unit to unit and between different 
positions in the asher chamber, it is difficult to specify the 
conditions that should be used. This is one area of the method that 
requires further evaluation. Insufficient etching will result in a 
failure to expose embedded filters, and too much etching may result in 
loss of particulate from the surface. As an interim measure, it is 
recommended that the time for ashing of a known weight of a collapsed 
filter be established and that the etching rate be calculated in terms 
of micrometers per second. The actual etching time used for a particular 
asher and operating conditions will then be set such that a 1-2 [micro]m 
(10 percent) layer of collapsed surface will be removed.
    ii. Place the slide containing the collapsed filters into a low-
temperature plasma asher, and etch the filter.
    g. Transfer the slide to a rotating stage inside the bell jar of a 
vacuum evaporator. Evaporate a 1 mm x 5 mm section of graphite rod onto 
the cleared filter. Remove the slide to a clean, dry, covered petri 
dish.
    h. Prepare a second petri dish as a Jaffe washer with the wicking 
substrate prepared from filter or lens paper placed on top of a 6 mm 
thick disk of clean spongy polyurethane foam. Cut a V-notch on the edge 
of the foam and filter paper. Use the V-notch as a reservoir for adding 
solvent. The wicking substrate should be thin enough to fit into the 
petri dish without touching the lid.
    i. Place carbon-coated TEM grids face up on the filter or lens 
paper. Label the grids by marking with a pencil on the filter paper or 
by putting registration marks on the petri dish lid and marking with a 
waterproof marker on the dish lid. In a fume hood, fill the dish with 
acetone until the wicking substrate is saturated. The level of acetone 
should be just high enough to saturate the filter paper without creating 
puddles.
    j. Remove about a quarter section of the carbon-coated filter 
samples from the glass slides using a surgical knife and tweezers. 
Carefully place the section of the filter, carbon side down, on the 
appropriately labeled grid in the acetone-saturated petri dish. When all 
filter sections have been transferred, slowly add more solvent to the 
wedge-shaped trough to bring the acetone level up to the highest 
possible level without disturbing the sample preparations. Cover the 
petri dish. Elevate one side of the petri dish by placing a slide under 
it. This allows drops of condensed solvent vapors to form near the edge 
rather than in the center where they would drip onto the grid 
preparation.

                              G. TEM Method

    1. Instrumentation.
    a. Use an 80-120 kV TEM capable of performing electron diffraction 
with a fluorescent screen inscribed with calibrated gradations. If the 
TEM is equipped with EDXA it must either have a STEM attachment or be 
capable of producing a spot less than 250 nm

[[Page 338]]

in diameter at crossover. The microscope shall be calibrated routinely 
(see Unit III.J.) for magnification and camera constant.
    b. While not required on every microscope in the laboratory, the 
laboratory must have either one microscope equipped with energy 
dispersive X-ray analysis or access to an equivalent system on a TEM in 
another laboratory. This must be an Energy Dispersive X-ray Detector 
mounted on TEM column and associated hardware/software to collect, save, 
and read out spectral information. Calibration of Multi-Channel Analyzer 
shall be checked regularly for A1 at 1.48 KeV and Cu at 8.04 KeV, as 
well as the manufacturer's procedures.
    i. Standard replica grating may be used to determine magnification 
(e.g., 2160 lines/mm).
    ii. Gold standard may be used to determine camera constant.
    c. Use a specimen holder with single tilt and/or double tilt 
capabilities.
    2. Procedure.
    a. Start a new Count Sheet for each sample to be analyzed. Record on 
count sheet: analyst's initials and date; lab sample number; client 
sample number microscope identification; magnification for analysis; 
number of predetermined grid openings to be analyzed; and grid 
identification. See the following Figure 4:

[[Page 339]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.011

    b. Check that the microscope is properly aligned and calibrated 
according to the manufacturer's specifications and instructions.
    c. Microscope settings: 80-120 kV, grid assessment 250-1000X, then 
15,000-20,000X screen magnification for analysis.
    d. Approximately one-half (0.5) of the predetermined sample area to 
be analyzed shall be performed on one sample grid preparation and the 
remaining half on a second sample grid preparation.
    e. Determine the suitability of the grid.

[[Page 340]]

    i. Individual grid openings with greater than 5 percent openings 
(holes) or covered with greater than 25 percent particulate matter or 
obviously having nonuniform loading shall not be analyzed.
    ii. Examine the grid at low magnification (<1000X) to determine its 
suitability for detailed study at higher magnifications.
    iii. Reject the grid if:
    (1) Less than 50 percent of the grid openings covered by the replica 
are intact.
    (2) It is doubled or folded.
    (3) It is too dark because of incomplete dissolution of the filter.
    iv. If the grid is rejected, load the next sample grid.
    v. If the grid is acceptable, continue on to Step 6 if mapping is to 
be used; otherwise proceed to Step 7.
    f. Grid Map (Optional).
    i. Set the TEM to the low magnification mode.
    ii. Use flat edge or finder grids for mapping.
    iii. Index the grid openings (fields) to be counted by marking the 
acceptable fields for one-half (0.5) of the area needed for analysis on 
each of the two grids to be analyzed. These may be marked just before 
examining each grid opening (field), if desired.
    iv. Draw in any details which will allow the grid to be properly 
oriented if it is reloaded into the microscope and a particular field is 
to be reliably identified.
    g. Scan the grid.
    i. Select a field to start the examination.
    ii. Choose the appropriate magnification (15,000 to 20,000X screen 
magnification).
    iii. Scan the grid as follows.
    (1) At the selected magnification, make a series of parallel 
traverses across the field. On reaching the end of one traverse, move 
the image one window and reverse the traverse.
    Note: A slight overlap should be used so as not to miss any part of 
the grid opening (field).
    (2) Make parallel traverses until the entire grid opening (field) 
has been scanned.
    h. Identify each structure for appearance and size.
    i. Appearance and size: Any continuous grouping of particles in 
which an asbestos fiber within aspect ratio greater than or equal to 5:1 
and a length greater than or equal to 0.5 [micro]m is detected shall be 
recorded on the count sheet. These will be designated asbestos 
structures and will be classified as fibers, bundles, clusters, or 
matrices. Record as individual fibers any contiguous grouping having 0, 
1, or 2 definable intersections. Groupings having more than 2 
intersections are to be described as cluster or matrix. See the 
following Figure 5:

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[GRAPHIC] [TIFF OMITTED] TC01AP92.012


[[Page 342]]


[GRAPHIC] [TIFF OMITTED] TC01AP92.013

An intersection is a non-parallel touching or crossing of fibers, with 
the projection having an aspect ratio of 5:1 or greater. Combinations 
such as a matrix and cluster, matrix and bundle, or bundle and cluster 
are categorized by the dominant fiber quality--cluster, bundle, and 
matrix, respectively. Separate categories will be maintained for fibers 
less than 5 [micro]m and for fibers greater than or equal to 5 [micro]m 
in length. Not required, but useful, may be to record the fiber length 
in 1 [micro]m intervals. (Identify each structure morphologically and 
analyze it as it enters the ``window''.)
    (1) Fiber. A structure having a minimum length greater than 0.5 
[micro]m and an aspect ratio (length to width) of 5:1 or greater and 
substantially parallel sides. Note the appearance of the end of the 
fiber, i.e., whether it is flat, rounded or dovetailed, no 
intersections.
    (2) Bundle. A structure composed of 3 or more fibers in a parallel 
arrangement with each fiber closer than one fiber diameter.
    (3) Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group; groupings must have more than 2 intersections.

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    (4) Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    (5) NSD. Record NSD when no structures are detected in the field.
    (6) Intersection. Non-parallel touching or crossing of fibers, with 
the projection having an aspect ratio 5:1 or greater.
    ii. Structure Measurement.
    (1) Recognize the structure that is to be sized.
    (2) Memorize its location in the ``window'' relative to the sides, 
inscribed square and to other particulates in the field so this exact 
location can be found again when scanning is resumed.
    (3) Measure the structure using the scale on the screen.
    (4) Record the length category and structure type classification on 
the count sheet after the field number and fiber number.
    (5) Return the fiber to its original location in the window and scan 
the rest of the field for other fibers; if the direction of travel is 
not remembered, return to the right side of the field and begin the 
traverse again.
    i. Visual identification of Electron Diffraction (ED) patterns is 
required for each asbestos structure counted which would cause the 
analysis to exceed the 70 s/mm\2\ concentration. (Generally this means 
the first four fibers identified as asbestos must exhibit an 
identifiable diffraction pattern for chrysotile or amphibole.)
    i. Center the structure, focus, and obtain an ED pattern. (See 
Microscope Instruction Manual for more detailed instructions.)
    ii. From a visual examination of the ED pattern, obtained with a 
short camera length, classify the observed structure as belonging to one 
of the following classifications: chrysotile, amphibole, or nonasbestos.
    (1) Chrysotile: The chrysotile asbestos pattern has characteristic 
streaks on the layer lines other than the central line and some 
streaking also on the central line. There will be spots of normal 
sharpness on the central layer line and on alternate lines (2nd, 4th, 
etc.). The repeat distance between layer lines is 0.53 nm and the center 
doublet is at 0.73 nm. The pattern should display (002), (110), (130) 
diffraction maxima; distances and geometry should match a chrysotile 
pattern and be measured semiquantitatively.
    (2) Amphibole Group [includes grunerite (amosite), crocidolite, 
anthophyllite, tremolite, and actinolite]: Amphibole asbestos fiber 
patterns show layer lines formed by very closely spaced dots, and the 
repeat distance between layer lines is also about 0.53 nm. Streaking in 
layer lines is occasionally present due to crystal structure defects.
    (3) Nonasbestos: Incomplete or unobtainable ED patterns, a 
nonasbestos EDXA, or a nonasbestos morphology.
    iii. The micrograph number of the recorded diffraction patterns must 
be reported to the client and maintained in the laboratory's quality 
assurance records. The records must also demonstrate that the 
identification of the pattern has been verified by a qualified 
individual and that the operator who made the identification is 
maintaining at least an 80 percent correct visual identification based 
on his measured patterns. In the event that examination of the pattern 
by the qualified individual indicates that the pattern had been 
misidentified visually, the client shall be contacted. If the pattern is 
a suspected chrysotile, take a photograph of the diffraction pattern at 
0 degrees tilt. If the structure is suspected to be amphibole, the 
sample may have to be tilted to obtain a simple geometric array of 
spots.
    j. Energy Dispersive X-Ray Analysis (EDXA).
    i. Required of all amphiboles which would cause the analysis results 
to exceed the 70 s/mm\2\ concentration. (Generally speaking, the first 4 
amphiboles would require EDXA.)
    ii. Can be used alone to confirm chrysotile after the 70 s/mm\2\ 
concentration has been exceeded.
    iii. Can be used alone to confirm all nonasbestos.
    iv. Compare spectrum profiles with profiles obtained from asbestos 
standards. The closest match identifies and categorizes the structure.
    v. If the EDXA is used for confirmation, record the properly labeled 
spectrum on a computer disk, or if a hard copy, file with analysis data.
    vi. If the number of fibers in the nonasbestos class would cause the 
analysis to exceed the 70 s/mm\2\ concentration, their identities must 
be confirmed by EDXA or measurement of a zone axis diffraction pattern 
to establish that the particles are nonasbestos.
    k. Stopping Rules.
    i. If more than 50 asbestiform structures are counted in a 
particular grid opening, the analysis may be terminated.
    ii. After having counted 50 asbestiform structures in a minimum of 4 
grid openings, the analysis may be terminated. The grid opening in which 
the 50th fiber was counted must be completed.
    iii. For blank samples, the analysis is always continued until 10 
grid openings have been analyzed.
    iv. In all other samples the analysis shall be continued until an 
analytical sensitivity of 0.005 s/cm\3\ is reached.
    l. Recording Rules. The count sheet should contain the following 
information:
    i. Field (grid opening): List field number.
    ii. Record ``NSD'' if no structures are detected.
    iii. Structure information.

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    (1) If fibers, bundles, clusters, and/or matrices are found, list 
them in consecutive numerical order, starting over with each field.
    (2) Length. Record length category of asbestos fibers examined. 
Indicate if less than 5 [micro]m or greater than or equal to 5 [micro]m.
    (3) Structure Type. Positive identification of asbestos fibers is 
required by the method. At least one diffraction pattern of each fiber 
type from every five samples must be recorded and compared with a 
standard diffraction pattern. For each asbestos fiber reported, both a 
morphological descriptor and an identification descriptor shall be 
specified on the count sheet.
    (4) Fibers classified as chrysotile must be identified by 
diffraction and/or X-ray analysis and recorded on the count sheet. X-ray 
analysis alone can be used as sole identification only after 70s/mm\2\ 
have been exceeded for a particular sample.
    (5) Fibers classified as amphiboles must be identified by X-ray 
analysis and electron diffraction and recorded on the count sheet. (X-
ray analysis alone can be used as sole identification only after 70s/
mm\2\ have been exceeded for a particular sample.)
    (6) If a diffraction pattern was recorded on film, the micrograph 
number must be indicated on the count sheet.
    (7) If an electron diffraction was attempted and an appropriate 
spectra is not observed, N should be recorded on the count sheet.
    (8) If an X-ray analysis is attempted but not observed, N should be 
recorded on the count sheet.
    (9) If an X-ray analysis spectrum is stored, the file and disk 
number must be recorded on the count sheet.
    m. Classification Rules.
    i. Fiber. A structure having a minimum length greater than or equal 
to 0.5 [micro]m and an aspect ratio (length to width) of 5:1 or greater 
and substantially parallel sides. Note the appearance of the end of the 
fiber, i.e., whether it is flat, rounded or dovetailed.
    ii. Bundle. A structure composed of three or more fibers in a 
parallel arrangement with each fiber closer than one fiber diameter.
    iii. Cluster. A structure with fibers in a random arrangement such 
that all fibers are intermixed and no single fiber is isolated from the 
group. Groupings must have more than two intersections.
    iv. Matrix. Fiber or fibers with one end free and the other end 
embedded in or hidden by a particulate. The exposed fiber must meet the 
fiber definition.
    v. NSD. Record NSD when no structures are detected in the field.
    n. After all necessary analyses of a particle structure have been 
completed, return the goniometer stage to 0 degrees, and return the 
structure to its original location by recall of the original location.
    o. Continue scanning until all the structures are identified, 
classified and sized in the field.
    p. Select additional fields (grid openings) at low magnification; 
scan at a chosen magnification (15,000 to 20,000X screen magnification); 
and analyze until the stopping rule becomes applicable.
    q. Carefully record all data as they are being collected, and check 
for accuracy.
    r. After finishing with a grid, remove it from the microscope, and 
replace it in the appropriate grid hold. Sample grids must be stored for 
a minimum of 1 year from the date of the analysis; the sample cassette 
must be retained for a minimum of 30 days by the laboratory or returned 
at the client's request.

                      H. Sample Analytical Sequence

    1. Carry out visual inspection of work site prior to air monitoring.
    2. Collect a minimum of five air samples inside the work site and 
five samples outside the work site. The indoor and outdoor samples shall 
be taken during the same time period.
    3. Analyze the abatement area samples according to this protocol. 
The analysis must meet the 0.005 s/cm\3\ analytical sensitivity.
    4. Remaining steps in the analytical sequence are contained in Unit 
IV. of this Appendix.

                              I. Reporting

    The following information must be reported to the client. See the 
following Table II:

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[GRAPHIC] [TIFF OMITTED] TC01AP92.014

    1. Concentration in structures per square millimeter and structures 
per cubic centimeter.
    2. Analytical sensitivity used for the analysis.
    3. Number of asbestos structures.
    4. Area analyzed.
    5. Volume of air samples (which was initially provided by client).
    6. Average grid size opening.
    7. Number of grids analyzed.
    8. Copy of the count sheet must be included with the report.

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    9. Signature of laboratory official to indicate that the laboratory 
met specifications of the AHERA method.
    10. Report form must contain official laboratory identification 
(e.g., letterhead).
    11. Type of asbestos.

                       J. Calibration Methodology

    Note: Appropriate implementation of the method requires a person 
knowledgeable in electron diffraction and mineral identification by ED 
and EDXA. Those inexperienced laboratories wishing to develop 
capabilities may acquire necessary knowledge through analysis of 
appropriate standards and by following detailed methods as described in 
References 8 and 10 of Unit III.L.
    1. Equipment Calibration. In this method, calibration is required 
for the air-sampling equipment and the transmission electron microscope 
(TEM).
    a. TEM Magnification. The magnification at the fluorescent screen of 
the TEM must be calibrated at the grid opening magnification (if used) 
and also at the magnification used for fiber counting. This is performed 
with a cross grating replica. A logbook must be maintained, and the 
dates of calibration depend on the past history of the particular 
microscope; no frequency is specified. After any maintenance of the 
microscope that involved adjustment of the power supplied to the lenses 
or the high-voltage system or the mechanical disassembly of the electron 
optical column apart from filament exchange, the magnification must be 
recalibrated. Before the TEM calibration is performed, the analyst must 
ensure that the cross grating replica is placed at the same distance 
from the objective lens as the specimens are. For instruments that 
incorporate an eucentric tilting specimen stage, all speciments and the 
cross grating replica must be placed at the eucentric position.
    b. Determination of the TEM magnification on the fluorescent screen.
    i. Define a field of view on the fluorescent screen either by 
markings or physical boundaries. The field of view must be measurable or 
previously inscribed with a scale or concentric circles (all scales 
should be metric).
    ii. Insert a diffraction grating replica (for example a grating 
containing 2,160 lines/mm) into the specimen holder and place into the 
microscope. Orient the replica so that the grating lines fall 
perpendicular to the scale on the TEM fluorescent screen. Ensure that 
the goniometer stage tilt is 0 degrees.
    iii. Adjust microscope magnification to 10,000X or 20,000X. Measure 
the distance (mm) between two widely separated lines on the grating 
replica. Note the number of spaces between the lines. Take care to 
measure between the same relative positions on the lines (e.g., between 
left edges of lines).
    Note: The more spaces included in the measurement, the more accurate 
the final calculation. On most microscopes, however, the magnification 
is substantially constant only within the central 8-10 cm diameter 
region of the fluorescent screen.
    iv. Calculate the true magnification (M) on the fluorescent screen:

M = XG/Y

where:

X = total distance (mm) between the designated grating lines;
G = calibration constant of the grating replica (lines/mm):
Y = number of grating replica spaces counted along X.

    c. Calibration of the EDXA System. Initially, the EDXA system must 
be calibrated by using two reference elements to calibrate the energy 
scale of the instrument. When this has been completed in accordance with 
the manufacturer's instructions, calibration in terms of the different 
types of asbestos can proceed. The EDXA detectors vary in both solid 
angle of detection and in window thickness. Therefore, at a particular 
accelerating voltage in use on the TEM, the count rate obtained from 
specific dimensions of fiber will vary both in absolute X-ray count rate 
and in the relative X-ray peak heights for different elements. Only a 
few minerals are relevant for asbestos abatement work, and in this 
procedure the calibration is specified in terms of a ``fingerprint'' 
technique. The EDXA spectra must be recorded from individual fibers of 
the relevant minerals, and identifications are made on the basis of 
semiquantitative comparisons with these reference spectra.
    d. Calibration of Grid Openings.
    i. Measure 20 grid openings on each of 20 random 200-mesh copper 
grids by placing a grid on a glass slide and examining it under the PCM. 
Use a calibrated graticule to measure the average field diameter and use 
this number to calculate the field area for an average grid opening. 
Grids are to be randomly selected from batches up to 1,000.
    Note: A grid opening is considered as one field.
    ii. The mean grid opening area must be measured for the type of 
specimen grids in use. This can be accomplished on the TEM at a properly 
calibrated low magnification or on an optical microscope at a 
magnification of approximately 400X by using an eyepiece fitted with a 
scale that has been calibrated against a stage micrometer. Optical 
microscopy utilizing manual or automated procedures may be used 
providing instrument calibration can be verified.
    e. Determination of Camera Constant and ED Pattern Analysis.
    i. The camera length of the TEM in ED operating mode must be 
calibrated before ED patterns on unknown samples are observed. This can 
be achieved by using a carbon-coated grid on which a thin film of gold 
has been

[[Page 347]]

sputtered or evaporated. A thin film of gold is evaporated on the 
specimen TEM grid to obtain zone-axis ED patterns superimposed with a 
ring pattern from the polycrystalline gold film.
    ii. In practice, it is desirable to optimize the thickness of the 
gold film so that only one or two sharp rings are obtained on the 
superimposed ED pattern. Thicker gold film would normally give multiple 
gold rings, but it will tend to mask weaker diffraction spots from the 
unknown fibrous particulates. Since the unknown d-spacings of most 
interest in asbestos analysis are those which lie closest to the 
transmitted beam, multiple gold rings are unnecessary on zone-axis ED 
patterns. An average camera constant using multiple gold rings can be 
determined. The camera constant is one-half the diameter, D, of the 
rings times the interplanar spacing, d, of the ring being measured.

     K. Quality Control/Quality Assurance Procedures (Data Quality 
                               Indicators)

    Monitoring the environment for airborne asbestos requires the use of 
sensitive sampling and analysis procedures. Because the test is 
sensitive, it may be influenced by a variety of factors. These include 
the supplies used in the sampling operation, the performance of the 
sampling, the preparation of the grid from the filter and the actual 
examination of this grid in the microscope. Each of these unit 
operations must produce a product of defined quality if the analytical 
result is to be a reliable and meaningful test result. Accordingly, a 
series of control checks and reference standards is performed along with 
the sample analysis as indicators that the materials used are adequate 
and the operations are within acceptable limits. In this way, the 
quality of the data is defined and the results are of known value. These 
checks and tests also provide timely and specific warning of any 
problems which might develop within the sampling and analysis 
operations. A description of these quality control/quality assurance 
procedures is summarized in the following Table III:

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[GRAPHIC] [TIFF OMITTED] TC01AP92.015

    1. When the samples arrive at the laboratory, check the samples and 
documentation for completeness and requirements before initiating the 
analysis.
    2. Check all laboratory reagents and supplies for acceptable 
asbestos background levels.
    3. Conduct all sample preparation in a clean room environment 
monitored by laboratory blanks and special testing after cleaning or 
servicing the room.
    4. Prepare multiple grids of each sample.
    5. Provide laboratory blanks with each sample batch. Maintain a 
cumulative average of these results. If this average is greater than 53 
f/mm\2\ per 10 200-mesh grid openings, check the system for possible 
sources of contamination.
    6. Check for recovery of asbestos from cellulose ester filters 
submitted to plasma asher.
    7. Check for asbestos carryover in the plasma asher by including a 
blank alongside the positive control sample.

[[Page 349]]

    8. Perform a systems check on the transmission electron microscope 
daily.
    9. Make periodic performance checks of magnification, electron 
diffraction and energy dispersive X-ray systems as set forth in Table 
III of Unit III.K.
    10. Ensure qualified operator performance by evaluation of replicate 
counting, duplicate analysis, and standard sample comparisons as set 
forth in Table III of Unit III.K.
    11. Validate all data entries.
    12. Recalculate a percentage of all computations and automatic data 
reduction steps as specified in Table III.
    13. Record an electron diffraction pattern of one asbestos structure 
from every five samples that contain asbestos. Verify the identification 
of the pattern by measurement or comparison of the pattern with patterns 
collected from standards under the same conditions.

The outline of quality control procedures presented above is viewed as 
the minimum required to assure that quality data is produced for 
clearance testing of an asbestos abated area. Additional information may 
be gained by other control tests. Specifics on those control procedures 
and options available for environmental testing can be obtained by 
consulting References 6, 7, and 11 of Unit III.L.

                              L. References

    For additional background information on this method the following 
references should be consulted.
    1. ``Guidelines for Controlling Asbestos-Containing Materials in 
Buildings,'' EPA 560/5-85-024, June 1985.
    2. ``Measuring Airborne Asbestos Following an Abatement Action,'' 
USEP/Office of Pollution Prevention and Toxics, EPA 600/4-85-049, 1985.
    3. Small, John and E. Steel. Asbestos Standards: Materials and 
Analytical Methods. N.B.S. Special Publication 619, 1982.
    4. Campbell, W.J., R.L. Blake, L.L. Brown, E.E. Cather, and J.J. 
Sjoberg. Selected Silicate Minerals and Their Asbestiform Varieties. 
Information Circular 8751, U.S. Bureau of Mines, 1977.
    5. Quality Assurance Handbook for Air Pollution Measurement System. 
Ambient Air Methods, EPA 600/4-77-027a, USEPA, Office of Research and 
Development, 1977.
    6. Method 2A: Direct Measurement of Gas Volume Through Pipes and 
Small Ducts. 40 CFR Part 60 Appendix A.
    7. Burdette, G.J. Health & Safety Exec., Research & Lab. Services 
Div., London, ``Proposed Analytical Method for Determination of Asbestos 
in Air.''
    8. Chatfield, E.J., Chatfield Tech. Cons., Ltd., Clark, T., PEI 
Assoc. ``Standard Operating Procedure for Determination of Airborne 
Asbestos Fibers by Transmission Electron Microscopy Using Polycarbonate 
Membrane Filters.'' WERL SOP 87-1, March 5, 1987.
    9. NIOSH. Method 7402 for Asbestos Fibers, December 11, 1986 Draft.
    10. Yamate, G., S.C. Agarwall, R.D. Gibbons, IIT Research Institute, 
``Methodology for the Measurement of Airborne Asbestos by Electron 
Microscopy.'' Draft report, USEPA Contract 68-02-3266, July 1984.
    11. Guidance to the Preparation of Quality Assurance Project Plans. 
USEPA, Office of Pollution Prevention and Toxics, 1984.

IV. Mandatory Interpretation of Transmission Electron Microscopy Results 
               To Determine Completion of Response Actions

                             A. Introduction

    A response action is determined to be completed by TEM when the 
abatement area has been cleaned and the airborne asbestos concentration 
inside the abatement area is no higher than concentrations at locations 
outside the abatement area. ``Outside'' means outside the abatement 
area, but not necessarily outside the building. EPA reasons that an 
asbestos removal contractor cannot be expected to clean an abatement 
area to an airborne asbestos concentration that is lower than the 
concentration of air entering the abatement area from outdoors or from 
other parts of the building. After the abatement area has passed a 
thorough visual inspection, and before the outer containment barrier is 
removed, a minimum of five air samples inside the abatement area and a 
minimum of five air samples outside the abatement area must be 
collected. Hence, the response action is determined to be completed when 
the average airborne asbestos concentration measured inside the 
abatement area is not statistically different from the average airborne 
asbestos concentration measured outside the abatement area.
    The inside and outside concentrations are compared by the Z-test, a 
statistical test that takes into account the variability in the 
measurement process. A minimum of five samples inside the abatement area 
and five samples outside the abatement area are required to control the 
false negative error rate, i.e., the probability of declaring the 
removal complete when, in fact, the air concentration inside the 
abatement area is significantly higher than outside the abatement area. 
Additional quality control is provided by requiring three blanks 
(filters through which no air has been drawn) to be analyzed to check 
for unusually high filter contamination that would distort the test 
results.
    When volumes greater than or equal to 1,199 L for a 25 mm filter and 
2,799 L for a 37 mm filter have been collected and the average number of 
asbestos structures on samples inside the abatement area is no greater 
than 70 s/mm \2\ of filter, the response action

[[Page 350]]

may be considered complete without comparing the inside samples to the 
outside samples. EPA is permitting this initial screening test to save 
analysis costs in situations where the airborne asbestos concentration 
is sufficiently low so that it cannot be distinguished from the filter 
contamination/background level (fibers deposited on the filter that are 
unrelated to the air being sampled). The screening test cannot be used 
when volumes of less than 1,199 L for 25 mm filter or 2,799 L for a 37 
mm filter are collected because the ability to distinguish levels 
significantly different from filter background is reduced at low 
volumes.
    The initial screening test is expressed in structures per square 
millimeter of filter because filter background levels come from sources 
other than the air being sampled and cannot be meaningfully expressed as 
a concentration per cubic centimeter of air. The value of 70 s/mm \2\ is 
based on the experience of the panel of microscopists who consider one 
structure in 10 grid openings (each grid opening with an area of 0.0057 
mm \2\) to be comparable with contamination/background levels of blank 
filters. The decision is based, in part, on Poisson statistics which 
indicate that four structures must be counted on a filter before the 
fiber count is statistically distinguishable from the count for one 
structure. As more information on the performance of the method is 
collected, this criterion may be modified. Since different combinations 
of the number and size of grid openings are permitted under the TEM 
protocol, the criterion is expressed in structures per square millimeter 
of filter to be consistent across all combinations. Four structures per 
10 grid openings corresponds to approximately 70 s/mm\2\.

                    B. Sample Collection and Analysis

    1. A minimum of 13 samples is required: five samples collected 
inside the abatement area, five samples collected outside the abatement 
area, two field blanks, and one sealed blank.
    2. Sampling and TEM analysis must be done according to either the 
mandatory or nonmandatory protocols in Appendix A. At least 0.057 mm\2\ 
of filter must be examined on blank filters.

                      C. Interpretation of Results

    1. The response action shall be considered complete if either:
    a. Each sample collected inside the abatement area consists of at 
least 1,199 L of air for a 25 mm filter, or 2,799 L of air for a 37 mm 
filter, and the arithmetic mean of their asbestos structure 
concentrations per square millimeter of filter is less than or equal to 
70 s/mm \2\; or
    b. The three blank samples have an arithmetic mean of the asbestos 
structure concentration on the blank filters that is less than or equal 
to 70 s/mm \2\ and the average airborne asbestos concentration measured 
inside the abatement area is not statistically higher than the average 
airborne asbestos concentration measured outside the abatement area as 
determined by the Z-test. The Z-test is carried out by calculating
[GRAPHIC] [TIFF OMITTED] TC01AP92.016

where YI is the average of the natural logarithms of the 
inside samples and YO is the average of the natural 
logarithms of the outside samples, nI is the number of inside 
samples and nO is the number of outside samples. The response 
action is considered complete if Z is less than or equal to 1.65.
    Note: When no fibers are counted, the calculated detection limit for 
that analysis is inserted for the concentration.
    2. If the abatement site does not satisfy either (1) or (2) of this 
Section C, the site must be recleaned and a new set of samples 
collected.

                    D. Sequence for Analyzing Samples

    It is possible to determine completion of the response action 
without analyzing all samples. Also, at any point in the process, a 
decision may be made to terminate the analysis of existing samples, 
reclean the abatement site, and collect a new set of samples. The 
following sequence is outlined to minimize the number of analyses needed 
to reach a decision.
    1. Analyze the inside samples.
    2. If at least 1,199 L of air for a 25 mm filter or 2,799 L of air 
for a 37 mm filter is collected for each inside sample and the 
arithmetic mean concentration of structures per square millimeter of 
filter is less than or equal to 70 s/mm \2\, the response action is 
complete and no further analysis is needed.
    3. If less than 1,199 L of air for a 25 mm filter or 2,799 L of air 
for a 37 mm filter is collected for any of the inside samples, or the 
arithmetic mean concentration of structures per square millimeter of 
filter is greater than 70 s/mm \2\, analyze the three blanks.
    4. If the arithmetic mean concentration of structures per square 
millimeter on the blank filters is greater than 70 s/mm \2\, terminate 
the analysis, identify and correct the source of blank contamination, 
and collect a new set of samples.
    5. If the arithmetic mean concentration of structures per square 
millimeter on the blank filters is less than or equal to 70 s/mm\2\, 
analyze the outside samples and perform the Z-test.

[[Page 351]]

    6. If the Z-statistic is less than or equal to 1.65, the response 
action is complete. If the Z-statistic is greater than 1.65, reclean the 
abatement site and collect a new set of samples.

[52 FR 41857, Oct. 30, 1987]



           Sec. Appendix B to Subpart E of Part 763 [Reserved]



 Sec. Appendix C to Subpart E of Part 763--Asbestos Model Accreditation 
                                  Plan

             I. Asbestos Model Accreditation Plan for States

    The Asbestos Model Accreditation Plan (MAP) for States has eight 
components:
    (A) Definitions
    (B) Initial Training
    (C) Examinations
    (D) Continuing Education
    (E) Qualifications
    (F) Recordkeeping Requirements for Training Providers
    (G) Deaccreditation
    (H) Reciprocity
    (I) Electronic reporting
A. Definitions
    For purposes of Appendix C:
    1. ``Friable asbestos-containing material (ACM)'' means any material 
containing more than one percent asbestos which has been applied on 
ceilings, walls, structural members, piping, duct work, or any other 
part of a building, which when dry, may be crumbled, pulverized, or 
reduced to powder by hand pressure. The term includes non-friable 
asbestos-containing material after such previously non-friable material 
becomes damaged to the extent that when dry it may be crumbled, 
pulverized, or reduced to powder by hand pressure.
    2. ``Friable asbestos-containing building material (ACBM)'' means 
any friable ACM that is in or on interior structural members or other 
parts of a school or public and commercial building.
    3. ``Inspection'' means an activity undertaken in a school building, 
or a public and commercial building, to determine the presence or 
location, or to assess the condition of, friable or non-friable 
asbestos-containing building material (ACBM) or suspected ACBM, whether 
by visual or physical examination, or by collecting samples of such 
material. This term includes reinspections of friable and non-friable 
known or assumed ACBM which has been previously identified. The term 
does not include the following:
    a. Periodic surveillance of the type described in 40 CFR 763.92(b) 
solely for the purpose of recording or reporting a change in the 
condition of known or assumed ACBM;
    b. Inspections performed by employees or agents of Federal, State, 
or local government solely for the purpose of determining compliance 
with applicable statutes or regulations; or
    c. visual inspections of the type described in 40 CFR 763.90(i) 
solely for the purpose of determining completion of response actions.
    4. ``Major fiber release episode'' means any uncontrolled or 
unintentional disturbance of ACBM, resulting in a visible emission, 
which involves the falling or dislodging of more than 3 square or linear 
feet of friable ACBM.
    5. ``Minor fiber release episode'' means any uncontrolled or 
unintentional disturbance of ACBM, resulting in a visible emission, 
which involves the falling or dislodging of 3 square or linear feet or 
less of friable ACBM.
    6. ``Public and commercial building'' means the interior space of 
any building which is not a school building, except that the term does 
not include any residential apartment building of fewer than 10 units or 
detached single-family homes. The term includes, but is not limited to: 
industrial and office buildings, residential apartment buildings and 
condominiums of 10 or more dwelling units, government-owned buildings, 
colleges, museums, airports, hospitals, churches, preschools, stores, 
warehouses and factories. Interior space includes exterior hallways 
connecting buildings, porticos, and mechanical systems used to condition 
interior space.
    7. ``Response action'' means a method, including removal, 
encapsulation, enclosure, repair, and operation and maintenance, that 
protects human health and the environment from friable ACBM.
    8. ``Small-scale, short-duration activities (SSSD)'' are tasks such 
as, but not limited to:
    a. Removal of asbestos-containing insulation on pipes.
    b. Removal of small quantities of asbestos-containing insulation on 
beams or above ceilings.
    c. Replacement of an asbestos-containing gasket on a valve.
    d. Installation or removal of a small section of drywall.
    e. Installation of electrical conduits through or proximate to 
asbestos-containing materials.
    SSSD can be further defined by the following considerations:
    f. Removal of small quantities of ACM only if required in the 
performance of another maintenance activity not intended as asbestos 
abatement.
    g. Removal of asbestos-containing thermal system insulation not to 
exceed amounts greater than those which can be contained in a single 
glove bag.
    h. Minor repairs to damaged thermal system insulation which do not 
require removal.
    i. Repairs to a piece of asbestos-containing wallboard.

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    j. Repairs, involving encapsulation, enclosure, or removal, to small 
amounts of friable ACM only if required in the performance of emergency 
or routine maintenance activity and not intended solely as asbestos 
abatement. Such work may not exceed amounts greater than those which can 
be contained in a single prefabricated mini-enclosure. Such an enclosure 
shall conform spatially and geometrically to the localized work area, in 
order to perform its intended containment function.

                           B. Initial Training

    Training requirements for purposes of accreditation are specified 
both in terms of required subjects of instruction and in terms of length 
of training. Each initial training course has a prescribed curriculum 
and number of days of training. One day of training equals 8 hours, 
including breaks and lunch. Course instruction must be provided by EPA 
or State-approved instructors. EPA or State instructor approval shall be 
based upon a review of the instructor's academic credentials and/or 
field experience in asbestos abatement.
    Beyond the initial training requirements, individual States may wish 
to consider requiring additional days of training for purposes of 
supplementing hands-on activities or for reviewing relevant state 
regulations. States also may wish to consider the relative merits of a 
worker apprenticeship program. Further, they might consider more 
stringent minimum qualification standards for the approval of training 
instructors. EPA recommends that the enrollment in any given course be 
limited to 25 students so that adequate opportunities exist for 
individual hands-on experience.
    States have the option to provide initial training directly or 
approve other entities to offer training. The following requirements are 
for the initial training of persons required to have accreditation under 
TSCA Title II.
    Training requirements for each of the five accredited disciplines 
are outlined below. Persons in each discipline perform a different job 
function and distinct role. Inspectors identify and assess the condition 
of ACBM, or suspect ACBM. Management planners use data gathered by 
inspectors to assess the degree of hazard posed by ACBM in schools to 
determine the scope and timing of appropriate response actions needed 
for schools. Project designers determine how asbestos abatement work 
should be conducted. Lastly, workers and contractor/supervisors carry 
out and oversee abatement work. In addition, a recommended training 
curriculum is also presented for a sixth discipline, which is not 
federally-accredited, that of ``Project Monitor.'' Each accredited 
discipline and training curriculum is separate and distinct from the 
others. A person seeking accreditation in any of the five accredited MAP 
disciplines cannot attend two or more courses concurrently, but may 
attend such courses sequentially.
    In several instances, initial training courses for a specific 
discipline (e.g., workers, inspectors) require hands-on training. For 
asbestos abatement contractor/supervisors and workers, hands-on training 
should include working with asbestos-substitute materials, fitting and 
using respirators, use of glovebags, donning protective clothing, and 
constructing a decontamination unit as well as other abatement work 
activities.

                               1. Workers

    A person must be accredited as a worker to carry out any of the 
following activities with respect to friable ACBM in a school or public 
and commercial building: (1) A response action other than a SSSD 
activity, (2) a maintenance activity that disturbs friable ACBM other 
than a SSSD activity, or (3) a response action for a major fiber release 
episode. All persons seeking accreditation as asbestos abatement workers 
shall complete at least a 4-day training course as outlined below. The 
4-day worker training course shall include lectures, demonstrations, at 
least 14 hours of hands-on training, individual respirator fit testing, 
course review, and an examination. Hands-on training must permit workers 
to have actual experience performing tasks associated with asbestos 
abatement. A person who is otherwise accredited as a contractor/
supervisor may perform in the role of a worker without possessing 
separate accreditation as a worker.
    Because of cultural diversity associated with the asbestos 
workforce, EPA recommends that States adopt specific standards for the 
approval of foreign language courses for abatement workers. EPA further 
recommends the use of audio-visual materials to complement lectures, 
where appropriate.
    The training course shall adequately address the following topics:
    (a) Physical characteristics of asbestos. Identification of 
asbestos, aerodynamic characteristics, typical uses, and physical 
appearance, and a summary of abatement control options.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
periods for asbestos-related diseases; a discussion of the relationship 
of asbestos exposure to asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Employee personal protective equipment. Classes and 
characteristics of respirator

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types; limitations of respirators; proper selection, inspection; 
donning, use, maintenance, and storage procedures for respirators; 
methods for field testing of the facepiece-to-face seal (positive and 
negative-pressure fit checks); qualitative and quantitative fit testing 
procedures; variability between field and laboratory protection factors 
that alter respiratory fit (e.g., facial hair); the components of a 
proper respiratory protection program; selection and use of personal 
protective clothing; use, storage, and handling of non-disposable 
clothing; and regulations covering personal protective equipment.
    (d) State-of-the-art work practices. Proper work practices for 
asbestos abatement activities, including descriptions of proper 
construction; maintenance of barriers and decontamination enclosure 
systems; positioning of warning signs; lock-out of electrical and 
ventilation systems; proper working techniques for minimizing fiber 
release; use of wet methods; use of negative pressure exhaust 
ventilation equipment; use of high-efficiency particulate air (HEPA) 
vacuums; proper clean-up and disposal procedures; work practices for 
removal, encapsulation, enclosure, and repair of ACM; emergency 
procedures for sudden releases; potential exposure situations; transport 
and disposal procedures; and recommended and prohibited work practices.
    (e) Personal hygiene. Entry and exit procedures for the work area; 
use of showers; avoidance of eating, drinking, smoking, and chewing (gum 
or tobacco) in the work area; and potential exposures, such as family 
exposure.
    (f) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire and explosion 
hazards, scaffold and ladder hazards, slips, trips, and falls, and 
confined spaces.
    (g) Medical monitoring. OSHA and EPA Worker Protection Rule 
requirements for physical examinations, including a pulmonary function 
test, chest X-rays, and a medical history for each employee.
    (h) Air monitoring. Procedures to determine airborne concentrations 
of asbestos fibers, focusing on how personal air sampling is performed 
and the reasons for it.
    (i) Relevant Federal, State, and local regulatory requirements, 
procedures, and standards. With particular attention directed at 
relevant EPA, OSHA, and State regulations concerning asbestos abatement 
workers.
    (j) Establishment of respiratory protection programs.
    (k) Course review. A review of key aspects of the training course.

                        2. Contractor/Supervisors

    A person must be accredited as a contractor/supervisor to supervise 
any of the following activities with respect to friable ACBM in a school 
or public and commercial building: (1) A response action other than a 
SSSD activity, (2) a maintenance activity that disturbs friable ACBM 
other than a SSSD activity, or (3) a response action for a major fiber 
release episode. All persons seeking accreditation as asbestos abatement 
contractor/supervisors shall complete at least a 5-day training course 
as outlined below. The training course must include lectures, 
demonstrations, at least 14 hours of hands-on training, individual 
respirator fit testing, course review, and a written examination. Hands-
on training must permit supervisors to have actual experience performing 
tasks associated with asbestos abatement.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    Asbestos abatement supervisors include those persons who provide 
supervision and direction to workers performing response actions. 
Supervisors may include those individuals with the position title of 
foreman, working foreman, or leadman pursuant to collective bargaining 
agreements. At least one supervisor is required to be at the worksite at 
all times while response actions are being conducted. Asbestos workers 
must have access to accredited supervisors throughout the duration of 
the project.
    The contractor/supervisor training course shall adequately address 
the following topics:
    (a) The physical characteristics of asbestos and asbestos-containing 
materials. Identification of asbestos, aerodynamic characteristics, 
typical uses, physical appearance, a review of hazard assessment 
considerations, and a summary of abatement control options.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; synergism between 
cigarette smoking and asbestos exposure; and latency period for 
diseases.
    (c) Employee personal protective equipment. Classes and 
characteristics of respirator types; limitations of respirators; proper 
selection, inspection, donning, use, maintenance, and storage procedures 
for respirators; methods for field testing of the facepiece-to-face seal 
(positive and negative-pressure fit checks); qualitative and 
quantitative fit testing procedures; variability between field and 
laboratory protection factors that alter respiratory fit (e.g., facial 
hair); the components of a proper respiratory protection program; 
selection and use of personal protective clothing; and use, storage,

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and handling of non-disposable clothing; and regulations covering 
personal protective equipment.
    (d) State-of-the-art work practices. Proper work practices for 
asbestos abatement activities, including descriptions of proper 
construction and maintenance of barriers and decontamination enclosure 
systems; positioning of warning signs; lock-out of electrical and 
ventilation systems; proper working techniques for minimizing fiber 
release; use of wet methods; use of negative pressure exhaust 
ventilation equipment; use of HEPA vacuums; and proper clean-up and 
disposal procedures. Work practices for removal, encapsulation, 
enclosure, and repair of ACM; emergency procedures for unplanned 
releases; potential exposure situations; transport and disposal 
procedures; and recommended and prohibited work practices. New 
abatement-related techniques and methodologies may be discussed.
    (e) Personal hygiene. Entry and exit procedures for the work area; 
use of showers; and avoidance of eating, drinking, smoking, and chewing 
(gum or tobacco) in the work area. Potential exposures, such as family 
exposure, shall also be included.
    (f) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire and explosion 
hazards, scaffold and ladder hazards, slips, trips, and falls, and 
confined spaces.
    (g) Medical monitoring. OSHA and EPA Worker Protection Rule 
requirements for physical examinations, including a pulmonary function 
test, chest X-rays and a medical history for each employee.
    (h) Air monitoring. Procedures to determine airborne concentrations 
of asbestos fibers, including descriptions of aggressive air sampling, 
sampling equipment and methods, reasons for air monitoring, types of 
samples and interpretation of results.
    EPA recommends that transmission electron microscopy (TEM) be used 
for analysis of final air clearance samples, and that sample analyses be 
performed by laboratories accredited by the National Institute of 
Standards and Technology's (NIST) National Voluntary Laboratory 
Accreditation Program (NVLAP).
    (i) Relevant Federal, State, and local regulatory requirements, 
procedures, and standards, including:
    (i) Requirements of TSCA Title II.
    (ii) National Emission Standards for Hazardous Air Pollutants (40 
CFR part 61), Subparts A (General Provisions) and M (National Emission 
Standard for Asbestos).
    (iii) OSHA standards for permissible exposure to airborne 
concentrations of asbestos fibers and respiratory protection (29 CFR 
1910.134).
    (iv) OSHA Asbestos Construction Standard (29 CFR 1926.58). (v)EPA 
Worker Protection Rule, (40 CFR part 763, subpart G).
    (j) Respiratory Protection Programs and Medical Monitoring Programs.
    (k) Insurance and liability issues. Contractor issues; worker's 
compensation coverage and exclusions; third-party liabilities and 
defenses; insurance coverage and exclusions.
    (l) Recordkeeping for asbestos abatement projects. Records required 
by Federal, State, and local regulations; records recommended for legal 
and insurance purposes.
    (m) Supervisory techniques for asbestos abatement activities. 
Supervisory practices to enforce and reinforce the required work 
practices and discourage unsafe work practices.
    (n) Contract specifications. Discussions of key elements that are 
included in contract specifications.
    (o) Course review. A review of key aspects of the training course.

                              3. Inspector

    All persons who inspect for ACBM in schools or public and commercial 
buildings must be accredited. All persons seeking accreditation as an 
inspector shall complete at least a 3-day training course as outlined 
below. The course shall include lectures, demonstrations, 4 hours of 
hands-on training, individual respirator fit-testing, course review, and 
a written examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate. Hands-on training should include conducting 
a simulated building walk-through inspection and respirator fit testing. 
The inspector training course shall adequately address the following 
topics:
    (a) Background information on asbestos. Identification of asbestos, 
and examples and discussion of the uses and locations of asbestos in 
buildings; physical appearance of asbestos.
    (b) Potential health effects related to asbestos exposure. The 
nature of asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
periods for asbestos-related diseases; a discussion of the relationship 
of asbestos exposure to asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Functions/qualifications and role of inspectors. Discussions of 
prior experience and qualifications for inspectors and management 
planners; discussions of the functions of an accredited inspector as 
compared to those of an accredited management planner; discussion of 
inspection process including inventory of ACM and physical assessment.
    (d) Legal liabilities and defenses. Responsibilities of the 
inspector and management

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planner; a discussion of comprehensive general liability policies, 
claims-made, and occurrence policies, environmental and pollution 
liability policy clauses; state liability insurance requirements; 
bonding and the relationship of insurance availability to bond 
availability.
    (e) Understanding building systems. The interrelationship between 
building systems, including: an overview of common building physical 
plan layout; heat, ventilation, and air conditioning (HVAC) system 
types, physical organization, and where asbestos is found on HVAC 
components; building mechanical systems, their types and organization, 
and where to look for asbestos on such systems; inspecting electrical 
systems, including appropriate safety precautions; reading blueprints 
and as-built drawings.
    (f) Public/employee/building occupant relations. Notifying employee 
organizations about the inspection; signs to warn building occupants; 
tact in dealing with occupants and the press; scheduling of inspections 
to minimize disruptions; and education of building occupants about 
actions being taken.
    (g) Pre-inspection planning and review of previous inspection 
records. Scheduling the inspection and obtaining access; building record 
review; identification of probable homogeneous areas from blueprints or 
as-built drawings; consultation with maintenance or building personnel; 
review of previous inspection, sampling, and abatement records of a 
building; the role of the inspector in exclusions for previously 
performed inspections.
    (h) Inspecting for friable and non-friable ACM and assessing the 
condition of friable ACM. Procedures to follow in conducting visual 
inspections for friable and non-friable ACM; types of building materials 
that may contain asbestos; touching materials to determine friability; 
open return air plenums and their importance in HVAC systems; assessing 
damage, significant damage, potential damage, and potential significant 
damage; amount of suspected ACM, both in total quantity and as a 
percentage of the total area; type of damage; accessibility; material's 
potential for disturbance; known or suspected causes of damage or 
significant damage; and deterioration as assessment factors.
    (i) Bulk sampling/documentation of asbestos. Detailed discussion of 
the ``Simplified Sampling Scheme for Friable Surfacing Materials (EPA 
560/5-85-030a October 1985)''; techniques to ensure sampling in a 
randomly distributed manner for other than friable surfacing materials; 
sampling of non-friable materials; techniques for bulk sampling; 
inspector's sampling and repair equipment; patching or repair of damage 
from sampling; discussion of polarized light microscopy; choosing an 
accredited laboratory to analyze bulk samples; quality control and 
quality assurance procedures. EPA's recommendation that all bulk samples 
collected from school or public and commercial buildings be analyzed by 
a laboratory accredited under the NVLAP administered by NIST.
    (j) Inspector respiratory protection and personal protective 
equipment. Classes and characteristics of respirator types; limitations 
of respirators; proper selection, inspection; donning, use, maintenance, 
and storage procedures for respirators; methods for field testing of the 
facepiece-to-face seal (positive and negative-pressure fit checks); 
qualitative and quantitative fit testing procedures; variability between 
field and laboratory protection factors that alter respiratory fit 
(e.g., facial hair); the components of a proper respiratory protection 
program; selection and use of personal protective clothing; use, 
storage, and handling of non-disposable clothing.
    (k) Recordkeeping and writing the inspection report. Labeling of 
samples and keying sample identification to sampling location; 
recommendations on sample labeling; detailing of ACM inventory; 
photographs of selected sampling areas and examples of ACM condition; 
information required for inclusion in the management plan required for 
school buildings under TSCA Title II, section 203 (i)(1). EPA recommends 
that States develop and require the use of standardized forms for 
recording the results of inspections in schools or public or commercial 
buildings, and that the use of these forms be incorporated into the 
curriculum of training conducted for accreditation.
    (l) Regulatory review. The following topics should be covered: 
National Emission Standards for Hazardous Air Pollutants (NESHAP; 40 CFR 
part 61, subparts A and M); EPA Worker Protection Rule (40 CFR part 763, 
subpart G); OSHA Asbestos Construction Standard (29 CFR 1926.58); OSHA 
respirator requirements (29 CFR 1910.134); the Asbestos-Containing 
Materials in School Rule (40 CFR part 763, subpart E; applicable State 
and local regulations, and differences between Federal and State 
requirements where they apply, and the effects, if any, on public and 
nonpublic schools or commercial or public buildings.
    (m) Field trip. This includes a field exercise, including a walk-
through inspection; on-site discussion about information gathering and 
the determination of sampling locations; on-site practice in physical 
assessment; classroom discussion of field exercise.
    (n) Course review. A review of key aspects of the training course.

                          4. Management Planner

    All persons who prepare management plans for schools must be 
accredited. All persons seeking accreditation as management planners 
shall complete a 3-day inspector training course as outlined above and a 
2-day

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management planner training course. Possession of current and valid 
inspector accreditation shall be a prerequisite for admission to the 
management planner training course. The management planner course shall 
include lectures, demonstrations, course review, and a written 
examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    TSCA Title II does not require accreditation for persons performing 
the management planner role in public and commercial buildings. 
Nevertheless, such persons may find this training and accreditation 
helpful in preparing them to design or administer asbestos operations 
and maintenance programs for public and commercial buildings.
    The management planner training course shall adequately address the 
following topics:
    (a) Course overview. The role and responsibilities of the management 
planner; operations and maintenance programs; setting work priorities; 
protection of building occupants.
    (b) Evaluation/interpretation of survey results. Review of TSCA 
Title II requirements for inspection and management plans for school 
buildings as given in section 203(i)(1) of TSCA Title II; interpretation 
of field data and laboratory results; comparison of field inspector's 
data sheet with laboratory results and site survey.
    (c) Hazard assessment. Amplification of the difference between 
physical assessment and hazard assessment; the role of the management 
planner in hazard assessment; explanation of significant damage, damage, 
potential damage, and potential significant damage; use of a description 
(or decision tree) code for assessment of ACM; assessment of friable 
ACM; relationship of accessibility, vibration sources, use of adjoining 
space, and air plenums and other factors to hazard assessment.
    (d) Legal implications. Liability; insurance issues specific to 
planners; liabilities associated with interim control measures, in-house 
maintenance, repair, and removal; use of results from previously 
performed inspections.
    (e) Evaluation and selection of control options. Overview of 
encapsulation, enclosure, interim operations and maintenance, and 
removal; advantages and disadvantages of each method; response actions 
described via a decision tree or other appropriate method; work 
practices for each response action; staging and prioritizing of work in 
both vacant and occupied buildings; the need for containment barriers 
and decontamination in response actions.
    (f) Role of other professionals. Use of industrial hygienists, 
engineers, and architects in developing technical specifications for 
response actions; any requirements that may exist for architect sign-off 
of plans; team approach to design of high-quality job specifications.
    (g) Developing an operations and maintenance (O&M) plan. Purpose of 
the plan; discussion of applicable EPA guidance documents; what actions 
should be taken by custodial staff; proper cleaning procedures; steam 
cleaning and HEPA vacuuming; reducing disturbance of ACM; scheduling O&M 
for off-hours; rescheduling or canceling renovation in areas with ACM; 
boiler room maintenance; disposal of ACM; in-house procedures for ACM--
bridging and penetrating encapsulants; pipe fittings; metal sleeves; 
polyvinyl chloride (PVC), canvas, and wet wraps; muslin with straps, 
fiber mesh cloth; mineral wool, and insulating cement; discussion of 
employee protection programs and staff training; case study in 
developing an O&M plan (development, implementation process, and 
problems that have been experienced).
    (h) Regulatory review. Focusing on the OSHA Asbestos Construction 
Standard found at 29 CFR 1926.58; the National Emission Standard for 
Hazardous Air Pollutants (NESHAP) found at 40 CFR part 61, Subparts A 
(General Provisions) and M (National Emission Standard for Asbestos); 
EPA Worker Protection Rule found at 40 CFR part 763, subpart G; TSCA 
Title II; applicable State regulations.
    (i) Recordkeeping for the management planner. Use of field 
inspector's data sheet along with laboratory results; on-going 
recordkeeping as a means to track asbestos disturbance; procedures for 
recordkeeping. EPA recommends that States require the use of 
standardized forms for purposes of management plans and incorporate the 
use of such forms into the initial training course for management 
planners.
    (j) Assembling and submitting the management plan. Plan requirements 
for schools in TSCA Title II section 203(i)(1); the management plan as a 
planning tool.
    (k) Financing abatement actions. Economic analysis and cost 
estimates; development of cost estimates; present costs of abatement 
versus future operation and maintenance costs; Asbestos School Hazard 
Abatement Act grants and loans.
    (l) Course review. A review of key aspects of the training course.

                           5. Project Designer

    A person must be accredited as a project designer to design any of 
the following activities with respect to friable ACBM in a school or 
public and commercial building: (1) A response action other than a SSSD 
maintenance activity, (2) a maintenance activity that disturbs friable 
ACBM other than a SSSD maintenance activity, or (3) a response action 
for a major fiber release episode. All persons seeking accreditation as 
a project designer shall complete at least a minimum

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3-day training course as outlined below. The project designer course 
shall include lectures, demonstrations, a field trip, course review and 
a written examination.
    EPA recommends the use of audiovisual materials to complement 
lectures, where appropriate.
    The abatement project designer training course shall adequately 
address the following topics:
    (a) Background information on asbestos. Identification of asbestos; 
examples and discussion of the uses and locations of asbestos in 
buildings; physical appearance of asbestos.
    (b) Potential health effects related to asbestos exposure. Nature of 
asbestos-related diseases; routes of exposure; dose-response 
relationships and the lack of a safe exposure level; the synergistic 
effect between cigarette smoking and asbestos exposure; the latency 
period of asbestos-related diseases; a discussion of the relationship 
between asbestos exposure and asbestosis, lung cancer, mesothelioma, and 
cancers of other organs.
    (c) Overview of abatement construction projects. Abatement as a 
portion of a renovation project; OSHA requirements for notification of 
other contractors on a multi-employer site (29 CFR 1926.58).
    (d) Safety system design specifications. Design, construction, and 
maintenance of containment barriers and decontamination enclosure 
systems; positioning of warning signs; electrical and ventilation system 
lock-out; proper working techniques for minimizing fiber release; entry 
and exit procedures for the work area; use of wet methods; proper 
techniques for initial cleaning; use of negative-pressure exhaust 
ventilation equipment; use of HEPA vacuums; proper clean-up and disposal 
of asbestos; work practices as they apply to encapsulation, enclosure, 
and repair; use of glove bags and a demonstration of glove bag use.
    (e) Field trip. A visit to an abatement site or other suitable 
building site, including on-site discussions of abatement design and 
building walk-through inspection. Include discussion of rationale for 
the concept of functional spaces during the walk-through.
    (f) Employee personal protective equipment. Classes and 
characteristics of respirator types; limitations of respirators; proper 
selection, inspection; donning, use, maintenance, and storage procedures 
for respirators; methods for field testing of the facepiece-to-face seal 
(positive and negative-pressure fit checks); qualitative and 
quantitative fit testing procedures; variability between field and 
laboratory protection factors that alter respiratory fit (e.g., facial 
hair); the components of a proper respiratory protection program; 
selection and use of personal protective clothing; use, storage, and 
handling of non-disposable clothing.
    (g) Additional safety hazards. Hazards encountered during abatement 
activities and how to deal with them, including electrical hazards, heat 
stress, air contaminants other than asbestos, fire, and explosion 
hazards.
    (h) Fiber aerodynamics and control. Aerodynamic characteristics of 
asbestos fibers; importance of proper containment barriers; settling 
time for asbestos fibers; wet methods in abatement; aggressive air 
monitoring following abatement; aggressive air movement and negative-
pressure exhaust ventilation as a clean-up method.
    (i) Designing abatement solutions. Discussions of removal, 
enclosure, and encapsulation methods; asbestos waste disposal.
    (j) Final clearance process. Discussion of the need for a written 
sampling rationale for aggressive final air clearance; requirements of a 
complete visual inspection; and the relationship of the visual 
inspection to final air clearance.
    EPA recommends the use of TEM for analysis of final air clearance 
samples. These samples should be analyzed by laboratories accredited 
under the NIST NVLAP.
    (k) Budgeting/cost estimating. Development of cost estimates; 
present costs of abatement versus future operation and maintenance 
costs; setting priorities for abatement jobs to reduce costs.
    (l) Writing abatement specifications. Preparation of and need for a 
written project design; means and methods specifications versus 
performance specifications; design of abatement in occupied buildings; 
modification of guide specifications for a particular building; worker 
and building occupant health/medical considerations; replacement of ACM 
with non-asbestos substitutes.
    (m) Preparing abatement drawings. Significance and need for 
drawings, use of as-built drawings as base drawings; use of inspection 
photographs and on-site reports; methods of preparing abatement 
drawings; diagramming containment barriers; relationship of drawings to 
design specifications; particular problems related to abatement 
drawings.
    (n) Contract preparation and administration.
    (o) Legal/liabilities/defenses. Insurance considerations; bonding; 
hold-harmless clauses; use of abatement contractor's liability 
insurance; claims made versus occurrence policies.
    (p) Replacement. Replacement of asbestos with asbestos-free 
substitutes.
    (q) Role of other consultants. Development of technical 
specification sections by industrial hygienists or engineers; the multi-
disciplinary team approach to abatement design.
    (r) Occupied buildings. Special design procedures required in 
occupied buildings; education of occupants; extra monitoring 
recommendations; staging of work to minimize occupant exposure; 
scheduling of renovation to minimize exposure.

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    (s) Relevant Federal, State, and local regulatory requirements, 
procedures and standards, including, but not limited to:
    (i) Requirements of TSCA Title II.
    (ii) National Emission Standards for Hazardous Air Pollutants, (40 
CFR part 61) subparts A (General Provisions) and M (National Emission 
Standard for Asbestos).
    (iii) OSHA Respirator Standard found at 29 CFR 1910.134.
    (iv) EPA Worker Protection Rule found at 40 CFR part 763, subpart G.
    (v) OSHA Asbestos Construction Standard found at 29 CFR 1926.58.
    (vi) OSHA Hazard Communication Standard found at 29 CFR 1926.59.
    (t) Course review. A review of key aspects of the training course.

                           6. Project Monitor

    EPA recommends that States adopt training and accreditation 
requirements for persons seeking to perform work as project monitors. 
Project monitors observe abatement activities performed by contractors 
and generally serve as a building owner's representative to ensure that 
abatement work is completed according to specification and in compliance 
with all relevant statutes and regulations. They may also perform the 
vital role of air monitoring for purposes of determining final 
clearance. EPA recommends that a State seeking to accredit individuals 
as project monitors consider adopting a minimum 5-day training course 
covering the topics outlined below. The course outlined below consists 
of lectures and demonstrations, at least 6 hours of hands-on training, 
course review, and a written examination. The hands-on training 
component might be satisfied by having the student simulate 
participation in or performance of any of the relevant job functions or 
activities (or by incorporation of the workshop component described in 
item ``n'' below of this unit).
    EPA recommends that the project monitor training course adequately 
address the following topics:
    (a) Roles and responsibilities of the project monitor. Definition 
and responsibilities of the project monitor, including regulatory/
specification compliance monitoring, air monitoring, conducting visual 
inspections, and final clearance monitoring.
    (b) Characteristics of asbestos and asbestos-containing materials. 
Typical uses of asbestos; physical appearance of asbestos; review of 
asbestos abatement and control techniques; presentation of the health 
effects of asbestos exposure, including routes of exposure, dose-
response relationships, and latency periods for asbestos-related 
diseases.
    (c) Federal asbestos regulations. Overview of pertinent EPA 
regulations, including: NESHAP, 40 CFR part 61, subparts A and M; AHERA, 
40 CFR part 763, subpart E; and the EPA Worker Protection Rule, 40 CFR 
part 763, subpart G. Overview of pertinent OSHA regulations, including: 
Construction Industry Standard for Asbestos, 29 CFR 1926.58; Respirator 
Standard, 29 CFR 1910.134; and the Hazard Communication Standard, 29 CFR 
1926.59. Applicable State and local asbestos regulations; regulatory 
interrelationships.
    (d) Understanding building construction and building systems. 
Building construction basics, building physical plan layout; 
understanding building systems (HVAC, electrical, etc.); layout and 
organization, where asbestos is likely to be found on building systems; 
renovations and the effect of asbestos abatement on building systems.
    (e) Asbestos abatement contracts, specifications, and drawings. 
Basic provisions of the contract; relationships between principle 
parties, establishing chain of command; types of specifications, 
including means and methods, performance, and proprietary and 
nonproprietary; reading and interpreting records and abatement drawings; 
discussion of change orders; common enforcement responsibilities and 
authority of project monitor.
    (f) Response actions and abatement practices. Pre-work inspections; 
pre-work considerations, precleaning of the work area, removal of 
furniture, fixtures, and equipment; shutdown/modification of building 
systems; construction and maintenance of containment barriers, proper 
demarcation of work areas; work area entry/exit, hygiene practices; 
determining the effectiveness of air filtration equipment; techniques 
for minimizing fiber release, wet methods, continuous cleaning; 
abatement methods other than removal; abatement area clean-up 
procedures; waste transport and disposal procedures; contingency 
planning for emergency response.
    (g) Asbestos abatement equipment. Typical equipment found on an 
abatement project; air filtration devices, vacuum systems, negative 
pressure differential monitoring; HEPA filtration units, theory of 
filtration, design/construction of HEPA filtration units, qualitative 
and quantitative performance of HEPA filtration units, sizing the 
ventilation requirements, location of HEPA filtration units, qualitative 
and quantitative tests of containment barrier integrity; best available 
technology.
    (h) Personal protective equipment. Proper selection of respiratory 
protection; classes and characteristics of respirator types, limitations 
of respirators; proper use of other safety equipment, protective 
clothing selection, use, and proper handling, hard/bump hats, safety 
shoes; breathing air systems, high pressure v. low pressure, testing for 
Grade D air, determining proper backup air volumes.
    (i) Air monitoring strategies. Sampling equipment, sampling pumps 
(low v. high volume), flow regulating devices (critical and

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limiting orifices), use of fibrous aerosol monitors on abatement 
projects; sampling media, types of filters, types of cassettes, filter 
orientation, storage and shipment of filters; calibration techniques, 
primary calibration standards, secondary calibration standards, 
temperature/pressure effects, frequency of calibration, recordkeeping 
and field work documentation, calculations; air sample analysis, 
techniques available and limitations of AHERA on their use, transmission 
electron microscopy (background to sample preparation and analysis, air 
sample conditions which prohibit analysis, EPA's recommended technique 
for analysis of final air clearance samples), phase contrast microscopy 
(background to sample preparation, and AHERA's limits on the use of 
phase contrast microscopy), what each technique measures; analytical 
methodologies, AHERA TEM protocol, NIOSH 7400, OSHA reference method 
(non clearance), EPA recommendation for clearance (TEM); sampling 
strategies for clearance monitoring, types of air samples (personal 
breathing zone v. fixed-station area) sampling location and objectives 
(pre-abatement, during abatement, and clearance monitoring), number of 
samples to be collected, minimum and maximum air volumes, clearance 
monitoring (post-visual-inspection) (number of samples required, 
selection of sampling locations, period of sampling, aggressive 
sampling, interpretations of sampling results, calculations), quality 
assurance; special sampling problems, crawl spaces, acceptable samples 
for laboratory analysis, sampling in occupied buildings (barrier 
monitoring).
    (j) Safety and health issues other than asbestos. Confined-space 
entry, electrical hazards, fire and explosion concerns, ladders and 
scaffolding, heat stress, air contaminants other than asbestos, fall 
hazards, hazardous materials on abatement projects.
    (k) Conducting visual inspections. Inspections during abatement, 
visual inspections using the ASTM E1368 document; conducting inspections 
for completeness of removal; discussion of ``how clean is clean?''
    (l) Legal responsibilities and liabilities of project monitors. 
Specification enforcement capabilities; regulatory enforcement; 
licensing; powers delegated to project monitors through contract 
documents.
    (m) Recordkeeping and report writing. Developing project logs/daily 
logs (what should be included, who sees them); final report preparation; 
recordkeeping under Federal regulations.
    (n) Workshops (6 hours spread over 3 days). Contracts, 
specifications, and drawings: This workshop could consist of each 
participant being issued a set of contracts, specifications, and 
drawings and then being asked to answer questions and make 
recommendations to a project architect, engineer or to the building 
owner based on given conditions and these documents.
    Air monitoring strategies/asbestos abatement equipment: This 
workshop could consist of simulated abatement sites for which sampling 
strategies would have to be developed (i.e., occupied buildings, 
industrial situations). Through demonstrations and exhibition, the 
project monitor may also be able to gain a better understanding of the 
function of various pieces of equipment used on abatement projects (air 
filtration units, water filtration units, negative pressure monitoring 
devices, sampling pump calibration devices, etc.).
    Conducting visual inspections: This workshop could consist, ideally, 
of an interactive video in which a participant is ``taken through'' a 
work area and asked to make notes of what is seen. A series of questions 
will be asked which are designed to stimulate a person's recall of the 
area. This workshop could consist of a series of two or three videos 
with different site conditions and different degrees of cleanliness.

                             C. Examinations

    1. Each State shall administer a closed book examination or 
designate other entities such as State-approved providers of training 
courses to administer the closed-book examination to persons seeking 
accreditation who have completed an initial training course. 
Demonstration testing may also be included as part of the examination. A 
person seeking initial accreditation in a specific discipline must pass 
the examination for that discipline in order to receive accreditation. 
For example, a person seeking accreditation as an abatement project 
designer must pass the State's examination for abatement project 
designer.
    States may develop their own examinations, have providers of 
training courses develop examinations, or use standardized examinations 
developed for purposes of accreditation under TSCA Title II. In 
addition, States may supplement standardized examinations with questions 
about State regulations. States may obtain commercially developed 
standardized examinations, develop standardized examinations 
independently, or do so in cooperation with other States, or with 
commercial or non-profit providers on a regional or national basis. EPA 
recommends the use of standardized, scientifically-validated testing 
instruments, which may be beneficial in terms of both promoting 
competency and in fostering accreditation reciprocity between States.
    Each examination shall adequately cover the topics included in the 
training course for that discipline. Each person who completes a

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training course, passes the required examination, and fulfills whatever 
other requirements the State imposes must receive an accreditation 
certificate in a specific discipline. Whether a State directly issues 
accreditation certificates, or authorizes training providers to issue 
accreditation certificates, each certificate issued to an accredited 
person must contain the following minimum information:
    a. A unique certificate number
    b. Name of accredited person
    c. Discipline of the training course completed.
    d. Dates of the training course.
    e. Date of the examination.
    f. An expiration date of 1 year after the date upon which the person 
successfully completed the course and examination.
    g. The name, address, and telephone number of the training provider 
that issued the certificate.
    h. A statement that the person receiving the certificate has 
completed the requisite training for asbestos accreditation under TSCA 
Title II.
    States or training providers who reaccredit persons based upon 
completion of required refresher training must also provide 
accreditation certificates with all of the above information, except the 
examination date may be omitted if a State does not require a refresher 
examination for reaccreditation.
    Where a State licenses accredited persons but has authorized 
training providers to issue accreditation certificates, the State may 
issue licenses in the form of photo-identification cards. Where this 
applies, EPA recommends that the State licenses should include all of 
the same information required for the accreditation certificates. A 
State may also choose to issue photo-identification cards in addition to 
the required accreditation certificates.
    Accredited persons must have their initial and current accreditation 
certificates at the location where they are conducting work.
    2. The following are the requirements for examination in each 
discipline:
    a. Worker:
    i. 50 multiple-choice questions
    ii. Passing score: 70 percent correct
    b. Contractor/Supervisor:
    i. 100 multiple-choice questions
    ii. Passing score: 70 percent correct
    c. Inspector:
    i. 50 Multiple-choice questions
    ii. Passing score: 70 percent correct
    d. Management Planner:
    i. 50 Multiple-choice questions
    ii. Passing score: 70 percent correct
    e. Project Designer:
    i. 100 multiple-choice questions
    ii. Passing score: 70 percent correct

                         D. Continuing Education

    For all disciplines, a State's accreditation program shall include 
annual refresher training as a requirement for reaccreditation as 
indicated below:
    1. Workers: One full day of refresher training.
    2. Contractor/Supervisors: One full day of refresher training.
    3. Inspectors: One half-day of refresher training.
    4. Management Planners: One half-day of inspector refresher training 
and one half-day of refresher training for management planners.
    5. Project Designers: One full day of refresher training.
    The refresher courses shall be specific to each discipline. 
Refresher courses shall be conducted as separate and distinct courses 
and not combined with any other training during the period of the 
refresher course. For each discipline, the refresher course shall review 
and discuss changes in Federal, State, and local regulations, 
developments in state-of-the-art procedures, and a review of key aspects 
of the initial training course as determined by the State. After 
completing the annual refresher course, persons shall have their 
accreditation extended for an additional year from the date of the 
refresher course. A State may consider requiring persons to pass 
reaccreditation examinations at specific intervals (for example, every 3 
years).
    EPA recommends that States formally establish a 12-month grace 
period to enable formerly accredited persons with expired certificates 
to complete refresher training and have their accreditation status 
reinstated without having to re-take the initial training course.

                            E. Qualifications

    In addition to requiring training and an examination, a State may 
require candidates for accreditation to meet other qualification and/or 
experience standards that the State considers appropriate for some or 
all disciplines. States may choose to consider requiring qualifications 
similar to the examples outlined below for inspectors, management 
planners and project designers. States may modify these examples as 
appropriate. In addition, States may want to include some requirements 
based on experience in performing a task directly as a part of a job or 
in an apprenticeship role. They may also wish to consider additional 
criteria for the approval of training course instructors beyond those 
prescribed by EPA.
    1. Inspectors: Qualifications - possess a high school diploma. 
States may want to require an Associate's Degree in specific fields 
(e.g., environmental or physical sciences).

[[Page 361]]

    2. Management Planners: Qualifications - Registered architect, 
engineer, or certified industrial hygienist or related scientific field.
    3. Project Designers: Qualifications - registered architect, 
engineer, or certified industrial hygienist.
    4. Asbestos Training Course Instructor: Qualifications - academic 
credentials and/or field experience in asbestos abatement.
    EPA recommends that States prescribe minimum qualification standards 
for training instructors employed by training providers.

          F. Recordkeeping Requirements for Training Providers

    All approved providers of accredited asbestos training courses must 
comply with the following minimum recordkeeping requirements.
    1. Training course materials. A training provider must retain copies 
of all instructional materials used in the delivery of the classroom 
training such as student manuals, instructor notebooks and handouts.
    2. Instructor qualifications. A training provider must retain copies 
of all instructors' resumes, and the documents approving each instructor 
issued by either EPA or a State. Instructors must be approved by either 
EPA or a State before teaching courses for accreditation purposes. A 
training provider must notify EPA or the State, as appropriate, in 
advance whenever it changes course instructors. Records must accurately 
identify the instructors that taught each particular course for each 
date that a course is offered.
    3. Examinations. A training provider must document that each person 
who receives an accreditation certificate for an initial training course 
has achieved a passing score on the examination. These records must 
clearly indicate the date upon which the exam was administered, the 
training course and discipline for which the exam was given, the name of 
the person who proctored the exam, a copy of the exam, and the name and 
test score of each person taking the exam. The topic and dates of the 
training course must correspond to those listed on that person's 
accreditation certificate. States may choose to apply these same 
requirements to examinations for refresher training courses.
    4. Accreditation certificates. The training providers or States, 
whichever issues the accreditation certificate, shall maintain records 
that document the names of all persons who have been awarded 
certificates, their certificate numbers, the disciplines for which 
accreditation was conferred, training and expiration dates, and the 
training location. The training provider or State shall maintain the 
records in a manner that allows verification by telephone of the 
required information.
    5. Verification of certificate information. EPA recommends that 
training providers of refresher training courses confirm that their 
students possess valid accreditation before granting course admission. 
EPA further recommends that training providers offering the initial 
management planner training course verify that students have met the 
prerequisite of possessing valid inspector accreditation at the time of 
course admission.
    6. Records retention and access. (a) The training provider shall 
maintain all required records for a minimum of 3 years. The training 
provider, however, may find it advantageous to retain these records for 
a longer period of time.
    (b) The training provider must allow reasonable access to all of the 
records required by the MAP, and to any other records which may be 
required by States for the approval of asbestos training providers or 
the accreditation of asbestos training courses, to both EPA and to State 
Agencies, on request. EPA encourages training providers to make this 
information equally accessible to the general public.
    (c) If a training provider ceases to conduct training, the training 
provider shall notify the approving government body (EPA or the State) 
and give it the opportunity to take possession of that providers 
asbestos training records.

                           G. Deaccreditation

    1. States must establish criteria and procedures for deaccrediting 
persons accredited as workers, contractor/supervisors, inspectors, 
management planners, and project designers. States must follow their own 
administrative procedures in pursuing deaccreditation actions. At a 
minimum, the criteria shall include:
    (a) Performing work requiring accreditation at a job site without 
being in physical possession of initial and current accreditation 
certificates;
    (b) Permitting the duplication or use of one's own accreditation 
certificate by another;
    (c) Performing work for which accreditation has not been received; 
or
    (d) Obtaining accreditation from a training provider that does not 
have approval to offer training for the particular discipline from 
either EPA or from a State that has a contractor accreditation plan at 
least as stringent as the EPA MAP.
    EPA may directly pursue deaccreditation actions without reliance on 
State deaccreditation or enforcement authority or actions. In addition 
to the above-listed situations, the Administrator may suspend or revoke 
the accreditation of persons who have been subject to a final order 
imposing a civil penalty or convicted under section 16 of TSCA, 15 
U.S.C. 2615 or 2647, for violations of 40 CFR part 763, or section 113 
of the Clean

[[Page 362]]

Air Act, 42 U.S.C. 7413, for violations of 40 CFR part 61, subpart M.
    2. Any person who performs asbestos work requiring accreditation 
under section 206(a) of TSCA, 15 U.S.C. 2646(a), without such 
accreditation is in violation of TSCA. The following persons are not 
accredited for purposes of section 206(a) of TSCA:
    (a) Any person who obtains accreditation through fraudulent 
representation of training or examination documents;
    (b) Any person who obtains training documentation through fraudulent 
means;
    (c) Any person who gains admission to and completes refresher 
training through fraudulent representation of initial or previous 
refresher training documentation; or
    (d) Any person who obtains accreditation through fraudulent 
representation of accreditation requirements such as education, 
training, professional registration, or experience.

                             H. Reciprocity

    EPA recommends that each State establish reciprocal arrangements 
with other States that have established accreditation programs that meet 
or exceed the requirements of the MAP. Such arrangements might address 
cooperation in licensing determinations, the review and approval of 
training programs and/or instructors, candidate testing and exam 
administration, curriculum development, policy formulation, compliance 
monitoring, and the exchange of information and data. The benefits to be 
derived from these arrangements include a potential cost-savings from 
the reduction of duplicative activity and the attainment of a more 
professional accredited workforce as States are able to refine and 
improve the effectiveness of their programs based upon the experience 
and methods of other States.

                         I. Electronic Reporting

    States that choose to receive electronic documents must include, at 
a minimum, the requirements of 40 CFR Part 3--(Electronic reporting) in 
their programs.

        II. EPA Approval Process for State Accreditation Programs

    A. States may seek approval for a single discipline or all 
disciplines as specified in the MAP. For example, a State that currently 
only requires worker accreditation may receive EPA approval for that 
discipline alone. EPA encourages States that currently do not have 
accreditation requirements for all disciplines required under section 
206(b)(2) of TSCA, 15 U.S.C. 2646(b)(2), to seek EPA approval for those 
disciplines the State does accredit. As States establish accreditation 
requirements for the remaining disciplines, the requested information 
outlined below should be submitted to EPA as soon as possible. Any State 
that had an accreditation program approved by EPA under an earlier 
version of the MAP may follow the same procedures to obtain EPA approval 
of their accreditation program under this MAP.
    B. Partial approval of a State Program for the accreditation of one 
or more disciplines does not mean that the State is in full compliance 
with TSCA where the deadline for that State to have adopted a State Plan 
no less stringent than the MAP has already passed. State Programs which 
are at least as stringent as the MAP for one or more of the accredited 
disciplines may, however, accredit persons in those disciplines only.
    C. States seeking EPA approval or reapproval of accreditation 
programs shall submit the following information to the Regional Asbestos 
Coordinator at their EPA Regional office:
    1. A copy of the legislation establishing or upgrading the State's 
accreditation program (if applicable).
    2. A copy of the State's accreditation regulations or revised 
regulations.
    3. A letter to the Regional Asbestos Coordinator that clearly 
indicates how the State meets the program requirements of this MAP. 
Addresses for each of the Regional Asbestos Coordinators are shown 
below:
EPA, Region 1, Asbestos Coordinator, 5 Post Office Square--Suite 100 
(05-4), Boston, MA 02109-3912, (617) 918-1563.
EPA, Region II, (MS-500), Asbestos Coordinator, 2890 Woodbridge Ave., 
Edison, NJ 08837-3679, (908) 321-6671.
EPA, Region III, (3AT-33), Asbestos Coordinator, 841 Chestnut Bldg., 
Philadelphia, PA 19107, (215) 597-3160.
EPA, Region IV, Asbestos Coordinator, 345 Courtland St., N.E., Atlanta, 
GA 30365, (404) 347-5014.
EPA, Region V, (SP-14J), Asbestos Coordinator, 77 W. Jackson Blvd., 
Chicago, IL 60604-3590, (312) 886-6003.
EPA, Region VI, (ECD), Asbestos Coordinator, 1201 Elm Street, Suite 500, 
Dallas, TX 75270, (214) 655-2760.
EPA, Region VII, (WWPD/TOPE), Asbestos Coordinator, U.S. Environmental 
Protection Agency, 11201 Renner Boulevard, Lenexa, Kansas 66219. (800) 
223-0425 or (913) 551-7122.
EPA, Region VIII, (8AT-TS), Asbestos Coordinator, 1 Denver Place, Suite 
500 999 - 18th St., Denver, CO 80202-2405, (303) 293-1442.
EPA, Region IX, Asbestos NESHAPs Contact, Air Division (A-5), 75 
Hawthorne Street, San Francisco, CA 94105, (415) 972-3989.
EPA, Region X, (AT-083), Asbestos Coordinator, 1200 Sixth Ave., Seattle, 
WA 98101, (206) 553-4762.
    EPA maintains a listing of all those States that have applied for 
and received EPA approval for having accreditation requirements that are 
at least as stringent as the MAP for

[[Page 363]]

one or more disciplines. Any training courses approved by an EPA-
approved State Program are considered to be EPA-approved for purposes of 
accreditation.

                    III. Approval of Training Courses

    Individuals or groups wishing to sponsor training courses for 
disciplines required to be accredited under section 206(b)(1)(A) of 
TSCA, 15 U.S.C. 2646(b)(1)(A), may apply for approval from States that 
have accreditation program requirements that are at least as stringent 
as this MAP. For a course to receive approval, it must meet the 
requirements for the course as outlined in this MAP, and any other 
requirements imposed by the State from which approval is being sought. 
Courses that have been approved by a State with an accreditation program 
at least as stringent as this MAP are approved under section 206(a) of 
TSCA, 15 U.S.C. 2646(a), for that particular State, and also for any 
other State that does not have an accreditation program as stringent as 
this MAP.

                   A. Initial Training Course Approval

    A training provider must submit the following minimum information to 
a State as part of its application for the approval of each training 
course:
    1. The course provider's name, address, and telephone number.
    2. A list of any other States that currently approve the training 
course.
    3. The course curriculum.
    4. A letter from the provider of the training course that clearly 
indicates how the course meets the MAP requirements for:
    a. Length of training in days.
    b. Amount and type of hands-on training.
    c. Examination (length, format, and passing score).
    d. Topics covered in the course.
    5. A copy of all course materials (student manuals, instructor 
notebooks, handouts, etc.).
    6. A detailed statement about the development of the examination 
used in the course.
    7. Names and qualifications of all course instructors. Instructors 
must have academic and/or field experience in asbestos abatement.
    8. A description of and an example of the numbered certificates 
issued to students who attend the course and pass the examination.

                  B. Refresher Training Course Approval

    The following minimum information is required for approval of 
refresher training courses by States:
    1. The length of training in half-days or days.
    2. The topics covered in the course.
    3. A copy of all course materials (student manuals, instructor 
notebooks, handouts, etc.).
    4. The names and qualifications of all course instructors. 
Instructors must have academic and/or field experience in asbestos 
abatement.
    5. A description of and an example of the numbered certificates 
issued to students who complete the refresher course and pass the 
examination, if required.

                C. Withdrawal of Training Course Approval

    States must establish criteria and procedures for suspending or 
withdrawing approval from accredited training programs. States should 
follow their own administrative procedures in pursuing actions for 
suspension or withdrawal of approval of training programs. At a minimum, 
the criteria shall include:
    (1) Misrepresentation of the extent of a training course's approval 
by a State or EPA;
    (2) Failure to submit required information or notifications in a 
timely manner;
    (3) Failure to maintain requisite records;
    (4) Falsification of accreditation records, instructor 
qualifications, or other accreditation information; or
    (5) Failure to adhere to the training standards and requirements of 
the EPA MAP or State Accreditation Program, as appropriate.
    In addition to the criteria listed above, EPA may also suspend or 
withdraw a training course's approval where an approved training course 
instructor, or other person with supervisory authority over the delivery 
of training has been found in violation of other asbestos regulations 
administered by EPA. An administrative or judicial finding of violation, 
or execution of a consent agreement and order under 40 CFR 22.18, 
constitutes evidence of a failure to comply with relevant statutes or 
regulations. States may wish to adopt this criterion modified to include 
their own asbestos statutes or regulations. EPA may also suspend or 
withdraw approval of training programs where a training provider has 
submitted false information as a part of the self-certification required 
under Unit V.B. of the revised MAP.
    Training course providers shall permit representatives of EPA or the 
State which approved their training courses to attend, evaluate, and 
monitor any training course without charge. EPA or State compliance 
inspection staff are not required to give advance notice of their 
inspections. EPA may suspend or withdraw State or EPA approval of a 
training course based upon the criteria specified in this Unit III.C.

[[Page 364]]

  IV. EPA Procedures for Suspension or Revocation of Accreditation or 
                        Training Course Approval.

    A. If the Administrator decides to suspend or revoke the 
accreditation of any person or suspend or withdraw the approval of a 
training course, the Administrator will notify the affected entity of 
the following:
    1. The grounds upon which the suspension, revocation, or withdrawal 
is based.
    2. The time period during which the suspension, revocation, or 
withdrawal is effective, whether permanent or otherwise.
    3. The conditions, if any, under which the affected entity may 
receive accreditation or approval in the future.
    4. Any additional conditions which the Administrator may impose.
    5. The opportunity to request a hearing prior to final Agency action 
to suspend or revoke accreditation or suspend or withdraw approval.
    B. If a hearing is requested by the accredited person or training 
course provider pursuant to the preceding paragraph, the Administrator 
will:
    1. Notify the affected entity of those assertions of law and fact 
upon which the action to suspend, revoke, or withdraw is based.
    2. Provide the affected entity an opportunity to offer written 
statements of facts, explanations, comments, and arguments relevant to 
the proposed action.
    3. Provide the affected entity such other procedural opportunities 
as the Administrator may deem appropriate to ensure a fair and impartial 
hearing.
    4. Appoint an EPA attorney as Presiding Officer to conduct the 
hearing. No person shall serve as Presiding Officer if he or she has had 
any prior connection with the specific case.
    C. The Presiding Officer appointed pursuant to the preceding 
paragraph shall:
    1. Conduct a fair, orderly, and impartial hearing, without 
unnecessary delay.
    2. Consider all relevant evidence, explanation, comment, and 
argument submitted pursuant to the preceding paragraph.
    3. Promptly notify the affected entity of his or her decision and 
order. Such an order is a final Agency action.
    D. If the Administrator determines that the public health, interest, 
or welfare warrants immediate action to suspend the accreditation of any 
person or the approval of any training course provider, the 
Administrator will:
    1. Notify the affected entity of the grounds upon which the 
emergency suspension is based;
    2. Notify the affected entity of the time period during which the 
emergency suspension is effective.
    3. Notify the affected entity of the Administrator's intent to 
suspend or revoke accreditation or suspend or withdraw training course 
approval, as appropriate, in accordance with Unit IV.A. above. If such 
suspension, revocation, or withdrawal notice has not previously been 
issued, it will be issued at the same time the emergency suspension 
notice is issued.
    E. Any notice, decision, or order issued by the Administrator under 
this section, and any documents filed by an accredited person or 
approved training course provider in a hearing under this section, shall 
be available to the public except as otherwise provided by section 14 of 
TSCA or by 40 CFR part 2. Any such hearing at which oral testimony is 
presented shall be open to the public, except that the Presiding Officer 
may exclude the public to the extent necessary to allow presentation of 
information which may be entitled to confidential treatment under 
section 14 of TSCA or 40 CFR part 2.

                       V. Implementation Schedule

    The various requirements of this MAP become effective in accordance 
with the following schedules:

              A. Requirements applicable to State Programs

    1. Each State shall adopt an accreditation plan that is at least as 
stringent as this MAP within 180 days after the commencement of the 
first regular session of the legislature of the State that is convened 
on or after April 4, 1994.
    2. If a State has adopted an accreditation plan at least as 
stringent as this MAP as of April 4, 1994, the State may continue to:
    a. Conduct TSCA training pursuant to this MAP.
    b. Approve training course providers to conduct training and to 
issue accreditation that satisfies the requirements for TSCA 
accreditation under this MAP.
    c. Issue accreditation that satisfies the requirements for TSCA 
accreditation under this MAP.
    3. A State that had complied with an earlier version of the MAP, but 
has not adopted an accreditation plan at least as stringent as this MAP 
by April 4, 1994, may:
    a. Conduct TSCA training which remains in compliance with the 
requirements of Unit V.B. of this MAP. After such training has been 
self-certified in accordance with Unit V.B. of this MAP, the State may 
issue accreditation that satisfies the requirement for TSCA 
accreditation under this MAP.
    b. Sustain its approval for any training course providers to conduct 
training and issue TSCA accreditation that the State had approved before 
April 4, 1994, and that remain in compliance with Unit V.B. of this MAP.
    c. Issue accreditation pursuant to an earlier version of the MAP 
that provisionally

[[Page 365]]

satisfies the requirement for TSCA accreditation until October 4, 1994.
    Such a State may not approve new TSCA training course providers to 
conduct training or to issue TSCA accreditation that satisfies the 
requirements of this MAP until the State adopts an accreditation plan 
that is at least as stringent as this MAP.
    4. A State that had complied with an earlier version of the MAP, but 
fails to adopt a plan as stringent as this MAP by the deadline 
established in Unit V.A.1., is subject to the following after that 
deadline date:
    a. The State loses any status it may have held as an EPA-approved 
State for accreditation purposes under section 206 of TSCA, 15 U.S.C. 
2646.
    b. All training course providers approved by the State lose State 
approval to conduct training and issue accreditation that satisfies the 
requirements for TSCA accreditation under this MAP.
    c. The State may not:
    i. Conduct training for accreditation purposes under section 206 of 
TSCA, 15 U.S.C. 2646.
    ii. Approve training course providers to conduct training or issue 
accreditation that satisfies the requirements for TSCA accreditation; or
    iii. Issue accreditation that satisfies the requirement for TSCA 
accreditation.
    EPA will extend EPA-approval to any training course provider that 
loses State approval because the State does not comply with the 
deadline, so long as the provider is in compliance with Unit V.B. of 
this MAP, and the provider is approved by a State that had complied with 
an earlier version of the MAP as of the day before the State loses its 
EPA approval.
    5. A State that does not have an accreditation program that 
satisfies the requirements for TSCA accreditation under either an 
earlier version of the MAP or this MAP, may not:
    a. Conduct training for accreditation purposes under section 206 of 
TSCA, 15 U.S.C. 2646;
    b. Approve training course providers to conduct training or issue 
accreditation that satisfies the requirements for TSCA accreditation; or
    c. Issue accreditation that satisfies the requirement for TSCA 
accreditation.

      B. Requirements applicable to Training Courses and Providers

    As of October 4, 1994, an approved training provider must certify to 
EPA and to any State that has approved the provider for TSCA 
accreditation, that each of the provider's training courses complies 
with the requirements of this MAP. The written submission must document 
in specific detail the changes made to each training course in order to 
comply with the requirements of this MAP and clearly state that the 
provider is also in compliance with all other requirements of this MAP, 
including the new recordkeeping and certificate provisions. Each 
submission must include the following statement signed by an authorized 
representative of the training provider: ``Under civil and criminal 
penalties of law for the making or submission of false or fraudulent 
statements or representations (18 U.S.C. 1001 and 15 U.S.C. 2615), I 
certify that the training described in this submission complies with all 
applicable requirements of Title II of TSCA, 40 CFR part 763, Appendix C 
to subpart E, as revised, and any other applicable Federal, state, or 
local requirements.'' A consolidated self-certification submission from 
each training provider that addresses all of its approved training 
courses is permissible and encouraged.
    The self-certification must be sent via registered mail, to EPA 
Headquarters at the following address: Attn. Self-Certification Program, 
Field Programs Branch, Chemical Management Division (7404), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460. A duplicate copy of the 
complete submission must also be sent to any States from which approval 
had been obtained.
    The timely receipt of a complete self-certification by EPA and all 
approving States shall have the effect of extending approval under this 
MAP to the training courses offered by the submitting provider. If a 
self-certification is not received by the approving government bodies on 
or before the due date, the affected training course is not approved 
under this MAP. Such training providers must then reapply for approval 
of these training courses pursuant to the procedures outlined in Unit 
III.

            C. Requirements applicable to Accredited Persons.

    Persons accredited by a State with an accreditation program no less 
stringent than an earlier version of the MAP or by an EPA-approved 
training provider as of April 3, 1994, are accredited in accordance with 
the requirements of this MAP, and are not required to retake initial 
training. They must continue to comply with the requirements for annual 
refresher training in Unit I.D. of the revised MAP.

          D. Requirements applicable to Non-Accredited Persons.

    In order to perform work requiring accreditation under TSCA Title 
II, persons who are not accredited by a State with an accreditation 
program no less stringent than an earlier version of the MAP or by an 
EPA-approved training provider as of April 3, 1994,

[[Page 366]]

must comply with the upgraded training requirements of this MAP by no 
later than October 4, 1994. Non-accredited persons may obtain initial 
accreditation on a provisional basis by successfully completing any of 
the training programs approved under an earlier version of the MAP, and 
thereby perform work during the first 6 months after this MAP takes 
effect. However, by October 4, 1994, these persons must have 
successfully completed an upgraded training program that fully complies 
with the requirements of this MAP in order to continue to perform work 
requiring accreditation under section 206 of TSCA, 15 U.S.C. 2646.

[59 FR 5251, Feb. 3, 1994, as amended at 60 FR 31922, June 19, 1995; 70 
FR 59889, Oct. 13, 2005; 75 FR 69353, Nov. 12, 2010; 76 FR 49674, Aug. 
11, 2011; 78 FR 37978, June 25, 2013; 84 FR 34070, July 17, 2019; 84 FR 
44232, Aug. 23, 2019]



  Sec. Appendix D to Subpart E of Part 763--Transport and Disposal of 
                             Asbestos Waste

    For the purposes of this appendix, transport is defined as all 
activities from receipt of the containerized asbestos waste at the 
generation site until it has been unloaded at the disposal site. Current 
EPA regulations state that there must be no visible emissions to the 
outside air during waste transport. However, recognizing the potential 
hazards and subsequent liabilities associated with exposure, the 
following additional precautions are recommended.
    Recordkeeping. Before accepting wastes, a transporter should 
determine if the waste is properly wetted and containerized. The 
transporter should then require a chain-of-custody form signed by the 
generator. A chain-of-custody form may include the name and address of 
the generator, the name and address of the pickup site, the estimated 
quantity of asbestos waste, types of containers used, and the 
destination of the waste. The chain-of-custody form should then be 
signed over to a disposal site operator to transfer responsibility for 
the asbestos waste. A copy of the form signed by the disposal site 
operator should be maintained by the transporter as evidence of receipt 
at the disposal site.
    Waste handling. A transporter should ensure that the asbestos waste 
is properly contained in leak-tight containers with appropriate labels, 
and that the outside surfaces of the containers are not contaminated 
with asbestos debris adhering to the containers. If there is reason to 
believe that the condition of the asbestos waste may allow significant 
fiber release, the transporter should not accept the waste. Improper 
containerization of wastes is a violation of the NESHAPs regulation and 
should be reported to the appropriate EPA Regional Asbestos NESHAPs 
contact below:

                                Region I

    Asbestos NESHAPs Contact, Enforcement and Compliance Assurance 
Division, USEPA, Region I, 5 Post Office Square--Suite 100 (05-4), 
Boston, MA 02109-3912, (617) 918-1739.

                                Region II

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region II, 26 Federal Plaza, New York, NY 10007, (212) 264-6770.

                               Region III

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region 
III, 841 Chestnut Street, Philadelphia, PA 19107, (215) 597-9325.

                                Region IV

    Asbestos NESHAPs Contact, Air, Pesticide & Toxic Management, USEPA, 
Region IV, 345 Courtland Street, NE., Atlanta, GA 30365, (404) 347-4298.

                                Region V

    Asbestos NESHAPs Contact, Air Management Division, USEPA, Region V, 
77 West Jackson Boulevard, Chicago, IL 60604, (312) 353-6793.

                                Region VI

    Asbestos NESHAP Contact, Enforcement and Compliance Assurance 
Division, USEPA Region VI, 1201 Elm Street, Suite 500, Mail Code 6ECD, 
Dallas, Texas 75270-2102, (214) 655-2760.

                               Region VII

    Asbestos NESHAPs Contact, Air and Waste Management Division, U.S. 
Environmental Protection Agency, Region 7, 11201 Renner Boulevard, 
Lenexa, Kansas 66219. (800) 223-0425 or (913) 551-7122.

                               Region VIII

    Asbestos NESHAPs Contact, Air & Waste Management Division, USEPA, 
Region VIII, 999 18th Street, Suite 500, Denver, CO 80202, (303) 293-
1814.

                                Region IX

    Asbestos NESHAPs Contact, Air Division, USEPA, Region IX, 75 
Hawthorne Street, San Francisco, CA 94105, (415) 972-3989.

                                Region X

    Asbestos NESHAPs Contact, Air & Toxics Management Division, USEPA, 
Region X, 1200 Sixth Avenue, Seattle, WA 98101, (206) 442-2724.


[[Page 367]]


    Once the transporter is satisfied with the condition of the asbestos 
waste and agrees to handle it, the containers should be loaded into the 
transport vehicle in a careful manner to prevent breaking of the 
containers. Similarly, at the disposal site, the asbestos waste 
containers should be transferred carefully to avoid fiber release.
    Waste transport. Although there are no regulatory specifications 
regarding the transport vehicle, it is recommended that vehicles used 
for transport of containerized asbestos waste have an enclosed carrying 
compartment or utilize a canvas covering sufficient to contain the 
transported waste, prevent damage to containers, and prevent fiber 
release. Transport of large quantities of asbestos waste is commonly 
conducted in a 20-cubic-yard ``roll off'' box, which should also be 
covered. Vehicles that use compactors to reduce waste volume should not 
be used because these will cause the waste containers to rupture. Vacuum 
trucks used to transport waste slurry must be inspected to ensure that 
water is not leaking from the truck.
    Disposal involves the isolation of asbestos waste material in order 
to prevent fiber release to air or water. Landfilling is recommended as 
an environmentally sound isolation method because asbestos fibers are 
virtually immobile in soil. Other disposal techniques such as 
incineration or chemical treatment are not feasible due to the unique 
properties of asbestos. EPA has established asbestos disposal 
requirements for active and inactive disposal sites under NESHAPs (40 
CFR Part 61, subpart M) and specifies general requirements for solid 
waste disposal under RCRA (40 CFR Part 257). Advance EPA notification of 
the intended disposal site is required by NESHAPs.
    Selecting a disposal facility. An acceptable disposal facility for 
asbestos wastes must adhere to EPA's requirements of no visible 
emissions to the air during disposal, or minimizing emissions by 
covering the waste within 24 hours. The minimum required cover is 6 
inches of nonasbestos material, normally soil, or a dust-suppressing 
chemical. In addition to these Federal requirements, many state or local 
government agencies require more stringent handling procedures. These 
agencies usually supply a list of ``approved'' or licensed asbestos 
disposal sites upon request. Solid waste control agencies are listed in 
local telephone directories under state, county, or city headings. A 
list of state solid waste agencies may be obtained by calling the RCRA 
hotline: 1-800-424-9346 (382-3000 in Washington, DC). Some landfill 
owners or operators place special requirements on asbestos waste, such 
as placing all bagged waste into 55-gallon metal drums. Therefore, 
asbestos removal contractors should contact the intended landfill before 
arriving with the waste.
    Receiving asbestos waste. A landfill approved for receipt of 
asbestos waste should require notification by the waste hauler that the 
load contains asbestos. The landfill operator should inspect the loads 
to verify that asbestos waste is properly contained in leak-tight 
containers and labeled appropriately. The appropriate EPA Regional 
Asbestos NESHAPs Contact should be notified if the landfill operator 
believes that the asbestos waste is in a condition that may cause 
significant fiber release during disposal. In situations when the wastes 
are not properly containerized, the landfill operator should thoroughly 
soak the asbestos with a water spray prior to unloading, rinse out the 
truck, and immediately cover the wastes with nonasbestos material prior 
to compacting the waste in the landfill.
    Waste deposition and covering. Recognizing the health dangers 
associated with asbestos exposure, the following procedures are 
recommended to augment current federal requirements:
     Designate a separate area for asbestos waste 
disposal. Provide a record for future landowners that asbestos waste has 
been buried there and that it would be hazardous to attempt to excavate 
that area. (Future regulations may require property deeds to identify 
the location of any asbestos wastes and warn against excavation.)
     Prepare a separate trench to receive asbestos 
wastes. The size of the trench will depend upon the quantity and 
frequency of asbestos waste delivered to the disposal site. The 
trenching technique allows application of soil cover without disturbing 
the asbestos waste containers. The trench should be ramped to allow the 
transport vehicle to back into it, and the trench should be as narrow as 
possible to reduce the amount of cover required. If possible, the trench 
should be aligned perpendicular to prevailing winds.
     Place the asbestos waste containers into the 
trench carefully to avoid breaking them. Be particularly careful with 
plastic bags because when they break under pressure asbestos particles 
can be emitted.
     Completely cover the containerized waste within 
24 hours with a minimum of 6 inches of nonasbestos material. Improperly 
containerized waste is a violation of the NESHAPs and EPA should be 
notified.
    However, if improperly containerized waste is received at the 
disposal site, it should be covered immediately after unloading. Only 
after the wastes, including properly containerized wastes, are 
completely covered, can the wastes be compacted or other heavy equipment 
run over it. During compacting, avoid exposing wastes to the air or 
tracking asbestos material away from the trench.
     For final closure of an area containing asbestos 
waste, cover with at least an additional 30 inches of compacted 
nonasbestos

[[Page 368]]

material to provide a 36-inch final cover. To control erosion of the 
final cover, it should be properly graded and vegetated. In areas of the 
United States where excessive soil erosion may occur or the frost line 
exceeds 3 feet, additional final cover is recommended. In desert areas 
where vegetation would be difficult to maintain, 3-6 inches of well 
graded crushed rock is recommended for placement on top of the final 
cover.
    Controlling public access. Under the current NESHAPs regulation, EPA 
does not require that a landfill used for asbestos disposal use warning 
signs or fencing if it meets the requirement to cover asbestos wastes. 
However, under RCRA, EPA requires that access be controlled to prevent 
exposure of the public to potential health and safety hazards at the 
disposal site. Therefore, for liability protection of operators of 
landfills that handle asbestos, fencing and warning signs are 
recommended to control public access when natural barriers do not exist. 
Access to a landfill should be limited to one or two entrances with 
gates that can be locked when left unattended. Fencing should be 
installed around the perimeter of the disposal site in a manner adequate 
to deter access by the general public. Chain-link fencing, 6-ft high and 
topped with a barbed wire guard, should be used. More specific fencing 
requirements may be specified by local regulations. Warning signs should 
be displayed at all entrances and at intervals of 330 feet or less along 
the property line of the landfill or perimeter of the sections where 
asbestos waste is deposited. The sign should read as follows:

ASBESTOS WASTE DISPOSAL SITE
BREATHING ASBESTOS DUST MAY CAUSE LUNG DISEASE AND CANCER

    Recordkeeping. For protection from liability, and considering 
possible future requirements for notification on disposal site deeds, a 
landfill owner should maintain documentation of the specific location 
and quantity of the buried asbestos wastes. In addition, the estimated 
depth of the waste below the surface should be recorded whenever a 
landfill section is closed. As mentioned previously, such information 
should be recorded in the land deed or other record along with a notice 
warning against excavation of the area.

[52 FR 41897, Oct. 30, 1987, as amended at 62 FR 1834, Jan. 14, 1997; 75 
FR 69353, Nov. 12, 2010; 76 FR 49674, Aug. 11, 2011; 78 FR 37978, June 
25, 2013; 84 FR 34070, July 17, 2019; 84 FR 44233, Aug. 23, 2019]



    Sec. Appendix E to Subpart E of Part 763--Interim Method of the 
          Determination of Asbestos in Bulk Insulation Samples

                  Section 1. Polarized Light Microscopy

                     1.1 Principle and Applicability

    Bulk samples of building materials taken for asbestos identification 
are first examined for homogeneity and preliminary fiber identification 
at low magnification. Positive identification of suspect fibers is made 
by analysis of subsamples with the polarized light microscope.
    The principles of optical mineralogy are well established. \1 2\ A 
light microscope equipped with two polarizing filters is used to observe 
specific optical characteristics of a sample. The use of plane polarized 
light allows the determination of refractive indices along specific 
crystallographic axes. Morphology and color are also observed. A 
retardation plate is placed in the polarized light path for 
determination of the sign of elongation using orthoscopic illumination. 
Orientation of the two filters such that their vibration planes are 
perpendicular (crossed polars) allows observation of the birefringence 
and extinction characteristics of anisotropic particles.
    Quantitative analysis involves the use of point counting. Point 
counting is a standard technique in petrography for determining the 
relative areas occupied by separate minerals in thin sections of rock. 
Background information on the use of point counting \2\ and the 
interpretation of point count data \3\ is available.
    This method is applicable to all bulk samples of friable insulation 
materials submitted for identification and quantitation of asbestos 
components.

                                1.2 Range

    The point counting method may be used for analysis of samples 
containing from 0 to 100 percent asbestos. The upper detection limit is 
100 percent. The lower detection limit is less than 1 percent.

                            1.3 Interferences

    Fibrous organic and inorganic constituents of bulk samples may 
interfere with the identification and quantitation of the asbestos 
mineral content. Spray-on binder materials may coat fibers and affect 
color or obscure optical characteristics to the extent of masking fiber 
identity. Fine particles of other materials may also adhere to fibers to 
an extent sufficient to cause confusion in identification. Procedures 
that may be used for the removal of interferences are presented in 
Section 1.7.2.2.

[[Page 369]]

                       1.4 Precision and Accuracy

    Adequate data for measuring the accuracy and precision of the method 
for samples with various matrices are not currently available. Data 
obtained for samples containing a single asbestos type in a simple 
matrix are available in the EPA report Bulk Sample Analysis for Asbestos 
Content: Evaluation of the Tentative Method.\4\

                              1.5 Apparatus

                          1.5.1 Sample Analysis

    A low-power binocular microscope, preferably stereoscopic, is used 
to examine the bulk insulation sample as received.
 Microscope: binocular, 10-45X (approximate).
 Light Source: incandescent or fluorescent.
 Forceps, Dissecting Needles, and Probes
 Glassine Paper or Clean Glass Plate
    Compound microscope requirements: A polarized light microscope 
complete with polarizer, analyzer, port for wave retardation plate, 
360[deg] graduated rotating stage, substage condenser, lamp, and lamp 
iris.
 Polarized Light Microscope: described above.
 Objective Lenses: 10X, 20X, and 40X or near 
equivalent.
 Dispersion Staining Objective Lens (optional)
 Ocular Lens: 10X minimum.
 Eyepiece Reticle: cross hair or 25 point Chalkley 
Point Array.
 Compensator Plate: 550 millimicron retardation.

                        1.5.2 Sample Preparation

    Sample preparation apparatus requirements will depend upon the type 
of insulation sample under consideration. Various physical and/or 
chemical means may be employed for an adequate sample assessment.
 Ventilated Hood or negative pressure glove box.
 Microscope Slides
 Coverslips
 Mortar and Pestle: agate or porcelain. (optional)
 Wylie Mill (optional)
 Beakers and Assorted Glassware (optional)
 Certrifuge (optional)
 Filtration apparatus (optional)
 Low temperature asher (optional)

                              1.6 Reagents

                        1.6.1 Sample Preparation

 Distilled Water (optional)
 Dilute CH3COOH: ACS reagent grade (optional)
 Dilute HCl: ACS reagent grade (optional)
 Sodium metaphosphate (NaPO3)6 
(optional)

                        1.6.2 Analytical Reagents

    Refractive Index Liquids: 1.490-1.570, 1.590-1.720 in increments of 
0.002 or 0.004.
 Refractive Index Liquids for Dispersion Staining: 
high-dispersion series, 1.550, 1.605, 1.630 (optional).
 UICC Asbestos Reference Sample Set: Available from: 
UICC MRC Pneumoconiosis Unit, Llandough Hospital, Penarth, Glamorgan CF6 
1XW, UK, and commercial distributors.
 Tremolite-asbestos (source to be determined)
 Actinolite-asbestos (source to be determined)

                             1.7 Procedures

    Note: Exposure to airborne asbestos fibers is a health hazard. Bulk 
samples submitted for analysis are usually friable and may release 
fibers during handling or matrix reduction steps. All sample and slide 
preparations should be carried out in a ventilated hood or glove box 
with continuous airflow (negative pressure). Handling of samples without 
these precautions may result in exposure of the analyst and 
contamination of samples by airborne fibers.

                             1.7.1 Sampling

    Samples for analysis of asbestos content shall be taken in the 
manner prescribed in Reference 5 and information on design of sampling 
and analysis programs may be found in Reference 6. If there are any 
questions about the representative nature of the sample, another sample 
should be requested before proceeding with the analysis.

                             1.7.2 Analysis

                        1.7.2.1 Gross Examination

    Bulk samples of building materials taken for the identification and 
quantitation of asbestos are first examined for homogeneity at low 
magnification with the aid of a stereomicroscope. The core sample may be 
examined in its container or carefully removed from the container onto a 
glassine transfer paper or clean glass plate. If possible, note is made 
of the top and bottom orientation. When discrete strata are identified, 
each is treated as a separate material so that fibers are first 
identified and quantified in that layer only, and then the results for 
each layer are combined to yield an estimate of asbestos content for the 
whole sample.

                       1.7.2.2 Sample Preparation

    Bulk materials submitted for asbestos analysis involve a wide 
variety of matrix materials. Representative subsamples may not be 
readily obtainable by simple means in heterogeneous materials, and 
various steps may be required to alleviate the difficulties encountered. 
In most cases, however, the best preparation is made by using forceps to 
sample at several places from the bulk material. Forcep samples are 
immersed in a refractive index liquid on a microscope slide, teased 
apart, covered with a cover glass, and

[[Page 370]]

observed with the polarized light microscope.
    Alternatively, attempts may be made to homogenize the sample or 
eliminate interferences before further characterization. The selection 
of appropriate procedures is dependent upon the samples encountered and 
personal preference. The following are presented as possible sample 
preparation steps.
    A mortar and pestle can sometimes be used in the size reduction of 
soft or loosely bound materials though this may cause matting of some 
samples. Such samples may be reduced in a Wylie mill. Apparatus should 
be clean and extreme care exercised to avoid cross-contamination of 
samples. Periodic checks of the particle sizes should be made during the 
grinding operation so as to preserve any fiber bundles present in an 
identifiable form. These procedures are not recommended for samples that 
contain amphibole minerals or vermiculite. Grinding of amphiboles may 
result in the separation of fiber bundles or the production of cleavage 
fragments with aspect ratios greater than 3:1. Grinding of vermiculite 
may also produce fragments with aspect ratios greater than 3:1.
    Acid treatment may occasionally be required to eliminate 
interferences. Calcium carbonate, gypsum, and bassanite (plaster) are 
frequently present in sprayed or trowelled insulations. These materials 
may be removed by treatment with warm dilute acetic acid. Warm dilute 
hydrochloric acid may also be used to remove the above materials. If 
acid treatment is required, wash the sample at least twice with 
distilled water, being careful not to lose the particulates during 
decanting steps. Centrifugation or filtration of the suspension will 
prevent significant fiber loss. The pore size of the filter should be 
0.45 micron or less. Caution: prolonged acid contact with the sample may 
alter the optical characteristics of chrysotile fibers and should be 
avoided.
    Coatings and binding materials adhering to fiber surfaces may also 
be removed by treatment with sodium metaphosphate.\7\ Add 10 mL of 10g/L 
sodium metaphosphate solution to a small (0.1 to 0.5 mL) sample of bulk 
material in a 15-mL glass centrifuge tube. For approximately 15 seconds 
each, stir the mixture on a vortex mixer, place in an ultrasonic bath 
and then shake by hand. Repeat the series. Collect the dispersed solids 
by centrifugation at 1000 rpm for 5 minutes. Wash the sample three times 
by suspending in 10 mL distilled water and recentrifuging. After 
washing, resuspend the pellet in 5 mL distilled water, place a drop of 
the suspension on a microscope slide, and dry the slide at 110 [deg]C.
    In samples with a large portion of cellulosic or other organic 
fibers, it may be useful to ash part of the sample and view the residue. 
Ashing should be performed in a low temperature asher. Ashing may also 
be performed in a muffle furnace at temperatures of 500 [deg]C or lower. 
Temperatures of 550 [deg]C or higher will cause dehydroxylation of the 
asbestos minerals, resulting in changes of the refractive index and 
other key parameters. If a muffle furnace is to be used, the furnace 
thermostat should be checked and calibrated to ensure that samples will 
not be heated at temperatures greater than 550 [deg]C.
    Ashing and acid treatment of samples should not be used as standard 
procedures. In order to monitor possible changes in fiber 
characteristics, the material should be viewed microscopically before 
and after any sample preparation procedure. Use of these procedures on 
samples to be used for quantitation requires a correction for percent 
weight loss.

                      1.7.2.3 Fiber Identification

    Positive identification of asbestos requires the determination of 
the following optical properties.
 Morphology
 Color and pleochroism
 Refractive indices
 Birefringence
 Extinction characteristics
 Sign of elongation

Table 1-1 lists the above properties for commercial asbestos fibers. 
Figure 1-1 presents a flow diagram of the examination procedure. Natural 
variations in the conditions under which deposits of asbestiform 
minerals are formed will occasionally produce exceptions to the 
published values and differences from the UICC standards. The sign of 
elongation is determined by use of the compensator plate and crossed 
polars. Refractive indices may be determined by the Becke line test. 
Alternatively, dispersion staining may be used. Inexperienced operators 
may find that the dispersion staining technique is more easily learned, 
and should consult Reference 9 for guidance. Central stop dispersion 
staining colors are presented in Table 1-2. Available high-dispersion 
(HD) liquids should be used.

[[Page 371]]


                                Table 1-1--Optical Properties of Asbestoc Fibers
----------------------------------------------------------------------------------------------------------------
                                             Refractive indices \b\
      Mineral         Morphology, color  -----------------------------  Birefring-    Extinction       Sign of
                             \a\            [alpha]        [gamma]         ence                       elonation
----------------------------------------------------------------------------------------------------------------
Chrysotile          Wavy fibers. Fiber    1.493-1.560  1.517-1.562\f\         .008  | to fiber                +
(asbestiform         bundles have                       (normally                    length.            (length
serpentine).         splayed ends and                   1.556).                                           slow)
                     ``kinks''. Aspect
                     ratio typically 10:1.
                     Colorless \3\,
                     nonpleochroic.
Amosite             Straight, rigid       1.635-1.696  1.655-1.729 \f    .020-.033  | to fiber                +
 (asbestiform        fibers. Aspect                     \ (normally                  length.            (length
 grunerite).         ratio typically 10:1.
                     Colorless to brown,
                     nonpleochroic or
                     weakly so. Opaque
                     inclusions may be
                     present.
Crocidolite         Straight, rigid       1.654-1.701  1.668-1.717\3e    .014-.016  | to fiber                -
 (asbestiform        fibers. Thick                      \ (normally                  length.            (length
 Riebeckite).        fibers and bundles                 close to                                          fast)
                     common, blue to                    1.700).
                     purple-blue in
                     color. Pleochroic.
                     Birefringence is
                     generally masked by
                     blue color.
Anthophyllite-      Straight fibers and   1.596-1.652  1.615-1.676 \f    .019-.024  | to fiber                +
 asbestos.           acicular cleavage                  \.                           length.            (length
                     fragments.\d\ Some                                                                   slow)
                     composite fibers.
                     Aspect ratio <10:1.
                     Colorless to light
                     brown.
Tremolite-          Normally present as   1.599-1.668  1.622-1.688 \f    .023-.020  Oblique                   +
 actinolite-         acicular or                        \.                           extinction,        (length
 asbestos.           prismatic cleavage                                              10-20[deg]           slow)
                     fragments.\d\                                                   for
                     Single crystals                                                 fragments.
                     predominate, aspect                                             Composite
                     ratio <10:1.                                                    fibers show |
                     Colorless to pale                                               extinction.
                     green.
----------------------------------------------------------------------------------------------------------------
\a\ From reference 5; colors cited are seen by observation with plane polarized light.
\b\ From references 5 and 8.
\c\ Fibers subjected to heating may be brownish.
\d\ Fibers defined as having aspect ratio 3:1.
\e\ to fiber length.
\f\ |To fiber length.


[[Page 372]]

[GRAPHIC] [TIFF OMITTED] TC01AP92.017


[[Page 373]]


                             Table 1-2--Central Stop Dispersion Staining Colors \a\
----------------------------------------------------------------------------------------------------------------
                 Mineral                    RI Liquid              [eta]                    [eta][verbar]
----------------------------------------------------------------------------------------------------------------
Chrysotile...............................   1.550 \HD\  Blue.......................  Blue-magenta
Amosite..................................   1.680       Blue-magenta to pale blue..  Golden-yellow
                                            1.550\HD\   Yellow to white............  Yellow to white
Crocidolite \b\..........................   1.700       Red magenta................  Blue-magenta
                                            1.550\HD\   Yellow to white............  Yellow to white
Anthophyllite............................   1.605\HD\   Blue.......................  Gold to gold-magenta
Tremolite................................   1.605HD c   Pale blue..................  Gold
Actinolite...............................   1.605\HD\   Gold-magenta to blue.......  Gold
                                            1.630HD c   Magenta....................  Golden-yellow
----------------------------------------------------------------------------------------------------------------
a From reference 9.
\b\ Blue absorption color.
\c\ Oblique extinction view.

                1.7.2.4 Quantitation of Asbestos Content

    Asbestos quantitation is performed by a point-counting procedure or 
an equivalent estimation method. An ocular reticle (cross-hair or point 
array) is used to visually superimpose a point or points on the 
microscope field of view. Record the number of points positioned 
directly above each kind of particle or fiber of interest. Score only 
points directly over asbestos fibers or nonasbestos matrix material. Do 
not score empty points for the closest particle. If an asbestos fiber 
and a matrix particle overlap so that a point is superimposed on their 
visual intersection, a point is scored for both categories. Point 
counting provides a determination of the area percent asbestos. Reliable 
conversion of area percent to percent of dry weight is not currently 
feasible unless the specific gravities and relative volumes of the 
materials are known.
    For the purpose of this method, ``asbestos fibers'' are defined as 
having an aspect ratio greater than 3:1 and being positively identified 
as one of the minerals in Table 1-1.
    A total of 400 points superimposed on either asbestos fibers or 
nonasbestos matrix material must be counted over at least eight 
different preparations of representative subsamples. Take eight forcep 
samples and mount each separately with the appropriate refractive index 
liquid. The preparation should not be heavily loaded. The sample should 
be uniformly dispersed to avoid overlapping particles and allow 25-50 
percent empty area within the fields of view. Count 50 nonempty points 
on each preparation, using either
 A cross-hair reticle and mechanical stage; or
 A reticle with 25 points (Chalkley Point Array) and 
counting at least 2 randomly selected fields.

For samples with mixtures of isotropic and anisotropic materials 
present, viewing the sample with slightly uncrossed polars or the 
addition of the compensator plate to the polarized light path will allow 
simultaneous discrimination of both particle types. Quantitation should 
be performed at 100X or at the lowest magnification of the polarized 
light microscope that can effectively distinguish the sample components. 
Confirmation of the quantitation result by a second analyst on some 
percentage of analyzed samples should be used as standard quality 
control procedure.
    The percent asbestos is calculated as follows:
% asbestos = (a/n) 100%

where

a = number of asbestos counts,
n = number of nonempty points counted (400).
    If a = 0, report ``No asbestos detected.'' If 05-10 
percent). Detection of minor or trace amounts of asbestos may require 
special sample preparation and step-scanning analysis. All samples that 
exhibit diffraction peaks in the diagnostic regions for asbestiform 
minerals are submitted to a full (5[deg]-60[deg] 2[thetas]; 1[deg] 
2[thetas]/min) qualitative XRD scan, and their diffraction patterns are 
compared with standard reference powder diffraction patterns \3\ to 
verify initial peak assignments and to identify possible matrix 
interferences when subsequent quantitative analysis will be performed.

    Table 2-1--The Asbestos Minerals and Their Nonasbestiform Analogs
------------------------------------------------------------------------
                Asbestiform                        Nonasbestiform
------------------------------------------------------------------------
SERPENTINE
  Chrysotile                                Antigorite, lizardite
AMPHIBOLE
  Anthophyllite asbestos                    Anthophyllite
  Cummingtonite-grunerite asbestos          Cummingtonite-grunerite
   (``Amosite'')
  Crocidolite                               Riebeckite
  Tremolite asbestos                        Tremolite
  Actinolite asbestos                       Actinolite
------------------------------------------------------------------------


                        Table 2-2--Principal Lattice Spacings of Asbestiform Minerals \a\
----------------------------------------------------------------------------------------------------------------
                                             Principal d-spacings ([Aring]) and
                                                    relative intensities           JCPDS Powder diffraction file
                 Minerals                 ----------------------------------------           \3\ number
 
----------------------------------------------------------------------------------------------------------------
Chrysotile...............................     7.37100       3.6570       4.5750    21-543\b\
                                              7.36100       3.6680       2.4565    25-645
                                              7.10100       2.3380       3.5570    22-1162 (theoretical)
``Amosite''..............................     8.33100       3.0670       2.75670   17-745 (nonfibrous)
                                              8.22100       3.06085      3.2570    27-1170 (UICC)
Anthophyllite............................     3.05100       3.2460       8.2655    9-455
                                              3.06100       8.3370       3.2350    16-401 (synthetic)
Anthophyllite............................     2.72100       2.54100      3.48080   25-157
Crocidolite..............................     8.35100       3.1055       2.72035   27-1415 (UICC)
Tremolite................................     8.38100       3.12100      2.70590   13-437\b\
                                              2.706100      3.1495       8.4340    20-1310\b\ (synthetic)
                                              3.13100       2.70660      8.4440    23-666 (synthetic mixture
                                                                                    with richterite)
----------------------------------------------------------------------------------------------------------------
\a\ This information is intended as a guide, only. Complete powder diffraction data, including mineral type and
  source, should be referred to, to ensure comparability of sample and reference materials where possible.
  Additional precision XRD data on amosite, crocidolite, tremolite, and chrysotile are available from the U.S.
  Bureaus of Mines.\4\
\b\ Fibrosity questionable.

    Accurate quantitative analysis of asbestos in bulk samples by XRD is 
critically dependent on particle size distribution, crystallite size, 
preferred orientation and matrix absorption effects, and comparability 
of standard reference and sample materials. The most intense diffraction 
peak that has been shown to be free from interference by prior 
qualitative XRD analysis is selected for quantitation of each 
asbestiform mineral. A ``thin-layer'' method of analysis \5 6\ is 
recommended in which, subsequent to comminution of the bulk material to 
10 [micro]m by suitable cryogenic milling techniques, an accurately 
known amount of the sample is deposited on a silver membrane filter. The

[[Page 375]]

mass of asbestiform material is determined by measuring the integrated 
area of the selected diffraction peak using a step-scanning mode, 
correcting for matrix absorption effects, and comparing with suitable 
calibration standards. Alternative ``thick-layer'' or bulk methods, \7 
8\ may be used for semiquantitative analysis.
    This XRD method is applicable as a confirmatory method for 
identification and quantitation of asbestos in bulk material samples 
that have undergone prior analysis by PLM or other optical methods.

                        2.2 Range and Sensitivity

    The range of the method has not been determined.
    The sensitivity of the method has not been determined. It will be 
variable and dependent upon many factors, including matrix effects 
(absoprtion and interferences), diagnostic reflections selected, and 
their relative intensities.

                             2.3 Limitations

                           2.3.1 Interferences

    Since the fibrous and nonfibrous forms of the serpentine and 
amphibole minerals (Table 2-1) are indistinguishable by XRD techniques 
unless special sample preparation techniques and instrumentation are 
used,\9\ the presence of nonasbestiform serpentines and amphiboles in a 
sample will pose severe interference problems in the identification and 
quantitative analysis of their asbestiform analogs.
    The use of XRD for identification and quantitation of asbestiform 
minerals in bulk samples may also be limited by the presence of other 
interfering materials in the sample. For naturally occurring materials 
the commonly associated asbestos-related mineral interferences can 
usually be anticipated. However, for fabricated materials the nature of 
the interferences may vary greatly (Table 2-3) and present more serious 
problems in identification and quantitation.\10\ Potential interferences 
are summarized in Table 2-4 and include the following:
 Chlorite has major peaks at 7.19 [Aring] and 3.58 
[Aring] That interfere with both the primary (7.36 [Aring]) and 
secondary (3.66 [Aring]) peaks for chrysotile. Resolution of the primary 
peak to give good quantitative results may be possible when a step-
scanning mode of operation is employed.
 Halloysite has a peak at 3.63 [Aring] that interferes 
with the secondary (3.66 [Aring]) peak for chrysotile.
 Kaolinite has a major peak at 7.15 [Aring] that may 
interfere with the primary peak of chrysotile at 7.36 [Aring] when 
present at concentrations of 10 percent. However, the 
secondary chrysotile peak at 3.66 [Aring] may be used for quantitation.
 Gypsum has a major peak at 7.5 [Aring] that overlaps 
the 7.36 [Aring] peak of chrysotile when present as a major sample 
constituent. This may be removed by careful washing with distilled 
water, or be heating to 300 [deg]C to convert gypsum to plaster of 
paris.
 Cellulose has a broad peak that partially overlaps 
the secondary (3.66 [Aring]) chrysotile peak.\8\
 Overlap of major diagnostic peaks of the amphibole 
asbestos minerals, amosite, anthophyllite, crocidolite, and tremolite, 
at approximately 8.3 [Aring] and 3.1 [Aring] causes mutual interference 
when these minerals occur in the presence of one another. In some 
instances, adequate resolution may be attained by using step-scanning 
methods and/or by decreasing the collimator slit width at the X-ray 
port.

     Table 2-3--Common Constituents in Insulation and Wall Materials

A. Insulation materials

    Chrysotile
    ``Amosite''
    Crocidolite
    *Rock wool
    *Slag wool
    *Fiber glass
    Gypsum (CaSO4 [middot] 2H2O)
    Vermiculite (micas)
    *Perlite
    Clays (kaolin)
    *Wood pulp
    *Paper fibers (talc, clay, carbonate fillers)
    Calcium silicates (synthetic)
    Opaques (chromite, magnetite inclusions in serpentine)
    Hematite (inclusions in ``amosite'')
    Magnesite
    *Diatomaceous earth

B. Spray finishes or paints

    Bassanite
    Carbonate minerals (calcite, dolomite, vaterite)
    Talc
    Tremolite
    Anthophyllite
    Serpentine (including chrysotile)
    Amosite
    Crocidolite
    *Mineral wool
    *Rock wool
    *Slag wool
    *Fiber glass
    Clays (kaolin)
    Micas
    Chlorite
    Gypsum (CaSO4 [middot] 2H2O)
    Quartz
    *Organic binders and thickeners
    Hyrdomagnesite
    Wollastonite
    Opaques (chromite, magnetite inclusions in serpentine)
    Hematite (inclusions in ``amosite'')

[[Page 376]]

    *Amorphous materials____contribute only to overall scattered 
radiation and increased background radiation.

      Table 2-4--Interferences in XRD Analysis Asbestiform Minerals
------------------------------------------------------------------------
                                        Primary
                                      diagnostic
                                         peaks
        Asbestiform mineral          (approximate       Interference
                                      d-spacings,
                                      in [Aring])
------------------------------------------------------------------------
Serpentine
  Chrysotile                              7.4      Nonasbestiform
                                                    serpentines
                                                    (antigorite,
                                                    lizardite)
                                                   Chlorite
                                                   Kaolinite
                                                   Gypsum
                                          3.7      Chlorite
                                                   Halloysite
                                                   Cellulose
Amphibole
  ``Amosite''                             3.1      Nonasbestiform
  Anthophyllite <3-ln [>||<3-ln                  (cummingtonite-
   |<3-ln ]>                                        grunerite,
  Crocidolite                                       anthophyllite,
  Tremolite                                         riebeckite,
                                                    tremolite)
                                                   Mutual interferences
                                                   Carbonates
                                                   Talc
                                          8.3      Mutual interferences
------------------------------------------------------------------------

 Carbonates may also interfere with quantitative 
analysis of the amphibole asbestos minerals, amosite, anthophyllite, 
crocidolite, and tremolite. Calcium carbonate (CaCO3) has a 
peak at 3.035 [Aring] that overlaps major amphibole peaks at 
approximately 3.1 [Aring] when present in concentrations of 5 
percent. Removal of carbonates with a dilute acid wash is possible; 
however, if present, chrysotile may be partially dissolved by this 
treatment.\11\
 A major talc peak at 3.12 [Aring] interferes with the 
primary tremolite peak at this same position and with secondary peaks of 
crocidolite (3.10 [Aring]), amosite (3.06 [Aring]), and anthophyllite 
(3.05 [Aring]). In the presence of talc, the major diagnostic peak at 
approximately 8.3 [Aring] should be used for quantitation of these 
asbestiform minerals.
    The problem of intraspecies and matrix interferences is further 
aggravated by the variability of the silicate mineral powder diffraction 
patterns themselves, which often makes definitive identification of the 
asbestos minerals by comparison with standard reference diffraction 
patterns difficult. This variability results from alterations in the 
crystal lattice associated with differences in isomorphous substitution 
and degree of crystallinity. This is especially true for the amphiboles. 
These minerals exhibit a wide variety of very similar chemical 
compositions, with the result being that their diffraction patterns are 
chracterized by having major (110) reflections of the monoclinic 
amphiboles and (210) reflections of the orthorhombic anthophyllite 
separated by less than 0.2 [Aring]. \12\

                          2.3.2 Matrix Effects

    If a copper X-ray source is used, the presence of iron at high 
concentrations in a sample will result in significant X-ray 
fluorescence, leading to loss of peak intensity along with increased 
background intensity and an overall decrease in sensitivity. This 
situation may be corrected by choosing an X-ray source other than 
copper; however, this is often accompanied both by loss of intensity and 
by decreased resolution of closely spaced reflections. Alternatively, 
use of a diffracted beam monochromator will reduce background 
fluorescent raditation, enabling weaker diffraction peaks to be 
detected.
    X-ray absorption by the sample matrix will result in overall 
attenuation of the diffracted beam and may seriously interfere with 
quantitative analysis. Absorption effects may be minimized by using 
sufficiently ``thin'' samples for analysis. \5 13 14\ However, unless 
absorption effects are known to be the same for both samples and 
standards, appropriate corrections should be made by referencing 
diagnostic peak areas to an internal standard \7 8\ or filter substrate 
(Ag) peak. \5 6\

                     2.3.3 Particle Size Dependence

    Because the intensity of diffracted X-radiation is particle-size 
dependent, it is essential for accurate quantitative analysis that both 
sample and standard reference materials have similar particle size 
distributions. The optimum particle size range for quantitative analysis 
of asbestos by XRD has been reported to be 1 to 10 [micro]m.\15\ 
Comparability of sample and standard reference material particle size 
distributions should be verified by optical microscopy (or another 
suitable method) prior to analysis.

                   2.3.4 Preferred Orientation Effects

    Preferred orientation of asbestiform minerals during sample 
preparation often poses a serious problem in quantitative analysis by 
XRD. A number of techniques have been developed for reducing preferred 
orientation effects in ``thick layer'' samples. \7 8 15\ However, for 
``thin'' samples on membrane filters, the preferred orientation effects 
seem to be both reproducible and favorable to enhancement of the 
principal diagnostic reflections of asbestos minerals, actually 
increasing the overall sensitivity of the method. \12 14\ (Further 
investigation into preferred orientation effects in both thin layer and 
bulk samples is required.)

         2.3.5 Lack of Suitably Characterized Standard Materials

    The problem of obtaining and characterizing suitable reference 
materials for asbestos analysis is clearly recognized. NIOSH has

[[Page 377]]

recently directed a major research effort toward the preparation and 
characterization of analytical reference materials, including asbestos 
standards; \16 17\ however, these are not available in large quantities 
for routine analysis.
    In addition, the problem of ensuring the comparability of standard 
reference and sample materials, particularly regarding crystallite size, 
particle size distribution, and degree of crystallinity, has yet to be 
adequately addressed. For example, Langer et al. \18\ have observed that 
in insulating matrices, chrysotile tends to break open into bundles more 
frequently than amphiboles. This results in a line-broadening effect 
with a resultant decrease in sensitivity. Unless this effect is the same 
for both standard and sample materials, the amount of chrysotile in the 
sample will be underestimated by XRD analysis. To minimize this problem, 
it is recommended that standardized matrix reduction procedures be used 
for both sample and standard materials.

                       2.4 Precision and Accuracy

    Precision of the method has not been determined.
    Accuracy of the method has not been determined.

                              2.5 Apparatus

                        2.5.1 Sample Preparation

    Sample preparation apparatus requirements will depend upon the 
sample type under consideration and the kind of XRD analysis to be 
performed.
 Mortar and Pestle: Agate or porcelain.
 Razor Blades
 Sample Mill: SPEX, Inc., freezer mill or equivalent.
 Bulk Sample Holders
 Silver Membrane Filters: 25-mm diameter, 0.45-
[micro]m pore size. Selas Corp. of America, Flotronics Div., 1957 
Pioneer Road, Huntington Valley, PA 19006.
 Microscope Slides
 Vacuum Filtration Apparatus: Gelman No. 1107 or 
equivalent, and side-arm vacuum flask.
 Microbalance
 Ultrasonic Bath or Probe: Model W140, Ultrasonics, 
Inc., operated at a power density of approximately 0.1 W/mL, or 
equivalent.
 Volumetric Flasks: 1-L volume.
 Assorted Pipettes
 Pipette Bulb
 Nonserrated Forceps
 Polyethylene Wash Bottle
 Pyrex Beakers: 50-mL volume.
 Desiccator
 Filter Storage Cassettes
 Magnetic Stirring Plate and Bars
 Porcelain Crucibles
 Muffle Furnace or Low Temperature Asher

                          2.5.2 Sample Analysis

    Sample analysis requirements include an X-ray diffraction unit, 
equipped with:
 Constant Potential Generator; Voltage and mA 
Stabilizers
 Automated Diffractometer with Step-Scanning Mode
 Copper Target X-Ray Tube: High intensity, fine focus, 
preferably.
 X-Ray Pulse Height Selector
 X-Ray Detector (with high voltage power supply): 
Scintillation or proportional counter.
 Focusing Graphite Crystal Monochromator; or Nickel 
Filter (if copper source is used, and iron fluorescence is not a serious 
problem).
 Data Output Accessories:
     Strip Chart Recorder
     Decade Scaler/Timer
     Digital Printer
 Sample Spinner (optional).
 Instrument Calibration Reference Specimen: [alpha]-
quartz reference crystal (Arkansas quartz standard, 180-147-00, Philips 
Electronics Instruments, Inc., 85 McKee Drive, Mahwah, NJ 07430) or 
equivalent.

                              2.6 Reagents

                   2.6.1 Standard Reference Materials

    The reference materials listed below are intended to serve as a 
guide. Every attempt should be made to acquire pure reference materials 
that are comparable to sample materials being analyzed.
 Chrysotile: UICC Canadian, or NIEHS Plastibest. (UICC 
reference materials available from: UICC, MRC Pneumoconiosis Unit, 
Llandough Hospital, Penarth, Glamorgan, CF61XW, UK).
 Crocidolite: UICC
 Amosite: UICC
 Anthophyllite: UICC
 Tremolite Asbestos: Wards Natural Science 
Establishment, Rochester, N.Y.; Cyprus Research Standard, Cyprus 
Research, 2435 Military Ave., Los Angeles, CA 90064 (washed with dilute 
HCl to remove small amount of calcite impurity); India tremolite, 
Rajasthan State, India.
 Actinolite Asbestos

                             2.6.2 Adhesive

    Tape, petroleum jelly, etc. (for attaching silver membrane filters 
to sample holders).

                            2.6.3 Surfactant

    1 percent aerosol OT aqueous solution or equivalent.

                            2.6.4 Isopropanol

    ACS Reagent Grade.

[[Page 378]]

                              2.7 Procedure

                             2.7.1 Sampling

    Samples for analysis of asbestos content shall be collected as 
specified in EPA Guidance Document C0090, Asbestos-Containing Materials 
in School Buildings.\10\

                             2.7.2 Analysis

    All samples must be analyzed initially for asbestos content by PLM. 
XRD should be used as an auxiliary method when a second, independent 
analysis is requested.

    Note: Asbestos is a toxic substance. All handling of dry materials 
should be performed in an operating fume hood.

                       2.7.2.1 Sample Preparation

    The method of sample preparation required for XRD analysis will 
depend on: (1) The condition of the sample received (sample size, 
homogeneity, particle size distribution, and overall composition as 
determined by PLM); and (2) the type of XRD analysis to be performed 
(qualitative, quantitative, thin layer or bulk).
    Bulk materials are usually received as inhomogeneous mixtures of 
complex composition with very wide particle size distributions. 
Preparation of a homogeneous, representative sample from asbestos-
containing materials is particularly difficult because the fibrous 
nature of the asbestos minerals inhibits mechanical mixing and stirring, 
and because milling procedures may cause adverse lattice alterations.
    A discussion of specific matrix reduction procedures is given below. 
Complete methods of sample preparation are detailed in Sections 2.7.2.2 
and 2.7.2.3.

    Note: All samples should be examined microscopically before and 
after each matrix reduction step to monitor changes in sample particle 
size, composition, and crystallinity, and to ensure sample 
representativeness and homogeneity for analysis.

    2.7.2.1.1 Milling-- Mechanical milling of asbestos materials has 
been shown to decrease fiber crystallinity, with a resultant decrease in 
diffraction intensity of the specimen; the degree of lattice alteration 
is related to the duration and type of milling process. \19 22\ 
Therefore, all milling times should be kept to a minimum.
    For qualitative analysis, particle size is not usually of critical 
importance and initial characterization of the material with a minimum 
of matrix reduction is often desirable to document the composition of 
the sample as received. Bulk samples of very large particle size 
(2-3 mm) should be comminuted to 100 [micro]m. A mortar and 
pestle can sometimes be used in size reduction of soft or loosely bound 
materials though this may cause matting of some samples. Such samples 
may be reduced by cutting with a razor blade in a mortar, or by grinding 
in a suitable mill (e.g., a microhammer mill or equivalent). When using 
a mortar for grinding or cutting, the sample should be moistened with 
ethanol, or some other suitable wetting agent, to minimize exposures.
    For accurate, reproducible quantitative analysis, the particle size 
of both sample and standard materials should be reduced to 10 [micro]m 
(see Section 2.3.3). Dry ball milling at liquid nitrogen temperatures 
(e.g., Spex Freezer Mill, or equivalent) for a maximum time of 10 min. 
is recommended to obtain satisfactory particle size distributions while 
protecting the integrity of the crystal lattice. \5\ Bulk samples of 
very large particle size may require grinding in two stages for full 
matrix reduction to <10 [micro]m. \8 16\
    Final particle size distributions should always be verified by 
optical microscopy or another suitable method.
    2.7.2.1.2 Low temperature ashing--For materials shown by PLM to 
contain large amounts of gypsum, cellulosic, or other organic materials, 
it may be desirable to ash the samples prior to analysis to reduce 
background radiation or matrix interference. Since chrysotile undergoes 
dehydroxylation at temperatures between 550 [deg]C and 650 [deg]C, with 
subsequent transformation to forsterite,\23 24\ ashing temperatures 
should be kept below 500 [deg]C. Use of a low temperature asher is 
recommended. In all cases, calibration of the oven is essential to 
ensure that a maximum ashing temperature of 500 [deg]C is not exceeded.
    2.7.2.1.3 Acid leaching--Because of the interference caused by 
gypsum and some carbonates in the detection of asbestiform minerals by 
XRD (see Section 2.3.1), it may be necessary to remove these 
interferents by a simple acid leaching procedure prior to analysis (see 
Section 1.7.2.2).

                      2.7.2.2 Qualitative Analysis

    2.7.2.2.1 Initial screening of bulk material-- Qualitative analysis 
should be performed on a representative, homogeneous portion of the 
sample with a minimum of sample treatment.
    1. Grind and mix the sample with a mortar and pestle (or equivalent 
method, see Section 2.7.2.1.1.) to a final particle size sufficiently 
small (100 [micro]m) to allow adequate packing into the sample holder.
    2. Pack the sample into a standard bulk sample holder. Care should 
be taken to ensure that a representative portion of the milled sample is 
selected for analysis. Particular care should be taken to avoid possible 
size segregation of the sample. (Note: Use of a back-packing method \25\ 
of bulk sample preparation may reduce preferred orientation effects.)
    3. Mount the sample on the diffractometer and scan over the 
diagnostic peak regions for

[[Page 379]]

the serpentine (67.4 [Aring]) and amphibole (8.2-8.5 [Aring]) minerals 
(see Table 2-2). The X-ray diffraction equipment should be optimized for 
intensity. A slow scanning speed of 1[deg] 2[thetas]/min is 
recommended for adequate resolution. Use of a sample spinner is 
recommended.
    4. Submit all samples that exhibit diffraction peaks in the 
diagnostic regions for asbestiform minerals to a full qualitative XRD 
scan (5[deg]-60[deg] 2[thetas]; 1[deg]2[thetas]/
min) to verify initial peak assignments and to identify potential matrix 
interferences when subsequent quantitative analysis is to be performed.
    5. Compare the sample XRD pattern with standard reference powder 
diffraction patterns (i.e., JCPDS powder diffraction data \3\ or those 
of other well-characterized reference materials). Principal lattice 
spacings of asbestiform minerals are given in Table 2-2; common 
constituents of bulk insulation and wall materials are listed in Table 
2-3.
    2.7.2.2.2 Detection of minor or trace constituents-- Routine 
screening of bulk materials by XRD may fail to detect small 
concentrations (<5 percent) of asbestos. The limits of detection will, 
in general, be improved if matrix absorption effects are minimized, and 
if the sample particle size is reduced to the optimal 1 to 10 [micro]m 
range, provided that the crystal lattice is not degraded in the milling 
process. Therefore, in those instances where confirmation of the 
presence of an asbestiform mineral at very low levels is required, or 
where a negative result from initial screening of the bulk material by 
XRD (see Section 2.7.2.2.1) is in conflict with previous PLM results, it 
may be desirable to prepare the sample as described for quantitative 
analysis (see Section 2.7.2.3) and step-scan over appropriate 
2[thetas] ranges of selected diagnostic peaks (Table 2-2). 
Accurate transfer of the sample to the silver membrane filter is not 
necessary unless subsequent quantitative analysis is to be performed.

                      2.7.2.3 Quantitative Analysis

    The proposed method for quantitation of asbestos in bulk samples is 
a modification of the NIOSH-recommended thin-layer method for chrysotile 
in air. \5\ A thick-layer or bulk method involving pelletizing the 
sample may be used for semiquantitative analysis; \7 8\ however, this 
method requires the addition of an internal standard, use of a specially 
fabricated sample press, and relatively large amounts of standard 
reference materials. Additional research is required to evaluate the 
comparability of thin- and thick-layer methods for quantitative asbestos 
analysis.
    For quantitative analysis by thin-layer methods, the following 
procedure is recommended:
    1. Mill and size all or a substantial representative portion of the 
sample as outlined in Section 2.7.2.1.1.
    2. Dry at 100 [deg]C for 2 hr; cool in a desiccator.
    3. Weigh accurately to the nearest 0.01 mg.
    4. Samples shown by PLM to contain large amounts of cellulosic or 
other organic materials, gypsum, or carbonates, should be submitted to 
appropriate matrix reduction procedures described in Sections 2.7.2.1.2 
and 2.7.2.1.3. After ashing and/or acid treatment, repeat the drying and 
weighing procedures described above, and determine the percent weight 
loss; L.
    5. Quantitatively transfer an accurately weighed amount (50-100 mg) 
of the sample to a 1-L volumetric flask with approximately 200 mL 
isopropanol to which 3 to 4 drops of surfactant have been added.
    6. Ultrasonicate for 10 min at a power density of approximately 0.1 
W/mL, to disperse the sample material.
    7. Dilute to volume with isopropanol.
    8. Place flask on a magnetic stirring plate. Stir.
    9. Place a silver membrane filter on the filtration apparatus, apply 
a vacuum, and attach the reservoir. Release the vacuum and add several 
milliliters of isopropanol to the reservoir. Vigorously hand shake the 
asbestos suspension and immediately withdraw an aliquot from the center 
of the suspension so that total sample weight, WT, on the 
filter will be approximately 1 mg. Do not adjust the volume in the pipet 
by expelling part of the suspension; if more than the desired aliquot is 
withdrawn, discard the aliquot and resume the procedure with a clean 
pipet. Transfer the aliquot to the reservoir. Filter rapidly under 
vacuum. Do not wash the reservoir walls. Leave the filter apparatus 
under vacuum until dry. Remove the reservoir, release the vacuum, and 
remove the filter with forceps. (Note: Water-soluble matrix 
interferences such as gypsum may be removed at this time by careful 
washing of the filtrate with distilled water. Extreme care should be 
taken not to disturb the sample.)
    10. Attach the filter to a flat holder with a suitable adhesive and 
place on the diffractometer. Use of a sample spinner is recommended.
    11. For each asbestos mineral to be quantitated select a reflection 
(or reflections) that has been shown to be free from interferences by 
prior PLM or qualitative XRD analysis and that can be used unambiguously 
as an index of the amount of material present in the sample (see Table 
2-2).
    12. Analyze the selected diagnostic reflection(s) by step scanning 
in increments of 0.02[deg] 2[thetas] for an appropriate fixed 
time and integrating the counts. (A fixed count scan may be used 
alternatively; however, the method chosen should be used consistently 
for all samples and standards.) An appropriate scanning interval should 
be selected for each peak, and background corrections made. For a fixed 
time scan, measure the

[[Page 380]]

background on each side of the peak for one-half the peak-scanning time. 
The net intensity, Ia, is the difference between the peak 
integrated count and the total background count.
    13. Determine the net count, IAg, of the filter 2.36 
[Aring] silver peak following the procedure in step 12. Remove the 
filter from the holder, reverse it, and reattach it to the holder. 
Determine the net count for the unattenuated silver peak, 
IAg. Scan times may be less for measurement of silver peaks 
than for sample peaks; however, they should be constant throughout the 
analysis.
    14. Normalize all raw, net intensities (to correct for instrument 
instabilities) by referencing them to an external standard (e.g., the 
3.34 [Aring] peak of an [alpha]-quartz reference crystal). After each 
unknown is scanned, determine the net count, Ir, of the 
reference specimen following the procedure in step 12. Determine the 
normalized intensities by dividing the peak intensities by 
Ir:
[GRAPHIC] [TIFF OMITTED] TC01AP92.018

                             2.8 Calibration

               2.8.1 Preparation of Calibration Standards

    1. Mill and size standard asbestos materials according to the 
procedure outlined in Section 2.7.2.1.1. Equivalent, standardized matrix 
reduction and sizing techniques should be used for both standard and 
sample materials.
    2. Dry at 100 [deg]C for 2 hr; cool in a desiccator.
    3. Prepare two suspensions of each standard in isopropanol by 
weighing approximately 10 and 50 mg of the dry material to the nearest 
0.01 mg. Quantitatively transfer each to a 1-L volumetric flask with 
approximately 200 mL isopropanol to which a few drops of surfactant have 
been added.
    4. Ultrasonicate for 10 min at a power density of approximately 0.1 
W/mL, to disperse the asbestos material.
    5. Dilute to volume with isopropanol.
    6. Place the flask on a magnetic stirring plate. Stir.
    7. Prepare, in triplicate, a series of at least five standard 
filters to cover the desired analytical range, using appropriate 
aliquots of the 10 and 50 mg/L suspensions and the following procedure.
    Mount a silver membrane filter on the filtration apparatus. Place a 
few milliliters of isopropanol in the reservoir. Vigorously hand shake 
the asbestos suspension and immediately withdraw an aliquot from the 
center of the suspension. Do not adjust the volume in the pipet by 
expelling part of the suspension; if more than the desired aliquot is 
withdrawn, discard the aliquot and resume the procedure with a clean 
pipet. Transfer the aliquot to the reservoir. Keep the tip of the pipet 
near the surface of the isopropanol. Filter rapidly under vacuum. Do not 
wash the sides of the reservoir. Leave the vacuum on for a time 
sufficient to dry the filter. Release the vacuum and remove the filter 
with forceps.

                 2.8.2 Analysis of Calibration Standards

    1. Mount each filter on a flat holder. Perform step scans on 
selected diagnostic reflections of the standards and reference specimen 
using the procedure outlined in Section 2.7.2.3, step 12, and the same 
conditions as those used for the samples.
    2. Determine the normalized intensity for each peak measured, 
[Icirc]std, as outlined in Section 2.7.2.3, step 14.

                            2.9 Calculations

    For each asbestos reference material, calculate the exact weight 
deposited on each standard filter from the concentrations of the 
standard suspensions and aliquot volumes. Record the weight, w, of each 
standard. Prepare a calibration curve by regressing 
[Icirc]2std on w. Poor reproducibility (15 percent RSD) at any given level indicates problems in 
the sample preparation technique, and a need for new standards. The data 
should fit a straight line equation.
    Determine the slope, m, of the calibration curve in counts/
microgram. The intercept, b, of the line with the [Icirc]std 
axis should be approximately zero. A large negative intercept indicates 
an error in determining the background. This may arise from incorrectly 
measuring the baseline or from interference by another phase at the 
angle of background measurement. A large positive intercept indicates an 
error in determining the baseline or that an impurity is included in the 
measured peak.
    Using the normalized intensity, [Icirc]Ag, for the 
attenuated silver peak of a sample, and the corresponding normalized 
intensity from the unattenuated silver peak, [Icirc]Ag, of 
the sample filter, calculate the transmittance, T, for each sample as 
follows: \26 27\
[GRAPHIC] [TIFF OMITTED] TC01AP92.019

    Determine the correction factor, f(T), for each sample according to 
the formula:

                .................         -R (ln T)
                      f (T) =____
                .................          l-T\R\
 

where

[[Page 381]]


                  .....          sin [Theta]Ag
                    R =             ________
                  .....           sin [Theta]a
 

[thetas]Ag = angular position of the measured silver peak 
          (from Bragg's Law), and
[thetas]a = angular position of the diagnostic asbestos peak.
    Calculate the weight, Wa, in micrograms, of the asbestos 
material analyzed for in each sample, using the appropriate calibration 
data and absorption corrections:
[GRAPHIC] [TIFF OMITTED] TC01AP92.020

    Calculate the percent composition, Pa, of each asbestos 
mineral analyzed for in the parent material, from the total sample 
weight, WT, on the filter:

                   .....           Wa(1-.01L)
                    Pa =           ________--           x 100
                   .....               WT
 

where

Pa = percent asbestos mineral in parent material;
Wa = mass of asbestos mineral on filter, in [micro]g;
WT = total sample weight on filter, in [micro]g;
L = percent weight loss of parent material on ashing and/or acid 
          treatment (see Section 2.7.2.3).

                             2.10 References

    1. H. P. Klug and L. E. Alexander, X-ray Diffraction Procedures for 
Polycrystalline and Amorphous Materials, 2nd ed., New York: John Wiley 
and Sons, 1979.
    2. L. V. Azaroff and M. J. Buerger, The Powder Method of X-ray 
Crystallography, New York: McGraw-Hill, 1958.
    3. JCPDS-International Center for Diffraction Data Powder 
Diffraction File, U.S. Department of Commerce, National Bureau of 
Standards, and Joint Committee on Powder Diffraction Studies, 
Swarthmore, PA.
    4. W. J. Campbell, C. W. Huggins, and A. G. Wylie, Chemical and 
Physical Characterization of Amosite, Chrysotile, Crocidolite, and 
Nonfibrous Tremolite for National Institute of Environmental Health 
Sciences Oral Ingestion Studies, U.S. Bureau of Mines Report of 
Investigation RI8452, 1980.
    5. B. A. Lange and J. C. Haartz, Determination of microgram 
quantities of asbestos by X-ray diffraction: Chrysotile in thin dust 
layers of matrix material, Anal. Chem., 51(4):520-525, 1979.
    6. NIOSH Manual of Analytical Methods, Volume 5, U.S. Dept. HEW, 
August 1979, pp. 309-1 to 309-9.
    7. H. Dunn and J. H. Stewart, Jr., Quantitative determination of 
chrysotile in building materials, The Microscope, 29(1), 1981.
    8. M. Taylor, Methods for the quantitative determination of asbestos 
and quartz in bulk samples using X-ray diffraction, The Analyst, 
103(1231):1009-1020, 1978.
    9. L. Birks, M. Fatemi, J. V. Gilfrich, and E. T. Johnson, 
Quantitative Analysis of Airborne Asbestos by X-ray Diffraction, Naval 
Research Laboratory Report 7879, Naval Research Laboratory, Washington, 
DC, 1975.
    10. U.S. Environmental Protection Agency, Asbestos-Containing 
Materials in School Buildings: A Guidance Document, Parts 1 and 2, EPA/
OPPT No. C00090, March 1979.
    11. J. B. Krause and W. H. Ashton, Misidentification of asbestos in 
talc, pp. 339-353, in: Proceedings of Workshop on Asbestos: Definitions 
and Measurement Methods (NBS Special Publication 506), C. C. Gravatt, P. 
D. LaFleur, and K. F. Heinrich (eds.), Washington, DC: National 
Measurement Laboratory, National Bureau of Standards, 1977 (issued 
1978).
    12. H. D. Stanley, The detection and identification of asbestos and 
asbesti-form minerals in talc, pp. 325-337, in Proceedings of Workshop 
on Asbestos: Definitions and Measurement Methods (NBS Special 
Publication 506), C. C. Gravatt, P. D. LaFleur, and K. F. Heinrich 
(eds.), Washington, DC, National Measurement Laboratory, National Bureau 
of Standards, 1977 (issued 1978).
    13. A. L. Rickards, Estimation of trace amounts of chrysotile 
asbestos by X-ray diffraction, Anal. Chem., 44(11):1872-3, 1972.
    14. P. M. Cook, P. L. Smith, and D. G. Wilson, Amphibole fiber 
concentration and determination for a series of community air samples: 
use of X-ray diffraction to supplement electron microscope analysis, in: 
Electron Microscopy and X-ray Applications to Environmental and 
Occupation Health Analysis, P. A. Russell and A. E. Hutchings (eds.), 
Ann Arbor: Ann Arbor Science Publications, 1977.
    15. A. N. Rohl and A. M. Langer, Identification and quantitation of 
asbestos in talc, Environ. Health Perspectives, 9:95-109, 1974.
    16. J. L. Graf, P. K. Ase, and R. G. Draftz, Preparation and 
Characterization of Analytical Reference Minerals, DHEW (NIOSH) 
Publication No. 79-139, June 1979.
    17. J. C. Haartz, B. A. Lange, R. G. Draftz, and R. F. Scholl, 
Selection and characterization of fibrous and nonfibrous amphiboles for 
analytical methods development, pp. 295-312, in: Proceedings of Workshop 
on Asbestos: Definitions and Measurement Methods (NBS Special 
Publication 506), C. C. Gravatt, P. D. LaFleur, and K. F. Heinrich 
(eds.), Washington, DC: National Measurement Laboratory, National Bureau 
of Standards, 1977 (issued 1978).
    18. Personal communication, A. M. Langer, Environmental Sciences 
Laboratory, Mount

[[Page 382]]

Sinai School of Medicine of the City University of New York, New York, 
New York.
    19. A. M. Langer, M. S. Wolff, A. N. Rohl, and I. J. Selikoff, 
Variation of properties of chrysotile asbestos subjected to milling, J. 
Toxicol. and Environ. Health, 4:173-188, 1978.
    20. A. M. Langer, A. D. Mackler, and F. D. Pooley, Electron 
microscopical investigation of asbestos fibers, Environ. Health 
Perspect., 9:63-80, 1974.
    21. E. Occella and G. Maddalon, X-ray diffraction characteristics of 
some types of asbestos in relation to different techniques of 
comminution, Med. Lavoro, 54(10):628-636, 1963.
    22. K. R. Spurny, W. St[ouml]ber, H. Opiela, and G. Weiss, On the 
problem of milling and ultrasonic treatment of asbestos and glass fibers 
in biological and analytical applications, Am. Ind. Hyg. Assoc. J., 
41:198-203, 1980.
    23. L. G. Berry and B. Mason, Mineralogy, San Francisco: W. H. 
Greeman & Co., 1959.
    24. J. P. Schelz, The detection of chrysotile asbestos at low levels 
in talc by differential thermal analysis, Thermochimica Acta, 8:197-204, 
1974.
    25. Reference 1, pp. 372-374.
    26. J. Leroux, Staub-Reinhalt Luft, 29:26 (English), 1969.
    27. J. A. Leroux, B. C. Davey, and A. Paillard, Am. Ind. Hyg. Assoc. 
J., 34:409, 1973.

[47 FR 23369, May 27, 1982; 47 FR 38535, Sept. 1, 1982; Redesignated at 
60 FR 31922, June 19, 1995]

Subpart F [Reserved]



                  Subpart G_Asbestos Worker Protection

    Source: 65 FR 69216, Nov. 15, 2000, unless otherwise noted.



Sec.  763.120  What is the purpose of this subpart?

    This subpart protects certain State and local government employees 
who are not protected by the Asbestos Standards of the Occupational 
Safety and Health Administration (OSHA). This subpart applies the OSHA 
Asbestos Standards in 29 CFR 1910.1001 and 29 CFR 1926.1101 to these 
employees.



Sec.  763.121  Does this subpart apply to me?

    If you are a State or local government employer and you are not 
subject to a State asbestos standard that OSHA has approved under 
section 18 of the Occupational Safety and Health Act or a State asbestos 
plan that EPA has exempted from the requirements of this subpart under 
Sec.  763.123, you must follow the requirements of this subpart to 
protect your employees from occupational exposure to asbestos.



Sec.  763.122  What does this subpart require me to do?

    If you are a State or local government employer whose employees 
perform:
    (a) Construction activities identified in 29 CFR 1926.1101(a), you 
must:
    (1) Comply with the OSHA standards in 29 CFR 1926.1101.
    (2) Submit notifications required for alternative control methods to 
the Director, National Program Chemicals Division (7404), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460.
    (b) Custodial activities not associated with the construction 
activities identified in 29 CFR 1926.1101(a), you must comply with the 
OSHA standards in 29 CFR 1910.1001.
    (c) Repair, cleaning, or replacement of asbestos-containing clutch 
plates and brake pads, shoes, and linings, or removal of asbestos-
containing residue from brake drums or clutch housings, you must comply 
with the OSHA standards in 29 CFR 1910.1001.



Sec.  763.123  May a State implement its own asbestos worker protection plan?

    This section describes the process under which a State may be 
exempted from the requirements of this subpart.
    (a) States seeking an exemption. If your State wishes to implement 
its own asbestos worker protection plan, rather than complying with the 
requirements of this subpart, your State must apply for and receive an 
exemption from EPA.
    (1) What must my State do to apply for an exemption? To apply for an 
exemption from the requirements of this subpart, your State must send to 
the Director of EPA's Office of Pollution Prevention and Toxics (OPPT) a 
copy of its asbestos worker protection regulations and a detailed 
explanation of how your State's asbestos worker protection plan meets 
the requirements of TSCA section 18 (15 U.S.C. 2617).

[[Page 383]]

    (2) What action will EPA take on my State's application for an 
exemption? EPA will review your State's application and make a 
preliminary determination whether your State's asbestos worker 
protection plan meets the requirements of TSCA section 18.
    (i) If EPA's preliminary determination is that your State's plan 
does meet the requirements of TSCA section 18, EPA will initiate a 
rulemaking, including an opportunity for public comment, to exempt your 
State from the requirements of this subpart. After considering any 
comments, EPA will issue a final rule granting or denying the exemption.
    (ii) If EPA's preliminary determination is that the State plan does 
not meet the requirements of TSCA section 18, EPA will notify your State 
in writing and will give your State a reasonable opportunity to respond 
to that determination.
    (iii) If EPA does not grant your State an exemption, then the State 
and local government employers in your State are subject to the 
requirements of this subpart.
    (b) States that have been granted an exemption. If EPA has exempted 
your State from the requirements of this subpart, your State must update 
its asbestos worker protection regulations as necessary to implement 
changes to meet the requirements of this subpart, and must apply to EPA 
for an amendment to its exemption.
    (1) What must my State do to apply for an amendment to its 
exemption? To apply for an amendment to its exemption, your State must 
send to the Director of OPPT a copy of its updated asbestos worker 
protection regulations and a detailed explanation of how your State's 
updated asbestos worker protection plan meets the requirements of TSCA 
section 18. Your State must submit its application for an amendment 
within 6 months of the effective date of any changes to the requirements 
of this subpart, or within a reasonable time agreed upon by your State 
and OPPT.
    (2) What action will EPA take on my State's application for an 
amendment? EPA will review your State's application for an amendment and 
make a preliminary determination whether your State's updated asbestos 
worker protection plan meets the requirements of TSCA section 18.
    (i) If EPA determines that the updated State plan does meet the 
requirements of TSCA section 18, EPA will issue your State an amended 
exemption.
    (ii) If EPA determines that the updated State plan does not meet the 
requirements of TSCA section 18, EPA will notify your State in writing 
and will give your State a reasonable opportunity to respond to that 
determination.
    (iii) If EPA does not grant your State an amended exemption, or if 
your State does not submit a timely request for amended exemption, then 
the State and local government employers in your State are subject to 
the requirements of this subpart.

Subpart H [Reserved]



 Subpart I_Prohibition of the Manufacture, Importation, Processing, and 
   Distribution in Commerce of Certain Asbestos-Containing Products; 
                          Labeling Requirements

    Source: 54 FR 29507, July 12, 1989, unless otherwise noted.



Sec.  763.160  Scope.

    This subpart prohibits the manufacture, importation, processing, and 
distribution in commerce of the asbestos-containing products identified 
and at the dates indicated in Sec. Sec.  763.165, 763.167, and 763.169. 
This subpart requires that products subject to this rule's bans, but not 
yet subject to a ban on distribution in commerce, be labeled. This 
subpart also includes general exemptions and procedures for requesting 
exemptions from the provisions of this subpart.



Sec.  763.163  Definitions.

    For purposes of this subpart:
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    Agency means the United States Environmental Protection Agency.

[[Page 384]]

    Asbestos means the asbestiform varieties of: chrysotile 
(serpentine); crocidolite (riebeckite); amosite (cummingtonite-
grunerite); tremolite; anthophyllite; and actinolite.
    Asbestos-containing product means any product to which asbestos is 
deliberately added in any concentration or which contains more than 1.0 
percent asbestos by weight or area.
    Chemical substance, has the same meaning as in section 3 of the Act.
    Commerce has the same meaning as in section 3 of the Act.
    Commercial paper means an asbestos-containing product which is made 
of paper intended for use as general insulation paper or muffler paper. 
Major applications of commercial papers are insulation against fire, 
heat transfer, and corrosion in circumstances that require a thin, but 
durable, barrier.
    Corrugated paper means an asbestos-containing product made of 
corrugated paper, which is often cemented to a flat backing, may be 
laminated with foils or other materials, and has a corrugated surface. 
Major applications of asbestos corrugated paper include: thermal 
insulation for pipe coverings; block insulation; panel insulation in 
elevators; insulation in appliances; and insulation in low-pressure 
steam, hot water, and process lines.
    Customs territory of the United States means the 50 States, Puerto 
Rico, and the District of Columbia.
    Distribute in commerce has the same meaning as in section 3 of the 
Act, but the term does not include actions taken with respect to an 
asbestos-containing product (to sell, resale, deliver, or hold) in 
connection with the end use of the product by persons who are users 
(persons who use the product for its intended purpose after it is 
manufactured or processed). The term also does not include distribution 
by manufacturers, importers, and processors, and other persons solely 
for purposes of disposal of an asbestos-containing product.
    Flooring felt means an asbestos-containing product which is made of 
paper felt intended for use as an underlayer for floor coverings, or to 
be bonded to the underside of vinyl sheet flooring.
    Import means to bring into the customs territory of the United 
States, except for: (1) Shipment through the customs territory of the 
United States for export without any use, processing, or disposal within 
the customs territory of the United States; or (2) entering the customs 
territory of the United States as a component of a product during normal 
personal or business activities involving use of the product.
    Importer means anyone who imports a chemical substance, including a 
chemical substance as part of a mixture or article, into the customs 
territory of the United States. Importer includes the person primarily 
liable for the payment of any duties on the merchandise or an authorized 
agent acting on his or her behalf. The term includes as appropriate:
    (1) The consignee.
    (2) The importer of record.
    (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20.
    (4) The transferee, if the right to withdraw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
part 144.
    Manufacture means to produce or manufacture in the United States.
    Manufacturer means a person who produces or manufactures in the 
United States.
    New uses of asbestos means commercial uses of asbestos not 
identified in Sec.  763.165 the manufacture, importation or processing 
of which would be initiated for the first time after August 25, 1989.
    Person means any natural person, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof, or any 
municipality; any interstate body and any department, agency, or 
instrumentality of the Federal Government.
    Process has the same meaning as in section 3 of the Act.
    Processor has the same meaning as in section 3 of the Act.
    Rollboard means an asbestos-containing product made of paper that is 
produced in a continuous sheet, is flexible, and is rolled to achieve a 
desired thickness. Asbestos rollboard consists of two sheets of asbestos 
paper

[[Page 385]]

laminated together. Major applications of this product include: office 
partitioning; garage paneling; linings for stoves and electric switch 
boxes; and fire-proofing agent for security boxes, safes, and files.
    Specialty paper means an asbestos-containing product that is made of 
paper intended for use as filters for beverages or other fluids or as 
paper fill for cooling towers. Cooling tower fill consists of asbestos 
paper that is used as a cooling agent for liquids from industrial 
processes and air conditioning systems.
    State has the same meaning as in section 3 of the Act.
    Stock-on-hand means the products which are in the possession, 
direction, or control of a person and are intended for distribution in 
commerce.
    United States has the same meaning as in section 3 of the Act.

[59 FR 33208, June 28, 1994]



Sec.  763.165  Manufacture and importation prohibitions.

    (a) After August 27, 1990, no person shall manufacture or import the 
following asbestos-containing products, either for use in the United 
States or for export: flooring felt and new uses of asbestos.
    (b) After August 26, 1996, no person shall manufacture or import the 
following asbestos-containing products, either for use in the United 
States or for export: commercial paper, corrugated paper, rollboard, and 
specialty paper.
    (c) The import prohibitions of this subpart do not prohibit:
    (1) The import into the customs territory of the United States of 
products imported solely for shipment outside the customs territory of 
the United States, unless further repackaging or processing of the 
product is performed in the United States; or
    (2) Activities involving purchases or acquisitions of small 
quantities of products made outside the customs territory of the United 
States for personal use in the United States.

[59 FR 33209, June 28, 1994]



Sec.  763.167  Processing prohibitions.

    (a) After August 27, 1990, no person shall process for any use, 
either in the United States or for export, any of the asbestos-
containing products listed at Sec.  763.165(a).
    (b) After August 26, 1996, no person shall process for any use, 
either in the United States or for export, any of the asbestos-
containing products listed at Sec.  763.165(b).

[59 FR 33209, June 28, 1994]



Sec.  763.169  Distribution in commerce prohibitions.

    (a) After August 25, 1992, no person shall distribute in commerce, 
either for use in the United States or for export, any of the asbestos-
containing products listed at Sec.  763.165(a).
    (b) After August 25, 1997, no person shall distribute in commerce, 
either for use in the United States or for export, any of the asbestos-
containing products listed at Sec.  763.165(b).
    (c) A manufacturer, importer, processor, or any other person who is 
subject to a ban on distribution in commerce in paragraph (a) or (b) of 
this section must, within 6 months of the effective date of the ban of a 
specific asbestos-containing product from distribution in commerce, 
dispose of all their remaining stock-on-hand of that product, by means 
that are in compliance with applicable local, State, and Federal 
restrictions which are current at that time.

[59 FR 33209, June 28, 1994]



Sec.  763.171  Labeling requirements.

    (a) After August 27, 1990, manufacturers, importers, and processors 
of all asbestos-containing products that are identified in Sec.  
763.165(a) shall label the products as specified in this subpart at the 
time of manufacture, import, or processing. This requirement includes 
labeling all manufacturers', importers', and processors' stock-on-hand 
as of August 27, 1990.
    (b) After August 25, 1995, manufacturers, importers, and processors 
of all asbestos-containing products that are identified in Sec.  
763.165(b), shall label the products as specified in this subpart at the 
time of manufacture, import, or processing. This requirement includes

[[Page 386]]

labeling all manufacturers', importers', and processors' stock-on-hand 
as of August 25, 1995.
    (c) The label shall be placed directly on the visible exterior of 
the wrappings and packaging in which the product is placed for sale, 
shipment, or storage. If the product has more than one layer of external 
wrapping or packaging, the label must be attached to the innermost layer 
adjacent to the product. If the innermost layer of product wrapping or 
packaging does not have a visible exterior surface larger than 5 square 
inches, either a tag meeting the requirements of paragraph (d) of this 
section must be securely attached to the product's innermost layer of 
product wrapping or packaging, or a label must be attached to the next 
outer layer of product packaging or wrapping. Any products that are 
distributed in commerce to someone other than the end user, shipped, or 
stored without packaging or wrapping must be labeled or tagged directly 
on a visible exterior surface of the product as described in paragraph 
(d) of this section.
    (d)(1) Labels must be either printed directly on product packaging 
or in the form of a sticker or tag made of plastic, paper, metal, or 
other durable substances. Labels must be attached in such a manner that 
they cannot be removed without defacing or destroying them. Product 
labels shall appear as in paragraph (d)(2) of this section and consist 
of block letters and numerals of color that contrasts with the 
background of the label or tag. Labels shall be sufficiently durable to 
equal or exceed the life, including storage and disposal, of the product 
packaging or wrapping. The size of the label or tag must be at least 
15.25 cm (6 inches) on each side. If the product packaging is too small 
to accommodate a label of this size, the label may be reduced in size 
proportionately to the size of the product packaging or wrapping down to 
a minimum 2.5 cm (1 inch) on each side if the product wrapping or 
packaging has a visible exterior surface larger than 5 square inches.
    (2) Products subject to this subpart shall be labeled in English as 
follows:

                                 NOTICE

    This product contains ASBESTOS. The U.S. Environmental Protection 
Agency has banned the distribution in U.S. commerce of this product 
under section 6 of the Toxic Substances Control Act (15 U.S.C. 2605) as 
of (insert effective date of ban on distribution in commerce). 
Distribution of this product in commerce after this date and 
intentionally removing or tampering with this label are violations of 
Federal law.

    (e) No one may intentionally remove, deface, cover, or otherwise 
obscure or tamper with a label or sticker that has been applied in 
compliance with this section, except when the product is used or 
disposed of.

[59 FR 33209, June 28, 1994]



Sec.  763.173  Exemptions.

    (a) Persons who are subject to the prohibitions imposed by Sec.  
763.165, Sec.  763.167, or Sec.  763.169 may file an application for an 
exemption. Persons whose exemption applications are approved by the 
Agency may manufacture, import, process, or distribute in commerce the 
banned product as specified in the Agency's approval of the application. 
No applicant for an exemption may continue the banned activity that is 
the subject of an exemption application after the effective date of the 
ban unless the Agency has granted the exemption or the applicant 
receives an extension under paragraph (b)(4) or (5) of this section.
    (b) Application filing dates. (1) Applications for products affected 
by the prohibitions under Sec. Sec.  763.165(a) and 763.167(a) may be 
submitted at any time and will be either granted or denied by EPA as 
soon as is feasible.
    (2) Applications for products affected by the ban under Sec.  
763.169(a) may be submitted at any time and will be either granted or 
denied by EPA as soon as is feasible.
    (3) Applications for products affected by the ban under Sec. Sec.  
763.165(b) and 763.167(b) may not be submitted prior to February 27, 
1995. Complete applications received after that date, but before August 
25, 1995, will be either granted or denied by the Agency prior to the 
effective date of the ban for the product. Applications received after 
August 25, 1995, will be either granted or denied by EPA as soon as is 
feasible.

[[Page 387]]

    (4) Applications for products affected by the ban under Sec.  
763.169(b) may not be submitted prior to February 26, 1996. Complete 
applications received after that date, but before August 26, 1996, will 
be either granted or denied by the Agency prior to the effective date of 
the ban for the product. Applications received after August 26, 1996, 
will be either granted or denied by EPA as soon as is feasible.
    (5) The Agency will consider an application for an exemption from a 
ban under Sec.  763.169 for a product at the same time the applicant 
submits an application for an exemption from a ban under Sec.  763.165 
or Sec.  763.167 for that product. EPA will grant an exemption at that 
time from a ban under Sec.  763.169 if the Agency determines it 
appropriate to do so.
    (6) If the Agency denies an application less than 30 days before the 
effective date of a ban for a product, the applicant can continue the 
activity for 30 days after receipt of the denial from the Agency.
    (7) If the Agency fails to meet the deadlines stated in paragraphs 
(b)(3) and (b)(4) of this section for granting or denying a complete 
application in instances in which the deadline is before the effective 
date of the ban to which the application applies, the applicant will be 
granted an extension of 1 year from the Agency's deadline date. During 
this extension period the applicant may continue the activity that is 
the subject of the exemption application. The Agency will either grant 
or deny the application during the extension period. The extension 
period will terminate either on the date the Agency grants the 
application or 30 days after the applicant receives the Agency's denial 
of the application. However, no extension will be granted if the Agency 
is scheduled to grant or deny an application at some date after the 
effective date of the ban, pursuant to the deadlines stated in 
paragraphs (b)(3) and (b)(4) of this section.
    (c) Where to file. All applications must be submitted to the 
following location: TSCA Docket Receipts Office (7407), Office of 
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, 
Rm E-G99, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTENTION: 
Asbestos Exemption. For information regarding the submission of 
exemptions containing information claimed as confidential business 
information (CBI), see Sec.  763.179.
    (d) Content of application and criteria for decisionmaking.
    (1) Content of application. Each application must contain the 
following:
    (i) Name, address, and telephone number of the applicant.
    (ii) Description of the manufacturing, import, processing, and/or 
distribution in commerce activity for which an exemption is requested, 
including a description of the asbestos-containing product to be 
manufactured, imported, processed, or distributed in commerce.
    (iii) Identification of locations at which the exempted activity 
would take place.
    (iv) Length of time requested for exemption (maximum length of an 
exemption is 4 years).
    (v) Estimated amount of asbestos to be used in the activity that is 
the subject of the exemption application.
    (vi) Data demonstrating the exposure level over the life cycle of 
the product that is the subject of the application.
    (vii) Data concerning:
    (A) The extent to which non-asbestos substitutes for the product 
that is the subject of the application fall significantly short in 
performance under necessary product standards or requirements, including 
laws or ordinances mandating product safety standards.
    (B) The costs of non-asbestos substitutes relative to the costs of 
the asbestos-containing product and, in the case in which the product is 
a component of another product, the effect on the cost of the end use 
product of using the substitute component.
    (C) The extent to which the product or use serves a high-valued use.
    (viii) Evidence of demonstrable good faith attempts by the applicant 
to develop and use a non-asbestos substance or product which may be 
substituted for the asbestos-containing product or the asbestos in the 
product or use that is the subject to the application.
    (ix) Evidence, in addition to that provided in the other information 
required with the application, showing that the continued manufacture, 
importation,

[[Page 388]]

processing, distribution in commerce, and use, as applicable, of the 
product will not present an unreasonable risk of injury to human health.
    (2) Criteria for decision (existing products). After considering all 
the information provided by an applicant under paragraphs (d)(1) and (e) 
of this section, and any other information available to EPA, EPA will 
grant an exemption from the prohibitions in Sec.  763.165, Sec.  
763.167, or Sec.  763.169 for an applicant's asbestos-containing product 
only if EPA determines both of the following:
    (i) The applicant has made good faith attempts to develop and use a 
non-asbestos substance or product which may be substituted for the 
asbestos-containing product or the asbestos in the product or use, and 
those attempts have failed to produce a substitute or a substitute that 
results in a product that can be economically produced.
    (ii) Continued manufacturing, processing, distribution in commerce, 
and use, as applicable, of the product will not present an unreasonable 
risk of injury to human health.
    (3) Criteria for decision (new products). Requests to develop and 
use an asbestos substance or product will be treated as a petition 
pursuant to section 21 of TSCA.
    (e) The Agency reserves the right to request further information 
from an exemption applicant if necessary to complete the Agency's 
evaluation of an application.
    (f) Upon receipt of a complete application, the Agency will issue a 
notice in the Federal Register announcing its receipt and invite public 
comments on the merits of the application.
    (g) If the application does not include all of the information 
required in paragraph (d) of this section, the Agency will return it to 
the applicant as incomplete and any resubmission of the application will 
be considered a new application for purposes of the availability of any 
extension period. If the application is substantially inadequate to 
allow the Agency to make a reasoned judgment on any of the information 
required in paragraph (d) of this section and the Agency chooses to 
request additional information from the applicant, the Agency may also 
determine that an extension period provided for in paragraph (b)(5) of 
this section is unavailable to the applicant.
    (h) When denying an application, the Agency will notify the 
applicant by registered mail of its decision and rationale. Whenever 
possible, the Agency will send this letter prior to the appropriate ban. 
This letter will be considered a final Agency action for purposes of 
judicial review. A notice announcing the Agency's denial of the 
application will be published in the Federal Register.
    (i) If the Agency proposes to approve an exemption, it will issue a 
notice in the Federal Register announcing this intent and invite public 
comments. If, after considering any timely comments received, the Agency 
approves an exemption, its decision will be published in the Federal 
Register. This notice will be considered a final Agency action for 
purposes of judicial review.
    (j) The length of an exemption period will be specified by the 
agency when it approves the exemption. To extend an exemption period 
beyond the period stipulated by EPA, applicants must submit a new 
application to the Agency, following the application procedures 
described in this section. Applications may not be submitted prior to 15 
months before the expiration of the exemption period, unless stated 
otherwise in the notice granting the exemption. Applications received 
between 15 months and 1 year before the end of the exemption period will 
be either granted or denied by the Agency before the end of the 
exemption period. Applications received after the date 1 year prior to 
the end of the exemption period will be either granted or denied by the 
Agency as soon as is feasible. Applicants may not continue the activity 
that is the subject of the renewal application after the date of the end 
of the exemption period.

[54 FR 29507, July 12, 1989; 54 FR 37531, Sept. 11, 1989, as amended at 
54 FR 46898, Nov. 8, 1989; 59 FR 33210, June 28, 1994]



Sec.  763.175  Enforcement.

    (a) Failure to comply with any provision of this subpart is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (b) Failure or refusal to establish and maintain records, or to 
permit access

[[Page 389]]

to or copying of records as required by section 11 of the Act (15 U.S.C. 
2610) is a violation of section 15 of the Act (15 U.S.C. 2614).
    (c) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (d) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (e) The Agency may seek to enjoin the manufacture, import, 
processing, or distribution in commerce of asbestos-containing products 
in violation of this subpart, or act to seize any asbestos-containing 
products manufactured, imported, processed, or distributed in commerce 
in violation of this subpart, or take any other actions under the 
authority of section 7 or 17 of the Act (15 U.S.C. 2606 or 2616) that 
are appropriate.



Sec.  763.176  Inspections.

    The Agency will conduct inspections under section 11 of the Act (15 
U.S.C. 2610) to ensure compliance with this subpart.



Sec.  763.178  Recordkeeping.

    (a) Inventory. (1) Each person who is subject to the prohibitions 
imposed by Sec. Sec.  763.165 and 763.167 must perform an inventory of 
the stock-on-hand of each banned product as of the effective date of the 
ban for that product for the applicable activity.
    (2) The inventory shall be in writing and shall include the type of 
product, the number of product units currently in the stock-on-hand of 
the person performing the inventory, and the location of the stock.
    (3) Results of the inventory for a banned product must be maintained 
by the person for 3 years after the effective date of the Sec.  763.165 
or Sec.  763.167 ban on the product.
    (b) Records. (1) Each person whose activities are subject to the 
bans imposed by Sec. Sec.  763.165, 763.167, and 763.169 for a product 
must, between the effective date of the Sec.  763.165 or Sec.  763.167 
ban on the product and the Sec.  763.169 ban on the product, keep 
records of all commercial transactions regarding the product, including 
the dates of purchases and sales and the quantities purchased or sold. 
These records must be maintained for 3 years after the effective date of 
the Sec.  763.169 ban for the product.
    (2) Each person who is subject to the requirements of Sec.  763.171 
must, for each product required to be labeled, maintain a copy of the 
label used in compliance with Sec.  763.171. These records must be 
maintained for 3 years after the effective date of the ban on 
distribution in commerce for the product for which the Sec.  763.171 
requirements apply.

[54 FR 29507, July 12, 1989, as amended at 54 FR 46898, Nov. 8, 1989; 58 
FR 34205, June 23, 1993]



Sec.  763.179  Confidential business information claims.

    (a) Applicants for exemptions under Sec.  763.173 may assert a 
Confidential Business Information (CBI) claim for information in an 
exemption application or supplement submitted to the Agency under this 
subpart only if the claim is asserted in accordance with this section, 
and release of the information would reveal trade secrets or 
confidential commercial or financial information, as provided in section 
14(a) of the Act. Information covered by a CBI claim will be treated in 
accordance with the procedures set forth in 40 CFR part 2, subpart B. 
The Agency will place all information not claimed as CBI in the manner 
described in this section in a public file without further notice to the 
applicant.
    (b) Applicants may assert CBI claims only at the time they submit a 
completed exemption application and only in the specified manner. If no 
such claim accompanies the information when it is received by the 
Agency, the information may be made available to the public without 
further notice to the applicant. Submitters that claim information as 
business confidential must do so by writing the word ``Confidential'' at 
the top of the page on which the information appears and by underlining, 
circling, or placing brackets ([ ]) around the information claimed CBI.
    (c) Applicants who assert a CBI claim for submitted information must 
provide the Agency with two copies of their exemption application. The 
first copy must be complete and contain all

[[Page 390]]

information being claimed as CBI. The second copy must contain only 
information not claimed as CBI. The Agency will place the second copy of 
the submission in a public file. Failure to furnish a second copy of the 
submission when information is claimed as CBI in the first copy will be 
considered a presumptive waiver of the claim of confidentiality. The 
Agency will notify the applicant by certified mail that a finding of a 
presumptive waiver of the claim of confidentiality has been made. The 
applicant has 30 days from the date of receipt of notification to submit 
the required second copy. Failure to submit the second copy will cause 
the Agency to place the first copy in a public file.
    (d) Applicants must substantiate all claims of CBI at the time the 
applicant asserts the claim, i.e., when the exemption application or 
supplement is submitted, by responding to the questions in paragraph (e) 
of this section. Failure to provide substantiation of a claim at the 
time the applicant submits the application will result in a waiver of 
the CBI claim, and the information may be disclosed to the public 
without further notice to the applicant.
    (e) Applicants who assert any CBI claims must substantiate all 
claims by providing detailed responses to the following:
    (1) Is this information subject to a patent or patent application in 
the United States or elsewhere? If so, why is confidentiality necessary?
    (2) For what period do you assert a claim of confidentiality? If the 
claim is to extend until a certain event or point in time, please 
indicate that event or time period. Explain why such information should 
remain confidential until such point.
    (3) Has the information that you are claiming as confidential been 
disclosed to persons outside of your company? Will it be disclosed to 
such persons in the future? If so, what restrictions, if any, apply to 
use or further disclosure of the information?
    (4) Briefly describe measures taken by your company to guard against 
undesired disclosure of the information you are claiming as confidential 
to others.
    (5) Does the information claimed as confidential appear or is it 
referred to in advertising or promotional materials for the product or 
the resulting end product, safety data sheets or other similar materials 
for the product or the resulting end product, professional or trade 
publications, or any other media available to the public or to your 
competitors? If you answered yes, indicate where the information 
appears.
    (6) If the Agency disclosed the information you are claiming as 
confidential to the public, how difficult would it be for the competitor 
to enter the market for your product? Consider in your answer such 
constraints as capital and marketing cost, specialized technical 
expertise, or unusual processes.
    (7) Has the Agency, another Federal agency, or a Federal court made 
any confidentiality determination regarding this information? If so, 
provide copies of such determinations.
    (8) How would your company's competitive position be harmed if the 
Agency disclosed this information? Why should such harm be considered 
substantial? Describe the causal relationship between the disclosure and 
harm.
    (9) In light of section 14(b) of TSCA, if you have claimed 
information from a health and safety study as confidential, do you 
assert that disclosure of this information would disclose a process used 
in the manufacturing or processing of a product or information unrelated 
to the effects of asbestos on human health and the environment? If your 
answer is yes, explain.



PART 766_DIBENZO-PARA-DIOXINS/DIBENZOFURANS--Table of Contents



                      Subpart A_General Provisions

Sec.
766.1 Scope and purpose.
766.2 Applicability and duration of this part.
766.3 Definitions.
766.5 Compliance.
766.7 Submission of information.
766.10 Test standards.
766.12 Testing guidelines.
766.14 Contents of protocols.
766.16 Developing the analytical test method.

[[Page 391]]

766.18 Method sensitivity.

       Subpart B_Specific Chemical Testing/Reporting Requirements

766.20 Who must test.
766.25 Chemical substances for testing.
766.27 Congeners and LOQs for which quantitation is required.
766.28 Expert review of protocols.
766.32 Exclusions and waivers.
766.35 Reporting requirements.
766.38 Reporting on precursor chemical substances.

    Authority: 15 U.S.C. 2603 and 2607.

    Source: 52 FR 21437, June 5, 1987, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  766.1  Scope and purpose.

    (a) This part identifies requirements for testing under section 4 of 
the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603, to ascertain 
whether certain specified chemical substances may be contaminated with 
halogenated dibenzodioxins (HDDs)/dibenzofurans (HDFs) as defined in 
Sec.  766.3, and requirements for reporting under section 8 of TSCA, 15 
U.S.C. 2607.
    (b) Section 766.35(b) requires manufacturers and processors of 
chemical substances identified in Sec.  766.25 to submit to EPA:
    (1) Any existing test data showing analysis of the chemical 
substances for concentrations of HDDs/HDFs, applicable protocols, and 
the results of the analysis for HDDs/HDFs, (2) allegations of 
significant adverse reactions to HDDs/HDFs, compiled in accordance with 
part 717 of this chapter, and (3) health and safety studies on the HDDs/
HDFs, in accordance with applicable provisions of part 716 of this 
chapter.
    (c) Section 766.35(a) requires manufacturers and, under certain 
circumstances, processors of chemical substances identified in Sec.  
766.25 to submit letters of intent to test and protocols for the 
analysis of the chemical substances for the presence of HDDs/HDFs. 
Section 766.20 requires these manufacturers and processors to test their 
chemical substances for the presence of HDDs/HDFs. Any submissions must 
be in accordance with the EPA Procedures Governing Testing Consent 
Agreements and Test Rules contained in part 790 of this chapter and any 
modifications to such procedures contained in this part.
    (d) Section 766.32 specifies conditions under which persons required 
to test may request an exclusion or waiver from testing.
    (e) Deadlines for submission to EPA of protocols, reports, studies, 
and test results are specified in part 790, subpart C and Sec.  766.35.
    (f) Sections 766.10, 766.12, 766.14, 766.16, and 766.18 prescribe 
analytical methods required; Sec.  766.27 prescribes target levels of 
quantitation (LOQ) for each congener for which quantitation is required.
    (g) If results of existing tests or tests performed under this part 
indicate the presence of HDDs/HDFs in the identified chemical substance 
above the LOQ specified in Sec.  766.27, Sec.  766.35(c) requires the 
following additional reporting on the specified chemicals: production, 
process, use, exposure and disposal data under section 8(a) of TSCA; 
health and safety studies under section 8(d) of TSCA; and reports of 
allegations of significant adverse reactions under section 8(c) of TSCA. 
In some cases, additional reporting may be required of manufacturers 
reporting no contamination of the identified chemical substances under 
Sec.  766.35(c)(2).
    (h) Section 766.38 requires manufacturers of chemical substances 
produced from chemical substances identified as possible precursors to 
HDD/HDF formation, to report on chemical substances produced from such 
precursors.



Sec.  766.2  Applicability and duration of this part.

    (a) Chemical substances subject to testing. (1) This part is 
applicable to each person who, at any time during the duration of this 
part, manufactures (and/or imports), or processes, a chemical substance 
identified under Sec.  766.25.
    (2) The duration of this part for any testing requirement for any 
chemical substance is the period commencing with the effective date of 
this part to the end of the reimbursement period, as defined in Sec.  
766.3, for each chemical substance. All reporting requirements for any 
chemical substance listed under Sec.  766.25 shall be in effect for the

[[Page 392]]

same period as the testing requirement.
    (b) Precursor chemical substances. (1) This part is applicable to 
each person who manufactures (and/or imports) a chemical substance from 
any precursor chemical substance identified in Sec.  766.38.
    (2) The requirement for precursor reporting under Sec.  766.38 shall 
be in effect until three years after the effective date of this part.
    (3) Small manufacturers are exempt from reporting process and 
reaction condition data on chemical substances made from precursor 
chemical substances listed under Sec.  766.38.



Sec.  766.3  Definitions.

    The definitions in section 3 of TSCA and the definitions of 
Sec. Sec.  704.3, 716.3, 717.3, and 790.3 of this chapter also apply to 
this part.
    Central Data Exchange or CDX means EPA's centralized electronic 
submission receiving system.
    Chemical Information Submission System or CISS means EPA's 
electronic, web-based reporting tool for the completion and submission 
of data, reports, and other information, or its successors.
    Congener means any one particular member of a class of chemical 
substances. A specific congener is denoted by unique chemical structure, 
for example 2,3,7,8-tetrachlorodibenzofuran.
    Dibenzofuran means any of a family of compounds which has as a 
nucleus a triple-ring structure consisting of two benzene rings 
connected through a pair of bridges between the benzene rings. The 
bridges are a carbon-carbon bridge and a carbon-oxygen-carbon bridge at 
both substitution positions.
    Dibenzo-p-dioxin or dioxin means any of a family of compounds which 
has as a nucleus a triple-ring structure consisting of two benzene rings 
connected through a pair of oxygen atoms.
    Guidelines means the Midwest Research Institute (MRI) publication 
Guidelines for the Determination of Polyhalogenated Dioxins and 
Dibenzofurans in Commercial Products, EPA contract No. 68-02-3938; MRI 
Project No. 8201-A(41), 1985.
    HDD or 2,3,7,8-HDD means any of the dibenzo-p-dioxins totally 
chlorinated or totally brominated at the following positions on the 
molecular structure: 2,3,7,8; 1,2,3,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8; 
1,2,3,7,8,9; and 1,2,3,4,7,8,9.
    HDF or 2,3,7,8-HDF means any of the dibenzofurans totally 
chlorinated or totally brominated at the following positions on the 
molecular structure: 2,3,7,8; 1,2,3,7,8; 2,3,4,7,8; 1,2,3,4,7,8; 
1,2,3,6,7,8; 1,2,3,7,8,9; 2,3,4,6,7,8; 1,2,3,4,6,7,8; and 1,2,3,4,7,8,9.
    Homolog means a group of isomers that have the same degree of 
halogenation. For example, the homologous class of tetrachlorodibenzo-p-
dioxins consists of all dibenzo-p-dioxins containing four chlorine 
atoms. When the homologous classes discussed in this part are referred 
to, the following abbreviations for the prefix denoting the number of 
halogens are used:
    tetra-, T (4 atoms)
    penta-, Pe (5 atoms)
    hexa-, Hx (6 atoms)
    hepta-, Hp (7 atoms)

    HRGC means high resolution gas chromatography.
    HRMS means high resolution mass spectrometry.
    Level of quantitation or LOQ means the lowest concentration at which 
HDDs/HDFs can be reproducibly measured in a specific chemical substance 
within specified confidence limits, as described in this part.
    Polybrominated dibenzofurans refers to any member of a class of 
dibenzofurans with two to eight bromine substituents.
    Polybrominated dibenzo-p-dioxin or PBDD means to any member of a 
class of dibenzo-p-dioxins with two to eight bromine substituents.
    Polychlorinated dibenzofuran means any member of a class of 
dibenzofurans with two to eight chlorine substituents.
    Polychlorinated dibenzo-p-dioxin or PCDD means any member of a class 
of dibenzo-p-dioxins with two to eight chlorine substituents.
    Polyhalogenated dibenzofuran or PHDF means any member of a class of 
dibenzofurans containing two to eight chlorine, bromine, or a 
combination of chlorine and bromine substituents.
    Polyhalogenated dibenzo-p-dioxin or PHDD means any member of a class 
of dibenzo-p-dioxins containing two to

[[Page 393]]

eight chlorine substituents or two to eight bromine substituents.
    Positive test result means: (1) Any resolvable gas chromatographic 
peak for any 2,3,7,8-HDD or HDF which exceeds the LOQ listed under Sec.  
766.27 for that congener, or (2) exceeds LOQs approved by EPA under 
Sec.  766.28.
    Precursor means a chemical substance which is not contaminated due 
to the process conditions under which it is manufactured, but because of 
its molecular structure, and under favorable process conditions, it may 
cause or aid the formation of HDDs/HDFs in other chemicals in which it 
is used as a feedstock or intermediate.
    QA means quality assurance.
    QC means quality control.
    Reimbursement period means the period that begins when the data from 
the last test to be completed under this part for a specific chemical 
substance listed in Sec.  766.25 is submitted to EPA, and ends after an 
amount of time equal to that which had been required to develop that 
data or 5 years, whichever is later.
    TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

[52 FR 21437, June 5, 1987, as amended at 78 FR 72828, Dec. 4, 2013]



Sec.  766.5  Compliance.

    Any person who fails or refuses to comply with any aspect of this 
part is in violation of section 15 of TSCA. Section 15(1) makes it 
unlawful for any person to fail or refuse to comply with any rule or 
order issued under section 4. Section 15(3) makes it unlawful for any 
person to fail or refuse to submit information required under this part. 
Section 16 provides that a violation of section 15 renders a person 
liable to the United States for a civil penalty and possible criminal 
prosecution. Under section 17 of TSCA, the district courts of the United 
States have jurisdiction to restrain any violation of section 15.



Sec.  766.7  Submission of information.

    (a) All information (including letters of intent, protocols, data, 
forms, studies, and allegations) submitted to EPA under this part must 
bear the applicable Code of Federal Regulations (CFR) section number 
(e.g., Sec.  766.20).
    (b) You must use the CISS tool to complete and submit all data, 
reports, and other information required under this part except for 
records and reports of allegations of significant adverse reactions, 
which must be submitted in accordance with paragraph (c) of this 
section.
    (1) Submissions must be submitted to EPA via CDX.
    (2) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP/
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and 
for further instructions to go http://www.epa.gov/oppt/chemtest/
ereporting/index.html.
    (c) You must submit records and reports of allegations of 
significant adverse reactions and the accompanying cover letters by one 
of the following methods:
    (1) Mail, preferably certified, 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, ATTN: Dioxin/Furan report part 766, Allegations of significant 
adverse reactions.
    (2) Hand delivery to OPPT Document Control Office (DCO), EPA East, 
Rm. 6428, 1201 Constitution Ave. NW., Washington, DC, ATTN: Dioxin/Furan 
report part 766, Allegations of significant adverse reactions. The DCO 
is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the DCO is (202) 564-8930. Such 
deliveries are only accepted during the DCO's normal hours of operation.

[78 FR 72828, Dec. 4, 2013]



Sec.  766.10  Test standards.

    Testing required under subpart B of this part must be performed 
using the protocols submitted to and reviewed by the EPA expert panel 
established under Sec.  766.28. All new data, documentation, records, 
protocols, specimens, and reports generated as a result of testing under 
subpart B of this part must be fully developed and retained in 
accordance with part 792 of this chapter. These items must be made 
available during an inspection or submitted to

[[Page 394]]

EPA upon request by EPA or its authorized representative. Laboratories 
conducting testing for submission to EPA in response to a test rule 
promulgated under section 4 of TSCA must adhere to the TSCA Good 
Laboratory Practices (GLPs) published in part 792 of this chapter. 
Sponsors must notify the laboratory that the testing is being conducted 
pursuant to TSCA section 4. Sponsors are also responsible for ensuring 
that laboratories conducting the testing abide by the TSCA GLP 
standards. At the time test data are submitted, manufacturers must 
submit a certification to EPA that the laboratory performing the testing 
adhered to the TSCA GLPs.



Sec.  766.12  Testing guidelines.

    Analytical test methods must be developed using methods equivalent 
to those described or reviewed in Guidelines for the Determination of 
Polyhalogenated Dibenzo-p-dioxins and Dibenzofurans in Commercial 
Products. Copies are available from the Director, Environmental 
Assistance Division (7408), Office of Pollution Prevention and Toxics, 
U.S.Environmental Protection Agency, Room E-543B, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 
544-0551. Publicly available docket materials are available at the 
addresses in Sec.  700.17(b)(1) and (2) of this chapter.

[60 FR 34466, July 3, 1995, as amended at 77 FR 46292, Aug. 3, 2012]



Sec.  766.14  Contents of protocols.

    Protocols should include all parts of the Quality Assurance Plan for 
Measurement of Brominated or Chlorinated Dibenzofurans and 
Dibenzodioxins, as stated in the Guidelines. For each chemical substance 
and each process, the manufacturer must submit a statement of how many 
grades of the chemical substance it produces, a justification for 
selection of the specific grade of chemical substance for testing, 
specific plans for collection of samples from the process stream, naming 
the point of collection, the method of collecting the sample, and an 
estimate of how well the samples will represent the material to be 
characterized; a description of how control samples (blanks) and HDD/
HDF-reinforced control samples, or isotopically labeled compounds 
(standards) and duplicate samples will be handled; a description of the 
chemical extraction and clean up procedures to be used; how extraction 
efficiency and measurement efficiency will be established; and a 
description of instrument hardware and operating conditions, including 
type and source of columns, carrier gas and flow rate, operating 
temperature range, and ion source temperature.



Sec.  766.16  Developing the analytical test method.

    Because of the matrix differences of the chemicals listed for 
testing, no one method for sample selection, preparation, extraction and 
clean up is prescribed. For analysis, High Resolution Gas Chromatography 
(HRGC) with High Resolution Mass Spectrometry (HRMS) is the method of 
choice, but other methods may be used if they can be demonstrated to 
reach the target LOQs as well as HRGC/HRMS.
    (a) Sample selection. The chemical product to be tested should be 
sampled so that the specimens collected for analysis are representative 
of the whole. Additional guidance for sample selection is provided under 
Sec.  766.12.
    (b) Sample preparation. The sample must be mechanically homogenized 
and subsampled as necessary. Subsamples must be spiked or reinforced 
with surrogate compounds or with standard stock solutions, and the 
surrogates or standards must be thoroughly incorporated by mechanical 
agitation. Additional guidance is provided under Sec.  766.12.
    (c) Sample extraction and cleanup. The spiked samples must be 
treated to separate the HDDs/HDFs from the sample matrix. Methods are 
reviewed in the Guidelines under Sec.  766.12, but the final method or 
methods are left to the discretion of the analyst, provided the 
instrumental response of the surrogates meets the criteria listed in the 
Quality Assurance Plan for Measurement of Brominated or Chlorinated 
Dibenzofurans and Dibenzodioxins, Appendixes B and C of the Guidelines. 
Cleanup techniques are described in the Guidelines. These

[[Page 395]]

are chosen at the discretion of the analyst to meet the requirements of 
the chemical matrix.
    (d) Analysis. The method of choice is High Resolution Gas 
Chromatographic/High Resolution Mass Spectrometric Determination, (HRGC/
HRMS) but alternate methods may be used if the manufacturer can 
demonstrate that the method will reach the target LOQs as well as HRGC/
HRMS. Specific operating requirements are found in the Guidelines.



Sec.  766.18  Method sensitivity.

    The target level of quantitation required under Sec.  766.27 for 
each HDD/HDF congener is the level which must be attempted for each 
resolved HRGC peak for that congener. For at least one product sample, 
at least two analyses of the same isotopically labeled HDD/HDF internal 
calibration standards spiked to a final product concentration equal to 
the LOQ for that congener must be reproducibly extracted, cleaned up, 
and quantified to within 20 percent of each other. 
For each spiked product sample, the signal to noise ratio for the 
calibration standard peaks after complete extraction and cleanup must be 
10:1 or greater. The recovery of the internal calibration standards in 
the extracted and cleaned up product samples must be within 50 to 150 
percent of the amount spiked, and the results must be corrected for 
recovery.



       Subpart B_Specific Chemical Testing/Reporting Requirements



Sec.  766.20  Who must test.

    (a) Any person who manufactures, imports, or processes a chemical 
substance listed in Sec.  766.25 must test that chemical substance and 
must submit appropriate information to EPA according to the schedules 
described in Sec.  766.35. Chemical substances manufactured, imported or 
processed between January 1, 1984 and the date of promulgation of this 
part are subject to testing upon the effective date of this part. All 
other chemical substances are subject to testing immediately upon 
manufacture, import or processing. EPA expects that only manufacturers 
and importers will perform testing, and that the cost of testing will be 
passed on to processors through the pricing mechanism, thereby enabling 
them to share in the cost of testing. However, processors will be called 
upon to sponsor testing should manufacturers and importers fail to do 
so. A processor may apply for an exemption from testing upon 
certification to EPA that a manufacturer or importer is testing the 
chemical substance which that person processes.
    (b) If no manufacturer or importer described in Sec.  766.20 submits 
a letter of intent to perform testing within the period described under 
Sec.  766.35(a), or an exemption application under Sec.  790.45(a), or a 
request for an exclusion or waiver under Sec.  766.32, EPA will issue a 
notice in the Federal Register to notify all processors of that chemical 
substance. The notice will state that EPA has not received any of the 
documents described in the previous sentence, and that current 
processors will have 30 days to submit either a letter of intent to 
perform the test or submit an exemption application.
    (c) If no manufacturer, importer or processor submits a letter of 
intent to perform testing of a specific chemical substance produced by a 
specific process, EPA will notify all manufacturers, importers, and 
processors, either by notice in the Federal Register or by letter, that 
all exemption applications will be denied and that within 30 days all 
manufacturers, importers, and processors will be in violation of this 
part until a proposed study plan is submitted for required testing.
    (d) Manufacturers, importers, and processors who are subject to this 
part must comply with the test rule development and exemption procedures 
in part 790 of this chapter, except as modified in this part.



Sec.  766.25  Chemical substances for testing.

    (a) Listing of chemical substances. Chemical substances required to 
be tested for HDDs/HDFs under this rule are listed in this section. The 
listing is by Chemical Abstracts Service (CAS) Number and common name.

    Note: For purposes of guidance only, EPA lists the chemical 
substances subject to testing under this part in two classes--those

[[Page 396]]

known to be manufactured or imported between January 1, 1984, and 
promulgation of this part, and those not known to be manufactured or 
imported at the time of promulgation of this part.
    (1) Chemicals substances known to be manufactured between January 1, 
1984 and date of promulgation of this part.

------------------------------------------------------------------------
   CAS No.                           Chemical name
------------------------------------------------------------------------
     79-94-7  Tetrabromobisphenol-A.
    118-75-2  2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4-dione.
    118-79-6  2,4,6-Tribromophenol.
    120-83-2  2,4-Dichlorophenol.
   1163-19-5  Decabromodiphenyloxide.
   4162-45-2  Tetrabromobisphenol-A-bisethoxylate.
  21850-44-2  Tetrabromobisphenol-A-bis-2,3-dibromopropyl ether.
  25327-89-3  Allyl ether of tetrabromobisphenol-A.
  32534-81-9  Pentabromodiphenyloxide.
  32536-52-0  Octabromodiphenyloxide.
  37853-59-1  1,2-Bis(tribromophenoxy)-ethane.
  55205-38-4  Tetrabromobisphenol-A diacrylate.
------------------------------------------------------------------------

    (2) Chemicals not known to be manufactured between January 1, 1984 
and the date of promulgation of this part.

------------------------------------------------------------------------
   CAS No.                           Chemical name
------------------------------------------------------------------------
     79-95-8  Tetrachlorobisphenol-A.
     87-10-5  3,4',5-Tribromosalicylanilide.
     87-65-0  2,6-Dichlorophenol.
     95-77-2  3,4-Dichlorophenol.
     95-95-4  2,4,5-Trichlorophenol.
     99-28-5  2,6-Dibromo-4-nitrophenol.
    120-36-5  2[2,4-(Dichlorophenoxy)]-propionic acid.
    320-72-9  3,5-Dichlorosalicyclic acid.
    488-47-1  Tetrabromocatechol.
    576-24-9  2,3-Dichlorophenol.
    583-78-8  2,5-Dichlorophenol.
    608-71-9  Pentabromophenol.
    615-58-7  2,4-Dibromophenol.
    933-75-5  2,3,6-Trichlorophenol.
   1940-42-7  4-Bromo-2,5-dichlorophenol.
   2577-72-2  3,5-Dibromosalicylanilide.
   3772-94-9  Pentachlorophenyl laurate.
  37853-61-5  Bismethylether of tetrabromobisphenol-A.
              Alkylamine tetrachlorophenate.
              Tetrabromobisphenol-B.
------------------------------------------------------------------------

    (b) Grade to be tested. If the same process is used to manufacture 
all grades of the same chemical substance, only one grade need be 
tested. The grade to be tested must be the grade subject to the most 
intense heat and alkalinity for the longest duration of time, 
manufactured under each different process. If the heat, alkalinity and 
duration of reaction do not differ for various grades, the test 
substance must be the grade of chemical substance with the highest 
volume of sales.



Sec.  766.27  Congeners and LOQs for which quantitation is required.

    Quantitation at the target LOQ shown for each of the following HDDs/
HDFs which may be present in the chemical substances is required for the 
chemical substances listed under Sec.  766.25. Analysis must take place 
for either chlorinated or brominated dibenzodioxins or dibenzofurans, 
whichever is predominantly expected to occur in the chemical substance 
to be tested. Only chlorinated and brominated congeners need be 
quantified; for chemical substances containing predominantly chlorine 
atoms, only congeners totally chlorinated at the numbered positions need 
be quantified; for chemical substances containing predominantly bromine 
atoms, only congeners totally brominated at the numbered positions need 
be quantified.

------------------------------------------------------------------------
        Chlorinated dioxins          Brominated dioxins         LOQ
------------------------------------------------------------------------
2,3,7,8-TCDD......................  2,3,7,8-TBDD........  0.1 ppb.
1,2,3,7,8-PeCDD...................  1,2,3,7,8-PeBDD.....  0.5 ppb.
1,2,3,4,7.8-HxCDD.................  1,2,3,4,7,8-HxBDD...  2.5 ppb.
1,2,3,6,7,8-HxCDD.................  1,2,3,6,7,8-HxBDD...  2.5 ppb.
1,2,3,7,8,9-HxCDD.................  1,2,3,7,8,9-HxBDD...  2.5 ppb.
1,2,3,4,6,7,8-HpCDD...............  1,2,3,4,6,7,8-HpBDD.  100 ppb.
2,3,7,8-TCDF......................  2,3,7,8-TBDF........  1 ppb.
1,2,3,7,8-PeCDF...................  1,2,3,7,8-PeBDF.....  5 ppb.
2,3,4,7,8-PeCDF...................  2,3,4,7,8-PeBDF.....  5 ppb.
1,2,3,4,7,8-HxCDF.................  1,2,3,4,7,8-HxBDF...  25 ppb.
1,2,3,6,7,8-HxCDF.................  1,2,3,6,7,8-HxBDF...  25 ppb.
1,2,3,7,8,9-HxCDF.................  1,2,3,7,8,9-HxBDF...  25 ppb.
2,3,4,6,7,8-HxCDF.................  2,3,4,6,7,8-HxBDF...  25 ppb.
1,2,3,4,6,7,8-HpCDF...............  1,2,3,4,6,7,8-HpBDF.  1 ppm.
1,2,3,4,7,8,9-HpCDF...............  1,2,3,4,7,8,9-HpBDF.  1 ppm.
------------------------------------------------------------------------



Sec.  766.28  Expert review of protocols.

    EPA will gather a panel of experts in analysis of chemical matrices 
for HDDs/HDFs to review the protocols for testing submitted to EPA. The 
panel members will be employees of EPA and/or of other U.S. Government 
agencies who have had experience in analysis of chemical matrices and/or 
chemical wastes for HDDs/HDFs. The panel will recommend to the Director, 
EPA Office of Pollution Prevention and Toxics, whether the protocol 
submitted is likely to allow analysis down to the target LOQs, or if 
not, whether the protocol represents a good faith effort on the part of 
the tester to achieve the

[[Page 397]]

lowest possible LOQs. The final determination to accept or reject the 
protocol will be made by the Director, Office of Pollution Prevention 
and Toxics. EPA will review the submitted protocols as rapidly as 
possible and will complete the review within 90 days after receipt. EPA 
may require submission of revised protocols. Comments and 
recommendations will be transmitted to the submitter, and if revisions 
are required, a final protocol must be submitted to EPA within 90 days 
after EPA transmits such recommendations.



Sec.  766.32  Exclusions and waivers.

    (a) Reasons for exclusions and waivers. Any person subject to the 
testing requirements of this part may request an exclusion or waiver 
from testing for any one of the following reasons:
    (1) Exclusions may be granted if. (i) Testing of the appropriate 
grade of the chemical substance has already been carried out, either 
analytical testing at the lowest LOQ possible, with appropriate QA/QC, 
or a well-designed bioassay with appropriate QA/QC or;
    (ii) Process and reaction conditions of the chemical substance such 
that no HDDs/HDFs could be produced under those conditions;
    (2) Waivers may be granted if. (i) A responsible company official 
certifies that the chemical substance is produced only in quantities of 
100 kilograms or less per year, only for research and development 
purposes; or
    (ii) In the judgement of EPA, the cost of testing would drive the 
chemical substance off the market, or prevent resumption of manufacture 
or import of the chemical substance, if it is not currently 
manufactured, and the chemical substance will be produced so that no 
unreasonable risk will occur due to its manufacture, import, processing, 
distribution, use, or disposal. (In this case, the manufacturer must 
submit to EPA all data supporting the determination.)
    (iii) Waivers may be appropriately conditioned with respect to such 
factors as time and conditions of manufacture or use. The grade of 
decabromodiphenyl oxide produced by Dow Chemical Company (Dow) for the 
National Toxicology Program (NTP) bioassay on that chemical is excluded 
from the testing requirement under this part. Provided, however, that 
this exclusion will not apply if Dow fails to supply to EPA within 60 
days of the effective date of this section evidence showing which grade 
was used for the NTP bioassay.
    (b) Timing. Exclusion or waiver requests and detailed supporting 
data must be submitted to EPA within 60 days from the effective date of 
this part for persons manufacturing, importing or processing a chemical 
substance as of the date of promulgation, or 60 days prior to the date 
of resumption of manufacture or import for a chemical substance produced 
by a specific process if the chemical substance is not manufactured, 
imported or processed as of the date of promulgation.
    (c) Publication. Within 10 days of receipt of any exclusion or 
waiver request, EPA will issue in the Federal Register a notice of such 
receipt. EPA will also issue a notice of its decision on each exclusion 
or waiver request within 60 days of receipt.
    (d) Decision. The EPA Director of the Office of Pollution Prevention 
and Toxics will make the decision to grant or deny waivers or 
exclusions.



Sec.  766.35  Reporting requirements.

    (a) Letters of intent, exemption applications, and protocols--(1) 
Letters of intent. (i) Persons who have manufactured or imported 
chemical substances listed under Sec.  766.25 between January 1, 1984, 
and the effective date of this part are required to submit under Sec.  
790.45 of this chapter a letter of intent to test or an exemption 
application. These letters must be submitted no later than September 3, 
1987.
    (ii) Persons who commence manufacture, import or processing of a 
chemical substance listed under Sec.  766.25 that has not been 
manufactured, imported or processed between January 1, 1984 and the 
effective date of this part must submit under Sec.  790.45 of this 
chapter, within 60 days after the commencement of manufacture, import, 
or processing of the chemical substance, a letter of intent to test or 
an exemption application.
    (iii) Persons who commence manufacture, import or processing of a

[[Page 398]]

chemical substance listed under Sec.  766.25 between the effective date 
of this part and the end of the reimbursement period for that particular 
chemical substance produced by a specific process must submit under 
Sec.  790.45 of this chapter, within 60 days after the commencement of 
manufacture, import or processing of the chemical substance, a letter of 
intent to test or an exemption application.
    (2) Protocols. (i) Each person who is manufacturing or processing a 
chemical substance listed in Sec.  766.25 as of the effective date of 
this part who submits a notice of intent to test under Sec.  
766.35(a)(1) must submit a protocol for the test as follows:
    (A) The protocols for each chlorinated chemical substance produced 
by each process to be tested must be submitted to EPA no later than 12 
months after the effective date of this part.
    (B) The protocol for each brominated chemical substance produced by 
each process to be tested must be submitted to EPA no later than 24 
months after the effective date of this part except for the following 
chemicals.
    (1) The deadline for submitting the protocols for 
tetrabromobisphenol-A (CAS No. 79-94-7); 2,4,6 tribromophenol (CAS. No. 
118-79-6); decabromodiphenyloxide (CAS No. 1163-19-5); and 1,2-
bis(tribromophenoxy)-ethane (CAS No. 37853-59-1) is January 31, 1991.
    (2) The deadline for submitting protocols for octabromodiphenyloxide 
(CAS No. 32536-52-0) and allyl ether of tetrabromobisphenol-A (CAS No. 
25327-89-3) is January 31, 1991.
    (3) The deadline for submitting protocols for 
pentabromodiphenyloxide (CAS No. 32534-81-9) is February 6, 1995. The 
deadline for submitting tetrabromobisphenol-A-bisethoxylate (CAS No. 
4126-45-2) is January 31, 1991.
    (4) The deadline for submitting protocols for 3,4',5-
tribromosalicylanilide (CAS No. 87-10-5) is September 5, 1990.
    (ii) For chemical substances produced by a specific process not 
manufactured or processed as of the effective date of this part, a 
person who begins manufacture and submits a notice of intent to test 
must submit protocols for the test as follows:
    (A) Except as noted for the submitter and substance specified in the 
following table, protocols for testing must be submitted 12 months after 
manufacture or importation begins for chlorinated chemical substances.

----------------------------------------------------------------------------------------------------------------
 CAS No.               Submitter                              Chemical                          Due date
----------------------------------------------------------------------------------------------------------------
 118-75-2  Rhone-Poulenc....................  2,3,5,6-tetrachloro-2,5-cyclohexaniene-   March 4, 1994
                                               1,4-dione.
----------------------------------------------------------------------------------------------------------------

    (B) Protocols for testing must be submitted 24 months after 
manufacture begins for brominated chemical substances.
    (iii) For persons who have been granted exemptions, waivers or 
exclusions from testing, protocols must be submitted 12 months after 
expiration of the exemption, waiver or exclusion for chlorinated 
chemical substances, and 24 months after expiration of the exemption, 
waiver or exclusion for brominated chemical substances.
    (b) Information that must be submitted to EPA. (1) Persons who 
manufacture or import a chemical substance listed under Sec.  766.25 
must report no later than October 5, 1987 or 90 days after the person 
first manufactures or imports the chemical substance, whichever is 
later, the results of all existing test data which show that chemical 
substance has been tested for the presence of HDDs/HDFs.
    (2) Any manufacturer or importer of a chemical substance listed in 
Sec.  766.25 in possession of unpublished health and safety studies on 
HDDs/HDFs is required to submit copies of such studies to EPA no later 
than October 5, 1987 or 90 days after the person first manufactures or 
imports the chemical substance, whichever is later. The following 
provisions of part 716 of this chapter apply to submission of these 
studies: Sec. Sec.  716.3, 716.10(a) (1) and (4); 716.20(a) (1), (2), 
(3), (4), (7), (8) and (10); 716.25; 716.30; 716.35(a) (1), (2), and (4) 
[if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; 
and 716.60(a)(2).

[[Page 399]]

    (3) No later than October 5, 1987 or 90 days after the person first 
manufactures or imports the substance listed in Sec.  766.25, any 
manufacturer or importer of a chemical substance listed in Sec.  766.25 
must submit records required to be held under part 717 of this chapter 
on any HDDs/HDFs.
    (4) Test results. (i) Test results must be submitted to EPA not 
later than 270 days after EPA's transmission of comments or 180 days 
after a final protocol is submitted to EPA, whichever is shorter, except 
as noted for the submitters and substances specified in the following 
table:

----------------------------------------------------------------------------------------------------------------
     CAS No.           Submitter                 Chemical                     Due Date           Effective Date
----------------------------------------------------------------------------------------------------------------
         79-94-7  Great Lakes         Tetrabromobisphenol-A           May 26, 1992              May 28, 1993
         79-94-7  Ethyl               Tetrabromobisphenol-A           August 10, 1992           May 28, 1993
         79-94-7  Ameribrom           Tetrabromobisphenol-A           April 15, 1994            September 29,
                                                                                                 1995
         87-10-5  Pfister             3,4',5-tribromosalicylanilide   45 days after protocol    May 28, 1993
                                                                       approval
        118-75-2  Rhone-Poulenc Inc.  2,3,5,6-tetrachloro-2,5-        July 5, 1996              June 30, 1997
                                       cyclohexadiene-1,4-dione
        118-79-6  Great Lakes         2,4,6-Tribromophenol            May 26, 1992              May 28, 1993
       1163-19-5  Ameribrom           Decabromodiphenyloxide          April 15, 1994            September 29,
                                                                                                 1995
       1163-19-5  Ethyl               Decabromodiphenyloxide          May 26, 1992              May 28, 1993
       1163-19-5  Great Lakes         Decabromodiphenyloxide          May 26, 1992              May 28, 1993
       4162-45-2  Great Lakes         Tetrabromobisphenol-A-          June 2, 1993              September 8,
                                       bisethoxylate                                             1994
      25327-89-3  Great Lakes         Allyl Ether of                  August 10, 1992           May 28, 1993
                                       Tetrabromobisphenol-A
      32534-81-9  Great Lakes         Pentabromodiphenyloxide         March 22, 1993            September 8,
                                                                                                 1994
      32534-81-9  Akzo Chemicals      Pentabromodiphenyloxide         February 6, 1995          September 29,
                   Inc.                                                                          1995
      32534-81-9  Ameribrom           Pentabromodiphenyloxide         March 22, 1993            September 8,
                                                                                                 1994
      32536-52-0  Ameribrom           Octabromodiphenyloxide          January 8, 1993           September 29,
                                                                                                 1995
      32536-52-0  Ethyl               Octabromodiphenyloxide          May 15, 1994              May 28, 1993
      32536-52-0  Great Lakes         Octabromodiphenyloxide          May 26, 1992              May 28, 1993
      37853-59-1  Great Lakes         1,2-bis(tribromophenoxy)ethane  January 24, 1995          September 29,
                                                                                                 1995
----------------------------------------------------------------------------------------------------------------

    (ii) For purposes of reporting test results to EPA, and for further 
reporting triggered by a positive test result under Sec.  766.35(c), a 
positive test result is defined at Sec.  766.3.
    (iii) Reporting of test results must follow procedures set out in 
part 790 of this chapter, except as modified in this part.
    (c) Information required to be submitted to EPA after submission of 
a positive test result. (1) Any person who submits a positive test 
result for a specific chemical substance listed under Sec.  766.25 must 
submit to EPA no later than 90 days after the date of submission of the 
positive test result the following:
    (i) A completed form (EPA 7710-51) for that chemical substance. The 
form and instructions are available online at http://www.epa.gov/oppt/
chemtest/ereporting/index.html. One form must be submitted for each 
chemical substance for which a positive test result has been submitted.
    (ii) Health and safety studies for the chemical substance for which 
a positive test result has been reported. The following provisions of 
part 716 of this chapter apply to submission of these studies: 
Sec. Sec.  716.3; 716.10 (a) (1), (2), (3) and (4); 716.20; 716.25; 
716.30; 716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and 
(c); 716.40 (a) and (b); 716.50; 716.55; 716.60(a)(2).
    (iii) Copies of records on the chemical substances required to be 
held under part 717 of this chapter.
    (2) If a positive test result on a chemical substance is received 
from one person but not from others, EPA may issue a notice in the 
Federal Register listing that chemical substance and requiring any 
person manufacturing, importing or processing that chemical substance 
who has not submitted a positive test result to submit the information 
required in Part II of EPA Form 7710-51. Such a notice will be published 
only if EPA needs additional

[[Page 400]]

process data to make a determination of unreasonable risk.
    (d)-(e) [Reserved]
    (f) Effective date. (1) The effective date of this final rule is 
July 6, 1987, except for paragraphs (a)(2)(i)(B) introductory text, 
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), (a)(2)(i)(B)(3), (a)(2)(i)(B)(4), the 
table in paragraph (a)(2)(ii)(A), and the table in paragraph (b)(4)(i) 
of this section.
    (2) The effective date for paragraph (a)(2)(i)(B) introductory text, 
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and (a)(2)(i)(B)(4), is May 21, 1991. 
The effective date of paragraphs (a)(2)(i)(B)(3), and the table in 
paragraph (a)(2)(ii)(A) is September 29, 1995. The effective date of 
paragraph (b)(4)(i) introductory text is May 28, 1993, and the effective 
date of the entries in the table in paragraph (b)(4)(i) is shown in the 
effective dates column of the table.
    (3) The guidelines and other test methods cited in this rule are 
referenced as they exist on the effective date of the final rule.

[52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57 
FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June 
23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 31922, June 19, 1995; 60 FR 
50433, Sept. 29, 1995; 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 30, 
1997; 78 FR 72829, Dec. 4, 2013]



Sec.  766.38  Reporting on precursor chemical substances.

    (a) Identification of precursor chemical substances. Precursor 
chemical substances are produced under conditions that will not yield 
HDDs and HDFs, but their molecular structure is conducive to HDD/HDF 
formation under favorable reaction conditions when they are used to 
produce other chemicals or products. The following precursor chemical 
substances are identified by Chemical Abstract Service (CAS) number and 
name.

------------------------------------------------------------------------
             CAS No.                           Chemical name
------------------------------------------------------------------------
85-22-3..........................  Pentabromoethylbenzene.
87-61-6..........................  1,2,3-Trichlorobenzene.
87-84-3..........................  1,2,3,4,5-Pentabromo-6-chloro-
                                    cyclohexane.
89-61-2..........................  1,4-Dichloro-2-nitrobenzene.
89-64-5..........................  4-Chloro-2-nitrophenol.
89-69-0..........................  2,4,5-Trichloronitrobenzene.
92-04-6..........................  2-Chloro-4-phenylphenol.
94-74-6..........................  4-Chloro-o-toloxy acetic acid.
94-81-5..........................  4-(2-Methyl-4-chlorophenoxy) butyric
                                    acid.
95-50-1..........................  o-Dichlorobenzene.
95-56-7..........................  o-Bromophenol.
95-57-8..........................  o-Chlorophenol.
95-88-5..........................  4-Chlororesorcinol.
95-94-3..........................  1,2,4,5-Tetrachlorobenzene.
97-50-7..........................  5-Chloro-2,4-dimethoxyaniline.
99-30-9..........................  2,6-Dichloro-4-nitroaniline.
99-54-7..........................  1,2-Dichloro-4-nitrobenzene.
106-46-7.........................  p-Dichlorobenzene.
108-70-3.........................  1,3,5-Trichlorobenzene.
108-86-1.........................  Bromobenzene.
108-90-7.........................  Chlorobenzene.
117-18-0.........................  1,2,4,5-Tetrachloro-3-nitrobenzene.
120-82-1.........................  1,2,4-Trichlorobenzene.
348-51-6.........................  o-Chorofluorobenzene.
350-30-1.........................  3-Chloro-4-fluoronitrobenzene.
615-67-8.........................  Chlorohydroquinone.
626-39-1.........................  1,3,5-Tribromobenzene.
827-94-1.........................  2,6-Dibromo-4-nitroaniline.
------------------------------------------------------------------------

    (b) Persons required to report. All persons who manufacture or 
import a chemical product produced using any of the chemical substances 
listed in paragraph (a) of this section as feedstocks or intermediates 
must report no later than September 29, 1987. Small manufacturers and 
those manufacturers and importers who produce the precursor chemical 
substances in quantities of 100 kilograms or less per year only for 
research and development purposes are not required to report under this 
section
    (c) Data to be reported. Manufacturers and importers of chemical 
products made from precursor chemical substances identified in paragraph 
(a) of this section must report process and reaction condition data on 
Part II of EPA Form 7710-51 for each chemical product. A separate EPA 
Form 7710-51 must be submitted for each chemical product reported, and 
the precursor chemical substance used must be identified. All forms must 
be submitted to EPA no later than September 29, 1987.

[52 FR 21437, June 5, 1987, as amended at 60 FR 31922, June 19, 1995]

                        PARTS 767	769 [RESERVED]



PART 770_FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD PRODUCTS--Table of Contents



                      Subpart A_General Provisions

Sec.
770.1 Scope and applicability.
770.2 Applicability and compliance dates.
770.3 Definitions.

[[Page 401]]

770.4 Exemption from the hardwood plywood definition for certain 
          laminated products.
770.5 Prohibited acts.

      Subpart B_EPA TSCA Title VI Third-Party Certification Program

770.7 Third-party certification.
770.8 Applications, notifications, and reports.

                    Subpart C_Composite Wood Products

770.10 Formaldehyde emission standards.
770.12 Stockpiling.
770.15 Composite wood product certification.
770.17 No-added formaldehyde-based resins.
770.18 Ultra low-emitting formaldehyde resins.
770.20 Testing requirements.
770.21 Quality control manual, facilities, and personnel.
770.22 Non-complying lots.
770.24 Samples for testing.
770.30 Importers, fabricators, distributors, and retailers.
770.40 Reporting and recordkeeping.
770.45 Labeling.

                  Subpart D_Incorporation by Reference

770.99 Incorporation by reference.

    Authority: 15 U.S.C. 2697(d).

    Source: 81 FR 89724, Dec. 12, 2016, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  770.1  Scope and applicability.

    (a) This part contains formaldehyde emission standards, testing and 
certification provisions, and other requirements for the manufacture 
(including import), distribution, and sale of composite wood products, 
component parts that contain composite wood products, and finished goods 
that contain composite wood products.
    (b) This part applies to:
    (1) Laboratory Accreditation Bodies (ABs) and Product ABs that are 
accrediting third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 
2697(d)) purposes and those that wish to commence accrediting TPCs for 
TSCA Title VI purposes.
    (2) TPCs that are certifying composite wood products for TSCA Title 
VI compliance and those that wish to commence certifying composite wood 
products for TSCA Title VI compliance.
    (3) Any composite wood products, and component parts or finished 
goods containing these materials, that are sold, supplied, offered for 
sale, or manufactured (including imported) in the United States, 
including composite wood products used or installed in manufactured 
housing.
    (c) Subparts B, C, and D of this part do not apply to the following:
    (1) Any finished good that has previously been sold or supplied to 
an end user, an individual or entity that purchased or acquired the 
finished good in good faith for purposes other than resale. For example, 
subparts B, C, and D of this part do not apply to antiques or secondhand 
furniture.
    (2) Hardboard.
    (3) Structural plywood, as specified in PS 1-19 (incorporated by 
reference, see Sec.  770.99).
    (4) Structural panels, as specified in PS 2-18 (incorporated by 
reference, see Sec.  770.99).
    (5) Structural composite lumber, as specified in ASTM D5456-21e1 
(incorporated by reference, see Sec.  770.99).
    (6) Oriented strand board.
    (7) Glued laminated lumber, as specified in ANSI A190.1-2017, 
Standard for Wood Products--Structural Glued Laminated Timber 
(incorporated by reference, see Sec.  770.99).
    (8) Prefabricated wood I-joists, as specified in ASTM D5055-19e1 
(incorporated by reference, see Sec.  770.99).
    (9) Finger-jointed lumber.
    (10) Wood packaging, including pallets, crates, spools, and dunnage.
    (11) Composite wood products used inside the following:
    (i) New vehicles (other than recreational vehicles) that are 
constructed entirely from new parts and that have never been the subject 
of a retail sale or registered with the applicable State or other 
governmental agency.
    (ii) New rail cars.
    (iii) New boats.
    (iv) New aerospace craft.
    (v) New aircraft.
    (d) The emission standards in Sec.  770.10 do not apply to windows 
that contain composite wood products, if the windows contain less than 
five percent by

[[Page 402]]

volume of composite wood products, combined, in relation to the total 
volume of the finished window.
    (e) The emission standards in Sec.  770.10 do not apply to exterior 
doors and garage doors that contain composite wood products, if:
    (1) The doors are made from composite wood products manufactured 
with no-added formaldehyde-based resins or ultra low-emitting 
formaldehyde resins; or
    (2) The doors contain less than three percent by volume of composite 
wood products, combined, in relation to the total volume of the finished 
exterior door or garage door.

[81 FR 89724, Dec. 12, 2016, as amended at 83 FR 5345, Feb. 7, 2018; 88 
FR 10476, Feb. 21, 2023]



Sec.  770.2  Applicability and compliance dates.

    (a) [Reserved]
    (b) Laboratory and Product ABs that wish to accredit TPCs for TSCA 
Title VI purposes may apply to EPA beginning May 22, 2017, to become 
recognized. Laboratory and Product ABs must be recognized by EPA before 
they begin to provide and at all times while providing TSCA Title VI 
accreditation services.
    (c) TPCs that are not approved by the California Air Resources Board 
(CARB) that wish to provide TSCA Title VI certification services may 
apply to EPA beginning May 22, 2017, to become recognized. TPCs must be 
recognized by EPA and comply with all of the applicable requirements of 
this part before they begin to provide and at all times while providing 
TSCA Title VI certification services.
    (d) Notwithstanding any other provision of this part, TPCs that are 
approved by CARB to certify composite wood products have until March 22, 
2019, to become accredited by an EPA TSCA Title VI AB(s) pursuant to the 
requirements of this part. During this two-year transition period, 
existing CARB-approved TPCs that are recognized by EPA and CARB TPCs 
approved during this transition period may carry out certification 
activities under TSCA Title VI, provided that they remain approved by 
CARB and comply with all aspects of this part other than the 
requirements of Sec.  770.7(c)(1)(i) and (ii) and (c)(2)(iii) and (iv). 
After the two-year transition period, CARB-approved TPCs may continue to 
certify composite wood products under TSCA Title VI provided the TPC 
maintains its CARB approval, follows the requirements under this part, 
submits to EPA documentation from CARB supporting their eligibility for 
reciprocity and has received EPA recognition as an EPA TSCA Title VI 
TPC. All TPCs that are certifying products as compliant with TSCA Title 
VI, both during and after the transition period, are subject to 
enforcement actions for any violations of TSCA Title VI or these 
regulations.
    (e) Beginning June 1, 2018, all manufacturers (including importers), 
fabricators, suppliers, distributors, and retailers of composite wood 
products, and component parts or finished goods containing these 
materials, must comply with this part, subject to the following:
    (1) Beginning June 1, 2018, laminated product producers must comply 
with the requirements of this part that are applicable to fabricators.
    (2) Beginning March 22, 2024, producers of laminated products must 
comply with the requirements of this part that are applicable to 
hardwood plywood panel producers (in addition to the requirements of 
this part that are applicable to fabricators) except as provided at 
Sec.  770.4.
    (3) Beginning March 22, 2024, producers of laminated products that, 
as provided at Sec.  770.4, are exempt from the definition of ``hardwood 
plywood'' must comply with the recordkeeping requirements in Sec.  
770.40(c) and (d) (in addition to the requirements of this part that are 
applicable to fabricators).
    (4) Composite wood products manufactured (including imported) before 
June 1, 2018 may be sold, supplied, offered for sale, or used to 
fabricate component parts or finished goods at any time.

[82 FR 44536, Sept. 25, 2017, as amended at 84 FR 43523, Aug. 21, 2019]



Sec.  770.3  Definitions.

    For the purposes of this part, the following definitions apply:

[[Page 403]]

    Accreditation Body or AB means an organization that provides an 
impartial verification of the competency of conformity assessment bodies 
or TPCs.
    Agent for Service means an entity designated by a TPC or AB to 
receive legal documents on their behalf.
    Article means a manufactured item which:
    (1) Is formed to a specific shape or design during manufacture;
    (2) Has end use functions dependent in whole or in part upon its 
shape or design during the end use; and
    (3) 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 19 
CFR 12.120(a)(2), except that fluids and particles are not considered 
articles regardless of shape or design.
    Assessment means a process to include an on-site review undertaken 
by an AB to assess the competence of all operations of a conformity 
assessment body and TPC, based on particular standard(s) and/or other 
normative documents for a defined scope of accreditation, as defined in 
ISO/IEC 17011:2017(E) (incorporated by reference, see Sec.  770.99).
    Bundle means more than one composite wood product, component part, 
or finished good fastened together for transportation or sale.
    Combination core means a platform for making hardwood plywood or 
laminated products that consists of a combination of layers of veneer 
and particleboard or medium density fiberboard.
    Component part means an object other than a panel that contains one 
or more composite wood products and is used in the construction or 
assembly of finished goods. Component parts that are sold directly to 
consumers are considered finished goods.
    Composite core means a platform for making hardwood plywood or 
laminated products that consists of particleboard and/or medium density 
fiberboard, or combination core.
    Composite wood product means hardwood plywood made with a veneer or 
composite core, medium-density fiberboard, and particleboard.
    Distributor means any person or entity to whom a composite wood 
product, component part, or finished good is sold or supplied for the 
purposes of resale or distribution in commerce, except that 
manufacturers and retailers are not distributors.
    Engineered veneer means a type of veneer that is created by dyeing 
and gluing together leaves of veneer in a mold to produce a block. The 
block is then sliced into leaves of veneer with a designed appearance 
that is highly repeatable.
    EPA TSCA Title VI Laboratory Accreditation Body or EPA TSCA Title VI 
Laboratory AB means an AB that has a recognition agreement with EPA 
under the EPA TSCA Title VI Third-Party Certification Program, accredits 
a TPC's testing laboratory or contract testing laboratory to ISO/IEC 
17025:2017(E) (incorporated by reference, see Sec.  770.99) with a scope 
of accreditation to include this part and the formaldehyde test methods 
used to comply with this part, and assesses the testing laboratory's 
conformance to ISO/IEC 17020:2012(E) (incorporated by reference, see 
Sec.  770.99) in order to perform laboratory testing services.
    EPA TSCA Title VI Product Accreditation Body or EPA TSCA Title VI 
Product AB means an AB that has a recognition agreement with EPA under 
the EPA TSCA Title VI Third-Party Certification Program, accredits a TPC 
to ISO/IEC 17065:2012(E) (incorporated by reference, see Sec.  770.99) 
with a scope of accreditation to include composite wood products and 
this part, and assesses the TPC's conformance to ISO/IEC 17020:2012(E) 
(incorporated by reference, see Sec.  770.99) in order to perform 
product certification.
    EPA TSCA Title VI Third-Party Certifier or EPA TSCA Title VI TPC 
means a conformity assessment body that provides both product 
certification services and laboratory testing services (either directly 
or through contracted services), is accredited by an EPA TSCA Title VI 
Product AB and an EPA TSCA Title VI Laboratory AB (unless the laboratory 
testing services are contracted to a laboratory accredited by an EPA 
TSCA Title VI Laboratory AB), and is recognized by EPA pursuant to Sec.  
770.7(c).

[[Page 404]]

    Fabricator means a person or entity who incorporates composite wood 
products into component parts or into finished goods. This includes 
laminated product producers, but persons or entities in the construction 
trades are not fabricators by renovating or remodeling buildings.
    Finished good means any good or product, other than a panel, that 
contains hardwood plywood (with a veneer or composite core), 
particleboard, or medium-density fiberboard and that is not a component 
part or other part used in the assembly of a finished good. Site-built 
buildings or other site-built real property improvements are not 
considered finished goods.
    Hardboard means a composite panel composed of cellulosic fibers, 
consolidated under heat and pressure in a hot press by: A wet process; 
or a dry process that uses a phenolic resin, or a resin system in which 
there is no formaldehyde as part of the resin cross-linking structure; 
or a wet formed/dry pressed process; and that is commonly or 
commercially known, or sold, as hardboard, including any product 
conforming to one of the following ANSI standards: Basic Hardboard (ANSI 
A135.4-2012) (incorporated by reference, see Sec.  770.99), Prefinished 
Hardboard Paneling (ANSI A135.5-2012) (incorporated by reference, see 
Sec.  770.99), Engineered Wood Siding (ANSI A135.6-2012) (incorporated 
by reference, see Sec.  770.99), or Engineered Wood Trim (ANSI A135.7-
2012) (incorporated by reference, see Sec.  770.99). There is a 
rebuttable presumption that products emitting more than 0.06 ppm 
formaldehyde as measured by ASTM E1333-14 (incorporated by reference, 
see Sec.  770.99) or ASTM D6007-14 (incorporated by reference, see Sec.  
770.99) are not hardboard.
    Hardwood plywood means a hardwood or decorative panel that is 
intended for interior use and composed of (as determined under ANSI/HPVA 
HP-1-2020 (incorporated by reference, see Sec.  770.99)) an assembly of 
layers or plies of veneer, joined by an adhesive with a lumber core, a 
particleboard core, a medium-density fiberboard core, a hardboard core, 
a veneer core, or any other special core or special back material. 
Hardwood plywood does not include military-specified plywood, curved 
plywood, or any plywood specified in PS 1-19 (incorporated by reference, 
see Sec.  770.99), or PS 2-18 (incorporated by reference, see Sec.  
770.99). In addition, hardwood plywood includes laminated products 
except as provided at Sec.  770.4.
    Importer means any person or entity who imports composite wood 
products, component parts, or finished goods into the customs territory 
of the United States (as defined in general note 2 of the Harmonized 
Tariff Schedules of the United States pursuant to 15 U.S.C. 2612(a)(1)). 
Importer includes:
    (1) The entity primarily liable for the payment of any duties on the 
products; or
    (2) An authorized agent acting on the entity's behalf.
    Intended for interior use means intended for use or storage inside a 
building or recreational vehicle, or constructed in such a way that it 
is not suitable for long-term use in a location exposed to the elements. 
Windows, doors, and garage doors with at least one interior-facing side 
are intended for interior use.
    Laboratory Accreditation Body or Laboratory AB means an AB that 
accredits conformity assessment body testing laboratories.
    Laminated product means a product in which a wood or woody grass 
veneer is affixed to a particleboard core or platform, a medium-density 
fiberboard core or platform, or a veneer core or platform. A laminated 
product is a component part used in the construction or assembly of a 
finished good. In addition, a laminated product is produced by either 
the fabricator of the finished good in which the product is incorporated 
or a fabricator who uses the laminated product in the further 
construction or assembly of a component part.
    Laminated product producer means a manufacturing plant or other 
facility that manufactures (excluding facilities that solely import 
products) laminated products on the premises. Laminated product 
producers are fabricators and, beginning March 22, 2024, laminated 
product producers are also hardwood plywood panel producers except as 
provided at Sec.  770.4.

[[Page 405]]

    Lot means the panels produced from the beginning of production of a 
product type until the first quality control test; between one quality 
control test and the next; or from the last quality control test to the 
end of production for a particular product type.
    Medium-density fiberboard means a panel composed of cellulosic 
fibers made by dry forming and pressing a resinated fiber mat (as 
determined under ANSI A208.2-2022 (incorporated by reference, see Sec.  
770.99)).
    No-added formaldehyde-based resin means a resin formulated with no 
added formaldehyde as part of the resin crosslinking structure in a 
composite wood product that meets the emission standards in Sec.  
770.17(c).
    Non-complying lot means any lot of composite wood product 
represented by a quarterly test value or quality control test result 
that indicates that the lot exceeds the applicable standard for the 
particular composite wood product in Sec.  770.10(b). A quality control 
test result that exceeds the QCL is considered a test result that 
indicates that the lot exceeds the applicable standard. Future 
production of the product type(s) represented by a failed quarterly test 
are not considered certified and must be treated as a non-complying lot 
until the product type(s) are re-qualified through a successful 
quarterly test.
    Panel means a thin (usually less than two inches thick), flat, 
usually rectangular piece of particleboard, medium-density fiberboard or 
hardwood plywood. Embossing or imparting of an irregular surface on the 
composite wood products by the original panel producer during pressing 
does not remove the product from this definition. Cutting a panel into 
smaller pieces, without additional fabrication, does not make the panel 
into a component part or finished good. This does not include items made 
for the purpose of research and development, provided such items are not 
sold, supplied, or offered for sale.
    Panel producer means a manufacturing plant or other facility that 
manufactures (excluding facilities that solely import products) 
composite wood products on the premises.
    Particleboard means a panel composed of cellulosic material in the 
form of discrete particles (as distinguished from fibers, flakes, or 
strands) that are pressed together with resin (as determined under ANSI 
A208.1-2022 (incorporated by reference, see Sec.  770.99)). 
Particleboard does not include any product specified in PS 2-18 
(incorporated by reference, see Sec.  770.99).
    Phenol-formaldehyde resin means a resin that consists primarily of 
phenol and formaldehyde and does not contain urea-formaldehyde.
    Product Accreditation Body or Product AB means an AB that accredits 
conformity assessment bodies who perform product certification.
    Product type means a type of composite wood product, or group of 
composite wood products, made by the same panel producer with the same 
resin system that differs from another product type based on panel 
composition and formaldehyde emission characteristics. Grouped products 
must have similar formaldehyde emission characteristics and their 
emissions must fit the same correlation curve or linear regression.
    Production line means a set of operations and physical industrial or 
mechanical equipment used to produce a composite wood product in one 
facility utilizing the same or similar equipment and quality assurance 
and quality control procedures.
    Purchaser means any panel producer, importer, fabricator, 
distributor, or retailer that acquires composite wood products, 
component parts, or finished goods for purposes of resale in exchange 
for money or its equivalent.
    Quality control limit or QCL means the value from the quality 
control method test that is the correlative equivalent to the applicable 
emission standard based on the ASTM E1333-14 method (incorporated by 
reference, see Sec.  770.99) or, upon showing equivalence in accordance 
with Sec.  770.20(d), the ASTM D6007-14 method (incorporated by 
reference, see Sec.  770.99).
    Reassessment means an assessment, as described in sections 7.4 to 
7.13 of ISO/IEC 17011:2017(E) (incorporated by reference, see Sec.  
770.99), except that experience gained during previous assessments shall 
be taken into account.
    Recreational vehicle means a vehicle which is:
    (1) Built on a single chassis;

[[Page 406]]

    (2) Four hundred square feet or less when measured at the largest 
horizontal projections;
    (3) Self-propelled or permanently towable by a light duty truck; and
    (4) Designed primarily not for use as a permanent dwelling but as 
temporary living quarters for recreational, camping, travel, or seasonal 
use.
    Resin system means type of resin used, including but not limited to 
urea-formaldehyde, soy, phenol-formaldehyde, or melamine-urea-
formaldehyde.
    Retailer means any person or entity that sells, offers for sale, or 
supplies directly to consumers composite wood products, component parts 
or finished goods that contain composite wood products, except that 
persons or entities in the construction trades are not considered 
retailers by selling, renovating, or remodeling buildings.
    Scavenger means a chemical or chemicals that can be applied to 
resins or composite wood products either during or after manufacture and 
that react with residual or excess formaldehyde to reduce the amount of 
formaldehyde that can be emitted from composite wood products.
    Shipping quality control limit means a quality control limit that is 
developed in conjunction with an EPA TSCA Title VI TPC that is based on 
panels prior to shipment rather than immediately after manufacturing.
    Stockpiling means manufacturing or purchasing composite wood 
products, whether in the form of panels or incorporated into component 
parts or finished goods, between July 7, 2010 and June 12, 2017 at an 
average rate at least 20% greater than the average rate of manufacture 
or purchase during the 2009 calendar year for the purpose of 
circumventing the emission standards and other requirements of this 
subpart.
    Surveillance On-Site Assessment means a set of on-site activities 
that are less comprehensive than reassessment, to monitor the continued 
fulfilment by accredited conformance assessment bodies of requirements 
for accreditation, as described in sections 7.4 to 7.13 of ISO/IEC 
17011:2017(E) (incorporated by reference, see Sec.  770.99).
    Thin medium-density fiberboard means medium-density fiberboard that 
has a thickness less than or equal to 8 millimeters or 0.315 inches.
    Third-party certifier or TPC means a conformity assessment body that 
provides both product certification services and laboratory testing 
services (either directly or through contracted services).
    TPC laboratory means a laboratory or contract laboratory of an EPA 
TSCA Title VI TPC that is accredited by an EPA TSCA Title VI Laboratory 
AB to ISO/IEC 17025:2017(E) (incorporated by reference, see Sec.  
770.99), and whose inspection activities are in conformance with ISO/IEC 
17020:2012(E) (incorporated by reference, see Sec.  770.99).
    Ultra low-emitting formaldehyde resin means a resin in a composite 
wood product that meets the emission standards in Sec.  770.18(c).
    Veneer means a sheet of wood or woody grass with a maximum thickness 
of 6.4 millimeters (\1/4\ inch) that is rotary cut, sliced, or sawed 
from a log, bolt, flitch, block, or culm; including engineered veneer.
    Veneer core means a platform for making hardwood plywood or 
laminated products that consists of veneer.
    Woody grass means a plant of the family Poaceae (formerly Gramineae) 
with hard lignified tissues or woody parts.

[81 FR 89724, Dec. 12, 2016, as amended at 82 FR 44537, Sept. 25, 2017; 
83 FR 5345, Feb. 7, 2018; 84 FR 43524, Aug. 21, 2019; 88 FR 10476, Feb. 
21, 2023]



Sec.  770.4  Exemption from the hardwood plywood definition for certain
laminated products.

    (a) Current exemptions. The definition of the term ``hardwood 
plywood'' in Sec.  770.3 does not include:
    (1) Laminated products made by attaching a wood or woody grass 
veneer with a phenol-formaldehyde resin to a platform that has been 
manufactured in compliance with this part (including either certified in 
accordance with Sec.  770.15, manufactured with no-added formaldehyde-
based resins under Sec.  770.17, or manufactured with ultra low-emitting 
formaldehyde-based resins under Sec.  770.18).
    (2) Laminated products made by attaching a wood or woody grass 
veneer with a resin formulated with no-added

[[Page 407]]

formaldehyde as part of the resin cross-linking structure to a platform 
that has been manufactured in compliance with this part (including 
either certified in accordance with Sec.  770.15, manufactured with no-
added formaldehyde-based resins under Sec.  770.17, or manufactured with 
ultra low-emitting formaldehyde-based resins under Sec.  770.18).
    (b) Rulemaking petitions for exemption. (1) Any person may petition 
the Agency to initiate a rulemaking for additional exemptions for 
laminated products from the definition of the term ``hardwood plywood,'' 
pursuant to 15 U.S.C. 2697(a)(3)(C)(i)(I).
    (2) Each petition should provide all available and relevant 
information, including studies conducted and formaldehyde emissions 
data. Submit petitions to: TSCA Confidential Business Information Center 
(7407M), WJC East; Room 6428; Attn: TSCA Title VI Program, U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW, 
Washington, DC 20460-0001.
    (3) EPA will promptly review each submitted petition and, where 
appropriate, publish a proposed rule in the Federal Register based on 
the petition and provide a public comment period of generally 30 days 
before taking a final action.

[81 FR 89724, Dec. 12, 2016, as amended at 88 FR 10476, Feb. 21, 2023]



Sec.  770.5  Prohibited acts.

    (a) Failure or refusal to comply with any requirement of TSCA 
section 601 (15 U.S.C. 2697) or this part is a violation of TSCA section 
15 (15 U.S.C. 2614).
    (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 
part, is a violation of TSCA section 15 (15 U.S.C. 2614).
    (c) Making false or misleading statements in any statement, 
certification, or record required by this part is a violation of TSCA 
section 15 (15 U.S.C. 2614).
    (d) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.



      Subpart B_EPA TSCA Title VI Third-Party Certification Program



Sec.  770.7  Third-party certification.

    (a) EPA TSCA Title VI Product ABs. To participate in the EPA TSCA 
Title VI Third-Party Certification Program as an EPA TSCA Title VI 
Product AB, a Product AB must have the qualifications described in this 
section, submit an application and enter into a recognition agreement 
with EPA as described in this section, and, upon recognition from EPA, 
impartially perform the responsibilities described in this section.
    (1) Qualifications. To qualify for recognition by EPA in the EPA 
TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI 
Product AB, an applicant Product AB must:
    (i) Be a signatory to the International Accreditation Forum, Inc.'s 
(IAF) Multilateral Recognition Arrangement (MLA) through level three, or 
have membership in one of the IAF recognized regional accreditation 
cooperations, or an equivalent organization as determined by EPA;
    (ii) Be in conformance with ISO/IEC 17011:2017(E) (incorporated by 
reference, see Sec.  770.99); and
    (iii) Be competent to perform accreditation activities for product 
certification according to ISO/IEC 17065:2012(E) (incorporated by 
reference, see Sec.  770.99).
    (2) Application. To be recognized by EPA under the EPA TSCA Title VI 
Third-Party Certification Program, a Product AB must submit an 
application to EPA in accordance with Sec.  770.8 that contains the 
following:
    (i) Name, address, telephone number, and email address of the 
organization or primary contact;
    (ii) Documentation of IAF MLA signatory status, membership in one of 
the IAF recognized regional accreditation cooperations, or an equivalent 
organization as determined by EPA;
    (iii) Description of any other qualifications related to the Product 
AB's experience in performing product accreditation of TPCs for 
manufactured products including an affirmation that assessors will be 
technically competent to assess a TPC's ability to perform

[[Page 408]]

their activities under paragraph (c)(4) of this section; and
    (iv) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the AB or any of its officers or employees for any action by 
EPA or otherwise by the United States related to the requirements of 
this part. ABs may share an agent for service.
    (3) Recognition agreement. To be recognized by EPA under the EPA 
TSCA Title VI Third-Party Certification Program, a Product AB must enter 
into a recognition agreement with EPA that describes the EPA TSCA Title 
VI Product AB's responsibilities under this subpart.
    (i) Each recognition agreement will be valid for three years.
    (ii) Each recognition agreement will identify an EPA Recognition 
Agreement Implementation Officer and an EPA TSCA Title VI Product AB 
Implementation Officer that will serve as the point of contact for the 
EPA TSCA Title VI Third-Party Certification Program.
    (iii) To renew a recognition agreement for an additional three-year 
period, the EPA TSCA Title VI Product AB must submit an application for 
renewal in accordance with Sec.  770.8 before the three-year period of 
the recognition agreement lapses. The application must indicate any 
changes from the EPA TSCA Title VI Product AB's initial application or 
most recent renewal application.
    (iv) If an EPA TSCA Title VI Product AB fails to submit an 
application for renewal prior to the expiration of the previous 
recognition agreement, its recognition will lapse and the EPA TSCA Title 
VI Product AB may not provide accreditation services under TSCA Title 
VI.
    (v) If an EPA TSCA Title VI Product AB does submit an application 
for renewal prior to the expiration of the previous recognition 
agreement, it may continue to provide TSCA Title VI accreditation 
services under the terms of its previous recognition agreement until EPA 
has taken action on its application for renewal of the recognition 
agreement.
    (4) Impartiality. EPA TSCA Title VI Product ABs must act impartially 
when performing activities under the EPA TSCA Title VI Third-Party 
Certification Program. To demonstrate impartiality, Product ABs must:
    (i) Ensure that an accreditation decision regarding a TPC is made by 
persons different from those who conducted the assessment of the TPC; 
and
    (ii) Ensure that the AB's personnel who assess TPCs or make 
decisions regarding accreditation do not receive financial benefit from 
the outcome of an accreditation decision.
    (5) Responsibilities. Each EPA TSCA Title VI Product AB has the 
following responsibilities under the EPA TSCA Title VI Third-Party 
Certification Program:
    (i) Accreditation. EPA TSCA Title VI Product ABs must determine the 
accreditation eligibility, and accredit if appropriate, each TPC seeking 
recognition under the EPA TSCA Title VI Third-Party Certification 
Program by performing an assessment of each TPC as described in this 
section. The assessment must include all of the following components:
    (A) An on-site assessment by the EPA TSCA Title VI Product AB to 
determine whether the TPC meets the requirements of ISO/IEC 
17065:2012(E), is in conformance with ISO/IEC 17020:2012(E) as required 
under ISO/IEC 17065:2012(E) section 6.2.1 and section 6.2.2 
(incorporated by reference, see Sec.  770.99) and the EPA TSCA Title VI 
TPC requirements under this part. In performing the on-site assessment, 
the EPA TSCA Title VI Product AB must:
    (1) Develop a checklist of the EPA TSCA Title VI TPC requirements 
under paragraph (c)(4) of this section and the key accreditation 
elements of ISO/IEC 17065:2012(E) (incorporated by reference, see Sec.  
770.99); and
    (2) Use the checklist for each on-site assessment.
    (B) A review of the approach that the TPC will use to verify the 
accuracy of the formaldehyde emissions tests conducted by the TPC 
laboratory and the formaldehyde quality control tests conducted by or 
for the panel producers producing composite wood products that are 
subject to the requirements of TSCA Title VI.

[[Page 409]]

    (C) A review of the approach that the TPC will use for evaluating a 
panel producer's quality assurance and quality control processes, the 
proficiency of the panel producer's quality assurance and quality 
control personnel, the required elements of a panel producer's quality 
assurance and quality control manual, and sufficiency of on-site testing 
facilities as applicable.
    (D) A review of the approach that the TPC laboratory will use for 
establishing correlation or equivalence between ASTM E1333-14 and ASTM 
D6007-14, if used, (incorporated by reference, see Sec.  770.99) or 
allowable formaldehyde test methods listed under Sec.  770.20.
    (E) A review of the approach that the TPC will use for evaluating 
the process for sample selection, handling, and shipping procedures that 
the panel producer will use for quality control testing as applicable.
    (F) A review of the accreditation credentials of the TPC laboratory, 
including a verification that the laboratory has been accredited to ISO/
IEC 17025:2017(E) (incorporated by reference, see Sec.  770.99) with a 
scope of accreditation to include this part--Formaldehyde Standards for 
Composite Wood Products and the formaldehyde test methods ASTM E1333-14 
and ASTM D6007-14, if used, by an EPA TSCA Title VI Laboratory AB 
(incorporated by reference, see Sec.  770.99).
    (ii) Reassessment. Each EPA TSCA Title VI Product AB must, in 
accordance with ISO/IEC 17011:2017(E) section 7.9 (incorporated by 
reference, see Sec.  770.99), conduct an on-site reassessment or 
surveillance on-site assessment at least every two years of each EPA 
TSCA Title VI TPC that the AB has accredited.
    (iii) Suspension, reduction, withdrawal. Each EPA TSCA Title VI 
Product AB must suspend, reduce, or withdraw the accreditation of an EPA 
TSCA Title VI TPC that the AB has accredited when circumstances warrant.
    (iv) Notifications. Each EPA TSCA Title VI Product AB must provide, 
in accordance with Sec.  770.8, the following notifications to EPA, as 
applicable:
    (A) Notification of the loss of its status as a signatory to the IAF 
MLA, or loss of membership in one of the IAF recognized regional 
accreditation cooperations, or an equivalent organization as determined 
by EPA must be provided within five calendar days of the date that the 
body receives notification of the loss of its signatory or membership 
status.
    (B) Notification that an EPA TSCA Title VI TPC has failed to comply 
with any provision of this part must be provided within 72 hours of the 
time the Product AB identifies the deficiency. The notice must include a 
description of the steps taken to address the deficiency.
    (C) Notification of suspension, reduction or withdrawal of an EPA 
TSCA Title VI TPC's accreditation must be provided within 72 hours of 
the time that the suspension, reduction or withdrawal takes effect.
    (D) Notification of a change in a non-domestic Product AB's agent 
for service must be provided within five calendar days.
    (v) Records. Each EPA TSCA Title VI Product AB must maintain, in 
electronic form, the checklists and other records documenting compliance 
with the requirements for assessment, reassessment, and surveillance on-
site assessments of EPA TSCA Title VI TPCs for three years.
    (vi) Annual report. Each EPA TSCA Title VI Product AB must provide, 
in accordance with Sec.  770.8, an annual report on or before March 1st 
of each year for the AB services performed during the previous calendar 
year including the number and locations of assessment, reassessment, and 
surveillance on-site assessments performed for each EPA TSCA Title VI 
TPC.
    (vii) EPA meetings. Each EPA TSCA Title VI Product AB must meet with 
EPA at least once every two years in person, via teleconference, or 
through other virtual methods to discuss the implementation of the EPA 
TSCA Title VI Third-Party Certification Program.
    (viii) Inspections. Each EPA TSCA Title VI Product AB must allow 
inspections of the AB's facilities by EPA, at reasonable times, within 
reasonable limits, and in a reasonable manner, upon the presentation of 
appropriate credentials and a written notification to the AB.

[[Page 410]]

    (b) EPA TSCA Title VI Laboratory ABs. To participate in the EPA TSCA 
Title VI Third-Party Certification Program as an EPA TSCA Title VI 
Laboratory AB, a Laboratory AB must have the qualifications described in 
this section, submit an application and enter into a recognition 
agreement with EPA as described in this section, and, upon recognition 
from EPA, impartially perform the responsibilities described in this 
section.
    (1) Qualifications. To qualify for recognition by EPA under the EPA 
TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI 
Laboratory AB, an applicant Laboratory AB must:
    (i) Be a signatory to the International Laboratory Accreditation 
Cooperation (ILAC) Mutual Recognition Arrangement (MRA), or have 
membership in one of the ILAC recognized regional accreditation 
cooperations, or an equivalent organization as determined by EPA;
    (ii) Be in conformance with ISO/IEC 17011:2017(E) (incorporated by 
reference, see Sec.  770.99);
    (iii) Be competent to perform accreditation activities for 
laboratory accreditation according to ISO/IEC 17025:2017(E) 
(incorporated by reference, see Sec.  770.99); and
    (iv) Be competent to ensure EPA TSCA Title VI TPC inspection 
activities are in conformance with ISO/IEC 17020:2012(E) (incorporated 
by reference, see Sec.  770.99).
    (2) Application. To be recognized by EPA under the EPA TSCA Title VI 
Third-Party Certification Program, a Laboratory AB must submit an 
application to EPA, which may be submitted in conjunction with a Product 
AB application. For recognition, a Laboratory AB must submit an 
application in accordance with Sec.  770.8 that contains the following:
    (i) Name, address, telephone number, and email address of the 
organization or primary contact;
    (ii) Documentation of ILAC MRA signatory status, membership in one 
of the ILAC recognized regional accreditation cooperations, or an 
equivalent organization as determined by EPA;
    (iii) Description of any other qualifications related to the 
Laboratory AB's experience in performing laboratory accreditation and 
inspection certification of TPCs including an affirmation that assessors 
will be technically competent to assess TPCs ability to perform their 
activities under paragraph (c)(4) of this section; and
    (iv) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the AB or any of its officers or employees for any action by 
EPA or otherwise by the United States related to the requirements of 
this part. ABs may share an agent for service.
    (3) Recognition agreement. To be recognized by EPA under the EPA 
TSCA Title VI Third-Party Certification Program, a Laboratory AB must 
enter into a recognition agreement with EPA that describes the EPA TSCA 
Title VI Laboratory AB's responsibilities under this subpart.
    (i) Each recognition agreement will be valid for three years.
    (ii) Each recognition agreement will identify an EPA Recognition 
Agreement Implementation Officer and an EPA TSCA Title VI Laboratory AB 
Implementation Officer that will serve as the point of contact for the 
EPA TSCA Title VI Third-Party Certification Program.
    (iii) To renew a recognition agreement for an additional three-year 
period, the EPA TSCA Title VI Laboratory AB must submit an application 
for renewal in accordance with Sec.  770.8 before the three-year period 
of the recognition agreement lapses. The application must indicate any 
changes from the EPA TSCA Title VI Laboratory AB's initial application 
or most recent renewal application.
    (iv) If an EPA TSCA Title VI Laboratory AB fails to submit an 
application for renewal prior to the expiration of the previous 
recognition agreement, its recognition will lapse and the EPA TSCA Title 
VI Laboratory AB may not provide accreditation services under TSCA Title 
VI.
    (v) If an EPA TSCA Title VI Laboratory AB does submit an application 
for renewal prior to the expiration of the previous recognition 
agreement, it may continue to provide TSCA Title VI accreditation 
services under the terms of

[[Page 411]]

its previous recognition agreement until EPA has taken action on its 
application for renewal of the recognition agreement.
    (4) Impartiality. EPA TSCA Title VI Laboratory ABs must act 
impartially when performing activities under the EPA TSCA Title VI 
Third-Party Certification Program. To demonstrate impartiality, 
Laboratory ABs must:
    (i) Ensure that an accreditation decision regarding a TPC is made by 
persons different from those who conducted the assessment of the TPC; 
and
    (ii) Ensure that the AB's personnel who assess TPCs or make 
decisions regarding accreditation do not receive financial benefit from 
the outcome of an accreditation decision.
    (5) Responsibilities. Each EPA TSCA Title VI Laboratory AB has the 
following responsibilities under the EPA TSCA Title VI Third-Party 
Certification Program:
    (i) Accreditation. EPA TSCA Title VI Laboratory ABs must determine 
the accreditation eligibility, and accredit if appropriate, each TPC 
seeking recognition under the EPA TSCA Title VI Third-Party 
Certification Program by performing an assessment of each TPC. The 
assessment must include an on-site assessment by the EPA TSCA Title VI 
Laboratory AB to determine whether the laboratory meets the requirements 
of ISO/IEC 17025:2017(E) (incorporated by reference, see Sec.  770.99), 
is in conformance with ISO/IEC 17020:2012(E) (incorporated by reference, 
see Sec.  770.99) and the EPA TSCA Title VI TPC requirements under this 
part including the formaldehyde test methods ASTM E1333-14 and ASTM 
D6007-14 (incorporated by reference, see Sec.  770.99), if used. In 
performing the on-site assessment, the EPA TSCA Title VI Laboratory AB 
must:
    (A) Develop a checklist of the TPC requirements under paragraph 
(c)(4) of this section and the key conformity elements of ISO/IEC 
17025:2017(E) (incorporated by reference, see Sec.  770.99); and
    (B) Use the checklist for each on-site assessment.
    (ii) Reassessment. Each EPA TSCA Title VI Laboratory AB must, in 
accordance with ISO/IEC 17011:2017(E) section 7.9 (incorporated by 
reference, see Sec.  770.99), conduct a follow-up reassessment or 
surveillance on-site assessment of each TPC laboratory that the AB has 
accredited.
    (iii) Proficiency. Each EPA TSCA Title VI Laboratory AB must verify 
the accuracy of the formaldehyde emissions tests conducted by the TPC 
laboratory by ensuring the TPC laboratory participates in the CARB 
interlaboratory comparison for formaldehyde emissions when offered. In 
lieu of participation in the CARB interlaboratory comparison ensure that 
the TPC laboratory participates in an EPA-recognized proficiency testing 
program, if available.
    (iv) Suspension, reduction, withdrawal. Each EPA TSCA Title VI 
Laboratory AB must suspend, reduce, or withdraw the accreditation of a 
TPC laboratory that the AB has accredited when circumstances warrant.
    (v) Notifications. Each EPA TSCA Title VI Laboratory AB must 
provide, in accordance with Sec.  770.8, the following notifications to 
EPA as applicable:
    (A) Notification of the loss of its status as a signatory to the 
ILAC MRA, or loss of membership in one of the ILAC recognized regional 
accreditation cooperations, or an equivalent organization as determined 
by EPA, within five calendar days of the date that the body receives 
notice of the loss of its signatory or membership status.
    (B) Notification that a TPC laboratory has failed to comply with any 
provision of this part within 72 hours of the time the Laboratory AB 
identifies the deficiency. The notice must include a description of the 
steps taken to address the deficiency.
    (C) Notification of suspension, reduction or withdrawal of a TPC 
laboratory's accreditation within 72 hours of the time that the 
suspension, reduction or withdrawal takes effect.
    (D) Notification of a change in a non-domestic Laboratory AB's agent 
for service within five calendar days.
    (vi) Records. Each EPA TSCA Title VI Laboratory AB must maintain, in 
electronic form, the checklists and other records documenting compliance 
with the requirements for assessment, reassessment, and surveillance on-
site assessments of TPC laboratories for three years.

[[Page 412]]

    (vii) Annual report. Each EPA TSCA Title VI Laboratory AB must 
provide, in accordance with Sec.  770.8, an annual report to EPA on or 
before March 1st of each year for AB services performed during the 
previous calendar year including the number and locations of assessment, 
reassessment, and surveillance on-site assessments performed for each 
TPC laboratory.
    (viii) EPA meetings. Each EPA TSCA Title VI Laboratory AB must meet 
with EPA at least once every two years in person, via teleconference, or 
through other virtual methods to discuss the implementation of the EPA 
TSCA Title VI Third-Party Certification Program.
    (ix) Inspections. Each EPA TSCA Title VI Laboratory AB must allow 
inspections of the AB's facilities by EPA, at reasonable times, within 
reasonable limits, and in a reasonable manner, upon the presentation of 
appropriate credentials and a written notification to the AB.
    (c) EPA TSCA Title VI Third-Party Certifiers. To participate in the 
EPA TSCA Title VI Third-Party Certification Program as an EPA TSCA Title 
VI TPC, a TPC must be accredited by an EPA TSCA Title VI Product AB, use 
a laboratory that is accredited by an EPA TSCA Title VI Laboratory AB, 
have the other qualifications described in this subsection, submit an 
application and be recognized by EPA, and, upon recognition from EPA, 
impartially perform the responsibilities described in this section. 
Alternatively, CARB-approved TPCs must meet the criteria for reciprocity 
in paragraph (d) of this section and comply with the requirements of 
this part in order to be recognized by EPA as an EPA TSCA Title VI TPC.
    (1) Qualifications. To qualify for recognition by EPA in the EPA 
TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI 
TPC, an applicant TPC must:
    (i) Be accredited by an EPA TSCA Title VI Product AB to ISO/IEC 
17065:2012(E) (incorporated by reference, see Sec.  770.99), with a 
scope of accreditation that includes include composite wood products and 
this part--Formaldehyde Standards for Composite Wood Products;
    (ii) Be, or have a contract with a laboratory that is, accredited by 
an EPA TSCA Title VI Laboratory AB to ISO/IEC 17025:2017(E) 
(incorporated by reference, see Sec.  770.99) with a scope of 
accreditation to include this part--Formaldehyde Standards for Composite 
Wood Products--and the formaldehyde test methods ASTM E1333-14 and ASTM 
D6007-14, if used (incorporated by reference, see Sec.  770.99);
    (iii) Have the ability to conduct inspections of composite wood 
products and properly train and supervise inspectors to inspect 
composite wood products in conformance with ISO/IEC 17020:2012(E) as 
required under ISO/IEC 17065:2012(E) section 6.2.1 and section 6.2.2 
(incorporated by reference, see Sec.  770.99);
    (iv) Have demonstrated experience in the composite wood product 
industry with at least one type of composite wood product and indicated 
the specific product(s) the applicant intends to certify; and
    (v) Have demonstrated experience in performing or verifying 
formaldehyde emissions testing on composite wood products, including 
experience with test method ASTM E1333-14 and ASTM D6007-14, if used, 
(incorporated by reference, see Sec.  770.99), and experience evaluating 
correlation between test methods. Applicant TPCs that have demonstrated 
experience with test method ASTM D6007-14 only, must be contracting 
testing with a laboratory that has a large chamber and demonstrate its 
experience with ASTM E1333-14.
    (2) Application. Before certifying any products under this part, a 
TPC must be recognized by EPA under the EPA TSCA Title VI Third-Party 
Certification Program. To be recognized by EPA, a TPC must submit an 
application in accordance with Sec.  770.8 and renew that application 
every two years. The application must contain the following:
    (i) Email address of the organization or primary contact, 
organization name, organization telephone number, and organization 
address;
    (ii) Type of composite wood products that the applicant intends to 
certify;
    (iii) A copy of the TPC's certificate of accreditation from an EPA 
TSCA

[[Page 413]]

Title VI Product AB to ISO/IEC 17065:2012(E) (incorporated by reference, 
see Sec.  770.99) with a scope of accreditation that includes composite 
wood products and this part--Formaldehyde Standards for Composite Wood 
Products;
    (iv) A copy of the TPC laboratory's certificate of accreditation 
from an EPA TSCA Title VI Laboratory AB to ISO/IEC 17025:2017(E) 
(incorporated by reference, see Sec.  770.99) with a scope of 
accreditation to include this part--Formaldehyde Standards for Composite 
Wood Products--and the formaldehyde test methods ASTM E1333-14 and ASTM 
D6007-14 (incorporated by reference, see Sec.  770.99), if used;
    (v) An affirmation of the TPC's ability to conduct inspections of 
composite wood products and properly train and supervise inspectors to 
inspect composite wood products in conformance with ISO/IEC 
17020:2012(E) as required under ISO/IEC 17065:2012(E) section 6.2.1 and 
section 6.2.2 (incorporated by reference, see Sec.  770.99);
    (vi) A description of the TPC's experience in the composite wood 
product industry with at least one type of composite wood product and 
indicate the specific product(s) the applicant intends to certify;
    (vii) A description of the TPC's experience in performing or 
verifying formaldehyde emissions testing on composite wood products;
    (viii) A description of the TPC's experience with test method ASTM 
E1333-14 and/or ASTM D6007-14, if used, (incorporated by reference, see 
Sec.  770.99), and experience evaluating correlation between test 
methods. Applicant TPCs that have experience with test method ASTM 
D6007-14 only, must be contracting testing with a laboratory that has a 
large chamber and describe its experience with ASTM E1333-14; and
    (ix) If not a domestic entity, the name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the TPC or any of its officers or employees for any action by 
EPA or otherwise by the United States related to the requirements of 
this part. TPCs may share an agent for service.
    (3) Impartiality. EPA TSCA Title VI TPCs must act impartially in 
accordance with their accreditation when performing activities under the 
EPA TSCA Title VI Third-Party Certification Program. To demonstrate 
impartiality, TPCs must:
    (i) Not also be, or have a financial interest in a panel producer, 
fabricator, laminated product producer, importer, designer, distributor 
or retailer of composite wood products;
    (ii) Ensure that TPC management personnel and TPC personnel involved 
in the review and certification decision-making process for composite 
wood products are not involved in activities within the same or separate 
legal entity that may compromise the impartiality of its certification 
decision-making process, such as advocacy or consulting activities;
    (iii) Ensure that TPC management personnel and TPC personnel of the 
same or separate legal entity involved in activities such as advocacy or 
consulting are not involved in the management of the certification body, 
the review, or the certification decisions; and
    (iv) Ensure that TPC management personnel and TPC personnel 
certifying composite wood products sign a conflict of interest statement 
attesting that they will receive no financial benefit from the outcome 
of certification.
    (4) Responsibilities. Each EPA TSCA Title VI TPC has the following 
responsibilities under the EPA TSCA Title VI Third-Party Certification 
Program:
    (i) Certification. EPA TSCA Title VI TPCs certify composite wood 
products that are produced in accordance with this part and that comply 
with the emission standards of TSCA Title VI and this part, in 
accordance with ISO/IEC 17065:2012(E) (incorporated by reference, see 
Sec.  770.99). For each panel producer making composite wood products 
certified by the TPC, the EPA TSCA Title VI TPC must:
    (A) Verify that each panel producer has adequate quality assurance 
and quality control procedures and is complying with the applicable 
quality assurance and quality control requirements of this part;
    (B) Verify each panel producer's quality control test results 
compared with test results from ASTM E1333-14 and ASTM D6007-14, if 
used, (incorporated by reference, see Sec.  770.99) by having the

[[Page 414]]

TPC laboratory conduct quarterly tests and evaluate test method 
equivalence and correlation as required under Sec.  770.20;
    (C) In consultation with the panel producer, establish quality 
control limits (QCLs) for formaldehyde emissions, and, if applicable, 
shipping quality control limits or other formaldehyde emission limits, 
for each panel producer and product type;
    (D) Establish, for each panel producer, the process that will be 
used to determine if products are exceeding the applicable QCL;
    (E) Provide its CARB or EPA TPC number to each panel producer for 
labeling and recordkeeping; and
    (F) Inspect each panel producer, its products, and its records at 
least quarterly in conformance with ISO/IEC 17020:2012(E) as required 
under ISO/IEC 17065:2012(E) section 6.2.1 and section 6.2.2 
(incorporated by reference, see Sec.  770.99).
    (G) In the event a government entity has identified the existence of 
unsafe conditions (e.g., natural disasters, outbreaks, political unrest, 
epidemics, and pandemics) in the area of a composite wood product 
manufacturing panel producer that would prevent the required quarterly 
inspections from being conducted in-person on-site, a TPC may opt to 
perform a remote quarterly inspection in lieu of the in-person on-site 
inspection. Such a remote inspection may occur only during the period of 
the unsafe conditions. For such a remote inspection during the period of 
the unsafe conditions, the TPC must conduct a remote quarterly 
inspection via live remote technology (e.g., video/teleconference) 
operating as directed by the TPC to satisfy the requirements of 
paragraph (c)(4)(i)(F) of this section, and work with the panel producer 
quality control manager at that time to select, package, sign, and ship 
the TPC panels/samples for the quarterly test according to Sec.  
770.20(c). TPCs and panel producers must remain in close communication 
with each other to ensure any changes or developments that might affect 
the panel producer or product type certification are managed according 
to the TSCA Title VI regulations in this part. The standard practice for 
a TPC providing certification services for composite wood panel 
producers remains that a TPC conducts in-person quarterly inspections 
and sample collection, packaging, signature, and shipping for quality 
control testing.
    (ii) Laboratories. For quarterly testing, each EPA TSCA Title VI TPC 
must use only laboratories that have been accredited by an EPA TSCA 
Title VI Laboratory AB and that either participate in the CARB 
interlaboratory comparison for formaldehyde emissions when offered or in 
an EPA-recognized proficiency or interlaboratory program, if available.
    (iii) NAF and ULEF. For panel producers that do not receive approval 
for NAF or ULEF third-party certification exemptions or ULEF reduced 
testing from CARB, EPA TSCA Title VI TPCs must review applications for 
NAF or ULEF third-party certification exemptions or ULEF reduced 
testing. Each EPA TSCA Title VI TPC must approve these applications 
within 90 calendar days of receipt if the panel producer demonstrates 
that the requirements for third-party certification exemption under 
Sec.  770.17 or Sec.  770.18 or reduced testing under Sec.  770.18 are 
met.
    (iv) Reduced testing for medium-density fiberboard or fiberboard. 
EPA TSCA Title VI TPCs must review applications from panel producers to 
reduce the number of quality control tests for particleboard and medium-
density fiberboard, and approve these applications within 90 calendar 
days of receipt if the panel producer demonstrates that the requirements 
for reduced testing under Sec.  770.20(b)(2)(ii) are met.
    (v) Notifications to EPA. Each EPA TSCA Title VI TPC must provide, 
in accordance with Sec.  770.8, the following notifications to EPA, as 
applicable:
    (A) Notification of an approved or rejected application, including a 
renewal application, for a NAF or ULEF third-party certification 
exemption or ULEF reduced testing within five calendar days of the 
approval or rejection with copies of all approved applications forwarded 
to EPA within 30 calendar days of approval.
    (B) Notification of an approved or rejected application, including a 
renewal application, for reduced testing for medium-density fiberboard 
or

[[Page 415]]

particleboard within five calendar days of the approval or rejection 
with copies of all approved applications forwarded to EPA within 30 
calendar days of approval.
    (C) Notification of a panel producer exceeding its established QCL 
for three consecutive quality control tests within 72 hours of the time 
that the TPC becomes aware of the third consecutive exceedance. The 
notice must include the product type, dates of the quality control tests 
that exceeded the QCL, quality control test results, ASTM E1333-14 
(incorporated by reference, see Sec.  770.99) or ASTM D6007-14 method 
(incorporated by reference, see Sec.  770.99) correlative equivalent 
values in accordance with Sec.  770.20(d), the established QCL value(s) 
and the quality control method used.
    (D) Notification of each failed quarterly test, that is any sample 
that exceeds the applicable formaldehyde emission standard in Sec.  
770.10, within 72 hours. Information in this notification is not 
eligible for treatment as confidential business information.
    (E) Notification of a change in a non-domestic TPC's agent for 
service within five calendar days.
    (F) Notification of a loss of accreditation or notification that the 
TPC has discontinued its participation in the EPA TSCA Title VI Third-
Party Certification Program must be provided within 72 hours.
    (vi) Other notifications. Each EPA TSCA Title VI TPC must provide 
the following notifications, if applicable:
    (A) Notification of each failed quarterly test, that is any sample 
that exceeds the applicable formaldehyde emission standard in Sec.  
770.10, to the panel producer in writing within 72 hours. Information in 
this notification is not eligible for treatment as confidential business 
information.
    (B) Notification of a loss of accreditation or notification that the 
TPC has discontinued its participation in the EPA TSCA Title VI Third-
Party Certification Program within 72 hours to all panel producers for 
which it provides EPA TSCA Title VI certification services.
    (C) Notification of any changes in personnel qualifications, 
procedures, or laboratories used, to the TPC's EPA TSCA Title VI ABs 
within 30 calendar days.
    (vii) Records. Each EPA TSCA Title VI TPC must maintain, in 
electronic form, the following records for three years from the date the 
record is created, and provide them to EPA within 30 calendar days of a 
request from EPA:
    (A) A list of panel producers and their respective products and 
product types, including type of resin systems used, that the EPA TSCA 
Title VI TPC has certified;
    (B) Results of inspections and formaldehyde emissions tests 
conducted for and linked to each panel producer and product type;
    (C) A list of laboratories used by the EPA TSCA Title VI TPC, as 
well as all test methods used, including test conditions and 
conditioning time, and quarterly test results;
    (D) Methods and results for establishing test method correlations 
and equivalence;
    (E) Documentation for NAF or ULEF third-party certification 
exemptions or ULEF reduced testing approvals, including the name of the 
panel producer, facility, products approved, type of resin systems used 
and dates of approval;
    (F) Documentation of reduced testing approval for panel producers of 
medium-density fiberboard or particleboard, including the name of the 
panel producer, products approved and dates of approval; and
    (G) A copy of the most recent assessment, reassessment, and/or 
surveillance on-site assessment report provided by its EPA TSCA Title VI 
ABs.
    (viii) Annual report. Each EPA TSCA Title VI TPC must provide, in 
accordance with Sec.  770.8, an annual report on or before March 1st of 
each year for the TPC services performed during the previous calendar 
year. Quarterly test results, the test method, date of test, and product 
tested (including the product name or description and panel producer 
name) are not eligible for treatment as confidential business 
information. The report must contain all of the following elements, as 
applicable:
    (A) The following information for each panel producer making 
composite

[[Page 416]]

wood products certified by the EPA TSCA Title VI TPC:
    (1) Composite wood products that the EPA TSCA Title VI TPC has 
certified during the previous calendar year;
    (2) Types of resin systems used for the composite wood products 
certified;
    (3) Dates of quarterly inspections; for any inspection(s) conducted 
remotely in accordance with paragraph (c)(4)(i)(G) of this section, the 
TPC must certify that a government entity identified the existence of 
unsafe conditions at the time of the inspection(s);
    (4) For each quarterly test, the date, result, test method, and 
whether a contract laboratory was used;
    (5) For each failed quarterly test, the product type, the volume of 
product affected, the results of recertification testing, and a 
description of the final disposition of the affected product, including 
how the non-complying lot was addressed;
    (6) For each non-complying lot resulting from a failed quality 
control test, the test date, method, product type, volume of product 
affected, lot numbers, the results of retesting, and a description of 
the final disposition of the affected product, including how the non-
complying lot was addressed; and
    (7) Any corrective actions that resulted from quarterly tests and 
inspections.
    (B) A list of laboratories and test methods used by the TPC, number 
and volume (cubic meters) of large and small chambers, date of 
equivalence determination and equivalence data.
    (C) Any non-conformities identified by its EPA TSCA Title VI AB(s) 
and how they were addressed.
    (D) The results compared with the mean of the interlaboratory 
comparison for all formaldehyde emissions interlaboratory comparison 
tests other than the CARB interlaboratory comparison or, if available, 
the results of an EPA-recognized proficiency testing program.
    (ix) Assessments and inspections. Upon request, each EPA TSCA Title 
VI TPC must allow EPA representatives to:
    (A) Accompany the TPC's staff during an assessment, reassessment or 
surveillance on-site assessment of the TPC by its AB(s); and
    (B) Inspect the TPC's facilities, at reasonable times, within 
reasonable limits, and in a reasonable manner, upon the presentation of 
appropriate credentials and a written notification to the TPC.
    (d) Reciprocity for third-party certifiers approved by the 
California Air Resources Board (CARB)--(1) During transitional period. 
The transitional period is defined as the period beginning on December 
12, 2016 and ending on March 22, 2019. TPCs already approved by CARB and 
TPCs subsequently approved by CARB during the transitional period must 
apply for EPA recognition in accordance with Sec.  770.8 before they can 
certify any products under this part. Once recognized by EPA, CARB-
approved TPCs become EPA TSCA Title VI TPCs and may certify composite 
wood products under TSCA Title VI until March 22, 2019, as long as they:
    (i) Remain approved by CARB; and
    (ii) Comply with all aspects of this part other than the 
requirements of paragraphs (c)(1)(i) and (ii) and (c)(2)(iii) and (iv) 
of this section. This includes:
    (A) Provide panel producers with the TPC number issued by CARB; and
    (B) Provide the annual report required by paragraph (c)(4)(viii) of 
this section to CARB and EPA during the two-year transitional period.
    (C) Provide notifications required by paragraph (c)(4)(v) to EPA.
    (2) After transition period. (i) TPCs approved by CARB may continue 
to certify composite wood products under TSCA Title VI after the two-
year transitional period if the TPC:
    (A) Maintains its CARB approval;
    (B) Complies with the requirements of this part;
    (C) Submits to EPA, in accordance with Sec.  770.8:
    (1) Documentation from CARB that specifies eligibility for 
reciprocity; and
    (2) A copy of the application submitted to CARB to be recognized as 
a TPC under the CARB ATCM.
    (D) Receives EPA recognition as an EPA TSCA Title VI TPC.
    (ii) EPA retains the authority to deny recognition of CARB-approved 
TPCs who seek recognition through reciprocity in the EPA TSCA Title VI 
Third-Party Certification Program if

[[Page 417]]

EPA has information indicating that the TPC is not qualified.
    (e) Suspension, revocation or modification of recognition--(1) 
Third-party certifiers. EPA may suspend, revoke or modify the 
recognition of a TPC, if the TPC:
    (i) Fails to comply with any requirement of TSCA Title VI or this 
part;
    (ii) Makes any false or misleading statements on its application, 
records, or reports; or
    (iii) Makes substantial changes to personnel qualifications, 
procedures, or laboratories that make the TPC or TPC laboratory unable 
to comply with any applicable requirements of this part.
    (2) ABs. EPA may suspend, revoke or modify the recognition of an AB 
if the AB:
    (i) No longer maintains signatory status to the IAF MLA or ILAC MRA, 
membership in one of the IAF/ILAC recognized regional accreditation 
cooperations, or an equivalent organization as determined by EPA;
    (ii) Fails to comply with any requirement of TSCA Title VI or this 
part;
    (iii) Makes any false or misleading statements on its application, 
records, or reports; or
    (iv) Makes substantial changes to personnel qualifications or 
procedures that make the AB, TPC and/or TPC laboratory unable to comply 
with any applicable requirements of this part.
    (3) Process for suspending, revoking or modifying recognition. (i) 
Prior to taking action to suspend, revoke or modify recognition, EPA 
will notify the participant AB or the participant TPC in writing of the 
following:
    (A) The legal and factual basis for the proposed suspension, 
revocation or modification;
    (B) The anticipated commencement date and duration of the 
suspension, revocation or modification;
    (C) Actions, if any, which the affected AB or TPC may take to avoid 
suspension, revocation or modification, or to receive recognition in the 
future; and
    (D) The opportunity and method for requesting a hearing with EPA 
prior to final suspension, revocation or modification.
    (ii) If the affected AB or TPC requests a hearing in writing to EPA 
within 30 calendar days of receipt of the notification, EPA will:
    (A) Provide the affected AB or TPC an opportunity to offer written 
statements in response to EPA's assertions of the legal and factual 
basis for the proposed action; and
    (B) Appoint an impartial EPA official as Presiding Officer to 
conduct the hearing. The Presiding Officer will:
    (1) Conduct a fair, orderly, and impartial hearing within 90 
calendar days of the request for a hearing;
    (2) Consider all relevant evidence, explanations, comments, and 
arguments submitted; and
    (3) Notify the affected AB or TPC in writing within calendar 90 days 
of completion of the hearing of his or her decision and order. Such an 
order is a final EPA action which may be subject to judicial review. The 
order must contain the basis, commencement date, and duration of the 
suspension, revocation or modification.
    (iii) If EPA determines that the public health, interest, or welfare 
warrants immediate action to revoke the recognition of an AB or TPC 
prior to the opportunity for a hearing, it will notify the affected AB 
or TPC of its right to request a hearing on the immediate revocation 
within 15 calendar days of the revocation taking place and the 
procedures for the conduct of such a hearing.
    (iv) Any notification, 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 TSCA section 14. 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 TSCA 
section 14.
    (v) EPA will maintain a publicly available list of ABs on its Web 
site whose recognition has been suspended, revoked or modified, or 
reinstated and a publicly available list of TPCs whose

[[Page 418]]

recognition has been suspended, revoked, modified, or reinstated.
    (vi) Unless the decision and order issued under paragraph (e)(3) of 
this section specify otherwise, an AB or a TPC whose recognition has 
been revoked must reapply for recognition in order to become recognized 
under this part again.
    (vii) Unless the decision and order issued under paragraph (e)(3) of 
this section specify otherwise, an AB whose recognition has been revoked 
or a TPC whose recognition has been revoked, must immediately notify all 
TPCs or panel producers to which it provides TSCA Title VI accreditation 
or certification services of the revocation.
    (f) Effect of the loss of recognition or accreditation. (1) If an AB 
is removed or withdraws from the EPA TSCA Title VI Third-Party 
Certification Program:
    (i) For reasons other than fraud or providing false or misleading 
statements, and other than a reason that implicates a particular TPC in 
a violation of TSCA Title VI, TPCs accredited by that AB can continue to 
certify products under TSCA Title VI for 180 calendar days, after which 
the TPCs must be accredited again by another EPA TSCA Title VI AB and 
re-recognized by EPA.
    (ii) Due to fraud or providing false or misleading statements with 
respect to a particular TPC, or for any other reason that implicates a 
particular TPC in a violation of TSCA Title VI, that TPC may not provide 
any TSCA Title VI certification services until it has been accredited 
again by another EPA TSCA Title VI AB and re-recognized by EPA.
    (2) If a TPC loses its accreditation, or if TPC is removed or 
withdraws from the EPA TSCA Title VI Third-Party Certification Program:
    (i) For reasons other than fraud or providing false or misleading 
statements, and other than a reason that implicates a particular panel 
producer in a violation of TSCA Title VI, the panel producers that used 
the TPC to certify their products must enlist another EPA TSCA Title VI 
TPC to certify their products within 90 calendar days. If the panel 
producer is not able to obtain the services of another EPA TSCA Title VI 
TPC within 90 days, the panel producer may request from EPA a 90 
calendar day extension. During the time a panel producer is seeking a 
new TPC, it must continue to comply with all other requirements of TSCA 
Title VI, including quality control testing.
    (ii) Due to fraud or providing false or misleading statements with 
respect to a particular panel producer, or for any other reason that 
implicates a particular panel producer in a violation of TSCA Title VI, 
that panel producer may not sell, supply, offer for sale, or manufacture 
composite wood products for sale in the United States until its 
composite wood products have been recertified by another EPA TSCA Title 
VI TPC.
    (g) Process for denying EPA TSCA Title VI recognition. (1) Upon EPA 
denying a request for recognition of an AB or TPC, EPA will notify the 
AB or TPC in writing of the following:
    (i) The legal and factual basis for the denial; and
    (ii) Actions, if any, which the affected AB or TPC may take to 
receive recognition in the future.
    (2) [Reserved]

[81 FR 89724, Dec. 12, 2016, as amended at 82 FR 44537, Sept. 25, 2017; 
83 FR 5346, Feb. 7, 2018; 84 FR 43524, Aug. 21, 2019; 88 FR 10476, Feb. 
21, 2023]



Sec.  770.8  Applications, notifications, and reports.

    (a) All applications, notifications, and reports that are required 
to be submitted to EPA under this subpart must be submitted via the EPA 
Central Data Exchange (CDX) found at https://cdx.epa.gov.
    (b) If the EPA CDX is unavailable, EPA will so inform EPA TSCA Title 
VI ABs and TPCs and will make electronic applications and reporting 
forms available online at http://www.epa.gov/formaldehyde.
    (c)(1) Persons submitting a notice under this rule are subject to 
EPA confidentiality regulations at 40 CFR part 2, subpart B, except that 
the certification in paragraph (c)(2) of this section must also be 
provided when asserting a claim of confidentiality.
    (2) In submitting a claim of confidentiality, a person must certify 
the truth of the following four statements concerning all information 
which is claimed as confidential:

[[Page 419]]

    (i) My company has taken measures to protect the confidentiality of 
the information.
    (ii) I have determined that the information is not required to be 
disclosed or otherwise made available to the public under any other 
Federal law.
    (iii) I have a reasonable basis to conclude that disclosure of the 
information is likely to cause substantial harm to the competitive 
position of the person.
    (iv) I have a reasonable basis to believe that the information is 
not readily discoverable through reverse engineering.



                    Subpart C_Composite Wood Products



Sec.  770.10  Formaldehyde emission standards.

    (a) Except as otherwise provided in this part, the emission 
standards in this section apply to composite wood products sold, 
supplied, offered for sale, or manufactured (including imported) on or 
after June 1, 2018 in the United States. These emission standards apply 
regardless of whether the composite wood product is in the form of a 
panel, a component part, or incorporated into a finished good.
    (b) The emission standards are based on test method ASTM E1333-14 
(incorporated by reference, see Sec.  770.99), and are as follows:
    (1) For hardwood plywood made with a veneer core or a composite 
core, 0.05 parts per million (ppm) of formaldehyde.
    (2) For medium-density fiberboard, 0.11 ppm of formaldehyde.
    (3) For thin medium-density fiberboard, 0.13 ppm of formaldehyde.
    (4) For particleboard, 0.09 ppm of formaldehyde.

[81 FR 89724, Dec. 12, 2016, as amended at 83 FR 5347, Feb. 7, 2018; 84 
FR 43524, Aug. 21, 2019]



Sec.  770.12  Stockpiling.

    (a) The sale of stockpiled inventory of composite wood products, 
whether in the form of panels or incorporated into component parts or 
finished goods, is prohibited after June 1, 2018.
    (b) To determine whether stockpiling has occurred, the rate of 
manufacture or purchase is measured as follows:
    (1) For composite wood products in the form of panels, the rate is 
measured in terms of square footage of panels produced.
    (2) For composite wood products incorporated into component parts or 
finished goods, the rate is measured in terms of the square footage of 
composite wood product panels purchased for the purpose of incorporating 
them into component parts or finished goods.
    (c) Manufacturers or purchasers who have, in an annual year, a 
greater than 20% increase in manufacturing or purchasing composite wood 
products relative to annual year 2009 for some reason other than 
circumventing the emission standards would not be in violation of this 
section. Such reasons may include, but are not limited to:
    (1) A quantifiable immediate increase in customer demand or sales.
    (2) A documented and planned business expansion.
    (3) The manufacturer or purchaser was not in business at the 
beginning of calendar year 2009.
    (4) An increase in production to meet increased demand resulting 
from an emergency event or natural disaster.
    (d) In order to be found to be stockpiling an entity must be 
increasing the rate of manufacturing or purchasing for the purpose of 
circumventing the emission standards.

[81 FR 89724, Dec. 12, 2016, as amended at 84 FR 43524, Aug. 21, 2019]



Sec.  770.15  Composite wood product certification.

    (a) Beginning June 1, 2018, only certified composite wood products, 
whether in the form of panels or incorporated into component parts or 
finished goods, are permitted to be sold, supplied, offered for sale, or 
manufactured (including imported) in the United States, unless the 
product is specifically exempted by this part.
    (b) Certified composite wood products are those that are produced or 
fabricated in accordance with all of the provisions of this part.
    (c) To obtain product certification, a panel producer must apply to 
an EPA TSCA Title VI TPC.

[[Page 420]]

    (1) For panel producers that do not have any previous product 
certifications from a CARB-approved TPC or an EPA TSCA Title VI TPC, the 
application must contain the following:
    (i) The panel producer's name, address, telephone number, and other 
contact information;
    (ii) A copy of the panel producer's quality control manual as 
required by Sec.  770.21(a);
    (iii) Name and contact information for the panel producer's quality 
control manager;
    (iv) An identification of the specific products for which 
certification is requested, and the resin system used in panel 
production;
    (v) At least five tests conducted under the supervision of an EPA 
TSCA Title VI TPC pursuant to test method ASTM E1333-14 or ASTM D6007-14 
(incorporated by reference, see Sec.  770.99). Test results obtained by 
ASTM D6007-14 must include a showing of equivalence in accordance with 
Sec.  770.20(d)(1);
    (vi) At least five quality control tests conducted in accordance 
with Sec.  770.20(b)(1);
    (vii) Correlation data and linear regression equation (or, under the 
threshold approach, the correlation data and the upper limit); and
    (viii) Results of an initial, on-site inspection by the TPC of the 
panel producer. In the event a government entity has identified the 
existence of unsafe conditions as outlined in Sec.  770.7(c)(4)(i)(G) 
and in order to conduct the required initial, on-site inspection 
associated with new certification activities, the TPC may conduct a 
virtual inspection via on-site video/teleconference technology 
(operating as directed by the TPC) and that aligns with the standard 
operating procedure the TPC would normally employ during an in-person 
inspection to satisfy the requirements of this paragraph (c)(1)(viii).
    (2) For panel producers applying for certification of a new product 
type but that have previous product certifications from a CARB-approved 
TPC or an EPA TSCA Title VI TPC, the application must contain the 
following:
    (i) The panel producer's name, address, and telephone number;
    (ii) An identification of the specific products for which 
certification is requested, and the resin system used in panel 
production;
    (iii) At least five tests conducted under the supervision of an EPA 
TSCA Title VI TPC pursuant to test method ASTM E1333-14 or ASTM D6007-14 
(incorporated by reference, see Sec.  770.99). Test results obtained by 
ASTM D6007-14 must include a showing of equivalence in accordance with 
Sec.  770.20(d)(1);
    (iv) At least five quality control tests conducted in accordance 
with Sec.  770.20(b)(1);
    (v) Correlation data and linear regression equation (or, under the 
threshold approach, the correlation data and the upper limit); and
    (vi) Description of any changes in the panel producer's quality 
control manual and a copy of those changes.
    (d) The EPA TSCA Title VI TPC must act on a panel producer's 
complete application within 90 calendar days of receipt by reviewing all 
of the components of the application.
    (1) If the application indicates that the candidate product achieves 
the applicable emission standards described in Sec.  770.10, adequate 
correlation as described in Sec.  770.20(d)(2), and that the panel 
producer is meeting the requirements in Sec.  770.21, the EPA TSCA Title 
VI TPC will approve the application.
    (2) If the application is from a panel producer that did not 
previously have products certified by a CARB-approved TPC or an EPA TSCA 
Title VI TPC, the EPA TSCA Title VI TPC will review the quality control 
manual and results of the on-site initial inspection and approve or 
disapprove the quality control manual.
    (3) If the application does not demonstrate that the candidate 
product achieves the applicable emission standards described in Sec.  
770.10, the EPA TSCA Title VI TPC will disapprove the application. A new 
application may be submitted for the candidate product at any time.
    (e) If a product is certified by a CARB-approved TPC that is also 
recognized by EPA, the product will also be considered certified under 
TSCA Title VI until March 22, 2019 after which the TPC needs to comply 
with all the requirements of this part as an EPA

[[Page 421]]

TSCA Title VI TPC under Section 770.7(d) in order for the product to 
remain certified.
    (f) To maintain certification, the panel producer making the 
certified product must get inspected by its EPA TSCA Title VI TPC 
quarterly as well as meet the testing requirements under Sec.  770.20.
    (g) If the certified product fails a quarterly test, certification 
for any product types represented by the sample is suspended until a 
compliant quarterly test result is obtained in accordance with Sec.  
770.22.

[81 FR 89724, Dec. 12, 2016, as amended at 82 FR 44537, Sept. 25, 2017; 
83 FR 5347, Feb. 7, 2018; 84 FR 43524, Aug. 21, 2019; 88 FR 10477, Feb. 
21, 2023]



Sec.  770.17  No-added formaldehyde-based resins.

    (a) Producers of composite wood product panels made with no-added 
formaldehyde-based resins may apply to an EPA TSCA Title VI TPC or to 
CARB for a two-year exemption from the testing requirements in Sec.  
770.20 and certification requirements in Sec. Sec.  770.15 and 
770.40(b). The application must contain the following:
    (1) The panel producer's name, address, and telephone number;
    (2) An identification of the specific product and the resin system;
    (3) At least one test conducted under the supervision of an EPA TSCA 
Title VI TPC pursuant to test method ASTM E1333-14 or ASTM D6007-14 
(incorporated by reference, see Sec.  770.99). Test results obtained by 
ASTM D6007-14 must include a showing of equivalence in accordance with 
Sec.  770.20(d)(1); and
    (4) Three months of routine quality control tests under Sec.  
770.20, including a showing of correlation in accordance with Sec.  
770.20(d)(2), totaling not less than thirteen quality control tests.
    (b) The EPA TSCA Title VI TPC will approve a panel producer's 
application within 90 calendar days of receipt if the application is 
complete and demonstrates that the candidate product achieves the 
emission standards described in paragraph (c) of this section.
    (c) As measured according to paragraphs (a)(3) and (4) of this 
section, the emission standards for composite wood products made with 
no-added formaldehyde-based resins are as follows:
    (1) No test result higher than 0.05 parts per million (ppm) of 
formaldehyde for hardwood plywood and 0.06 ppm for particleboard, 
medium-density fiberboard, and thin medium-density fiberboard.
    (2) Ninety percent of the three months of routine quality control 
testing data and the results of the one primary or secondary method test 
(required under paragraphs (a)(3) and (4) of this section) must be shown 
to be no higher than 0.04 ppm.
    (d) Products that meet the requirements specified under Sec.  
770.17(c)(1) and (2) and have obtained exemption from the California Air 
Resources Board will also be exempt from the requirements in Sec. Sec.  
770.15, 770.20, and 770.40(b), as long as the requirements of the 
California Air Resources Board remain as stringent as EPA's 
requirements.
    (e) After the two-year period of the initial exemption, and every 
two years thereafter, in order to continue to qualify for the exemption 
from the testing and certification requirements, the panel producer must 
reapply to an EPA TSCA Title VI TPC or to CARB and obtain at least one 
test result in accordance with paragraph (a)(3) of this section that 
complies with the emission standards in paragraph (c)(1) of this 
section.
    (f) Any time there is an operational or process change that is 
likely to affect formaldehyde emissions, such as a change in resin 
formulation, press cycle duration, temperature, or amount of resin used 
per panel, at least one quality control test under Sec.  770.20 and at 
least one test result in accordance with paragraph (a)(3) of this 
section that indicate compliance with the emission standards in 
paragraph (c)(1) of this section are required.
    (g) A change in the resin system invalidates the exemption for any 
product produced with the different resin after such a change.

[81 FR 89724, Dec. 12, 2016, as amended at 83 FR 5347, Feb. 7, 2018; 84 
FR 43524, Aug. 21, 2019; 88 FR 10477, Feb. 21, 2023]

[[Page 422]]



Sec.  770.18  Ultra low-emitting formaldehyde resins.

    (a) Producers of composite wood product panels made with ultra low-
emitting formaldehyde resins may apply to an EPA TSCA Title VI TPC or 
CARB for approval either to conduct less frequent testing than is 
specified in Sec.  770.20 or approval for a two-year exemption from the 
testing requirements in Sec.  770.20 and certification requirements in 
Sec. Sec.  770.15 and 770.40(b). The application must contain the 
following:
    (1) The panel producer's name, address, and telephone number;
    (2) An identification of the specific product type, including resin 
system;
    (3) At least two tests conducted under the supervision of an EPA 
TSCA Title VI TPC pursuant to test method ASTM E1333-14 or ASTM D6007-14 
(incorporated by reference, see Sec.  770.99). Test results obtained by 
ASTM D6007-14 must include a showing of equivalence in accordance with 
Sec.  770.20(d)(1); and
    (4) Six months of routine quality control tests under Sec.  770.20, 
including a showing of correlation in accordance with Sec.  
770.20(d)(2), totaling not less than twenty-six quality control tests.
    (b) The EPA TSCA Title VI TPC will approve a panel producer's 
application within 90 calendar days of receipt if the application is 
complete and demonstrates that the candidate product achieves the 
emission standards required for reduced testing as described in 
paragraph (c) of this section or the emission standards required for a 
two-year exemption as described in paragraph (d) of this section.
    (c) As measured according to paragraphs (a)(3) and (4) of this 
section, the emission standards for reduced testing for composite wood 
products made with ultra low-emitting formaldehyde resins are as 
follows:
    (1) No test result higher than 0.05 parts per million (ppm) of 
formaldehyde for hardwood plywood, 0.08 ppm for particleboard, 0.09 ppm 
for medium-density fiberboard, and 0.11 ppm for thin medium-density 
fiberboard.
    (2) For 90% of the six months of routine quality control testing 
data required under paragraph (a)(4) of this section, no higher than 
0.05 ppm of formaldehyde for particleboard, no higher than 0.06 ppm of 
formaldehyde for medium-density fiberboard, and no higher than 0.08 ppm 
of formaldehyde for thin medium-density fiberboard.
    (d) As measured according to paragraphs (a)(3) and (4) of this 
section, the emission standards for an exemption from the testing and 
certification requirements of Sec.  770.20 for composite wood products 
made with ultra low-emitting formaldehyde resins are as follows:
    (1) No test result higher than 0.05 ppm of formaldehyde for hardwood 
plywood or 0.06 ppm of formaldehyde for particleboard, medium-density 
fiberboard, and thin medium-density fiberboard.
    (2) Ninety percent of six months of routine quality control testing 
data and the results of two quarterly primary or secondary method tests 
(required under paragraphs (a)(3) and (4) of this section) must be shown 
to be no higher than an ultra-low-emitting formaldehyde resins (ULEF)-
target value of 0.04 ppm.
    (e) Products that have obtained an exemption from the California Air 
Resources Board will also be exempt from the requirements in Sec. Sec.  
770.15, 770.20, and 770.40(b) if they meet the requirements under Sec.  
770.18(d) and the requirements of the California Air Resources Board 
remain as stringent as EPA's requirements. Products that have obtained 
approval for reduced testing from the California Air Resources Board 
will be granted approval to conduct less frequent testing than is 
specified in Sec.  770.20 if they meet the requirements under Sec.  
770.18(c) and the requirements of the California Air Resources Board 
remain as stringent as EPA's requirements.
    (f) Products that are represented by a quarterly test result that 
exceeds the applicable emission standard in this section or a quality 
control test that indicates that the product exceeds the applicable 
emission standard in this section lose their reduced testing approval 
and must reapply as specified under Sec.  770.18(a).
    (g) After the two-year period of the initial exemption, and every 
two years thereafter, in order to continue to qualify for the exemption 
from the testing and certification requirements,

[[Page 423]]

the panel producer must reapply to an EPA TSCA Title VI TPC or CARB and 
obtain at least two test results in accordance with paragraph (a)(3) of 
this section that comply with the emission standards in paragraph (d)(1) 
of this section.
    (h) Any time there is an operational or process change such as a 
change in resin formulation, press cycle duration, temperature, or 
amount of resin used per panel, at least five quality control tests 
under Sec.  770.20 and at least one test result in accordance with 
paragraph (a)(3) of this section that indicate compliance with the 
emission standards in paragraph (d)(1) of this section are required.
    (i) A change in the resin system invalidates the exemption or 
reduced testing approval for any product type produced after such a 
change.

[81 FR 89724, Dec. 12, 2016, as amended at 83 FR 5347, Feb. 7, 2018; 84 
FR 43524, Aug. 21, 2019; 88 FR 10477, Feb. 21, 2023]



Sec.  770.20  Testing requirements.

    (a) General requirements. (1) All panels must be tested prior to the 
application of a finishing or topcoat. Conditioning of panels for 
testing must start as soon as possible after panel production, but no 
later than 30 calendar days after the panels were produced.
    (2) Facilities that conduct the formaldehyde testing required by 
this section must follow the procedures and specifications, such as 
testing conditions and loading ratios, of the test method being used.
    (3) All equipment used in the formaldehyde testing required by this 
section must be calibrated and otherwise maintained and used in 
accordance with the equipment manufacturer's instructions.
    (b) Quality control testing--(1) Allowable methods. Quality control 
testing must be performed using any of the following methods, with a 
showing of correlation for each method pursuant to paragraph (d) of this 
section:
    (i) ASTM D6007-14 (incorporated by reference, see Sec.  770.99).
    (ii) ASTM D5582-14 (incorporated by reference, see Sec.  770.99).
    (iii) BS EN ISO 12460-3:2020 (incorporated by reference, see Sec.  
770.99) or ISO 12460-3:2020(E) (incorporated by reference, see Sec.  
770.99).
    (iv) DMC 2007 User's Manual (incorporated by reference, see Sec.  
770.99).
    (v) DMC 2012 GP User's Manual (incorporated by reference, see Sec.  
770.99).
    (vi) BS EN ISO 12460-5:2015 E (Perforator Method) (incorporated by 
reference, see Sec.  770.99).
    (vii) JIS A 1460:2021(E) (24-hr Desiccator Method) (incorporated by 
reference, see Sec.  770.99).
    (2) Frequency of testing. (i) Particleboard and medium-density 
fiberboard must be tested at least once per shift (eight or twelve 
hours, plus or minus one hour of production) for each production line 
for each product type. Quality control tests must also be conducted 
whenever:
    (A) A product type production ends, even if eight hours of 
production has not been reached;
    (B) The resin formulation is changed so that the formaldehyde to 
urea ratio is increased;
    (C) There is an increase by more than ten percent in the amount of 
formaldehyde resin used, by square foot or by panel;
    (D) There is a decrease in the designated press time by more than 
20%; or
    (E) The quality control manager or quality control employee has 
reason to believe that the panel being produced may not meet the 
requirements of the applicable standards.
    (ii) Particleboard and medium-density fiberboard panel producers are 
eligible for reduced quality control testing if they demonstrate 
consistent operations and low variability of test values.
    (A) To qualify, panel producers must:
    (1) Apply in writing to an EPA TSCA Title VI TPC; and
    (2) Maintain a 30 panel running average.
    (B) With respect to reduced quality control testing, EPA TSCA Title 
VI TPCs:
    (1) May approve a reduction to one quality control test per 24-hour 
production period if the 30 panel running average remains two standard 
deviations below the designated QCL for the previous 60 consecutive 
calendar days or more;

[[Page 424]]

    (2) May approve a reduction to one quality control test per 48-hour 
production period if the 30 panel running average remains three standard 
deviations below the designated QCL for the previous 60 consecutive 
calendar days or more;
    (3) Will approve a request for reduced quality control testing as 
long as the data submitted by the panel producer demonstrate compliance 
with the criteria and the EPA TSCA Title VI TPC does not otherwise have 
reason to believe that the data are inaccurate or the panel producer's 
production processes are inadequate to ensure continued compliance with 
the emission standards; and
    (4) Will revoke approval for reduced quality control testing if 
testing or inspections indicate a panel producer no longer demonstrates 
consistent operations and low variability of test values.
    (iii) Hardwood plywood must be tested as follows:
    (A) At least one test per week per product type if the weekly 
hardwood plywood production at the panel producer is more than 100,000 
but less than 200,000 square feet.
    (B) At least two tests per week per product type if the weekly 
hardwood plywood production at the panel producer is 200,000 square feet 
or more, but less than 400,000 square feet.
    (C) At least four tests per week per product type if the weekly 
hardwood plywood production at the panel producer is 400,000 square feet 
or more.
    (D) If weekly production of hardwood plywood at the panel producer 
is 100,000 square feet or less, at least one test per 100,000 square 
feet for each product type produced; or, if less than 100,000 square 
feet of a particular product type is produced, one quality control test 
of that product type every month that it is produced.
    (E) Quality control tests must also be conducted whenever:
    (1) The resin formulation is changed so that the formaldehyde to 
urea ratio is increased;
    (2) There is an increase by more than ten percent in the amount of 
formaldehyde resin used, by square foot or by panel;
    (3) There is an increase by more than 20% in the adhesive 
application rate;
    (4) There is a decrease in the designated press time by more than 
20%; or
    (5) The quality control manager or quality control employee has 
reason to believe that the panel being produced may not meet the 
requirements of the applicable standard.
    (iv) Composite wood products that have been approved by an EPA TSCA 
Title VI TPC or CARB for reduced testing under Sec.  770.18(b) through 
(c) must be tested at least once per week per product type and, for 
particle board and medium-density fiberboard, per production line, for 
products produced that week, except that hardwood plywood panel 
producers who qualify for less frequent testing under paragraph 
(b)(2)(iii)(D) of this section may continue to perform quality control 
testing under that provision.
    (3) Results. Any test result that exceeds the QCL established 
pursuant to Sec.  770.7(c)(4)(i)(C) must be reported to the EPA TSCA 
Title VI TPC in writing within 72 hours. The panel producer must comply 
with Sec.  770.22 with respect to any lot represented by a quality 
control sample that exceeds the QCL. Where multiple products are grouped 
in a single product type for testing, this includes all products in the 
group represented by the sample.
    (c) Quarterly testing. Quarterly testing must be supervised by EPA 
TSCA Title VI TPCs and performed by TPC laboratories.
    (1) Allowable methods. Quarterly testing must be performed using 
ASTM E1333-14 (incorporated by reference, see Sec.  770.99) or, with a 
showing of equivalence pursuant to paragraph (d) of this section, ASTM 
D6007-14 (incorporated by reference, see Sec.  770.99).
    (2) Sample selection. (i) Samples must be randomly chosen by an EPA 
TSCA Title VI TPC.
    (ii) Samples must be selected from each certified product type for 
quarterly testing purposes. For hardwood plywood samples, the samples 
must be randomly selected from products that represent the range of 
formaldehyde emissions of products produced by the panel producer.

[[Page 425]]

    (iii) Samples must not include the top or the bottom composite wood 
product of a bundle.
    (iv) Test results may represent a single chamber value or, if using 
the ASTM D6007-14 apparatus, the average value of testing nine specimens 
representing evenly distributed portions of an entire panel. The nine 
specimens must be tested in groups of three specimens, resulting in 
three data points, which must be averaged to represent one test value 
for the panel those specimens represent.
    (3) Sample handling. Samples must be closely stacked or air-tight 
wrapped between the time of sample selection and the start of test 
conditioning. Samples must be labeled as such, signed by the EPA TSCA 
Title VI TPC, bundled air-tight, wrapped in polyethylene, protected by 
cover sheets, and promptly shipped to the TPC laboratory. Conditioning 
must begin as soon as possible, but no later than 30 calendar days after 
the samples were produced.
    (4) Results. Any sample that exceeds the applicable formaldehyde 
emission standard in Sec.  770.10 must be reported by the EPA TSCA Title 
VI TPC to the panel producer in writing and to EPA, in accordance with 
Sec.  770.8, within 72 hours. The panel producer must comply with Sec.  
770.22 with respect to any lot represented by a sample result that 
exceeds the applicable formaldehyde emission standard. Where multiple 
products are grouped in a single product type for testing, this includes 
all products in the group represented by the sample.
    (5) Reduced testing frequency. Composite wood products that have 
been approved by an EPA TSCA Title VI TPC or CARB for reduced testing 
under Sec.  770.18(c) need only undergo quarterly testing every six 
months.
    (d) Equivalence or correlation. Equivalence between ASTM E1333-14 
(incorporated by reference, see Sec.  770.99) and ASTM D6007-14 
(incorporated by reference, see Sec.  770.99) must be demonstrated by 
EPA TSCA Title VI TPCs at least once each year or whenever there is a 
significant change in equipment, procedure, or the qualifications of 
testing personnel, or reason to believe that the equivalence is no 
longer valid. Equivalence may be demonstrated between several similar 
model or size and construction ASTM E1333-14 (incorporated by reference, 
see Sec.  770.99) and ASTM D6007-14 (incorporated by reference, see 
Sec.  770.99) apparatuses located in the same EPA TSCA Title VI TPC 
laboratory. Once equivalence has been established for three consecutive 
years, equivalence must be demonstrated every two years or whenever 
there is a significant change in equipment, procedure, or the 
qualifications of testing personnel. Correlation between ASTM E1333-14 
(incorporated by reference, see Sec.  770.99) or, upon a showing of 
equivalence in accordance with paragraph (d) of this section, ASTM 
D6007-14 (incorporated by reference, see Sec.  770.99) and any other 
test method used for quality control testing must be demonstrated by EPA 
TSCA Title VI TPCs or panel producers, respectively, before the 
certification of composite wood products, and then whenever there is a 
significant change in equipment, procedure, the qualifications of 
testing personnel, or reason to believe that the correlation is no 
longer valid. Correlation may be established between several similar 
model or size and construction mill quality control test methods defined 
in paragraph (b)(1) of this section located at any one physical mill 
quality control testing laboratory to the EPA TSCA Title VI TPC's 
laboratory's ASTM E1333-14 (incorporated by reference, see Sec.  770.99) 
and/or ASTM D6007-14 (incorporated by reference, see Sec.  770.99) 
apparatus. If the TPC laboratory's ASTM E1333-14 or equivalent ASTM 
D6007-14 test chamber is used for panel producer quality control 
testing, no correlation as determined in paragraph (d)(2) of this 
section would be required. Equivalence and correlation sample selection 
should be conducted in accordance with paragraph (c)(2)(iv) of this 
section.
    (1) Equivalence between ASTM E1333-14 and ASTM D6007-14 when used by 
the TPC for quarterly testing. Equivalence must be demonstrated for at 
least five comparison sample sets in each range tested by the TPC, which 
compare the results of the two methods. Equivalence must be demonstrated 
for any ranges listed in paragraph (d)(1)(iv) of

[[Page 426]]

this section that represent the formaldehyde emissions of composite wood 
products tested by the TPC.
    (i) Samples. (A) For the ASTM E1333-14 method (incorporated by 
reference, see Sec.  770.99), each comparison sample must consist of the 
result of testing panels, using the applicable loading ratios specified 
in the ASTM E1333-14 method (incorporated by reference, see Sec.  
770.99), from similar panels of the same product type tested by the ASTM 
D6007-14 method (incorporated by reference, see Sec.  770.99).
    (B) For the ASTM D6007-14 method (incorporated by reference, see 
Sec.  770.99), each comparison sample shall consist of testing specimens 
representing portions of panels similar to the panels tested in the ASTM 
E1333-14 method (incorporated by reference, see Sec.  770.99) and 
matched to their respective ASTM E1333-14 method (incorporated by 
reference, see Sec.  770.99) comparison sample result. The ratio of air 
flow to sample surface area specified in ASTM D6007-14 (incorporated by 
reference, see Sec.  770.99) must be used.
    (C) The five comparison sample must consist of testing a minimum of 
five sample sets as measured by the ASTM E1333-14 method (incorporated 
by reference, see Sec.  770.99).
    (ii) Average and standard deviation. The arithmetic mean, x, and 
standard deviation, S, of the difference of all comparison sets must be 
calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR07FE18.001


Where x = arithmetic mean; S = standard deviation; n = number of sets; D 
i = difference between the ASTM E1333-14 and ASTM D6007-14 method 
(incorporated by reference, see Sec.  770.99) values for the i th set; 
and i ranges from 1 to n.
    (iii) Equivalence determination. The ASTM D6007-14 method 
(incorporated by reference, see Sec.  770.99) is considered equivalent 
to the ASTM E1333-14 method (incorporated by reference, see Sec.  
770.99) if the following condition is met:

[verbar]X[verbar] + 0.88S <= C

Where C is equal to:

0.026 for the lower range;
0.038 for the intermediate range; and
0.052 for the upper range.

    (iv) Equivalence Ranges. EPA TSCA Title VI TPCs must demonstrate 
equivalence in at least two of the three formaldehyde emission ranges 
listed in paragraphs (d)(1)(iv)(A) through (C) of this section unless 
the EPA TSCA Title VI TPC will only certify hardwood plywood products in 
the low range. If the EPA TSCA Title VI TPC will only certify hardwood 
plywood products in the low range, the EPA TSCA Title VI TPC may 
demonstrate equivalence in only that range and would then be restricted 
to only certifying those composite wood products in that range. 
Equivalence in one range must be demonstrated for at least five 
comparison sample sets in that range which compare the two methods.
    (A) Lower Range: Less than, or equal to 0.05 ppm.
    (B) Intermediate Range: Greater than 0.05 ppm to less than or equal 
to 0.15 ppm.
    (C) Upper Range: Greater than 0.15 ppm.
    (2) Correlation between ASTM E-1333-14 (incorporated by reference, 
see Sec.  770.99), or equivalent ASTM D6007-14 (incorporated by 
reference, see Sec.  770.99), and any quality control test method. 
Correlation must be demonstrated by establishing an acceptable 
correlation coefficient (``r'' value) or following the threshold 
approach at paragraph (d)(2)(i)(B) of this section.
    (i) Correlation. The correlation must be based on a minimum sample 
size of

[[Page 427]]

five data pairs and a simple linear regression (unless the threshold 
approach at paragraph (d)(2)(i)(B) of this section is used) where the 
dependent variable (Y-axis) is the quality control test value and the 
independent variable (X-axis) is the ASTM E1333-14 (incorporated by 
reference, see Sec.  770.99) test value or, upon a showing of 
equivalence in accordance with paragraph (d) of this section, the 
equivalent ASTM D6007-14 (incorporated by reference, see Sec.  770.99) 
test value. Either composite wood products or formaldehyde emissions 
reference materials can be used to establish the correlation.
    (A) Cluster Approach. A panel producer may work with its EPA TSCA 
Title VI TPC to develop a correlation and linear regression between the 
TPC's ASTM E1333-14 (incorporated by reference, see Sec.  770.99) or 
equivalent ASTM D6007-14 (incorporated by reference, see Sec.  770.99) 
test method and the panel producer's quality control method under 
paragraph (b) of this section. In the event of clustered test results, a 
panel producer may fit a line through a point near the origin (the 
intersection of the X and Y axes) and the average value of the clustered 
data pairs. The point near the origin should represent the value for the 
EPA TSCA Title VI TPC's ASTM E1333-14 (incorporated by reference, see 
Sec.  770.99) or equivalent ASTM D6007-14 (incorporated by reference, 
see Sec.  770.99) test method and the panel producer's quality control 
method under Sec.  770.20(b) when each testing apparatus is empty or 
when a very low emitting sample is tested. The average value of the 
clustered data pairs represents the average of a minimum of five data 
pairs that compare the test results of the EPA TSCA Title VI TPC's ASTM 
E1333-14 (incorporated by reference, see Sec.  770.99) or equivalent 
ASTM D6007-14 (incorporated by reference, see Sec.  770.99) test method 
with the panel producer's quality control method under paragraph (b) of 
this section. The line between the point near the origin and the average 
value of the cluster provides the linear regression. This line may be 
used by the panel producer and TPC to develop a quality control limit 
for the product.
    (B) Threshold Approach. As an alternative to the linear regression 
and cluster approaches, a panel producer may use the average value of 
the clustered data pairs from the EPA TSCA Title VI TPC's ASTM E1333-14 
(incorporated by reference, see Sec.  770.99) or equivalent ASTM D6007-
14 (incorporated by reference, see Sec.  770.99) test method and the 
panel producer's quality control method under paragraph (b) of this 
section as the quality control limit for the product. In this approach, 
no linear regression line is established. The average value would be 
assigned as the upper quality control limit for production of the 
subject composite wood product and must be below the applicable emission 
standard.
    (ii) Minimum acceptable correlation coefficients (``r'' values). The 
minimum acceptable correlation coefficients are as follows, where ``n'' 
is equal to the number of data pairs, and ``r'' is the correlation 
coefficient:

------------------------------------------------------------------------
                Degrees of freedom (n-2)                    ``r'' value
------------------------------------------------------------------------
3.......................................................           0.878
4.......................................................           0.811
5.......................................................           0.754
6.......................................................           0.707
7.......................................................           0.666
8.......................................................           0.632
9.......................................................           0.602
10 or more..............................................           0.576
------------------------------------------------------------------------

    (iii) Variation from previous results. If data from an EPA TSCA 
Title VI TPC's quarterly test results and a panel producer's quality 
control test results do not fit the previously established correlation, 
the panel producer must have its TPC establish a new correlation and new 
QCLs.
    (iv) Failed quarterly tests. If a panel producer fails two quarterly 
tests in a row for the same product type, the panel producer must have 
its TPC establish a new correlation curve.
    (e) Quality assurance and quality control requirements for panel 
producers. Panel producers are responsible for product compliance with 
the applicable emission standards.

[81 FR 89724, Dec. 12, 2016, as amended at 83 FR 5347, Feb. 7, 2018; 84 
FR 43524, Aug. 21, 2019; 88 FR 10477, Feb. 21, 2023]



Sec.  770.21  Quality control manual, facilities, and personnel.

    (a) Quality control manual. (1) Each panel producer must have a 
written

[[Page 428]]

quality control manual. The manual must contain, at a minimum, the 
following:
    (i) A description of the organizational structure of the quality 
control department, including the names of the quality control manager 
and quality control employees;
    (ii) A description of the sampling procedures to be followed;
    (iii) A description of the method of handling samples, including a 
specific maximum time period for analyzing quality control samples;
    (iv) A description of the frequency of quality control testing;
    (v) A description of the procedures used to identify changes in 
formaldehyde emissions resulting from production changes (e.g., increase 
in the percentage of resin, increase in formaldehyde/urea molar ratio in 
the resin, or decrease in press time);
    (vi) A description of provisions for additional testing;
    (vii) A description of recordkeeping procedures;
    (viii) A description of labeling procedures;
    (ix) The average percentage of resin and press time for each product 
type;
    (x) A description of product types, and if applicable, a description 
of product variables covered under each product type;
    (xi) Procedures for reduced quality control testing, if applicable; 
and
    (xii) Procedures for handling non-complying lots, including a 
description of how the panel producer will ensure compliance with the 
notification requirements of Sec.  770.22(d)(1).
    (2) The quality control manual must be approved by an EPA TSCA Title 
VI TPC.
    (b) Quality control facilities. Each panel producer must designate a 
quality control facility for conducting quality control formaldehyde 
testing.
    (1) The quality control facility must be an EPA TSCA Title VI TPC, a 
contract laboratory, or a laboratory owned and operated by the panel 
producer.
    (2) Each quality control facility must have quality control 
employees with adequate experience and/or training to conduct accurate 
chemical quantitative analytical tests. The quality control manager must 
identify each person conducting formaldehyde quality control testing to 
the EPA TSCA Title VI TPC.
    (c) Quality control manager. Each panel producer must designate a 
person as quality control manager with adequate experience and/or 
training to be responsible for formaldehyde emissions quality control. 
The quality control manager must:
    (1) Have the authority to take actions necessary to ensure that 
applicable formaldehyde emission standards are being met on an ongoing 
basis;
    (2) Be identified to the EPA TSCA Title VI TPC that will be 
overseeing the quality control testing. The panel producer must notify 
the EPA TSCA Title VI TPC in writing within ten calendar days of any 
change in the identity of the quality control manager and provide the 
EPA TSCA Title VI TPC with the new quality control manager's 
qualifications;
    (3) Review and approve all reports of quality control testing 
conducted on the production of the panel producer;
    (4) Ensure that the samples are collected, packaged, and shipped 
according to the procedures specified in the quality control manual; and
    (5) Inform the EPA TSCA Title VI TPC in writing of any significant 
changes in production that could affect formaldehyde emissions within 72 
hours of making those changes.



Sec.  770.22  Non-complying lots.

    (a) Non-complying lots are not certified composite wood products and 
they may not be sold, supplied or offered for sale in the United States 
except in accordance with this section.
    (b) Non-complying lots must be isolated from certified lots.
    (c) Non-complying lots must either be disposed of or retested and 
certified using the same test method, if each panel is treated with a 
scavenger or handled by other means of reducing formaldehyde emissions, 
such as aging. Tests must be performed as follows:
    (1) Quality control tests. (i) At least one test panel must be 
selected from each of three separate bundles. The panels must be 
selected so that they are representative of the entire non-complying lot 
and they are not the top or bottom panel of a bundle. The panels

[[Page 429]]

may be selected from properly stored samples set aside by the panel 
producer for retest in the event of a failure.
    (ii) All samples must test at or below the level that indicates that 
the product is in compliance with the applicable emission standards in 
Sec.  770.10.
    (2) Quarterly tests. (i) At least one test panel must be randomly 
selected so that it is representative of the entire non-complying lot 
and is not the top or bottom panel of a bundle. Panel sampling shall be 
conducted according to the quarterly testing procedure at Sec.  
770.20(c)(2)(iv). The panel may be selected from properly stored samples 
set aside by the panel producer for retest in the event of a failure.
    (ii) The average of the three samples or the single chamber value 
(as described in Sec.  770.20(c)(2)(iv)) must test at or below the level 
that indicates that the product is in compliance with the applicable 
emission standards in Sec.  770.10.
    (d) If composite wood products belonging to a non-complying lot have 
been shipped to a fabricator, importer, distributor, or retailer before 
the test results are received, the panel producer must:
    (1) Ensure that the composite wood products are not distributed 
further by notifying, within 72 hours of the time that the panel 
producer is made aware of the failing test result, the fabricators, 
importers, distributors, and retailers that received the composite wood 
products. The notification must include the following:
    (i) Panel producer name, contact information, and date of notice;
    (ii) A description of the composite wood products that belong to the 
non-complying lot that is sufficient to allow the fabricator, importer, 
distributor, or retailer to identify the products;
    (iii) Whether the failed test result was of a quarterly test, a 
quality control test, or a retest of composite wood products belonging 
to a non-complying lot;
    (iv) A statement that composite wood products belonging to the non-
complying lot must be isolated from other composite wood products and 
cannot be further distributed in commerce; and
    (v) A description of the steps the panel producer intends to take to 
either recall the composite wood products belonging to the non-complying 
lot or to treat and retest the products and certify the lot.
    (2) Do one of the following:
    (i) Recall the composite wood products belonging to the non-
complying lot and either treat and retest products belonging to the non-
complying lot or dispose of them; or
    (ii) Treat and retest composite wood products belonging to the non-
complying lot while they remain in possession of a fabricator, importer, 
distributor, or retailer.
    (e) Information on the disposition of non-complying lots, including 
product type and amount of composite wood products affected, lot 
numbers, mitigation measures used, results of retesting, and final 
disposition, must be provided to the EPA TSCA Title VI TPC within seven 
calendar days of final disposition.
    (f) Fabricators, importers, distributors, or retailers who are 
notified that they have received composite wood products belonging to a 
non-complying lot and who have further distributed the composite wood 
products are responsible for notifying the purchasers of the composite 
wood products in accordance with paragraph (d)(1) of this section.
    (1) If a fabricator, importer, distributor, or retailer is notified 
that they have been supplied a non-complying lot after those composite 
wood products have been fabricated into component parts or finished 
goods, the notification requirement at paragraph (d)(1) of this section 
does not apply.
    (2) [Reserved]

[81 FR 89724, Dec. 12, 2016, as amended at 84 FR 43525, Aug. 21, 2019]



Sec.  770.24  Samples for testing.

    (a) Composite wood products may be shipped into and transported 
across the United States for quality control or quarterly tests. TPCs 
that ship composite panels into or across the United States solely for 
quality control or quarterly tests are not considered importers or 
distributors or importers for the purposes of Sec.  770.7(c)(3)(i).

[[Page 430]]

    (1) Such panels must not be sold, offered for sale or supplied to 
any entity other than a TPC laboratory before testing in accordance with 
Sec.  770.17, Sec.  770.18, or Sec.  770.20.
    (2) If test results for such products demonstrate compliance with 
the emission standards in this subpart, the panels may be relabeled in 
accordance with Sec.  770.45 and sold, offered for sale, or supplied.
    (b) [Reserved]



Sec.  770.30  Importers, fabricators, distributors, and retailers.

    (a) Importers, fabricators, distributors, and retailers must take 
reasonable precautions to ensure that the composite wood products they 
sell, supply, offer for sale, or hold for sale, whether in the form of 
panels, component parts, or finished goods, comply with the emission 
standards and other requirements of this subpart.
    (b) Importers must demonstrate that they have taken reasonable 
precautions by maintaining, for three years, bills of lading, invoices, 
or comparable documents that include a written statement from the 
supplier that the composite wood products, component parts, or finished 
goods are TSCA Title VI compliant or were produced before June 1, 2018 
and by ensuring the following records are made available to EPA within 
30 calendar days of request:
    (1) Records identifying the panel producer and the date the 
composite wood products were produced; and
    (2) Records identifying the supplier, if different, and the date the 
composite wood products, component parts, or finished goods were 
purchased.
    (c) Fabricators, distributors, and retailers must demonstrate that 
they have taken reasonable precautions by obtaining bills of lading, 
invoices, or comparable documents that include a written statement from 
the supplier that the composite wood products, component parts, or 
finished goods are TSCA Title VI compliant or that the composite wood 
products were produced before June 1, 2018.
    (d) Beginning March 22, 2019, importers of articles that are 
regulated composite wood products, or articles that contain regulated 
composite wood products, must comply with the import certification 
regulations for ``Chemical Substances in Bulk and As Part of Mixtures 
and Articles,'' as found at 19 CFR 12.118 through 12.127.
    (e) Records required by this section must be maintained in 
accordance with Sec.  770.40(d).

[81 FR 89724, Dec. 12, 2016, as amended at 82 FR 44537, Sept. 25, 2017; 
84 FR 43525, Aug. 21, 2019]



Sec.  770.40  Reporting and recordkeeping.

    (a) Panel producers must maintain the following records for a period 
of three years, except that records demonstrating initial eligibility 
for reduced testing or third-party certification exemption under Sec.  
770.17 or Sec.  770.18 must be kept for as long as the panel producer is 
producing composite wood products with reduced testing or under a third-
party certification exemption. The following records must also be made 
available to the panel producers' EPA TSCA Title VI TPCs. Panel 
producers must make the records described in paragraph (a)(1) of this 
section available to direct purchasers of their composite wood products. 
This information may not be withheld from direct purchasers as 
confidential business information.
    (1) Records of all quarterly emissions testing. These records must 
identify the EPA TSCA Title VI TPC conducting or overseeing the testing. 
These records must also include the date, the product type tested, the 
lot number that the tested material represents, the test method used, 
and the test results.
    (2) Records of all ongoing quality control testing. These records 
must identify the EPA TSCA Title VI TPC conducting or overseeing the 
testing and the facility actually performing the testing. These records 
must also include the date, the product type tested, the lot number that 
the tested material represents, the test method used, and the test 
results.
    (3) Production records, including a description of the composite 
wood product(s), the date of manufacture, lot numbers, and tracking 
information allowing each product to be traced to a specific lot 
produced.

[[Page 431]]

    (4) Records of changes in production, including changes of more than 
ten percent in the resin use percentage, changes in resin composition 
that result in a higher ratio of formaldehyde to other resin components, 
and changes in the process, such as changes in press time by more than 
20%.
    (5) Records demonstrating initial and continued eligibility for the 
reduced testing provisions in Sec. Sec.  770.17 and 770.18, if 
applicable. These records must include:
    (i) Approval for reduced testing from an EPA TSCA Title VI TPC or 
CARB;
    (ii) Amount of resin use reported by volume and weight;
    (iii) Production volume reported as square feet per product type;
    (iv) Resin trade name, resin manufacturer contact information (name, 
address, phone number, and email), and resin supplier contact 
information (name, address, phone number, and email); and
    (v) Any changes in the formulation of the resin.
    (6) Purchaser information for each composite wood product, if 
applicable, including the name, contact person if available, address, 
telephone number, email address if available, purchase order or invoice 
number, and amount purchased.
    (7) Transporter information for each composite wood product, if 
applicable, including name, contact person, address, telephone number, 
email address if available, and shipping invoice number.
    (8) Information on the disposition of non-complying lots, including 
product type and amount of composite wood products affected, lot 
numbers, purchasers who received product belonging to non-complying lots 
(if any), copies of purchaser notifications used (if any), mitigation 
measures used, results of retesting, and final disposition.
    (9) Representative copies of labels used.
    (b) Panel producers must provide their EPA TSCA Title VI TPC with 
monthly product data reports for each production facility, production 
line, and product type, maintain copies of the reports for a minimum of 
three years from the date that they are produced. Monthly product data 
reports must contain a data sheet for each specific product type with 
test and production information, and a quality control graph containing 
the following:
    (1) QCL;
    (2) Shipping QCL (if applicable);
    (3) Results of quality control tests; and
    (4) Retest values.
    (c) Laminated product producers whose products are exempt from the 
definition of hardwood plywood must keep records demonstrating 
eligibility for the exemption. These records must be kept for a minimum 
of three years from the date they are produced and must include:
    (1) Resin trade name, resin manufacturer contact information (name, 
address, phone number, and email), resin supplier contact information 
(name, address, phone number, and email), and resin purchase records;
    (2) Panel producer contact information and panel purchase records;
    (3) For panels produced in-house, records demonstrating that the 
panels have been certified by an EPA TSCA Title VI TPC; and
    (4) For resins produced in-house, records demonstrating the 
production of phenol-formaldehyde resins or resins formulated with no 
added formaldehyde as part of the resin cross-linking structure.
    (d) Importers, fabricators, distributors, and retailers must 
maintain the records described in Sec.  770.30 for a minimum of three 
years from the import date or the date of the purchases or shipments 
described therein.



Sec.  770.45  Labeling.

    (a) Panels or bundles of panels that are imported, sold, supplied, 
or offered for sale in the United States must be labeled with the panel 
producer's name, the lot number, the number of the EPA TSCA Title VI 
TPC, and a statement that the products are TSCA Title VI certified. If a 
composite wood panel is not individually labeled, the panel producer, 
importer, distributor, fabricator, or retailer must have a method (e.g., 
color-coded edge marking) sufficient to identify the supplier of the 
panel and linking the information on the label to the products. This 
information must be made available to

[[Page 432]]

potential customers upon request. The label may be applied as a stamp, 
tag, or sticker.
    (1) A panel producer number may be used instead of a name to protect 
identity, so long as the identity of the panel producer can be 
determined at the request of EPA.
    (2) Only panels or bundles of panels manufactured in accordance with 
Sec.  770.17 may also be labeled that they were made with no-added 
formaldehyde-based resins in addition to the other information required 
by this section.
    (3) Only panels or bundles of panels manufactured in accordance with 
Sec.  770.18 may also be labeled that they were made with ultra low-
emitting formaldehyde resins in addition to the other information 
required by this section.
    (b) Panels imported into or transported across the United States for 
quarterly or quality control testing purposes in accordance with Sec.  
770.20 must be labeled ``For TSCA Title VI testing only, not for sale in 
the United States.'' The panels may be re-labeled if test results are 
below the applicable emission standards in this subpart.
    (c) Fabricators of finished goods containing composite wood products 
must label every finished good they produce or every box or bundle 
containing finished goods. If a finished good (including component parts 
sold separately to end users) is not individually labeled, the importer, 
distributor, or retailer must retain a copy of the label, be able to 
identify the products associated with that label, and make the label 
information available to potential customers upon request.
    (1) The label may be applied as a stamp, tag, or sticker.
    (2) The label must include, at a minimum, in legible English text, 
the fabricator's name, the date the finished good was produced (in 
month/year format), and a statement that the finished goods are TSCA 
Title VI compliant.
    (3) Finished goods made from panels manufactured in accordance with 
Sec.  770.17 and/or Sec.  770.18 may also be labeled that they were made 
with no-added formaldehyde-based resins, or ultra low-emitting 
formaldehyde resins in addition to the other information required by 
this section. They may be labeled as being made with a combination of 
compliant composite wood, no-added formaldehyde-based resins, and ultra 
low-emitting formaldehyde resins, if this is accurate.
    (4) Fabricators may substitute the name of a responsible downstream 
fabricator, importer, distributor, or retailer for their name on the 
label if they obtain and maintain written consent from the downstream 
entity.
    (d) Importers, distributors, and retailers must leave intact labels 
on finished goods, including component parts sold separately to end 
users.
    (e) Finished goods, including component parts sold separately to end 
users, containing only a de minimis amount of regulated composite wood 
product are excepted from the labeling requirements. A finished good, 
including component parts sold directly to consumers, contains a de 
minimis amount of regulated composite wood product if its regulated 
composite wood product content does not exceed 144 square inches, based 
on the surface area of its largest face. The exception does not apply to 
finished goods or component parts that are designed to be used in 
combination or in multiples to create larger surfaces, finished goods, 
or component parts.
    (f) All panels (or bundles of panels) and finished goods (or boxes 
or bundles containing finished goods) must be properly labeled pursuant 
to paragraphs (a), (b), and (c) of this section before being imported 
into the United States, except as provided in paragraph (e) of this 
section.

[81 FR 89724, Dec. 12, 2016, as amended at 82 FR 31924, July 11, 2017; 
84 FR 43526, Aug. 21, 2019]



                  Subpart D_Incorporation by Reference



Sec.  770.99  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than 
that specified in this section, the Environmental Protection Agency 
(EPA) must publish a document in the Federal Register

[[Page 433]]

and the material must be available to the public. All approved 
incorporation by reference (IBR) material is available for inspection at 
the EPA and at the National Archives and Records Administration (NARA). 
Contact EPA at: OPPT Docket in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
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. For information on the availability of 
this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-
locations.html or email [email protected]. The material may be 
obtained from the following sources:
    (a) APA. APA--The Engineered Wood Association, 7011 S 19th Street, 
Tacoma, WA 98466-5333; (253) 565-6600; www.apawood.org.
    (1) ANSI A190.1-2017, Standard for Wood Products--Structural Glued 
Laminated Timber, Approved January 24, 2017; IBR approved for Sec.  
770.1(c).
    (2) [Reserved]
    (b) ASTM. ASTM International, 100 Barr Harbor Dr., P.O. Box C700, 
West Conshohocken, PA 19428-2959; (877) 909-ASTM; www.astm.org.
    (1) ASTM D5055-19e1, Standard Specification for Establishing and 
Monitoring Structural Capacities of Prefabricated Wood I-Joists, 
Approved March 1, 2019; IBR approved for Sec.  770.1(c).
    (2) ASTM D5456-21e1, Standard Specification for Evaluation of 
Structural Composite Lumber Products, Approved February 1, 2021; IBR 
approved for Sec.  770.1(c).
    (3) ASTM D5582-14, Standard Test Method for Determining Formaldehyde 
Levels from Wood Products Using a Desiccator, Approved August 1, 2014; 
IBR approved for Sec.  770.20(b).
    (4) ASTM D6007-14, Standard Test Method for Determining Formaldehyde 
Concentrations in Air from Wood Products Using a Small-Scale Chamber, 
Approved October 1, 2014; IBR approved for Sec. Sec.  770.3; 770.7(a) 
through (c); 770.15(c); 770.17(a); 770.18(a); 770.20(b) through (d).
    (5) ASTM E1333-14, Standard Test Method for Determining Formaldehyde 
Concentrations in Air and Emission Rates from Wood Products Using a 
Large Chamber, Approved October 1, 2014; IBR approved for Sec. Sec.  
770.3; 770.7(a) through (c); 770.10(b); 770.15(c); 770.17(a); 770.18(a); 
770.20(c) and (d).
    (c) BSI. British Standards Institute, 12950 Worldgate Dr., Suite 
800, Herndon, VA 20170; (800) 862-4977; www.bsigroup.com.
    (1) BS EN ISO 12460-3:2020, Wood-based panels.--Determination of 
formaldehyde release--Part 3: Gas analysis method, Published 31 October 
2020; IBR approved for Sec.  770.20(b).
    (2) BS EN ISO 12460-5:2015 E, Wood based panels.--Determination of 
formaldehyde release--Part 5: Extraction method (called the perforator 
method), December 2015; IBR approved for Sec.  770.20(b).
    (d) CPA. Composite Panel Association, 19465 Deerfield Avenue, Suite 
306, Leesburg, Virginia 20176; (703) 724-1128; www.compositepanel.org.
    (1) ANSI A135.4-2012, Basic Hardboard, Approved June 8, 2012; IBR 
approved for Sec.  770.3.
    (2) ANSI A135.5-2012, Prefinished Hardboard Paneling, Approved March 
29, 2012; IBR approved for Sec.  770.3.
    (3) ANSI A135.6-2012, Engineered Wood Siding, Approved June 5, 2012; 
IBR approved for Sec.  770.3.
    (4) ANSI A135.7-2012, Engineered Wood Trim, Approved July 17, 2012; 
IBR approved for Sec.  770.3.
    (5) ANSI A208.1-2022, Particleboard, Approved June 22, 2022; IBR 
approved for Sec.  770.3.
    (6) ANSI A208.2-2022, Medium Density Fiberboard (MDF) for Interior 
Applications, Approved April 14, 2022; IBR approved for Sec.  770.3.
    (e) Georgia Pacific. Georgia-Pacific Chemicals LLC, 133 Peachtree 
Street, Atlanta, GA 30303; (877) 377-2737; www.gp.com.
    (1) The Dynamic Microchamber computer integrated formaldehyde test 
system, User Manual, revised March 2007 (DMC 2007 User's Manual); IBR 
approved for Sec.  770.20(b).
    (2) The GP Dynamic Microchamber Computer-integrated formaldehyde

[[Page 434]]

test system, User Manual, copyright 2012 (DMC 2012 GP User's Manual); 
IBR approved for Sec.  770.20(b).
    (f) HPVA. Decorative Hardwoods Association (formerly known as 
Hardwood Plywood and Veneer Association (HPVA)), 42777 Trade West Dr., 
Sterling, VA 20166; (703) 435-2900; www.decorativehardwoods.org.
    (1) ANSI/HPVA HP-1-2020, American National Standard for Hardwood and 
Decorative Plywood, Approved August 17, 2020; IBR approved for Sec.  
770.3.
    (2) [Reserved]
    (g) ISO. International Organization for Standardization, 1, ch. de 
la Voie- Creuse, CP 56, CH-1211, Geneve 20, Switzerland; +41-22-749-01-
11; www.iso.org.
    (1) ISO 12460-3:2020(E), Wood-based panels--Determination of 
formaldehyde release--Part 3: Gas analysis method, Third edition, 
October 2020; IBR approved for Sec.  770.20(b).
    (2) ISO/IEC 17011:2017(E) Conformity assessments--Requirements for 
accreditation bodies accrediting conformity assessments bodies (Second 
Edition), November 2017; IBR approved for Sec. Sec.  770.3; 770.7(a) and 
(b).
    (3) ISO/IEC 17020:2012(E), Conformity assessment--Requirements for 
the operation of various bodies performing inspection, Second edition, 
2012-03-01; IBR approved for Sec. Sec.  770.3; 770.7(a) through (c).
    (4) ISO/IEC 17025:2017(E), General requirements for the competence 
of testing and calibration laboratories (Third Edition), November 2017; 
IBR approved for Sec. Sec.  770.3; 770.7(a) through (c).
    (5) ISO/IEC 17065:2012(E), Conformity assessment--Requirements for 
bodies certifying products, processes and services, First edition, 2012-
09-15; IBR approved for Sec. Sec.  770.3; 770.7(a) and (c).
    (h) Japanese Standards Association. Japanese Industrial Standards, 
1-24, Akasaka 4, Minatoku, Tokyo 107- 8440, Japan; +81-3-3583-8000; 
www.jsa.or.jp/en/.
    (1) JIS A 1460:2021(E), Determination of the emission of 
formaldehyde from building boards--Desiccator method, First English 
edition, November 2021; IBR approved for Sec.  770.20(b).
    (2) [Reserved]
    (i) NIST. National Institute of Standards and Technology, Public 
Inquiries Unit, NIST, 100 Bureau Dr., Stop 1070, Gaithersburg, MD 20899-
1070; (301) 975-NIST or (800) 553-6847; www.nist.gov.
    (1) PS 1-19, Structural Plywood, Effective December 1, 2019; IBR 
approved for Sec. Sec.  770.1(c); 770.3.
    (2) PS 2-18, Performance Standard for Wood Structural Panels, March 
2019; IBR approved for Sec. Sec.  770.1(c); 770.3.

    Note 1 to paragraph (i): To purchase paper copies from NIST, call 
(301) 975-NIST for an order number. To purchase paper copies from GPO 
(with a stock number), mail: U.S. Government Publishing Office, P.O. Box 
979050, St. Louis, MO 63197-9000; call: (866) 512-1800 or (DC Area only: 
(202) 512-1800); fax (202) 512-2104.

[88 FR 10477, Feb. 21, 2023]

                        PARTS 771	789 [RESERVED]

[[Page 435]]



                              FINDING AIDS




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

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 437]]



                    Table of CFR Titles and Chapters




                      (Revised as of July 1, 2023)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--599)
        VI  National Capital Planning Commission (Parts 600--699)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Guidance (Parts 200--
                299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300--
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
         X  Department of the Treasury (Parts 1000--1099)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Department of Housing and Urban Development (Parts 
                2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)

[[Page 438]]

     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)
      XXIX  Department of Labor (Parts 2900--2999)
       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
     XXXVI  Office of National Drug Control Policy, Executive 
                Office of the President (Parts 3600--3699)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)
       LIX  Gulf Coast Ecosystem Restoration Council (Parts 5900--
                5999)
        LX  Federal Communications Commission (Parts 6000--6099)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
        IV  Office of Personnel Management and Office of the 
                Director of National Intelligence (Parts 1400--
                1499)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)

[[Page 439]]

      XXVI  Department of Defense (Parts 3600--3699)
    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)
    XXXIII  U.S. International Development Finance Corporation 
                (Parts 4300--4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
     XXXVI  Department of Homeland Security (Parts 4600--4699)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)

[[Page 440]]

    LXXIII  Department of Agriculture (Parts 8300--8399)
     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (Parts 9600--
                9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
    XCVIII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)
      XCIX  Military Compensation and Retirement Modernization 
                Commission (Parts 9900--9999)
         C  National Council on Disability (Parts 10000--10049)
        CI  National Mediation Board (Parts 10100--10199)
       CII  U.S. Office of Special Counsel (Parts 10200--10299)
       CIV  Office of the Intellectual Property Enforcement 
                Coordinator (Part 10400--10499)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--199)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)

[[Page 441]]

      VIII  Agricultural Marketing Service (Federal Grain 
                Inspection Service, Fair Trade Practices Program), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)
       XVI  [Reserved]
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  [Reserved]
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]

[[Page 442]]

      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)
         L  Rural Business-Cooperative Service, and Rural 
                Utilities Service, Department of Agriculture 
                (Parts 5000--5099)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)
        II  Agricultural Marketing Service (Fair Trade Practices 
                Program), Department of Agriculture (Parts 200--
                299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  [Reserved]
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  (Parts 900--999)[Reserved]

[[Page 443]]

         X  Consumer Financial Protection Bureau (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research, Department of the 
                Treasury (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)

[[Page 444]]

      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  National Technical Information Service, Department of 
                Commerce (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
        XV  Office of the Under-Secretary for Economic Affairs, 
                Department of Commerce (Parts 1500--1599)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399) [Reserved]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599) [Reserved]

[[Page 445]]

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  United States Agency for Global Media (Parts 500--599)
       VII  U.S. International Development Finance Corporation 
                (Parts 700--799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

[[Page 446]]

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)
        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799) 
                [Reserved]
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799) [Reserved]

[[Page 447]]

        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099) [Reserved]
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--899)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900--999)
        VI  Office of the Assistant Secretary, Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--799)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)

[[Page 448]]

        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)
      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance

[[Page 449]]

         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of Investment Security, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)
         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Department of Defense, Defense Logistics Agency (Parts 
                1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army, Department 
                of Defense (Parts 200--399)
        IV  Great Lakes St. Lawrence Seaway Development 
                Corporation, Department of Transportation (Parts 
                400--499)

[[Page 450]]

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Career, Technical, and Adult Education, 
                Department of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599) 
                [Reserved]
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  [Reserved]
       XII  National Council on Disability (Parts 1200--1299)

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  U.S. Copyright Office, Library of Congress (Parts 
                200--299)

[[Page 451]]

       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  National Institute of Standards and Technology, 
                Department of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)
       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)
      VIII  Gulf Coast Ecosystem Restoration Council (Parts 1800--
                1899)
        IX  Federal Permitting Improvement Steering Council (Part 
                1900)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  (Parts 103-001--104-099) [Reserved]
       105  General Services Administration (Parts 105-1--105-999)

[[Page 452]]

       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Federal Acquisition Supply Chain Security
       201  Federal Acquisition Security Council (Parts 201-1--
                201-99).
            Subtitle E [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
   II--III  [Reserved]
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--699)
         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1099)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

[[Page 453]]

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
        IX  Denali Commission (Parts 900--999)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Administration for Children and Families, Department 
                of Health and Human Services (Parts 1300--1399)
       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission of Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Parts 2300--2399)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

[[Page 454]]

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)
         V  The First Responder Network Authority (Parts 500--599)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Department of Health and Human Services (Parts 300--
                399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)
        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)

[[Page 455]]

        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199) [Reserved]
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)
         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)

[[Page 456]]

        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

[[Page 457]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of July 1, 2023)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     5, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, VIII, IX, X, XI; 9, 
                                                  II
Agricultural Research Service                     7, V
Agriculture, Department of                        2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, VIII, IX, X, XI; 9, 
                                                  II
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV
  Rural Utilities Service                         7, XVII, XVIII, XLII
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force, Department of                          32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII
Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
   Compliance Board
[[Page 458]]

Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI; 38, II
Army, Department of                               32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Benefits Review Board                             20, VII
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
  Federal Acquisition Regulation                  48, 19
Career, Technical, and Adult Education, Office    34, IV
     of
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazard Investigation Board    40, VI
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X, XIII
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce, Department of                           2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Affairs, Office of the Under-          15, XV
       Secretary for
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II; 37, IV
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Technical Information Service          15, XI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Secretary of Commerce, Office of                15, Subtitle A
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
     for the District of Columbia
Customs and Border Protection                     19, I
Defense, Department of                            2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III; 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I

[[Page 459]]

  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy, Department of                             32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
Denali Commission                                 45, IX
Disability, National Council on                   5, C; 34, XII
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Affairs, Office of the Under-Secretary   15, XV
     for
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Career, Technical, and Adult Education, Office  34, IV
       of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Policy, National Commission for        1, IV
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Environmental Quality, Council on               40, V
  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         2, XXXVI; 21, III
  National Security Council                       32, XXI; 47, II
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
     States
[[Page 460]]

Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Acquisition Security Council              41, 201
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 2, LX; 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Permitting Improvement Steering Council   40, IX
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission of                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV
Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5

[[Page 461]]

  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Great Lakes St. Lawrence Seaway Development       33, IV
     Corporation
Gulf Coast Ecosystem Restoration Council          2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X, XIII
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 5, XXXVI; 6, I; 8, 
                                                  I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V
Independent Counsel, Office of                    28, VII
Independent Counsel, Offices of                   28, VI
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II

[[Page 462]]

Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Intellectual Property Enforcement Coordinator,    5, CIV
     Office of
Inter-American Foundation                         5, LXIII; 22, X
Interior, Department of                           2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Safety and Environmental Enforcement, Bureau    30, II
       of
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Development Finance Corporation,    5, XXXIII; 22, VII
     U.S.
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice, Department of                            2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Independent Counsel, Offices of                 28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor, Department of                              2, XXIX; 5, XLII
  Benefits Review Board                           20, VII
  Employee Benefits Security Administration       29, XXV
  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Federal Acquisition Regulation                  48, 29

[[Page 463]]

  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I, VI
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Libraries and Information Science, National       45, XVII
     Commission on
Library of Congress                               36, VII
  Copyright Royalty Board                         37, III
  U.S. Copyright Office                           37, II
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Military Compensation and Retirement              5, XCIX
     Modernization Commission
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV, VI
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           2, XXXVI; 21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Geospatial-Intelligence Agency           32, I
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II; 37, IV
National Intelligence, Office of Director of      5, IV; 32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          5, CI; 29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI
National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI; 47, II

[[Page 464]]

National Technical Information Service            15, XI
National Telecommunications and Information       15, XXIII; 47, III, IV, V
     Administration
National Transportation Safety Board              49, VIII
Natural Resource Revenue, Office of               30, XII
Natural Resources Conservation Service            7, VI
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy, Department of                               32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, IV, XXXV; 45, VIII
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Privacy and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Contracts, Department of Labor             41, 50
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Safety and Environmental Enforcement, Bureau of   30, II
Science and Technology Policy, Office of          32, XXIV; 47, II
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State, Department of                              2, VI; 22, I; 28, XI

[[Page 465]]

  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Tennessee Valley Authority                        5, LXIX; 18, XIII
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Great Lakes St. Lawrence Seaway Development     33, IV
       Corporation
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury, Department of the                       2, X; 5, XXI; 12, XV; 17, 
                                                  IV; 31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
Truman, Harry S. Scholarship Foundation           45, XVIII
United States Agency for Global Media             22, V
United States and Canada, International Joint     22, IV
     Commission
United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
U.S. Copyright Office                             37, II
U.S. Office of Special Counsel                    5, CII
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs, Department of                   2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I, VII
World Agricultural Outlook Board                  7, XXXVIII

[[Page 467]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2018 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.govinfo.gov. For changes to this volume of the 
CFR prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 
1964-1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. 
The ``List of CFR Sections Affected 1986-2000'' is available at 
www.govinfo.gov.

                                  2018

40 CFR
                                                                   83 FR
                                                                    Page
Chapter I
723.175 Revised....................................................52719
725.25 (i) added...................................................52723
725.33 (a)(9) and (10) revised.....................................52723
770.1 (c)(3), (4), (5), (7), and (8) revised........................5345
770.3 Amended.......................................................5345
770.7 (a)(5)(i)(A) introductory text, (b)(1)(iv), (c)(1)(iii), 
        (2)(v), and (4)(i)(F) amended; (a)(5)(i)(D), (F), 
        (b)(5)(i) introductory text, (c)(1)(ii), (v), (2)(iv), 
        (viii), (4)(i)(B), and (v)(C) revised.......................5346
770.10 (b) introductory text revised................................5347
770.15 (c)(1)(v) and (2)(iii) revised...............................5347
770.17 (a)(3) revised...............................................5347
770.18 (a)(3) revised...............................................5347
770.20 (b)(1)(i), (ii), (iii), (vi), (vii), (c)(1), (d) 
        introductory text, (1), (2) introductory text, and (i) 
        revised.....................................................5347
770.99 (a) introductory text, (5) through (8), (b)(1) through (5), 
        (c)(1), (2), (f)(1), (g)(1), and (2) revised................5348

                                  2019

40 CFR
                                                                   84 FR
                                                                    Page
Chapter I
745.65 (b) revised.................................................32648
745.227 (h)(3)(i) revised..........................................32648
745.325 (e) revised................................................32648
751 Added..........................................................11435
763.80--763.99 (Subpart E) Appendix C amended...............34070, 44232
763.80--763.99 (Subpart E) Appendix D amended...............34070, 44233
770.2 (e) introductory text, (1), and (4) revised..................43523
770.3 Amended......................................................43524
770.7 (a)(1)(ii), (5)(i)(F), (ii), (b)(1)(ii), (iii), (5)(i) 
        introductory text, (A), (ii), (c)(1)(ii), and (2)(iv) 
        amended; (c)(4)(v)(C) revised..............................43524
770.10 (a) revised.................................................43524
770.12 (a) revised.................................................43524
770.15 (a), (c)(1)(vii), and (2)(v) revised........................43524
770.17 (a)(4) revised..............................................43524
770.18 (a)(4) revised..............................................43524
770.20 (c)(2)(iv) and (d)(1)(iv) added; (d) introductory text, (1) 
        introductory text, (2) introductory text, and (i) revised 
                                                                   43524
770.22 (c)(2)(i) and (ii) revised; (f)(1) and (2) added............43525
770.30 (b) introductory text and (c) revised.......................43525

[[Page 468]]

770.45 (a) introductory text revised; (f) added....................43526
770.99 (e)(1) and (3) revised......................................43526

                                  2020

40 CFR
                                                                   85 FR
                                                                    Page
Chapter I
725.3 Amended......................................................13772
725.420 (k) and (l) added..........................................13772

                                  2021

40 CFR
                                                                   86 FR
                                                                    Page
Chapter I
725.1079 Added; eff. 7-6-21........................................24336
725.1080 Added.....................................................22875
745.223 Amended......................................................994
745.227 (e)(8)(viii) revised.........................................994
751.401--751.413 (Subpart E) Added...................................879
751.403 Amended.......................................894, 909, 922, 932
751.405 Added........................................................894
751.407 Added........................................................909
751.407 (a)(2)(iii) added; (d)(4) revised..........................51832
751.411 Added........................................................922
751.413 Added........................................................932

                                  2022

40 CFR
                                                                   87 FR
                                                                    Page
Chapter I
723.50 (a)(1) introductory text and (e)(2)(xi)(A) revised; 
        (e)(2)(xiii) added.........................................39769
723.50 Correction: Technical correction............................47103
723.250 (e)(3) Table 1 and (j)(1) amended..........................39769
725.1081 Added.....................................................73955
751.407 (a)(2)(iii) and (d)(4) amended; (e)(3)(i) through (iii) 
        revised....................................................12886

                                  2023

   (Regulations published from January 1, 2023, through July 1, 2023)

40 CFR
                                                                   88 FR
                                                                    Page
Chapter I
723.50 (l) revised; eff. 8-7-23....................................37173
723.250 (f) introductory text and (n) revised; eff. 8-7-23.........37173
725.80 Revised; eff. 8-7-23........................................37173
725.85 Removed; eff. 8-7-23........................................37173
725.92 Removed; eff. 8-7-23........................................37174
725.94 Removed; eff. 8-7-23........................................37174
725.95 Revised; eff. 8-7-23........................................37174
725.190 (c) revised; (e) and (f) added; eff. 8-7-23................37174
770.1 (c)(3) through (5) and (8) revised...........................10476
770.3 Amended......................................................10476
770.4 (b)(2) revised...............................................10476
770.7 (a)(5)(i)(A) introductory text, (c)(1)(iii), (2)(v), 
        (4)(i)(F), (viii)(A) introductory text, and (3) revised; 
        (c)(4)(i)(G) added.........................................10476
770.15 (c)(1)(viii) revised........................................10477
770.17 (c)(2) revised..............................................10477
770.18 (d)(2) revised..............................................10477
770.20 (a)(1), (b)(1)(iii), (vii), and (d)(1)(iii) revised.........10477
770.99 Revised.....................................................10477


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